Medical Negligence
Medical Negligence
RIGHT TO HEALTH
TITLE
MEDICAL NEGLIGENCE
The determination and study of medical professional performance in the ordinary exercise of their
activity aims to determine who is responsible for proving the facts in the
that is based on a possible professional negligence, and then, in case that is so,
the effects of the test must be determined
It is very important to know that there are many medical negligence cases that focus on fields
different doctors in the family, administrative, and not just in medical practice, many
Patients believe that it is only a matter belonging to surgery and mistakes made by the surgeon.
And it is not so since the fact that a service is denied both at the first level and at the third is
considered a fault.
That a patient is misdiagnosed by their doctor or a hospital, if they receive the diagnosis
wrong they also receive the wrong treatment plan can have as
result death.
Patients and their families may seek a form of compensation for suffering the loss, with
the help of qualified lawyers for medical malpractice.
Having proper records and documentation is an absolute duty when it comes to negligence.
medical. Many patients find themselves in a long legal journey when it comes to lawsuits.
for professional medical negligence. The insurance carriers that cover doctors with insurance
negligence: the more documentation a patient has, the better. Such paperwork
You can demonstrate essential evidence in the room. All exams, X-rays, and documents.
that belong to the diagnosis and additional treatment, the diaries that document the
patient experience with the doctor and other critical documents must be at hand and
prepared.
* Secretariat of Health (Mexico). Health Statistics 2000. Public Health Mexico Sep-Oct 2001;
43(5):494-510.
Coordinate the design and execution of the Equality of Opportunity Plan for patients in
Chiapas, with the government agencies, as well as with active and committed participation
from the social sector.
Design and propose public policies that guarantee the full exercise of rights.
of the patient, through plans, programs, and actions with a gender perspective.
Integrate diagnostics and studies with a gender perspective that allow for a comprehensive view.
updated on the medical issues in the municipalities of the state in general.
Develop and execute programs of public or private institutions, coordinating with the
regulatory policies for access to programs, as well as promoting the efficient integration of
the perspective of medical care and attention in government programs.
Call on the various civil and social organizations, as well as the academic sectors and
educational in order to develop proposals, plans, and programs to improve the quality of life of the
patients.
Propose strategies for directing resources to projects that contribute to
improvement of the economic, political, cultural, and social conditions of people
concentrating efforts and resources on the sectors with the greatest lag in the entity.
To influence the mass media with the aim of combating stereotypes and
images that violate the dignity of the human being.
* Develop an Annual Operating Program that serves as a permanent link with the
dependencies of the State Executive, the social and academic sectors, in order to maintain
updated the system of registration and tracking of the actions taken in the State
favor of the people.
Foster and widely spread a culture of non-violence towards equality and respect among
genres.
Promote respect for cultural diversity within the framework of the recognition of Rights
of the human being.
The others established by laws, rules, and regulations or entrusted to it by the head of the
of health.
Official Mexican Standard NOM-178-SSA1-1998, which establishes the minimum requirements for
infrastructure and equipment of establishments for the medical care of patients. Daily
Official of the Federation, December 14, 1998.
JUSTIFICATION
It is well known both in the world of Medicine and in that of Law and, in general, in the
current society, the problem of medical malpractice or medical negligence and the importance of
same, for reasons that we will try to analyze and that take up a lot of space in daily work of
exercise of medicine; currently health is not considered a privilege, but a right, to
the doctor is considered a professional (technician) and not as a magician, their image has been
deteriorated and, consequently, its credibility, it is very important that when we speak
We are not only talking about medical negligence but also about all the personnel that provides a service already.
sea doctor, nurse, laboratory technicians, radiologist, specialist, stretcher bearer and this not only not
it refers to a bad surgery if it is not from the denial of services from the first level to the
third level from an appointment etc.
That is why the legislation behaves this way regarding it; it is somewhat indefinite and poor, the problems
The issues that arise have their legal norm, but are very variable depending on the different bodies.
jurisdictional and, therefore, with non-uniform criteria that lead to little security
legal, which consider a specific regulation of liability absolutely unnecessary
medical, as they believe that with it, only a much more rigid and cumbersome system would be achieved than the one
In general, it is clear that the quality of medical care cannot be quantified, and the use of
Techniques for trying it can reduce the chances of providing high-quality medical care.
quality, so subjecting doctors to have greater academic up-to-date and carry a
quality control which would provide us with greater advantages and minimal inconveniences.
The administration that justice imparts, in the most essential for a human being, is life.
physical and mental integrity and the right to health, whose importance and significance is obvious; it is
It is important not to forget other assets that, although secondary to those mentioned, are very
important, such as the economy, the position, and the prestige of those who, by their profession and
knowledge is entrusted with the protection of those rights.
The criticism tarnishes a doctor's professional competence and injures their honor, professionally.
specialties with higher risk and frequencies are: Cardiovascular Surgery, Neurosurgery, Surgery
Plastic or Thoracic Surgery, although Traumatology, Gynecology, and General Surgery respectively,
Doctors are not magicians, they are only human beings who provide their services for care.
patients and that ethically none would be capable of harming a human being, but let's not forget
that as people make mistakes and that each patient reacts differently.
There are three reasons that have justified why only a % of the complaints have reached the courts:
The lack of means to initiate the judicial process, little credibility in justice, and because when
someone dies, their family wonders why report it if no one is going to bring them back, people do not
knows how to act in this situation, finding themselves at a crossroads when it comes to them or someone
it is their relatives who have to live that harsh reality.
* on the other hand, such interests have a negative impact on the prestige and economy of the
doctors, secondarily in Health Administration and, in the long run, in the organization itself
services of the same, having to invest large amounts in compensations.
Finally, it is necessary to acknowledge that the solution to the problems of liability for wrongdoing
Judicial practice leaves much to be desired, as it is far from having any parameters.
acceptable security, resolution time, reasonable quantification of compensations,
agility, etc.
1 Official Mexican Standard NOM-178-SSA1-1998, which establishes the minimum requirements for
infrastructure and equipment of establishments for the medical care of patients. Daily
Official of the Federation, December 14, 1998.
Dr. Moisés Ponce Mala, the new director of the Central Division of Forensic Medical Examinations.
GENERAL OBJECTIVES
Promote the development of ethical and legal behaviors by health professionals, more
beyond the assistance or administrative, defining legal responsibilities in the workplace
daily quality of service of healthcare professionals, creating a culture and awareness
of forecasting legal medical problems.
SPECIFIC OBJECTIVES
Know how to define the extent of the ethical and legal responsibility of healthcare providers.
HYPOTHESIS
How can we establish the degrees of criminal responsibility in medical negligence and its
aggravating factors.
How to determine when the crime of medical negligence is committed, raising the
possible causes that can lead to medical negligence.
What are the criteria that lead us to determine with certainty whether the doctor acted with guilt or
no.
RESEARCH METHODOLOGY
The methodology is a process that, through the application of the scientific method, obtains the
relevant information, to understand, verify, correct or apply knowledge, and obtain some
To achieve a clear and precise result, it is necessary to apply some type of research.
The Method We can also say that the method is the set of logical procedures to
through which scientific problems are raised and hypotheses are tested and the
research instruments studied.
Synthesis: it uses analysis without reaching synthesis, the knowledge is not understood
truly and when the opposite occurs the analysis yields results unrelated to reality.
THEORETICAL FRAMEWORK
CHAPTER ONE
1.1 MALPRACTICE
1.1.1 NEGLIGENCE
1.1.2 NEGLIGENCE
1.1.3 IMPERFECTION
CHAPTER TWO
PROFESSIONAL
CHAPTER THREE
3.4 JURISPRUDENCE
CHAPTER FOUR
4.- CONCLUSION
4.1 BIBLIOGRAPHY
CHAPTER SUMMARY
The present work aims to develop the historical background and its evolution of development.
from human activity, regrettable facts that are sanctioned by society have come
being addressed throughout our history with the aim of finding solutions to the problems
social
Thus, the appropriate experience in the application of your profession, since if you do not have the
Knowledge and the precise application of it will cause human and material losses.
lamentable, which should be sanctioned by law, this occurs in all human activity,
In the case at hand, the doctor either acts or fails to act with commitment, whether in the...
Forms of negligence, recklessness, or incompetence can result in serious consequences in life.
or in people's health, which is why medical knowledge will be valued.
Professional medical practice is dedicated to the defense of life and the care of integral health.
of the person, family, and community. The work that the doctor does and the results they achieve, are
they fall within the realm of probability and not of guarantee, as when it is granted
in the case of simple products, the number of
patients seeking guarantees in medical intervention,
In the very nature of the medical act, there are uncontrollable factors that can provoke
results opposite to those sought and generate serious or minor damages, immediate or delayed, that
they are classified as iatrogenic. This is almost always attributed to incompetence or negligence or
poor management of therapy or error in risk assessment.
Due to this, it is very important to have knowledge and scientific information related to the
medical malpractice that provides us with objectivity and current criteria in order to solve
problems.
Moral problems are considered 'the good or just', the justification of decision-making in
conditions of uncertainty that the professional faces in clinical practice, considering and
hierarchizing moral values to adopt the most human behavior, that is why the
different responsibilities are oriented towards the moral, civil, administrative, and medical.
they come accompanied by many human values of utmost importance for life and not for the
death to thus elevate them with our professional practice, acquiring the commitment of
to preserve human integrity, related to health and psycho-social well-being.
One cannot talk about a healthcare system without ideas coming to mind.
related to their moral commitment. In the sense of health care, it implicitly carries the
search for the good for human beings, whether they are healthy or sick individuals, or groups that are afflicted
of some problem or those that are intended to avoid it by taking preventive actions.
The central concern of medicine and, of course, that of the doctor, is the well-being of the
patients and the moral responsibility that this implies. In this sense, most of the
Moral and civil issues are based on ethical reflection around the doctor-patient relationship.
The sum of patient autonomy allows for the modification of the traditional position of
Doctor, decisions cannot be solely technical as they involve multiple factors.
characteristics and conditions of every human being, their family, in case this is feasible,
it will allow things to be done conveniently for both, that is why in order to avoid any
A problem in medical practice is of utmost importance to give the patient; the information always
It must be true, it is never justified to lie to the patient. The call must be eliminated.
"pious lie" that poses a risk in medicine.
An appropriate language must be used for each patient, their age, cultural level, and ability.
understanding. It is even advisable to ensure that he has understood by having him repeat it
information, or asking questions. Some mistakes can be made when providing the
patient information
Medical negligence includes the non-compliance with care standards for the
treatment of the patient's condition, or lack of knowledge, or negligence in providing the
patient care, which is the direct cause of an accident during medical treatment,
it was the result of the treating physician's lack of knowledge, it is an accident
unfortunate event for which the doctor is not responsible. Compensation for patients victims of
medical malpractice can be determined by national laws if it involves negligence
medical or from an unfortunate accident that occurs during medical care and treatment.
The laws must provide for the procedures in order to establish liability.
demands for medical negligence 6 and determine the amount of compensation and if it will be
economic, in cases where negligence is proven.
Organize information campaigns for the public about the inherent risks of certain
advanced medical treatments and surgery; for professionals, training programs on
the need to obtain informed consent from patients regarding such treatments
and surgery responsible for improving the quality of medical care and treatments.
Implement an informative guideline for doctors who have insufficient knowledge about
the laws, including a policy of limiting professional practice until such
deficiencies are corrected and thus seek legal protection for doctors when patients
they suffer accidents that are not the result of medical negligence.
6 OYARZABAL, CAFERINO, .The historical course of medicine. Edit. Everest Mexicana. Mexico 1983
7 PALENCIA OYARZABAL, CAFERINO, .The doctor historical course. Edit. Everest Mexicana.
Mexico1983
The main goal is to amicably resolve the differences between Patients and Providers of the
Health for medical care reasons In general terms, and with the understanding that everything
right brings an obligation, users of medical services, in accordance with what is stated in the
Regulation of the General Health Law on the Provision of Medical Care Services,
has the right to obtain timely health benefits, of suitable quality, and to receive care
professionally and ethically responsible, as well as respectful and dignified treatment of professionals,
technicians and assistants, while being obligated to adhere to the institution's provisions
service provider of medical care regarding the use and maintenance of furniture,
medical equipment and materials that are made available to you.
Law of the Institute of Security and Social Services for State Workers
Regulations for the Procedures for the Attention of Medical Complaints and Expert Management
CONAMED
Civil Codes
Penal Codes
State Legislation
Clinical Guidelines
Law of Art
LEGAL FRAMEWORK
Article 4
The right to health protection, as a social guarantee, was elevated to constitutional rank in
1983
Article 51
Users will have the right to obtain timely and suitable quality health services.
and to receive professional and ethically responsible attention, as well as respectful and dignified treatment
the professionals, technicians and auxiliaries.
Article 9
Medical care must be carried out in accordance with scientific principles and
ethics that guide medical practice.
All the actions that the doctor performs carry a set of duties and therefore
obligations.
The behavior of a healthcare professional who, at a certain moment, does not agree with the
lex artis gives rise to what is commonly referred to as malpractice.
CRIMINAL RESPONSIBILITY
Professionals, artists or technicians and their assistants will be responsible for the crimes that
they commit in the exercise of their profession, under the following terms and without detriment to the
preventive measures contained in the General Health Law or in other regulations on professional practice,
in your case:
I.- In addition to the penalties established for the crimes that are consummated, depending on whether they are intentional or
culpable parties will be suspended from one month to two years in the practice of the profession or
definitive in case of recidivism; and
They will be obliged to repair the damage caused by their own actions and by those of their auxiliaries.
when these act according to the instructions of those.
Article 229.
The previous article will apply to doctors who have granted responsibility to take charge.
the care of an injured or sick person, abandon them in their treatment without justified cause, and
without immediately notifying the corresponding authority.
CIVIL LIABILITY
For negligence
Due to incompetence
Lack of knowledge
The lack of basic and essential technical skills or knowledge that must be possessed.
mandatory in a certain profession.
Intent is required, the will aimed at causing a result; that is to say, to act with the
forecast of a certain result.
Criminal Responsibility
Causal Relationship
It allows for the scientific determination of who should be attributed a harmful result.
Provide the objective parameters, essential for calibrating the extent of compensation,
through a predetermined system of imputing consequences.
RESPONSIBILITIES
It is incurred by any act or omission that involves non-compliance with any legal provision.
regulatory or administrative related to public service.
ADMINISTRATIVE RESPONSIBILITY
Economic sanction.
Arbitration Process
The CONAMED was created in June 1996, through a decree by the President of the Republic.
as a decentralized body of the Ministry of Health, with full technical autonomy to
issue their opinions, agreements, and rulings, indicating as the object, according to what is provided in the article
to contribute to resolving conflicts arising between users of the services
doctors and providers of such services.
II. Address the complaints regarding a possible irregularity or denial of medical services;
9 General Health Law. Decree amending the General Health Law. Official Journal of the
Federation (Mexico). May 26, 2000.
10 Ministry of Health (Mexico). Health Statistics 2000. Public Health Mexico Sep-Oct 2001;
43(5):494-510.
11 Mexican Official Standard NOM-178-SSA1-1998, which establishes the minimum requirements for
infrastructure and equipment of establishments for the medical care of patients
outpatient facilities. Official Journal of the Federation, December 14, 1998.
HISTORICAL BACKGROUND
Since primitive times, the origin of diseases was not attributed to physical causes and
organic. The evils of the body were still produced by the punishment of the Gods, which is why
those who played the role of doctors were the priests, they acted as mediators between the
divine and the earthly, interceding for the health of his fellow beings. If the priest did not manage
Restoring the patient's setbacks, no responsibility could be attributed to him.
CARDONA HERNANDEZ states that if the patient continued to be affected after treatment
of his ailments or suffered serious complications or did not heal, he took it as a curse from the
living beings, understood that the Gods did not want to perform the healing and therefore that sick person
I had to endure abandonment, and the fulfillment of that higher will.
These were the drastic penalties of the punishment, the doctor was not only susceptible to sanction.
amputation of the hands, but was also obliged to compensate for the damage
resulting from professional activity so I had to replace it with another slave.
In the ANCIENT TIME OF THE EGYPTIANS, they regulated a more drastic form of medical practice.
death penalty
In the time of Alexander the Great, the concept of medical responsibility is amplified.
ordering the crucifixion of a doctor for having culpably abandoned his patient.
The history of medicine is the branch of history dedicated to the study of knowledge and
medical practices over time.
Since its origins, human beings have tried to explain reality and events.
transcendentals that take place in it such as life, death, or illness. The first
civilizations and human cultures based their medical practice on two seemingly pillars
opposites: a primitive empiricism of a pragmatic nature (fundamentally applied to the use of
herbs or remedies obtained from nature) and a magical-religious medicine, which resorted to the
gods to try to understand the inexplicable. With Alcmeon of Croton, in the year 500 B.C., he
it began a stage based on tekhne ('technique'), defined by the conviction that the
the disease originated from a series of natural phenomena that could be modified or
reverted. That was the germ of modern medicine, although over the next two
Millennia will bring forth many other currents (mechanicism, vitalism...) and models will be incorporated.
doctors from other cultures with a long medical tradition, such as Chinese.
At the end of the 19th century, French doctors Bérard and Gubler summarized the role of medicine
Until that moment: 'Cure seldom, alleviate often, console always.'
The medicine of the 20th century, driven by scientific and technical development, was consolidating as
a more resolutive discipline, although not ceasing to be the synergistic fruit of medical practices
experienced up to that moment: scientific medicine, based on evidence, relies on a
fundamentally biologist paradigm, but admits and proposes a model of health-
disease determined by biological, psychological, and sociocultural factors.
To talk about the origins of medicine, it is necessary to do so before the traces left by the
disease in the oldest known human remains and, to the extent that is possible,
of the marks that medical activity may have left on them.
Mark Armand Ruffer (1859-1917), British physician and archaeologist, defined paleopathology as
the science of diseases that can be demonstrated in human remains of great
antiquity.
