International Regulations and legal aspects for Biomedicine, testing on the human genome, embryo protection

Legal aspects
Whether the application of PGD is legally permitted or prohibited strongly depends on the legal definition of embryo protection in the respective country.

International regulations

Council of Europe

The 1997 Council of Europe’s Convention on Human Rights and Biomedicine – which has not yet been signed by Germany – authorises diagnostic testing on the human genome under certain conditions. PGD, however, is not explicitly regulated. In 2004, the European Parliament issued the directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. This directive had to be enacted by the member states until 7th April 2006.
A comparison of existing laws and directives in European countries on the application of PGD shows that the legal protection of the embryo is organised in very different ways.
2. Regulations in individual countries

Germany

In Germany, the provisions for PGD in the framework of the embryo protection law (Embryonenschutzgesetz (ESchG)) are regulated. With the law of regulation of the preimplantation genetic diagnosis, which got approved by the German parliament on November 21st 2011, and the change of embryo protection law related to it, and despite its fundamental prohibition, the genetic examination of the pluripotent cells of the embryo in vitro, before its intrauterine transfer, within exceptions and tight limits, is declared not illegal. Hence there is an explicitly legal regulation of PGD for the first time. Applying PGD on the basis of the new law is however only permitted once the regulation on the legitimate implementation of preimplantation genetic diagnosis is legally valid. After the German Federal Council had agreed to the draft regulation on February 1st 2013 under the condition of an amendment of the regulation, the German Cabinet passed an accordingly modified version of the regulation on February 19th 2013, which will come to force twelve months later.
In both its original version of 1991 and its revised version of 2001, the embryo protection law doesn’t comment explicitly on PGD. Since the beginning of the debate, however, it is beyond dispute that on the basis of the embryo protection law, it is forbidden to carry out PGD on cells extracted in their blastomere stage which are hence totipotent. The situation hasn’t changed with the new law expansion. The discussion on PGD, which found expression in the expansion of the embryo protection law, was rather concerned with the question whether carrying out PGD on blastocysts is allowed by the German legislation. Blastocysts are no longer totipotent cells; they are only pluripotent, and can no longer evolve into a human being, but only into different human organs. In reality, PGD was not carried out in Germany until 2010 due to the existing uncertainties. With the world wide establishment of PGD in the reproductive medical practice, there was a demand for an explicit regulation of PGD in the context of a law of regulation of reproductive medicine, from which the embryo protection law should rise.
On February 25th 2002, the Study Commission on “Law and Ethics in Modern Medicine” of the 14th German Bundestag (Enquete-Kommission “Recht und Ethik der modernen Medizin”) concluded its deliberations on PGD. The recommendations are laid down in the Commission’s Final Report (section on PGD) which was submitted to the President of the Bundestag and published on May 14th 2002. According to the report, a majority of 16 Commission members voted in favour of prohibiting PGD in Germany and of amending the Embryo Protection Act to include PGD explicitly in the existing ban on in vitro fertilisation for diagnostic purposes. A minority of three members recommended to exceptionally authorise the use of PGD for help-seeking couples at high genetic risk in special circumstances.
In 2004, the National Ethics Council published a separate opinion on polar body diagnosis. The Ethics Council does not see any need for legislative action with regard to polar body diagnosis; it repeats however its recommendation that the legislator should pass a comprehensive law on reproductive medicine. 
The district court of Berlin decided in May 2009 that the PGD of pluripotent cells of the embryo which are obtained by trophoblast biopsy does not violate any legal rule of the Embryo Protection Act if it is carried out with the purpose of inducing a pregnancy and to screen out impending hereditary diseases. After the public prosecutor’s office had initially appealed on points of law, the Federal Court of Justice confirmed this decision on July 10th 2010. Given the mentioned requirements (with the aim of bringing about a pregnancy and examining trophoblasts in the blastocyst stage to exclude any serious genetic diseases), carrying out PGD is not subject to prosecution.
On July 7th 2011, members of the German Bundestag voted by a majority for a draft law according to which PGD should be permitted, as far as there is high probability for serious genetic disease or in cases in which miscarriage or stillbirth are likely. A clarification of the terms high probability and serious genetic disease is missing. The approval of the law by the Federal Council took place on September 26th. The law is effective since December 8th 2011. For both cases described in the legislative text, the written consent from the potential parents must be submitted. Moreover, PGD is only allowed to be implemented when the parents become well informed about the medical, psychic and social consequences of the diagnostic, and when an ethics committee examined whether the mentioned requirements are met. For the implementation of PGD, only qualified physicians in licensed centres are authorised to perform preimplantation genetic diagnosis.
