In addition, regulatory bodies have been placed in competition with each other for industry fees, and where there are institutional incentives, not to reject new drugs. This situation arose indirectly from the Europeanisation of pharmaceutical regulation, as a result of the European Commission's adoption, to a large extent, of the industry's vision for Europeanised drug regulation. The international pharmaceutical industry is interested in European harmonisation and streamlining of drug regulation because this allows a drug to be marketed in several states more or less simultaneously, taking advantage of “efficient” fast approval rates, rather than having to negotiate with separate national regulatory regimes.
Since January 1998, new drugs can be licensed in more than one European Union country at once in one of two ways: mutual recognition or centralised procedure (box ). To accommodate the industry's desire for more rapid approval times, a strict timescale—210 days—has been prescribed by the European Commission for the mutual recognition procedure. Moreover, the largest amount of regulatory work (and hence the most fees from industry) comes from being the first state to which an application is submitted within the mutual recognition procedure, and being the rapporteur in the centralised procedure. As the regulatory agencies in the European Union are now largely funded by industry, and because companies look for fast approval rates as a key criterion when choosing where to submit the application for approval of a new drug, regulatory agencies are, in effect, competing with each other for “regulatory business” by attempting to approve drugs at an ever faster pace.
Drug regulation in multiple EU member states
The competition for fees from industry means that regulatory agencies are not satisfied to meet the European Commission's requirement of approval or rejection within 210 days. For example, the British Medicines Control Agency's average net in-house assessment time for new drugs fell from 154 working days in 1989 to 44 days by 1998 (fig ).4
The drug regulatory review times for Germany, Sweden, other EU countries, and the United States have also fallen dramatically.4,20
It might be argued that this competition between agencies will enhance drug safety and efficacy, but even if competition were to encourage some regulatory agencies to try to improve their safety and efficacy regulation, this would be in a context of increasingly less time for all EU regulatory agencies to check drug safety and efficacy data.
Decreasing approval times for new drugs at the UK Medicines Control Agency, 1989-2000
The suggestion that such interagency competition is driven by concern to improve safety and efficacy is further undermined by the fact that different approaches have been taken towards rejections of new drug applications and rejection of “old” unproved products at present on the market. The Swedish regulatory agency has extended the response period for a company whose product licence application faced rejection from six weeks to three months. Meanwhile, in Germany, “old” products, whose efficacy has never been demonstrated against the modern standards of the 1976 German drug law, were granted extended “licences of right” until 2004. Despite the potential disadvantages of these measures for the public, they were not regarded by the government authorities as “inefficient.”4
Evidently, the time taken for regulatory processes and decision making may be extended rather than accelerated if this is in the interests of the industry.
Moreover, under the mutual recognition procedure, a heavy emphasis on widening the scope of new drug approvals coexists with institutional incentives not to block approval. If a member state does not wish to accord mutual recognition to the approval of a new drug by another member state on public health grounds, it must immediately inform the company, the reference member state, the other member states concerned, and the Committee for Proprietary Medicinal Products, stating the reasons for its decision and indicating how the gaps it perceives in the new drug application might be filled so as to facilitate mutual recognition. A compulsory conciliation stage then follows to facilitate the member state's recognition of the reference member state's approval.4
Thus, regulators are under pressure to adopt quickly a position on the reference member state's approval, and to assemble robust supporting evidence if they propose to reject an application on public health grounds. There is no such pressure if they intend to mutually recognise the reference member state's approval.
It might be argued that the acceleration of approval times for new drugs has been adopted so that patients can gain faster access to new treatments such as anti-AIDS drugs. In Europe, evidence to support this hypothesis is at best scanty compared with the evidence that the rapid drug approval times have been a consequence of making regulatory agencies responsive to the commercial interests of the pharmaceutical industry. Fast tracking of genuinely needed drugs can accommodate this demand from patients. Furthermore, if the acceleration of approval times for new drugs was genuinely driven by a desire to provide faster access to new treatments, a concomitant introduction of regulatory requirements for comparative efficacy testing would be required to show that a new drug offers a real advance. Yet neither the European Commission nor the governments of the European Union, North America, or Japan have introduced such requirements, even though this would help bodies, such as the National Institute of Clinical Excellence in Britain, to assess the cost effectiveness of drugs.21