Recommendations for simplifying and standardising the enforcement of administrative regulations in the area of genetic engineering activities at safety level S1

From the perspective of the research community, the German research system has been subjected to a significant increase in bureaucratic and legal control in recent decades. However, this has not been matched by the same level of regular review and adaptation of the regulations so as to bring them into line with the latest state of the art. 

German genetic engineering legislation dating back to 1990 requires a fundamental overhaul in the long term. In the view of the Permanent Senate Commission on Genetic Research of the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), research, development and application in the field of genetic engineering in Germany is in danger of falling behind internationally in the near future. For this reason, the Commission has compiled a number of recommendations that can be implemented in the short term and that are capable of reducing the bureaucratic burden in genetic engineering facilities, at least at the lowest of four safety levels (S1). The aim is to strike a balance between meeting safety requirements and creating a legal framework that promotes research.

The Commission firmly believes that this is essential, since according to the German Genetic Engineering Act, facilities operating at safety level S1 are not expected to pose a risk to human health or the environment. In addition, there are almost 5,000 such facilities, so they account for by far the largest share of genetic engineering centres in Germany. “Over a period of more than 30 years we have gained experience in research and administration of how to consistently operate S1 genetic engineering facilities securely and how to safely implement genetic engineering work at S1 level. For this reason, the Senate Commission considers an unbureaucratic and more risk-oriented enforcement of genetic engineering legislation to be appropriate and indeed urgently necessary if we are to remain internationally competitive,” says the Chairman of the Senate Commission and DFG Vice President Professor Dr. Axel A. Brakhage.

“We welcome the fact that in its strategy paper on improving the framework conditions for the pharmaceutical sector in Germany, the federal government has recognised the need to accelerate medical research and reduce the level of bureaucracy involved. We also firmly support the envisaged standardisation in enforcing the Genetic Engineering Act in the area of medicinal products,” Brakhage continued. “However, in order to ensure that research, development and production remain efficient and capable of competing internationally, a thorough revision of German genetic engineering legislation is required in the long term. The recommendations drawn up by the Commission nonetheless provide short-term and immediately effective relief – without compromising safety.”

The DFG Senate Commission’s recommendations propose four measures. By adapting the administrative implementation of genetic engineering legislation, these measures seek to streamline administrative structures and thus significantly increase the efficiency of research, development and production. At the same time, the aim is to enable considerable cost savings for the public sector as well as for research and development facilities and production sites. The measures are designed to be introduced at the level of the ordinances issued by the responsible ministry, the Federal Ministry of Food and Agriculture, and could be implemented directly and uniformly by the administrations of all federal states.

“The issue of reducing bureaucracy is hugely important for research organisations and indeed for society as a whole,” states Brakhage, adding that this was why representatives of other member organisations of the Alliance of Science Organisations in Germany, such as the German National Academy of Sciences Leopoldina, were also involved in drawing up the recommendations as members of the DFG Senate Commission. In addition, a working group of Secretary Generals has been established at Alliance level, in particular so as to make more progress on the issue in cooperation with the federal states.

Further information

To the recommendations Entbürokratisierung und Vereinheitlichung des Vollzugs des Gentechnikrechts bei gentechnischen Arbeiten der Sicherheitsstufe S1 [Recommendations on Reducing Bureaucracy and Harmonising the Implementation of Genetic Engineering Legislation in Relation to Genetic Engineering Activities at Safety Level S1, available in German only] issued by the Permanent Senate Commission on Genetic Research:

• www.dfg.de/resource/blob/337150/ff49f9c67aef91ef8bce10259eb17789/sk-genforschung-gentechnikrecht-data.pdf

Further information on the Permanent Senate Commission on Genetic Research:

• www.dfg.de/sc_genetic_research