EMEA and UK's NICE accused of failings

Separate criticisms of the European Medicines Agency (EMEA) and the National Institute for Health and Clinical Excellence (NICE) have brought into question the effectiveness of both regulatory agencies, with somewhat contradictory proposals being argued for each.

The British Medical Journal carried an article by Silvio Garattini and Vittorio Bertele, of the Mario Negri Institute of Pharmacological Research, Italy, who argue that the EMEA's present arrangements overly favor drugmakers. Meanwhile, expert testimony to the UK's House of Commons Health Select Committee has claimed that the NICE excludes specialist medical advice from its decisions on drug reimbursement by the National Health Service in England and Wales, on the grounds that the agency fears that there might be conflicts of interest, given the links between many experts and drugmakers.

The EMEA should refuse to endorse products, unless they are more effective than existing medicines, the BMJ article argues. The Commons Health Select Committee heard that lack of transparency and the exclusion of expert advice led to "very significant flaws" in some of the NICE's work.