EFPIA warns that German drug pricing measures are hampering innovation
New AMNOG law ‘flawed and inflexible’
‘Punitive’ drug pricing measures introduced in Germany are hindering innovation, said the European Federation of Pharmaceutical Industries and Associations (EFPIA) last week.
These measures include the 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, said EFPIA director general Richard Bergström.
‘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,’ he said.
‘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,’ he said, but added that early experience with the Act for Restucturing the Pharmaceutical Market in Statutory Health Insurance (AMNOG) – which took effect on 1 January 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,’ Bergström said.
EFPIA said 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 new medicines towards generic prices, which is undermining incentives to 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,’ the EFPIA said.
The EFPIA has found ‘the set-up very rigid’, added Bergström. ‘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.
Bergström said AMNOG is ‘in a learning-phase. The original intent was good, but some things were lost in translation to the practical model’.
Another concern is the choice of reference countries as a basis for price negotiations. ‘The decision by the arbitration panel to include Greece in the basket of countries is hard to understand,’ he added.
‘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. And Germany has benefited more than most countries from investments by the pharmaceutical industry.’
Birgit Fischer, director general of the German research-based industry association VFA, emphasised that Europe is in a crisis, that growth will only come from sectors that innovate, and 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 said.
