Genetic Engineering & Biotechnology

Genetic and biotechnological research is increasingly leading to market-ready products from the field of genetic engineering and biotechnology, which will form the standard of medical care in the future. The aim should be to provide the individual with optimal care in the sense of personalized medicine. From a regulatory point of view, such products are regularly covered only as exceptions to the existing legal framework.

In addition to classic legal questions on the topics of data protection, clinical trials, drug and medical device safety, product definitions and manufacture or import into or into Germany, we have been specializing for years in the reimbursement of such products at the expense of the statutory health insurance in Germany.

Pharmaceutical companies face particular challenges in this regard, particularly with regard to the proof of efficacy and benefits. The subject of subpopulations and the associated stratification are explicitly mentioned in the AMNOG procedure and their formation is also desirable for the purpose of finding reimbursement amounts appropriate to the use.

However, a degree of stratification appropriate to genetic and biotechnological products contradicts the requirements for valid and reproducible study results of the highest level of evidence, especially when compared to appropriate comparator therapies.

Competent advice from the moment of product development is essential for successful marketing of innovative products. Our law firm is therefore committed to supporting the scientific and technological progress of healthcare on both a legal and political level.