Among the diagnosed pathologies in remains of humans dated to the Neolithic, there
include congenital anomalies such as endocrine diseases (gigantism, dwarfism,
acromegaly, gout), degenerative diseases (arthritis, spondylosis) and even some tumors
(osteosarcomas), mainly identified on bone remains, dated around 5000 years
before our era.
Since their remote origins, both Law and Medicine have reached a vast
development, so that currently they require very special knowledge for their
exercise, what determines a marked trend towards specialization due to the difficulty of mastery
of all the material that each one encompasses. And that difficulty increases when that occurs.
interrelationship between both. For the lawyer, it is not easy to apply their technique to medical science if there exists
a complete ignorance of this.
It is also not easy for the doctor to understand the work of the lawyer if they ignore the basic principles.
on which the Law is based. Something that both sciences also have in common is that neither
Of them is exact, which undoubtedly increases the difficulty of any control system.
Nowadays there is a popular trend towards, let's say, passionate litigation against those
behaviors that were traditionally conceived in a certain elite. And the light judgment arises
whenever the conflict is directed against those who enjoy a position that is socially
consideration of encumbrance.
The demand for accountability for harmful results is being increasingly asserted.
strength to overcome all kinds of misfortunes.
The restorative law therefore gains unusual strength, and we have witnessed, since the beginning of the century, to
a profound social transformation in this aspect, and as a consequence to a significant
legislative and jurisprudential evolution.
Never before, like today, has the so-called responsibility acquired special relevance.
It is surprising how high the economic amount of the compensations reaches.
derivatives of the culpable offense.
It is good that times have been surpassed where certain groups seemed to escape that.
responsibility for fault, like the fact that the compensations derived from those events hardly
they will alleviate the damage suffered by the victim. But it is also worth saying that it is not good for the
Right the flight towards other extremes with the correlative consequences of constraining the exercise
of a profession or bring about the ruin of a person when the responsibility is
disproportionate in relation to the act from which it proceeds.
12.-BUERES, ALBERTO J., "Civil liability of doctors", vol. 1 p. 162, Ed. Hammurabi, 2nd
ed., 1992. As Professor Bueres clearly states, this is without prejudice to the requirements set by law.
establish under certain circumstances for its proof.
14. MOTA LÓPEZ A. and MOTA MORENO A. Ethical and Legal Aspects in Clinical Practice: The Secret
Professional in Intensive Care Units. Bioethics and Health Sciences Journal. Vol. 4
No. 4. Section: Research.
There will be malpractice in the healthcare field when harm is caused to the body or health.
of the human person, whether this damage is partial or total, limited in time or permanent, such as
consequences of professional actions with recklessness or negligence, incompetence in their
profession or art of healing or for noncompliance with the regulations or duties under their responsibility with
departure from the applicable legal regulations.
First of all, there must be a verifiable damage to the body, understood as an organism, or
in health, extending the concept to both physical and mental health, being this
comprehensive of all psychiatric, psychological, and labor-related disorders and conditions,
individuals and relationships, with an impact on other people. The breadth of the concept encompasses
not only the direct harm to the individual, but by extension, it also projects onto
practically all of the affected person's activities.
Secondly, the damage caused must necessarily originate from a reckless act or
negligent or the result of incompetence or due to the deviation from the norms and duties at hand
causing harm or deviation from the applicable current regulations.
While it is true that the medical services contract is free-form or informal, it is also
It is true that, generally, it is successive in nature. Precisely, the development of the life of that
The contract is reflected in a document that will be completed throughout the care process.
medical, and as such it will serve to identify in the future the quality of these services, and very
it will particularly become a tool of singular importance when
determine civil, criminal, or administrative responsibilities. To provide an adequate service
of services, serving as a guide to professionals.
Thus, the successive nature of the medical service provision, when necessary,
resumption, it will be enough with a quick consultation of the medical history, as it contains all the
patient interest data.
Ultimately, the medical record, in addition to being an important complement to the duty of
to inform, has an undoubted instrumental character regarding the provision of assistance
doctor.
15 BUERES, ALBERTO J., “Civil liability of doctors”, vol. 1 p. 162, Ed. Hammurabi, 2nd
ed., 1992. As Professor Bueres clearly states, this is without prejudice to the requirements established by law.
establish in certain circumstances for its proof. 89.
The autonomy of the patient, abandoning old paternalistic forms, demands the realization of
a documented medicine, and it is precisely the medical history, the best tool of the
act as a professional. This is why it has been stated that 'in close relation to the duty of
to inform, and to record in a document of great importance for evidentiary purposes, since in
It reflects all that is related to the patient's illness.
the organized and detailed relationship of all data and knowledge, both previous and personal
and relatives, such as current ones, related to a sick person, which serves as the basis for the completed judgment of the
current illness 17.
Fernández Costales mentions that this documentation has been considered as
Absolutely necessary, under development in the medical services contract, as it provides
greater seriousness and scientific security, avoiding possible negligence of action or omission.
This documentation must be carried out from the very moment of personal contact with the doctor.
and of the patient
Based on this, it has been said that the complete and permanent nature of the medical record of a
The patient is in modern medicine a condition of quality of medical care or of the
proper medical attendance.
Ghersi mentions that the medical sequences in the patient's life are significant for their transcendence.
to judge the responsibility for damages caused to the patient, and especially to give us the key
in the relationship of causality
Adornó has stated, "It is undoubtedly of interest to remember that the implementation of
the different medical sequences in the patient's life are of transcendent importance for
to judge the responsibility for damages caused to the patient, as it may give us the key to the
mentioned causal relationship. Thus, the value it has in this matter
denominated clinical history
18 AMELIA SÁNCHEZ GÓMEZ "Medical services contract and hospital services contract"
Edit. Tecnos, Madrid 1998, p. 89.
19 Terminological Dictionary of Medical Sciences Ed. Salvat S.A. Tenth edition 1968 Barcelona.
20 FERNANDEZ COSTALES, JAVIER, 'The medical services contract', p. 196, Ed. Civitas, Madrid,
1988.
In this way and through the presumption test, that insufficient medical history is
constitutes another clue that must be taken into account by the court when analyzing
the behaviors of professionals.
But of course, a simple mistake in the documentation we have been analyzing cannot
constitute sufficient evidence to establish medical malpractice, much less the
causal relationship that is an element of responsibility distinct from the attribution factor.
This last point must be insisted upon. Causal relationship cannot be confused with guilt; both are
different budgets from the duty to respond. In the field of medical civil liability,
Many times this confusion occurs. This may be due to the fact that both
budgets are generally closely linked.
In this sense, the Spanish Supreme Court states, 'There are occasions when the confirmation of the link'
causal and blame are so closely intertwined that their delimitation becomes a
very complicated labor. Precisely as a consequence, the relationship has been confused.
causality with blame, ending up justifying their failures on a lack of negligence when in
The reality was that there was no causal link between the medical act and the damage. Perhaps
this happens because as González Morán rightly points out, the jurisprudence places more emphasis on the
discovery of the culpable conduct of the agent that establishes the causal link.
21 CALIXTO DÍAZ REGAÑÓN GARCÍA ALCALÁ "The Regime of Evidence in Civil Liability"
"Medical" Edit. Aranzadi, Pamplona 1996, p. 250.
Imprudence
It is to perform an act lightly, without the appropriate precautions; that is to say, it is the lack of
temperance or moderation. Or also, the behavior contrary to what common sense advises,
to undertake unusual acts outside of the ordinary, to do more than what is necessary; that implies a
dangerous conduct. It is the active violation of the rules of care or caution established by the
prudence, acting without sanity, moderation, discernment, sensibility or good judgment.
In the strict sense, it is identified with practical knowledge and therefore suitable and apt for the
carrying out the medical act with experience, understanding of the case, and clarity.
Within the broad concept of negligence, in its civil and criminal aspects, medical negligence is one of
those that offer special interest due to the multitude of problems they suggest and the interests they affect. If
The concept of recklessness is already complex in the field of law, let alone when it comes to it.
one the problem of medical science, where it will have such an important impact.
Law and Medicine are undoubtedly two of the oldest sciences, almost as old as man.
Well, if this one needed medicine in his thirst for survival, he also required the Law.
to arbitrate coexistence.
The above has colloquially served as an introduction to the legal problem of the
recklessness, where we will try to clarify its concept in general before delving into
the specific issue of professional negligence, and specifically medical negligence.
It is not easy to give a concept of guilt, and the issue becomes more complicated when the manifestations of
those are diverse, since in principle, following the legal criterion, we must distinguish between
civil liability and criminal liability.
The fault is not actually a figure that we can consider a typical crime or a civil fact.
illicit without more. It actually comes to be a manifestation of responsible guilt in
contraposition to the fraudulent form. If we can qualify fraud as direct intentionality, the
blame is reserved for those outcomes that the agent did not intend to cause, but
that arise from their lack of diligence or foresight.
The classical position considers guilt as the omission of the diligence required of the agent. That lack
Diligence comes to be the distinctive note of guilt, where its essential elements would be the
predictability and the measure of due diligence required.
CASTAN defines in a strict sense guilt or negligence as 'the omission of the required diligence.'
in social relationships, through whose application a contrary result could have been avoided
to the right and not wanted. For negligence to occur, it is enough that the result has been
foreseen as possible or it should have been foreseen.
But against that spiritualist theory of responsibility, a modern one has arisen.
concept of objective responsibility, in which the internal point of view is replaced by the
guilt from the external point of view of simple causality.
This also leads to the so-called theory of risk, according to which, one who causes another to be born...
A risk must respond for the damage it causes, even if there is no fault on its part. 'It is said
then of a social guilt or guilt without culpability
This social guilt addresses the harmful consequences of a behavior and largely disregards
from the diligence of the responsible party, the subjective rights, while civil wrongdoing has a
much broader projection. As a consequence, civil liability requires a minimum illegality,
a very slight fault is enough to respond, while criminal liability requires a greater severity.
SANTOS BRIZ points out that 'it is in the dimension of the feeling of reproach where the index is found.'
of criminal liability
For CASTAN, the penalty carries with it an offense that affects social and public interest or, what is
Likewise, a violation in the penal sphere (punishable acts), while the civil one only contains a
violation of civil law.
Examples:
To transfuse blood without determining the blood type, HIV, VDRL, hepatitis, etc.
Transmit contagious diseases, by the doctor or the instruments (TB, syphilis, HIV).
Perform operations or amputations with a cancer diagnosis based only on clinical examination.
22 J. CASTAÑAN TOBEÑAS.- Civil Law, Common and Regional. Volume I-Volume 11.
24 JAIME SANTOS BRIZ.- Civil Code. Doctrine and Jurisprudence. Volume VI.
Since its definition, recklessness seems to have little to do with typicality alone, as failing
A duty of care implies violating a standard of care. It is determined as a concept.
normative that is linked to the unlawful or unjust. It affects a legal norm, but does not want
to say that it has no relation to typicality, describes reckless assumptions in the abstract and the
typicality also implies valuations when attributing behaviors to the type, only at a level
General. 25 The separation of levels of judgment only proceeds if the distinction is accepted between
typicality and anti-legalism. Therefore, it is advisable to first clarify what is criminally unjust and the relationship between
those categories (typicity and unlawfulness), and then to review when a behavior violates the
care is needed and it can be criminally charged. For this, it is necessary to define beforehand the
notion of injustice that is taken as the basis for analysis. From there, the difficulties will be examined.
of attributing behavior and unjust results.
It is not easy to establish negligence in care, and when it is determined, it is not always possible to take action.
responsible to the doctor who performs that "dangerous" behavior if the harmful result occurs due to
a behavior unrelated to their intervention and later the inappropriate behavior is added or
improper, it is not only important to determine the behaviors for which one must respond, but also for
what results.
25 FRISCH, WOLF GANG (2009). "The fascinating, the accurate, and the problematic of the theory of the
"Objective imputation of the result" Causality, risk, and imputation. Hammurabi, pp. 345-381.
NEGLIGENCE.
The nature of negligence consists of the harm caused by the doctor in the exercise of their
profession, when it is involuntary, is considered culpable, since there has been no intention of
committing it, is always directed against the human person, if the intention is to hurt, provoke
the suffering with psychological and/or physical harm to negotiate the suppression of evil by evil
intended.
The harmful result, in turn, is visible, immediate in most cases, almost irreparable.
always and cloaked in singular suffering for human nature. Many other errors of
other professions go unnoticed. Except for the mistakes of doctors.
It is the negligence, omission or lack of application or diligence in the execution of a medical act. It is
To say, it is the lack of attention during medical exercise. It can create a defect or a
omission or doing less, ceasing to do or doing what should not be done. It is not exercising caution.
necessary or to have indifference towards the act being performed. Negligence is synonymous with carelessness and
Omission. It is the passive form of negligence and includes the forgetting of precautions.
imposed by caution, whose observance would have prevented the damage.
Improve the practice of medicine to prevent medical errors and provide healthy relationships
among health professionals, through the resolution of conflicts between patients or
your relatives and the health service provider staff, with efficiency and satisfaction of the
users and acting with impartiality, objectivity, gratuity, confidentiality, and respect.
Influence the improvement of public and private medicine practices in the State of Sonora and be a
trust factor between health service providers, users, and the community.
To indicate or prescribe medications (recklessness) without having previously conducted the test of
sensitivity (negligence).
Perform surgical interventions and leave some instrument behind (carelessness) and not
to take them out (negligence).
Perform a uterine curettage (recklessness) without monitoring the patient's condition or notifying the ...
familiar or responsible person (negligence), and authorize the discharge if "feels better"
making her judge (Doctor) of her own state (recklessness).
It is a form of culpable action that occurs when there is a demand or verbal order.
or written, arranged for the purpose of preventing harm and ordered by a responsible superior,
the subordinate does not comply, causing harm to the patient. It can be limited to the
administrative sphere if it does not harm the patient.
Examples:
Do not inform the patient or family members about their illness or prognosis.
Not regularly and at short intervals control the temperature of the incubator, the
artificial respirator, etc.
Do not leave written records about authorizations, allergies, referrals, auxiliary tests.
requested, established treatment.
It also considers the risks that arise, sometimes from its own exercise, risks
consciously assumed by those who submit to them, and other times, reactions
abnormal and unexpected in the patient themselves, which, in the current state of science, although
they could be foreseen are difficult to avoid. The greater the duty to act with prudence and
with full knowledge of things, the obligation resulting from the consequences will be greater
possible facts.
There is no crime if the damage or death is caused by the fault of the victim themselves or of third parties.
Where all precautions have been taken, negligence cannot be penalized.
nevertheless the harmful result.
If negligence is proven, it will create a judicial presumption of fault against the doctor or hospital.
he will be released if he proves that he acted with diligence. Since the resource of human presumptions
It doesn't matter a repeal of the burden of proof regime, since it is the plaintiff who must
to present the factual data so that the magistrates, based on the criterion of probability, can extract
by empirical deduction, a guilt in an indirect manner
To err is human, and the actions of the doctor are not exempt from it, but it is also human to
capacity for foresight, acting with awareness, and providing the minimum care and respect when assuming
the protection and management of people's lives, therefore the responsibility falls directly
about the health professional, but it also commits the actions of society as a
Just as the scientific duty of the doctor should not detract from their human duty, the
the patient's right to address their needs does not exempt them from their duties in self-care and the
co-responsibility, this interaction constitutes one of the main pillars of
current Colombian health system.
27 Daniel Roque and others vs. British Hospital and others for damages, American Journal
Infection Control, 2003, p. 291-295
VAZQUEZ FARREYRA, R. A fair criterion in the field of hospital medical civil liability.
"Civil Responsibility", 2002 p. 350 and following
IATROGENESIS
It is the damage to the body or health of the patient, caused by the doctor through their actions.
professionals, diagnostic, therapeutic, surgical, psychotherapeutic behaviors or means, etc.
and that this damage or undesirable result is not legally attributable to them. That is to say, iatrogenesis is
the harmful result that does not arise from the will or fault of the doctor in causing the damage,
is the product of an unforeseen (or rather unpredictable) event that escapes all possibility of
to be avoided by the usual or normal means of individual or collective care.
In a broad sense, it means everything produced by the doctor in the patient, in their relatives and/or
in society. Therefore, it includes not only the harmful consequences of the intervention of
optional, but also the successes of medicine, the healing of diseases and the
health conservation.
Manuel Quijano (2000) states that 'the value of an act resides not in its consequences but in a
diagnostic or therapeutic act, more than to the result
Clinics can be necessary and unnecessary negatives. Among the medico-legal ones, distinctions are made.
those that originate from negligence, lack of skill, and recklessness. It is also clarified that in
occasionally, negative iatrogenesis can lead to the commission of a civil offense or in
a crime. In turn, the crime committed in the course of the medical act can be intentional or
negligent.
The intention of the legal act, the offenses committed in the course of professional practice are
generally of a culpable nature.
It is important to emphasize that medical activity is a field in which one is required, in certain circumstances
circumstances, to a bold behavior limited only by intellectual knowledge and
practices of the medical professional, in such a way that it must ensure the non-application of a
reckless behavior.
Although iatrogenesis is subject to various classifications, the one that interests us for our purposes
of the present work, is related to the negative result on health or physical integrity of
patient.
From the legal perspective, regarding the professional responsibility of the physician, Conamed
(2003) proposes: "It can be specified that the responsibility in the actions of any professional
It derives from the consequences of both one's own active or omitted conduct and that of those who ...
are under their direction or dependence
Although there is extensive legislation regulating professional medical activity, not every act
a doctor can be explicitly regulated. Therefore, in addition to adhering closely to the
legal aspect, the practice of medicine is largely governed by the lex artis medical (rules of
medical art) and medical deontology (medical ethics) 30.
In other words, medical practice must be governed by the legislation on medical matters.
up-to-date scientific knowledge and the ethical principles that guide it.
Examples:
Acute duodenal ulcer caused by the administration of high doses of corticosteroids, being
this is the indicated treatment.
There is one when acting outside the field in which one was authorized by the title itself.
academic.
There is relative incompetence when, even though authorized by the professional title itself, one...
will reveal limited technical competition.
When a patient is scheduled for surgery due to a lack of knowledge without needing it.
