目标:ART和IUI是如何监管的,资助,并在欧洲国家注册,以及自2018年以来情况如何变化?
结论:在欧洲进行ART和IUI的43个国家中,并参与调查,只有39个国家有具体的立法,公共资金因国家而异,有时在国家内部(四个国家缺乏或很少),33个国家建立了国家登记册;只发现了少量变化,他们中的大多数朝着提高可访问性的方向发展,通过增加公共财政支持和/或开放其他分组。
背景:欧洲IVF监测联盟(EIM)的年度报告清楚地表明,整个欧洲在ART和IUI治疗的可及性和有效性方面存在不同的方法。在之前的调查中,收集了一些关于这些技术如何被监管的连贯信息,资助,并在欧洲国家注册,表明多样性是这个医学领域的范式。
方法:使用SurveyMonkey工具设计了一项调查,该调查包含90个问题,涵盖多个领域(法律,资金,和登记处),并考虑第三方捐赠情况的具体细节。新问题扩大了上一次调查的范围。答案是指2022年12月31日各国的情况。
方法:邀请所有EIM成员参加。检查收到的答案,并要求初始响应者解决不清楚的答案,并提供任何其他相关信息。然后将合并数据产生的表格发送给ESHRE国家代表委员会成员,请求第二次检查。冲突的信息通过直接联系得到澄清。
结果:从执行ART和IUI的45个欧洲国家中的43个收到了信息。有39个国家制定了关于ART的具体立法,其中33例人工授精被认为是ART技术。在43个国家中,只有8个国家的不孕夫妇可以获得。在5个国家,ART和IUI也被允许用于单身女性和所有同性伴侣的治疗,共有33位单身女性提供治疗,19位女性夫妇提供治疗。除两个国家外,所有国家都允许使用捐赠的精子。38个国家允许捐赠卵母细胞,32个国家允许同时捐赠精子和卵母细胞,29个国家允许捐赠胚胎。植入前基因检测(PGT)-M/SR(用于单基因疾病,结构重排)在3个国家不允许,而PGT-A(用于非整倍体)在10个国家不允许;代孕在15个国家被接受。除了婚姻/性情况,女性年龄是最常见的限制合法获得ART的限制标准:最低年龄通常设定为18岁,最大年龄范围为42~54岁,有些国家没有使用数字定义.男性的最高年龄是在极少数的国家。在允许第三方捐赠者的情况下,年龄通常是一个限制标准(男性最大年龄从35到50;女性最大年龄从30到37)。第三方捐赠的其他法律限制是同一捐赠者出生的孩子数量(或,在一些国家,有来自同一捐赠者的孩子的家庭数量)和,在12个国家,有一个最大数量的卵母细胞捐赠。各国如何处理匿名问题是多种多样的:严格匿名,匿名只为收件人(不为达到法定成年年龄的儿童),混合系统(匿名和非匿名捐赠),严格的非匿名。询问捐赠者的基因筛查表明,大多数国家都执行了强制性或科学的建议,排除了最常见的遗传疾病,虽然,再次,多样性是显而易见的。30多个欧洲国家都有报销/补偿制度,大约有10个描述明确定义的最大金额被认为是可以接受的。公共资金系统是非常可变的。一个国家不向ART/IUI患者提供财政援助,三个国家仅提供最低限度的支持。提供资金的限制在其他方面定义,即年龄(女性最高年龄是最常用的),以前孩子的存在,BMI,公众支持的最大治疗数量,和无权获得资助的技术。在一些国家,报销与临床政策有关。IVF/ICSI周期内涵盖的费用类型的定义,达到哪个极限,患者自付费用的比例也非常不同。在向调查捐款的43个国家中,有33个国家建立了抗逆转录病毒疗法的国家登记册,其中19个国家建立了捐助者登记册。与以前的调查结果相比,主要变化是:(I)扩大了ART技术(和IUI)的受益者,在九个国家/地区明显;(ii)阿尔巴尼亚和亚美尼亚现在存在公共财政支持;(iii)在卢森堡,唯一的ART中心扩大了现场活动;(iv)与2018年相比,有6个国家的捐赠者受孕儿童有权了解捐赠者身份;(v)另有4个国家设定了卵母细胞捐赠的最大数量.
结论:尽管回答是由消息灵通且坚定的个人提供的,并提交了双重检查,官方机构没有正式确认。因此,不能排除可能的不准确性。给出的结果是一个时间的横截面,欧洲国家内部的ART和IUI框架不断修改。最后,ART活动的某些领域被故意排除在本调查范围之外.
结论:我们的研究结果提供了欧洲国家ART和IUI情况的详细最新视图。它为国家一级与ART使用有关的许多相关问题提供了广泛的答案,可供国家和欧洲两级的机构和政策制定者使用。
背景:这项研究没有外部资金,所有费用都由ESHRE承担。没有竞争的利益。
OBJECTIVE: How are ART and IUI regulated, funded, and registered in European countries, and how has the situation changed since 2018?
CONCLUSIONS: 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.
BACKGROUND: 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.
METHODS: 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.
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.
RESULTS: 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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
BACKGROUND: The study has no external funding, and all costs were covered by ESHRE. There were no competing interests.