Clinical Ethics > Volume 3, Number 4 > Pp. 176-179

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Public Policy & Law

The regulation of preimplantation genetic diagnosis (PGD) in the Netherlands and the UK: a comparative study of the regulatory frameworks and outcomes for PGD

Eva C A Asscher  

Tilburg Institute for Law, Technology and Society, University of Tilburg, The Netherlands

E-mail: e.asscher{at}uvt.nl

Developments in biotechnology present difficult social and ethical challenges that need to be resolved by regulators among others. One crucial problem for regulators of new technologies is to ensure that regulation is both clear and sufficiently flexible to respond to new developments. This is particularly difficult to achieve in contentious fields such as medical biotechnology. In the European Union there is a divergence in the solutions to this problem which has lead to different regulatory frameworks for medical biotechnology. This paper compares and contrasts the British and Dutch regulatory frameworks for the selection of embryos by preimplantation genetic diagnosis as an example of the regulation of medical biotechnology. Some of the outcomes of the regulatory choices and possible reasons behind the divergent frameworks are discussed, such as the ethical outlooks and political systems in these countries.

	Introduction

Top Introduction Background Regulation of PGD Some conclusions References and notes

 
Developing medical genetics and improvements in reproductive technologies are providing a continuously increasing number of possible selection criteria which may be applied to human embryos and fetuses. The acceptability of any kind of selection appears to diverge in different countries and cultures. For instance, in the Netherlands it has recently become standard practice to offer pregnant women of any age the triple test,¹ which estimates the chance of carrying a fetus with Down's syndrome, although the risk for women aged under 35 years is very low. In contrast, selection by preimplantation genetic diagnosis (PGD) is relatively rare and not universally acceptable, and, when it is allowed, the selection criteria is diverge.² This paper focuses on the similarities and differences of the regulation of PGD in the Netherlands and the UK.

In the countries of the European Union, national regulation has lead to different outcomes with respect to the permissiveness towards reproductive technologies and PGD. The UK is fairly liberal. In other words the UK leaves many choices about reproductive technologies up to the prospective parents, whereas, for example, Italy and Germany are much more restrictive.³ This divergence in regulatory outcomes is interesting because of the reasons behind these differences, such as the cultural, historical, political background and the regulatory framework, and because of the implications of diverging national rules within the European open market community in an increasingly globalized world, whereby reproductive tourism is an option and accessible for many.⁴ This paper aims to study one element of the differences in regulation in Europe by comparing the regulation of PGD in the UK and the Netherlands. The focus will be on the comparison of the regulatory frameworks to elucidate whether these may have influenced the regulatory outcomes, i.e. the selection criteria for PGD.

PGD is an important example of a new medical biotechnology, which offers great benefit to couples suffering from, or carrying, genetic diseases. As the technique relies on the creation of embryos outside the body and manipulation for genetic testing of the embryos, it raises existential questions about the status of the human embryo during development and the role of mankind in shaping its own future. Any regulatory response to this technique has to engage with these questions, and this is perhaps one of the reasons why legal frameworks for assisted reproduction and PGD were only established after delay.⁵

In view of the following comparison of the regulatory frameworks for PGD, it is important to consider conflicting challenges for the regulation of new technologies more generally. Regulation has to be both clear and consistent, and flexible enough to cope with rapid developments often inherent in emerging technologies. The solutions chosen for these particular problems are perhaps at the core of the difference between the regulatory frameworks for PGD in the Netherlands and the UK.

	Background

Top Introduction Background Regulation of PGD Some conclusions References and notes

 
There are some important differences between the UK and the Netherlands.⁶ This may have lead to divergent ethical approaches towards human embryos and reproduction in the UK and the Netherlands. Whereas the UK chose to articulate clear ethical and practical principles developed by the Warnock Committee as a response to the challenges posed by artificial reproduction,⁷ the Netherlands repeatedly considered ethical arguments when the need for regulation was deemed necessary due to further advances.⁸ The Netherlands lacks over-arching ethical principles, and consequently the ethical outlook consists of a medley of premises and arguments, subject to change (for instance with changes in political climate). In the UK, the Warnock Committee report provided ethical principles with a largely utilitarian philosophical position and clear practical conclusions. As a result, the UK has been responding to new challenges on the basis of its chosen ethical principles, whereas the Netherlands appears to respond in accordance with the ethical views of those currently in power.

