Demands in the Coalition Proposal: Hearing on the Law on the New Regulation of the Medication Market

At the end of September, BIO Deutschland welcomed the willingness of the Federal Government to continue to facilitate the development of medical innovations. This was reflected in the amendment proposal by the government coalition on the Law on the New Regulation of the Medication Market in Statutory Health Insurance, which was discussed in the relevant public hearing of the Bundestag’s Standing Committee on Health.

For many small and medium-sized medication developers working on the development of medication for rare diseases (orphan drugs), it is good news that one of the main demands by BIO Deutschland – the exclusion of these innovative medications from benefit assessments – has been taken into account in the amendment proposal. Orphan drugs listed in the Community Register for Orphan Medicinal Products have already proved their use or additional use in accordance with European Regulation (EC No. 141/2000). However, there is a risk that orphan drugs will face discrimination as compared with other medications during their first year on the market, as the time range for their unregulated pricing would be shorter according to the current wording. In a statement published on this matter, BIO Deutschland has therefore suggested that the current article be amended along the lines of the amendment proposal for orphan drugs agreed by the Bundesrat (Bundesrat Publication 484/10 – resolution).

Peter Heinrich, Chairman of the Board of BIO Deutschland, also warned that the incentive for investments in medical advances and the planning certainty for maintaining operations must be safeguarded for the companies that conduct research and develop new agents and treatment options for patients. He added, “Small and medium-sized biotechnology companies in particular are a main source of innovations and play a key role in the discovery of new therapeutic active principles and methods of treatment. They are thus an important component of the value-added chain in medicine. Short-term and disadvantageous changes in the parameters mean that small and medium-sized manufacturers of medication and therapy providers more rapidly and more often face insolvency than is good for Germany as an economic location.”

Robert Schupp, Chairman of BIO Deutschland’s Working Group on Health Policies added, “The new negotiation or agreement solutions can only lead to the loss of refinancing margins for innovations.  The attractive price of an innovation creates opportunities for further research. There is still great medical need, especially in oncology and in many small indication areas. The targeted price points research funding in these directions. Exaggerated price reductions erode this incentive and research endeavours are reduced as a result.”