EU Pharmaceutical industry leaders call for revision of German model for assessment of new medicines

13-06-2012: In a meeting in Berlin the leading pharmaceutical companies of Europe, represented in EFPIA, asked the German Government for urgent action to protect patient access to new medicines and ensure that Germany remains a home for pharmaceutical innovation.

"Recent years have seen the introduction of a series of punitive measures in Germany. A 16% rebate; an international reference pricing system that links the price of medicines in Germany to those in countries like Greece; and a medicines assessment system that links the price of new medicines to generics. The net effect is that German citizens will not benefit from access to innovative therapies that are available to citizens across Europe and the rest of the world", says Richard Bergström, Director General of EFPIA.

He adds: "Germany has traditionally led the rest of Europe in providing quick access to new medicines for its citizens and recognising the value of new medicines and vaccines. This position is now under serious threat. It is absolutely appropriate that Germany manages its healthcare budget carefully and assesses medicines to ensure that they are priced at a level that reflects the value they deliver. However, early experience with AMNOG is very disappointing. The problems lie with a law that is flawed in parts, inflexible interpretation, and an unwillingness to consider creative solutions. "

EFPIA member companies have found that the choice of comparator often differs from that chosen for the development programme after consultation with the European Medicines Agency, EMA. Indeed, the choice of comparator is being used to force German pricing for new medicines towards generic prices. Forcing the price of innovative medicines that deliver clinical benefit to match that of much older products will undermine incentives to life-changing medical discovery.

German patients would benefit from a more thoughtful and interactive choice of comparators, based on medical and patient reality. Price comparisons should be made with patented products, not generics, and there should be more meaningful consultation and discussion.