New Report Calls for Regulatory Changes in Europe

September 19, 2014

Applied Clinical Trials

The current regulatory system for medicines in Europe could be used in a more efficient and effective manner, according to a report from Escher.

The current regulatory system for medicines in Europe could be used in a more efficient and effective manner, according to a report from Escher, a Dutch-based company.

“Overall, the EU regulatory system operates well, however important recent changes have not yet been evaluated,” said André Broekmans, chairman of Escher. “One of our conclusions is that pathways that were intended to bring important new medicines faster to the market are not used in the right way. We are therefore missing opportunities to make medicines available to patients earlier.”

Escher collaborated with researchers from Utrecht University, the Netherlands, to look into areas that might be improved: pharmacovigilance, conditional approval, pediatric investigation plans, and decentralized authorization procedures.

The team’s research shows that some regulations are not achieving their goals. For example, the conditional marketing authorization pathway was intended to bring much-needed products, e.g., for cancer treatment, to the market faster. In practice, the researchers found that it has often been used as a back-up for the ‘normal’ approval pathway, because requesting conditional approval had some perceived drawbacks (e.g. potential reimbursement issues and the level of post-marketing obligations).

They also identified opportunities for making the regulatory system more efficient, without compromising public health, for example by adjusting the timing of the submission and the level of detail of plans for the investigation of medicines in children. Broekmans thinks such discrepancies between the initial objectives of legislation and the effects of regulatory instruments in practice should be better monitored.

Accord to Richard Bergström, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), “Our latest learning from genomics and our improved understanding of human biology have resulted in a record number of promising break-through medicines in development. Entering a new era of personalized medicine, the current model for medicines development and approval may not be appropriate. Against this background EFPIA decided to provide an unrestricted research grant to the Escher platform to explore if the model is fit for purpose."

Read the full release here.

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