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(2000; 36 pages) [French] [Spanish]
Delhi Declaration on trade issues
A balancing of rights and obligations under the TRIPS Agreement was one of the main demands of the Delhi Declaration released at the end of a two day workshop on trade issues held in New Delhi in October 1999. In a hard-hitting statement the 65 delegates called for strong, clearly defined compulsory licensing provisions; protection of traditional knowledge from all forms of patenting; and strengthening of existing anti-monopoly practices by developing countries.
Participants argued that as international trade agreements contribute to widening the socioeconomic and technological gap between developed and developing countries, it is necessary to have an alternative framework, incorporating greater self-reliance.
As well as the TRIPS (Trade-related Aspects of Intellectual Property Rights) Agreement the national and international experts present also addressed issues such as food security, competition policies and electronic commerce.
The International Brainstorming Workshop on World Trade Organization Agreements and People’s Concerns was organized by the Centre for Study of Global Trade System and Development and the National Working Group on Patent Laws.
Copies of the Delhi Declaration are available from: Centre for Study of Global Trade System and Development, A-388, Sarita Vihar, New Delhi 110 044, India. Tel/fax: + 91 11 694 7403, e-mail: firstname.lastname@example.org
Fears over new regional patent agreement
A new agreement on patent protection formedicines could endanger people’s health in some of Africa’s poorest nations, according to Médecins Sans Frontières. The organization has urged countries not to ratify the Bangui Accord, created last year by 15 French-speaking African nations. In these countries, patents are granted through the African Intellectual Property Organization (OAPI), which acts as a patent office for all its Member States. Patents are granted and regulated according to the Bangui Agreement (signed in 1977), which was recently revised to comply with WTO rules, increasing patent protection from 10 to 20 years.
A report1 issued jointly by WHO, UNAIDS and MSF says the new treaty, which has not yet come into force, could lead to increased prices for medicines. This is because the new Bangui Agreement is more stringent than the TRIPS Agreement and provides little come back in case of patent abuse, the report states. Compulsory licences are only available provided that the patented drug can be manufactured locally, yet there is little manufacturing capacity in the region. Parallel imports are only possible between OAPI Member States whereas lower prices might be found in other parts of the world.
OAPI counters that in revising the Bangui Accord Member States have affirmed their conviction that bringing intellectual property rights into line with the TRIPS Agreement will attract investors and stimulate technology transfer. In an Information Memo* the Organization says that its critics need to look elsewhere for the reasons why many Africans lack access to essential drugs.
* The Information Memo is available on the web at: http://www.oapi.wipo.net/
Under WTO rules, the so-called “least-developed countries” - 10 of which are covered by the Bangui Accord - have until January 2006 to change their patent systems. But if the Accord is ratified by at least 10 members, countries will find themselves forced to change their systems immediately. So far eight nations have ratified.
1. MSF/WHO. Revue of the pharmaceutical policy in Cameroon - Medicine patents in francophone Africa. Joint Mission MSF-WHO-UNAIDS. Geneva: Médecins Sans Frontières and World Health Organization; 2000. (Available in English and French).
Patents from a public health perspective
* Carlos Correa is Director of the Masters Programme on Science and Technology Policy and Management at the University of Buenos Aires, Argentina. He is a specialist in global intellectual property law, and was involved in the negotiations on TRIPS during the Uruguay Round of trade negotiations. Further information on legal options for drawing up TRIPS-compatible national legislation can be found in Professor Correa’s new books, Integrating public health concerns into patent legislation in developing countries, and Intellectual property rights, the WTO and developing countries. (See Published Lately pages 33 and 34).
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires all WTO Member Countries to adapt their laws to the minimum standards set forth by the Agreement, within established transitional periods. Developing countries face a special challenge in conforming to international trade obligations, particularly the TRIPS Agreement which covers intellectual property rights of pharmaceutical products and processes.
The way in which countries reform their legislation may have a significant impact on public health policies, and particularly on access to drugs. Any property rights system must strike a balance between creating incentives for innovation, and people’s need for availability and affordability of protected goods. So when they draw up their own intellectual property rights rules, it is important that developing countries realise the scope they have - within the framework of international treaties - to produce their own patent laws.
The TRIPS Agreement does not establish a uniform international law or even uniform legal requirements. World Trade Organization Member Countries must comply with the Agreement’s minimum standards. But countries may legitimately adopt regulations that ensure a balance between the minimum standards of intellectual property protection and the public good. Moreover, they can adopt measures which are conducive to social and economic welfare (Article 7 of the Agreement). These include steps necessary to protect public health, nutrition and the public interest in sectors of vital importance for socio-economic and technological development. Countries can also adopt measures to prevent the abuse of intellectual property rights (Article 8.1 and 8.2).
