On 14 November 2012 the Federal Cabinet adopted a draft “Order on the Lawful Conduct of Preimplantation Genetic Diagnosis” (PIDV). The authority for making this Order is contained in section 3a(3) sentence 3 of the Embryo Protection Act (ESchG), which was added to that Act by the Act on the Regulation of Preimplantation Genetic Diagnosis (Preimplantation Genetic Diagnosis Act – PräimpG) of 21 November 2011. It provides that the Federal Government is empowered to lay down detailed requirements on the number and licensing of centres at which PGD is permissible, on the establishment, appointment, rules of procedure and funding of the ethics committees for PGD, on the central documentation unit for PGD and on the reporting obligations of the documentation unit. The Order requires the consent of the Upper House of the Federal Parliament (Bundesrat).
Having considered the PGD Order, the German Ethics Council makes the following recommendations:
1. Ensuring compliance with the principle of strict limitation of the permissibility of PGD to exceptional cases
In the view of the German Ethics Council, the provisions of section 3a ESchG – categorical prohibition of PGD other than in exceptional circumstances – must be strictly applied in the Order. The organizational and procedural stipulations contained in the draft adopted by the Federal Cabinet do not satisfy these requirements. This is manifested in particular in their inadequate transparency and insufficient provision for monitoring by the legislature, in the failure to limit the number of PGD centres and in deficiencies in the regulation of the ethics committees’ rules of procedure.
2. Ensuring transparency and permitting monitoring by the legislature
The German Ethics Council welcomes the proposal set out in the explanatory memorandum to the Order concerning agreement by the Federal States on a single licensing unit for PGD centres for the entire Federal Republic. This is the best way to guarantee the necessary high level of quality in patient counselling, in the assessment of applications by an ethics committee and in the conduct of PGD, as well as transparency in the conduct of PGD in Germany in accordance with uniform criteria applicable throughout the Federal Republic.
The German Ethics Council considers that the requirements concerning information to be furnished by the PGD centres to the central documentation unit as laid down in section 3a ESchG must be formulated in such a way as to provide both society and the German Federal Parliament (the Bundestag) with an overview of the application of the limited permissibility of PGD so that corrective legislative action can be taken if necessary. As in other European countries, detailed information on the nature of the PGD measures carried out and their number must afford an up-to-date general view of the practice of PGD in Germany, not only for the centres and the couples concerned, but also for society, while also contributing to quality assurance. The recording of the mode of transmission of a hereditary disorder (chromosomal abnormality, autosomal-dominant, autosomal-recessive and sex-linked), as additionally included in the current version of the Order, is not sufficient for this purpose. Instead, information on the probability of occurrence of a disorder in descendants and its anticipated severity is required in the case of the first justifying category for the conduct of PGD (a high risk of a severe inherited disorder in the descendants). With regard to the second justifying category (a high probability of stillbirth or miscarriage), the reason for the assumption that severe damage to the embryo is likely and the assumed probability of its occurrence should be specified. This may help to prevent the indirect creation of a list of indications while not depriving the Bundestag of the possibility of monitoring for a shift in the boundaries of the application of PGD inconsistent with the will of the legislature.
3. Limitation of the number of PGD centres
The German Ethics Council holds that the aims of the Act cannot be achieved solely by the setting of quality requirements; for this purpose, a limit on the number of PGD centres should instead be specified in the Order, as provided in the legislation. According to the explanatory memorandum to the Order, a maximum of 300 preimplantation genetic diagnoses per year are currently anticipated in Germany. The number of centres to be established should be determined by the need to ensure that this volume of diagnoses can be carried out appropriately, that the centres are accessible to patients, that PGD is confined to exceptional cases and is conducted in accordance with high medical standards. On this basis, the German Ethics Council considers a limitation to three centres to be desirable. This means that not all institutions that satisfy the quality requirements can be licensed as centres upon application, as currently provided in the Order. In addition to the numerical limitation, the requirements for licensing stipulated in the Order should be discretionary. Furthermore, the German Ethics Council deems it inappropriate for institutions in the fields of reproductive medicine and human genetics to establish PGD centres under cooperation agreements (section 3(2) of the Order).
4. Limitation of the number of ethics committees
For reasons of quality assurance and the uniform application of law, the German Ethics Council further recommends that the number of ethics committees be limited correspondingly. There may also be fewer ethics committees than PGD centres.
5. Rules of procedure for the ethics committees to be the same throughout the Federal Republic
The Federal Government’s proposed Order confines itself to an outline stipulation of the composition of the ethics committees and of their independence; the precise details of their composition, appointment, internal rules of procedure and funding are left to the Federal States. This carries the risk of non-uniform provisions and decision-making practices. The German Ethics Council takes the view that this paucity of regulation is inadequate having regard to the fundamental rights at issue in PGD. Apart from this consideration, the German Ethics Council believes that detailed determination of the committees’ rules of procedure and powers cannot, under the provisions relating to the statutes of such bodies, be a matter for self-governing entities under Federal State law, since the aspects material to fundamental rights must at least be addressed by the Federal States’ legislatures.