Senior Scientist, UMIT - Private University for Health Sciences, Medical Informatics and Technology Institute of Public Health, Medical Decision Making and Health Technology Assessment (HTA) Hall in Tyrol Austria.
Eur J Health Law. 2020 May 7;27(3):274-289. doi: 10.1163/15718093-BJA10006.
For patients, innovations in healthcare can be both a great blessing (when saving people's life or improving quality of life), as well as a curse (when only few people have access, e.g., because of high prices). Thus, when healthcare innovations are proven safe and ready for application, decision makers have to apply access policies and sometimes face difficult assessments. In this context, health technology assessment (HTA) plays a crucial role at European Union level, forming an evidence-based, transparent basis for decision making through joint assessments. However, pricing and reimbursement aspects are exempt from collaborative assessments, since these are in the responsibility of the EU Member States: according to Art. 168(7) TFEU the 'organisation and delivery of health services and medical care [… including] the allocation of the resources assigned to them' remain an exclusive competence of Member States. However, future challenges may require further cooperation.
对于患者而言，医疗保健领域的创新既可能是福祉（例如挽救生命或提高生活质量），也可能是诅咒（例如只有少数人能够获得，因为价格高昂）。因此，当医疗保健创新被证明安全且可应用时，决策者必须制定准入政策，有时还需要进行艰难的评估。在这种情况下，卫生技术评估（HTA）在欧盟层面发挥着至关重要的作用，通过联合评估为决策提供基于证据、透明的基础。然而，定价和报销方面不在联合评估范围内，因为这些方面属于欧盟成员国的责任范围：根据《欧盟运作条约》第 168 条第 7 款，“卫生服务和医疗保健的组织和提供[包括]分配给它们的资源”仍然是成员国的专属权限。然而，未来的挑战可能需要进一步合作。
