The medical innovation bill: Will parliament sleepwalk into danger for patients and access to justice?

P. Walsh
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Abstract

Lord Saatchi’s Medical Innovation Bill (also known as the ‘Saatchi Bill’) had its second reading in the House of Lords on 27 June and at the time of writing is about to start the committee stage. It purports to encourage innovative medical treatment by removing the fear of litigation. In my view, the Bill is both unnecessary and poses a grave threat to both patient safety and access to justice. The level of debate so far has been disappointing, but once peers appreciate the seriousness of what is being proposed and its (hopefully) unintended consequences, I am hopeful that it will receive proper scrutiny. The Bill is based on what most serious commentators seem to agree is a completely false premise – that innovative and potentially life-saving treatment is being denied to patients because of doctors’ fear of clinical negligence litigation. Lord Saatchi has failed to provide any evidence to back his assertion that this is the case, whereas those who are in the best position to know, including the likes of the NHS Litigation Authority, the Medical Defence Union, and the British Medical Association, all confirm that there is no evidence of such a problem. If treatment is refused, it is likely that this is either because the NHS will not fund the treatment, or simply because the doctor does not think it is the right treatment or safe. However, the Bill ignores all of that and would sweep away current definitions of negligence. It would allow an individual doctor to carry out any treatment provided that the patient consents to it, even if this flies in the face of all the evidence and advice from experts. The Bill has been presented by Lord Saatchi and his considerable publicity machine as if it is all about providing a last chance for cancer patients who have exhausted all evidence-based treatment options. However, that is not the case. As was confirmed in the debate in the Lords, as currently worded the changes would apply to any kind of medical treatment, including cosmetic treatment. All the doctor would need to do to be in the clear is persuade the patient and to ‘consult’ others (not to get approval from anyone). This has serious patient safety implications. Anyone who is familiar with the case of Dr Ian Paterson who damaged scores of women in the Midlands whom he persuaded to agree to his own variation of breast surgery can see how getting consent from patients is not a sufficient safeguard on its own. The strongest voice of reason in the Lords debate came from cross-bench peer Baroness Masham, who is a longstanding advocate of patients’ rights. As well as the threat to patient safety, she pointed out that the Bill would leave patients who have been harmed by negligent treatment (as we would define it now) without any redress. This is something which supporters of the Bill and many of the peers who took part in the debate do not even seem to have recognised as something worth worrying about. She challenged Lord Saatchi for evidence to support his claim that innovative treatment is being denied because of fear of litigation – but with no response. Lord Saatchi made it clear that he expects the Bill to sail through the Lords and to become law before the next election (in 2015). Those who value patient safety and justice must hope that it does not, and that the Bill receives the scrutiny that such an important topic deserves. Basing legislation on an emotional response to the death of loved ones and pure anecdote is not a good idea. Parliament must not sleepwalk into this dangerous and unnecessary legislation.
医疗创新法案:议会是否会梦游,给病人和诉诸司法的机会带来危险?
萨奇勋爵的医疗创新法案(也被称为“萨奇法案”)于6月27日在上议院进行了二读,在撰写本文时即将开始委员会阶段。它旨在通过消除对诉讼的恐惧来鼓励创新医疗。在我看来,该法案既没有必要,又对患者安全和诉诸司法构成严重威胁。到目前为止,辩论的水平令人失望,但一旦同行们认识到所提出的建议的严重性及其(希望)意想不到的后果,我希望它能得到适当的审查。大多数严肃的评论家似乎都认为,该法案是基于一个完全错误的前提——由于医生害怕临床过失诉讼,病人无法获得创新和可能挽救生命的治疗。萨奇勋爵未能提供任何证据来支持他的说法,而那些最了解情况的人,包括NHS诉讼管理局、医疗辩护联盟和英国医学协会,都证实没有证据表明存在这样的问题。如果患者拒绝接受治疗,很可能是因为NHS不愿意为治疗提供资金,或者仅仅是因为医生认为这不是正确的治疗方法或不安全。然而,该法案忽略了所有这些,并将扫除目前对疏忽的定义。它将允许医生在病人同意的情况下实施任何治疗,即使这违背了所有专家的证据和建议。萨奇勋爵和他庞大的宣传机器提出了这项法案,好像这一切都是为了给那些已经用尽了所有循证治疗方案的癌症患者提供最后的机会。然而,事实并非如此。正如在上议院辩论中证实的那样,按照目前的措辞,这些变化将适用于任何种类的医疗,包括美容治疗。医生所需要做的就是说服病人并“咨询”其他人(而不是得到任何人的批准)。这对患者安全有严重影响。任何熟悉伊恩·帕特森(Ian Paterson)医生的案例的人都知道,他说服了许多中部地区的妇女同意他自己的乳房手术,这一案例伤害了她们,因此得到患者的同意本身是不够的。在上议院辩论中,最具理性的声音来自跨席议员马沙姆男爵夫人,她长期以来一直倡导患者的权利。除了对病人安全的威胁外,她还指出,该法案将使那些因治疗疏忽而受到伤害的病人(正如我们现在所定义的那样)得不到任何补偿。这是该法案的支持者和许多参加辩论的同僚似乎都没有意识到值得担心的事情。她向萨奇勋爵提出挑战,要求他拿出证据来支持他的说法,即由于害怕诉讼,创新疗法被拒绝了——但萨奇没有回应。萨奇勋爵明确表示,他希望该法案能在上议院顺利通过,并在下一次选举(2015年)之前成为法律。那些重视患者安全和正义的人必须希望它不会发生,并希望该法案受到如此重要话题应得的审查。将立法建立在对亲人死亡的情感反应和纯粹的轶事上并不是一个好主意。议会不能梦游般地通过这项危险和不必要的立法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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