Sap 401 Lect Ii - Pharm Laws
Sap 401 Lect Ii - Pharm Laws
BY
LECTURE SERIES II
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1.0 CONSUMER PROTECTION COUNCIL LAW
1.1 Introduction
Consumer rights encompass the set of principles and protections that empower individuals as they
engage in economic transactions, ensuring their dignity, safety, and fair treatment. These rights are
established to counteract imbalances in power between consumers and businesses, aiming to promote
ethical conduct, transparency, and accountability in the marketplace. Components of consumer right
include;
a. Right to Safety: Consumers have the right to expect that the products and services they
purchase are safe for their intended use. This includes protection against hazards such as
defective products, harmful substances, or inadequate warnings.
b. Right to Information: Consumers have the right to accurate and transparent information
about products and services before making a purchase. This includes details about pricing,
ingredients, warranties, and terms of sale, enabling consumers to make informed decisions.
c. Right to Choice: Consumers have the right to a variety of options in the marketplace,
allowing them to choose from competing products and services that best meet their needs and
preferences. This promotes competition, innovation, and quality improvement.
d. Right to Redress: Consumers have the right to seek compensation or remedies if they are
sold faulty or unsatisfactory products, or if they receive poor-quality services. This may
involve refunds, replacements, repairs, or other forms of restitution.
e. Right to Representation: Consumers have the right to be heard and represented in matters
that affect their interests. This includes the right to form consumer advocacy groups,
participate in regulatory processes, and voice concerns about unfair business practices.
f. Right to Consumer Education: Consumers have the right to access information and
resources that empower them to make informed choices and assert their rights effectively.
This includes education about consumer rights and responsibilities, financial literacy, and
awareness of available recourse mechanisms.
g. Right to Privacy: Consumers have the right to control the collection, use, and disclosure of
their personal information by businesses. This includes protection against unauthorized data
collection, identity theft, and intrusive marketing practices.
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Pharmacists and other stakeholders have a duty to protect the health and well-being of consumers,
and consumer protection policies and regulations help to support this duty by promoting transparency,
accountability, and quality in the provision of services as well as helping to prevent fraud, abuse, and
other unethical practices in the business world.
In the light of this, Nigerian Consumer Protection Council (CPC) ACT was established by decree No
66 of 1992. The agency was officially established on 23rd day of November 1992. The Council
however commenced operations in 1999 with its main functions encapsulated in section 2 of the
CPC ACT. The ACT was formed to protect and enhance consumers’ interest through information,
education and enforcement of appropriate standards for goods and services. The Act also provides
that consumers can bring complaints where they have suffered a loss, injury or damage as well as
provide opportunity for consumers to get redress thus making the Act adequate to meet consumer
rights.
An ACT was established to provide for the establishment of the consumer protection council and for
matters connected therewith. CPC Act contains 5 Parts and 33 sections. Key provision of the ACT
include;
Part I
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a. Apply to court to prevent the circulation of any product which constitutes an imminent
public hazard;
b. Compel a manufacturer to certify that all safety standards are met in their products;
c. Cause as it deems necessary, quality tests to be conducted on a consumer product;
d. Demand production of label showing date and place of manufacture of a commodity as well
as certification of compliance;
e. Compel a manufacturer, dealer and service company where appropriate, to give public
notice of any health hazards inherent in their products;
f. Ban the sale, distribution, advertisement of products which do not comply with safety or
health regulations.
Part II
6. Compliant
1) A consumer or community that has suffered a loss, injury or damage as a result of the use or
impact of any good, product or service may make a complaint in writing to or seek redress
through a State Committee.
2) Where a consumer, or a person having an interest in a matter is an illiterate or is subject to
any physical disability and thereby unable to write, the clerk or other official working with
the State Committee shall cause such consumer or person's statement to be written at no fee
or payment of any kind from such consumer, or person.
