The question is far from academic. Major developments not only in biotech, but also in genomics and stem cell research now offer exciting and far-reaching opportunities for health care in conditions ranging from Alzheimer's and Parkinson's disease to genetic disorders. However the pharmaceutical companies who could otherwise be expected to bring the relevant treatments to the market place are facing turbulent relations with policy makers, regulators and members of the public.
Patents expert at the Edinburgh University School of Law, Dr. Graeme Laurie says, "How can property rights be granted over genes which, after all, seem to be no more than mere discoveries?" He goes on to ask "How appropriate is it to grant a monopoly over the building blocks of life or indeed life itself in the guise of genetically engineered organisms?"
Laurie quotes the recent severe set-back for Genentech Inc. who foresaw the therapeutic value of a protein occurring naturally in the human body that assists in the dissolution of blood clots. The company spent considerable sums in using recombinant DNA technology to bring the product to the brink of the marketplace and applied for a protective patent. But despite the company's outlay and effort, this was refused because several other companies had also been racing to develop the drug. Consequently although Genentech had won the contest, the development was legally deemed "an obvious next step" which is technically unpatentable.
The very substantial funds needed to discover and develop new blockbuster drugs are in any case already at risk because existing medically and financially successful drugs are nearing the end of their patent life. Added to this the industry now faces searching questions about how to bring radically new types of product such as drugs designed on the basis of ongoing genetic investigations, or stem-cell research to the market place.
What regulations will they face? How far will stakeholders and indeed the public accept the new drugs and who will work out safe medical procedures?
These are just some of the issues to be addressed at the forthcoming international conference on the Evolution of the Life Science Industries. Held by the Economic and Social Research Council's Centre for Social and Economic Research on Innovation in Genomics at the Edinburgh International Conference Centre, it runs from 23 to 25 February. State of the art research, development and problems will be discussed and speakers with international reputations will begin to shape future pathways of innovation in the life sciences.
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