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Public Health and Patents

Introduction

Although scientific and technological innovation has contributed to significant improvements in health conditions, health crises, relating, in particular, to HIV/AIDS, malaria, tuberculosis, and, most recently, avian influenza, continue to create major problems in many parts of the world. In various national and international fora, solutions are sought in respect of the role of patents in pharmaceutical innovation and fair and affordable access to health care.

The patent system is designed to promote innovation and, at the same time, offer a mechanism ensuring that the fruits of that innovation are accessible to society. In the contexts of public health, the challenge for policy makers is to find an optimal balance between the rights of patent owners, who provide technological innovations to improve health conditions, and the needs of the general public.

In general, the development of new drugs requires heavy investment and long-term research, coupled with expensive clinical trials and regulatory approval procedures. The exclusive right conferred by a patent is one of the incentives for developers of new drugs to make the necessary investments into that research. Clearing issues, such as ownership and licensing policies for innovation derived from public research, would contribute to the promotion of a more effective deployment of public funds and public R&D programs. At the same time, the patent system also contributes to society by making available patent information, which is freely available to other researchers to further improve existing technologies. With a view to facilitating commercialization and ensuring access to patented technologies, the patent system is primarily based on conferring an exclusive right, in conjunction with a voluntary licensing mechanism. However, taking into account the public interest and policy objectives beyond the patent system, there are a number of flexible mechanisms built in the patent system, such as the possibility of issuing compulsory licenses, research exceptions and parallel imports.

On the other hand, some consider that the current patent system does not adequately address public health crises. It is argued that the commercial incentives provided by the patent system are not sufficient to ensure the development of new products in certain areas, for example, in respect of neglected diseases, and that patent rights, which are enforced on the basis of commercial and market-based considerations, prevent access to, or increase prices of, essential medicines. Some criticize that the safeguard mechanisms built in the patent system, such as compulsory licenses or research exceptions, are not sufficiently broad to cover existing needs. Further, the number and, at times, the broad scope of patents granted in the field of early fundamental research have raised concerns about patent thickets and royalty stacking. In particular, reach-through claims in respect of research tools are considered a potential obstacle to further research and development.

 

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