8. Redress
Whereupon an investigation by the Council or State Committee of a complaint by a consumer,
it is proved that-
a. The consumer's right has been violated; or
b. That a wrong has been committed by way of trade, provision of services, supply of
information or advertisement thereby causing injury or loss to the consumer; the consumer
shall, in addition to the redress which the State Committee, subject to the approval of the
Council may impose, have a right of civil action for compensation or restitution in any
competent court.
9. Unforeseen Hazard and Duty to Inform Public
1) It shall be the duty of the manufacturer or distributor of a product, on becoming aware after
such a product has been placed on the market, of any unforeseen hazard arising from the use
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of such product, to notify immediately the general public of such risk or danger and cause to
be withdrawn from the market such product.
2) Any person who violates the provision of subsection (1) of this section is guilty of an offence
and liable on conviction to N= 50,000 fine or imprisonment for five years or to both such fine
and imprisonment.
11. Issuing Wrong Advertisement
Any person who issues or aids in issuing any wrong advertisement about a consumer item, is
guilty of an offence and liable on conviction to a fine of N= 50,000 or to imprisonment of five
years or to both such fine and imprisonment.
12. Contravention of Enactment Protecting Consumer
Any person who, in contravention of any enactment whatsoever for the protection of the
consumer-
a. Sells or offers for sale any unsafe or hazardous goods; or
b. Provides any service or proffers any information or advertisement thereby causing injury or
loss to a consumer, is guilty of an offence under this Decree and liable on conviction to N=
50,000 fine or to five years imprisonment or to both such fine and imprisonment.
13. Compensation Order
1) A court by or before which a person is convicted of an offence may in addition to dealing with
such person in any other way, make an order (in this Decree referred to "as compensation
order") requiring the person to pay compensation for any personal injury, loss or damage
resulting from that offence of such amount as it may deem fit or as assessed by competent
professional authority.
2) In determining whether to make a compensation order against any person, and in determining
the amount to be paid by any person under such an order, the court shall have regard to the
means of the respondent in so far as they appear or are known to the Court.
Part V
Miscellaneous
31. Regulations
The Council shall with the approval of the Minister have power to make regulations as may in
its opinion be necessary or expedient for giving full effects to the provisions of this Decree and
for the administration thereof. The regulations provide that:
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1. All products (manufactured or imported) in Nigeria shall be registered by applying for
registration and non-refundable registration (exemption or reduction for products registered for
NAFDAC may apply).
2. A certificate of registration is issued if the council is satisfied. Upon issuance of the certificate,
the owner of the product registered with the council is mandated to promptly respond to
consumers’ complaints and act on them within 14 days from the date of receipt of such
complaint.
3. Any person who contravenes the provisions of the Regulation shall be prohibited from carrying
on manufacture, distribution, sale, advertisement and importation of the product completely or
for such a period as the council may determine in addition to payment of fine of 50,000.
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2.0 UNITED NATIONS COMMISSION ON NARCOTIC DRUGS (CND)
2.1 INTRODUCTION
This is a policy making body of the United Nations with the prime responsibility in drug related
matters. The Commission on Narcotic Drugs (CND) reviews and analyzes the global drug situation,
considering the interrelated issues of prevention of drug abuse, rehabilitation of drug users and supply
and trafficking in illicit drugs. It takes action through resolutions and decisions.
Overall, the CND's work is essential to ensuring that narcotic drugs are used safely and appropriately
in medical practice, and that pharmacists have the information and tools they need to provide high-
quality care to their patients. In addition, the CND provides a forum for member states to discuss
drug control issues and share information and best practices. This can help pharmacists to stay up-to-
date on the latest developments in drug control policies and practices, and to learn from the
experiences of other countries and regions.
