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Office of Technology Assessment at the German Bundestag Office of Technology Assessment at the German Bundestag

Information on the project

Status quo and developments of pre-implantation genetic diagnosis

Thematic area: Biomedical technologies
Analytical approach: Monitoring
Topic initiative: Comittee on Health and Committee on Education, Research and Technology Assessment
Status: completed
Duration: 2016 till 2018

Subject and objective of the study

Pre-implantation genetic diagnosis (PGD) was long considered to be illegal in Germany and was regulated at a comparatively late stage. With an amendment to the German Embryo Protection Act in 2011, the prerequisite for an application of PGD was created. Under narrowly defined conditions, couples are now able to test whether an embryo created from their germ cells has genetic variations which could possibly lead to disease, disability, stillbirth or miscarriage. The amendment was preceded by a long and intense public debate. To this day, the regulation is still controversial, as fundamental ethical and social issues are involved.

With the entry into force of the »Order on the Lawful Conduct of Pre-implantation Genetic Diagnosis« (German: »Verordnung zur Regelung der Präimplantationsdiagnostik«, PIDV) in 2014 and the subsequent establishment of PGD centres in Germany, attention now focuses on the implementation of the statutory regulations. The objective of the TAB monitoring project was to prepare a focused overview of the scientific and technological developments, the application of the method as well as the social-scientific and societal debate on PGD. By means of an expert opinion, the assessments and experiences of a wide variety of stakeholders were collected, including physicians, members and staff of the PGD Ethics Committees as well as representatives of the concerns of those affected. The aim was also to provide an outlook with regard to the expected future developments and their influencing factors.

Key results

Since 2014, the application of PGD in Germany has been developing continuously. There are eleven authorised PGD centres and the number of fertility clinics involved has increased to 19. According to media reports, more than 300 applications for PGD were submitted to one of the five PGD Ethics Committees in 2018, most of which were approved. Observers assume that the number of treatments will not significantly exceed this value in the future as long as the characterising factors do not change. These factors include:

  • the costs for a PGD (which usually amount to several thousand euros) and the regulation that these are not reimbursed by the health insurance companies;
  • the spectrum of admissible indications of PGD as well as the interpretation of the legal framework conditions by those involved in PGD centres and ethics committees and by courts (pending proceedings concern both decisions by ethics committees and the fundamental scope of the law);
  • the technologies used (next-generation sequencing methods are increasingly applied, they can accelerate the examination and broaden the spectrum of anomalies examined).

Currently, there is no acute need for action with regard to a change in the legal regulation of PGD. However, developments should continue to be closely monitored. Monitoring can be based on improving the knowledge base, which can be achieved by the latest publication of PGD application data and by the promotion of studies on the perspective of the couples concerned and on medical quality criteria. Moreover, due to the fundamental significance of the questions associated with pre-implantation genetic diagnosis at the societal level, it seems to be recommendable to repeatedly address these issues in the public political debate.

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