Statement on Orphan Drugs Published
In a statement published on 18 May on the occasion of a hearing of the Bundestag Standing Committee on Health, Bio Deutschland urged that the path to innovative medical drugs not be blocked. The paper refers to the draft of a law on changing the health insurance legal regulations and other rules (specifically the increase of the manufacturer’s discount in clause 130a of the Social Security Code, Chapter V.)
The governmental parties suggest introducing an increase in the manufacturer’s discount from six to 16 per cent. Peter Heinrich, Chairman of the Board of BIO Deutschland, said: “This would obstruct the development of medications for so-called ‘rare diseases’ in particular”. He added that innovations are hardly possible, especially for small companies in biotechnology, which are very active in this field. This new regulation would remove the targeted support of these companies and their chances of recouping the costs of development. In its statement, Bio Deutschland therefore urges that all medications for rare diseases, which are registered in the Joint Register of Medical Drugs for Rare Diseases, be exempt from the increase of the manufacturer’s discount to 16 per cent. This would avoid disincentives and unnecessary bureaucracy costs.
“The planned increased of the compulsory discount would mean a huge financial challenge for these companies,” Robert Schupp, Chairman of Bio Deutschland’s Working Group on Health Policies, stressed. In the view of the association, it is not a consistent policy if medications for rare diseases first receive funding, but then the recouping of high-risk and capital-intensive investments is made more difficult. Schupp added: “The result will be a significant slowing down and a decrease in the development of new products. There is a danger that the successes that have been achieved so far, which have been able to considerably improve the living situation of patients with rare diseases in many cases, will be destroyed again by the new law.”
Around four million people currently suffer from a rare disease in Germany. A directive (141/2000/EG) was passed by the EU ten years ago in order to allow people with rare diseases the same access to diagnostics and therapy. The aim of the directive was to make it easier for companies to develop medication for rare diseases. The German Federal Government even founded a National Action Alliance for People with Rare Diseases (NAMSE) in March 2010.
The statement is available in German at http://www.biodeutschland.org/positionspapiere.html.