German drug approval and pricing laws are prompting Pharmas to abandon the market says the EFPIA, which has called for ‘urgent action’ to protect innovation and access to medicines.
The European industry group made the comments last week describing Germany’s Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) laws – which were introduced in January 2011 to control the price of drugs sold in the country – as ‘punitive measures’ that hamper innovation.
EFPIA director general Richard Bergstrom said that: “Germany has traditionally led the rest of Europe in providing quick access to new medicines…this position is now under threat” adding that while management of healthcare budgets is essential “the 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.”
Bergstrom cited the practice of matching the price of new drugs to generics as one of the key challenges for industry under AMNOG and suggested that the rules may be already having an impact on the availability of medicines in the country.
“Many of my member companies have been forced to announce that several new medicines will not be made available in Germany, because the [AMNOG] model seeks to base the price for new medicines on what is paid for much older generic medicines.”
This trend was confirmed by Association of Research-Based Pharmaceutical Companies (vfa) spokeswoman Susan Knoll who told in-Pharmatechnologist.com that: "Boehringer-Ingelheim and Lilly, GSK, Novartis and Pfizer decided not to bring some new medicines to the German market."
To try and prevent this from happening the EFPIA wants a more 'interactive' choice of comparators with branded products rather generic being used to determine the price of innovative products under regulatory review.
Bergstrom told in-pharmatechnologist.com that German authorities should undertake "dialogue with companies on the choice of the drug comparator, according to the development programme" arguing that this would "make the system more flexible and more workable."
This idea was also reiterated by Knoll who told us "the choice of comparator [in Germany under AMNOG] often differs from that chosen for the development programme after consultation with the European Medicines Agency, EMA. So we need more 'security of expectation' in the early benefit assessment in Germany.
"For big international companies it is important to know what is expected of them in every national health care system. They need security. Especially in the early benefit assessment in Germany we saw serious problems which caused confusion."
Greece is the word
The EFPIA was also critical of the international reference pricing system – which links the price of drugs sold in Germany to those sold in other European countries – with Bergstrom describing the Government’s decision to include Greece in the list of comparators as “hard to understand.”
“The pharmaceutical industry accepts short term sacrifices in Greece to support the country at a crisis moment. When trying to benefit from lower prices in Greece, German policy makers fail to acknowledge that some countries have to pay more to sustain innovation."