Comments from stakeholders invited until 18 May 2017
The European Medicines Agency (EMA) launches today a public consultation on the proposed revision to its policy on access to documents. The policy describes the rules EMA applies to grant access to the documents that it holds, in accordance with Regulation (EC) No 1049/2001, which gives citizens a right to access EU documents.
The revision is based on EMA’s experience with the original policy introduced in 2010. The new version extends the scope of the policy to include explicitly corporate documents and takes into account the Agency’s proactive approach to transparency that has led to the publication of many more documents on the EMA website since 2010.
The three principal documents are:
- The policy which has a new title to emphasise that it covers both scientific and corporate documents held by EMA;
- A new table with the access rules for corporate documents held by EMA: Output of the EMA policy on access to documents related to corporate documents;
- A revised table with the access rules for documents related to medicines for human and veterinary use held by EMA: Output of the EMA policy on access to documents related to medicinal products for human and veterinary use.
Other changes include a new classification of the documents into ‘releasable’ or ‘non-releasable’ (previously, documents were classified as ‘public’ and ‘confidential’); more clarity on when procedures are considered to be concluded and documents become releasable; and a new section that details the level of information to be made available in relation to requesters.
Providing access to documents is an important element of EMA’s continued commitment to transparency. Since October 2016, the Agency has also given open access to clinical reports for new medicines for human use authorised in the EU. For every new medicine, citizens, including researchers and academics, can directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of their marketing-authorisation applications. By providing open access to clinical data, EMA became one of the most transparent regulatory bodies worldwide.
The revisions to the access to documents policy are marked in yellow in the policy document. Stakeholders can submit their comments on the proposed revisions and the two output tables until 18 May 2017. This form should be used for comments and needs to be sent as a Word document to email@example.com.
All comments submitted will be reviewed and considered before a final version of the policy, the arrangements for implementation and both output tables are submitted to EMA’s Management Board for adoption.
Regulation (EC) No 1049/2001 of the European Parliament and the Council of the EU aimed to enhance transparency by giving the European citizens and legal entities the right of access to documents of EU institutions, in line with principles, conditions and limits defined by legislation.