Statement by BIO Deutschland on the amendment of the Medical Products Act

BIO Deutschland calls for the interests of innovative small and medium-sized enterprises (SMEs) to be taken into account to a greater extent in the amendment of the Medical Products Act. In a statement issued to coincide with a hearing at the Federal Ministry of Health in Bonn on 10 January 2012, BIO Deutschland underlined that incentives for investments in medical advances and planning certainty for the maintenance of operations must be safeguarded for companies that conduct research and develop new agents and therapeutically effective forms of treatment for patients.

“The association fundamentally welcomes the fact that the Federal Ministry of Health is using the adaptation of the Medical Products Act to current European regulations to tackle other outstanding changes. However, it is not taking the opportunity to make urgently needed improvements,” said Peter Buckel, Chairperson of BIO Deutschland’s Working Group on Regulatory Matters.

One example of this is the planned new approach to immune and blood stem cell preparations under the amendment. Stem cell transplants are carried out in cases of life-threatening haematological diseases such as acute leukaemia. The patients are often children who receive cells from unknown donors. The immune system must be re-established after this type of transplant. During this period, patients are particularly susceptible to infections. The immune cells (lymphocyte preparation) of the donor, who has since been identified, can be used to treat such infections. According to the new regulation, stem cell transplants would be permitted, but a significant amount of time and effort would be involved in treating subsequent infections. It is to be feared that many children/patients could not be treated in the best possible way as a result of this bureaucracy.

If it is deemed necessary to make donor lymphocyte preparations subject to the planned authorisation procedure, BIO Deutschland believes that a transitional arrangement would be appropriate. “SMEs that conduct research will primarily need some time to adapt to the changed situation and adjust their business model,” said Markus Hofbauer, Co-chairperson of BIO Deutschland’s Working Group on Regulatory Matters. He also pointed out that it is important to ensure that donor lymphocyte preparations may still be distributed until a decision has been made on an approval motion in accordance with section 21a, paragraph 1 of the Medical Products Act.

Rules that would restrict clinical research on medical drugs in Germany are a further example of measures in the new amendment to the Medical Products Act that would threaten the country’s role as a research location. BIO Deutschland warns that the requirement in the redraft of section 40, paragraph 1a of the Medical Products Act by which the “tester (…) must appoint at least one representative with the same qualifications” will lead to a situation whereby it will no longer be feasible to conduct clinical tests in many German test centres. This mainly affects doctors’ surgeries, but will also have an impact on many test centres in clinics. BIO Deutschland therefore calls for the last sentence of the new version of section 40, paragraph 1a to be deleted so that clinical research on medical drugs in Germany is not endangered.

BIO Deutschland points out that biotech SMEs in particular are not only an important part of the value-added chain in medicine, but also a source of new business models, products and processes. Above all, these companies play an above-average role in creating jobs and investing in research and development. The association therefore calls for a critical assessment of some of the planned changes to the Medical Products Act and for the amendment to be carried out in the interests of innovations for patients and the strengthening of Germany as a location for innovation.

During the public hearing, BIO Deutschland took the stance stated in its written position paper, particularly as regards the amendments to sections 4b, 13, 20b and 21/21a of the Medical Products Act.

The draft is scheduled to be presented to the Bundesrat (upper chamber) by July 2012. The legislative process thus has a tight deadline.

The complete text of BIO Deutschland’s position paper is available in German at:

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