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The TRIPS Council also continued to discuss technical assistance, incentives to transfer technology, and least developed countries, with Rwanda becoming the latest member to report on its priority needs.

And delegates learnt about new methods of sharing information on-line, including the new “transparency toolkit” on the WTO website, a new joint “portal” for governments to submit information on their laws simultaneously to the WTO and World Intellectual Property Organization (WIPO), and latest developments in WIPO’s online services.

The work on the WTO’s side is partly in response to a letter from the General Council chairperson to all councils and committees on ways to make notifications and other information flows more up-to-date and more complete in the areas they handle.


Some detail

The ‘Triplets’: Article 27.3(b), biodiversity and traditional knowledge

The discussion covered two related issues.

The “disclosure” proposal. This issue is explained here. Members broadly stuck to their previous positions.

Bolivia’s paper (IP/C/W/545). This was first introduced at short notice in the previous meeting in March. Members have now had more time to consider it and could discuss it more fully.

Bolivia is calling for:

  • a ban on the patenting of all life forms, including plants, animals and parts of plants or animals, gene sequences, micro organisms as well as all processes including biological, microbiological and non biological processes for the production of life forms and their parts

  • ensuring the protection of the innovations of indigenous and local farming communities and the continuation of the traditional farming practices including the right to save, exchange and save seeds, and sell their harvest

  • preventing anti competitive practices which threaten food sovereignty of people in developing countries

  • protection for the rights of indigenous communities and prevent any private monopolistic intellectual property claims over their traditional knowledge.

This would be undertaken through the reviews of the relevant provision of the TRIPS Agreement —Article 27.3(b) — and would involve amending the agreement.

Article 27.3(b) deals with patentability or non-patentability of plant and animal inventions, and the protection of plant varieties. Broadly speaking, it allows governments to exclude some kinds of inventions from patenting, ie, plants, animals and “essentially” biological processes (but micro-organisms, and non-biological and microbiological processes have to be eligible for patents). However, plant varieties have to be eligible for protection either through patent protection or a system created specifically for the purpose (“sui generis”), or a combination of the two.

In other words, Art.27.3(b) offers countries the choice in some circumstances of whether to protect or not, but in others requires them to provide protection of some kind. Bolivia’s proposed ban would turn that around.

Some developing countries supported Bolivia. Others said it should be considered seriously, but one added that its own law does protect some forms of inventions, including plants.

Some countries — mainly developed —countered that patent protection is needed for biotechnology inventions, which is important for health and food through new medicines and agricultural chemicals. They also said that if the financial benefits or royalties from inventions are to be shared, then the inventions have to be patented, as in the “disclosure” proposal.

TRIPS and public health

The Par.6 system and the annual review. The 2003 “waiver” (and the 2005 pending TRIPS amendment) removes a requirement that generics produced under compulsory licence should be mainly for the domestic market, which would hinder their export to countries that cannot make the medicines. It is sometimes called the “Paragraph 6” system after the provision in the 2001 Doha Declaration on TRIPS and Public Health that led to its creation. See explanation.

The TRIPS Council reviews how well the system is working every year, usually in October, but more recently with little depth or detail.

Agreed and not agreed: Following a number of consultations earlier this year, members have now agreed that at this October meeting, the TRIPS Council will set aside a whole day to discuss the issue. They also agree 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.

They disagree on whether the earlier meeting should include representatives of non-governmental organizations, pharmaceutical companies and other experts (proposed by India, China and some other developing countries), or whether it should only be for members’ delegates (the view of mainly developed countries). Some others are non-committal.

Two proposed compromises were suggested in this meeting, neither receiving consensus approval.

Chairperson Martin 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 others said they wanted the broader event also to be a TRIPS Council activity.

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

Countries favouring an event with broader participation said similar workshops have been organized in other subjects in the WTO. Those opposing it said 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 said 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.

Amb.Glass will continue his consultations on the event or events to be held before the October annual review. (Some countries also said they would like the additional event to be held close to the October review so that delegates from capitals could attend.)

Underlying the difference is the view from some developing countries that the “Par.6” system may not be working since it has only been used once, and that one occasion (exports from Canada to Rwanda) took a long time, a view repeated in this meeting.

Canada, the only country to have described its experience in the TRIPS Council, repeated that the time spent on implementing the actual Par.6 requirements was short, and that additional time needed overall was because of other factors.

Some other developed countries argued that the Par.6 system itself might not be the reason for the system being rarely used: patented medicines might be available at lower prices that are influenced by the threat of a compulsory licence; or generics could be made in countries that are able to manufacture them and where the medicines are not under patent protection, for example.

