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Ownership of knowledge--the role of patents in pharmaceutical R&D.

Both the public and the private sectors contribute to research and development (R&D) in pharmaceuticals. The public sector originates many of the discoveries of new drugs. The private sector, which focuses on development, is heavily reliant on patents. Though patents are presumed to reward genuine inventions, lax rules on patentability and shortcomings in procedures permit protection to be obtained on a myriad of minor developments. These patents, though weak and possibly invalid in many cases, are used to restrain competition and delay the entry of generic competition. Developing countries should design and implement their patent laws so as to prevent strategic patenting and promote competition and access to medicines.

Developed Countries↗

[Legal protection of biotechnological inventions. The European Parliament's perspective].

In 1996, the European Commission put forward a proposal for a Parliament and Concil Directive on the legal protection of biotechnology inventions. The article looks at vicissitudes which characterised the progress of the proposal in the Council and the European Parliament. The future directive will regulate the patentability of biological material, which is a particularly sensitive issue when the material is of human origin. The article also seeks to set the proposed directive in a wider context by referring to forthcoming international Convention Law on biotechnology and to the legal situation in Spain at present.

Biotechnology↗

Legal issues to address when managing clinical information across Europe: the ECIT case study (www.ECIT.info).

This paper identifies issues which will need to be addressed in pursuing the aims and objectives of the European Classification of Infertility Taskforce (ECIT), namely: to establish classification codes for infertility management; to improve the consistency of infertility information collection by specialist centres, particularly but not exclusively by computerised systems; to use these codes to enable the transfer of infertility information from specialist centres to national infertility data registries; to develop a Grid linking the data held in European infertility data registries; to use Grid processing to mine the data in the European infertility data registries to optimise patient management improving the effectiveness of treatment and reducing the risk.

Commodification↗

A small step for science, a big one for commerce.

The excellent work that is being performed in medical science advances is to be admired and applauded. In each case the quest is for perfection and to bring the task in hand to its final solution. Along the way there are milestones being passed that may be overlooked, as to their particular merits, because the eyes are focused all the time on the ultimate goal. The conference highlights so many areas of interest and endeavour some of which parallel, duplicate, overlap and/or compliment others.

Biomedical Technology↗

Manufacturing in China.

China offers advantages, but establishing production facilities in the country is complex. This article reports one company's observations on operating there.

Biotechnology↗

The information revolution reaches pharmaceuticals: balancing innovation incentives, cost, and access in the post-genomics era.

Recent developments in genomics--the science that lies at the intersection of information technology and biotechnology--have ushered in a new era of pharmaceutical innovation. Professor Rai advances a theory of pharmaceutical development and allocation that takes account of these recent developments from the perspective of both patent law and health law--that is, from both the production side and the consumption side. She argues that genomics has the potential to make reforms that increase access to prescription drugs not only more necessary as a matter of equity but also more feasible as a matter of innovation policy. On the production end, so long as patent rights in upstream genomics research do not create transaction cost bottlenecks, genomics should, in the not-too-distant future, yield some reduction in drug research and development costs. If these costs reductions are realized, it may be possible to scale back certain features of the pharmaceutical patent regime that cause patent protection for pharmaceuticals to be significantly stronger than patent protection for other innovation. On the consumption side, genomics should make drug therapy even more important in treating illness. This reality, coupled with empirical data revealing that cost and access problems are particularly severe for those individuals who are not able to secure favorable price discrimination through insurance, militates in favor of government subsidies for such insurance. As contrasted with patent buyouts, the approach favored by many patent scholars, subsidies would take account of, and indeed capitalize on, the institutional realities of health care consumption. These subsidies should, however, be linked to insurance regulation that works to channel innovation in a cost-effective direction by requiring coverage of drugs that provide significant benefit relative to their cost.

Drug Industry↗