Prior to the decision of the German parliament, many expert committees had commented the topic. Both the German Ethics Council and the German Medical Association have declared themselves in favour of a legalisation of PGD implementation within tight limits.
Proponents of the new regulation are hoping for clarification regarding the contradiction in the legality of PGD and PND in the mother’s womb. Following the previous regulation, the woman can decide to terminate pregnancy if a genetic disorder is diagnosed, while PGD, as a method which aims at the same result, but is performed prior to implantation and thus at an earlier moment, is not legal. It is argued that the background is the same in both cases, i.e. the anticipation of unacceptable postnatal burdens. This comparison is rejected by opponents of the new regulation who argue that the initial situations are different and therefore have to be assessed in a differentiated manner. In their opinion, the interests of life of mother and child are already set against each other in the case of PND, whereas in the case of PGD this situation is created deliberately by the generation of embryos.
PGD is permitted within the prescribed legal limits once the implementation regulation comes to force. However, in July 2010 the implementation of PGD of the non-totipotent trophoblasts in the blastocyst stage was already declared as no subject to prosecution by the German Federal Court of Justice (BGH). According to a survey of the Federal Association of Centre of Reproductive Medicine (BRZ), in which 72 of the 124 German IVF-centres took part, at least 40 PGDs were carried out in this phase of cell division in the first nine months after the judgement of the German Federal Court of Justice. Since the law for regulation of PGD has been adopted, it is controversial whether the method of genetic examination through trophoblast biopsy, which is legal according to the judgement of the German Federal Court of Justice, may be performed until the decree of the regulation.
On July 11th 2012, the health minister at that time, Daniel Bahr, submitted a draft regulation on the legitimate implementation of preimplantation genetic diagnosis. In this draft, the standards for licensing PGD centres and for the qualification of the doctors who are registered there were specified. Furthermore, the establishment, composition, procedural methods and funding of the ethics committees, which decide on the admission of individual cases to PGD, are regulated. Moreover, the modalities of the establishment and organisation of a documentation centre for the conducted measures in PGD as well as the notification of those measures and their documentation are defined.
The draft law regulation has been criticised from the members of the German parliament and the church. In its statement from November 23rd 2012, the National Ethics Council criticised that the organisational and procedural aspects of the PGD centres and the corresponding ethics committees are ill-defined and to some extent are for the countries to decide upon, so that uniformity, transparency and monitoring possibilities cannot be insured by the lawmaker. The German Medical Association considers the submitted draft inconvertible and proposed some amendments. Also, a joint opinion on the draft regulation has been submitted by the following associations: The German Society for Gynecology and Obstetrics, the Federal Association of Reproductive Medicine Centres, the German Society of Reproductive Medicine, the Umbrella Association of Reproductive Biology and Medicine with the Working Group Reproductive Biology of the Human, the German Society for Andrology and the German IVF-Register.
After a long debate, the German Federal Council eventually agreed to the draft regulation on February 1st 2013, however it required an amendment of the regulation: The German Federal Council demanded that the PGD centres are authorised separately and thus limited to a smaller number. On February 19th 2013, the German Cabinet passed a modified version of the regulation, which meets the requirements of the German Federal Council. The regulation came to force twelve months after it was passed in order to give the federal states enough time for the establishment of the necessary structures. 
The Ethikkommission für Präimplantationsdiagnostik bei der Landesärztekammer Baden-Württemberg was established on 7th of June, 2015 for the states of Baden-Württemberg, Hesse, Rhineland-Palatinate, Saarland, Sachsen and Thuringia. This commission anonymously sends a yearly report to the Ministry of Social Affairs of Baden-Württemberg about the amount of positively granted and rejected applications as well as about which hereditary diseases were tested. A corresponding ethics commission was established in Bavaria on the 9th of May, 2015 that operates from an office at the State Ministry of Health and Care. Critics find fault with an eventual special treatment of Bavaria regarding the application of ethical standards and further point at a danger of strong political influence given that the members of the ethics commission have been appointed directly by the ministry.
 