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iv. Consider what changes may be required in the existing machinery for the international
control of narcotic drugs and submit proposals thereon to the Council;
v. Perform such other functions relating to narcotic drugs as the Council may direct.
b. Powers
i. The Commission may make recommendations to the Council concerning any sub
commission which it considers should be established.
ii. The Commission is authorized by the Council to appoint in a consultative capacity, and
without the right to vote, representatives of bodies created under the terms of international
conventions on narcotic drugs.
c. Composition
i. The Commission shall be composed of fifteen Members of the United Nations which are
important producing or manufacturing countries or countries in which illicit traffic in
narcotic drugs constitutes a serious social problem. The term of office of members is three
years. They are eligible for re-appointment.
ii. The Council requests the following Governments to designate one representative each to
constitute the Commission: Canada, China, Egypt, France, India, Iran, Mexico,
Netherlands, Peru, Poland, Turkey, United Kingdom, United States of America, Union of
Soviet Socialist Republics and Yugoslavia
iii. The CND has 53 member States that are elected by ECOSOC and is chaired by a Bureau,
including one member per Regional Group
iv. The CND has five subsidiary bodies that help them in implementing their policies in
different countries. They are:
Heads of National Drug Law Enforcement Agencies in Europe (HONEUR)
Heads of National Drug Law Enforcement Agencies in Latin America and the Caribbean
(HONLAC)
Heads of National Drug Law Enforcement Agencies in Asia and the Pacific (HONLAP)
Heads of National Drug Law Enforcement Agencies in Africa (HONLAF)
Sub Commission on Illicit Drug traffic and related matters in the near and Middle East.
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2.3 Structure of CND
In 1999, ECOSOC resolution requested the CND to structure its agenda with two distinct segments:
a normative segment and an operational segment.
i. Normative Segment
This segment is responsible for discharging treaty-based and normative functions. It focuses
on the development of international drug treaties and conventions as well as the review and
analysis of their implementation. This segment also includes the consideration of new and
emerging drug-related issues and the development of policy recommendations to address
them. The normative segment is a critical part of the CND’s work as it helps to ensure that
international drug control efforts are based on sound evidences and best practices.
ii. Operational Segment
This segment is responsible for exercising the role as the governing body of United Nations
Office on Drugs and Crime (UNODC). It focuses on the implementation of international drug
policies and programs. This segment includes the consideration of technical assistance and
capacity-building initiatives as well as the review and analysis of national drug control
strategies and programs. The operational segment is important for ensuring that international
drug control policies are effectively implemented at the national level and that member states
have the necessary resources and support to address the world drug problem.
1. The main mandate of CND involves overseeing the implementation of the three international
drug control conventions which are:
i. The Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol:
It aims to control the production, distribution, and use of narcotic drugs as well as ensuring
that while narcotic drugs are available for medical and scientific purposes, strict regulatory
controls help to prevent diversion into the illicit market.
ii. The Convention on Psychotropic Substances of 1971: It aims to control the production,
distribution and use of psychotropic substances such as amphetamines, barbiturates and
hallucinogens ensuring that these drugs are used appropriately and safely in psychiatric
and neurological treatments.
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iii. The United Nations Convention against Illicit Traffic in Narcotic Drugs and
Psychotropic Substances of 1988: It aims to combat the illegal production, distribution,
and trafficking of controlled substances by enhancing border controls and stricter
import/export regulations as well as prompting healthcare providers and pharmacists to
work closely with regulatory authorities to ensure uninterrupted access to essential
medications for patients.
These conventions provide the legal framework for international drug control and are widely
recognized as the cornerstone of global policy. They provide a basis for cooperation between
countries in the fight against drug trafficking and drug abuse, and help to ensure that
controlled substances are used for legitimate purposes. The CND plays a key role in
monitoring compliance with these conventions, and in promoting their implementation at the
national and international levels.
2. CND holds annually thematic discussions to foster the implementation of all international drug
policy commitments in the follow-up to the 2019 Ministerial Declaration.
3. The CND reviews and analyzes the global drug situation, considering supply and demand
reduction. It takes action through resolutions and decisions.
