by Chakravarthi Raghavan

Geneva, 5 May 2000 -- Member governments of the ASEAN countries have been asked to develop national legislation on protection of indigenous and/or traditional knowledge and on that basis formulate an ASEAN position to be advocated at international level.

This is one of the recommendations on 'Biodiversity, Biotechnology, Traditional/Indigenous knowledge, and Traditional medicine,' coming out of an ASEAN regional working group meeting in Jakarta, Indonesia (2-4 May) on the TRIPS Agreement and its Impact on Pharmaceuticals.

The workshop consisted of experts of member-countries and from some international organizations including the World Health Organization, some regional non-government groups and resource persons from outside.

The WHO representative in Indonesia, Dr. Georg Petersen, speaking at the opening session, said that the market had failed and children were dying of diseases for which there were cures but the parents and the countries could not afford those cures. The market has failed, and new ways have to be found to link supply to demand and to need.

The workshop has recommended that since the WTO's Agreement on Trade-Related Intellectual Property (TRIPs) does not include specific provisions related to the protection of traditional/indigenous knowledge (systems, practices, naturally-occurring plants, products), new methodologies/instruments need to be developed.

The current international instruments/ process available such as the Convention on Biological Diversity (CBD), Convention on International Trade of Endangered Species (CTIES), Declaration of Chiang Mai, Declaration of Belem, and also trade marks, trade secrets, geographical indications, plant variety protection should all be taken into consideration in developing new methodologies and instruments.

Also, the outcome of the WIPO meeting on intellectual property and genetic resources held in Geneva on April 17th-18th should also be taken into account.

Based on these, ASEAN member countries need to first develop national legislation, followed by the formulation of an ASEAN position on the protection of traditional/indigenous knowledge, and this should then be advocated at the international level.

Countries should develop an inventory and registry of their biological resources and traditional/indigenous knowledge, taking into account the intellectual property implications of such inventories and registries.

There should be a network of information exchange and networking among the ASEAN member countries for this purpose. The workshop also recommended collaboration on the various aspects on intellectual property rights through the approach of R & D.

ASEAN member countries, it was recommended, should have a collective position on the sovereign rights in genetic resources and traditional knowledge, including traditional resources rights. Efforts should be made to plan for an international agreement on the sovereign rights in genetic resources and traditional knowledge, including traditional resources rights.

ASEAN member countries should have a collective position under the provision of TRIPs article 27.3 (b), relating to patentability of plants and animals, other than micro-organisms, and the right/duty of countries to put in place a system for plant and animal varieties through a sui generis system.

[The issue of review of this TRIPS provision in 1999, has been clouded by the outcome of the 3rd Ministerial at Seattle. But at the last meeting of the Council on TRIPS, the US was reported as taking the position that it was willing to consider this question.]

In respect of the protection of plant varieties, a sui generis system of protection is preferable, and each country should be fully independent to develop an appropriate system, the ASEAN workshop recommended.

The working group also recommended that "patentable microorganism should be confined to only genetically engineered microorganisms."

"Naturally occurring and mutated/selected microorganism should be excluded from patentability," it added..

The working group also recommended that an ASEAN expert group be set up to discuss the relevant issues in depth, including gene, vector, process and products. Members of the expert group should include technical experts, NGOs and communities.

The Human Development Report in 1999 on the risks on genetic engineering should be taken into account before examining the options in international agreements on biotechnology.

The WHO, WTO, WIPO, UNDP and other specialised international organisations were requested to provide technical assistance to ASEAN member countries.

In an opening address to the meeting on 2 May, the WHO's representative to Indonesia, Dr. Petersen said that there was "a need to find a balance between pressing public health needs and legitimate private sector interests".

Petersen noted that in the context of globalization, many WHO members had raised concerns on the possible impact of TRIPS on access to drugs.

"In a very diverse world, the TRIPS Agreement had set uniform high standards for protection of Intellectual Property Rights, including the patenting of pharmaceuticals."

These high standards it was believed by some would encourage research and development of new medicines. Others argued that these standards would increase prices, and thereby reduce access to drugs, especially of the poor.

New medicines, the WTO official noted, were needed to combat old and re-emerging diseases, such as malaria and TB, and to deal with newer diseases like AIDS. But the new medicines "are of little help if those who need them most cannot afford them, and if they widen the health gap, instead of bridging it."

A balance has to be found between pressing public health needs and legitimate private sector interests. New solutions have to be sought, by everyone working together and ways found to link supply to demand and need.

Petersen added: "Together, we have to succeed where the market has failed. For, the market has failed. Today the children are dying of diseases for which we have the cures - but their parents or their countries cannot afford them." The priorities set for R & D in the pharmaceutical market were imperfect. "Research priorities may match economic demand, but often do not match medical need."

"Essential drugs are not simple commodities, like any other. But medicines are traded. They are produced, marketed and sold across the globe - benefitting some, but failing to reach too many others.

"So the rules regulating this trade are crucial."

Petersen said the trade rules in the WTO's TRIPS agreement laid down some safeguards to protect public interest and public health. These should be fully understood and used. The options of the TRIPS should be studied carefully and wise decisions made to protect public health, without hampering trade unnecessarily.

Speaking at the workshop, the Deputy Secretary-General of ASEAN, Dr.Suthad Setboonsarg, said that the availability and accessibility of drugs at affordable prices for people was essential in ASEAN and this would remain one of the priorities in ASEAN's health policy in the future.

Hence in bringing their legislation in line with TRIPS, sufficient attention must be given by ASEAN countries to ensure the health of the people - since TRIPS could have an impact on accessibility of medicines.

In an opening address, Indonesia Health Minister Dr. Achmad Sujudi said that though social benefits might arise from pharmaceutical patent protection, through discovery of new drugs, studies indicated that the globally harmonized high standards of the TRIPS patent system might have great impact on the health sector and might affect negatively on the access of drugs in developing and least developed countries.

The TRIPS agreement, he added, contained very complex and controversial issues and it was necessary to carefully study and explore them with the help of international experts, the Minister added. (SUNS4662)

The above article first appeared in the South-North Development Monitor (SUNS) of which Chakravarthi Raghavan is the Chief Editor.

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