TRIPS Council: Members Debate Biodiversity, Access to Medicine

9 March 2011

WTO members last week debated how current global intellectual property rules affect biodiversity protection and access to medicine, but made little progress on either issue, both of which are priorities for developing countries.

The Council for Trade-related Aspects of Intellectual Property Rights (TRIPS) met on 1 March to discuss the use of a system intended to smooth poor countries' access to patented drugs, as well as whether WTO rules need to be amended to require patent applicants to disclose the use of any genetic materials in an invention. Such disclosure requirements have long been a demand of many developing countries, backed by a number of developed countries. The recently completed Nagoya Protocol to the Convention on Biological Diversity (CBD) provided new fuel for the longstanding debate; the absence of disclosure requirements in the protocol rekindled demands for amending TRIPS to prevent biopiracy.

Ultimately both discussions, which continued from the TRIPS Council's last session October, resulted in few new country positions.

Biodiversity and TRIPS

The TRIPS Council spent the bulk of its time addressing the relationship between the TRIPS Agreement and the Convention on Biological Diversity.

Members addressed three points: the status of the CBD secretariat in the TRIPS Council, a proposal by Bolivia to exclude life forms from patentability, and a proposal to add a "disclosure requirement" to TRIPS Article 27.3(b) to make up for its absence in the Nagoya Protocol.  Of these three points, the last consumed the majority of the speakers' time.

On the status of the CBD, many WTO members, and especially developing countries such as Brazil, South Africa, and India, called for allowing a CBD secretariat representative to participate in TRIPS Council discussions. They argued that doing so would help clarify issues such as the implications for TRIPS of the Nagoya Protocol, instead of requiring WTO members to figure it out for themselves.  (In the absence of a CBD representative, Japan briefed the session on the Nagoya Protocol and its relation to TRIPS.)  The United States argued against including a CBD representative, on the basis that doing so would unnecessarily waste the limited time of the Council. Members, the US delegate contended, already had to acquaint themselves with Nagoya anyway.  The issue was left unresolved.

Beyond the process issue of whether to let the CBD attend Council meetings, members also had substantive questions about the Nagoya Protocol and its relation to TRIPS Article 27.3(b), which covers the patentability (or exclusion from patentability) of plant and animal inventions.  Although many governments had hoped to include a disclosure requirement for patent-seekers in the Nagoya Protocol, they did not succeed in doing so.  As a result, many developing countries reiterated support last week for amending the TRIPS agreement to include a disclosure requirement -- one that would punish failure to disclose with patent revocation. As in the past, this support ran into opposition from some developed countries.

While developing country backers of a disclosure requirement argue that it would add transparency to the patent process and discourage biopiracy, some developed countries, most prominently the United States, argued that it would be unduly burdensome and stifle innovation.  The US instead supported an alternative transparency mechanism proposed by Canada, namely a patent information database.  However, developing countries such as Colombia and Brazil argued that a database would be insufficient to cover the universe of traditional knowledge. The issue was left unresolved.

Proposals for more far-reaching amendments to Article 27 also arose during the meeting.  Bolivia, with the support of Venezuela, proposed changing the TRIPS agreement to exclude life forms from patentability altogether.  Bolivia argued that the "privatization of life itself" reduced human moral development, and that these concerns should not be assessed on the basis of economic value alone.  Other developing countries expressed interest in evaluating the Bolivian proposal, but few endorsed it altogether. Switzerland and the US argued that patents only apply to new, commercial inventions anyway, and that life as such cannot be patented under the current rules.  Overall, the Bolivian proposal received little attention compared to the other topics.

Debate over ‘Paragraph 6 system' continues

Delegations also discussed the provision of generic medicines to countries that lack domestic capacity to produce them.

In the wake of concerns that drug patent rules in the TRIPS agreement were making lifesaving drugs inaccessibly expensive in poor countries, WTO members agreed on a system for allowing cheap generic copies of patented drugs to be produced under compulsory licences for the purpose of export to countries that needed them. However, that ‘Paragraph 6  system' - so named for the relevant section of a 2001 declaration in Doha reaffirming that TRIPS should not prevent governments from taking measures to protect public health - has been criticised by some for being almost unusable because of complex procedural requirements. Since the Paragraph 6 system was set up in August 2003, it has been successfully used only once, by a Canadian generic manufacturer exporting HIV/AIDS medicine to Rwanda.

As a result, much of the Paragraph 6 discussion in the TRIPS Council centered on why it has been used so little.  Some countries offered their own experiences with the use of compulsory licensing.  Brazil, for example, described its domestic HIV/AIDS compulsory license program. In 2007, in an attempt to restrain the growing cost of its HIV/AIDS treatment programme, Brazil issued compulsory licenses authorising the generic production of the widely used HIV/AIDS drug Efavirenz, which cut the per dose price by two-thirds, from $1.59 to $0.53.  As HIV/AIDS patients grow resistant to older drugs, they require new, generally more expensive drugs.

Recognising that pharmaceutical innovation in more effective HIV/AIDS drugs came with serious research and development costs,  Brazil suggested that WTO members look at the balance of incentives underpinning the Paragraph 6 system..Brazil called for a "a balance between the rights granted to IPR owners and the interests of society as a whole", and in this regard, "to include other stakeholders in this discussions so that we can better understand why the system is no being used and agree on ways to improve it."

Indeed, both developing and developed countries called upon each other to provide more information so that the Paragraph 6 system could work properly.  In the previous TRIPS Council in October, developing countries asked developed countries to provide more information on their technology transfer and safety regulations for exporters, since these regulations could prevent developed country generic companies from exporting to developing countries.  In turn, developed countries asked developing countries to provide answers about how developing country importers experienced the Paragraph 6 system.  To the frustration of developed countries, developing countries did not have answers ready at the time of the latest TRIPS Council meeting.  However, the developed countries were able to provide some answers to the developing countries' questions on technology transfer and safety regulations.

Finally, some developing countries requested information workshops that would gather NGOs, pharmaceutical companies, and relevant practitioners in the field to explore more deeply the reasons behind the failure to implement Paragraph 6.  Developed countries left the option open, but emphasised that governments' experience should be shared in the TRIPS Council regardless.  Whether the workshops will be undertaken remains to be seen.

ICTSD reporting; "Nagoya gives new context to old views in intellectual property council," WORLD TRADE ORGANIZATION, 1 March 2011; "Patentable subject matter, IP waiver for health discussed at WTO," EUROPEAN AIDS TREATMENT GROUP, 3 March 2011.

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