UHC Technical brief
Data exclusivity and other
“trips-plus” measures
Regulating medicines be tested, the production procedures would have to
be documented and validated, and the production
facility may have to be inspected.
The pharmaceutical market is highly regulated. Two
sets of laws and regulations play a crucial role in The safety and efficacy of pharmaceuticals
this market. These are (i) the intellectual property is demonstrated mainly via preclinical and clinical
laws and (ii) the laws and regulations on drug trials. Safety and efficacy can also be demonstrated
registration. These two sets of laws have different by showing that a product is chemically and
objectives, and are administered by different biologically equivalent to an existing medicine (the
government agencies. safety and efficacy of which are already known).
Intellectual property rights, notably patents However, by definition, “bioequivalence” cannot
(on which this briefing note will focus, as they be demonstrated for entirely new pharmaceuticals,
have the most profound implications on access as there will be no similar existing medicines with
to medicines), are meant to reward innovation which to compare them. Thus, in practice, only
by providing inventors with temporary monopoly generic manufacturers demonstrate the safety and
rights. Patents, however, confer negative rights: a efficacy of their products via bioequivalence tests.
patent on a certain pharmaceutical product means
This latter point is important, as bioequivalence
that the patent holder can prevent others from
tests are much smaller in scale than full-fledged
producing, selling or importing that product. But it
clinical and preclinical trials. Thus, they can be
does not give the patent holder the right to actually
conducted faster and are considerably less expensive.
sell that medicine. In order to be allowed to sell a
medicine, it has to be registered by the national
drug regulatory authority. Data exclusivity
The drug regulatory system, or registration The clinical and preclinical trial data that originator
system, seeks to ensure that only medicines of companies submit to the regulatory authority are
assured safety, quality and efficacy are available at the centre of the debate on “data exclusivity”.
on the national market, referred to as market
authorization. This is important, as consumers Bioequivalence data prove that a generic
do not normally have sufficient information and medicine behaves in the human body in the same
knowledge about a pharmaceutical product to make way as the original product. The safety and efficacy
their own assessment about its quality, safety and of the particular medicine will have already been
efficacy. In addition, medicines that are ineffective established through the clinical trial data provided
or of poor quality can be dangerous, both for the by the originator company. This (apart from the
patient and for public health. bioequivalence data) is what a regulatory authority
often indirectly relies on in approving the generic
In order to assess the quality, safety and efficacy version.
of a product, the drug regulatory authority would
normally require the manufacturer to provide Originator companies argue that, as they
relevant information. For instance, in order to assess invested substantially in these trials, they deserve
the quality of the product, samples would have to a period of “data exclusivity”; a certain length of
These UHC technical briefs summarize current knowledge on strengthening health systems
to achieve Universal Health Coverage. They outline key technical issues and international
experience relevant to health policy and practice in low- and middle-income countries in the
South-East Asia Region.
© World Health Organization 2017
time during which the regulatory authority cannot Second, if a period of data exclusivity is
rely on the originator’s data in order to register a also granted when an existing medicine obtains
generic version of the same product. marketing authorization (or registration) for a second
or new indication or for a new form, as in the case of
By implication, as long as the exclusivity lasts, paediatric versions of already approved drugs, data
generic producers would have to submit their exclusivity could (be used to) extend the period of
own data to prove safety and efficacy, which exclusivity of the originator product (Fig. 2).
would oblige them to repeat the clinical trials and
other tests. This would cause significant delay, Fig. 2: Extension of data exclusivity for
which many generic manufacturers cannot afford. second indication
Moreover, it would raise serious ethical questions,
Registration
as clinical trials would have to be repeated, purely 2nd indication
for commercial reasons. End patent
Patent Registration
granted market entry term
Alternatively – and in practice much more
likely – generic producers would have to delay
the launch of their product until the end of the Data exclusitvity Data exclusitvity
exclusivity period.a Thus, data exclusivity diminishes
the likelihood of speedy marketing of generics, and
delays competition and price reductions. Finally, data exclusivity could prevent the
registration of generic versions of medicines even
when there is no patent on a medicine, e.g. when
Implications of data exclusivity a pharmaceutical product does not meet the
Proponents of data exclusivity at times point out standards for patentability (e.g. because it is not
that it does not have major implications, as the new or an inventive step), the patent lapses, when
period of data exclusivity would normally be shorter a country has no patent law, or when patents are
than the patent duration (Fig. 1a). not being granted for pharmaceuticals. The latter
situation can arise in least-developed countries that
Fig. 1a: “Standard” situation are World Trade Organization (WTO) Members,
which do not have to grant or enforce patents for
Patent Registration End patent
granted market entry term pharmaceuticals until 2033.b
TRIPS does not require data
Data exclusitvity
exclusivity
Yet, there are some questions as to whether It has at times been argued that Article 39.3 of the
data exclusivity could prevent the registration of TRIPS Agreement makes it mandatory for countries
medicines produced under a compulsory license to grant data exclusivity. However, careful reading
(Fig. 1b). If so, data exclusivity would effectively of Article 39.3 (see Box 1) does not warrant this
render the compulsory license inoperative. conclusion; the text of the Article does not make
any reference whatsoever to exclusivity or exclusive
Fig. 1b: Effect of data exclusivity on rights.