29. GARCIA F and Colleagues. Iatrogenesis and Medical Dyspraxis: A Bioethical Approach. Journal of the Faculty of
Medicine. 2005, vol.28, no.1, p.6-11
A duty of care that must translate into a set of essential obligations, the
doctrinally can be classified, according to Conamed (2003), in the following way:
Obligations of means
They are rooted in the application of suitable procedures available for an adequate and timely
attention, in order to achieve the greatest possible benefit.
These obligations consist of the commitment assumed to provide medical attention, not a
determined result.
Security obligations
Through these, any complications to patients are taken care of and the risks of
use of diagnostic and therapeutic resources. This type of obligation, which refers to the duty of
avoiding accidents, are related to the proper use and maintenance of the equipment and
machines with the intention of preventing accidents. They are attributable not only to the staff
medical staff, but also to the maintenance and administrative personnel.
Obligations of results
They can only be satisfied when it is possible to obtain a certain result as a consequence of
professional service offered. They come into effect when a specific result is promised.
medical attention. In these cases, the doctor promised a result and is responsible for it as long as not
he may invoke some extenuating circumstance of responsibility, as in the case of cosmetic surgery.
In the obligation of results, the provision of services has a specific purpose: if not,
the expected result is obtained, there is a breach of duty, and the obligated party assumes
responsibility for not fulfilling the obligation they promised.
There is no doubt that the health conditions of the Mexican population have improved.
during the last decades.
One of the indicators that has changed the most is life expectancy at birth, which has
from 42 years in 1940 to 75 in 2000. However, significant inequalities still persist.
in the field of health and medical care. For its part, the Mexican health system has
evolved to become a set of institutions with articulation problems and
without the possibility of providing universal coverage.
It is for all these reasons that despite the achievements made, the gaps and deficiencies in the field
health is still broad, and it becomes especially evident when carried out
comparisons between population groups and geographic areas.
The practice of medicine has undergone considerable transformations, to such an extent that it has
transition from a descriptive and contemplative medicine to an active and decision-making medicine
decisions. Before it was enough to observe and wait, however today it is necessary to intervene.
as soon as possible, it is even required to anticipate the appearance of symptoms.
The transformations are remarkable, to such an extent that the techniques and even the own
medications become obsolete even before they have demonstrated their effectiveness
therapeutic. In the face of this situation, the position of the doctor is complicated; they must certainly be
the day regarding new techniques and therapies. The real difficulty for the practitioner lies in
distinguish between all the information it receives, those that truly represent a
true scientific advance.
At this point, it is necessary to establish that when analyzing the possible responsibility of
doctor, it is assumed that the only thing that should be required of the physician is the obligation to
means, that is, an obligation of activity, of diligence, in the sense that one is obliged to put
all the means available according to the scientific standards of that time and of the
circumstances of the place and time in which that work is carried out, in order to try to achieve a
result that in this case is the cure and that in no way can be guaranteed.
At the same time that medicine was transforming, the perception of also evolved
medical world on the part of society, and the doctor-patient relationship took on a very
different. While just thirty years ago society's interest in treatments
doctors were very limited, to the point that only some hypochondriacs flipped through every now and then
when some encyclopedia about health, which are also very well documented, and the media
we are bombarded with health topics.
34 PALENCIA OYARZABAL, CAFERINO, .The doctor historical course. Edit. Everest Mexican.
Mexico1983
HIPPOCRATIC OATH
I swear by Apollo, the healer, by Asclepius, Hygieia, and Panacea, and by all the gods and goddesses, to whom
I put as witnesses to the observance of the following oath, that I am obliged to fulfill what
I offer, with all my strength and will. I will tribute to my medicine teacher the same respect.
that to the authors of my days, sharing with them my fortune, and helping them if they needed it
I will treat your children like my brothers, and if they want to learn science, I will teach it to them.
selflessly and without any kind of reward. I will instruct with precepts, oral lessons
and other ways of teaching my children, those of my teacher, and the disciples who join me
under the agreement and oath determined by medical law, and to no one else.
I will establish the regime for the sick in a way that is most beneficial to them, according to my
faculties and my understanding, avoiding all evil and all injustice. I will not agree to claims that
I will not direct anyone to the poison administration, nor will I induce anyone to such suggestions; I
I will also refrain from applying abortive measures to women. I will spend my life and practice my
profession with innocence and purity. I will not execute the carving, leaving such operation to those who are dedicated to it.
to practice it.
In any house I enter, I will carry no other object but the good of the sick, freeing myself from
voluntarily committing defamatory offenses or corrupt actions, and especially avoiding the
seduction of women and young people, free or enslaved. I will keep secret what I hear or see in the
society and it is not necessary that it be disclosed, whether it is within the scope of my profession or not, considering the
to be discreet as a duty in such cases. If I faithfully observe my oath, let it be to me
granted to enjoy my life and my profession happily, always honored among men; if it
I am a break and I am perjury, may the contrary fortune fall upon me.
35. BOYLAN, Michael (2006), Hippocrates, Internet Encyclopedia of Philosophy Joanna, Jacques;
Hippocrates: Medicine and Culture
Press. ISBN 9780801868184.
One of the most important documentary elements in the doctor-patient relationship and
An essential part of the evaluation of the Medical Act is the 'CLINICAL HISTORY'. Let's remember that...
Throughout the centuries, it has been used in medical practice and nothing can replace its place.
of scientific, legal, professional, and personal importance.
Within the medical-legal and deontological context of the practice of health professions, the
The Clinical History acquires its maximum dimension in the legal world, because it is the document
where it not only reflects the medical practice or medical act, but also the fulfillment of
some of the main duties of healthcare staff towards the patient: duty of care,
duty to inform, etc.
becoming the documentary evidence that evaluates the level of care quality in
circumstances of liability claims against healthcare professionals and/or to the
public institutions.
The Clinical History can be defined from different perspectives as a legal aspect,
medical-care concept, or understood from the field of legal medicine,
defining itself in such a circumstance as the medical-legal document where all is recorded
relationship between medical staff and the patient. Conducted with him and all data related to his
health, which is developed with the purpose of facilitating their assistance, from birth to their
death, and that can be used by all healthcare centers that the patient visits.
It is the most important document of the documents that any health team produces.
especially the physician, and has scientific, technical, and legal value that highlights prevalence and
importance in the exercise of activities in the health sector.
the fundamental and essential document of medical knowledge where information is gathered
entrusted by the patient to the doctor, to obtain the diagnosis, treatment, and possible cure
of his illness,” we say that it is the legal-medical document where it is recorded:
1).- The entire relationship of the healthcare staff with the patient;
2).- All medical and sanitary acts and activities carried out
3) All data related to your health. It is prepared in order to facilitate your assistance and has
right to her for being a holder of the right to quality medical assistance.
In the case of a Medical Professional Responsibility arising from an order
judicial in the main material proof.
b).- In which he demonstrates that the doctor did not conform to the Lex Artis for the case, as it constitutes
the most objective testimony of the quality or lack of quality of medical practice, and
c).- Likewise, in cases where it failed to fulfill its duty to inform and obtain the
patient consent.
the very preparation of the medical history is very important, as it must be taken into account that
other people who access this document are not doctors, let alone the one who ultimately
will rule 37
We believe it is valid at this time to make some suggestions regarding the preparation of the
Medical History:
While all annotations are important, there are some that require special attention.
attention not to omit your documentation in the Clinical History, as in case it is needed, it is necessary to
resorting to other means of evidence of lower hierarchy will consequently be more difficult
test the actions taken and not reported. We are referring to cases such as, for example, not leaving
recorded in the History the denial of allergic background by a patient or not
submit the examination request due to institutional restrictions
37. ROMEO Carlos and CASTELLANO María. The intimacy of the patient from the perspective of
medical secrecy and access to the medical history. Law and Health. Vol. 1, No. 1, July-December
1993. Page 4 - 18.
38. JÚDEZ Javier et al. Confidentiality in Clinical Practice: Medical History and Management of
Information. Clinical Medicine. Barcelona. 2002; 118 (1): 18-37.
GHERARDI Carlos and GHERARDI Natalia. The Judicialization of the Medical Act and the generation of
new conflicts. MEDICINE. Volume
INFORMED CONSENT
Although today the enormous importance of the right that everyone has is understood
patient to be adequately informed for the purpose of giving or not giving their consent to
being subjected to a diagnostic procedure or medical or surgical treatment, this does not
it has always been this way. Indeed, in ancient times, as expressed by the distinguished Peruvian jurist, "in
times that cannot be considered remote, the doctor imposed his personal decision, regarding
to the treatment that the patient should undergo”39 in this sense, in the face of the paternalistic attitude
from the doctor, the patient only had to accept the decision or the treatment that he was given,
often remaining ignorant of the details and potential consequences that could arise.
Currently, the patient has the right to be informed about the prescription of
medications and the therapeutic decisions made by the doctor; this is referred to as
conception as Informed Consent. This has caused the doctor-patient relationship to have
suffered changes that have made classic paternalistic models obsolete, where the doctor was
who made the decision for the patient. Now people have been recognized with rights and
values in all modes of human relationships, which makes patients demand that they be
respected these rights when making decisions that involve them, as a corollary of the
dignity and autonomy of individuals, and therefore, as an obligation of this relationship
doctor-patient.
39 HOOFT Pedro F. The Democratization and Jurisdiction of Society: The Autonomy of the Person
and the Doctrine of Informed Consent. Bioethics and Biolaw. 29-32.
There are several methods we can rely on, but among the most important ones
we have the following.
Synthesis: it uses analysis without reaching synthesis, the knowledge is not understood
truly and when the opposite occurs the analysis yields results unrelated to reality.
THEORETICAL FRAMEWORK
CHAPTER ONE
1.1 MALPRACTICE
1.1.1 NEGLIGENCE
1.1.2 NEGLIGENCE
1.1.3 IMPERFECTION
CHAPTER TWO
PROFESSIONAL
Responsible.
2. Information.- The information must be prior to the procedures and/or treatments that are
must be made to the patient. The options must be comprehensible and must include the objective of the
treatment or study, its procedure, the benefits and potential risks, and that it is always
the patient has the option to refuse treatment or study once started in any
at the moment, without it being able to harm him in other treatments.
Following characteristics:
It is a verbal process: Health professionals every day and at every moment when talking and
they are developing informed consent processes with the
patients and it is not necessary to document them in writing. This need arises in the form of
exceptional, for reasons of safety or certainty and in that case it should be resorted to
informed consent form, therefore, one thing is consent and another thing is
it is the form.
It is a voluntary process: The decision must be made freely, therefore, it is not valid.
that will that manifests under coercion or manipulation. The use of the
persuasion, that is, the use of logical reasoning to try to convince the patient that
that is the best option. There are special cases like patients with mental issues, in children.
and older adults or seniors for whom it is difficult to make the process voluntary, because this group
usually has a significant degree of economic, physical, psychological, and emotional dependence on
regarding their family group, so many times they make decisions not to satisfy their
own desires, but rather not to bother others.
It is an information process: The information must be appropriate, sufficient, understandable, and truthful.
Exceptionally, information can be 'dosed', when due to the characteristics of the patient
It is presumed that the delivery of all the information may be harmful to him (privilege
therapeutic). The information, regarding informed consent, must previously be
always consider: Who to inform?, Who must inform?, How should it be reported?,
When to report?
It is a process that requires the ability to understand: Where the patient's personal aptitude leads them
allows understanding the information being provided, evaluating it, deliberating, and issuing a
decision, assuming the consequences of it.
It is a criterion not linked to the age of individuals, but to their moral maturity. It is one of the
most difficult aspects, as determining which patients can decide for themselves and which ones cannot
They require others to decide, it is not an easy task.
Informative: The information provided clearly and in a timely manner allows the consultants
to understand the disorder in particular, its causes, implications, and prognosis. It also clarifies the
fundamentals, purposes, and ethical criteria of the procedures to be used in any
stage of the process.
Declarative: The actions followed in the process itself are indicated and specified.
(Interview, joint reading, questions and answers during the dialogue), the activities to be carried out,
the principles and values that guide the process.
I buy missive or commitative: In the event of indicating the actions to be followed by each actor of
therapeutic process, a commitment to fulfilling such purposes is expressed.
Pre active: It encourages the participation of the patient (or their support group) and actively in their
process of recovering quality of life. It also compels the clinician to fulfill the actions
stipulated. Since Informed Consent derives from the right that every citizen has to the
free self-determination; from this point of view, it exercises 07 primary functions:
1.- Promote the autonomy of individuals.- Being a voluntary act, and of a personal nature, the
the same that is closely linked to one's own dignity, aims to exercise
effectively the patient's personal decision-making.
2.- Promote rationality in medical decision-making.- The best decision to make is the
What is taken when having a desire for possibilities, for just this is what the pursuit is about.
informed consent to apply a decision that is not only reasonable but also proportional.
3.- Protect the sick and the subjects of experimentation.- Function linked to preventing excesses.
regarding professional conduct, since necessarily the aforementioned must adhere to applying
your knowledge for the benefit of the patient.
4.- Avoid fraud and coercion.- Every informed person cannot be subject to deception, nor
much less obliged to undergo a specific treatment or medical intervention.
5.- Encourage self-evaluation and self-examination of health professionals.
The same clinician benefits from knowing the patient's expectations, doubts, and fears; it allows
develop research in human communities, respecting ethical aspects
fundamentals.
6.- Reduce distrust and alleviate fears. The information provided must be clear and sufficient to
guide decision-making. One should not resort to personal or subjective interpretations or to
particular beliefs of the specialist and can be verified by the consultant (in the literature
specific, or other specialists).
7.- Introduce a medicine a more probabilistic mindset and one that is better equipped to face the
uncertainty.
1.- Implicit consent: It is when a patient does not give their consent in writing or in
oral form, but understood the circumstances surrounding the procedure or treatment in
issue. For example, consent can be implied when a patient offers to
a relatively simple and non-invasive procedure. Likewise, consent is often
implicit for the necessary procedures that a surgeon may perform during a
surgical procedure for which the patient gave their consent.
Depending on whom it should be reported to: Informed consent can also be from
two types:
Direct Consent: It is the event where it can be obtained directly from the patient.
affected, their consent for the performance of a specific medical act. To obtain the
patient's will, he must have autonomy, that is, be aware of what is happening
in full use of their faculties, and must have the capacity, that is, full ability to
to self-govern.
b).- Adult lacking full mental faculties: In this case, there are the
incapable lunatics, and deaf-mutes who cannot make themselves understood in writing. We make the
exception that the deaf-mute who is able to understand by some type of language and who
the same way it can express its will, it can express its direct consent which will have
full value.
c).- Patient who, despite having enjoyed his mental faculties, is in a state of
unconsciousness: This is the case of an adult person, capable, who due to an accident or
any pathology arrives at the hospital in a state of unconsciousness and requires intervention
immediately, but she cannot receive information or express her decision regarding the
procedure. In these three cases, the rights to the free development of personality, to freedom
of cults and of conscience, are always in the background compared to the right to life that must
primarily when individuals cannot express their consent regarding the act themselves.
doctor.
BENEFITS: It is possible to point out that there are real and measurable benefits of Consent.
Informed. Such benefits are:
Legal: Protecting the clinician in the sense that the actions taken are specified and the
the consultant's compliance with such actions. It also protects the patient by being informed
your rights and obligations within the process.
Quality of the shared information: It allows the consultant access to information.
validated, coherent, and specific to its condition, constituting the foundation for understanding of
its current state.
Extension of disciplinary knowledge: Derived from the above, the quality of information that the
the patient will allow the spread of more correct concepts within their community of
relationships.
Objective agreement and commitment: By clearly and objectively outlining the actions of the
participants, allows to clarify the agreed points, reducing ambiguities and
uncertainties that could interfere with the therapeutic process.
ARGUMENTS AGAINST: There are also opposing arguments used by those who still
they oppose the patient having a primary role in decision-making. The arguments
the most frequently used traditional ones are the following:
The information often disproportionately frightens the patient and may lead them to
reject interventions that only carry a minimal risk;
The same doctor rarely knows the data with the precision and certainty that are required.
patients;
Knowing the bare truth and the limitations that the doctor has deprives the patient of the effect.
placebo that provides hope and confidence.
All these arguments contain some elements worthy of consideration, but in their
set can be seen as the expression of a traditional point of view.
And from a logical standpoint, they seem to be rationalizations and justifications of a practice
pre-established, more than objective reasons to maintain it. At the present moment it can
to say that the doctor has the duty to sufficiently inform the patient and educate them so that
be able to make a decision consistent with their own values.
2).- Emergency Situation: In cases of emergency, there is sometimes no time to obtain the
informed consent of a patient, or the patient may be unconscious and
incapable of communicating. If delays are not allowed due to the risk of death or injury
irreversible.
3).- Incompetent patients or those without the capacity to decide: Those who, by definition, cannot
grant valid consent. Every adult is considered competent to make decisions
unless declared incompetent by judicial declaration.
4).- Medical therapeutic privilege: Due to Risk of Significant Emotional and Physical Harm. The case
particular of the therapeutic privilege introduced in American jurisprudence and not recognized
Under Spanish legislation, it refers to the privilege that enables the doctor to conceal information.
to the patient regarding the risks of the procedure to which he/she is going to be subjected, in the case that
it is evident that such a revelation would pose a serious threat to the psychological integrity of the
patient, this decision must be solidly founded and not made on speculative indications;
5).- Legal imperative: If the procedure is ordered by a judicial order; by Mandatory Evidence.
consent is not required when a patient must attend an exam or treatment
mandatory, for example, in cases of mental health issues or contagious diseases.
6).- Explicit rejection of all information by the patient: The patient's right must be respected
patient not knowing. Situations in which the patient hands over their decision-making authority
to the doctor or third parties. In this case, there must be some family member or legal substitute willing to take responsibility
the responsibility of decisions.