These countries also said that before the discussion is broadened to include outsiders, members should describe what exactly the problems are. Are they, for example, the notification requirement of the Par.6 system? Or the packaging and other methods needed to prevent the drugs being diverted to the wrong markets? Or difficulties in finding generic producers? Or issues to do with ensuring that the generics are effective and safe (a topic that the African Group wants to discuss)?

When one country mentioned that it was aware of other attempts to use the system, which had not borne fruit, another delegation said that members should provide details.


Compulsory licensing: Ecuador

Ecuador said a 2009 presidential decree had created the legal basis for the government to grant compulsory licenses for medicines, and it had recently used the decree to issue a compulsory licence to import a generic version of Ritonavir/Lopinavir, an important AIDS medicine.

Speaking under the “other business” part of the agenda, Ecuador said the decree has allowed it to use the flexibilities that are allowed under the TRIPS Agreement. India and Cuba welcomed the move, as did Egypt, which added that it hoped this rare use of compulsory licensing by a developing country would help to fight the stigma attached to its use.

(Note that because the imported generic medicine was not manufactured under compulsory licensing, this was not a use of the Par.6 system. See explanation)


Enforcement trends

Concern: China and India, supported by a number of other developing countries, called for this topic to be discussed because they are concerned about provisions that go beyond the standards of the TRIPS Agreement in bilateral, regional and plurilateral agreements, in this case on enforcement.

Causing particular concern to them is the draft Anti-Counterfeiting Trade Agreement (ACTA) being negotiated by Australia, Canada, the EU and its 27 member states, Japan, Rep.Korea, Mexico, Morocco, New Zealand, Singapore, Switzerland and the US.

Briefly, China’s and India’s lengthy statements argued that ACTA and other agreements could:

  • Conflict with TRIPS Agreement (a reference to TRIPS Art.1.1) and other WTO agreements, and cause legal uncertainty

  • Undermine the balance of rights, obligations and flexibilities that were carefully negotiated in the various WTO agreements

  • Distort trade or create trade barriers, and disrupt goods in transit or transhipment

  • Undermine flexibilities built into TRIPS (such as for public health, and trade in generic medicines)

  • Undermine governments’ freedom to allocate resources on intellectual property by forcing them to focus on enforcement

  • Set a precedent that would require regional and other agreements to follow suit. (One example cited was negotiations involving CARIFORUM, the group of Caribbean states. However, a delegation representing CARIFORUM said it understood the concerns but denied that CARIFORUM would have to apply ACTA’s provisions.)

They also argued that the focus on enforcement did not take into account a country’s level of development.

A number of developing countries broadly supported the concern.

Reaction: ACTA participants voiced their concerns about what they saw as a steadily increasing level of counterfeiting and piracy. They countered that the draft ACTA agreement will not conflict with TRIPS and other WTO provisions. They denied it would upset the negotiated balance, distort legitimate trade or undermine TRIPS flexibilities. One said generic medicines would not be affected since ACTA does not deal with patents.

They said that ACTA was necessary because counterfeiting is no longer a question of products such as fake luxury watches, but involves commercial scale production of fake medicines, car and aircraft parts and other products, which are dangerous to health and safety, and that developing countries are particularly vulnerable.

Some of them also said they had to get together outside the WTO because countries had opposed discussing enforcement substantively in the TRIPS Council.

Conclusion: The TRIPS Council took note of the comments. (This is not a permanent agenda item and whether or not it is discussed in future meetings depends on what members propose.)


The two African organizations that will be invited to observe TRIPS Council sessions, meeting by meeting, are: the anglophone African Regional Industrial Property Organization (ARIPO) and francophone Organisation Africaine de la Propriété Intellectuelle (OAPI).

Members continued to disagree on whether the Secretariat of the Convention on Biological Diversity should be an observer in the council.

Chairperson: Mr Martin Glass of Hong Kong, China.

Next meetings

Tuesday-Wednesday 26—27 October 2009 (could change)

 Jargon buster 

• CBD: Convention on Biological Diversity.

• geographical indications (GIs): Place names (or words associated with a place) used to identify products (for example, “Champagne”, “Tequila” or “Roquefort”) which have a particular quality, reputation or other characteristic because they come from that place.

• modalities: The way or method of doing something — in the Doha Development Agenda negotiations these are blueprints for the final deal, eg, how to cut tariffs, and reduce agricultural subsidies and support, along with flexibilities to deal with various sensitivities. Once the modalities have been agreed, countries can apply the formulas to tariffs on thousands of products and to various support programmes.

• special sessions: meetings of WTO councils and committees focusing only on the Doha Development Agenda negotiations.

• TRIPS: Trade-related aspects of intellectual property rights.

> More jargon: glossary

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