For personal use. Only reproduce with permission from The Lancet Publishing Group. mutual recognition procedure has created a situation in which regulatory agencies of member states are encouraged to compete with each other for business by selling themselves as the fastest at approval of new drugs. 27 Some senior regulatory officials have now adopted the industry view that short regulatory review times are desirable because they deliver drugs to patients in the fastest possible time. However, critical regulators note that the new European system is putting pressure on them to approve drugs without any incentive to be stringent in reviewing of new drug applications. Moreover, they point out that such pressure could be a threat to public health, because it results in regulators having to increase the amount of trust they place in industry since they have less time to check companies’ drug-testing data (table 1). 24 This difficulty has, to some extent, been addressed by the EU’s parallel centralised procedure, within which the European Commission’s European Medicines Evaluation Agency (EMEA) and expert scientific Committee for Proprietary Medicinal Products (CPMP) assess whether new products should have an EU-wide licence, because the EMEA, rather than companies, select the regulators who do the assessment (known as rapporteurs). Nonetheless, manufacturers can state the rapporteurs whom they would prefer to do the regulatory work, and even the centralised procedure imposes rapid review times on rapporteurs. 24 Such developments need to be understood in the context of industry’s wider economic importance to, and political influence on, government. For example, the UK Department of Health’s academia-industry interface group was set up in 2000 to make the UK a more conducive investment environment for pharmaceutical companies. This group concentrates on maintenance of industry’s
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell.