28 November 2014
Joint Press Release
At the end of November 2014, the European Medicines Agency has announced the adoption of a “more balanced approach to handling conflicts of interests” to become effective on 30 January 2015. In reality, this revised EMA COI policy relaxes EMA’s position in relation to the conflicts of interest of experts with pharmaceutical companies. The evaluation of the efficacy and harms of medicines must be free from undue influence and be based on scientific data, so that the Agency’s work can benefit public health. The Agency’s integrity is at stake
The International Society of Drug Bulletins (ISDB), Medicines in Europe Forum (MiEF), Health Action International (HAI) Europe, Nordic Cochrane Centre (NCC) and Public Citizen submitted this joint response to the WHO public consultation on public disclosure of clinical trial results.
Medicines are not just a commodity: the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum (MiEF) and the Nordic Cochrane Centre (NCC) welcome the decision to leave responsibility for medicinal products with Health Commissioner (joint press release).
On 2 October 2014, the European Medicines Agency (EMA) finally adopted its policy on access to clinical data. From 1 January 2015 onwards, the general public will be able to “view on screen” selected parts of trial reports submitted in support of marketing authorisations, and academic and non-commercial researchers will be allowed to download this data. The policy, unfortunately, also gives pharmaceutical companies the upper hand in deciding the contents of the clinical reports by allowing them to redact data on the grounds of “commercial confidentiality”. The implementation of the policy will need careful monitoring.