The obtaining of informed consent is another opportunity for closer interaction between
the actors, a possibility that can be very limited in hospitals. There is nothing that can replace
a sincere and friendly conversation, especially when it revolves around a topic of
Concern. Obtaining informed consent helps reduce the anxiety of the group.
familiar with the existing health situation, which can be exacerbated by a lack of information and
little understanding of the medical problem. It is an opportunity for the patient and family members
formulate questions about the situation, which might not occur if the process of is omitted
information, with the consequent risk that some problem in the relationship may arise later
patient with the healthcare professional. Therefore, the process allows for better preparation of
patient, both emotionally and clinically. Knowing and understanding their health situation, based on
a clear, simple, timely, kind, and truthful explanation makes him a collaborator of the
health personnel.
The right of each person to information and to give, or not give, their consent before each
healthcare action derives from the basic right to have personal autonomy respected in the
situation of illness. When we refer to the legal obligation of the doctor to provide
information to the user about their illness, the term is generally used
informed consent. However, the medical duty to inform the user is a duty
autonomous and prior to consent, since the breach of obligation occurs beforehand
from the issuing of consent: "To consent, one must first know."
The above also implies the obligation that falls on the physician to provide you with all the
necessary, truthful, and sufficient information to the patient about their current health status; the -or the
procedures that according to science should be applied to address the patient's situation; the
consequences that the treatment will bring for the patient; the consequences that would occur in
in case the patient does not undergo the treatment, etc.
So; we must note that in the medical act, unlike what happens within
other contractual relationships, the duty of information on the part of the physician extends
beyond the moment of perfection of the legal business, still projecting into the execution of
same and in the moments that followed.
Therefore, throughout the second half of the 20th century, it has been established as a legal obligation in
most countries.
In principle, Informed Consent is always necessary. But the ethical and legal obligation to
obtaining it explicitly can be greater or lesser depending on the circumstances of the case.
Therapeutic information is a continuous process over time, which does not end with the
obtaining informed consent. Likewise, regarding the diagnosis, it is recalled from
the medical point of view, the fundamental role that information plays for the establishment of
a quality doctor-patient relationship, in which it seems essential at first that the
patient adopt and understand their illness, which will help them organize or adapt their
behavior during the period of the illness, and the doctor to base the rest on it
from their explanations and to justify their request for complementary analyses and their decisions
therapeutic.
In summary; the relationship between the professional and the patient is a tacit contract of trust and goodwill.
there exists an informational asymmetry between the two that leads to legal consequences
such as the doctor's obligation to inform and obtain the patient's consent to proceed
a specific diagnostic and/or therapeutic procedure is carried out. It should be informed in a manner
clear and precise about the type of intervention to be carried out and its possible variants, benefits, and risks
probables, side effects, adverse reactions, complications and the consequences of not
carry it out.
Sometimes, it is mandatory to do it in writing, leaving a record of having informed
duly, certifying that the patient has understood the information provided. In the presence of the
hard regarding the way to inform and obtain the patient's consent, it is recommended
do it expressly. The informed consent signed by the patient does not mean the
validation of the proposed treatment, leaving open the possibility of its review. Moreover,
does not exempt the professional from committing malpractice if the procedures used are not the
Correct. The omission of this duty can lead to guilt for not having informed or for having done so.
defectively made, even in the presence of a correct performance.
Well carried out, the informed consent process is a virtuous instrument that
it deepens the doctor-patient relationship, makes it transparent and enriches it. It is useful for delimitation
of the responsibilities, for the clarification of the terms of the doctor-patient relationship and
for the future and eventual demonstration of serious and mature behavior by the
treating physician.
42. SÁNCHEZ GONZÁLEZ Miguel Á. Informed Consent: A Right of the Patient and a
distinct way of making decisions. Notebooks of the Regional Bioethics Program No. 2 April of
1996–Pan American Health Organization
43 MONTI Guido. Legal and Ethical Value of Informed Consent. Journal of the Italian Hospital
from Buenos Aires. Vol. 26; No. 1, 31-33. March 2006
The contract is a legal act that generates obligations. According to Kant, the contract is a limitation.
that the person voluntarily imposes on their freedom, in effect, the subject that contracts binds themselves;
promises to give, to do, not to do something that, if it weren't for this agreement, would not be a burden.
It has been widely discussed what type of contract is established between the patient and their
doctor, several theories have been studied and partially dismissed, including the one of
mandate, that of services provision, that of work provision, that of services provision, that of
location of work, that of unnamed contract and many others, to end up accepting that the act
Medical is a special form of contract called, precisely, "Medical Assistance."
In recent decades, it has been common, also in our country, that many medical decisions
they are subjected to judicial scrutiny for various reasons. The diversity of motivations and the
the extensive theme that encompasses the issues addressed requires that any comment on
such judicial processes refer to the possibility of an additional conflict arising from that
The courts are theoretically called to resolve.
The two essential motivations that lead to this new scenario have been, on the one hand, the
important advance in biological and scientific knowledge that incorporated new elements into medicine
special situations at the beginning, course, and end of life (such as fertilization in
in vitro, genetic diagnostics, life support, severe comorbidities, vegetative states,
etc.) and, on the other hand, at the same time the incorporation of patient rights into medicine
to decide autonomously about their lives and well-being in light of the new options provided by the
scientific knowledge. It should also be noted, as a not insignificant circumstance, that in the
All these events occur within a bureaucratic health structure that
interacts, and sometimes intervenes, in the traditional relationship between the doctor and the patient.
When the doctor acts as such, he has to manipulate techniques and knowledge with a view to
achieve a concrete result; but this sought-after end by the practice of medicine can or
it has legal implications. Therefore, the Medical Act (whatever it may be) is a source of the
that emanate legal consequences for the professional who carries it out and for the patient who has
has been the subject of this activity, although not the only source.
From the Medical Act, two types of legal consequences can be derived: those that
result from the legal act ("liability" for the act) and those that result from the legal fact
damages compensable for the unlawful act capable of generating implications in the Law
the crime, for example-). Both types of consequences are included in the law (in the
civil or criminal codes) and are related to the subjective rights of the parties involved in
the medical act: medical professional and patient (by themselves or their relatives).
It has been widely discussed in the field of jurisprudence what type of contract is the one that is
establishes between the patient and their doctor. Several theories have been studied and discarded.
partially. They include the mandate, the service lease, the work lease, the
of unnamed contract and many others, ultimately accepting that the Medical Act is a
a special form of contract called, precisely, 'Medical Assistance'. The Contract of
Medical Services or Assistance is classified as one of the "obligations of means and not of result."
The doctor does not promise to cure the patient. Therefore, the only outcome that can be anticipated is
who will put all the effort, diligence, skill, knowledge, prudence, and care for a
correct execution, without promising, assuring or guaranteeing anything.
Responsibility is the obligation of the doctor to repair and meet the consequences.
of their acts, omissions, and voluntary or involuntary errors, within certain limits and committed
in the exercise of his profession, that is, the doctor who, in the course of treatment, causes by
blame a harm to the patient, must remedy it and such responsibility has its budget in the
general principles of Responsibility; according to which every fact or act carried out with
discernment (capability), intention (will), and freedom generate obligations for its author in the
to the extent that harm is caused to another.
DIFFERENT TYPES:
Professional Responsibility: When the professional acts with intent, recklessness, negligence, etc.
It causes harm to the person who has requested his services, the responsibility of the doctor is
It begins with the Oath of good performance in the profession in relation to the patient, as
duty of loyalty, professional secrecy, and compensation for any damage caused.
Medical liability is a type of professional liability.
Civil Liability: Arises from the obligation to financially compensate for the damages caused to
the victim.
Criminal responsibility: Arises from the interest of the State and of individuals, interested in maintaining
the legal harmony and public order; hence the sanctions (penalties) are those imposed by the
Criminal code (prison, confinement, fine, disqualification).
Objective Responsibility: It arises from the harmful, unexpected result of the action of
A doctor can cause, regardless of the blame that falls on them.
Subjective Responsibility: It arises from the subjectivity of the doctor, put at the service of a
certain actions punishable by law, (for example abortions, false certificates, violation of
professional secrecy.
Contractual Responsibility: It arises from a contract, which does not necessarily have to be
written (it can be tacit or consensual), whose non-compliance may give rise to legal action.
Action responsibility: This is incurred when, for example, an imprudent action is taken.
a surgical intervention, without specifying whether it was necessary or not, if it is carried out with incapacity,
without the appropriate instrumental and following such or such procedure.
Liability for omission: This occurs when what is necessary is not done or
convenient, when one stops doing what needs to be done. Not giving the required instructions.
for the application or use of the medication.
Culpable Responsibility. One in which damage is caused without the intention of producing it.
Intentional Liability: That which causes damage intentionally. Some examples of this
these are the cases in which the doctor intentionally kills the patient while hiding under the disguise of
treatment, or commits acts of rape or offenses against public decency in clinics or offices, with
use of narcotics or moral pressures.
Social Responsibility: It refers to the responsibility that doctors have to support the
society when there are massive disasters, epidemics, health campaigns, etc.
MEDICAL LIABILITY
During the practice of Medicine, there are moments when the Doctor must make decisions.
transcendental, especially in life or death situations of a patient; in these
In circumstances, the doctor does not stop to ask himself whether what he proposes to do may entail
legal consequences, as doing so could become a deadly brake, which ultimately
such circumstances would only harm the patient. However, the doctor can make mistakes, the
the same that will not be ethically and legally reproachable, if it has treated the patient with the means
suitable, with current knowledge and with the standards that their duty imposes on them. Here it could
a doubt arises.
One of the inherent rights of the human being is the Right to Health, which very often
it is confused with a Right to Healing, as the patient believes that the Right to Treatment
must necessarily involve a result
Positive. 46
The practice of medicine has undergone considerable transformation in recent years, such that
way that has shifted from a descriptive and contemplative medicine to an active and
decision making. Before it was enough to observe and wait, however nowadays it is necessary
intervene as soon as possible, even it is required to anticipate the appearance of symptoms.
The transformations that modern medicine is undergoing are remarkable, so much so that the
techniques and even the medications themselves become obsolete, even before having
demonstrated its therapeutic effectiveness. In this situation, the doctor's position is
complicated. Certainly, one must stay updated on new techniques and therapies. The true
the difficulty for the doctor lies in distinguishing between all the information he receives,
those that truly represent a real scientific advance. At this point, it is necessary
establish that when analyzing the possible responsibility of the doctor, it is based on the premise that it
the only thing that should be required of the physician is the obligation of means, that is, an obligation of
activity, of diligence, in the sense that one is obliged to put forth all the means available.
according to the scientific standards of that moment and the circumstances of the place and time
in which this work is carried out, in order to try to achieve a result that in this case is the
healing and which in no way can guarantee.
At the same time that medicine was transforming, the perception of also evolved.
medical world on the part of society, and the doctor-patient relationship took on a very
different. Whereas just thirty years ago the society's interest in treatments
doctors were very limited, to the point that only a few hypochondriacs would occasionally browse through
when some encyclopedia about health, which are also very well documented, and the media
We are bombarded with health topics in general information.
As a consequence of this excess of information, it is common for the population to demand the
effectiveness of a certain treatment.
These two situations, that is, the rapid scientific advances and the vast information that is received by the
population, makes the doctor-patient relationship complex and is the source of many
complaints.
The information provided to the patient and their relatives is precisely the key piece.
of most medical malpractice claims, and also represents an element of
of capital importance when the claim is through judicial means.
Sometimes, it is about understanding the reason for the death that occurred during a
surgical intervention, or wanting to understand why a test that seemingly has no risks has
finished with a serious sequel for the patient, or even know if an opinion was requested from someone
more experienced professional.
An overly strict attitude from society and the justice system when it comes to demanding
responsibility to the doctor, has the consequence of stifling initiatives that could benefit the
sick or multiply the tests in an absolutely useless way with the sole purpose of
surround themselves with guarantees in view of a future claim. Compensate a patient with severe
damages occurring in an unforeseen accident, as a consequence of a justified medical condition
perfectly executed, it is a perfectly defensible position in the name of solidarity,
as long as the force majeure that caused the accident is perfectly clarified. The
The danger would lie in the fact that every accident would be considered inevitable and that with this
excuses will cover up medical negligence.
48. GHERSI, Carlos A., 'Responsibility for medical care provision', p. 97, Ed. Hammurabi,
1987
CIVIL RESPONSIBILITY
Civil liability consists of the obligation that falls on a person to repair the damage.
that has caused to another, whether in nature or by a monetary equivalent, (normally
through the payment of compensation for damages). Díez-Picazo defines responsibility as
the subjection of a person who violates a duty of conduct imposed in the interest of another subject
to the obligation to repair the damage caused.
Although the person who responds is normally the author of the damage, it is possible that it is done
responsible to a person other than the author of the damage, in which case we speak of "responsibility"
for external facts," as happens, for example, when parents are made to answer for
the damages caused by your children, or to the vehicle owner for the damages caused by it
driver due to the circulation.
Civil liability can be contractual or extracontractual. When the legal norm violated
it is a law (in a broad sense), we talk about extracontractual liability, which in turn,
it can be criminal or penal (if the damage caused was due to an action classified as a crime), or
quasi-delictual or non-intentional (if the damage originated from an unintentional fault). When the norm
transgressed legal obligation is an obligation established in a particular declaration of will
(contract, unilateral offer, etc.), we are then talking about contractual liability.
49. Luis Díez-Picazo and Antonio Gullón: System of Civil Law, vol. II, Tecno, 1989. ISBN 84-309-
0813-7
Civil liability can be contractual when it arises from the breach of a contract.
valid, and extracontractual, when it occurs by legal declaration, without unlawful act or negligence
of the responsible party, or when there is intent or negligence.
Precisely in the area of civil liability of the doctor, one of the most debated issues
It has been the contractual or extracontractual nature of the doctor-patient relationship, the doctrine of
the legal relationship between doctor and patient has traditionally been built on the basis of the contract,
initially qualified as a service lease, although it is referred to more modernly
understand that it is a special contractual figure.
However, the relationship can arise on bases unrelated to the contract, as long as the patient
have a legal title, whatever it may be, to be entitled to the provision of assistance
sanitary.
The progress of health sciences and their rapid development, with the emergence of new
increasingly complex and sophisticated techniques show the inadequacy of the traditional model
contractual of the professional-patient relationships and are determining the emergence of a new
model exercise of health professions, already common in medical specialties, of
the way in which the provision of services by a professional to a patient is not based on the
a typical figure of a contract, but its typology is multiple.
The patient does not acquire their right to treatment from the conclusion of a contract with the
professional, but of another title such as affiliation to social security, or free insurance
disease, which determines whether it is a Public or Private Organization that guarantees or with the
who cares about their health, and to whose service the professional is legally bound
obligated to provide the patient with the healthcare they require.
The general sense of evolution has focused, externally, on the shift from the bilateral relationship.
between the service provider and the recipient, to other multilateral organizations involved,
in addition a healthcare facility, an intermediary medical society or a
Public Administration.
Therefore, the basis of the intervention of the medical professional is no longer found in a
contract that he has concluded with the patient, but in the accommodation of his activity to the
guiding norms of the practice of the profession, obligations that are required with special rigor in
virtue of professional dedication, which is further strengthened when the intervention is carried out by professionals
lacks a healing purpose and is primarily aimed at improving the physical appearance,
aesthetic or functional.
Although there is agreement in doctrine that the differences in liability should be erased
contractual and extracontractual, it is no less true that de lege data the differences, although
limited, they still exist.
The most important ones, without a doubt, are those related to the statute of limitations and with
the extent of compensation. Regarding the statute of limitations, it is worth noting that the period is 10
years if it concerns contractual liability, while it is reduced to two years if we are
in the face of a supposed tort liability.
For many years, the nature of medical professional responsibility was discussed,
but currently there is no divergence regarding the fact that as a general rule, responsibility
The relationship between the doctor and their patient is contractual.
Nevertheless, there are exceptional situations in which responsibility will have a different nature.
extracontractual.
In summary, it can be said that 'it is a peaceful and virtually unanimous criterion in national doctrine.
and foreign to consider the emerging responsibility of the doctor-patient relationship as
contractual nature, whatever essence may be assigned to that relationship.
a- The medical services required by a person other than the patient, as long as,
by logic, that does not contractually bind the last one by virtue of a legal representation or
voluntary.
b- When a crime of criminal law is configured in which case the option of the article is viable.
1107 of the Civil Code.
c- When the contract made between the healthcare provider and the patient is null.
d- When the medical service is provided by the doctor spontaneously, without intervention
some of the patient's will (example of the doctor assisting the victim of an accident in
the public road).
The doctor's attention to a person who is unable to communicate with the respective parties.
legal representative.
f- The activity of the doctor carried out against the will of the patient
Suicide assistance.
When the relationship between doctor and patient is imposed coercively on the latter, as a result of the
hyperactivity of a legal or administrative provision.
When the doctor acts with the intention of causing harm, that is, with criminal intent, what
set up a civil offense.
i- The case in which the patient dies as a result of medical care and those who claim
They are their relatives. In such a case, the claim must go through the extracontractual route.
50. Roberto A. Vázquez Ferreyra titled 'The Evidence of Medical Fault: Things in Their Rightful Place'
place.” The ruling was published in Argentine Jurisprudence 1999, Volume II, page 495 and following.
51. Alberto J. BUERES For an expansion of these characters see the previously cited work, on page.
154 y Gates Federal Civil and Commercial Court, Chamber II, July 7, 1998 "P., L vs. National State"
The
The constitutionalization of the right to health protection should, on the other hand,
singular duties, corresponding to the rights of the patient, whose non-compliance can be
constitutive of the contravention of the essential content of the provision of medical services.
Well, there have been voices that have criticized the current classificatory distinction, it is no less true
that today is more relevant than ever, especially when it comes to judging the
professional responsibility of doctors and lawyers.
Some authors have argued that it is a classificatory criterion that originated in France but
that has not been used for over fifty years.
Such a statement does not hold up to analysis when considering that the main European courts...
they constantly refer to this classification when it comes to judging the behavior of the
doctors.
In our country, the jurisprudence is consistent in maintaining that in the case of professionals of the
art of healing, the committed provision is of means.
