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首页> 外文期刊>Cell and Tissue Banking >Business oriented EU human cell and tissue product legislation will adversely impact Member States’ health care systems
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Business oriented EU human cell and tissue product legislation will adversely impact Member States’ health care systems

机译：面向企业的欧盟人类细胞和组织产品立法将对成员国的医疗体系产生不利影响

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The transplantation of conventional human cell and tissue grafts, such as heart valve replacements and skin for severely burnt patients, has saved many lives over the last decades. The late eighties saw the emergence of tissue engineering with the focus on the development of biological substitutes that restore or improve tissue function. In the nineties, at the height of the tissue engineering hype, industry incited policymakers to create a European regulatory environment, which would facilitate the emergence of a strong single market for tissue engineered products and their starting materials (human cells and tissues). In this paper we analyze the elaboration process of this new European Union (EU) human cell and tissue product regulatory regime—i.e. the EU Cell and Tissue Directives (EUCTDs) and the Advanced Therapy Medicinal Product (ATMP) Regulation and evaluate its impact on Member States’ health care systems. We demonstrate that the successful lobbying on key areas of regulatory and policy processes by industry, in congruence with Europe’s risk aversion and urge to promote growth and jobs, led to excessively business oriented legislation. Expensive industry oriented requirements were introduced and contentious social and ethical issues were excluded. We found indications that this new EU safety and health legislation will adversely impact Member States’ health care systems; since 30 December 2012 (the end of the ATMP transitional period) there is a clear threat to the sustainability of some lifesaving and established ATMPs that were provided by public health institutions and small and medium-sized enterprises under the frame of the EUCTDs. In the light of the current economic crisis it is not clear how social security systems will cope with the inflation of costs associated with this new regulatory regime and how priorities will be set with regard to reimbursement decisions. We argue that the ATMP Regulation should urgently be revised to focus on delivering affordable therapies to all who are in need of them and this without necessarily going to the market. The most rapid and elegant way to achieve this would be for the European Commission to publish an interpretative document on “placing on the market of ATMPs,” which keeps tailor-made and niche ATMPs outside of the scope of the medicinal product regulation.
机译：在过去的几十年中，常规的人体细胞和组织移植物的移植，例如为严重烧伤的患者更换心脏瓣膜和皮肤，挽救了许多生命。八十年代末期，组织工程学的出现，专注于恢复或改善组织功能的生物替代物的开发。在90年代，在组织工程学炒作的高潮中，业界煽动政策制定者创建了欧洲监管环境，这将促进组织工程产品及其原料（人细胞和组织）的强大单一市场的出现。在本文中，我们分析了这种新的欧盟（EU）人类细胞和组织产品监管制度的制定过程，即欧盟细胞和组织指令（EUCTDs）和先进治疗药物（ATMP）法规，并评估其对成员国医疗体系的影响。我们证明，与欧洲的风险规避以及促进增长和就业的冲动相吻合，行业成功游说了行业的监管和政策流程，导致了过度以商业为导向的立法。引入了昂贵的面向行业的要求，排除了有争议的社会和道德问题。我们发现有迹象表明，这项新的欧盟安全与健康立法将对成员国的医疗体系产生不利影响；自2012年12月30日（ATMP过渡期结束）以来，公共卫生机构和中小型企业在EUCTD框架下提供的一些救生和既定ATMP的可持续性受到明显威胁。鉴于当前的经济危机，目前尚不清楚社会保障体系将如何应对与这一新监管制度相关的成本上涨，以及如何确定报销决策的优先事项。我们认为，应该紧急修订ATMP法规，以集中精力为所有需要这些药物的人们提供负担得起的疗法，而不必将其推向市场。实现这一目标的最快捷，最优雅的方法是让欧盟委员会发布一份有关“将ATMP投放市场”的解释性文件，该文件将量身定制的利基ATMP排除在药品法规范围之外。

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