Changes to the European Union pharmaceutical legislation: Implications of the 'Pharma Review' for biotechnology companies

Abstract

A global revision of the European regulatory framework for medicinal products, the 'Pharma Review', has recently been adopted by the European Institutions. This is an important step for the competitiveness of the European life sciences industry, as this 'Pharma Review' has numerous and significant implications for companies involved in the field of biotechnology. Three main amendments can be highlighted in this context: (1) the strengthening of the European Agency for the Evaluation of Medicinal Products (EMEA) as a scientific advisory body, which will enable biotechnology firms to get high-quality scientific advice early in the drug development process; (2) new marketing authorisation procedures, which will provide a simpler and faster market access for 'breakthrough' medicinal products when no therapeutic alternative is available; and (3) the establishment of an EU-harmonised data protection scheme, in order to set the appropriate balance between innovation and the development of the generics industry. The objective of this paper is to explore these essential regulatory changes, which all aim at meeting one critical challenge: enabling innovative firms to get streamlined access to the enlarged European market without compromising public health.