TWN Info Service on WTO and Trade Issues (June10/05)
21 June 2010
Third World Network

TRIPS Council discusses Art. 27.3 (b) review, "Para 6" system
Published in SUNS #6945 dated 16 June 2010

Geneva, 15 Jun (Kanaga Raja) -- The WTO TRIPS Council, at its next meeting in October, is to set aside a whole day to discuss the issue of the implementation of the "Paragraph 6" solution in respect of the Doha Declaration on the TRIPS Agreement and Public Health, according to trade officials.

A meeting of the regular TRIPS Council on 8-9 June held further discussions on the review of Article 27.3 (b) of the TRIPS Agreement concerning the patentability of life-forms and the protection of plant varieties, and the implementation of the "Paragraph 6" solution.

On the issue of the implementation of the "Paragraph 6" solution and the preparations for its annual review in October, TRIPS Council Chair Mr Martin Glass of Hong Kong-China has been consulting with Members on how best to discuss the annual review on how the Paragraph 6 system is working.

According to trade officials, Members have now agreed that at its October meeting, the TRIPS Council will set aside a whole day to discuss the issue.

They also agreed that they would like some kind of additional meeting or workshop before that to discuss experiences in using or trying to use the system in practice.

However, there is disagreement among Members on whether the earlier meeting should include representatives of non-governmental organizations, pharmaceutical companies and other experts, or whether participation should only be confined to delegations of WTO Members.

The TRIPS Council Chair will continue to consult on this.

The discussions on Article 27.3 (b) were under the agenda item of review of the provisions of Article 27.3 (b).

[Paragraph 19 of the Doha Declaration instructed the TRIPS Council, in pursuing its work programme including under the review of Article 27.3 (b), to also examine the relationship between the TRIPS Agreement and the UN Convention on Biological Diversity (CBD), and protection of traditional knowledge and folklore.]

According to trade officials, the discussions at the TRIPS Council under this agenda item covered the issues of whether the TRIPS Agreement should be amended to require patent applicants to disclose the origin of genetic material and associated traditional knowledge, as well as Bolivia's submission (IP/C/W/545) calling for an urgent and in-depth review of Article 27.3 (b).

According to trade officials, Members reiterated their previously-held positions on the "disclosure" issue.

Bolivia's paper on the review of Article 27.3 (b) argues that an urgent review of the article was needed to prohibit the patenting of all life-forms, ensure the protection of the innovations of indigenous and local farming communities and prevent anti-competitive practices that threaten food sovereignty in developing countries.

Bolivia first presented its paper at the last meeting of the TRIPS Council in March. (For full details of Bolivia's submission, see SUNS #6877 dated 5 March 2010.)

In a statement at the TRIPS Council on 8 June under this agenda item, Bolivia recalled that the review of the provisions of Article 27.3 (b) is still pending, when it should have taken place four years after the entry into force of the TRIPS Agreement.

For Bolivia, it is necessary and urgent that the Council, in the context of this review, does a thorough evaluation of the ethical implications, as well as the specific effects and impacts of Article 27.3 (b) and of the patents on life.

Bolivia noted that available information shows that up to 2000, in just five years after the entry into force of the TRIPS Agreement, more than 500,000 patent applications on genes and partial gene sequences of living organisms and more than 9,000 patents on human genes have already been submitted. Between 2000 and 2003, there has been six times more patents on cells and tissues of animals submitted than during the period of 1990-2000.

Bolivia voiced concern that the patent system has become an instrument of privatization and commoditization of life itself on a worrying scale and magnitude. It stressed that for the indigenous peoples of Bolivia and of many other peoples of the world, life is something sacred that under no circumstances should it be subject to private appropriation or considered as a commodity.

It was also extremely concerned over the concentration of innovation and of the control of biological resources in a few private hands, as a result of the adoption of the TRIPS Agreement and the effect of Article 27.3 (b).

Bolivia said that according to information available to it, from the thousands of seed companies and public institutions improving crops that existed 30 years ago, there are now only 10 corporations that control over two-thirds of the global sales of seeds, which are under intellectual property (protection). Six large agrochemical companies possess 70% of the patents on the five major crops consumed in the world.

Venezuela and Ecuador, according to trade officials, were among the Members that supported Bolivia.

On the other hand, several other Members including Switzerland, the US and the European Union argued that patent protection is needed for biotechnology inventions, which will be important for health and food through new medicines and agricultural chemicals.

The TRIPS Council also discussed, under the agenda item of implementation of the Paragraph 6 system, the preparations for the annual review in October 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.

According to trade officials, after a number of consultations held earlier in the year, Members have now agreed that at its October meeting, the TRIPS Council will set aside a whole day to discuss the issue. Members also agreed that they would like some kind of additional meeting or workshop before that to discuss experiences in using or trying to use the system in practice.

However, there is disagreement among Members on whether the earlier meeting should include representatives of non-governmental organizations, pharmaceutical companies and other experts (as proposed by India, China and some other developing countries), or whether it should only be for Members' delegates (as proposed by mainly the developed countries).

