Division of Reproductive Endocrinology & Infertility, The Sims Institute-Sims IVF/Department of Obstetrics & Gynaecology, School of Medicine, Royal College of Surgeons in Ireland; Dublin, Ireland.
Health Res Policy Syst. 2011 Jun 24;9:28. doi: 10.1186/1478-4505-9-28.
This analysis reports on Irish regulatory policies for in vitro fertilisation (IVF) from 2004-2009, in the context of membership changes within the Medical Council of Ireland. To achieve this, the current (2009) edition of the Guide to Professional Conduct & Ethics was compared with the immediately preceding version (2004). The statutory composition of the Medical Council from 2004-2009 was also studied. Content analysis of the two editions identified the following differences: 1) The 2004 guide states that IVF "should only be used after thorough investigation has failed to reveal a treatable cause of the infertility", while the 2009 guide indicates IVF "should only be used after thorough investigation has shown that no other treatment is likely to be effective"; 2) The 2004 stipulation stating that fertilized ovum (embryo) "must be used for normal implantation and must not be deliberately destroyed" is absent from the 2009 guidelines; 3) The option to donate "unused fertilised ova" (embryos) is omitted from the 2009 guidelines; 4) The 2009 guidelines state that ART should be offered only by "suitably qualified professionals, in appropriate facilities, and according to the international best practice"; 5) The 2009 guidelines introduce criteria that donations as part of a donor programme should be "altruistic and non-commercial". These last two points represent original regulatory efforts not appearing in the 2004 edition. The Medical Practitioners Act 2007 reduced the number of physicians on the Medical Council to 6 (of 25) members. The ethical guidelines from 2004 preceded this change, while the reconstituted Medical Council published the 2009 version. Between 2004 and 2009, substantial modifications in reproductive health policy were incorporated into the Medical Council's ethical guidelines. The absence of controlling Irish legislation means that patients and IVF providers in Ireland must rely upon these guidelines by default. Our critique traces the evolution of public policy on IVF during a time when the membership of the Medical Council changed radically; reduced physician contribution to decision-making was associated with diminished protection for IVF-derived embryos in Ireland. Considerable uncertainty on IVF practice in Ireland remains.
本分析报告介绍了 2004 年至 2009 年期间爱尔兰对体外受精(IVF)的监管政策,背景是爱尔兰医学委员会成员的变化。为了实现这一目标,比较了当前(2009 年)版的《专业行为和道德准则》与前一版(2004 年)。还研究了 2004 年至 2009 年期间医学委员会的法定组成。对两个版本的内容分析确定了以下差异:1)2004 年版的指南规定,IVF“只有在彻底调查未能发现不孕的可治疗原因后才应使用”,而 2009 年版的指南则表明 IVF“只有在彻底调查表明其他治疗方法可能无效后才应使用”;2)2004 年版规定受精的卵(胚胎)“必须用于正常植入,不得故意破坏”,这一规定在 2009 年版的指南中没有出现;3)2009 年版的指南中删除了捐赠“未使用的受精卵”(胚胎)的选项;4)2009 年版的指南规定,ART 应仅由“合格的专业人员,在适当的设施中,并根据国际最佳实践”提供;5)2009 年版的指南引入了作为捐赠计划一部分的捐赠应“利他和非商业性”的标准。最后两点是 2004 年版中没有出现的原始监管工作。2007 年的《医师法》将医学委员会的医生人数减少到 25 名成员中的 6 名。2004 年之前的道德准则就已经发生了这一变化,而重组后的医学委员会发布了 2009 年的版本。2004 年至 2009 年间,生殖健康政策的重大修改被纳入医学委员会的道德准则。由于缺乏控制爱尔兰立法,爱尔兰的患者和 IVF 提供者必须默认依靠这些准则。我们的批评追溯了 IVF 公共政策的演变,当时医学委员会的成员发生了巨大变化;医生对决策的贡献减少与爱尔兰 IVF 衍生胚胎的保护减少有关。爱尔兰的 IVF 实践仍然存在相当大的不确定性。