New Developments of Pharmaceutical Law in the EU

Innovation in human medicines has enabled patients to benefit from treatments which would have been unimaginable a few decades ago. But despite the major health challenges faced today, since the beginning of the 21st century, Europe has been losing ground in the field of pharmaceutical innovation: between 1990 and 2006, expenditure on pharmaceutical research and development grew 5 times in the US, whereas in Europe it only grew 2.9 times. In 2008, the European Commission adopted a Communication and three legislative proposals with the objective of ensuring that the citizens of Europe would increasingly be able to benefit from a competitive industry generating safe, innovative and affordable medicines. But the effective research, production and marketing chain which is the first responsibility of government and other actors is complex and if governments continue to focus only on the final price of medicines, neglecting their responsibility to foster a climate where research and innovation can flourish, the population will suffer as a result. Medicinal products are a basic tool to increase quality of life and life expectancy. The cost of such products should not be seen as expenditure, but as an investment in the human capital of health and well being. This book addresses issues currently of concern to the European pharmaceutical industry. Among the subjects it explores are: counterfeit medicines; the harmonization of regulatory standards; labels, leaflets and packaging; monopoly in the pharmaceutical sector; and, the role of the pharmacist in determining therapy costs.