Advanced Therapy Medicinal Products: BIO Deutschland Calls for Innovation-friendly EU Legislation

European legislation on regenerative medicine and its implementation in Germany in the new Law on Medication are slowing down the path to innovation for patients. This is the conclusion of a position paper published by BIO Deutschland to coincide with the Regenerative Medicine in European Conference, which took place in mid-April in Bilbao, Spain.

The development of innovative types of therapy (including regenerative medicine, cell and gene therapy) is a positive example of Germany as a high-tech location. The use of cell therapy products has already helped large numbers of patients, who could previously only be treated with difficulty or not at all. Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMP), which lays down special rules on their centralised approval and monitoring, came into effect at the end of 2008. BIO Deutschland expressly welcomes the fact that this new regulation has created clear legal parameters for ATMP. However, the new rules hinder development to a certain extent, particularly for innovative small and medium-sized enterprises (iSME).

“The ATMP regulations make time-consuming and expensive centralised European licensing compulsory,” said Markus Hofbauer, Chair of BIO Deutschland’s Working Group on Regulatory Matters. The stipulated transition period for obtaining central licensing for companies that already have products on the market (and have had so for several years in some cases), is so short that the necessary conditions can hardly be met within the deadline. Furthermore, some products that are already covered by the statutory health insurance companies must now be provided free of charge as investigational new drugs as part of the now required clinical studies, which places too great a burden on many SME in economic terms. As a result, many of the company affected will have to take some of their products off the market – with a corresponding negative impact on patients.

The working group, which wrote the position paper, therefore demands among other things that ATMP that are already legally available on the market remain for sale until a decision has been made on central licensing in cases where an application for licensing has been submitted to the European Medicines Agency before the transition period has ended. In addition, the costs of conducting the necessary clinical studies on these ATMP should be met by the compensation for the costs of investigational new drugs, which have previously been reimbursed by the statutory health insurance companies.

Peter Heinrich, Chairman of the Board of BIO Deutschland, added, “This segment is very interesting for iSME in particular. The market for ATMP is still relatively small, but contains great potential for growth. ATMP represent a field of activities that is highly suited to smaller companies, as creative developmental work still needs to be carried out in this area and products are manufactured individually. The enactment of laws and regulations that block innovations is not only detrimental to innovative small and medium-sized companies in Germany, but also in particular to patients who are denied access to innovative therapy options.”

The position paper is available in German at

Go back