	Regulation of PGD

Top Introduction Background Regulation of PGD Some conclusions References and notes

 
In both the UK and the Netherlands, core regulations for (human) embryos are laid down in legal texts; respectively, the Human Fertilisation and Embryology Act 1990 (HFE Act)⁹ and the Embryowet 2002¹⁰ in combination with the Wet op Bijzondere Medische Verrichtingen 1997¹¹ (WBMV, law concerning exceptional medical procedures). However, in these laws the possibility of genetic selection is not dealt with explicitly. In the case of the HFE Act, these techniques were only just becoming feasible at the time the Act was passed and thus were excluded from it. The Embryowet deals only with the handling of embryos including prohibitions on some of the possible manipulations.¹² The actual policy with regards to PGD in the two countries has been decided in divergent regulatory frameworks, by different bodies and in different ways. Before embarking on a fuller examination of these frameworks, it is useful to have an overview of the acceptable criteria for PGD in both the countries (Table 1).

View this table: [in this window] [in a new window]   Table 1 Allowed PGD criteria in the UK and in the Netherlands

 
UK regulatory approach

The legal framework of the HFE Act achieves several things.¹³ Crucially, it establishes the Human Fertilisation and Embryology Authority (HFEA), which is charged with licensing both individuals and clinics or laboratories for the following: treatments to alleviate infertility, for the storage of gametes and embryos, and for research on embryos.¹⁴ The HFEA is a relatively independent body, which has great decisional discretion¹⁵ as to which treatments may be licensed. It has dual roles, as highlighted by the House of Commons Select Committee on Science and Technology: ‘The HFEA is both a policy-making and a licensing body. Policy is discussed and passed by the Authority itself.’¹⁶ Thus, in the UK responsibility with regards to the development of policy and the regulation of treatments involving human embryos lies mainly with a semi-independent body. This raises important questions as to who the members of the HFEA are. The Act states that ‘All the members of the Authority ... shall be appointed by the Secretary of State’,¹⁷ leaving the responsibility for appointment with the government. In addition, there are clear requirements for the composition of the Authority: for instance, the HFEA consists of lay people and experts in order to allow balanced development of policy in this controversial area. The HFEA has great decisional discretion, as long as it remains in keeping with the spirit of the Act. Checks and balances are provided by the common law system, so that the decisions of the HFEA may be challenged by application to the courts. However, challenges brought to the extent of its remit have largely been unsuccessful.¹⁸

The regulatory framework in the UK can thus be characterized by the existence of a semi-independent body with a large amount of policy-making and decisional freedom, including more than 50% lay persons. The Authority acts within its legal framework based on the defined ethical framework. The HFE Act has been scrutinized by the Joint Select Committee on Science and Technology¹⁹ has been amended and was due to be replaced by the Human Fertilisation and Embryology Bill.²⁰ This Bill has recently been delayed but one important aspect of the current regulatory framework was due to remain – the use of a semi-independent body for policy development and licensing.

Regulation of PGD in the Netherlands

The regulatory framework in the Netherlands has some clear differences from that of the UK. Although the regulations are embedded in legal texts, PGD is not accommodated in a single law, instead two laws impact on the regulation of PGD: the Embryowet, which is concerned principally with human embryos, and the WBMV, which sets up a licensing framework for new and developing medical treatments and technologies, particularly those which may lead to ethical or social concerns. Under the WBMV, the Secretary of State for Health has the power to generate Ministerial Decisions on contentious techniques when regulation is required and there is not enough time to go through the usual channels of law-making. As PGD is still considered contentious, it qualifies for WBMV regulation.

Consequently, policies for PGD have been established through Ministerial Decisions. Checks and balances are incorporated in the WMBV, including limited validity for these Decisions and the possibility for Parliament to request a draft bill instead of a Ministerial Decision. In the case of PGD, Parliament has not challenged the Ministerial Decisions. The decisions are informed by advice from the Health Council of the Netherlands,²¹ as well as input from patient groups and others. The Secretary of State is not bound to follow this advice, and occasionally appears to disregard it. It is important to note that the Netherlands has a true multiparty system with coalition governments and that the Secretary belongs to one of the coalition parties, which may have different views on ethically charged subjects such as PGD. As a result of this, and considering the lack of overarching ethical framework, the personal views of the Secretary may influence the regulatory outcomes.

