(2000; 91 pages)
Recommendations from the Delegates to the ASEAN Workshop on the TRIPS Agreement and its Impact on Pharmaceuticals
Jakarta, 2-4 May 2000
The workshop recognizes the importance of access, at the national level, to affordable drugs which meet international standards of quality, efficacy and safety.
The workshop also recognizes that most ASEAN Member Countries are signatories to the WTO/TRIPS Agreement, and should therefore abide by its rules. However, it is stressed that the TRIPS Agreement allows for some flexibility, and ASEAN Countries are advised to use this flexibility to ensure that their national and developmental objectives are met and to protect public health.
The workshop also notes that compulsory licensing1, parallel import and a Bolar provision are in compliance with the TRIPS Agreement.
1 TRIPS however sets some conditions, which have to be followed when issuing a compulsory license.
The workshop recommends that:
1. National governments should adopt legislation specifying patentability criteria in order to ensure the protection of real inventions and to ensure a balance of rights and obligations of the patent holders and the end-users; these criteria should be applied strictly2.
2 Due to a very flexible interpretation of the criteria of novelty, inventive step and industrial application, at times the patent system is being misused and is becoming an obstacle to innovation, instead of a stimulus. More strict application of the criteria for patentability may help to prevent excesses.
2. National governments should pass patent legislation providing for compulsory licensing and parallel import and containing a Bolar provision.
3. An ASEAN ad-hoc expert meeting on the impact of globalization and trade liberalization on the health sector should be established immediately, in order to develop:
- model legislation, including appropriate provisions for compulsory licensing, parallel import and a Bolar provision,
- a system to monitor the implications of the TRIPS on access to drugs in the ASEAN Countries,
- guidelines on how to deal with disputes related to TRIPS and access to drugs,
- a common position in relation to the implementation of the TRIPS Agreement with a view to protect public health.
The ad-hoc expert meeting should include WHO and relevant NGOs as partners.
4. The workshop strongly recommends that ASEAN Member Countries should adopt a common and united stand against any pressures/actions against individual Member Countries in relation to measures, within the framework of TRIPS, which are meant to safeguard public health interests and/or access to drugs. The workshop strongly recommends that ASEAN Member Countries adopt a common position in any future trade negotiations affecting the health sector, including the review of the TRIPS Agreement.
5. ASEAN Countries Representatives to the WTO should request that WTO allows the involvement of WHO in negotiations in relation to trade agreements having an impact on the health sector, including the review of the TRIPS Agreement.
6. ASEAN Member Countries should further study TRIPS provisions on trademarks in relation to public health. To this end, expert reports should be obtained:
• from WIPO, on the status of national legislation and control measures with respect to trademark protection of health related products in WIPO member countries,
• from WHO, on the impact and public health consequences arising out of TRIPS provisions on trademarks, the use of generic names (INN) vs. brand names, the use of the generic name on package of medicines, prescribing by generic names, generic drug substitution and trade dress protection.
7. ASEAN Member Countries should gather information on various approaches for the protection against unfair commercial use of test data of new chemical entities, and on the implications of these approaches on access to drugs.
8. The workshop notes that the TRIPS Agreement does not include specific provisions related to the protection of traditional or indigenous knowledge (systems, practices, naturally occurring plants, products), and recommends that new methodologies and instruments be developed for this purpose. These should be based on the Convention on Biological Diversity (CBD) and other International Agreements currently available3.
3 Notably the Convention on International Trade of Endangered Species (CITES), the Declaration of Chiang Mai, the Declaration of Belem and the outcome of the WIPO meeting on intellectual property and genetic resources, Geneva, April 2000.
In this context, trade marks, trade secrets, geographical indications and plant variety protection should also be taken into consideration.
9. ASEAN Member Countries need to develop national legislation, as well as an ASEAN position on the protection of traditional/indigenous knowledge. This position should then be advocated at the international level.
10. ASEAN Countries should develop an inventory and registry of their biological resources and traditional knowledge, taking into account the intellectual property implications of such inventories and registries. There should be a network of information exchange among ASEAN Member Countries for this purpose. The workshop also recommends to further study the various aspects of intellectual property rights in relation to traditional systems of medicine and indigenous knowledge available in each country. This should be done in collaboration with various other organizations working in these areas.
11. ASEAN Member Countries should develop a collective position on the sovereign rights in genetic resources and traditional knowledge, including traditional resource rights. Efforts should be made for an international agreement on such rights.
12. ASEAN Member Countries should have a collective position for the interpretation arid review of TRIPS Article 27.3(b)4.
4 Article 27.3(b) addresses the patentability - or the exclusion from patentability - of plants, animals, micro-organisms and biological processes.
13. The patentability of micro-organisms should be confined to genetically engineered micro-organisms only. Naturally occurring and mutated or selected microorganisms should be excluded from patentability.
14. In respect of the protection of plant varieties, a sui generis system of protection is recommended. Countries are free to adopt a sui generis and/or patent system for the protection of plant varieties.
15. A second5 ASEAN ad-hoc expert meeting should be set up to discuss in depth issues related to biotechnology, including gene, vector, process and products. Members of the expert group should include technical experts, NGOs and community representatives. The Human Development Report 1999 on the risks of genetic engineering should be taken into account while examining the options in international agreements on biotechnology.
5 A first expert group is proposed in recommendation 3.
The workgroup further recommends that:
16. ASEAN Member Countries should request WHO to provide technical assistance with regard to the implementation of TRIPS bearing in mind that public health takes precedence over commercial and trade interests.
ASEAN Member Countries should request the WTO, WIPO, UNCTAD and other relevant organizations and NGOs to provide further appropriate assistance in order to help them to be consistent with the TRIPS Agreement and its reviews.
17. The recommendations and the report of this workshop should be sent to the ASEAN Secretariat, relevant ASEAN Ministries, WTO, WHO and WIPO, so that appropriate follow-up actions can commence without delay.