EU: Access to medicinal product dossier’s documents

By Mauro Turrini


On 7 July 2010, the European Ombudsman[1] published its Draft Recommendation of his inquiry into complaint 2560/2007/BEH against the European Medicines Agency (“EMA”) concerning the refusal to disclose clinical study reports and corresponding trial protocols concerning certain anti-obesity medicinal products which were submitted by two pharmaceutical companies to the EMA with a view to obtaining marketing authorisations.

In particular in the Draft Recommendation, the European Ombudsman called on the EMA to either disclose the documents in question or else explain why access should not be given by no later than 31 August 2010.

The Draft Recommendation follows a complaint from the Nordic Cochrane Centre, a group of Danish healthcare researchers, who wanted to conduct an independent analysis requiring access to the data in these documents but whose request was refused by EMA on the grounds that the disclosure of these documents would have undermined the medicinal products manufacturers' commercial interests (see Article 3(2)(a) of the “Rules for the implementation of Regulation (EC) No 1049/2001 on access to EMEA documents”).

In its compliant under Article 195 of the EC Treaty, the Nordic Cochrane Centre argued it was unlikely that clinical study reports would contain anything that could undermine the protection of a natural or legal person’s commercial interests and that “even if commercial interests are specifically and actually undermined by disclosure, access still has to be granted if there is an overriding public interest in disclosure”.

During his investigation, the Ombudsman inspected the relevant reports and protocols held by the EMA and, essentially agreeing with applicant’s argument, he concluded that their disclosure would not undermine the commercial interests of the companies involved. In particular, the Ombudsman stated that the documents did not contain information on the composition of the anti-obesity medicinal products, nor did they contain other commercially confidential information.

The final outcome of this complaint, due by the end of August 2010, is important because it may affect the attitude of EMA, and maybe also the attitude of the national regulatory authorities when subjected to similar requests. It is noteworthy, indeed, that the legislation applicable to EMA does not require applicants to state their reasons for the application (see Article 6 of Regulation (EC) 1049/2001 as also implemented by EMA Rules). Should the Draft Recommendation of European Ombudsman to disclose the concerned documents be followed, clinical study reports and corresponding trial protocols of medicinal products (which have always been claimed to be confidential by the companies involved) will in principle be freely available to any citizen of the EU and/or any natural or legal person residing or having its registered office in a Member State, including competitors of the companies involved.

[1]The European Ombudsman is the EU body charged with the investigation of complaints about the administrative acts of EU institutions. EU citizens, residents, enterprises and associations within a Member State can all lodge complaints with the Ombudsman.