A joint press release issued by ISDB, MiEF and Nordic Cochrane Centre regarding the recently published report on EMA's controversial "adaptive pathways" pilot project. The report includes no new factual data, with no information shared about the drug's indications, type of clinical trial data to be submitted or which patient representatives were consulted. Read more…
Joint response to an EMA public consultation
The European Medicines Agency (EMA) must stay true to the Clinical Trials Regulation: non-disclosure has to remain the exception, not become the norm!
Press release and joint response attached as PDF:
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
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).