Europe’s opportunity to open up drug regulationBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1578 (Published 30 March 2010) Cite this as: BMJ 2010;340:c1578
- Silvio Garattini, director,
- Vittorio Bertele’, head, drug regulatory policies laboratory
- 1Mario Negri Institute for Pharmacological Research, Via Giuseppe La Masa 19, 20156 Milan, Italy
- Correspondence to: S Garattini
- Accepted 14 February 2010
Questions about the benefits of the flu drug oseltamivir in otherwise healthy people1 2 have fuelled debate about the secrecy surrounding the documentation submitted for marketing authorisation of new medicines. Greater transparency would open drug dossiers to evaluation by the scientific community and help independent interested parties define the benefit-risk profile of new medicines before they are allowed on to the market. The recent movement of the European Medicines Agency (EMA) to the Health and Consumer Policy Directorate (DG Sanco) rather than the Enterprise and Industry Directorate presents an opportunity to introduce more openness.
The secrecy surrounding the dossiers presented by drug companies to obtain approval of new drugs has received little attention in Europe. Writing about the oseltamivir issue, Fiona Godlee states that “it is a legitimate scientific concern that data used to support important health policy strategies are held only by a commercial organisation and have not been subject to full external scrutiny and review.”1 This is important because a new drug authorised by the EMA can be marketed in all the European member states without further evaluation.
What we know about new drugs
EMA releases four documents when a new drug is approved
A press release the day after the approval containing only general information
The summary of product characteristics—a technical file intended for prescribers
A leaflet that is inserted in the drug package for patients’ information, and
The European public assessment report (EPAR), which summarises the documentation produced by the manufacturer and the procedures that have led the Committee for Human Medicinal Products to approve the new drug.
Except for the press release, …