For some time, the EU has been losing ground in the field of pharmaceutical innovation, and the beginning of the 21st century also saw Europe facing challenges such as the increasing globalization of the sector and scientific breakthroughs, as well as those of cooperation and harmonization and the perennial threat to both the economy and the safety of the population posed by counterfeit medicines. Taking the view that a more competitive and innovative industry would generate more growth and sustainable jobs and also foster the development of new medicines for unmet medical needs, the European Commission tabled a number of different proposals to address the challenges posed by issues of innovation, safety and cooperation.
This book presents papers which address various aspects of pharmaceuticals policy and law. Firstly, an editorial discusses the challenges for the pharmaceuticals policy of the EU. Further topics covered include: new European legislation on pharmacovigilance, pharmaco-economic evaluations, medicrime, generic drugs, the Supplementary Protection Certificate, homoeopathy and the disagreements surrounding the transposition of European rules on medicines into Spanish law. The final paper addresses the development of European pharmaceutical policy and remaining challenges from a public health perspective.