Joint announcement: Wrong signals on medicinal product supply and Germany as a R&D and business location

Press release from BIO Deutschland, BAH, BPI, VFA and Pro Generika

Berlin, 26 July 2016. The Federal Ministry of Health (BMG) has submitted a draft bill aimed at implementing the results of the Pharma Dialogue. But in the view of pharma and biotech associations, the draft bill includes market interventions that were never a topic of discussion during the Pharma Dialogue, such as an extension of the price moratorium and options for excluding approved medicinal products from reimbursement. In some areas the draft bill incorporates the results of the Pharma Dialogue, for example, the rules concerning reimbursements for companion diagnostics and improvements in the predictability of discount agreements. What is missing in the formulation of key provisions, however, is the clarity that is absolutely vital. This draft bill will not reach its goal of improving the supply of medicinal products.

A critical flaw of the draft bill is that it explicitly defines the legislation’s goals, yet fails to provide clear statutory provisions to achieve those same goals. A good example is the decision to forgo making reimbursement prices publicly available. The draft bill clearly states that foreign government agencies should be prevented from using the reimbursement prices negotiated in Germany as the basis for their pricing. But the specifics are lacking.

Counterproductive signals for Germany as a business location also include the curtailing of the free formation of prices and a turnover ceiling during the first year, which represent another significant intervention in a market that is already heavily regulated.

Reliable framework conditions are a “must” if the objectives of excellent patient care and strong economic growth are to be realised. The lack of a solid foundation of reliability will undercut Germany’s position as a healthcare, R&D and business location.

The press release can also be found here (in German):

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