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.
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.
Joint briefing paper by 7 organisations. The major advance in transparency brought by the adoption of the EU regulation on clinical trials needs to be preserved from neutralisation by industry lobbies.
Joint response by HAI, ISDB and MiEF to a WHO public consultation. The WHO proposal to assign a "biological qualifier" after the International Nonproprietary Name (INN) of glycosylated biosimilars offers an acceptable solution at global level.
Joint open letter to President Juncker by 28 organisations. Promoting profit over public health puts European citizens at risk. No, medicinal products are not just a commodity like any other.