Making European Regulations Work

A report released by Escher’s TI Pharma platform claims that the European regulatory system for medicines can be used in a more “efficient and effective manner”. At a first glance it may seem as if the report is damning the system but that certainly isn’t the case. “The European regulatory system is very effective in performing its key functions, but in our report we place emphasis on what could be done better,” explains André Broekmans, the Chair of Escher. “A number of pilots and experiments are underway to strengthen the link between marketing authorization and health technology assessment, and to explore how evidence generated during development can better reflect ‘real world’ safety and effectiveness. The effects of system changes need to be studied in order to see if public health objectives are being met and to assess whether or not society is getting ‘value for money’.”

The report is built around a number of case studies, based on the experiences of pharmaceutical companies (1). In particular, it claims that pathways introduced with the intention of bringing new medicines to market faster are not being used in the right way. For example, the conditional marketing authorization (CMA) route is meant to provide early access to medicines as it is granted on less comprehensive data than other marketing routes. In practice, however, the assessment timelines tend to be very long and it is often only discussed as a ‘rescue’ operation if a standard marketing authorization is declined. Another example relates to pediatric investigation plans (PIPs), which were introduced in Europe to make information on the use of medicines in children available earlier. “The case study on PIPs gives an indication of redundancy in efforts by companies and regulators in preparing and reviewing PIPs. Many PIPs need to be modified at a later stage and studies are sometimes designed and conducted for products that will not be marketed due to the termination of development plans (in 21% of all agreed PIPs),” says Broekmans.

Pharmacovigilance resources are also raised; one year after Europe’s new pharmacogivilance legislation came into force, 19 pharmaceutical companies (representing 50% of the European industry in terms of 2013 sales) said their workload had increased by 95%. Other areas discussed in the report include experiences with the mutual recognition and decentralized procedure and the cost effectiveness of post-authorization safety studies for new active substances. “One important recommendation from the report is that the way formal impact assessments of regulatory instruments are conducted should be strengthened. Better baseline measurements are needed for prior impact assessments of legislation. In addition there is a need for periodic re-assessments in order to evaluate whether or not regulations are achieving their pre-determined objectives. These assessments should involve all actors involved, regulators, companies, patient organizations, healthcare providers,” says Broekmans. What aspects of the European system would you like to see improved? Leave your comments below.

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