European Journal of Obstetrics & Gynecology and Reproductive Biology
Assisted human reproduction legislation: Acknowledging the voice of health care professionals
Introduction
The World Health Organization (WHO) notes that laws and policies regulating third party reproduction and assisted reproductive technology (ART) are critical to “ensure universal access without discrimination” and to “protect and promote the rights of all human parties involved” [1]. Legislation in ART is extremely complex, because it raises questions about the status of a human embryo and the creation of families outside the traditional male/female relationship. This requires, in contrast to other medical fields, regulation by both state law and medical guidelines [2], [3]. Regulatory authorities such as the Human Fertilisation and Embryo Authority (HFEA) in U.K. have proven invaluable in this regard [4]. While most countries practising AHR have some legislation in place, this varies widely, particularly regarding gamete and embryo donation, surrogacy, pre-implantation genetic testing (PGT) and other evolving techniques [5], [6]. The history of AHR legislation has been controversial in many countries. Restrictive Italian legislation introduced in 2004 was the subject of a failed national referendum in 2005, with aspects of the law overturned in 2009 when the Italian Constitutional Court deemed parts of the 2004 legislation unconstitutional [7], [8]. German legislation based on the 1990 Embryo Protection Act is also restrictive and described by Leopoldina, the German National Academy of Science, as “outdated and incompatible with the new diagnostic and therapeutic measures for fertility and with the new social concepts of marriage and family [9].” Surrounded by media controversy, France in June 2021 amended its legislation to allow AHR treatment for single women and lesbian couples.
In December 2021, the European Parliamentary Forum for Sexual and Reproductive Rights (EPF) along with Fertility Europe (ESHRE’s partner patient organisation) launched the “European Atlas of Fertility Treatment Policies” [2]. This scores 43 European countries based on the results of a European IVF Monitoring (EIM) Consortium [5]. Ireland was ranked 40th, as one of only five countries in Europe which lack specific AHR legislation. The need for Irish AHR legislation was recognised by the Irish state in 2000 and a Commission on Assisted Human Reproduction (CAHR) was established, producing a report in 2005 [10]. Progress since has been slow. The legal status of the human embryo and surrogacy have been raised in the Irish High Court and Supreme Court [11], [12], [13]. In 2015, the Children and Family Relationships Act (CFRA) was introduced to modernize Irish law in terms of parentage, including families created with the help of donor assisted reproduction [14]. The AHR aspects of this law were not implemented until May 2020. A more comprehensive General Scheme of an Assisted Human Reproduction Bill was published by the Department of Health in 2017 [15]. This underwent pre-legislative scrutiny by a parliamentary Joint Committee on Health in 2018/2019 [16]. A revised version of this Bill was published by the Irish government on 10th March 2022 [17] and will soon be debated in the Irish Dáil and Seanad (Houses of Parliament), with a view to enacting legislation this year.
We believe that it is important to involve healthcare practitioners and service providers in discussions regarding AHR legislation. Such consultation has proven beneficial in Belgium [18], [19] and might have averted problems in Italy and Germany. Ireland is now in a unique position to introduce an AHR law that reflects the many developments in ART and also the changes in social mores that have occurred in recent years. The aim of this study was to investigate the opinions of healthcare professionals towards the proposed national AHR legislation, as defined in the General Scheme of an AHR Bill 2017.
Section snippets
Patient and public involvement and questionnaire design
A survey was designed to investigate attitudes and perceptions towards a broad range of issues contained within the draft AHR Bill of 2017, focusing on six key themes: (1) a national AHR regulatory authority, (2) AHR treatment type and availability, (3) age limits for treatment, (4) counselling prior to ART, (5) surrogacy and (6) posthumous use of gametes and embryos. The survey questionnaire is available on request. Particular reference was made to aspects of the Bill that had been questioned
Demographics
Of the 245 respondents (Fig. 1), most were doctors, female and aged 31–59 years, with 42.2 % indicating current or previous experience working in AHR. Response rates among Consultant Obstetrician Gynaecologists and trainees were 32 % and 22 %, respectively. It was not possible to calculate a response rate for other groups due to the method of recruitment.
Attitudes to the implementation of AHR legislation in Ireland
Most respondents (93 %) support the establishment of a national regulatory authority and believe that board members should include medical,
Discussion
This study is, to our knowledge, the first to ascertain the views of healthcare professionals regarding every aspect of AHR for which regulation and legislation is proposed in a draft national Bill. Our findings confirm a desire for legislation among healthcare staff who deal with individuals facing reproductive challenges and shows that there is no resistance in Irish clinics, all of which are private, to legislation and regulation.
Support among respondents for all AHR techniques, including
Conclusion
Legislation and regulation are pivotal to AHR, where complex medical, legal and social issues intersect and several parties must be protected – most notably children and offspring, but also intending parents, donors of gametes and embryos, surrogates and their families and service providers. No country has perfect legislation but the international experience to date, and the results of this survey, should help to ensure that Ireland creates an international best practice model fit for the 21st
Declaration of Competing Interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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