• Intellectual property rights

Intellectual property rights

The implementation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) is emerging as a major concern for all developing countries (DCs). This paper intends to assist the DCs in their efforts to adapt their laws to the standards set by TRIPs in relation to pharmaceutical products and processes. Conforming with the agreement has posed a special challenge for DCs. The way in which the required legislative reform is made may have a significant impact on public health policies, and particularly on the population’s access to drugs. This paper presents options for the design and implementation of public-health-sensitive patent policies in DCs.

The TRIPs Agreement does not establish a uniform international law, nor even uniform legal requirements. World Trade Organisation (WTO) member countries are obliged to comply with the minimum standards of the TRIPs Agreement. Member countries can implement their own solutions on particular matters. Some countries have opted for legal systems that confer strong patents rights. However, less technologically advanced countries may prefer to promote the transfer of technologies needed for development.

There is broad recognition of the role that patents can play in stimulating health-related research and development (R&D). Patents are considered important given the costs and risks of R&D, and that this R&D may lead to inventions of potential use to all countries. Thus, there are price and competition costs to intellectual property rights (IPRs). On the other hand, the conditions that determine access to medicines are critical matters, especially for the low-income segments of the population. Any IPRs system must therefore strike a balance between creating incentives for innovation and consumers’ interest in the availability and access to the protected goods.

The paper presents some recommendations for designing a proper national patent system:

• the granting and exercise of patent rights should be consistent with the basic goals of the society, particularly promotion and protection of public health. Consequently, a pro-competitive approach in several aspects of patent legislation is required
• policy makers should also consider the protection of the environment, the promotion of competition and technology transfer
• governments should be able to act efficiently in cases of emergency
• patent laws should contain appropriate mechanisms to correct excesses in the exercise of patent rights
• careful consideration should be given to other regulatory measures affecting public health, such as those relating to the approval and registration of medicines
• governments can opt for different levels of protection in different areas of IPRs
• the system should be consistent with the level of development of each country
• DCs could incorporate a novelty requirement that encompasses any disclosure, including through use anywhere in the world
• compulsory licenses may constitute an important tool to promote competition and increase the affordability of drugs. However, determination of the compensation to be paid to the patent holder is a key issue

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