In those countries that are bound to introduce patent protection for pharmaceuticals as a result of TRIPS, patents will only be available for products for which a patent application was filed after 1 January 1995. This means that other products (including those already applied for or patented in other countries, or marketed before that date) will remain in the public domain. The exception is where the national law permits retroactive protection of the so-called “pipeline” products, as is the case in Brazil.
Scope for national differences
Given diverse national objectives, it is not surprising that different countries’ patent systems diverge, in some cases significantly. There is no single “patent system”. Moreover the solutions adopted in particular countries have changed over time. They treat specific patent issues - including eligibility requirements, scope of protection, exceptions to exclusive rights and compulsory licences - in quite different ways. In drawing up their own intellectual property rights rules, policy and law makers in developing countries need to be aware of this. They will be most successful in meeting their own needs if they can draw on the experiences of national systems worldwide.
Some countries - particularly developed countries - have opted for legal systems that confer strong patent rights. They have done so in order to protect revenues from their already established technological base and to promote investment in technological innovation. Considerable debate exists in such countries, however, on the level and scope of protection which are optimal to foster innovation without unduly restricting the free circulation of ideas and stifling competition. A growing concern is voiced in some countries on the shortcomings of the examination process and the proliferation of low quality patents. Moreover, the economics of patent law is still an uncertain area, for which a robust theoretical framework and empirical evidence are lacking.
Checks and balances
Countries with less advanced technologies may prefer to promote the transfer of those technologies needed for development, and to preserve and enhance competition. They do so in order to secure access to goods, services and technologies on the most favourable market conditions. Even in countries with the strongest intellectual property rights protection, national laws provide for checks and balances, to protect against possible abuse of the powers conferred by protection.
Policy-makers should consider crosscutting issues when they design a national patent system, for example: protection of public health and the environment; promotion of competition and technology transfer; protection of consumers; and support for small local inventors. Countries should also respect inventors’ rights to a reward for contributions to technical progress. Other regulatory measures affecting public health, such as those relating to medicines’ registration, must be carefully considered, so that there is a consistent legal framework that improves access to medicines.
A health-sensitive approach to patent legislation might address short-term emergencies that justify different temporary measures (for instance, medicines’ supply in cases of epidemics or natural disasters). Or the approach may be part of an integrated medium - or long-term patent policy. In some cases, a country may - within limits permitted by its international obligations - opt for different levels of protection in different areas of intellectual property. The level would depend on its competitive position and the expected role of national and foreign investors and technology suppliers. It may, for instance, be possible to emphasise protection for information technologies, through high levels of copyright protection for computer programmes and databases. At the same time lower levels of protection may be given in areas where local industrial and technological capabilities are low, and unlikely to be significantly improved through a high standard of patent protection.
The way in which such options are implemented should be consistent with the country’s level of development, particularly its research and manufacturing capabilities in the pharmaceutical sector. The options followed by a large developing country with significant capabilities may differ from those preferred by a small economy which is totally or substantially dependent on foreign supplies of pharmaceuticals. Likewise, patent laws may evolve as a country develops. It should be remembered, however, that problems of access to drugs caused by poverty and low income are common to most developing countries.
Taking the medicine in Guatemala. International trade agreements don’t just affect people in the rich industrialised nations
The protection of public health is one of the most pressing issues in developing countries. A large part of the global population still lacks access to essential drugs. In the poorest parts of Africa, for instance, over 50% of the population lack that access. An estimated 1,5 billion people are not expected to survive to age 60, and more than 880 million people lack access to health care. Of the more than 33 million HIV-positive people in the world, 95% live in developing countries, and most of them cannot afford required drugs. To deal with this dramatic situation, an integrated approach to the deeply inter-related issues of national health policy, pharmaceutical policy and patent policy is required. None of these policies can be framed or implemented in isolation.
If developing countries are not to be disadvantaged by new trade rules, they must look at options for designing and implementing public-health-sensitive patent policies. There must be a balance between the public and private interests involved, including the rights of states, patients and suppliers of health-related goods and services.
Other useful documents include Globalization and access to drugs. Perspectives on the WTO/TRIPS Agreement. Health Economics and Drugs, EDM Series No. 7, and Globalization, patents and drugs: an annotated bibliography, Second edition. Health Economics and Drugs, EDM Series No. 10. Both documents are available, free of charge, from: Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland.