抗逆转录病毒疗法和人工授精调查:欧洲国家的立法、法规、资金和登记--最新情况。

IF 6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY
C Calhaz-Jorge, J Smeenk, C Wyns, D De Neubourg, D P Baldani, C Bergh, I Cuevas-Saiz, Ch De Geyter, M S Kupka, K Rezabek, A Tandler-Schneider, V Goossens
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引用次数: 0

摘要

研究问题:欧洲国家对 ART 和 IUI 的监管、资助和注册情况如何,2018 年以来情况有何变化?在欧洲开展 ART 和 IUI 并参与调查的 43 个国家中,仅有 39 个国家制定了具体立法,公共资金在各国之间不尽相同,有时在国家内部也不尽相同(有 4 个国家缺乏公共资金或资金极少),有 33 个国家建立了国家注册机构;仅发现了少量变化,其中大多数变化是通过增加公共资金支持和/或向更多亚群体开放获取途径来改善可及性:欧洲试管婴儿监测联合会(EIM)的年度报告清楚地表明,欧洲各国在抗逆转录病毒疗法和人工授精疗法的可及性和疗效方面存在着不同的做法。在之前的一项调查中,我们收集到了一些有关欧洲国家如何监管、资助和注册这些技术的连贯信息,这表明在这一医疗领域存在着多样性:使用 SurveyMonkey 工具设计了一项调查,包括 90 个问题,涉及多个领域(法律、资金和注册),并考虑了第三方捐赠情况的具体细节。新的问题扩大了上次调查的范围。参与者/材料、设置、方法:邀请 EIM 的所有成员参与。对收到的答案进行了核对,并要求初步答复者对不明确的答案进行解释,并提供任何相关的补充信息。然后,将综合数据形成的表格发送给 ESHRE 国家代表委员会成员,要求进行第二次核对。主要结果和偶然性的作用:在进行抗逆转录病毒疗法和人工授精的 45 个欧洲国家中,有 43 个国家提供了相关信息。有 39 个国家制定了有关 ART 的专门法律,其中 33 个国家将人工授精视为 ART 技术。在这 43 个国家中,只有 8 个国家的不育夫妇可以获得人工授精。在 5 个国家, ART 和人工授精也被允许用于治疗单身女性和所有同性夫妇,而总共有 33 个国家为单身女性提供治疗,19 个国家为女性夫妇提供治疗。除 2 个国家外,其他所有国家都允许使用捐献的精子,38 个国家允许捐献卵细胞,32 个国家允许同时捐献精子和卵细胞,29 个国家允许捐献胚胎。3 个国家不允许进行植入前基因检测(PGT)-M/SR(检测单基因遗传疾病、结构重排),10 个国家不允许进行植入前基因检测-A(检测非整倍体);15 个国家接受代孕。除婚姻/性状况外,女性年龄是最常报告的限制合法接受抗逆转录病毒疗法的标准:最小年龄通常定为 18 岁,最大年龄从 42 岁到 54 岁不等,有些国家没有使用数字定义。只有极少数国家规定了男性的最高年龄。在允许第三方捐赠的国家,年龄往往是一个限制性标准(男性最高年龄从 35 岁到 50 岁不等;女性最高年龄从 30 岁到 37 岁不等)。第三方捐献的其他法律限制是同一捐献者所生子女的数量(或在某些国家,同一捐献者所生子女的家庭数量),在 12 个国家,卵细胞捐献数量有上限。各国处理匿名问题的方式多种多样:严格匿名、仅对受捐者匿名(对达到法定成年年龄的儿童不匿名)、混合制度(匿名和非匿名捐献)以及严格的非匿名。对捐献者基因筛查的调查显示,大多数国家都实施了强制性建议或科学建议,将最普遍的遗传疾病排除在外,但也存在明显的多样性。欧洲有 30 多个国家实行报销/补偿制度,其中约有 10 个国家明确规定了可接受的最高金额。公共资助制度的差异极大。有一个国家不向 ART/IUI 患者提供经济援助,有三个国家只提供最低限度的支持。其他国家则规定了提供资助的限制条件,如年龄(女性的最高年龄是最常用的)、是否生育过子女、体重指数、公共资助的最多治疗次数以及无权获得资助的技术。在少数国家,报销与临床政策挂钩。对试管婴儿/卵胞浆内单精子显微注射周期内的费用类型、最高限额以及患者自付费用比例的定义也极为不同。在参与调查的 43 个国家中,有 33 个国家建立了国家抗逆转录病毒疗法登记册,其中 19 个国家建立了捐献者登记册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Survey on ART and IUI: legislation, regulation, funding, and registries in European countries-an update.

Study question: How are ART and IUI regulated, funded, and registered in European countries, and how has the situation changed since 2018?

Summary answer: Of the 43 countries performing ART and IUI in Europe, and participating in the survey, specific legislation exists in only 39 countries, public funding varies across and sometimes within countries (and is lacking or minimal in four countries), and national registries are in place in 33 countries; only a small number of changes were identified, most of them in the direction of improving accessibility, through increased public financial support and/or opening access to additional subgroups.

What is known already: The annual reports of the European IVF-Monitoring Consortium (EIM) clearly show the existence of different approaches across Europe regarding accessibility to and efficacy of ART and IUI treatments. In a previous survey, some coherent information was gathered about how those techniques were regulated, funded, and registered in European countries, showing that diversity is the paradigm in this medical field.

Study design, size, duration: A survey was designed using the SurveyMonkey tool consisting of 90 questions covering several domains (legal, funding, and registry) and considering specific details on the situation of third-party donations. New questions widened the scope of the previous survey. Answers refer to the situation of countries on 31 December 2022.

Participants/materials, settings, methods: All members of the EIM were invited to participate. The received answers were checked and initial responders were asked to address unclear answers and to provide any additional information considered relevant. Tables resulting from the consolidated data were then sent to members of the Committee of National Representatives of ESHRE, requesting a second check. Conflicting information was clarified by direct contact.

Main results and the role of chance: Information was received from 43 out of the 45 European countries where ART and IUI are performed. There were 39 countries with specific legislation on ART, and artificial insemination was considered an ART technique in 33 of them. Accessibility is limited to infertile couples only in 8 of the 43 countries. In 5 countries, ART and IUI are permitted also for treatments of single women and all same sex couples, while a total of 33 offer treatment to single women and 19 offer treatment to female couples. Use of donated sperm is allowed in all except 2 countries, oocyte donation is allowed in 38, simultaneous donation of sperm and oocyte is allowed in 32, and embryo donation is allowed in 29 countries. Preimplantation genetic testing (PGT)-M/SR (for monogenetic disorders, structural rearrangements) is not allowed in 3 countries and PGT-A (for aneuploidy) is not allowed in 10; surrogacy is accepted in 15 countries. Except for marital/sexual situation, female age is the most frequently reported limiting criterion for legal access to ART: minimal age is usually set at 18 years and the maximum ranges from 42 to 54 with some countries not using numeric definition. Male maximum age is set in very few countries. Where third-party donors are permitted, age is frequently a limiting criterion (male maximum age ranging from 35 to 50; female maximum age from 30 to 37). Other legal restrictions in third-party donation are the number of children born from the same donor (or, in some countries, the number of families with children from the same donor) and, in 12 countries, there is a maximum number of oocyte donations. How countries deal with the anonymity is diverse: strict anonymity, anonymity just for the recipients (not for children when reaching legal adulthood age), a mixed system (anonymous and non-anonymous donations), and strict non-anonymity. Inquiring about donors' genetic screening showed that most countries have enforced either mandatory or scientific recommendations that exclude the most prevalent genetic diseases, although, again, diversity is evident. Reimbursement/compensation systems exist in more than 30 European countries, with around 10 describing clearly defined maximum amounts considered acceptable. Public funding systems are extremely variable. One country provides no financial assistance to ART/IUI patients and three offer only minimal support. Limits to the provision of funding are defined in the others i.e. age (female maximum age is the most used), existence of previous children, BMI, maximum number of treatments publicly supported, and techniques not entitled for funding. In a few countries reimbursement is linked to a clinical policy. The definitions of the type of expenses covered within an IVF/ICSI cycle, up to which limit, and the proportion of out-of-pocket costs for patients are also extremely dissimilar. National registries of ART are in place in 33 out of the 43 countries contributing to the survey and a registry of donors exists in 19 of them. When comparing with the results of the previous survey, the main changes are: (i) an extension of the beneficiaries of ART techniques (and IUI), evident in nine countries; (ii) public financial support exists now in Albania and Armenia; (iii) in Luxembourg, the only ART centre expanded its on-site activities; (iv) donor-conceived children are entitled to know the donor identity in six countries more than in 2018; and (v) four more countries have set a maximum number of oocyte donations.

Limitations, reasons for caution: Although the responses were provided by well-informed and committed individuals and submitted to double checking, no formal validation by official bodies was in place. Therefore, possible inaccuracies cannot be excluded. The results presented are a cross-section in time, and ART and IUI frameworks within European countries undergo continuous modification. Finally, some domains of ART activity were deliberately left out of the scope of this survey.

Wider implications of the findings: Our results offer a detailed updated view of the ART and IUI situation in European countries. It provides extensive answers to many relevant questions related to ART usage at the national level and could be used by institutions and policymakers at both national and European levels.

Study funding/competing interest(s): The study has no external funding, and all costs were covered by ESHRE. There were no competing interests.

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来源期刊
Human reproduction
Human reproduction 医学-妇产科学
CiteScore
10.90
自引率
6.60%
发文量
1369
审稿时长
1 months
期刊介绍: Human Reproduction features full-length, peer-reviewed papers reporting original research, concise clinical case reports, as well as opinions and debates on topical issues. Papers published cover the clinical science and medical aspects of reproductive physiology, pathology and endocrinology; including andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, early pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues.
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