Functioning of the Agency: transparency and document access are no longer optional extras

Many amendments voted by the EU Parliament aim at increasing the transparency of the European Medicines Evaluation Agency. Nearly all refer to the Code of Good Administrative Behaviour (European Ombudsman) and European Regulation 1049/2001 on public access to documents. The joint declaration of the Parliament and Council on 27 June 2001 stipulates that: "(…) the agencies and similar bodies created by the legislator should have rules on access to their documents which conform to those of this Regulation. To this effect, the European Parliament and the Council welcome the Commission's intention to propose, as soon as possible, amendments to the acts establishing the existing agencies and bodies and to include provisions in future proposals concerning the establishment of such agencies and bodies (…)" (1). The recital of Regulation 1049/2001 also states that: "In order to ensure the full application of this Regulation to all activities of the Union, all agencies established by the institutions should apply the principles laid down in this Regulation." (2). In addition, the creation of document registries mentioned in Regulation 1049/2001 fully applies to technical documents of the type held by agencies such as EMEA, which must be made readily accessible to the public. Article 11-1 of the Regulation states that: "To make citizens' rights under this Regulation effective, each institution shall provide public access to a register of documents (…). References to documents shall be recorded in the register without delay (...). The institutions shall immediately take the measures necessary to establish a register which shall be operational by 3 June 2002." Article 11-2 calls for a clear and logical referencing system for such documents.

Despite this framework and clear recommendations, article 51-1 of the draft Regulation lacks consistency and details regarding the different types of documents and the ways in which they can be accessed, although the Commission finds this satisfactory. For example, paragraph (b) mentions assessment reports and summaries of product characteristics, but it is not clear whether they are available on request or automatically (no doubt owing to a typing error made when the sentence was modified); paragraph (d) a database on adverse effects with different but undefined levels of access; paragraph (e) distribution of "appropriate" pharmacovigilance information; paragraph (j) a database on drugs, whose future contents are unclear, but which refers to point (b) according to article 51-2, etc.

The Medicines in Europe Forum considers it is time to clarify, simplify and effectively apply article 51, keeping in mind that access to documents is now the rule in Europe, even if it displeases the bureaucracies of some Member States. It is no longer sufficient to offer a facade of transparency; the right to reliable information must now be recognised. Article 70 is too flimsy on this point, simply stating that the management board should examine the degree of EMEA transparency, on the basis of proposals from the executive director.

©La revue Prescrire for the Medicines in Europe Forum 1 March 2003
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1- "Joint declaration relating to Regulation (EC) n° 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents" Official Journal of the European Communities 27 June 2001: 0005.
2- "Regulation (EC) N° 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents" Official Journal of the European Communities 31 May 2001: 143/43-145/48.