TWN Info Service
on WTO and Trade Issues (Feb10/12)
implementation of TRIPS "
Geneva, 15 Feb (Kanaga Raja*) -- WTO Members held an informal consultation on 12 February on the implementation of the "Paragraph 6" solution in respect of the TRIPS Agreement aimed at helping developing countries with insufficient or no manufacturing capacities in the pharmaceutical sector to import cheaper generic medicines produced under compulsory licensing.
In Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (November 2001), Ministers recognized that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement.
They instructed the Council for TRIPS to find an "expeditious solution" to this problem.
In a Decision of the General Council of 30 August 2003, WTO Members agreed that the obligations of an exporting Member under Article 31 (f) of the TRIPS Agreement shall be waived with respect to the grant by it of a compulsory license to the extent necessary for the purposes of production of a pharmaceutical product and its export to an eligible importing Member in accordance with the terms set out (in the Decision).
Article 31(f) of the TRIPS Agreement states that production under compulsory licensing must be predominantly for the domestic market. This provision has hampered the ability of countries that are unable to produce pharmaceutical products from importing cheaper generics from countries where pharmaceuticals are patented, according to trade officials.
In the Decision, Members agreed that the waiver will be in force until an amendment is made to the TRIPS article.
In 2005, Members approved changes to the TRIPS Agreement making permanent the 2003 Decision. This will be incorporated into the TRIPS Agreement when two-thirds of the Membership has ratified the amendments. There was a deadline of 1 December 2007 set for this, but the General Council extended the deadline to 31 December 2009 and subsequently to 31 December 2011. The waiver remains operative till then, according to trade officials.
According to trade officials, Members want to improve the present annual reviews in the TRIPS Council on how the waiver of 2003 (and the 2005 amendment to the TRIPS Agreement, when it takes effect) is working.
Paragraph 8 of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health of 30 August 2003 provides that the Council for TRIPS shall review annually the functioning of the system set out in the Decision with a view to ensuring its effective operation and shall annually report on its operation to the General Council.
(At a meeting of the TRIPS Council on 27-28 October 2009, several countries including Egypt, on behalf of the African Group, Tanzania, on behalf of the Least Developed Countries, India, Ecuador, Pakistan, Brazil and Venezuela, called for consultations to identify any difficulties encountered in the use of the system and suggestions to solve these problems. See IP/C/53.)
The Chair, Ambassador
Karen Tan of
So far, Canadian exports
[In a posting on the IP-Health list-server on 12 February, Richard Elliot, Executive Director of the Canadian HIV/AIDS Legal Network, noted that there is little reason at this time to think that the Canadian Access to Medicines Regime will be used again in the absence of some kind of reform. He further noted that dozens of Canadian civil society groups have called for reforms to the Canadian regime (which they have said is "seriously flawed"). A bill is currently before Parliament to simplify considerably the current Canadian legislation, he added.]
According to trade
officials, a number of countries including
Several other countries
According to trade officials, some of them argued that compulsory licensing is not the objective, and that it is rather one tool among many to ensure that the poor have access to affordable medicines. This has been achieved by improved international procurement, increased donations of free medicines and cut-price supplies by patent-owners, some of them said.
Pakistan and Nigeria (on behalf of the African Group) called for what Pakistan called a "performance evaluation" - to learn the lessons of how the WTO system is being implemented without changing the system itself, said trade officials.
In its intervention at the informal meeting, India said that it has always been of the view that the Doha Declaration on TRIPS and Public Health constituted a major landmark in the short history of TRIPS because it recognized the primacy of public health needs and the sensitivity of this Agreement to the problems faced by the poor in the less developed countries.
Along with several other Members, India worked relentlessly on the Doha Ministerial Declaration on Public Health (2001) and the Decision of 30 August 2003 on implementation of Para 6 of the Doha Ministerial Declaration. The hope was that the August 30 Decision would genuinely and completely address the problems faced by WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector to address their public health problems.
we are disappointed since the
"God forbid, if
"The Para 6 system, it may be recalled, was supposed to be an 'expeditious solution' to the crisis in access to medicines by countries with insufficient or no manufacturing capacity. Experience shows that it has neither been 'expeditious' nor a 'solution' to public health needs."
Access to medicines is a crucial issue particularly to the poorest populations of the world, said India, further noting that the issue has rightly attracted considerable interest in the UN Human Rights Council and has been highlighted in the report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
Numerous studies have
been done on this issue by experts, including some studies commissioned
by the European Parliament and Civil Society Organizations (CSOs) engaged
in public health. Empirical evidence of the actual functioning of the
"It is therefore
time for an in-depth study on the subject to be done through the establishment
of a Dedicated Workshop to discuss 'Implementation of the
As for participation,
India called for the workshop to be established as soon as possible so that it could report to the TRIPS Council meeting in October this year where a review as mandated in Para 8 of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health of 30 August 2003 could take place (WT/L/540).
emerging from the Workshop could then be considered in the TRIPS Council
for further necessary action, said
In its intervention
at the informal consultations,
Designed to provide
affordable medicines to countries with limited or no manufacturing capacity,
the Paragraph 6 system is a milestone in the history of the implementation
of the TRIPS Agreement, said
Pointing out that it
had accepted the Protocol amending the TRIPS Agreement on 13 November
In order to improve
the Paragraph 6 system, it is crucial to understand the difficulties
countries and international organizations have had in implementing it.
For this reason,
According to trade officials, India's call for a workshop was supported by Brazil, China, Venezuela, Pakistan, Indonesia, Ecuador, Nigeria (on behalf of the African Group), and Cuba.
Several others including
The Chair said that she will report to the TRIPS Council meeting of 2-3 March.
After that, the Council will have a new Chair and Ambassador Tan said that she would recommend that her successor undertake consultations on future steps, including the possibility of a workshop, in order to make the annual review more useful.
(* With inputs from Riaz K Tayob.)