TWN Info Service
on WTO and Trade Issues (Mar10/03)
addresses patents on life forms and access to medicines
Geneva, 4 Mar (Kanaga Raja) -- A meeting of the regular WTO TRIPS Council on 2 March amongst others discussed the implementation of the "Paragraph 6" solution in respect of the Doha Declaration on the TRIPS Agreement and Public Health, and the review of Article 27.3 (b) of the TRIPS Agreement relating to the patentability of life forms and the protection of plant varieties.
During the discussions
at the TRIPS Council on the review of Article 27.3 (b) of the TRIPS
Also at the meeting,
On the issue of the implementation of the "Paragraph 6" solution, which is aimed at helping developing countries with insufficient or no manufacturing capacities in the pharmaceutical sector to import cheaper generic medicines produced under compulsory licensing, trade officials said that there were continued differences among Members on whether the fact that the "Para 6" system was only used once would constitute sufficient evidence that the system is failing.
According to trade
officials, several developing countries reiterated the view that the
"Paragraph 6" system might be failing. They cited the fact
that the system has only been used once -
They again called for a workshop to look at real-life experiences in using the system or in trying to use the system.
On the other hand,
trade officials said that a number of developed countries continued
to argue that the single case in respect of
Speaking on this issue,
It expressed concern that the system has not been as helpful in addressing this critical public health problem as it had hoped. The fact that the system has only been used once raises questions as to its effectiveness, let alone expeditiousness.
These questions need
to be addressed, said
Karen Tan of
According to trade officials, in her summary, Ambassador Tan said that she found the informal meeting to be very constructive. She felt that Members were interested in sharing experiences on the use of the system and ready to engage in practical and fact-based discussions in order to have a full understanding of the operation of the system.
As regards the specific
points made by delegations, some of them were concerned that the system
had been used only once by
The meeting also heard that the fact that the system had only been used once did not imply that it was inadequate, since there were also other ways to get medicines to patients, she added.
Some delegations argued that the number of licences issued under the system was not the proper measure of its success, and that the use of the system by Rwanda and Canada had demonstrated that the system could work effectively; the system could only play a supportive role in the wider effort to improve access to essential medicines, and its mere existence might have had a positive impact on drug prices, said Ambassador Tan.
The Chairperson reported
that concerns were also expressed about a period of some three years
that it had taken to deliver the medicines to
As regards the topics that might warrant more discussion, the Chair said that some delegations suggested that the focus could be on the experience from the use of the system by Rwanda and Canada to consider whether the system is working effectively. Some delegations said that the performance of the system could be appraised more generally to assess whether there were any procedural problems regarding its operation.
Some Members said that, bearing in mind that the system was demand-driven, it would be helpful to know whether there were some concrete obstacles why potential importers did not procure under it. Among other issues mentioned that might merit further discussion were safety and efficacy of medicines procured under the system, government procurement, and the dissemination of information with a view to building capacity in developing countries to use the system, said the Chair.
According to the Chair, Members also discussed the appropriate ways to address these issues, agreeing that annual reviews were a good platform for sharing experiences and evaluating the operation of the system. However, some delegations wished to complement this work by organizing a dedicated workshop open to all stakeholders. Some other delegations said that the review process was a member-driven exercise, but believed that its usefulness could be enhanced, for example, by more factual input, she said.
She also reported that there were calls for the Chair to consult with interested delegations on how to best address the issues raised in the discussion. A number of delegations expressed their willingness to participate in any consultations that the Chair might decide to hold on the matter.
According to trade officials, Ambassador Tan's successor, Mr Martin Glass of Hong Kong-China, who took over at the end of the formal meeting, will consult with Members about the workshop.
However, trade officials
said that some developed countries pointed out that the informal consultation
on 12 February was already held in response to a call from several developing
countries that wanted an opportunity for Members to share their experience
in using or trying to use the system. Only
According to trade
The discussion on the
Speaking at the meeting,
Highlighting a number
Also, to stop the increasing concentration of corporate control over the agriculture industry due to various acquisitions and overuse of intellectual property rights, undermining the rights of indigenous peoples, local community and farmers, including the right to exchange and save seeds and the State's food security and sovereignty.
Another concern is to limit the proliferation of trade agreements and initiatives focused on enforcement of intellectual property that pressure developing countries to adopt a particular model of intellectual property, which is not in the best interest of the countries.
According to trade
under the agenda items of review of Article 27.3 (b), TRIPS/CBD relationship
and protection of traditional knowledge and folklore,
The TRIPS Agreement
continues to ignore the numerous IPR-related obligations in the CBD
including obliging countries to cooperate to ensure that patents and
other IP rights do not run counter to the objectives of the CBD (Article
16.5). This contradiction not only obstructs the proper implementation
of the CBD but also causes an imbalance in the TRIPS Agreement, said
It was disappointed to note that while work in the CBD has been progressing steadily, there has been lack of serious engagement in the TRIPS Council to address the issue of misappropriation of genetic resources (GR) and TK.
As regards the way forward, India pointed to document TN/C/W/52 as providing a sound basis for the way forward on substantive and procedural treatment of TRIPS-CBD, GI Extension and GI Register.
What Members are discussing
here is a mandatory disclosure requirement to be incorporated in the
TRIPS Agreement. Serious and meaningful discussions on this issue can
take place only at the WTO, said
Also speaking under
these agenda items,
It urged that the outcome of the negotiations on TRIPS/CBD should lead to the mandatory requirement for patent applicants to disclose the origin of biological material and traditional knowledge used in their inventions, evidence of prior informed consent and benefit sharing arrangements with the country of origin and the relevant communities.
It also welcomed the
proposal submitted by
Under other business,
It noted that in all cases, customs authorities acted on the basis of EU Regulation 1383/2003.
"We wish this
issue was addressed with the seriousness it deserves and resolved and
we did not need to raise this issue in this meeting. Unfortunately,
we do not see any concrete steps," said
As to what
India further said that its commerce secretary and its Ambassador to the EU had formally sought details of the seizures including (i) the duration of the seizure; (ii) names of the drug, exporter and importer; and (iii) details of the IPR holder whose rights have been allegedly infringed.
Stressing that the
seizures symbolize TRIPS plus enforcement,
India stressed that the widespread and repeated seizures, under EC Regulation 1383, have an adverse systemic impact on: (i) the principle of universal access to medicines; (ii) national public health budgets; (iii) legitimate trade of generic medicines; (iv) South-South commerce; (v) use of TRIPS flexibilities; and (vi) seriously impair the efforts of civil society organizations engaged in providing medicines and improving public health in the least developed parts of the world.
"As long as the Damocles' sword of the Regulation 1383/ 2003 is hanging over our heads, we cannot take comfort from the fact that the frequency of seizures has reduced or that the matter is being looked into," said India, reiterating its call to the EU to urgently review the Regulation and bring it in conformity with WTO provisions including GATT, TRIPS Agreement and the letter and spirit of the Doha Declaration on Public Health.
"That is still
the situation today... The fact that the possibility of new seizures
is still open is a matter of concern to us," said
According to trade officials, the EU said that it had provided information in lengthy bilateral meetings, and that its customs officers have to be able to check shipments because of the large amount of counterfeit drugs.
According to trade officials, the Council also discussed briefly "non-violation" cases, where positions remain unchanged, as well as various aspects of technical assistance.
At the end of the meeting, Ambassador Tan handed over the chair to Mr Martin Glass of Hong Kong-China. +