November 2002 Developments in Biotechnology Challenge Notions about the Quality of Human Life

Advancements in the biotechnology industry have raised a number of moral concerns about the affects of biotechnology on society including the affects of patenting products in this industry.

"Developments in biotechnology offer the choice of deciding what kind of society we want in the future and what kind of life quality. Whether or not the law adequately deals with public concerns about biotechnology is an open question," said Dr. Oliver Mills, lecturer in Commercial Law at NUI, Galway.

The 1998 Directive on the Legal Protection of Biotechnological Inventions is the main piece of legislation governing patents in Europe. The need to understand the exact nature of a patent is central to addressing concerns about the patenting of biotech products, according to Dr. Mills.

"A patent does not confer ownership. It gives the patentee the right to prevent third parties from exploiting the invention without his consent. It does not give the patent holder the right to commercially exploit the product. For the most part, exploitation is controlled by national regulatory authorities," said Dr. Mills.

There is a common misconception amongst many consumers that a patented product is superior. But, this is not the case, as a company can still put a non-patented product on the market. "Therefore denying a patent on the basis of moral concerns would not necessarily be a way of ensuring safety," said Dr. Mills.

Traditionally, patent law was regarded primarily as an instrument of economic policy. However, in the context of modern biotechnology the extent to which patent rights should be influenced by broader moral concerns means that the rationale underlying patent law may need to be re-evaluated. Many of these concerns centre around genetic engineering and its affect on human dignity.

"Who determines how the technology is to be used and who will derive the benefits are some of the key issues that remain unanswered," said Dr Mills. The main commercial applications of biotechnology to date have been in the domain of healthcare, agriculture and the environment.

The hope in relation to healthcare is that diseases such as cystic fibrosis and sickle-cell anaemia, which are caused by single gene deficiencies, will be eradicated using biotechnology. Looking ahead, it is hoped that benefits to the environment will be reaped with the increased use of physiologically altered crops, which could add nutrients to soil and water in drought areas to accelerate growth.

Genetically Modified (GM) foods is a major reason why biotechnology in the agricultural/food sectors is so controversial. Much attention has been focused in recent times on the use of biotechnology to genetically modify foods and the affect this will have on the environment. The hope is that farmers can produce better quality and higher yields of product with less reliance on pesticides thereby reducing environmental impact. Genetically modified soya beans, maize, corn, cotton and canola are currently available in the marketplace. Seeds of these products produce plants that don't need protection from insecticides.

Other developments include crops fortified with vitamins and minerals. The potential of 'vaccine crops,' which contain genetic material from pathogens that operate as vaccines when eaten, is currently being explored. Viral-resistant rice and frost-tolerant fruit are currently being developed but are not available on the market yet.

The 2001 Directive on the Deliberate Release of Genetically Modified Organisms by the European Commission introduces new concepts into the authorisation process ensuring that GM foods are safe for consumption before they are released into the public domain. EU countries have 18 months to implement this legislation.

If the promise of biotechnology is to be realised, wide public debate that should inform our decisions about the role of Law in regulating the development and application of the technology is necessary. However, according to Dr. Mills, the real question is "whether such control should be exercised in any significant way by means of moral considerations in the patent system. Where moral considerations do apply is in elucidating concerns to determine what is and what is not acceptable to society. Developing the moral objections to biotechnology could clarify public concerns and how these should be dealt with". Patent law is not designed to regulate biotechnology and any attempt to do so by denying patents on the basis of morality is misplaced.

For more information please contact: Máire Mhic Uidhir Press & Information Officer, NUI, Galway Tel: 091-750418 / 087-2986592

Notes to the editor Dr Oliver Mills holds a Science Degree and a Law Degree from University College Cork. He also has a Master of Laws Degree from Cambridge University and a Ph.D. from the University of Edinburgh. He has 10 years' experience in the pharmaceutical industry.