Prescrire Int. 2014 Dec;23(155):302-3, 305-7.
New regulations reorganising pharmacovigilance at the European level were adopted in late 2010, then revised in 2012 in the wake of the Mediator (benfluorex) disaster. The European Commission's original proposals, released in 2008, would have represented a major step backwards in the protection afforded to European citizens, in particular by facilitating earlier marketing authorisations. Thanks to the mobilisation of civil society, the Members of the European Parliament have improved these proposals, supported by EU health ministers. The role of the new European Pharmacovigilance Risk Assessment Committee (PRAC) has been strengthened. Patients in every Member State have the right to report adverse drug effects directly to health authorities. EU drug regulatory agencies are required to provide greater transparency, and public access to information about adverse effects has been improved. However, one major regression persists: the central role given to pharmaceutical companies in the collection and interpretation of reports of adverse drug effects, despite their conflicts of interest. Drug companies are asked to record the adverse effect reports of which they are aware in a vast European centralised database, Eudravigilance, without going through drug regulatory agencies. Pharmaceutical companies remain responsible for producing "a scientific evaluation of the risk-benefit balance" of their drug, as part of the periodic benefit-risk assessment reports they are required to submit to drug regulatory agencies. These reports are analysed for the entire EU by two Member States (one rapporteur and one co-rapporteur), so that harmonised decisions can be taken. But these decisions are based on data preanalysed by the drug companies. In addition, the independence of the European Medicines Agency is undermined by its financial reliance on the fees paid by pharmaceutical companies in exchange for these assessments. In 2012, following France's Mediator disaster, several modest measures were added to the European regulations adopted in late 2010. They were mainly concerned with harmonising urgent decisions taken by Member States in response to drug safety issues arising from pharmacovigilance data. In each Member State, regional and national health authorities have an important role to play in bringing safety signals to the attention of Europe's decision-making bodies. And for robust pharmacovigilance, it is crucial to encourage healthcare professionals, patients and their relatives to report adverse effects. Finally, it is vital that, in developing a centralised quantitative approach to pharmacovigilance, the clinical and pharmacological analysis of spontaneous reports by independent teams, especially in pharmacovigilance centres, is not abandoned.
2010年末通过了在欧洲层面重组药物警戒的新法规，随后在2012年因“美迪泰克”（苯氟雷司）事件灾难进行了修订。欧盟委员会2008年发布的最初提案，在保护欧洲公民方面可谓是大踏步后退，尤其是为更早的上市许可提供便利。多亏了民间社会的动员，欧洲议会议员在欧盟卫生部长的支持下改进了这些提案。新的欧洲药物警戒风险评估委员会（PRAC）的作用得到了加强。每个成员国的患者都有权直接向卫生当局报告药品不良反应。欧盟药品监管机构必须提高透明度，公众获取不良反应信息的渠道也得到了改善。然而，一个重大倒退仍然存在：尽管制药公司存在利益冲突，但它们在药品不良反应报告的收集和解读中仍占据核心地位。制药公司被要求将它们知晓的不良反应报告记录在一个庞大的欧洲集中数据库——欧洲药物警戒数据库（Eudravigilance）中，而无需通过药品监管机构。制药公司仍需负责对其药品进行“风险效益平衡的科学评估”，这是它们必须提交给药品监管机构的定期效益风险评估报告的一部分。由两个成员国（一名报告员和一名共同报告员）对整个欧盟的这些报告进行分析，以便做出统一的决策。但这些决策是基于制药公司预先分析的数据。此外，欧洲药品管理局的独立性因其在财政上依赖制药公司为这些评估支付的费用而受到损害。2012年，继法国的“美迪泰克”事件灾难之后，在2010年末通过的欧洲法规中增加了一些适度的措施。它们主要涉及协调成员国针对药物警戒数据引发的药品安全问题所做出的紧急决策。在每个成员国，地区和国家卫生当局在将安全信号提请欧洲决策机构注意方面发挥着重要作用。而对于强有力的药物警戒而言，鼓励医疗保健专业人员、患者及其亲属报告不良反应至关重要。最后，至关重要的是，在制定集中式定量药物警戒方法时，不能放弃由独立团队，尤其是药物警戒中心对自发报告进行临床和药理学分析。
