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EMA’s proposal to vet drug research that uses its data is “outdated,” say critics

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5076 (Published 11 August 2014) Cite this as: BMJ 2014;349:g5076
  1. Zosia Kmietowicz
  1. 1The BMJ

Campaigners for research transparency have criticised the European drugs regulator for proposing to censor scientists who wish to carry out studies using the agency’s side effects database. They called the European Medicines Agency’s (EMA) draft policy on using the data it holds on case reports of drug side effects as “outdated” and “a barrier to public scrutiny.”

The EMA oversees the EudraVigilance database, which holds reports on the side effects of drugs approved in Europe. Researchers can request access to the raw data held on the database, to perform their own analysis.

On 4 August the agency published a draft policy1 on extending the information it shares with researchers, to include individual case reports of patients’ experiences of side effects. The policy stated that researchers must agree to clear with the agency what they intend to write before they submit their analyses for publication. The agency said that this was to check …

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