For example, it has been said that "by providing medical assistance to a patient, the professional assumes
an obligation of means and not of results, that is to say, that their obligation consists in putting to
patient service the flow of scientific knowledge that the title accredits and provide it
diligent assistance that his condition requires
In some specialties, the nature of the service assumed has been questioned.
professional. For example, in the field of plastic surgery. It is argued that plastic surgeons
they assume obligations of results because otherwise the patient would not take on the risk of
intervention.
For our part, we believe that in all cases, medical professionals assume obligations.
of means as the inherent risk of any medical act is always present. This without prejudice to
that in certain cases it is easier to prove professional fault or that the extent of
informed consent to be broader.
In a similar sense to the one we promote, the jurisprudence has stated that 'It constitutes a
simplistic reasoning to hold, based on the fact that in cases of plastic or aesthetic surgery the
the surgeon's obligation is one of results, that when success is not achieved in these interventions
expected to eliminate the ugliness of the patient or of the part of their body that displayed it
The achievement of the goal directly involves the responsibility of the surgeon.
"But this does not mean, in any way, that every cosmetic surgery operation gives rise to,
fatal or necessarily, an obligation of result, nor that the mere non-obtainment of
"Pursued embellishment produces objective liability of the surgeon."54
The fact that the obligation assumed by doctors is one of means implies
necessarily the presence of a subjective attribution factor (culpability) for it to remain
their civil responsibility is compromised. Without fault (comprising both culpa in the broad sense and dolo) not
there is medical civil liability.
As previously stated, 'in the matter of medical responsibility and as a result of that
The central legal duty assumed by the practitioner is generally one of activity, in principle.
It is the burden of the patient (plaintiff) to prove the fault of the other party (defendant).
It is not enough, therefore, to reveal the mere structural infringement, that is, the causation of the medical damage to
to deduce explicitly and implicitly the subjective element (fault), although such transgression to the other does not
The act of harming provokes unlawfulness, which is a different matter.
52. GARCIA F and Cols. Iatrogenesis and Medical Dyslaxis: A Bioethical Approach. Journal of the Faculty of
Medicine. 2005, vol.28, no.1, p.6-11. ALBÚJAR Pedro. Medical Ethics. Diagnosis. Vol. 43, No. 5.
Oct.-Dec. 2004.
For an extension of these characters, see the aforementioned work by Alberto J. BUERES, on page.
154 and following.
54. National Civil and Commercial Federal Court, Room II, July 7, 1998 "P., L vs. National State"
Law, newspaper of February 12, 1999.
MORAL RESPONSIBILITY
It can be defined as the obligation that the professional has to answer for the consequences that
can be derived from their professional conduct regarding the ethical and moral code they have adopted. They
one can say that the lack of moral and deontological principles to be observed in the exercise of the
medicine is at least indirectly part of the current legal regulation as it is required
responsibility for the damages caused; this legal regulation is fundamental in the
public health protection as provided in Article 43 of the Spanish Constitution
1978. Medical deontology deals with regulating the principles and ethical rules that should inspire and
guiding the professional medical conduct, which is defined and executed in our inner court, and whose
Unappealable judge and always just, never makes a mistake.
SOCIAL RESPONSIBILITY
These changes and the demands they generate within society have deeply affected
the practice of medicine and makes it necessary for us to review its goals and the values that govern it, the
traditional values of medicine have lost the normative strength they once had in society
more homogeneous and authoritarian than in the past. In reality, the criticisms of medicine and the actions
medical professionals continuously surpass the conventional limits of science and technology and that
There are factors that play an important role in health and disease, which have not been addressed.
attributed the importance they deserve, psychological, ethical and social factors; in other words,
that medicine is essentially a science centered on the person, that is, a human science.
An important consequence of the humanistic approach in current medicine lies in the value
social that we give to the exercise of the profession; that doctors adhere to the principles
Traditional ethics may no longer be enough because also, their personal values, our
personal values may significantly differ from the values of the patients and of the
same society; for example, the views of some doctors on life, death, the
sex, drug use, suffering, poverty, etc., The important thing is that, from a
humanist position, the need to thoroughly examine value conflicts is recognized
involved in medical decisions. The obligations that the doctor has towards their patients are not
they derive from the ideology, the history or the sociology of the profession nor should they be influenced by the
the fact that the remuneration for your service is direct or indirect; it derives from the impact of the
disease about the human condition, about the vulnerability of the sick person, of their
need to be protected and the intrinsic nature of her relationship with the doctor. Certainly
the idea of medical humanism is already expressed in the oath and in other books of the
Hippocratic Corpus, but it must be acknowledged that these traditional formulations have been
rebased and not necessarily align with the modern concept of health and disease nor
with the conflicting values involved in the complex decisions that in the practice of the
Current medicine must be confronted. From humanism emerged the modern ideal of "Health"
for All", materialized in the famous Alma Ata declaration. They are the legal decisions,
economic and political factors that will make it possible for men to achieve the well-being they are entitled to
creditors simply for being men, but it is necessary that our medical values,
essentially individualistic, acquire a greater social dimension; that is why we talk about the
Social Responsibility of the Doctor.
It comes from the common people, as a result of the reflection of the environment, which is almost always unjust, but
that at times a Judge may be seen punishing with excessive severity the offenses committed; voice
of the people.
Legal responsibility, or legal sanction, which constitutes the essence of professional crime and derives from
our obligation to be responsible before the law, for the actions or facts that we as professionals
we have carried out.
Even local human rights commissions have begun to address this type of
matters such as in the case of recommendation 2/2001, issued by the National Commission of
Human Rights of the Federal District. Gazette of the CDHDF, number 4, year VII, April 2001
Talking about the responsibility of the physician, whether civil, criminal, administrative, disciplinary, etc., is
inevitably refers to a modern phenomenon, almost from our days. Only society
consumerist and assertive, jealously defending individual rights and, why not,
the fundamentals, could bench, to seek legal and material redress, to the
doctors who cause harm to the patient in the performance of their profession.
In the dawn of humanity, medical responsibility did not exist, given the sacred nature that
the doctor had, which placed him beyond all shame or any compensation
pecuniary. However, this was a social and legal concern that was corroborated with the
actions taken by Hammurabi, King of Babylon, in penalizing incompetent doctors and
negligent and the Roman Lex Aquila, which regulated compensation for damage caused to another,
just cite two cases. But that sacred immunity was sometimes violated by some Roman senator
that threw a doctor who was in his service to a pond of voracious fish, who
he was generally his slave, because he erred in the application of Hippocratic science or because
he was suspicious of the potion he believed to be poisoned. This type of responsibility arises when the
a doctor infringes any of the provisions established in the General Health Law, its Regulations
and other provisions that arise from said law, regardless of whether damage is caused or not
the health of the patient.
As an example, we can mention that, when carrying out their professional activity, the institutions of
health and the practitioners must comply with all and each of the obligations established in the
Regulations of the General Law on Health regarding the Provision of Medical Care Services,
that establishes the form and conditions under which said service must be provided.
Many
56. Aristotle Nicomachean Ethics, version, introduction JAVIER FERNANDEZ AGUADO. Institute of
Humanities. Angel Hayala. CIE Dossat Management Library
On the other hand, when it comes to professionals who, by virtue of the position held within
from the Health Sector, they have the status of public servants, they may be sanctioned in
terms set forth in the Federal Law on Responsibilities of Public Servants,
sanctions that may consist of dismissal and/or disqualification from performing a position again
public position.
Moral Responsibility.
It is the attribution or qualification that a person receives for their actions from the point of view of
an ethical theory or of particular moral values. It then deals with the responsibility that is
relates to actions and their moral value, dependent on the consequences of such actions.
Be then to the damage caused to an individual, to a group or to society as a whole by the actions or
the actions of another individual or group.
From a social point of view, moral responsibility differs from legal responsibility.
due to its internal nature, it mainly refers to the internal character of behaviors (the
awareness or intention of the one who acted), regardless of external aspects such as the fact that
these have been discovered or sanctioned.
It constitutes true professional awareness, it is innate in every man, and it comes into play here, in the
the practice of medicine, a special aspect, as it forms the most complete execution of value
optional. Health personnel must allow themselves to have sensitivity to understand the
anguish experienced by the patient and thus forcing himself of the safety and success for the benefit of the
patient. The more educated a doctor is, the more technical skills they possess in their craft, and with that, more...
develops his moral responsibility.
Only the ignorant are incapable of understanding the harm they can cause!
Criminal responsibility is a personal responsibility and this implies that the sanction (conviction)
the penalty provided can only be fulfilled by the person who is directly the author of the
crime or the infraction.
Therefore, the doctor will answer for the criminal sanction and their insurance entity if they have one contracted.
a liability policy) will cover the payment of compensation for injuries
caused.
It arises when a person, in violation of the norms that describe criminal behaviors,
commits intentionally or negligently any of the offenses provided for by those regulations,
crimes related to the professional practice of medicine are established in the
different penal codes of the Republic, in the General Health Law, as well as in various
regulations regarding professional practice.
It should be noted that the reparation for damage in criminal matters has the character of a public penalty and is
ex officio by the Public Ministry. The affected parties can provide evidence to demonstrate
the origin and the amount of the compensation.
Finally, it should be noted that when damages are required in the criminal proceeding, the compensation will be
set by the judges based on the evidence obtained in the process and, likewise, based on
as established by the Federal Labor Law. This responsibility of the professional is generated.
doctor who causes harm when his action or omission is classified in the Penal Code as
constitutive of a crime or an offense.
57J. Cuello; J. Serrano General part of criminal law, fundamentals and theory of attribution.
Translation of. 2nd ed. (German). Madrid: Marcial Pons.
.
MEDICAL NEGLIGENCE
It is a violation of a pre-existing obligation established by law or by a contract, understanding by
fault as the will omission of diligence in calculating the possible and foreseeable consequences
of the fact itself. This theory has been subject to various criticisms, which does not imply that it does not
recognize that the concept of predictability plays an important role in guilt, but not so much
only that element cannot be considered sufficient to serve as its foundation, given
that in other reasons, even if the outcome is predictable, the blame may not be assigned, if the subject has
acted with due diligence and caution.
Dolo: There is deliberate intent, that is, when the expectation of the result is certain, not
detain the author.
Guilt: The intention to harm is necessarily absent, but there is negligence, neglect, incompetence,
lack of precaution or diligence, carelessness or recklessness, that causes harm to another or that
frustrates the breach of an obligation and must be attributed to the one who causes it.
Fortuitous Event: The facts are strange to man, they occur by chance, that is to say, it is a consequence
extraordinary or exceptional of the action. The doctor did not foresee the outcome because it was not
foreseeable, therefore it cannot be attributed to him.
Types of guilt
Unconscious Guilt: It is the lack of foresight of a typically unlawful outcome that could and
it should have been anticipated when acting (he has acted with negligence or recklessness but not imagining
the criminal result of his action.
Professional Fault: It is when the specific rules of an activity have been violated, meaning there was
lack of suitability, recklessness or negligence.
Medical Malpractice: It is like negligence that occurs with all of your knowledge of it.
profession
59 Manuel Cansío Meliá. Mendoza: What does criminal law protect: legal assets or its validity
the standard Translation of Legal Editions Cuyo
Imprudence: It is to perform an act with carelessness and without caution, and behavior contrary to good
acting without considering the rules of care.
Negligence: Carelessness or omission during medical practice, that is, doing what should not be done without
take the necessary precautions
60 JESCHECK, H-H; WEIGEND, T. (2002) Treatise on Criminal Law. General part. Translation of
Miguel Olmedo Cardenete. 5th ed. Granada: Comares
Medicine is the science and art of preventing and curing diseases of the human body.
consequently, the medical act will be that activity carried out by individuals, authorized
legally, to prevent, diagnose, treat, and cure diseases of the human body, in
the extent to which the knowledge of your science and the human, scientific resources
(medications) and technological (instrumentation) available, as long as they allow it.
The medical act has four main characteristics that distinguish it:
2.- Typical execution refers to the fact that its execution must be in accordance with the Lex Artis, that is, subject to
to the standards of excellence and quality prevailing at that time.
In the practice of the medical act, the medical professional is obliged to use all their
sufficient and available knowledge and means of their science and art with the purpose of preventing,
diagnose, treat, and cure a specific disease. Consequently, the doctor incurs a
obligation of means for the entrusted purpose, and not an obligation of result, therefore,
The object of medical liability is only an obligation of means that the physician undertakes.
This obligation of means occurs at the different stages of the medical act, whether at the stage
of diagnosing the pathology, as well as in the stage of medical treatment, as well in the
stage of the surgical act and in the postoperative stage of the patient.61
From this obligation of means that the practitioner incurs, their ...
medical responsibility, which may be administrative, civil or criminal, depending on the nature and
circumstances of the particular case.
61. KÜNSEMÜLLER, Carlos (1986) "Criminal liability of the medical act". Chilean Journal of
Law. Vol. XIII, pp. 259-269.
Since the obligation assumed by the doctor is an obligation of means, the fault will consist in not
having employed sufficient means for the entrusted purpose, not having been diligent,
prudent or skillful or not having taken all the precautions that would have prevented the damage, since
for example, a culpable error in the diagnosis will usually influence the treatment
doctor, which will in turn import a second misunderstanding, which will generally be the
What gives rise to medical quasi-offenses. Likewise, a case of misdiagnosis could occur.
and an appropriate treatment; of an erroneous diagnosis not followed by treatment and of a
accurate diagnosis followed by erroneous treatment.
In the first two cases, we will be faced with the offense provided for in the Penal Code.
punished, with a monetary fine, from the moment there was negligence
professional without causing harm; and in the third case, we will be faced with a fault, a quasi
crime or a quasi-crime according to the eventual results produced or caused, if any.
The true harm to the patient will occur in the treatment deemed appropriate, which was done
to rest on the diagnostic error.
1.- Obligation to inform about the outcome, that is, the duty to inform the patient about the results.
the obtaining of informed consent from the patient.
3.- Obligation of result for examinations and simple analyses: the diagnoses and medical examinations
are subject to the interpretation that the professional must make regarding their scope and possible
effects. But there are tests or laboratory analyses that do not present any element
random, which do not require interpretation and about which the patient can expect
legitimately a result free of errors (for example, the determination of the group
sanguine
Since the object of medical responsibility is merely an obligation of means that is contracted by the
optional, however, the doctor must adhere to and observe the LEX ARTIS at all times,
Latin phrase, literally "law of the art" or rule of the technique of acting in the profession
doctor.62
In general terms, lex artis is defined as: "The way of proceeding of a qualified professional,
professional who has their degree legally recognized by university bodies
accredited and has the training and knowledge necessary to be practicing.
The Lex Artis, in the case of negligent medical crimes, has been used to refer to that
evaluation of whether the executed act conforms to the standards of excellence of the moment. Therefore
Thus, the type of performance and the result obtained are judged, taking into account the characteristics.
specialists who practice it, the state of development of the professional area in question,
complexity of the medical act, the availability of elements, the economic context of the moment
and the specific circumstances of each disease and each patient.
However, it should never be forgotten that the medical professional works, according to the
circumstances, based on the so-called "Permitted Risk", meaning "that risk had to be taken"
risk" 63 as the only way to heal or save the patient, who could perfectly have been
carried out adhering to the lex artis and within the correct deontological framework, however, the result
it was death or injuries for the patient.
The lex artis imposes certain duties on the doctor, as a form of risk exclusion from error.
guilty, among others:
a) follow the progress of science, learn about new medications and procedures
surgeries that surpass previous ones.
b) maintain a professional practice in accordance with the protocols of action for the case in which it
correspond to intervene.
c) to adhere to the generally accepted rules of the science and art of specialized health
which is dedicated.
d) act with caution, seeking the opinion of other specialists in those doubtful cases and
that may weaken or exceed their medical judgment.
e) to be aware of their personal limitations regarding the act to be performed, in order to exclude the
eventual form of fault caused by incompetence, since only by recognizing it and avoiding a
acting in such a situation may exclude criminal behavior.
f) to maintain compliance with the regulations aimed at governing health actions, the
medical protocols, surgical protocols, etc., aspects of medical oversight, among others.
Under the lex artis, it is only considered permissible to allow some audacity in medical treatment or
surgical procedure on the patient, in the case of an incurable disease or imminent fatal risk.
In conclusion, the doctrine unanimously asserts that for the existence of responsibility
quasi-delictual, and consequently, for the existence of negligent medical liability, it
requires the copulative existence of five conditions:
5) that there is a causal relationship between the negligent act and the resulting damage.
It is the 'Modification of the structure of a tissue, under the influence of a morbid cause.'
injury, from the Latin laesĭo, is a damage, harm, or detriment. The concept is usually linked to the
physical damage caused by a blow, a wound or an illness. Clinical medicine affirms that
an injury is an abnormal change in the structure or morphology of a part of the body, that
It can occur due to internal or external damage. Injuries cause alterations in the
functions of organs, devices, and body systems, generating health problems.
Although many injuries cause diseases, there are diseases in which it is not possible.
clearly identify a morphological lesion, as in the case of mental illnesses.
Certain injuries, on the other hand, do not cause illnesses nor require treatment, as
The term evolves over time. In the field of law, the notion of injury has several uses.
It may refer to the crime that consists of causing physical or psychological harm to another person, of
damage suffered in connection with other contracts or the damage caused in sales due to not
concretize them at their fair price:
In criminal law, it is understood as: 'Crime or offense derived from the bodily harm inflicted.'
willfully to a person without the intent to kill.
* In medicine, we understand by lesion: 'The damage or morbid alteration, organic or functional of the
fabrics
It is evident, from its definition, the great difference in the meaning of a word, depending on
who the interpreter is. From a clinical standpoint, the lesion is nothing more than the situation that motivates
medical work. Both in the care activity and when exercising functions
As expert doctors, it is necessary that there is some type of 'injury' that justifies the activity.
since without 'injury or illness, there is no medical activity as such, it obviously remains
preventive activity set aside.
It is necessary for a person to indicate that they are experiencing some symptoms or that we observe some signs of
a morbid process, in order to establish the diagnosis of the existence of an organic lesion and
initiate the treatment process aimed at trying to heal, cure, or improve.