4. The CND ensures that all Member States are asked to report data on the national drug situation
through an annual report questionnaire (ARQ).
5. As functional Commissions of the Economic and Social Council, the Commissions contribute
to the work of the ECOSOC and the General Assembly of the United Nations.
6. The Commissions actively contributes to the implementation of the 2030 Sustainable
Development Agenda, as sustainable development and the mandates of the Commissions are
strongly interrelated and mutually reinforcing.
7. The CND holds regular session, reconvened sessions, intersessional meetings, as well as
informal consultations and special events.
8. The CND establishes expert and working groups to examine specific issues and report back to
the commission.
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3.0 NATIONAL ENVIRONMENTAL STANDARDS AND REGULATIONS
ENFORCEMENT AGENCY (NESREA)
3.1 Introduction
NESREA was established as part of Nigeria’s effort to modernize environmental governance and
ensure that environmental management and pollution control are both effective and sustainable.
Enacted by legislation, NESREA was given the mandate to establish and enforce environmental
standards across the nation.
Before NESREA’s inception, environmental regulation in Nigeria was fragmented, with various
agencies (such as FEPA) handling different aspects of environmental issues without a unified national
framework. NESREA was developed to consolidate these efforts, provide clear environmental
guidelines, and empower the government to enforce standards rigorously.
The NESREA ACT was established in July 31st 2007 in Lagos state located at no. 25 of the 2007
ACT. It was established to protect and preserve the environment, ensuring that industrial progress or
environmental activities does not come at the expense of public health.
In Pharmacy, the enforcement of environmental standards helps to prevent diseases associated with
pollution through ensuring the safe disposal of drugs in pharmaceutical industries, community
pharmacies and hospitals.
4. Tenure of office.
5. Cessation of membership.
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PART II – FUNCTIONS AND POWERS OF THE AGENCY AND COUNCIL
16 Annual estimate.
18 Annual report.
19 Investment.
21 Ozone protection.
22 Noise.
24 Effluent limitations.
25 Environmental sanitation
32 Legal Proceedings
35 Application
37 Interpretations.
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3. Establishment and Composition of the Governing Council
a. A Chairman who shall be appointed by the President, on the recommendation of the Minister
b. The Permanent Secretary of the Federal Ministry of Environment or his representative;
c. A representative each, not below the rank of Director from the----
i. Federal Ministry of Solid Minerals Development,
ii. Federal Ministry of Agriculture and Natural Resources,
iii. Federal Ministry of Water Resources,
iv. Federal Ministry of Science and Technology,
v. a representative of the Standards Organization of Nigeria,
vi. a representative of the Manufacturers‘ Association of Nigeria,
vii. a representative of the Oil Exploratory and Production Companies in Nigeria;
d. The Director –General of the Agency; and
e. Three other persons to represent public interest, to be appointed by the Minister of
Environment.
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g. enforce compliance with regulations on the importation, exportation, production, distribution,
storage, sale, use, handling and disposal of hazardous chemicals and waste other than in the
oil and gas sector;
h. enforce through compliance monitoring, the environmental regulations and standards on
noise, air, land, seas, oceans and other water bodies other than in the oil and gas sector;
i. ensure that environmental projects funded by donor organizations and external support
agencies adhered to regulations in environmental safety and protection;
j. enforce environmental control measures through registration, licensing and permitting
systems other than in the oil and gas sector;
k. conduct environmental audit and establish data bank on regulatory and enforcement
mechanisms of environmental standards other than in the oil and gas sector;
l. create public awareness and provide environmental education on sustainable environmental
management, promote private sector compliance with environmental regulations other than
in the oil and gas sector and publish general scientific or other data resulting from the
performance of its functions;
m. carry out such activities as are necessary or expedient for the performance of its functions.
