Dispute Resolution Lawyer and Solicitor of England and Wales, Higher Rights of Audience to the UK Supreme Court, London, UK.
Ipswich Hospital NHS Trust, Heath Road, Ipswich, UK.
Eye (Lond). 2019 Apr;33(4):521-528. doi: 10.1038/s41433-018-0280-3. Epub 2018 Nov 29.
The English High Court recently dismissed the Bayer pharmaceutical company's challenge against a regional clinical commissioning group's policy allowing NHS Trusts to use a cheaper, but unlicensed, alternative to a sight preserving eye treatment. This makes sober reading for companies marketing "on-label" sales of medicines which are more expensive than off-label or unlicensed alternatives. Unsurprisingly, Bayer has sought to appeal the judgement. The Court has also created legal uncertainty for the NHS: the test for lawfulness is shifted from the Clinical Commission Groups and their policies to individual trusts which must ensure that every unlicensed use is lawful. This could generate legal action against NHS Trusts and ironically drive up costs for the public purse. What is clear is that the Court's conclusions were heavily influenced by fiscal constraints which it accepted as a legitimate counterweight to the commercial interests of pharmaceutical companies. It also appears to establish in law the duty for doctors to have concern for the wider societal costs of prescribed treatments. This article summarises this complex judgement and offers advice for navigating the increasing focus on limited budgets, both for companies and physicians.
英国高等法院最近驳回了拜耳制药公司对地区临床委托组允许国民保健制度信托机构使用更便宜但未经许可的替代视力保存眼治疗的政策的质疑。对于营销“标签内”销售的药品的公司来说，这是一个清醒的读物，这些药品比标签外或未经许可的替代品更昂贵。不出所料，拜耳已寻求对该判决提出上诉。该法院也为国民保健制度创造了法律不确定性：合法性的检验标准从临床委托组及其政策转移到每个信托机构，这些信托机构必须确保每一种未经许可的使用都是合法的。这可能会引发针对国民保健制度信托机构的法律诉讼，并讽刺地增加公共财政的成本。显而易见的是，法院的结论受到财政限制的严重影响，法院认为这是对制药公司商业利益的合法制衡。它似乎还在法律上确立了医生对处方治疗的更广泛社会成本的关注的责任。本文总结了这一复杂的判决，并为公司和医生应对日益关注有限预算提供了建议。
