Critical Evaluation by BIO Deutschland to the Forthcoming Amendments to the Drug Law

On the occasion of the hearing in the Bundestag (Lower Chamber in the German Federal Parliament) on amendments to the Drug Law (15th Amendments) at the beginning of May, BIO Deutschland demanded that the path to the development of innovative drugs by small and medium-sized companies not be blocked.

The association welcomed that the Federal Government was using the adaptation of the Drug Law to bring it into line with current European regulations as an opportunity to make other outstanding amendments. However, some of these planned amendments to the Drug Law must be viewed critically from the standpoint of small and medium-sized companies. In addition, the biotech industry expressed strong criticism of the Federal Government’s draft for not taking advantage of the opportunity to deal with urgently needed improvements to the parameters for clinical studies.

The payment for the provision of medication in cases of hardship independently of the statutory health insurance companies was harshly criticised by the association. In the new version of clause 21 of the Drug Law, it is stipulated that unlicensed drugs will be provided free of charge in hardship cases. It is correct that only the licensing of a drug makes it possible for it to be marketed. However, innovative companies should retain the opportunity to be paid for the supply of an unlicensed drug in a hardship case. Payment models that would not necessarily place a burden on the statutory health insurance companies would only be possible if the free provision of drugs is not compulsory, but rather is dealt with flexibly.

"Small companies are often involved in the development of drugs for serious illnesses such as cancer," Peter Heinrich, Chairman of the Board of BIO Deutschland, stressed. These companies mostly have only one or just a few drugs in development and have none on the market. The free provision of hitherto unlicensed medication, which has cost time and money to develop, creates a large burden on these companies that was not included in the business plan. Peter Heinrich demands that this regulation be reconsidered and payment be made possible in these cases, in the interests of patients who otherwise would not have access to these new promising agents.

"It is absolutely in the interests of patients that innovative researching entrepreneurs continue to work in a highly dedicated way on medical progress, in order to provide medical solutions for diseases that cannot be treated or can only be treated in a limited way to date," said Michael Pehl, Chairman of BIO Deutschland’s Working Group on Health Policies and VP Central Europe & Middle East of Celgene GmbH. However, he pointed out that this research is intensive in terms of time and costs and added that the planned regular free supply of drugs for German companies represents a further considerable financial burden, particularly for new and smaller biotechnology companies, and moreover a competitive disadvantage in comparison with neighbouring countries such as France, where the treatment of patients with drugs that have not yet been licensed is paid by funds from the public health sector.

The text of BIO Deutschland’s statement is available in German at:

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