Comparison of the regulatory frameworks

From the above it is clear that there are both similarities and differences between the regulatory frameworks for PGD in the UK and the Netherlands. First, both the UK and the Netherlands have enacted laws specifically to deal with human embryos created outside the body. Thus, both countries have felt the need for legislative action in response to the development of embryo manipulation outside the body, probably because of the contentious nature of human biotechnology. The resulting legal frameworks for embryo manipulation are important for the regulation of PGD. Both of these legal frameworks were developed based on ethical considerations; however, the motivation for policy decisions sometimes lacks clarity and transparency in the ethical arguments.²²

Second, in both the regulatory frameworks for PGD have delegated decisional discretion on policy, as is often inherent in technology regulation. However, the mode of delegation is different in the two countries. In the UK, a new regulatory authority was established for policy-making and administration with regards to human embryos (the HFEA). In contrast, in the Netherlands an existing legal framework was employed to grant the Secretary of State for Health decisional authority for PGD policy-making. Whereas the HFEA provides a relatively public forum for ethical deliberations during this process, the Dutch Secretary may grapple with the ethical aspects of regulatory decisions but this need neither be deliberative nor public.

Third, the temporary regulatory framework for PGD in the Netherlands has not been revised or developed into law; in contrast, the legislative regulation of human embryos in the UK is currently being amended. The reasons behind this appear to be country and framework specific: due to the adversarial nature of the common law system, the British regulation has faced challenge.²³ In addition, a broader public debate surrounding the regulation of artificial reproduction has developed, partially facilitated through public consultations by the HFEA.²⁴ In contrast, the previous Dutch Secretary of State had been reluctant to revisit the temporary measures, which may be due to her political and ethical views, as the Secretary during the most recent window for change was a member of Christian Democrat Party (Christen Democratisch Appel [CDA]). Debates in the Dutch Parliament on these ethically charged techniques and policy seem to be rare, which may be because they could cause friction in coalition governments. Such friction occurred in the current coalition (PvdA – Labour; CDA – Christian Democrats; ChristenUnie – Christian Union), when the Secretary (PvdA) sent a policy decision to Parliament announcing the acceptability of partially penetrant genetic disorders, such as the breast cancer genes, as criteria for PGD.²⁵ The junior coalition party, the Christen Unie (CU) threatened the coalition and demanded withdrawal of this letter.²⁶ The letter was withdrawn but a month later partially penetrant disorders were confirmed as acceptable criteria supported by the whole cabinet.²⁷ Interestingly, this crisis may lead to significant change in the regulatory framework, as the Cabinet also announced the creation of an ethics council, with some regulatory powers. However, the exact role and powers of this council will only be announced later.

Fourth, both the UK and the Netherlands have adopted a regulatory framework, whereby changes in policy regarding PGD are made by others than the elected Parliament. This aims to facilitate quick incorporation of new developments in regulation, as channels for law formation are notoriously slow and it may be some time before it is determined whether new technologies are allowed. However, those charged with decision-making are different in the two countries. In the UK, the HFEA is semi-independent, it has clear but loose ties to politics through the appointment of members of the authority, but there is limited direct political influence on the actions of it. The HFEA is empowered to make policy decisions based on the framework provided by the HFE Act and ethical principles from the Warnock report. In contrast, the Dutch system has charged the Secretary of State for Health to make regulatory decisions, thus allowing considerable political, and personal, decisional discretion on the regulation of PGD.

	Some conclusions

Top Introduction Background Regulation of PGD Some conclusions References and notes

 
As a result of these similarities and differences in regulatory principles and their respective regulatory outcomes, the following tentative conclusions can be drawn. The existence of a clear ethical framework, which in the UK was established by the Warnock Committee and the passage of the HFE Act through Parliament, may generate more predictable regulatory outcomes than the medley of ethical principles and arguments included for consideration in the Netherlands. However, it is important to note that this predictability has not always occurred as expected; the HFEA has been heavily criticized throughout its existence for inconsistency in its ethical approach, notably on the topic of tissue typing.^28,29 In addition, while predictability is desirable from a legal point of view, there may be political arguments against it. For instance, in the multiparty democracy of the Netherlands, new coalitions may prefer the possibility of re-negotiation of the ethical framework – as was done partially when the current coalition came to power, because the CU has a particularly strong and restrictive stance on medical ethics.³⁰

