On June 19, 2009, the European Medicines Agency (EMA) published a draft transparency policy for public consultation, which remained open as the subject of public consultation until September 25, 2009.
The draft policy covers the EMA's activities related to its role in review of applications for marketing authorisation of medicinal products and in monitoring of medicinal products, as well as the agency's interactions with stakeholders.
The general aim of the EMA's transparency policy is to ensure that a balance is struck between openness, communication and accountability of its actions and decision-making process, while ensuring the protection of personal data and commercially confidential information. In order to achieve this aim, the steps proposed in the document include a redefinition of the concept of commercially confidential information and proposed steps towards implementation of the EMA policy on access to documents.
The first objective of the draft policy is to apply a more proactive approach to the publication of both product-specific documents and general policy and information documents. This includes pro-active publication of agendas, press releases, minutes of meetings, work programmes and monthly reports of EMA scientific committees and working groups.
It also includes proactive publication of pharmacovigilance and safety information regarding centrally authorised medicinal products and information about the assessment of Periodic Safety Update Reports. The EMA already makes public many of these documents ahead of the adoption of the final transparency policy.
The second objective of the new transparency policy is to strengthen further interaction with stakeholders, including industry, patients and healthcare professionals.
The third objective is to enhance and promote co-operation and alignment of the transparency policies and practices of the EMA with the competent authorities of the EU member states in relation to the publication and disclosure of product-specific information and documents.
Preparatory and working documents, internal notes and opinions will not be disclosed by the EMA
The EMA is currently processing comments received during the consultation procedure. It is not, however, currently clear when the final transparency policy will be adopted.
Access to documents
In November 2010, the EMA published its policy regarding access to documents. Previously, requests for access to documents were handled by the EMA according to the rules governing response to requests for information set out in the EMA Code of Conduct and the decision of the EMA management board concerning the rules on access to documents of the EMA.
The new access policy became effective on December 1, 2010. Its main objective is to ensure the widest possible access to EMA's documents concerning any matter related to policies, activities and decisions falling within the agency's remit and responsibilities. This objective is, however, to be achieved while ensuring the protection of personal data and commercially confidential information.
The aim of the policy is to provide access to all business-related documents unless the disclosure of such documents has to be refused in order to respect the confidentiality arrangements with regulatory authorities outside the EU, as well as conforming with international relationships with third countries and international organisations. Access to documents may also be refused on the grounds of protection of personal data and commercially confidential information.
The policy acknowledges the absence of a legal definition of the term 'commercially confidential information' and defines it as: 'any information which is not in the public domain or publicly available and where disclosure may undermine the economic interest or competitive position of the owner of the information'. The term is not yet defined in the EU case law. The General Court has, however, held that not all information in relation to a company could fall in the scope of 'commercially confidential information'.
The policy provides that, irrespective of any applicable exception, access to documents or parts thereof may be granted whenever an overriding public interest in disclosure can be identified by the EMA, either further to a request for access to documents or on its own initiative.
According to the policy, documents relating to a medicinal product may be provided to the public only after the assessment of an application for marketing authorisation related to the product has been finalised. This limitation is intended to protect the independence of the internal opinion-making process of the EMA's scientific committees.
Their aim is to ensure a common approach between the EMA and the [EU] national competent authorities … in relation to the publication and disclosure of documents
Preparatory and working documents, internal notes and opinions will not, therefore, be disclosed by the EMA. The policy provides that the EMA shall, however, consider the need to grant public access to documents prior to the finalisation of the procedure 'in case of an overriding public interest in disclosure'. Curiously, the protection of the rights of the applicants is not included within the policy as an argument to justify non-disclosure of preparatory or working documents.
The EMA has produced an 'output table' of the policy, which lists documents classified as 'confidential' or 'public' and determines whether public access to such documents could be granted. The documents in the list include, among others, EMA documents concerning product-specific issues and documents submitted to the EMA both by applicants for marketing authorisation (MA) and MA holders. The output table states that the MA dossier and applications for MA or for variations of the MA will be considered confidential prior to the European Commission's decision regarding the application. These documents become public after the related decision of the Commission has been delivered.
The output table is complemented by the EMA and Heads of Medicines Agencies (HMA) draft guidance regarding the types of information included in a MA application that can be publicly released after the final decision on the application. The public consultation regarding this draft guidance closed on September 1, 2011.
The draft guidance is based on the EMA and HMA 'recommendations on release of information with regard to new applications for medicinal products before and after opinion or decision on granting of a marketing authorisation'. The recommendations were published in November 2010. Their aim is to ensure a common approach between the EMA and the national competent authorities of the EU member states in relation to the publication and disclosure of documents, as well as a common approach to what information is considered commercially confidential.
The recommendations provide that, prior to an opinion or decision regarding an application for a MA, the EMA and the national competent authorities of the EU member states may disclose only the name of the active substance and the therapeutic class of the medicinal product. After the opinion or decision, the competent authority may further disclose:
The draft guidance is intended to provide advice concerning the practical application of the provisions of the recommendations to the public disclosure of parts of the MA dossier.
The guidance classifies the sections of the MA dossier, structured and presented in the format of the Common Technical Document, according to four classifications. The sections of the MA dossier are classified as:
Sections classified in the dossier as commercially confidential information or personal data cannot be disclosed unless the information is redacted before release. The information in the sections classified as requiring case-by-case analysis cannot be released before the conduct of such analysis and before the redaction of commercially confidential information or personal data contained in them.
According to the draft guidance, detailed information concerning the quality and manufacturing of medicinal products is commercially confidential. The same determination applies to information concerning development of the product, including detailed information on the synthesis and manufacturing of the active substance, formulation, test procedures, validation, as well as manufacturers and suppliers of the active substance and excipients. Detailed descriptions of the manufacturing and control processes for the finished product are also considered to be commercially confidential.
The draft guidance contains a detailed table classifying each section of the MA dossier according to the four criteria discussed above.
The practical consequences of the EMA policies, guidance and recommendations are that data contained in MA dossiers held by the EMA could be publically disclosed unless such data is considered to constitute confidential commercial information or personal data.
Even with these new documents, there is still no coherent definition of what constitutes confidential commercial information. However, the recent investigation by the European Ombudsman into EMA's policy on access to documents, resulting from a complaint submitted to the ombudsman against EMA's refusal to disclose documents in 2007, included recommendations regarding the handling of requests for access to documents. A key point, to which the EMA agreed, was that the information could be considered commercially confidential – and thus not disclosed – only when it was demonstrated that disclosure would specifically and actually undermine commercial interests. This is a shift from the previous approach of the EMA, which was the object of the ombudsman's investigation, according to which potential risk was sufficient to justify non-disclosure.
In the future, therefore, it could be expected that more and more information submitted to the EMA by applicants may be made public or disclosed upon requests from the public.
Elisabethann Wright (left) is partner and Alexander Roussanov is associate, both at Hogan Lovells International LLP
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