Swedish National Council on Medical Ethics
In this opinion, the Swedish National Council on Medical Ethics raises issues on pre-implantation genetic diagnosis (PGD). PGD is performed in connection with assisted reproduction. The diagnostic means that a fertilised ovum (egg) is submitted to genetic testing before being inserted into a woman’s uterus, to develop into a foetus in due course.
PGD gives the possibility of obtaining complete information about the future child’s genetic make-up. So far, the method has mainly been of interest for genetic information known to be associated with severe diseases or disabilities. When there is an increased risk of such a gene being inherited in an individual case, it can thus be located and screened out.
PGD can also be used as a standard procedure in the treatment of involuntary childlessness. In each individual treatment, all fertilised eggs then undergo genetic testing with the aim of using the egg providing the greatest chance of a successful outcome of the treatment. Since this method involves PGD testing of all fertilised eggs, it is known as ‘pre-implantation genetic screening’, PGS.
At present, PGD is not subject to any explicit statutory regulation. However, in 1995, the Swedish Parliament endorsed certain guidelines. These are highly restrictive, and mean that PGD should only be used to screen for grave, progressive, inherited disorders leading to premature death and for which there is no cure or treatment. These guidelines have been followed in Swedish healthcare, while also being criticised as inappropriate in various respects. The Committee on Genetic Integrity, a government commission, is currently entrusted with reviewing them.
In this opinion, the Swedish National Council on Medical Ethics discusses the medical and ethical conditions for PGD. The Council’s deliberations have led to the conclusion that the use of the PGD technique should be allowed on a somewhat larger scale than what is permitted in the current guidelines. The Council also considers that all cases of PGD use should be reported to the National Board of Health and Welfare to facilitate monitoring and supervision.
According to the Council, pre-implantation genetic screening, PGS, should not be used as a standard procedure, given the current state of knowledge. Before a complete ethical assessment can be made, research and findings are needed that will identify possible advantages and disadvantages of this technique from medical, ethical and social points of view. However, the Council considers that PGS may, for the time being, be ethically acceptable within clearly defined research projects preceded by ethical assessment in a research ethics committee. Also in this case does the Council recommend an obligation to report to the National Board of Health and Welfare.
In conclusion, the Council finds that the PGD technique is under development and new areas of application will require further ethical standpoints. The technique can, for example, be used in situations where parents want a child who can become donor for a child they already have who suffers from a severe disease (so-called PGD/HLA typing). There are, however, several unresolved issues connected with this technology –– issues that the Council intends to address in its future work.
Chatrine Pålsson (a Christian Democratic member of the Swedish Parliament) has entered a reservation. She considers that PGD should be regulated in a special framework law in accordance with the guidelines adopted by the Swedish Parliament in 1995. She does not consider that PGS should be introduced in research.
Daniel Brattgård, expert member, has issued a special statement of opinion that, in content, tallies with Chatrine Pålsson’s reservation.
In a special statement of opinion, Sture Gustafsson, expert member, has entered a dissenting opinion with respect to PGD and PGS.