Distance exists in both countries between the elected Parliament and those charged with decisions on PGD regulation, with a larger distance in the UK than in the Netherlands. Such transfer of regulatory powers to others is often a feature of technology regulation and is likely to have profound impacts. The democratic legitimacy of the regulation may be negatively affected. When Parliament directly decides on laws and policy, democratic legitimacy is ensured. When these decisions are removed from the Parliament, a democratic legitimacy deficit emerges. It can be counter-balanced by other measures, such as either close control by the Parliament or the direct involvement of the public. The latter is the case particularly with the HFEA through the participation of lay members and public consultations. In the Dutch case, the power remains closer to the elected Parliament, but is centred on an individual. The removal of regulatory power away from Parliament may help in reducing the influence of passing fancies and minority views on the regulations. In the case of PGD, the further removed decision-making in the UK leads to relatively permissive policy in a European context, although this may be otherwise in countries with different ethical frameworks. In addition, during the passage of the new HFE Bill, Parliament has confirmed the decisions made by the HFEA. It is clear that recipients of delegated regulatory and decisional power should be carefully selected. Their mandates should be clear and their power curtailed by well-defined requirements with respect to transparency and legitimacy. The ethics council in the Netherlands that will be established needs both a clear mandate and boundaries of its function. This has not been achieved yet and thus renders the council ineffective at best or dangerous at worst.

	Acknowledgement

 
The research for this article contributes to and is funded by Professor Somsen's NWO subsidized PIONIER project.

	Footnotes

 
Dr Eva C A Asscher studied Natural Sciences with a focus on Genetics and Development at Cambridge. She finished her PhD in Developmental Neural Biology in 2006. Since then she has been a postdoctoral fellow at the Tilburg Institute for Law Technology and Society (TILT), University of Tilburg. She was a visiting fellow at the European University Institute in Florence from January until March 2008. Her research concerns the Regulation of Human Genetics and particularly preimplantation genetic diagnosis in Europe.

	References and notes

Top Introduction Background Regulation of PGD Some conclusions References and notes

 