2. Powers of the Agency
a. purchase or take on lease any interest in land, building or property;
b. build, equip and maintain the offices and premises for the performance of its functions under
this Act;
c. lease out any office or premises held by it, which is no longer required;
d. prohibit processes and use of equipment or technology that undermine environmental quality
e. conduct field follow-up compliance with set standards and take procedures prescribed by law
against any violator
f. subject to the provisions of the Constitution of the Federal Republic of Nigeria, 1999, and in
collaboration with relevant judicial authorities establish mobile courts to expeditiously
dispense cases of violation of environmental regulations
g. conduct public investigations on pollution and the degradation of natural resources, except
investigations on oil spillage
h. open and operate ordinary and domiciliary accounts for the Agency in recognized banking
institutions in Nigeria;
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i. borrow by overdraft or otherwise, with the approval of the Minister, such sums as it may
require for the performance of its functions under this Act;
j. accept gifts of land, money or other property, upon such terms and conditions, if any as may
be specified by the person or organization making the gift, as long as such conditions are
consistent with the functions of the Agency;
k. submit for the approval of the Minister, proposals for the evolution and review of existing
guidelines, regulations and standards on environment other than in the oil and gas sector
including---
i. atmospheric protection,
ii. air quality
iii. ozone depleting substances,
iv. noise control,
v. effluent limitations,
vi. water quality,
vii. waste management and environmental sanitation,
viii. erosion and flood control,
ix. coastal zone management,
x. dams and reservoirs,
xi. watershed
xii. deforestation and bush burning,
xiii. other forms of pollution and sanitation, and
xiv. Control of hazardous substances and removal control methods.
l. develop environmental monitoring networks, compile and synthesize environmental data
from all sectors other than in the oil and gas sector at national and international levels;
m. undertake, coordinate, utilize and promote the expansion of research experiments, surveys
and studies by public or private agencies, institutions and organizations concerning causes,
effects, extent, prevention, reduction and elimination of pollution and such other matters
related to environmental protection and natural resources conservation other than in the oil
and gas sector as the Agency may, from time to time, determine;
n. enter into agreement and contracts with public or private organizations and individuals to
develop, utilize, coordinate and share environmental monitoring programs, research effects,
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and basic data on chemical, physical and biological effects of various activities on the
environment and other environmental related activities other than in the oil and gas sector;
o. in collaboration with other relevant agencies and with the approval of the Minister, establish
programs for setting standards and regulations for the prevention, reduction and
p. elimination of pollution and other forms of environmental degradation in the nation‘s air,
land, oceans, seas and other water bodies and for restoration and enhancement of the nation‘s
environment and natural resources;
q. collect and make available , through publications and other appropriate means and in
cooperation with public or private organizations, basic scientific data and other information
pertaining to environmental standards;
r. charge fees for tests, investigations and other services performed by the Agency;
s. develop and promote such processes, methods, devices and materials as may be useful or
incidental in carrying out the purposes and provisions of this Act; and
t. do such other things other than in the oil and gas sector as are necessary for the efficient
performance of the functions of the Agency.
3. Functions of the Council
a. be responsible for the appointment, promotion and discipline of the staff of the agency;
b. advise the Agency with regard to financial, operational and administrative matters;
c. establish committees as may be expedient which shall be charged with specific functions;
d. encourage and promote activities related to the functions of the Agency
e. carry out such other activities as may be directed by the Minister.
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5. Effluent limitations
Effluent limitation refer to the maximum amount of concentrations of pollutants that can be
discharged into water bodies or air from industrial processes.
The Agency may make regulations on effluent limitations, on existing and new point sources,
other than in the oil and gas sector for the protection of human, animal, marine and plant life
Any person who violates the provisions of the regulations commits an offence and shall on
conviction, be liable to a fine not exceeding N200,000 or an imprisonment for a term not
exceeding 2 years or liable to both fine and imprisonment and an additional fine of N5,000
for every day the offence subsists.
