"Punitive" drug pricing measures introduced in Germany in recent years are jeopardising German patients' access to innovative therapies that are available to citizens throughout Europe and the rest of the world, the government has been warned.
These measures include the 16% mandatory rebate introduced in August 2010, plus "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," according to Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), speaking in Berlin on June 8.
"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 threat," he warned.
It was "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," he emphasised, but added that early experience with the Act for Restucturing the Pharmaceutical Market in Statutory Health Insurance (AMNOG) - which took effect on January 1, 2011 - has been "very disappointing."
"The problems lie with a law that is flawed in parts, inflexible interpretation and an unwillingness to consider creative solutions," he said.
EFPIA points out that its member companies have found the choice of comparator often differs from that chosen for the development programme after consultation with the European Medicines Agency (EMA), and that this is being used to force German pricing for innovative new medicines to match that of much older generic products, which is undermining incentives for R&D.
"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," it says.
The industry has found "the set-up very rigid," added Mr Bergstrom. "Unfortunately, many of my member companies have been forced to announce that several new medicines will not be made available in Germany, because the model seeks to base the price for new medicines on what is paid for much older, generic medicines. This is not good for German patients and not good for the country as it strives to retain companies and attract new investments." he said.
AMNOG is now "in a learning phase - the original intent was good, but some things were lost in translation to the practical model," he added.
Another concern is the choice of reference countries as a basis for price negotiations, Mr Bergstrom went on. "The decision by the arbitration panel to include Greece in the basket of countries is hard to understand," he said.
"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 policymakers fail to acknowledge hat some countries have to pay more to sustain innovation - and Germany has benefited more than most countries from investments by the pharmaceutical industry," he added.
Birgit Fischer, director general of the German research-based industry association VFA, emphasised that Europe is in crisis, that growth will only come from sectors which innovate, and that a key way forward is to invest in R&D.
Germany has the ability to strengthen Europe, but it also has the most to lose if Europe "appears resistant to innovation," she warned.
- Also last week, Germany's Federal Joint Committee (G-BA) asked, for the first time, for a benefit assessment of drugs launched before 2011. AMNOG allows for such a request if the products compete for other medicines for which there is an early benefit assessment or if they are considered to be therapeutically important.
The G-BA is seeking benefit assessments for a range of diabetes treatments - Merck & Co's Januvia (sitagliptin) and Janumet (metformin plus sitagliptin), Novartis' Galvus (vildagliptin) and Eucreas (metformin plus vildagliptin) and AstraZeneca/Bristol-Myers Squibb's Onglyza (saxagliptin) - because they are direct competitors to Boehringer Ingelheim's Trajenta (linagliptin), for which the committee issued a negative opinion at the end of march.
The manufacturers have until December 31 to submit the benefit data to the B-GA, which is due to commence an evaluation of gliptin drugs next January.