Debate on the Draft Regulation for the PGD

Critics of the legal regulation argue that this regulation leads to an expansion of the pre-implantation diagnostics law in favor of a more liberal and broader implementation of PGD. It has been criticized several times that the regulation draft doesn’t put limit to the number of PGD centers. This draft assumes that the qualifications necessary for the admission of these centers adequately limit the number of possible candidates. In its opinion on the draft regulation, the German Medical Association pointed out however that the planned possibility of the cooperation between the IVF centers and the human genetic institutions considerably expands the circle of eligible institutions. This would indicate that a limitation of PGD, as it is planned by the pre-implantation diagnostics law, not a target of the law regulation. By way of comparison: In France there are only three centers, in which PGD is implemented.

In addition, the number of Ethics Committees should be limited based on the opinion of the German Medical Association. According to the draft regulation, there should be at least one Ethics committee in each country that has an IVF center with PGD admission. Considering the relatively few anticipated cases of PGD (in comparison with England, there are 250 – 300 cases a year) and the mostly rare genetic diseases, which give rise to these cases, it is feared that through the distribution of these cases on many committees, only some could advice on a few cases and hardly collect experiences. The concrete decisions of the ethics committees in each individual case, according to the dominant conception, are decisive for an effective compliance of the limitations on the implementation of PGD planned from the pre-implantation diagnostics law. Therefore many have expressed critical views about the possibility acknowledged by the draft regulation which allows a once rejected proposal for PGD could be re-submitted to another ethics committee. There are concerns that a sort of tourism to ethics committees takes place so that the “more generous” committees would become popular compared to the other committees. According to the critics, the draft regulation, conversely, does not include a networking between the committees. According to the draft regulation, the central documentation agency included in the law should ascertain, whether the approval of the implementation of PGD shall be granted in case of a hereditary disease or the risk of a miscarriage or stillbirth. On the contrary, the concrete hereditary diseases should not be notified. That way it will be difficult to determine the reasons why a PGD is performed. According to the German Medical Association, the compliance of the nationwide standards must be ensured. The uniformity of criteria in deciding about a PGD could ultimately prevent an “Ethics-Committee-Tourism” in case of a negative response. The German Medical Association makes itself available for this sort of coordinative tasks.

In addition there are objections against the composition of the ethics committees. Half of the ethics committee should be physicians and one in eight members should be an ethics representative. According to many critics, a judgment of committees that is only based on medical facts is considered one-sided and insufficient. This evaluation corresponds to another point of criticism, which is suggested by Professional associations such as the association for gynecology and reproductive medicine. According to the draft regulation, the audit expertise refers only to the compliance of the requirements listed in § 3a section 2 EschG. Moreover, so the criticism, the psychic, social and ethical consequences are to be included by the ethics committee in every case discussion. These consequences cannot be indeed the focus of the evaluation competence. The elimination of these factors is however not possible, since terms such as “serious hereditary diseases” always have a subjective dimension.

The determination of the audit expertise of the ethics committees on the assessment of serious hereditary diseases is considered in the critical examination of the draft regulation to be not achieving its objective. According to this point of view, the ethics committees have too little scope to deny applications.

Both the German Medical Association and the professional associations for gynecology and reproductive medicine state the demand for a physician provision for the consultation for medical, psychic and social consequences for the PGD, which determined by the law. These associations, however, consider an open-ended non-medical psychosocial consultation desirable.

Powerful objections have been raised by the professional associations for reproductive medicine and gynecology against handling the so called minor findings included in the notes of the draft regulations. Minor findings or incidental findings are results that randomly arise upon diagnosis. These incidental findings result from the application of comparative genome hybridization, a diagnostic method within the PGD frame. In this process it is possible that these findings do not correspond to a reliable field of indication of the PGD. According to the draft regulation law, these findings are not supposed to interfere with the decision about the destination of the embryos. However and based on the opinion of the professional associations for gynecology and reproductive medicine, this non-interference of the incidental findings contradicts the treatment mandate of the physician, which implies that all the diagnostic results should be communicated to the patients, including the minor findings. Since these findings can affect the patients’ decision, they must be communicated to them even if a conflict situation arises as a result. An example would be the findings about Aneuploidy which does not endanger the life of the unborn child, such as the case of a trisomy 21. At best, the patient can be enabled before the examination to decide whether she wants to be informed about the incidental findings.

Proponents of the ordinance consider the draft adequate and emphasize the avoidance of too many regulations. They see that most of the criticism is due to a fundamental opposition to the PGD and due to the attempt to block PGD implementation on the administrative level. Since the pre-implantation diagnostic law has been already adopted by a large parliamentary majority in 2011, it is argued that it is inappropriate within the frame of ordinance arrangement to start a debate on principles again. However, not all the criticism is towards the PGD implementation in general. 

On February 1st 2013 the German Federal Council agreed to the draft regulation, however it required an amendment of the regulation. The German Federal Council demanded that the PGD centers are authorized separately by the federal states according to the need and thus limited to a smaller number. PGD centers therefore do not have a legal right to be granted authorization. These requirements of the German Federal Council were met by the modified version of the draft regulation, which was passed by the German Cabinet on February 19th 2013. 

The demand of Bavaria which consists in leaving the composition of the ethics committees to the countries to decide on, has not, however, been fulfilled. This demand combines with the conception that the numerical dominance of physicians in the ethics commissions, as provided in the draft regulation, is to be assessed critically. In the view of health minister Daniel Bahr, an unstandardized occupation of the committees could however lead to problems. The decisions, whether individual cases of PGD get approved should remain a medical decision und be treated as coherent as possible. Otherwise a kind of “tourism” to certain committees would be encouraged, as feared by critics.

Yet the regulation will come to force one year after it was passed to give the federal states enough time for the establishment of the necessary structures. 

Opinion of the German Medical Association Online version (German)

Joint opinion of the Federal Association of Reproductive Medicine Centers, the German Society of Reproductive Medicine, the Working Group Human Reproductive Biology, the German Society for Andrology, and the German IVF-Register (German)

Ordinance on the regulation of PGD from February 21th 2013 Online version (German)

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