[Ip-health] The Effects of TRIPS-Plus IP Provisions on Access to Affordable Medicines

Michael Palmedo mpalmedo at wcl.american.edu
Thu Jun 18 10:31:14 PDT 2015



The Effects of TRIPS-Plus IP Provisions on Access to Affordable


Jennifer Reid
June 18, 2015

The effects of patenting pharmaceutical products on access to medicines
in developing countries are relatively recent as these countries have
only been mandated by the World Trade Organization (WTO) Agreement on
Trade-Related Aspects of Intellectual Property (TRIPS) rules to grant
patents on pharmaceuticals since 2005. As a result there are a limited
number of empirical studies documenting these effects.

However, patents grant the patent holder a monopoly on the market that
allows the blocking of price-lowering generic competition and the
raising of prices which restricts affordable access to medicines. Where
patent and other intellectual property (IP) barriers do not exist,
generic competition has proven to lower prices of medicines. The
attached memo provides numerous examples
where intellectual property rules stronger than those required by TRIPS
have raised the cost of medicines.

For example, the US Food and Drug Administration reports that "on
average, the cost of a generic drug is 80 to 85 percent lower than the
brand name product."[i] <http://infojustice.org/archives/34601#_edn1>
The experience of HIV medicines prices illustrates this. When first-line
antiretroviral medicines were first introduced in developing countries,
they were priced out of reach of millions at more than US $10,000 per
patient, per year. Following the introduction of generic versions,
prices fell dramatically. Today prices for first line regimens in
developing countries are 99 percent lower - as low as $100 per person,
per year.[ii] <http://infojustice.org/archives/34601#_edn2> 

Evidence documenting the effect of TRIPS and patenting of
pharmaceuticals on promoting innovation is similarly lacking, however
some reports have already documented the lack of impact patents have in
promoting innovation targeting the specific needs of patients in
developing countries.[iii] <http://infojustice.org/archives/34601#_edn3>

Implementation of stricter IP obligations (referred to as TRIPS-plus) is
even more recent for many countries, but increasingly these additional
or expanded provisions that go beyond what is required by the TRIPS
agreement and which limit TRIPS flexibilities have been pushed for or
implemented in developing countries through trade agreements and other
tools. These include patent term extensions, patent linkage, data
exclusivity, lower patentability criteria and additional enforcement
measures. Examples of TRIPS-plus provisions appearing in trade
agreements include the Dominican Republic-Central America FTA
(DR-CAFTA), the US-Jordan free trade agreement and the currently under
negotiation Trans-Pacific Partnership Agreement (TPP) between 12
Pacific-Rim countries, including several developing countries.

The effects of TRIPS-plus provisions on access to affordable medicines
and pricing are not yet well documented, particularly in developing
countries. However, a review of existing literature indicates that a
number of studies, reports and statements, have in fact have documented,
assessed and/or projected the effects of TRIPS-plus provisions on access
to medicines, including at least 28 resources. Several of these are from
countries like the US that have had a longer experience in the
implementation of TRIPS-plus provisions in their national law.

The attached memo
compiles a preliminary and non-exhaustive collection of analyses,
reports and statements made by international experts, academics,
international organizations and other stakeholders that demonstrate or
project the impact TRIPS-plus intellectual property (IP) obligations
have had or could have on access to affordable medicines in any country.
Resources were collected by requesting recommendations through
listserves or from experts and stakeholders working on IP and access to
medicines and through supplemental Google Scholar searches. Abstracts or
excerpts were reviewed to determine the resources' relevance to this

Readers are encouraged to recommend additional sources for inclusion in
a subsequent draft of this memo that will provide more details and
commentary on the content of the resources listed.

FULL MEMO: The effects of TRIPS-Plus IP provisions on access to
Affordable medicines



[i] <http://infojustice.org/archives/34601#_ednref1>  United States Food
and Drug Administration. Facts about Generic Drugs [Online] FDA webpage,
updated 2012 [Cited 2015 June 8]. Available from:

[ii] <http://infojustice.org/archives/34601#_ednref2>  MSF. Untangling
the web of antiretroviral price reduction. [Online] 17th edition, 2014
[Cited 2015 June 17]. Available from:

[iii] <http://infojustice.org/archives/34601#_ednref3>  Commission on
Intellectual Property Rights, Innovation and Public Health. Public
health, innovation and intellectual property rights. [Online] World
Health Organization 2006 [Cited 2015 June 9]. Available from:




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