[Ip-health] WTO TRIPS Council: Brazil, China, Fiji, India, and South Africa table agenda item on IP and the Public Interest

Thiru Balasubramaniam thiru at keionline.org
Tue Jun 6 03:17:35 PDT 2017


http://keionline.org/node/2800

WTO TRIPS Council: Brazil, China, Fiji, India, and South Africa table
agenda item on IP and the Public Interest


Submitted by thiru <http://keionline.org/user/6> on 6. June 2017 - 11:54

On 31 May 2017, the delegations of Brazil, China, Fiji, India, and South
Africa tabled a paper to the World Trade Organization's (WTO) TRIPS Council
entitled "Intellectual Property and the Public Interest." In their
communication (IP/C/W/630), the proponents called for a series of
discussions at the WTO TRIPS Council on Intellectual Property and the
Public Interest. Brazil, China, Fiji, India, and South Africa proposed
compulsory licensing as the first theme of the TRIPS Council meeting in
June 2017.

In relation to TRIPS flexibilities, the proponents of public interest
discussions at the WTO highlight the political and economic pressures faced
by WTO members when endeavoring to use TRIPS flexibilities.

6. Many governments have not used the flexibilities available under the
TRIPS Agreement for various reasons, such as capacity constraints or
political pressure from states and corporations mentioned in the UN
Secretary-General's High Level Panel Report on Access to Medicines.
Moreover, even where some developing countries used the flexibilities
available to them under the TRIPS Agreement to address public interest
objectives through measures which are fully consistent with the TRIPS
Agreement, these attempts have been challenged legally as well as
politically. Political and economic pressure placed on governments to forgo
the use of TRIPS flexibilities violates the integrity and legitimacy of the
system of legal duties and rights created by the TRIPS Agreement, as
reaffirmed by the Doha Declaration.

The public interest coalition of WTO members underscored the upsurge of
regional free trade agreements that vitiate countries' room to maneuver,
including investor-state disputes.

7. A slew of regional trade agreements containing "TRIPS plus" standards of
IP protection and enforcement have the potential to significantly affect
the policy space available for effective and full use of the TRIPS
flexibilities. The most common "TRIPS plus" provisions in free trade
agreements (FTA) that affect the pharmaceutical sector are: the definition
of patentability criteria; patent term extensions; test data protection;
the linkage of regulatory approval with patents and enforcement of IPRs,
including border measures. Such provisions can delay market entry of
generics and increase prices of medicines. Investor-State disputes under
regional or bilateral investment protection agreements are also emerging as
significant threats to the use of TRIPS flexibilities in the public
interest.

In addition to addressing the challenges imposed by trade rules on access
to health technologies, Brazil, China, Fiji, India, and South Africa
highlighted how increased "copyright protections create similar problems of
access to knowledge goods, limiting the ability of many people around the
world to access print, audio, or visual works of education or entertainment
that we take for granted."

9. There is a growing concern about an imbalance between intellectual
property and the public interest. With regard to health technologies, for
example, patents and related monopoly rights in test data, without
sufficient use of balancing exceptions and limitations to protect the
public interest, permit companies to maintain high prices and exacerbate
crises of access around the world, where many patients cannot afford
medicines, and force governments with finite health budgets to ration care.
Increased copyright protections create similar problems of access to
knowledge goods, limiting the ability of many people around the world to
access print, audio, or visual works of education or entertainment that we
take for granted. These are only a few examples of the problem. There is a
need to pursue a development-oriented approach towards formulating IP laws
and policies rather than pursue an iconoclastic approach of IP for
development.

For the discussion on compulsory licensing scheduled for the 13-14 June
2017 meeting of the TRIPS Council, the proponents have proposed the
following points for consideration, including an exchange of state practice.

11. Compulsory licensing occurs when a government allows someone else to
produce the patented product or process without the consent of the patent
owner.9 Article 31 TRIPS lays down a set of conditions for issuing
compulsory licenses of patents. The Doha Declaration on the TRIPS Agreement
and Public Health states that, "Each Member has the right to grant
compulsory licenses and the freedom to determine the grounds upon which
such licenses are granted". In spite of the clarity of this language, WTO
Members around the world seeking to make use of compulsory licences as a
tool to increase access to affordable medicines have faced various
challenges/barriers.

12. Some possible grounds for compulsory licensing are suggested in Article
5A of the Paris Convention (e.g. abuse of patent rights, including failure
of the patent holder to work the invention) and in Article 31 of the TRIPS
Agreement (e.g. national emergency and public non-commercial use) .
However, this list is not exhaustive. The Doha Declaration on the TRIPS
Agreement and Public Health confirmed what was already implicit in the
TRIPS Agreement – that WTO Members have the freedom to determine the
grounds upon which compulsory licenses are granted. They are thus not
limited to emergencies or other urgent situations, as is sometimes
mistakenly believed. A range of grounds have been set out in national laws
like (i) non-working or insufficient working, (ii) anti-competitive
practices, (iii) public interest, (iv) dependant and blocking patents, (v)
Government use.

13. The sponsors of this communication invite Members to share their
national experiences and examples of using compulsory licenses. The
information exchange could serve to enhance understanding of Members on
various grounds available for issue of compulsory licenses and problems
faced by Members while using them.

Guiding questions:

• What grounds are available in their national laws to issue compulsory
licenses?
• What are the difficulties faced by WTO Members in using compulsory
licenses, including constraints, such as insufficient or no manufacturing
capacities?
• How the measure of compulsory licence was used by governments to obtain
price reduction from patent holders?
• What was the result of using compulsory licenses in terms of price and
access to affordable products and technologies?



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