Biological medicines in the age of biotech: Public policy issues

Norma Morris

Science and Public Policy, 1997, vol. 24, issue 1, 53-62

Abstract: The class of medicines known as ‘biologicals’ offer unique benefits and have been major life savers but they present particular problems for control of their purity and potency. In the past decade advances in molecular biology and methods of manufacture using biotechnology have led to an explosion of products and opened up new areas for treatment of disease. Is the current regulatory framework adequate for the protection of the public health? How will it be affected by political and economic trends which are causing government to question all public-sector activities, including control of biologicals? The issues include the impact of scientific and technical developments on regulatory workload, unresolved scientific questions of safety, impact of reduced public-sector funding, public input, social and ethical questions raised by new technology, and UK policy with regard to the increasing use and manufacture of biologicals in the developing world. Copyright , Beech Tree Publishing.

Date: 1997
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