1. Haddow JE, Palomaki GE, Knight GJ, Williams J, Miller WA, Johnson A. Screening of maternal serum for fetal Down's syndrome in the first trimester. Obstet Gynecol Surv 1998;53:595–7
2. See Table 1 for a comparison of the UK and the Netherlands. PGD is prohibited in Germany, Austria, and Italy. Belgium allows PGD to avoid serious genetic disorders; the UK and France allow PGD for serious genetic disorders and tissue typing. It is important to note that the definition of serious genetic diseases varies
3. Germany: Embryonenschutzgesetz, 1991; Italy: Law 40/2004; Fenton RA. Catholic doctrine versus women's rights: the new Italian law on assisted reproduction. Med Law Rev 2006;14:73–107[Free Full Text]
4. Deech R. Reproductive tourism in Europe: infertility and human rights. Global Govern 2003;9:425–32
5. The first successful IVF baby was born in 1978; PGD became possible in the late-1980s/early-1990s. Subsequently, the Human Fertilisation and Embryology Act was enacted only in 1990 (without any mention of PGD), and the Embryonenschutzgesetz of Germany in 1991. The Dutch law on embryos was established in 2002: Wet van 20 juni 2002, houdende regels inzake handelingen met geslachtscellen en embryo's (Embryowet) Staatsblad 2002;338. The Italian Act on embryology was only enacted in 2004. It is not, however, necessary to establish a legal framework, as in the USA, for instance, the regulation of fertility services (including PGD) is largely left to the market. In practice this has meant that many fertility techniques have been pioneered in the US, including PGD: Strom CM, Levin R, Strom S, Masciangelo C, Kuliev A, Verlinsky Y. Neonatal outcome of preimplantation genetic diagnosis by polar body removal: the first 109 infants. Pediatrics 2000;106:650–3
6. For instance the legal system: the common law system in the UK contrasts with the continental system in the Netherlands, which affects the possibilities of challenging laws already passed. Another important difference between the countries is the nearly two-party system in the UK versus a true multiparty system with proportional representation and coalition governments in the Netherlands. Kirejcezyk M. Parliamentary cultures and human embryos: the Dutch and British debates compared. Soc Stud Sci 1999;29:889–912[Abstract/Free Full Text]
7. Warnock M. A Question of Life: The Warnock Report on Human Fertilisation and Embryology. Oxford: Blackwell, 1985
8. Health Council of the Netherlands. Pre-implantation Genetic Diagnosis (Publication no. 2006/01). The Hague: Health Council of the Netherlands, 2006; and the Secretary of State's response: Kamerstuk 2005–2006, 30300 XVI, no. 136, 10-05-2006
9. Human Fertilisation and Embryology Act 1990
10. Wet van Zojuni 2002, houdende regels inzake handelingen met geslachtscellen en embryo's (Embryowet) Staatsblad 2002; 338. As in effect on 12 July 2007
11. Wet van 24 oktober 1997, houdende regels betreffende bijzondere verrichtingen op het gebied van de gezondheidszorg (Wet op bijzondere medische verrichtingen). Staatsblad 1997; 515. As in effect on 12 July 2007
12. Prohibitions on the generation of human embryos specifically for research (Embryowet, 2002, art. 24a) and cloning of human beings (Embryowet, 2002, art. 24f)
13. The HFE Act was due to be replaced by the Human Fertilisation and Embryology Bill (HL), previously known as the Human Tissue and Embryos (draft) Bill): draft revised legislation for assisted reproduction and embryo research (including establishment of the Regulatory Authority for Tissue and Embryos). See http://www.publications.parliament.uk/pa/ld200708/ldbills/006/08006.i-iv.html (last checked May 2007)
14. HFE Act, 1990; Art 11
15. See R (on the application of Quintavalle) v Human Fertilisation and Embryology Authority [2003] 3 All ER 257
16. House of Commons Select Committee on Science and Technology, Appendix 78; Supplementary memorandum from the Human Fertilisation and Embryology Authority. See http://www.publications.parliament.uk/pa/cm200405/cmselect/cmsctech/7/7we86.htm (last checked 13 July 2007)
17. HFE Act 1990, schedule 1, article 4(1)
18. For example: R (on the application of Quintavalle) v Human Fertilisation and Embryology Authority [2003] 3 All ER 257; R (on the application of Quintavalle) v Secretary of State for Health [2001] EWHC Admin 918
19. Joint Committee on the Human Tissue and Embryos (Draft) Bill Session 2006–07, Human Tissue and Embryos (Draft) Bill. Volume I: Report; and Human Tissue and Embryos (Draft) Bill Volume II: Evidence. London: The Stationery Office, 2007
20. Lords Hansard. Monday, 25 June 2007; Volume No. 693 (Part No. 107), Column WA101; Human Tissue and Embryos Bill (Draft); and Lords Hansard; Thursday, 10 January 2008; Volume No. 697 (Part No. 31), Column WA217
21. Health Council of the Netherlands. Pre-implantation Genetic Diagnosis (Publication no. 2006/01). The Hague: Health Council of the Netherlands, 2006
22. Asscher ECA. Op weg naar een ethocratie? Transparantie en bio-ethische beleidsargumentatie. [On our way to ethocracy? Transparency and bioethical motivation for policy decisions.] Nederlands Juristenblad 2008;83:1336–43
23. See reference 18: It is important to note that the challenges of the HFEA's remit have mainly come from the Quintavalles through their pressure groups. The repeated nature of the challenges may thus be a testament to their tenacity, rather than controversy surrounding the HFEA
24. HFEA closed consultation reports: Human Genetics Committee (HGC) and Human Fertilisation and Embryology Authority (HFEA). Outcome of the Public Consultation on Preimplantation Genetic Diagnosis. London: HFEA, 2001; Sex Selection: Options for Regulation. A Report on the HFEA 2002–2003 Review of Sex Selection Including a Discussion of Legislative and Regulatory Options. See http://www.hfea.gov.uk/en/1511.html (last checked on 8 August 2008). For a critical analysis of the latter, see Holms S. Like a frog in boiling water: the public, the HFEA and sex selection. Health Care Anal 2004;12:27–39
25. Brief staatssecretaris met haar standpunt inzake toepassing van pre-implementatie genetische diagnostiek (PD) 26 May 2008; Kamerstuk 2007–2008, 31200 XVI, no. 147, Tweede Kamer
26. Withdrawal of the letter (25): Prenatale screening; Brief staatssecretaris over toepassing preïmplantatie genetische diagnostiek (pgd) t.a.v. aandoeningen met onvolledige penetrantie, zoals bepaalde ernstige vormen van erfelijke kanker; Kamerstuk 2007–2008, 29323, no. 41, Tweede Kamer
27. The Dutch cabinet's policy decision on: Prenatale screening; Brief staatssecretaris over preïmplantatie genetische diagnostiek; Kamerstuk 2007–2008, 29323, no. 46, Tweede Kamer
28. Sheldon S, Wilkinson S. Hashmi and Whitaker: an unjustifiable and misguided distinction? Med Law Rev 2004;12:137–63[Medline]
29. Gavaghan C. Defending the Genetic Supermarket: The Law and Ethics of Selecting the Next Generation. London: Routledge-Cavendish, 2007:141–71
30. Coalitieakkoord tussen de Tweede Kamerfracties van CDA, PvdA en ChristenUnie. Samen werken, samen leven (7 February 2007)

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