64 Meaning and scope of objective imputation in Criminal Law" in Cerezo Mir, José:
Modern trends in the science of criminal law and criminology. Madrid: University
National Distance Education, pp. 389-408
An injury is an abnormal change in the morphology or structure of a part of the body produced
due to an external or internal damage. Skin wounds can be considered injuries caused by
an external damage like trauma. Injuries cause an alteration of function or
physiology of organs, systems, and apparatus, disrupting health and producing disease.
It could be said that all diseases are caused by an injury, but in many
diseases where a clear morphological lesion cannot be identified, such as in diseases
mental. Furthermore, not all injuries cause an illness, nor do they require treatment.
The medical specialty responsible for identifying the injuries of diseases, generally
through biopsies is the pathological anatomy.
In Law and Forensic Medicine, injuries include, in addition to external wounds, any
damage to the body that can be objectively determined and caused by an external factor in which it is involved
a third person.
In terms of the Penal Code, injury is a crime against life and personal health that
commits for causing another harm that leaves a mark on their body or alters their physical health or
mental.65
Cause of the injuries: Injuries are caused by various harmful or damaging mechanisms.
that alter cellular balance or homeostasis. Among the causes of injuries we find:
External causes
Chemical causes: Such as corrosive substances on the skin, like toxins or poisons.
Biological causes: They correspond to infectious agents, whether viruses, bacteria, or parasites.
Internal causes
Hereditary diseases.
Manifestation of injuries
Cells, after suffering damage from an external or internal agent, can evolve into two
situations:
Cellular adaptation: They are a series of cellular changes that affect growth and
cell differentiation and manifest in the form of atrophy, hypertrophy, hyperplasia, and metaplasia.
In some cases, it may progress to dysplasia and neoplasia.
Cell death: Pathological or abnormal cell death is called necrosis and physiological death
The programmed one is called apoptosis.
KÜNSEMÜLLER, Carlos (1986) "Criminal responsibility of the medical act". Chilean Journal of
Law. Vol. XIII, pp. 259-269
Origin of the legal obligation: From the moment that a health agent accepts the admission of
a patient to a public or private establishment or from when he begins in the care of
a patient, a mandatory compliance contract is born and with this contract the
rights and obligations of the parties. The patient's right to receive the appropriate care and the
appropriate obligation of health professionals to provide it. At the same time, the right of the
professionals to receive compensation for their services and the obligation of the patient or the Hospital
or the Sanatorium or the prepaid medical company to satisfy such fees or remuneration
agreed monthly.
Health agents involved: The doctrine emanating from court rulings encompasses
jointly, as agents of malpractice, all health professionals from
Medical institutions and doctors up to nurses and assistants, who have participated in the
attention to the harmed patient, distinguishing only the severity of the penalty or sanction
economic, according to the degree of participation of the health agents involved in the
treatment, they may have had in the effective production of harm.
All healthcare actions that do not involve criminal liability, because not
constitute a crime or offense, cause damage, are subject to civil liability, that is to say to the
obligation of the person who causes the damage to compensate for it.
This is a general responsibility for any action or omission that causes harm.
intervening guilt or negligence, and the author of the damage as well as others will respond for it.
linked to him by different relationships.
The civil route is used in relation to medical health actions carried out under the protection of
of private centers or treatments by medical professionals in the exercise of their profession of
totally private form and the absolute margin of public health since when the
Medical professionals carry out healthcare actions under the protection of health services.
publicly, aside from doctrinal controversies, it is possible to demand the responsibility of the administration in
administrative route.
65 LUZON PEÑA, Diego-Manuel (2002) Course of Criminal Law: General Part I. Madrid:
University.
To begin with, it is necessary to express that error is perfectly logical in any activity.
human and medicine is not exempt from this, it is not infallible. But the right to make mistakes is,
also, a responsibility that the individual assumes. However, there is a very significant difference.
big between error and malpractice, and that it hides behind the fact that medicine is not a
exact science; because it is presumed that those who practice it are professionals who are required a
experience and a category, especially when what must be protected is nothing less than life
a human being.
The dictionary of the Royal Spanish Academy defines medical responsibility in the laws and the
jurisprudence as the obligation to repair or satisfy, by oneself or by another, as a consequence of
a crime, from a fault or another legal cause. Taking into account the premise of the definition above
marked and to be more precise with the legal rigor that the concept of responsibility deserves,
We can say that responsibility is the assumption of the legal effects of a behavior.
improper, causing a financial or extra-patrimonial detriment but economically.
appreciable to the victim or passive subject of said alteration, with the consequent obligation of
perpetrator of compensating for such damages.
Medicine carries a huge responsibility that arises from the characteristics that encompass it.
practice, which is why there is a basic concept that every procedure, whether therapeutic,
surgical or diagnostic, carries a risk for the patient, represented in that the
actions of the doctor that cause any damage or psychological or physical sequelae. This risk, which is
supported by the patient and must be taken on by the doctor or practitioner, obviously has some
legal implications, given that the affected party may resort to justice if they feel
harmed.
Currently, the most accepted element regarding the obligation to repair due to the act
Third parties is the obligation of security and guarantee, through which it seeks to ensure that it is provided
to the patient (as an obligation of means, exceptionally of results, and also of purpose
determined), a minimum level of security regarding the professionals in an institution
(public or private) work and on the adequate and necessary elements for the desired end, which...
it is that the preservation of health can be achieved.
Likewise, this legal figure does not intend, at a certain moment and in the face of evident harm
caused to the patient, demonstrate the subjectivity of the action or omission of a medical professional,
but the breach of the principle of security and good faith.
Frequently, the doctor faces the dilemma of choosing between two or more solutions. It is raised,
on one hand, it is what must be done for the patient's well-being, within the scientific criteria
prevalent, and which of the probable actions is the most favorable or least harmful to this;
agreement with the inherent risks of the medical act and always obeying the principles of
respect for life, for human integrity, for the preservation of health, among others. Despite
this, every medical professional, today, is subject to an unpleasant and bitter
situation represented either in a civil lawsuit or administrative (call for guarantee or
repeated action) or criminal accusation due to alleged medical malpractice.
For all this, the legal truth lurks and tarnishes the medical professional practice; and in many
cases are not to be taken lightly, since there are mistakes that cannot be justified and should not be overlooked
high, because what is put at risk or danger is the integrity and life of a human being and
consequently, it causes harm and pain to their loved ones. Therefore, to the extent that
companies and healthcare professionals recognize their decisive role in society, they must
to assume social responsibilities in the construction of values of integrity and commitment to
return to society in services and values, what they take from it to develop their activity.
LEGAL
Many professional organizations express concern about the progress being made.
professional responsibility. This concern is unfounded, and on the contrary,
First, the purging of professions must be considered before thinking about union solidarity.
Well, the sued professional, if declared responsible, must respond.
For example, doctors cannot show solidarity with the defendant who has broken the rules of
the profession, when in a state of intoxication surgically intervenes on a patient, that it
prescribe a medication with unknown consequences and does not control its
patient or what leaves some element inside the body after an intervention.
In this situation, the demand for the professional's responsibility must be appreciated as a
healthy mechanism and improvement of exercise, as excellence in professional services
It must be the aspiration of the whole society.
From a constitutional point of view: The doctor generically speaking, when causing harm
unlawful to an individual, whether due to incompetence, imprudence, negligence, or violation of
regulation, delegitimizes the State as it transgresses one of its crucial purposes.
Likewise, the superior statute grants us such responsibility by establishing that the exercise of the
freedoms and rights imply responsibilities that must be fulfilled by every person,
in accordance with the constitution and the laws, respecting the rights of others and not abusing them
own.
From an administrative point of view: This aspect refers to the condemnation of the entity to which the
the doctor provides his services through the action of direct reparation and in this matter it is worth
refer to the relevant regulations so that it is handled procedurally where
the State will be able to exercise action against the physician and there will be two years to file a lawsuit against
starting from the total payment of the sentence that has been imposed.
From a disciplinary point of view: The disciplinary code establishes in the Law that the offenses
disciplinary actions in which public officials will incur for the improper exercise of their duties,
The doctor will be responsible for their actions, whether they are serious or minor.
We must remember that in the exercise of disciplinary power, the investigations carried out by it
the Public Ministry organism is prevalent, which indicates that it will be displaced by express
constitutional provision any investigation that is being carried out for disciplinary reasons.
From a criminal perspective: The professional performance of the doctor is, in itself, extremely
complex, since the person providing a medical service may adapt to typical behaviors,
unlawful and guilty individuals sanctioned with a penalty, as regulated by our Code.
Criminal. Example of the possible typical actions in which a doctor may incur if they do not practice.
within the parameters of ethics, morality, and legality.
The result of jurisprudence and doctrine in our country is that labeling has been overcome.
what used to be given to medical activity, since when the random element disappears for the
patient recovery or when the goal is not healing but achieving a
determined well-being or relief in human integrity, we are faced with a typical
result responsibility, as would be the case of prosthetics or cosmetic surgeries, where the
The doctor must indeed achieve the goal he committed to with his patient.
Therefore, the aesthetic surgeon is required to have greater accuracy in their procedures, in order to
obtain the expected result.
70 CABRERA Oscar and HEVIA Martín. Medical Professional Secrecy and Health Services in the
Jurisprudence of the Inter-American Court of Human Rights. Argentine Journal of Theory
Legal, Number 13, June 2009.
Legal Techniques
Set of procedures to be able to apply the law. At the level of the creation of the norm,
set of indicators so that the standard is developed under a series of requirements in order to
avoid contradictions, inappropriate language, etc.
When the Legislative Body receives the regulation, it must review a series of requirements concerning its
formal structure, its language, etc.
a.- FUNDAMENTAL: Composed of conditions for the viability of the future regulation (viability: that
the standard meets the objective for which it was created) through:
The determination of the object: Clearly define the behavior that the norm will regulate.
public officials, doctors, students, etc.
Determination of the subjects: Population to which the future regulation is directed. For example, regulation
of national application, foreigners in the territory, etc.
Generality: Every legal norm must contain a pattern of fact for application.
indeterminate, in order to establish its abstract character.
Obligation: Every rule must be drafted in a coercive, binding manner that constrains.
Absence of contradictions: The legislator must ensure that situations are resolved without
contradictions in its content.
Irretroactivity: The norms are only applicable in present and future situations, not past ones.
Only in exceptional cases may it have retroactive effect.
B) FORMAL: It is the art of legislating. A special procedure provided for by the Constitution in order to create
the law. Determine whether it is an organic law, special law, or regulatory law. The new text, after the
publication, will express the will of the creator State (legislator). It does not change or distort the
fundamental technique.
69 VEGA Franz. Legal and Medical-Legal Considerations Regarding the Definition of Act
Medical issued by the College of Physicians and Surgeons of Ordinary, vol. 26 (1), March 2009. ISSN
1409-0015.
70 Atienza, Legal Sociology and the Science of Legislation, in Bergalli (ed.), Law and its
Realities. Research and teaching of legal sociology, Barcelona, PPU, 1989.
Article 1.- Everyone has the right to free access to health services and to choose the
preferred social security system.
Article 2.- Everyone has the right to demand that the resources allocated for their health care
correspond to the characteristics and attributes indicated in your presentation and to all those that
they were accredited for their authorization. Likewise, they have the right to demand that the services provided to them
they provide attention to their health, meet the quality standards accepted in the
institutional and professional procedures and practices.
Article 3.- Everyone has the right to receive care at any health facility.
emergency medical-surgical care when needed and as long as the state of serious risk persists
for your life or your health.
The regulation establishes the criteria for qualifying the state of emergency, the
refund conditions for degrees and the responsibilities of the drivers of the
establishments.
Article 4.- No person may be subjected to medical or surgical treatment without their
prior consent or that of the person legally authorized to give it, as applicable or if it exists
prohibited from doing so. Emergency interventions are exempt from this requirement. The refusal
receiving medical or surgical treatment exempts the treating physician and the
health establishment, if applicable. In the event that the legal representatives of the absolutely
incapable or relatively incapable individuals, to the General Health Law that refers to numerals 1
to Article 44, paragraph 3 of the Civil Code, deny their consent for medical treatment or
surgical care of the individuals in their charge, the attending physician or the health facility, as the case may be,
you must inform the competent judicial authority to facilitate the actions to which
there would be room for the safeguarding of their life and health.
The regulation establishes the cases and the formal requirements that must be observed for the
consent is deemed to have been validly given.
Article 5.- Everyone has the right to be duly and timely informed.
by the Health Authority regarding hygiene measures and practices, proper diet, mental health,
reproductive health, communicable diseases, chronic degenerative diseases,
early diagnosis of diseases and other actions leading to the promotion of lifestyle
healthy life.
You have the right to receive information about the risks associated with smoking and alcoholism.
drug addiction, violence, and accidents.
Likewise, you have the right to demand the Health Authority to provide you, without stating a reason,
information on health matters, in accordance with what is established by this law.
Article 6.- Everyone has the right to freely choose their contraceptive method.
preference, including the natural ones, and to receive, prior to the prescription or application
of any contraceptive method, adequate information about the available methods, their
risks, contraindications, precautions, warnings, and physical, physiological or psychological effects
that its use or application can cause.
For the application of any contraceptive method, prior consent is required from the
patient. In the case of definitive methods, the consent declaration must be included in
written document.
Article 7.- Everyone has the right to seek treatment for their infertility, as well as to
procreate through the use of assisted reproduction techniques as long as the condition of mother
genetics and the gestational mother falls on the same person. For the application of techniques of
assisted reproduction requires the prior written consent of the biological parents.
The fertilization of human eggs for purposes other than procreation is prohibited, as is the
cloning of human beings.
Article 8.- Everyone has the right to receive organs or tissues from living human beings.
cadavers or animals to preserve their life or recover their health. It can also arrange to
free title of their organs and tissues for transplantation, grafting or transfusion purposes, provided that
Hello, do not cause serious harm to your health or compromise your life. The disposition of organs and
tissues from living human beings are subject to the express and written consent of the donor.
representatives of the incapacitated, included within the Scope of Article 4 of this law,
they lack the legal capacity to grant it.
For the disposal of organs and tissues from cadavers, it will be in accordance with what is stated in the Document.
National Identity unless a subsequent declaration to the contrary is made in life by the deceased that
it is established in an undeniable manner and the cases provided for in Article 110 of this law.
In the event of a person's death, without them having expressed their wish to donate their...
Organs or tissues, or the refusal to do so, correspond to their closest relatives to decide.
Article 9.- Every person who suffers from a physical, mental, or sensory disability has the right to
Treatment and rehabilitation the State gives preferential attention to children and adolescents.
Article 10.- Everyone has the right to receive a healthy and sufficient diet to meet
their biological needs. The feeding of people is the primary responsibility of the
family. In nutrition and food assistance programs, the State provides support
preferentially to the child, to the pregnant and breastfeeding mother, to the adolescent, and to the elderly in situations of
social abandonment.
Article 11.- Everyone has the right to recovery, rehabilitation, and promotion of their health.
mental. Alcoholism, drug dependence, psychiatric disorders, and violence issues
familiar problems are considered mental health issues. Mental health care is
primary responsibility of the family and the State.
Article 12.- The obligations referred to in Articles 10 and 11 of this law are
demandable, by the State or by those who have a legitimate interest, from the responsible parties or relatives, with
arrangement according to what is established in Articles 473 and following of Book Three, Section Four, Title
1, Chapter I, of 'Food', of the Civil Code. In the case of children or adolescents, it will be taken into account
what the law of the matter stipulates.
In cases where, due to the absence of family, the person is unprotected, the State must
assume their protection.
Article 13.- Every person has the right to be issued a certification of their health status.
when I consider it appropriate.
No public authority may require individuals to provide certification of their health status, card
sanitary card, health card or similar document, as a condition for the exercise of activities
professionals in production, commerce, or related fields.
The provisions in this regulation do not exempt individuals from compliance with the
provisions related to the vaccination card or certificate, in accordance with what
establish the health standard, nor those related to the certification of their health status
as a requirement to obtain licenses to drive vehicles, vessels, and aircraft, or to handle weapons
or explosives according to the law of the matter.
Article 15.- Every person, user of health services, has the right:
b) To require the reservation of information related to the medical act and its medical history, with the
exceptions established by the law;
c) Not to be subjected, without their consent, to exploration, treatment or display for purposes
teachers
d) Not to be subjected to experimentation for the application of medications or treatments without being
duly informed about the experimental condition of these, the risks involved, and without
that it measures previously their written consent or that of the person legally authorized to give it,
if it corresponded, or if it were prevented from doing so;
e) To not be discriminated against on the basis of any illness or condition that may affect them;
f) That accurate, timely, and complete information about the characteristics of the service is provided.
the economic conditions of the service provision and other terms and conditions of the service;
g) To be provided in understandable terms with complete and continuous information about their process,
including the diagnosis, prognosis, and treatment alternatives, as well as the risks,
contraindications, precautions, and warnings of the medications that are prescribed to you and
administrate;
h) That everything necessary is communicated to them so that they can give their informed consent.
prior to the application of any procedure or treatment, as well as refusing it;
i) To whom the discharge report is delivered at the end of their stay in the health facility and, if
requests a copy of the crisis and of his medical history.
Article 16.- Everyone must ensure the improvement, conservation, and recovery of their
health and that of the people under their care.
The personal duty to take care of one's own health can only be demanded when such omission
is susceptible to negatively impacting public health or that of third parties.
Article 17.- No person may act or assist in practices that pose a danger.
detriment or harm to the health of third parties in the population.
Article 18.- Every person is responsible to third parties for non-compliance with practices.
sanitary and hygiene measures aimed at preventing the occurrence and spread of diseases
transmissible, as well as by the acts or facts that cause environmental contamination.
Article 19.- It is the obligation of every person to comply with the safety regulations established
the relevant provisions and participate and collaborate in the prevention and reduction of risks
for accidents.
Article 20.- It is the duty of every person to participate in the improvement of the health culture of their
community.
Article 21.- Every person has the duty to participate and cooperate with public authorities in
the prevention and solution of the problems caused
TITLE II
CHAPTER I
Article 23.- The incompatibilities, limitations, and prohibitions as well as the regime of sanctions.
applicable to the professionals referred to in this Chapter are governed by the Codes of
Ethics and statutory regulations of the Professional Colleges concerned.
