Events and Milestones on the Road to 1992 — The Needs of Industry in View of the Internal Market and Evolving Regulatory Procedures

Abstract

1992 means free circulation of medicines. This could be an opportunity or a risk for the European pharmaceutical industry, depending largely on the mechanisms that are used to complete the internal market. In terms of regulatory affairs, the European Federation of Pharmaceutical Industries' Association (EFPIA) wishes to see a future marketing authorization system which serves all parties' interests by containing options and by not disrupting product registration; and is concerned that the proposed measures on information, advertising, distribution, and legal status of medicines should not seek to go beyond what is needed to complete the internal market; wide dialogue will contribute to a satisfactory evolution. In economic terms, EFPIA warns against the internal market becoming a pretext for measures which could damage rather than promote the interests of the European industry, and urges a step-by-step approach, which would include due consideration for the financial risks of R&D — such as a European measure to restore effective patent term. In addition, the European industry will have to adapt to the post-1992 competitive circumstances, deploying its resources effectively in response to the new challenges of a single market