compulsory licensing
Article 39.3 requires countries to protect
Patent Registration End patent undisclosed registration data about new chemical
granted market entry term
entities (i) against disclosure and (ii) against unfair
commercial use. Thus, regulatory authorities may
not publish registration data,c or share them with
Data exclusitvity
third parties (e.g. generic competitors). There is
some debate as to what exactly is meant by “unfair
commercial use”. Does the use of bioequivalence
? During this period, generics may not be able to
enter the market, even when a CL has been issued studies instead of full clinical trials represent
“unfair commercial use”? There is no “unfair
a In the United States, data exclusivity lasts five years for new chemical
entities and three years for new indications. Data exclusivity for
b See WTO Document IP/C/73.
biological drugs lasts 12 years. In the European Union, it is 10 years
c However, it is important to note that they may do so when this is
with a possible one-year extension in case the drug is registered for
necessary to protect the public.
a significant new indication.
2
commercial use” by the generic company: the first registration of the medicine anywhere in the
generic manufacturer never uses the originator’s world) and/or scope (e.g. only for new chemical
data, and does not even have access to them. entities), and by allowing registration of generic
Meanwhile, regulatory authorities also do not versions during the period of data exclusivity in case
normally use the originator’s data, though, as of compulsory licensing or non-patented medicines,
mentioned above, they may (indirectly) rely on when the government so notifies.
them. Even even if the regulators were to use
the data, it would not be commercial use, as the
regulatory agency is not a commercial organization. Other “TRIPS-plus” provisions
The unfair comercial use does not apply to the work
of a government regulatory body. Requirements to offer exclusive rights to originator
products that go beyond what is mandated by the
Thus, legal and public health experts believe
TRIPS Agreement are sometimes referred to as
that TRIPS requires data protection, but not data
“TRIPS-plus” requirements. Data exclusivity is an
exclusivity – and national laws do not need to be
important example, but not the only one. Some
more restrictive than TRIPS. It is important to note
instances of other “TRIPS-plus” requirements are
that least-developed countries are not required to
given below.
provide the data protection mandated by TRIPS on
pharmaceuticals till 2033. ~~ Patent term extensions, i.e. provisions to extend
the duration of a patent beyond the 20 years
Box 1. Article 39.3 of TRIPS required by TRIPS, in order to compensate for
Members, when requiring, as a condition of delays in granting the patent or in registering
approving the marketing of pharmaceutical the medicine. It is important to note that there
or of agricultural chemical products which is no obligation, from an international/legal
utilize new chemical entities, the submission of perspective, to grant such extensions.
undisclosed test or other data, the origination
~~ Limitations of the grounds for compulsory
of which involves a considerable effort, shall
licenses, which may preclude issuing a
protect such data against unfair commercial use.
In addition, Members shall protect such data compulsory license for reasons of public
against disclosure, except where necessary to health. Requirements to limit the grounds (or
protect the public, or unless steps are taken to reasons) for issuing a compulsory license go
ensure that the data are protected against unfair directly against the Doha Declaration,d which
commercial use. has unambiguously confirmed that countries
are free to determine the reasons for granting
It is also worthwhile noting that in developing compulsory licenses.
countries, regulatory authorities often rely on data ~~ Linkage between patent status and generic
that are already published or otherwise in the public registration, meaning that the regulatory
domain – and that therefore do not fall within the authority may not register generic versions
scope of Article 39.3 (which imposes protection of a pharmaceutical that is under patent.
only for undisclosed data). This would be problematic, as the regulatory
authority would probably lack the human and
Mitigating the impact other resources to check the patent status of
each product. Moreover, in case there is a
As mentioned above, from the perspective of public patent, regulators may not have the expertise
health and access to medicines, it is preferable not to assess whether the patent is valid and would
to grant data exclusivity. Moreover, there is no be infringed.e As a result, it is likely that they
requirement under international law that countries will enforce all patents, even invalid ones – and
grant data exclusivity; countries have to provide for thus create additional and unnecessary hurdles
data protection only. for generic competition.f
If a country, for some reason (see below), does d Declaration on the TRIPS Agreement and Public Health, WTO
grant data exclusivity or otherwise provides data Ministerial Conference, Doha, Nov. 2001 (or the “Doha Declaration”).
e For these reasons, regulatory agencies in the European Union (EU)
protection beyond that is mandated by TRIPS, it is have so far refused to implement such “linkage” between patent
important to limit the potential negative implications status and registration of medicines.
f In 2002, the US Federal Trade Commission found that when generic
of this on access to medicines. This can, for example, companies initiate patent litigation, they prevail in a significant
be done by limiting its duration (e.g. the start date number of cases. In 2009, the EU Competition DG reached similar
findings regarding patent litigation between originators and generic
for exclusivity could be counted from the date of companies in the EU.
3
~~ Other “TRIPS-plus” requirements deal with the means are likely to have negative implications for
administrative procedures related to patent access to medicines. Thus, countries would do well
applications and/or the granting and revocation to keep these systems separate to ensure access
of patents. The common feature of all “TRIPS- to medicines.
plus” provisions is that they have the effect of
complicating and/or delaying the marketing
of generics, and thereby reducing access to Bibliography
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