According to trade officials, two compromises have been proposed, but neither received consensus agreement. Mr Glass suggested two events in September, one for delegates under the auspices of the TRIPS Council and another for broader participation, as part of the WTO's Public Forum.

However, India, China and several other Members said that they wanted the broader event to also be a TRIPS Council activity.

India proposed a two-part TRIPS Council event with one session for delegates only and the other for broader participation.

In a statement at the TRIPS Council, India, referring to some Members particularly Japan and Switzerland saying that difficulties regarding the use of the Para 6 system have not been demonstrated, said that is precisely the reason why a dedicated workshop is being requested - i. e. to find the difficulties in the implementation of Para 6.

"We are not making any a priori assumption that Para 6 is unworkable or that it needs to be amended. We are just saying that the Para 6 system has been sub-optimally utilized so far and a thorough analysis need to be gone through," said India.

It noted that the idea of a workshop is not new. It is common in NAMA (non-agricultural market access negotiations), Services and other areas. It includes the private sector including companies also. Interestingly, it is the same Members opposing the Workshop here who propose and actively participate in the workshop (on NAMA, Services and other areas of negotiations), and are happy to involve the private sector in those workshops, added India.

India said that it seeks a fact-based substantive discussion. Such a discussion cannot be complete without the participation of all relevant stakeholders. Some Members have expressed their opinion on participation by Members only. "We have to arrive at the right mix of Members and other stakeholders. It is not our intention to have an open-ended workshop either in terms of participation or scope."

India proposed that the workshop should include pharmaceutical companies which have had first-hand experience in using the system. CSOs (civil society organizations) that have had first-hand experience of using the system should also be a part.

It proposed the following: A dedicated workshop with two separate parts, (I) one for Members only, and (ii) followed by another part for relevant stakeholders to make presentations on specified topics and an opportunity for Members to ask questions.

The stakeholders could be the same as the ones the WTO has been inviting for its Technical Assistance workshops such as the World Health Organization, and the World Intellectual Property Organization among Inter-Governmental Organizations (IGOs) and MSF, IFPMA etc among industry. "We have an open mind on which stakeholders to invite as also the scope."

This dedicated workshop should be held as soon as possible and certainly before the October TRIPS Council meeting so that substantive discussions could take place during the Annual Review, stressed India, adding that to have a meaningful discussion during the Annual Review, a substantive, fact-based discussion in a dedicated workshop is a must.

According to trade officials, Members that were in favour of an event with broader participation argued that similar workshops have been organized on other subjects in the WTO.

Those opposing it said that the first step should be for Members to exchange information on their experiences, which would then help delegates set the agenda for a broader event, if one is needed. These countries were further of the view that Members have not yet described any problems they have faced in trying to use the system, even though there have been numerous opportunities to do so.

The TRIPS Council Chair will continue with his consultations on the event or events to be held before the October annual review.

Some developing countries reiterated that the Paragraph 6 system may not be working since it has only been used once and that occasion (exports of drugs from Canada to Rwanda) took a long time. According to trade officials, Canada, the only country to have described its experience in the TRIPS Council, reiterated that the time taken to implement the Paragraph 6 requirements was short, and that the length of time needed overall was because of other factors.

Several other developed countries such as Switzerland argued that the Paragraph 6 system itself might not be the reason for the system not being used, for example, patented medicines might be available at lower prices that are influenced by the threat that compulsory licenses could be used, or generics could be made in countries that are able to manufacture them and where the medicines are not under patent protection.

Switzerland also said that before Members talk to others, they should describe what exactly the problems are. For example, are these problems related to the notification requirement of the Paragraph 6 system, or the packaging and other methods needed to prevent the drugs being diverted to the wrong markets. Or is it in difficulties in finding generic producers, or are they issues to do with ensuring that the generics are effective and safe - a topic that the African Group wants to discuss.

Referring to India's comments that it had heard of cases where countries had tried and failed to use the system, the European Union said that Members should elaborate on this if they have faced problems.

According to trade officials, Members that called for a broader workshop included India, Ecuador, China, Cuba, Brazil, Peru, Indonesia, Venezuela, Bolivia, Mauritius, Angola (for the Least Developed Countries), Nicaragua, Egypt, and South Africa.

Members that argued that countries should share experiences, at least first, or willing to accept the TRIPS Council Chair's compromise included Canada, New Zealand, the US, Switzerland, Japan, South Korea, Costa Rica, Australia and the EU.

The TRIPS Council also held discussions on technical assistance, technology transfer and particularly the priority needs of the least developed countries.

Under the agenda item of enforcement trends, a discussion was held on new trends in enforcement, including the Anti-Counterfeiting Trade Agreement (ACTA). (See separate article.)

The TRIPS Council also agreed to accept two African regional organizations as "ad hoc" observers (who will be invited to attend meeting-by-meeting): the African Regional Industrial Property Organization (ARIPO), and the African Intellectual Property Organization (OAPI). However, the Council still did not achieve consensus on accepting the Secretariat of the Convention on Biological Diversity.

The TRIPS Council also discussed briefly "non-violation" cases, where positions remain unchanged, said trade officials. +