May 01, 2012

EMA Toughens up on Transparency

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The European Medicines Agency (EMA) has released guidance that outlines a Europeanwide approach for dealing with transparency and access to information included in marketing authorisation applications. The guideline identifies which parts of an application dossier can or cannot be released in response to document requests and is a culmination of earlier, more tentative moves towards transparency. According to the EMA, the guidance is a "major step for transparency" and is the first time that a harmonised, European approach to the issue has been adopted. Going forward, all regulatory authorities in the European Economic Area will apply the same principles.

The guidance is pertinent to any medicine, irrespective of the authorisation procedure it has undergone, and limits the scope of what regulators will consider to be commercially confidential information and personal data. Exceptions mainly relate to information about the quality and manufacturing of a medicine, in addition to information about facilities and equipment, and some contractual arrangements. Also explained in the guidance documents is how to identify personal data relating to patients, experts or staff. Personal data will be defined by EU Directive 95/46/EC.

The adoption of the guidance will no doubt have been spurred by recent criticism directed at the EMA's perceived lack of transparency. In 2011, an article published in the British Medical Journal highlighted the difficulties in obtaining access to unpublished trial reports from the EMA, with the authors claiming that the EMA was "protecting drug company profits above patient welfare by withholding access to the data." In other related incidences, access to documents was only given after intervention by the European ombudsman.

Industry response

Support for the principle of a consistent datasharing policy across Europe has previously been declared from several important stakeholders, including the World Health Organisation, the European Commission, the European Ombudsman and the UK's Wellcome Trust, and much of the content of the guidance documents has been generally well-received by the research fraternity and the pharma industry. However, concerns have also been raised. In particular, stakeholders are worried about the proposed release of contractual arrangements between companies. Many pharmaceutical companies are also concerned about the disclosure of nonclinical data.

Richard Bergstrøm, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), has highlighted that the concept of 'regulatory data protection' (RDP) is now at odds with EMA guidance. Under the terms of current RDP, second applicants face a 10-year block to referencing previously submitted data. Bergstrøm explained: "The worry in the industry is not that data itself is made available, but the fact that data will be available for all sorts of re-analyses. It is important that EMA communicate best practices for re- and meta-analysis of data." He also acknowledged that the notion of confidential data is now "markedly reduced" and said that the focus should be on achieving international agreement against 'reliance on data.'

The final documents are expected to be presented to stakeholders in June at a meeting in Copenhagen (Denmark).

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