Article 24.- The issuing of prescriptions, certificates, and reports directly related to the
patient care, the execution of surgical interventions, the prescription or
drug experimentation, medication, or any product, substance, or agent intended for
diagnosis, prevention or treatment of diseases are considered acts of professional practice
of medicine and are subject to the oversight of the corresponding Professional Colleges.
Article 25.- All information related to the medical act performed is confidential.
health professional, the technician or the assistant who provides or disseminates, by any means,
information related to the medical act in which he/she participates or of which he/she is aware, incurs
in civil or criminal liability, as the case may be, without prejudice to the corresponding penalties.
application of the respective Professional Codes of Ethics.
The reservation of information related to the medical act is exempted in the following cases:
c) When used for academic or scientific research purposes, provided that the
Information obtained from the medical history should be recorded anonymously;
d) When it is provided to family members or close relatives of the patient for the purpose of
to benefit it, as long as it does not expressly prohibit it;
e) When discussing diseases and damages that require mandatory declaration and notification, always
that it be provided to the Health Authority;
f) When it is provided to the insurance or financing management entity
linked to the care provided to patient 168 National Seminar. Medical Act. As long as
were with the purposes of reimbursement, payment of benefits, oversight or audit; and,
Article 26.- Only doctors can prescribe medications. Dental surgeons and the
Obstetricians can only prescribe medications within the scope of their profession. When prescribing
medications must obligatorily state their International Nonproprietary Name (INN), the
brand name if applicable, the dosage form, posology, dosage and period of
administration. They are also required to inform the patient about the risks,
contraindications, adverse reactions, and interactions that its administration may cause and
about the precautions that should be taken for its correct and safe use.
Article 27.- The treating physician, as well as the dentist and the obstetrician, are obligated to
inform the patient about the diagnosis, prognosis, treatment, and management of their problem
health, as well as the risks and consequences of them. To apply treatments
special, to conduct risky tests or to practice interventions that may affect psychological or
physically examining the patient, the doctor is required to obtain their written consent
informed.
Article 28.- Experimental research involving people must adhere to special legislation.
about the subject and the ethical principles contained in the Helsinki Declaration and subsequent ones
statements that update the referred principles.
Article 29.- The medical act must be supported by a truthful and sufficient medical history that
contains the practices and procedures applied to the patient to address the health problem
diagnosed. The minimum information that the medical history must contain is governed by the
regulations of the present law. The physician and the dental surgeon are required to provide
copy of the medical record to the patient in case they or their representative request it. The interested party
assume the cost of the order.
Article 30.- The doctor providing medical attention to a person injured by a knife wound, injury
from a firearm, traffic accident, or due to another type of violence in the General Health Law
constitutes a prosecutable offense ex officio or when there are indications of criminal abortion, is obliged
to inform the competent authority of the fact.
Article 31.- It is the responsibility of the treating physician, the forensic physician who performs the autopsy or
from the doctor indicated by the health facility where the death occurs of the
person, to properly issue the corresponding death certificate.
Article 32.- Health professionals, technicians, and assistants are obliged to inform the
Health Authority cases of diseases and damages that are subject to mandatory declaration and notification.
Article 33.- The pharmaceutical chemist is responsible for dispensing and providing information.
user guidance on the administration, use, and dosage of the pharmaceutical product, its
interaction with other medications, their adverse reactions, and their storage conditions.
Likewise, you are authorized to offer the user alternatives of chemical medications.
pharmacologically equivalent to the prescribed medication in the same pharmaceutical form and dosage.
Article 34.- Health professionals who detect adverse reactions to medications that
gravity magazine, they are required to report to the National Health Authority, or to
who is this delegate, under responsibility.
Article 35.- Those who engage in professional, technical, or auxiliary activities related to
the health of individuals will be limited to practicing in the area that the title, certificate or authorization
legally issued determine.
Article 36.- The professionals, technicians, and assistants referred to in this Chapter are
responsible for the damages and harm caused to the patient due to negligent practice,
imprudent and inexperienced in his activities.
Article 37.- The health establishments and the medical support services, regardless of their
nature or management modality, must meet the requirements set forth by the regulations and
technical standards issued by the National Health Authority regarding physical facilities,
equipment, support staff, sanitation systems, and risk control related to
the physical, chemical, biological, and ergonomic environmental agents and National Seminar. Act
Doctors proceed attending to the nature and complexity of them.
The national health authority or whoever it delegates will periodically verify the
compliance with the provisions set forth in this regulation.
Article 38.- The health establishments and services referred to in this Chapter,
are subject to periodic evaluation and control and the audits provided by the Authority of
National health.
The national health authority issues the standards for evaluation, control, and auditing.
corresponding.
Article 39.- Health establishments, without exception, are required to provide care.
emergency medical-surgical, to those who need it and while the serious risk situation persists
for your life or health, in the manner and conditions established by the regulations.
Article 40.- Healthcare facilities and medical support services have the duty to
inform the patient and their family about the characteristics of the service, the conditions
economic aspects of the provision and other terms and conditions of the service, as well as the aspects
essentials related to the medical act.
No healthcare facility or supportive medical service may carry out actions that
correspond to acts that have not been previously authorized by the patient or by the person
legally summoned to do so, if applicable, or being unable to do so, in accordance with
with what is established by the regulations of this law.
Article 41.- Every health facility must, at the time of admission, record
written the patient's will to donate, in case of death, their organs and tissues for purposes of
transplant, graft, teaching or research, or, if applicable, the refusal to do so. It is exempt from
the provisions in this regulation the emergency admission.
Article 42.- Any medical act carried out in a health establishment or service
supporting doctor is susceptible to external audits in which various aspects can be verified
procedures to which the patient is subjected, whether to prevent, diagnose, or cure,
rehabilitate or conduct research actions.
Article 44.- Upon the patient's discharge, the person in charge of the health facility is obliged to
deliver to the patient or their representative the discharge report that contains the diagnosis of
admission, the procedures performed, the discharge diagnosis, prognosis, and recommendations of
condition that warranted hospitalization.
Similarly, when the patient or their representative requests it, a copy must be provided to them.
medical history, in which case the cost will be borne by the interested party.
Article 45.- The removal of organs or tissues for the purposes of transplantation or grafting may only be
to be carried out in duly accredited health establishments or in medical institutions-
legal, complying, in each case, with the procedures established by law. The transplants of
organs or tissue grafts can only be performed in health establishments that have
with duly accredited specialized services for this purpose.
The removal of organs and tissues as well as their transplantation or grafting are governed by
current law, the law of the matter and its regulations.
Health establishments may only dispose of organs and tissues for transplantation purposes or
free of charge graft
The health establishments authorized by the national Health Authority may install
and maintain, for therapeutic purposes, physical banks of organs and tissues.
Article 46.- The activities of obtaining, donating, conserving, transfusing, and supplying
human blood, its components and derivatives, as well as the functioning of blood banks,
blood therapy centers and hemo-derivative plants are governed by the law of matter and its
regulations and are subject to the supervision and oversight by the Health Authority of
national level or to whom it delegates.
It is not appropriate to practice necropsies for clinical reasons when the circumstances of the death of the
patients imply the obligation to perform the legal autopsy.
It is solely responsible for the damages and injuries inflicted on the patient due to not
having arranged or provided the means that would have prevented them from occurring, as long as
the provision of such means is enforceable considering the nature of the service provided.
Article 49.- The national health authority is responsible for health control of the
pharmaceutical and galenic products, as well as ensuring compliance with the regulations
that on the subject are established in this law and the regulation.
* USP
British Pharmacopoeia
German Pharmacopoeia
French Pharmacopoeia
Belgian Pharmacopoeia
European Pharmacopoeia
USP-DI
Swiss Pharmacopoeia
Japanese Pharmacopoeia
The obtaining of the Sanitary Registry for medications shall not be required under any condition.
by the health authority other documents, prior requirements or any kind of conditionality,
that those indicated below, under responsibility:
a) Application with the nature of a sworn statement including the corresponding registration number
Unified of the natural or legal person requesting, and ensuring quality, safety, and efficacy.
of the product.
b) Analysis protocol based on the methodological framework of one of the authorized pharmacopoeias.
c) Certificate of free marketing and certificate of consumption from the country of origin, issued by
the competent authority. Alternatively, both certifications may be included in a single
document
d) Project for labeling of the immediate and outer packaging in Spanish. They may also
producers who have not yet registered, whose formulation is not included in the works mentioned above.
designated, that are authorized by the competent authorities of the country of origin.
In this case, the requirements established in paragraphs a), c), and d) of this document will be enforceable.
article. Regarding the analysis protocol mentioned in paragraph b), it must be supported
in the methodologies applied in your country of origin, which will serve as a basis for the subsequent control of
quality.
The registration in the Sanitary Registry of medicines is automatic, with the mere presentation of
the documents established in this provision, with the health authority having a period
a maximum of 7 working days to issue the document certifying the registration number.
National Medicines, which contains the list of medications that are registered
sanitary in the country. Said Form automatically incorporates the registered products.
The National Form will be prepared by a Commission of Experts, whose composition and
functions will be determined by the corresponding regulation, and will specify the form
pharmaceutical, dosage, indications, contraindications, adverse reactions, warnings and others
specifications that ensure the efficacy and safety for the use of medications.
The guidelines for the preparation and update of the aforementioned Form are established in the
regulation.
Article 52.- For the importation of pharmaceutical and galenic products, the Customs of the
Republic, under responsibility, will proceed to dispatch the same requiring only a
sworn statement stating the following:
a) the sanitary registration number, or failing that, the date of submission of the application
corresponding; and
b) identification of the shipment by production batch and expiration date of the medication;
without prejudice to the general documentation required for imports. Additionally,
In the case of pharmaceutical products derived from human blood, it will be required for each batch of
manufacturing, an Analytical Certificate of negativity for human immunodeficiency viruses and
viral hepatitis A and B. The company name and the unified registration of the importer or general distributor.
must be clearly indicated by printing or labeling on each sales package
consumer, together with the expiration date of the medication.
The national health authority may provisionally authorize, in duly justified cases
qualified, the import and sale, without prior registration, of the products included in the
present chapter that corresponds, for emergency medicinal uses.
Article 53.- For exclusive research purposes, the importation, production, and
use of unregistered medications, in accordance with regulatory provisions
corresponding.
Article 54.- The Health Registration is temporary and renewable every five years.
The national Health Authority may suspend or cancel the registration of the products.
that do not meet the technical specifications that support their granting. Likewise
the suspension or cancellation of the Sanitary Registry will proceed when scientific information
from the World Health Organization determine that the product is unsafe or
ineffective in its use in the terms under which its registration was authorized.
Article 55.- The manufacturing, importation, possession, distribution, and transfer of is prohibited.
any title, of pharmaceutical products and others that the regulation indicates, contaminated,
adulterated, counterfeit, altered, and expired. The aforementioned products must be
immediately withdrawn from the market and properly destroyed, under responsibility.
Article 56.- In order to carry out their activities, natural or legal persons engaged in
manufacturing or storage of pharmaceutical products or carry out part of the processes that
these must have premises, technical equipment, and adequate controls
sufficient as established by the regulations. Likewise, they must adhere to the Good Practices of
Manufacturing, Laboratory, and Storage recommended by the World Organization of
the Health or those issued by the national Health Authority, and to the technical standards of
manufacturing as appropriate.
The National Health Authority or its delegate will periodically verify the
compliance with the provisions established in this regulation.
Article 57.- The entity responsible for the quality of pharmaceutical products is the manufacturing company.
if they are produced in the country. In the case of products made abroad, the
Responsibility lies with the importer or distributor.
When it comes to laboratories tasked with producing products on behalf of third parties, whether it is
in its entirety or at some stage of the production process, the responsibility for the
The quality of the product is jointly assumed by it and by the company that holds the Register.
Article 58.- Pharmaceutical products that are marketed in the country and others that
They must respond in their qualitative and quantitative analyses to the formula and
composition declared by the manufacturer and authorized for its manufacture and sale upon granting the
Sanitary Register.
Article 59.- The quality control of pharmaceutical products and other products that
correspondence is mandatory, comprehensive, and permanent. To ensure its quality, companies
manufacturers, under responsibility, must have a quality control system that encompasses
all aspects of the production process, from the raw materials used to the
finished products.
Article 60.- The national Health Authority is responsible for monitoring the quality of the
products covered in this Chapter. The control is carried out through inspections in the
manufacturers, distributors, and dispensaries and the execution of sample analyses
products researched at any of their stages of production, distribution, and sale.
Article 61.- The narcotic drugs, psychotropics, and precursors for medical use included in the
International agreements on the subject and those determined by the Health Authority at the level
national, are governed by this law and by its special legislation.
Article 62.- The National Health Authority establishes a list of medicinal plants of
restricted or prohibited use due to its toxicity or danger.
Article 63.- The marketing of medicinal plants and their preparations obtained in the form of
extracts, freeze-dried, distilled, tinctures, decoctions or any other galenic preparation with
therapeutic, diagnostic or preventive purpose in the condition of magistral formulas,
official preparations or medications are subject to the requirements and conditions established by the
regulation.
The national health authority or its delegate will periodically verify the
compliance with the provisions established in this disposition.
Article 66.- The chemical-pharmaceutical professional who assumes the technical direction or management of
Any pharmaceutical establishment is responsible for how it affects the identity, purity and
good condition of the products that are elaborated, prepared, handled, stored, or supplied in
these.
The responsibility of the technical director or the manager does not exclude, in any case, the
responsibility of the pharmaceutical establishment.
Article 67.- Medications must be identified by their brand name if they have one, and
with its International Nonproprietary Name (INN), established by the World Health Organization
Health.
DCIs or any others will not be able to be registered as trademarks to distinguish medicines.
designations that may be confused with these.
Article 68.- The national health authority will classify pharmaceutical products for
effects of its sale in the following categories:
a) For sale with a special numbered prescription presentation, which can only be dispensed in
pharmacies and drugstores, which will comply with the requirements set forth by the agreements
international agreements of which Peru is a part, the law on the subject and its regulations;
c) Over-the-counter sales that are sold exclusively in pharmacies and drugstores; and,
Article 69.- They may be subject to publicity through means that are within reach of
the general public, the pharmaceutical products that have Health Registration in the country and
authorized for sale without a prescription.
In addition to what is provided in the general regulations on advertising in defense of the consumer, the
advertisement aimed at the general public, must not contain exaggerations about its
properties that may mislead the consumer.
Only in exceptional cases and considering duly justified reasons, the Health Authority of
The national level may determine the pharmaceutical products that are sold by prescription.
they can be subject to advertising through means that are accessible to the public in
general. In this case, the advertising will prompt the consumer to read the instructions contained in the
prospectus or insert that accompanies the pharmaceutical product.
Article 71.- The promotion and advertising of pharmaceutical products authorized for sale under
medical prescription is restricted to the professionals who prescribe and dispense them. In the
in the case of graphic advertising, it can only be done through magazines
specialized, brochures, prospectuses, or any other printed form that contains information
technical and scientific.
By exception, the dissemination of introductory announcements and reminders directed at the
professionals from the Medical and Pharmaceutical Corps through means accessible to the public in
General. The content of the information provided is subject to the norm established by the Authority
National health dictates on this matter.
Article 73.- Producers and distributors of medications are obligated to inform the
National health authority the adverse reactions of which they have knowledge and that
could have arisen due to the use of the medications they manufacture or market, under
responsibility.
Article 74.- The national health authority collects and evaluates information on the
adverse reactions of the medications that are marketed in the country and adopts measures to
that there would be place for safeguarding the health of the population.
Article 75.- The National Health Authority ensures the rational use of medications,
promoting the provision of essential medications.
TRANSMISSIBLE DISEASES
Article 76.- The national health authority is responsible for directing and regulating the
actions aimed at preventing the spread and achieving the control and eradication of diseases
transmissible throughout the national territory, exercising epidemiological surveillance and intelligence
sanitary and issuing the corresponding provisions.
Likewise, it has the authority to promote and coordinate with individuals and public institutions or
private the execution of activities in the epidemiological and health field.
Article 77.- The competent Health Authority is responsible for the control of diseases.
transmissible within the scope of their jurisdiction.
Article 78.- The National Health Authority will determine the communicable diseases.
of mandatory declaration and notification. All natural or legal persons are obligated
to provide such epidemiological information, within the terms of responsibility,
classification, periodicity, destination and clarity as stated in the regulation.
Article 79.- The Health Authority is empowered to issue prevention and control measures.
to prevent the appearance and spread of transmissible diseases. All people
natural or legal persons, within the territory, are obliged to comply with these measures,
under sanction.
Article 80.- Exceptions may only be established for medical or biological reasons.
mandatory vaccination and revaccination, established by the National Health Authority.
Article 81.- The administrative, municipal, military, and police authorities, as well as the
Individuals are obligated to provide the support required by the Health Authority to control
the spread of communicable diseases in the areas of the national territory where
these acquire serious epidemic characteristics.
Article 82.- In the fight against epidemics, the Health Authority is authorized to dispose
the utilization of all medical assistance resources from the public and private sectors
existing in the affected areas and in the neighboring ones.
Article 83.- The Health Authority is responsible for health monitoring and control.
borders, as well as all maritime, air, river, lake, or land ports in the
national territory.
Article 84.- Temporarily, and only for reasons of public health, the Health Authority can
restrict the carrying out of activities related to the production of goods and services and those of commerce, as thus
as the transit of people, animals, vehicles, objects, and items that represent a serious
health risk to the population.
of this law, its regulations and the technical standards issued by the Health Authority of level
national, as well as by the treaties and international agreements to which Peru is a party.
Article 86.- Natural or legal persons who work with viruses, fungi, bacteria, or their
components and, in general, with biological agents hazardous to human health, must
comply with the corresponding biosafety measures. Their activities are subject to
surveillance by the competent Health Authority.
Article 88.- The production and trade of food and beverages intended for human consumption
as alcoholic beverages are subject to hygiene and health surveillance, in protection of the
health.
