New Legislation approved by the European Parliament on 2 April 2014 aims to increase transparency with respect to clinical trials by making the results publicly available. The Clinical Trials Regulation, which is expected to take effect in 2016, will require the results of all new clinical trials to be published within a year of the trial ending. The way, however, that the European Medicines Agency (EMA) is proposing to make this data available has been criticized.
The German Institute for Quality and Efficiency in Health Care (IQWiG) has said that the draft on the conditions of use for the EMA interface via which anyone should be able to access the data is ‘disappointing’.
According to EMA’s plans, interested parties will only be allowed to access the data in a ‘view on screen only’ mode. They will not be permitted to download, save, edit, photograph, print, distribute, or transfer the information. These conditions, according to IQWiG, ‘make any scientific analysis of clinical study data, for instance, within the context of benefit assessments of drugs, absolutely impossible’.
IQWiG is concerned that, ‘according to the draft, within the context of market approval applications drug manufacturers will be able to submit two versions of a clinical study report to EMA: a complete one, by means of which EMA will decide on approval, and an incomplete one for the public.’
Individual patient data, which may allow patients to be identified, will be deleted from the study reports. However, IQWiG is concerned that ‘now this step has been extended to cover study results, and the requirements are so vaguely worded that the extent of the redaction of the report is difficult to predict.’
The European Ombudsman, Ms Emily O’Reilly, has also expressed concern over EMA’s plans. Ms O’Reilly is ‘concerned about what appears to be a significant change in EMA’s policy, which could undermine the fundamental right of public access to documents established by EU law. European citizens, doctors and researchers need maximum information about the medicines they take, prescribe and analyse.’
EMA responded that there has been no change of direction and that ‘the adoption of the “Terms of Use” and the “screen-only-mode” was deemed a reasonable compromise among the interests of all stakeholders and institutions we consulted’.
Some originator companies have not been too happy about the introduction of the legislation. AbbVie and InterMune sued EMA to stop it releasing information from clinical trials of the companies’ drugs [1], although AbbVie later withdrew its court cases against EMA.
Related article
Results of clinical trials in Europe to be made publicly available
Reference
1. GaBI Online – Generics and Biosimilars Initiative. Pharma companies sue EMA to block release of data [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 20]. Available from: www.gabionline.net/Biosimilars/General/Pharma-companies-sue-EMA-to-block-release-of-data
Source: www.gabionline.net