Where an offence is committed by a body corporate, it shall on conviction, be liable to a fine,
not exceeding N1,000,000 and an additional fine of N50,000 for every day the offence
subsists.
6. Environmental sanitation
The Agency may make regulations for the purpose of protecting public health and promotion
of sound environmental sanitation.
Any person who violates the provisions of the regulations shall be guilty of an offence and
punished under the penalties imposed in the regulations made pursuant thereto.
7. Land resources and watershed quality.
The Agency may make regulations, guidelines and standards for the protection and
enhancement of the quality of land resources, natural watershed, coastal zone, dams and
reservoirs including prevention of flood and erosion, to serve the purpose of this Act
Any person who violates the provisions of the regulations commits an offence and shall on
conviction, be liable to a fine not exceeding N200,000 or an imprisonment for a term not
exceeding one year or both fine and imprisonment and an additional fine of N10,000 for every
day the offence subsists.
Where an offence is committed by a corporate body, it shall on conviction, be liable to a fine
not exceeding N1,000,000 and an additional fine of N50,000 for every day the offence
subsists.
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8. Discharge of hazardous substances and related offences.
The discharge of harmful quantities of any hazardous substance into the air or upon the land
and the waters of Nigeria or at the adjoining shorelines is prohibited, except where such
discharge is permitted or authorized under any law in force in Nigeria.
Any person who violates the provisions of such regulation, commits an offence and is liable
on conviction, to a fine, not exceeding N1,000,000 or an imprisonment for a term not
exceeding 5 years.
Where an offence is committed by a corporate body , it shall on conviction, be liable to a fine
not exceeding N1,000,000 and an additional fine of N50,000 for every day the offence
subsists.
Where an offence is committed by a corporate body, every person who at the time the offence
was committed was in charge of the corporate body shall be deemed to be guilty of such
offence and shall be liable to be proceeded against and punished accordingly except if a person
proves that the offence was committed without his knowledge or that he exercised all due
diligence to prevent the commission of such offence
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iv. open and examine, pursuant to paragraph (a) of this subsection, any container or package
which he reasonably believes may contain anything to which this Act or its regulations
apply or which may help in his investigations;
v. examine any book, document or other record found pursuant to paragraph (a) of this
subsection, which he reasonably believes may contain any information relevant to the
enforcement of this Act or the regulations and make copies thereof or extracts there from;
vi. seize and detain for such time as may be necessary for the purpose of this Act, any article
by means of or in relation to which he reasonable believes any provision of this Act or the
regulations has been contravened
vii. obtain an order of a court to suspend activities, seal and close down premises including
land, vehicle, tent, vessel, floating craft or any inland water and other structure
whatsoever.
b. A written receipt shall be given for any article or thing seized under subsection (1) of this
section and the reason for such seizure shall be stated on such receipt.
c. An article seized under this Act shall be kept or stored in such a place as the officer of the
Agency may direct and shall be returned to the owner or the person from whom it was seized
if the article upon analysis or examination is found to conform with the requirements of this
Act or regulations made under it.
d. An article other than in the oil and gas sector, seized by an officer of the Agency in pursuance
of this Act or the regulations made under it, may be submitted to an analyst for analysis or
examination and the analyst upon making such analysis or examination shall, issue a
certificate or report in the prescribed form, setting forth the result of such analysis or
examination and the officer of the Agency shall, on demand, deliver a copy of such certificate
or report to the owner of the article if the article is to be the subject of a proceeding under this
Act or regulations thereunder.
2. Penalties for Obstructing an Officer
a. A person who obstructs an officer of the Agency in the performance of his duties commits an
offence and is liable on conviction to a fine of not less than N200,000 for an individual or an
imprisonment for a term not exceeding one year or both fine and imprisonment, and an
additional fine of N20,000 for each day the offence subsist
b. In the case of a corporate body, it shall be liable for a fine of N2,000,000, on conviction and
an additional fine of N200,000 for every day the offence subsist.
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