Abraham J, Lewis G
Sociology Subject Group, University of Sussex, Falmer, Brighton, UK.
Soc Sci Med. 1999 Jun;48(11):1655-67. doi: 10.1016/s0277-9536(99)00042-8.
Europeanised procedures of marketing authorisation for medicines are becoming increasingly important within EU Member States relative to national licensing systems. Since 1 January 1998 parallel national applications for drug approvals in EU Member States have disappeared and it is only possible to market a new drug in more than one Member State via Europeanised procedures. Yet the implications of these Euro-procedures for public health remain little researched or debated. This paper discusses the health and safety implications of three key features of such Europeanisation, namely, the harmonisation of drug safety standards, the competition between the national regulatory agencies of Member States for application fees from industry and the industrial capture of regulators within the regulatory process. Drawing on 42 interviews in Brussels, Germany, Sweden, the Netherlands and the UK, the perspectives of European regulators, industrial scientists and regulatory affairs managers on these matters are analysed. While most industry sources believe that the new Euro-procedures will not harm public health, at least half of the regulators were concerned that European harmonisation of safety standards and competition between national agencies to accelerate approval times in order to attract industry fees pose a threat to public health and safety. National regulatory agencies find themselves in an internal EU market competing for regulatory fees from industry. This marketisation of regulation puts pressure on regulators to 'sell themselves' as the fastest in reviewing and approving drugs. Swedish regulators displayed the greatest anxieties about these matters. Unfortunately, we found it impossible to verify these regulators' worries or industry's optimism because of the secrecy that attends these Euro-procedures. Thus, a situation obtains in which a significant number of regulators are warning that the EU medicines licensing systems, which are being put in place, might well compromise safety, yet these systems are deficient in their capacity to accommodate independent scrutiny, upon which informed policy changes could be based.
相对于国家许可制度而言，欧洲化的药品上市许可程序在欧盟成员国中变得越来越重要。自1998年1月1日起，欧盟成员国中并行的国家药品审批申请已不复存在，现在只有通过欧洲化程序才能在一个以上的成员国销售新药。然而，这些欧洲化程序对公共卫生的影响仍未得到充分研究或讨论。本文讨论了这种欧洲化的三个关键特征对健康和安全的影响，即药品安全标准的协调统一、成员国国家监管机构之间为争夺来自制药行业的申请费用而展开的竞争，以及在监管过程中制药行业对监管机构的俘获。通过对布鲁塞尔、德国、瑞典、荷兰和英国的42次访谈，分析了欧洲监管机构、行业科学家和监管事务经理对这些问题的看法。虽然大多数行业人士认为新的欧洲化程序不会损害公众健康，但至少有一半的监管机构担心，欧洲安全标准协调统一以及国家机构之间为加快审批速度以吸引行业费用而展开的竞争，对公众健康和安全构成威胁。国家监管机构发现自己处于欧盟内部市场，为争夺来自制药行业的监管费用而竞争。这种监管的市场化给监管机构带来压力，促使它们将自己“推销”为审查和批准药品速度最快的机构。瑞典监管机构对这些问题表现出最大的担忧。不幸的是，由于这些欧洲化程序涉及保密，我们无法核实这些监管机构的担忧或行业的乐观态度。因此，出现了这样一种情况：大量监管机构警告说，正在建立的欧盟药品许可制度很可能损害安全性，但这些制度在容纳独立审查方面存在缺陷，而基于独立审查才能做出明智的政策改变。