Austria

The Austrian Law on Reproductive Medicine (Fortpflanzungsmedizingesetz – FMedG) only authorises the testing of cells capable of development if this is, in the light of current medical knowledge and experience, necessary for the establishment of a pregnancy (FMedG Art. 1 § 9).
In July 2004, the Austrian Bioethics Commission dealt, among other issues pertaining to reproductive medicine, with PGD. In the final vote 12 out of 19 members were in favour of a limited authorisation, whereas seven members came out in favour of maintaining the current legal situation.
The governing parties ÖVP and SPÖ filed a proposal for an amendment in November 2014. It resulted in the Fortpflanzungsmedizinrechts-Änderungsgesetz 2015 – FMedRÄG 2015 that came into force on the 24th of February, 2015. The prohibition of PDG remains valid. In some cases it is possible to test for serious hereditary illnesses with help of PDG embryos before their insertion in the uterus. An exception to the prohibition is granted if the genetic disposition of a parent causes a risk of death or miscarriage or a risk of a serious, non-treatable hereditary illness for the new-born that adds the risk of serious brain damage or severe pain or thanks to which the child would only survive with intensive medical care. It shall be possible to test embryos for their viability even after three unsuccessful IVF trials or three miscarriages. PDG as assistance for the production of a so-called saviour sibling remains prohibited.
Switzerland

In Switzerland, the selection of germ cells is permitted if there is a danger of transmitting a severe incurable disease to the offspring (Swiss law on reproductive medicine – Fortpflanzungsmedizingesetz Art. 5 III) In-vitro generation of embryos is only permitted in Switzerland if the intention is to overcome a couple’s infertility and other means of treatment have either failed or are considered futile (FMedG Art. 5). Polar body diagnosis is permitted, yet PGD on embryos has been prohibited to date (FMedG Art 5 III). In June 2013 however, the Federal Council handed a law proposal to the Parliament by which PDG should be permitted in certain cases. After the discussions of the Parliament in December 2014 an amendment of Art. 119 BV was accepted in a plebiscite held on the 14th of June, 2015 and came into force on the same day. PDG is now allowed if it is the only way to overcome the transfer of hereditary illnesses or a couple’s infertility. The discussion about the legal regulation of PDG, though, is not over: A referendum about the revised FMedG is expected to be held in summer 2016.
Great Britain

The Human Fertilization and Embryology Act which was passed in Great Britain in 1990 created a legal framework for the handling of in-vitro embryos. PGD and the involved embryo selection are generally permitted in licensed centres. In 2002, the British Department of Health released guidelines for the provision of PGD services. The reasons for requesting PGD include serious genetic disorders, chromosomal disorders and the suitability as a tissue donor for a living affected sibling under certain conditions. A selection in terms of the embryo’s sex is strictly regulated: According to paragraph 10D of the Code of Practice 8th Edition (2009) published by the Human Fertilisation and Embryology Authority (HFEA) such a selection is allowed to be carried out only in cases where there is a medical indication of a risk for a sex-related hereditary disease.
France

In France the application of PGD has been regulated by the Code de la santé publique (French Public Health Code). The regulations of PGD stated therein were amended several times by bioethics laws, most recently in July 2011. According to these laws, PGD is only permitted in order to prevent serious genetic diseases which are considered untreatable or incurable at the moment of the diagnosis. It may not be applied if the anomaly responsible for the specific disease has not been clearly diagnosed beforehand in one parent or a direct relative. Furthermore, the diagnosis may be applied for the selection of a saviour sibling. The diagnosis may only be conducted in an institution specially accredited for this purpose. In France, artificial insemination and thus PGD are exclusive to heterosexual couples.
The Netherlands

In the Netherlands, the Embryo Act came into force on 1st September 2002. It does not provide for a legal ban on PGD. However, sex selection of embryos is prohibited. Since June 2008 it is allowed to sort out embryos prior to implantation, which show an increased risk for diseases such as hereditary cancer.
Belgium

In Belgium PGD is not governed by explicit legal provisions. It is however implicitly regulated under the term “treatment” by the law on IVF embryo research (Loi relative à la recherche sur les embryons in vitro) that became effective on 11th March 2003. In case of medical indications and after submission of a request to the competent bioethics commission, it is carried out in licensed centres. Sex-specific embryo selection is prohibited, with the exception of selection in order to eliminate embryos with sex-linked diseases.
USA

In the USA PGD is governed by State law and thus regulated in very different ways. In some States (Florida, Louisiana, Maine, Minnesota and Pennsylvania) it is legally prohibited. Other States (Massachusetts, Michigan, North Dakota, New Hampshire and Rhode Island) authorise PGD in the case of medical indications. In most States however, there are no legal provisions regarding the authorisation and application of PGD. In those States, the area of application extends beyond medical indications and includes sex selection as well as selection according to specific criteria. A study on genetic testing of embryos in the U.S. illustrates that selection is also carried out with regard to the presence of a disability.
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