Article 89.- A food is legally fit for human consumption when it meets the
characteristics established by the health and quality standards approved by the Authority of
National health.
Article 91.- All food and beverages produced industrially, of national production or
foreign, can only be issued after Health Registration.
Article 92.- The National Health Authority is responsible for sanitary control of the
food and beverages, cosmetic products and similar items, as well as supplies, instruments and
medical-surgical or dental use equipment, sanitary products, and hygiene products
personal and domestic.
The Sanitary Registry of food and beverages, cosmetic products and similar items, as well as of
supplies, instruments, and medical-surgical or dental equipment, sanitary products and
personal and household hygiene products, will be automatic with just the presentation of a
request with the character of a sworn declaration stating the number of the unified registry of the
natural or legal person requesting, and the certification of free commercialization and use, being able to
to include both in a single document, issued by the competent authority of the country of origin or
of product export.
Registration in the referred Health Register is automatic, with the mere presentation of the
documents established in this provision, with the health authority having a deadline
a maximum of 7 working days to issue the document that certifies the registration number.
The mentioned Sanitary Registry is temporary and renewable. The Customs of the Republic
they will proceed to dispatch the goods referred to in this article, also requiring
of the general documentation required for importation, only the sworn declaration of the
importer stating the sanitary registration number, or failing that, the date of submission
from the corresponding application, as well as the expiration date in the case of food
packaged, the same that must be indicated by printing or labeling on the sale containers
consumer, together with the business name and Unified Registry of the importer or distributor
general.
Article 93.- The importation of any food or beverage whose trade, distribution and
consumption is not allowed in the country of origin as it poses a risk to health.
Article 94.- The personnel involved in the production, handling, transportation, preservation,
storage, sale, and supply of food must be carried out under conditions
hygienic and sanitary to prevent contamination.
The National Health Authority or its delegate will periodically verify the
compliance with the provisions established in this regulation.
Article 97.- When the importation, manufacture, transportation, storage, trade, and use
if a substance or product is considered dangerous to the health of the population, the State must
establish the corresponding protection and prevention measures.
Article 98.- The competent Health Authority issues regulations related to the qualification of
the hazardous substances and products, the conditions and limits of toxicity and danger of
said substances and products, the requirements regarding information, packaging, container, packaging,
transport, labeling and other aspects required to control risks and prevent damage
that these substances and products may cause harm to people's health.
Article 99.- The waste generated from establishments where they are manufactured,
formulate, package, or handle hazardous substances and products must be subjected to the
treatment and disposal indicated by the relevant regulations.
Such waste should not be discharged directly into water sources, courses, or reservoirs.
on the ground or in the air, at your own risk.
Article 100.- Those who lead or manage extraction, production, transportation activities
and trade in goods or services, whatever they may be, have the obligation to adopt the
necessary measures to ensure the promotion of health and safety of workers
of third parties in their facilities or work environments.
Article 101 - The hygiene and safety conditions that must be met by the workplaces,
equipment, machinery, facilities, materials, and any other elements related to the
performance of activities related to extraction, production, transportation, and trade of goods or services,
are subject to the provisions set forth by the competent Health Authority, which will oversee their
compliance.
Article 102.- The hygienic and sanitary conditions of all workplaces must be
uniforms and consistent with the nature of the activity being carried out without distinction of rank or
category, age or gender.
Article 103.- The protection of the environment is the responsibility of the State and individuals.
natural and legal persons, who have the obligation to maintain it within the standards that for
to preserve the health of individuals, the competent Health Authority is established.
Article 104.- Any natural or legal person is prohibited from discharging waste or
pollutant substances in water, air, or soil, without having taken the necessary precautions.
purification in the manner indicated by health and environmental protection regulations.
Article 105.- It is the responsibility of the competent Health Authority to issue the necessary measures to
minimize and control the health risks to individuals arising from elements, factors and
environmental agents, in accordance with what is established, in each case, by the law of the matter.
Article 107.- The supply of water, sewage, disposal of excreta, reuse of water
servers and waste disposal are subject to the provisions issued by the
Competent Health Authority, which will monitor its compliance.
Article 108 - Death puts an end to the person. The definitive cessation of life is considered absence of life.
the brain activity, regardless of whether some of its organs or tissues remain
biological activity and can be used for transplantation, grafting, or cultivation.
The founded diagnosis of definitive cessation of brain activity verifies death. When it is not
possible to establish such a diagnosis, the confirmation of irreversible cardiorespiratory arrest confirms
death.
None of these criteria that demonstrate or corroborate the death of the individual by verification,
they may be listed as causes of it in the documents that certify it.
Article 109.- The practice of the necropsy is allowed in the following cases:
a) For clinical reasons, to evaluate the accuracy and diagnostic precision and the quality of
patient treatment
b) For cremation purposes, to determine the cause of death and anticipate disappearance of
evidence of the commission of crimes;
c) For health reasons, to establish the cause of death for the purpose of protecting the
third-party health; and,
d) For medico-legal reasons, to determine the cause of death, in cases where the law requires it.
establish or when ordered by the competent judicial authority, or to clarify the identity of the
deceased.
Only the autopsy for clinical reasons requires the authorization referred to in Article 47 of
the present law.
The arrangement of organs and tissues from cadavers for the purposes outlined in this provision.
is governed by this law, the law of the material and its regulation.
Article 112.- Any corpse that enables the spread of diseases shall be cremated.
preliminary autopsy.
Article 113.- The competent Health Authority is obliged to order the eradication of
cemeteries when their location poses a risk to health.
Article 114.- The bodies of unidentified persons or, having been identified, not
they would have been claimed within thirty-six (36) hours after their entry to the
morgue, they may be dedicated to research or study purposes. For the same purposes, they may
to use corpses or human remains by the explicit will of the person before their death or
with the consent of their family members.
Article 115.- The burial, exhumation, transfer, and cremation of corpses or human remains,
the operation of cemeteries and crematories is governed by the provisions of this
law, the law of matter and its regulations.
Article 117.- Every natural or legal person is obliged to provide correctly and
opportune the data that the Health Authority requires for the elaboration of the statistics, the
evaluation of health resources and other special studies that need to be conducted and
they come together to understand health problems or the measures to address them.
Article 118.- In case of a declared epidemic or the danger of an epidemic, the press, the radio, the
Television and all other means of social communication must collaborate with the Health Authority.
competent in the manner that the Executive Branch disposes.
Without prejudice to the provisions in the general regulations on advertising in defense of the consumer, the
advertising about health service provision cannot offer preventive treatments,
dressings or rehabilitation methods whose effectiveness has not been scientifically proven.
Article 120.- All health information that public sector entities have
in their possession is public domain. Excluded is information that may affect the
personal and family intimacy or self-image, national security and foreign relations,
as well as that which refers to aspects protected by industrial property regulations
compliance with the law of the matter.
Article 121.- It is the obligation of the competent Health Authority to warn the population, for the
channels and media that are more suitable and best fit the circumstances, regarding the risks and
damages that certain products, substances, or can cause or may cause to health
activities.
Article 122.- The Health Authority is organized and exercised at a central, decentralized level and
decentralized. The Health Authority is exercised by the bodies of the Executive Power and the bodies
decentralized governments, in accordance with the powers granted to them by their
respective laws of organization and functions, organic laws or special laws in the field of
health.
Article 123.- It is understood that the National Health Authority is the specialized body
of the Executive Power responsible for the direction and management of the national health policy and
acts as the highest regulatory authority in health matters.
Article 124.- In application and compliance with the health regulations issued by the Health Authority
at the national level, the decentralized or deconcentrated bodies are empowered to
establish, within its scope, general or specific prevention and control measures
in the subjects of their competence.
Article 125.- The decentralized exercise of control competencies in health matters does not
does not imply, in any case, the exercise of regulatory competition, unless otherwise stipulated
the law itself.
The delegation of control powers in the field of health does not imply, in any case, the
delegation of regulatory powers.
Article 126.- No regulations may be issued that govern laws or that have hierarchy.
equivalent, that impact health matters, without the endorsement of the Health Authority at the level
national.
Article 127.- Subject to the supervision of the National Health Authority are the
public entities that by their organizational laws and functions, organic laws or laws
Specialized agencies are authorized to control health and environmental aspects.
Likewise, the schools are subject to super surveillance by the national Health Authority.
Health science professionals, only in regard to the surveillance they
they carry out on the activities that their associates perform in the exercise of their profession.
Article 128.- In the exercise of the powers granted by this law, the organic laws,
laws of organization and functions, other special laws, and regulations, the Health Authority
is authorized to carry out orientation and education activities, conduct inspections in any
whether movable or immovable property, take samples and proceed with the corresponding tests, gather
information and take any other actions deemed necessary to comply with your
functions, as well as, if applicable, apply safety measures and penalties.
Article 129.- The Health Authority may request the assistance of public force to ensure the
compliance with the provisions and measures adopted to safeguard health.
a) Isolation;
b) The quarantine;
c) Personal observation;
e) Animal observation;
k) The confiscation, seizure, immobilization, withdrawal from the market or destruction of objects,
products or substances;
l) The temporary suspension of production and trade activities and the restriction of
transit of people, animals, vehicles, objects, and items;
o) Those that, in the opinion of the Health Authority, are considered to be healthily justifiable,
to prevent any risk or harm to the health of the population from occurring or continuing.
Article 131.- Security measures are immediately enforceable and are applied without prejudice to the
corresponding sanctions.
Article 132.- All security measures taken by the Health Authority in application of the
The present law is subject to the following principles:
b) Its duration should not exceed what is required by the imminent and serious risk situation that the
justified; and,
c) Preference should be given to those measures that, while effective for the intended purpose, are less
harm the principle of free movement of people and goods, the freedom of enterprise
and any other affected rights.
Article 133.- The regulation establishes the procedure for the application of the measures of
security referred to in this Chapter.
Warning
b) Fine
Article 135.- When imposing a sanction, the Health Authority shall take into account:
Article 136.- All sanctions for the closure and temporary shutdown of establishments, as well as for
suspension or cancellation of the Sanitary Registration of products must be published, at the expense of
infractor, by the Health Authority in the manner established by the regulations.
Article 137.- The regulation establishes the classification of violations, the scale of penalties and the
procedure for its application.
First.- The establishments referred to in Article 37, the establishments dedicated to the
activities included in Articles 56, 64, 95, 96 of this law, as well as the agencies
funeral homes, wakes, and other funeral services related to them do not require
health authorization for its habilitation or operation.
Second.- The national health authority determines the fee for registration.
sanitary, which may not exceed 10% of the Tax Unit. The income
proceeds from this concept will be used exclusively for inspection actions and
quality control. Third.- In cases of sudden or accidental death, and until it is complete
The exchange of the Electoral Booklet for the National Identity Document referred to by the Laws
Nos. 26497 and 26745, the positive will of the deceased to donate their organs or tissues is presumed.
for transplantation or grafting purposes, without the acceptance of contrary evidence.
c) Law No. 2348, of November 23, 1916, on Declaration, Isolation and Disinfection
Mandatory Diseases;
d) Law on the Practice of Medicine and Pharmacy, dated November 28, 1888;
e) Decree Law No. 25596 which establishes the requirements for obtaining the Registration
Sanitary and Authorization for the importation and marketing of generic medicines and
of brand;
f) Third Complementary Provision of Decree Law No. 25988, on health card, as well as
any legal, administrative, and technical provision that establishes the obligation to obtain and
carry a health card or similar document, and
Fifth.- The Ministry of Health, within a maximum period of thirty (30) days, counted from the
validity of the present law, will present, for its approval, the regulations that are required for
the implementation of the provisions of this law.
Sixth.- This Law will come into force one hundred eighty (180) calendar days after its
publication, with the exception of Chapters III and V of Title Two, which govern from the day
following the publication of this Law.
JURISPRUDENCE
Jurisprudence is the correct interpretation and scope of the legal precepts issued by a
jurisdictional body when resolving the matters brought to its consideration, resulting in
mandatory for other lower jurisdictional bodies. The Mexican legal system provides for
the figure of jurisprudence in articles 192 to 197-B of the Amparo Law. It is a figure
process related to the amparo trial and aims to create legal certainty so that
cases that are submitted for consideration by judges be resolved in the same manner in order to avoid
contradictory criteria.
The contradiction of theses between Circuit Collegiate Courts can be resolved by the Chambers or
the Plenary of the Supreme Court of Justice of the Nation. In contrast, the contradiction of theses between
The chambers of the Supreme Court of Justice of the Nation can only be resolved by the Plenary.
this.
In order for there to be a contradiction of theses, it is necessary that it takes place between organs of equal
hierarchy, so it cannot take place between a Supreme Court Chamber and a Court
Collegiate.
It is important to mention that in addition to the case law due to reiteration and contradiction of
thesis, the Supreme Court of Justice of the Nation has ruled that the arguments presented in the
constitutional controversy rulings and actions of unconstitutionality also have the
character of jurisprudence. However, unlike jurisprudence by reiteration, by
contradiction of thesis and dealt with the unconstitutionality of a law or regulation, has no as
effect the repeal or nullification of the regulation declared unconstitutional.
Case law has procedural effects in the amparo trial, since the review resources
derivatives of indirect amparo trials challenging a federal law that has already been
declared unconstitutional through jurisprudence may be resolved by the Courts
Circuit Courts, without the need to refer the review resource to the Supreme Court of
Justice of the Nation.
In order for a jurisprudence to be interrupted, the same body that created that jurisprudence
must issue a contradictory ruling. Likewise, it is necessary for the ruling
that interrupts the jurisprudence is issued with the same suitable vote to integrate it, is
to say, by four votes if it is a Chamber of the Supreme Court of Justice, by eight votes if it is
by the Plenary of the Supreme Court and unanimously if it is from a Collegiate Circuit Court.
When a jurisprudence is interrupted, it loses its mandatory character. For this reason, the
lower courts that were previously forced to comply with case law will
freedom to decide whether to follow the criteria of interrupted jurisprudence, the criteria of the ruling
that interrupts her or, even, a different criterion.
The modification of jurisprudence occurs when the Ministers of the Supreme Court of
National Justice or the Magistrates of the Collegiate Circuit Courts request the body
that issued the jurisprudence its modification. In this regard, the Supreme Court of Justice has
determined that the modification of the jurisprudence is not limited to accidental elements of
the jurisprudence, but its essence and even its meaning can be altered.
Publication of Jurisprudence
The jurisprudence of the Plenary and Chambers of the Supreme Court of Justice of the Nation and the Courts
Circuit Collegiate Courts are published in the Judicial Weekly of the Federation, where it is stated that
heading, text and precedents that make up each of the case laws.
The Supreme Court of Justice has ruled through jurisprudence that for jurisprudence to be valid
mandatory sea does not need to be published, but the requirements must be met that
establish Articles 192 and 193 of the Amparo Law.
Supreme Court of Justice of the Nation (2004). Jurisprudence - its integration. Mexico City:
Supreme Court of Justice of the Nation. ISBN 970-712-355-9.
Supreme Court of Justice of the Nation (2005). Jurisprudence in Mexico. Mexico City: Supreme
National Court of Justice. ISBN 970-712-412-1.
The Amparo Trial
Góngora Pimentel, Genaro (2003). Introduction to the Study of Amparo Judgment. Mexico City:
Porrua Editorial. ISBN 970-07-3794-2.
Supreme Court of Justice of the Nation (2003). Amparo Trial Manual. Mexico City:
Editorial Themis. ISBN 968-454-451-0
CONCLUSIONS
The protection, promotion, and restoration of health, as well as the way in which care is provided
Medical services must be provided, they constitute an essential area in the task of any government.
Today we see that, despite the fact that the doctor is becoming more skilled in their specialty,
new techniques, pharmaceutical and scientific advances, updated through courses, conferences and
conferences, there is a significant increase in complaints about medical liability.
We have to reflect on the reason for this circumstance. It is likely that one of the reasons is
It is because many times the patient considers their healing as a right and not as
a possibility. If this is not achieved, the professional's attention is regarded as a failure.
In addition, our healthcare culture is very deficient; patients are, on many occasions,
in addition to being demanding, they are not very cooperative; but that is also part of a poor performance of
the health institutions and, in many other cases of medical training, of teaching in
health, of the number of people that a doctor must attend to in public service, of the number of
the hours they work and so many factors that you, better than me, could mention.
The practice of medicine poses a significant number of risks and it must be acknowledged that it does not
A positive outcome for the patient can always be guaranteed, without it implying neglect.
the negligence on the part of the practitioner.
It is true that the provider of this service is obligated to repair the damage when it occurs.
due to causes attributable to himself; but it is also true that, in pursuit of easy profit through a
monetary compensation, some patients advised by unethical lawyers see it as
doctor as the person who can "collaborate financially" to help them survive in their
needs.
That is why the doctor must have greater knowledge of what the exercise of their...
profession, in all aspects both academic, practical and from a legal point of view, is given
should provide ongoing advice to stay updated for better practice
educated in their profession. And also to raise awareness among patients that doctors are not gods who
they are human beings and that sometimes, and also to make patients aware that doctors do not
they are gods who are human beings.
One of the pieces of advice that any sensible lawyer should give to a doctor is to hire a
professional liability insurance. The main purpose of the insurance is to provide security to
optional when absorbing the risks derived from medical practice. However, it must be done
mention that the abuses in this coverage system have led other countries to extremes
unimaginable conflicts in the insurance sector that are not at all desirable to import.
The insurance will cover the consequences of the actions or omissions attributable to the professional, for the purpose of
to respond for what is owed to the patient or their beneficiary due to liability
civil or criminal in which I may incur.
Perhaps, the best recommendation that can be made to avoid professional liability is to
doctor and ensure, at the same time, adequate medical care, whether it is to promote a
culture of prevention among service providers and users, as a little is useful a
monetary compensation if one of the most valuable gifts has been lost or diminished
life: health.
That is why the doctor must have greater knowledge of what the exercise of his
profession, in all aspects both academic, practical and from a legal point of view, is given to him
I should provide continuous training to stay updated to perform better.
educated her profession.
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