An tOmbudsman Eorpach
Ghlac an Institiúid an dréachtmholadh seo
Cáipéisí gaolmhara
Made in accordance with Article 3(6) of the Statute of the European Ombudsman[1]
1. The European Medicines Agency ('the Agency') is responsible for the protection and promotion of public and animal health through the scientific evaluation and supervision of medicines for human and veterinary use. The Agency's tasks include the collection, management and dissemination of information on adverse reactions to medicines (pharmacovigilance).
In order to carry out its pharmacovigilance tasks, the Agency receives information concerning suspected adverse reactions to medicines from the holders of marketing authorisations[2] and the competent authorities of the Member States. The information received is stored, in encrypted form, in a central, EU-wide database known as EudraVigilance, which is administered by the Agency. On 21 September 2007, the complainant submitted an application to the Agency for access to documents and information relating to a medicinal product called Septrin[3]. Specifically, he requested access to "[i]nformation on the negative effect to human health related to Septrin as noted in the past 10 years"[4]. By letter dated 27 September 2007, the Agency informed him that it had decided to refuse his request for access to information held in the EudraVigilance database on the serious suspected adverse reactions to Septrin. The Agency based its decision on the exception to public access concerning the protection of commercial interests. In this respect, the Agency referred to Article 4(2) of Regulation 1049/2001 regarding public access to documents, and Article 3(2) of the Agency's Rules for the Implementation of Regulation 1049/2001 ('the Agency's Implementation Rules for Regulation 1049/2001')[5]. The provision concerning the protection of commercial interests in Article 3(2) of the Agency's Implementation Rules for Regulation 1049/2001 is essentially identical to Article 4(2) of Regulation 1049/2001. Article 3(2) of the Agency's Implementation Rules for Regulation 1049/2001 provides that "[t]he Agency shall refuse access to a document where disclosure would undermine the protection of: a) commercial interests of a natural or legal person, including intellectual property ... unless there is an overriding public interest in disclosure", and, likewise, Article 4(2) of Regulation 10419/2001 stipulates that "[t]he institutions shall refuse access to a document where disclosure would undermine the protection of: - commercial interests of a natural or legal person, including intellectual property, ... unless there is an overriding public interest in disclosure". The Agency informed the complainant that he could appeal against the Agency's decision on his initial request for access to documents by writing to the Executive Director of the Agency within a time-limit of 15 working days from the receipt of the initial reply.
2. On 11 October 2007, the complainant submitted to the Agency a confirmatory application for public access.
3. By letter dated 26 November 2007, the Agency replied to the confirmatory application. The Agency stated that (i) the application was handled in accordance with the Agency's Rules for the Implementation of Regulation 1049/2001, and (ii) the refusal to grant access was based on the exception to public access concerning the protection of commercial interests, namely, Article 3(2) of the Agency's Rules for the Implementation of Regulation 1049/2001, which states the following: "The Agency shall refuse access to a document where disclosure would undermine the protection of: a) commercial interests of a natural or legal person, including intellectual property ... unless there is an overriding public interest in disclosure." The Agency informed the complainant that, if he wished to appeal against the decision on the confirmatory application, he could either lodge a complaint with the European Ombudsman, or initiate Court proceedings against the Agency, under Article 228 or Article 263 of the TFEU.
4. The complainant submitted a complaint to the Ombudsman on 30 November 2007.
5. The Ombudsman opened an inquiry into the following allegation and claim:
The Agency's refusal of 26 November 2007 to give access to the requested data relating to 'adverse reactions' concerning the pharmaceutical product 'Septrin' stored in the EU-wide database (EudraVigilance) was contrary to the relevant rules (i.e., Regulation 1049/2001 (EC) and the Agency's implementing rules.
The Agency should grant access to the above-mentioned data.
6. On 21 April 2008, the Ombudsman forwarded the complaint to the Agency. The Agency then provided its opinion, which was forwarded to the complainant with an invitation to make observations. The complainant submitted his observations on 30 September 2008. The Ombudsman decided to carry out further inquiries and sent a relevant request to the Agency on 17 November 2008. The Agency submitted its response to the Ombudsman's further inquiries on 26 February 2009. The complainant submitted his observations to the Agency's response on 4 May 2009.
7. In its opinion, the Agency put forward the following arguments in support of its refusal to grant the complainant's request for public access to documents:
(i) a database is not a "document";
(ii) certain data stored in the EudraVigilance database are commercially confidential and are subject to personal data protection;
(iii) the Agency does not possess complete information which would indicate the safety of Septrin, but only fragmentary data, since Septrin was nationally authorised and the Agency was not involved in the marketing authorisation procedure;
(iv) as regards the possibility of an overriding public interest in access to the documents requested by the complainant, the burden of proof lies with the applicant. The evidence provided by the applicant concerning the overriding public interest was not sufficient to justify the disclosure of the data requested, and
(v) the information requested by the complainant will be covered by the Agency's future policy regarding access to EudraVigilance. According to the draft EudraVigilance access policy, no public access will be granted to raw data contained in the database, but only to aggregated information concerning such data.
8. In his observations, the complainant argued that the Agency had not sufficiently reasoned its decision to refuse public access.
9. In his further inquiries, the Ombudsman requested the Agency to provide him with a description of the form in which the data on the serious suspected adverse reactions to Septrin is held by the Agency (in a paper/printed format; saved in a database and/or saved on some other electronic medium), and (ii) to provide a detailed description of the way in which the data could be printed out and/or saved onto another electronic medium, including the approximate time it would take to do so.
10. In reply to the Ombudsman's further inquiries, the Agency put forward the following three arguments in support of its decision to refuse public access to the requested reports.
11. The Agency argued that Regulation 1049/2001 does not be apply to the complainant's request for access to the Individual Case Safety Reports on suspected serious adverse reactions ('suspected serious adverse reaction reports'), which are stored electronically in the EudraVigilance database, because the right of access to suspected serious adverse reaction reports is exclusively regulated by Article 26 and Article 57(1) (d) of Regulation 726/2004. According to the Agency, these provisions constitute a law which governs specific subject matter (that is, a lex specialis[6]), which overrides the provisions on access to documents contained in Regulation 1049/2001.
12. The Agency also pointed out that the indiscriminate release of the raw data would not be of benefit to citizens since, most of the time, it would result in the circulation of unreliable and misleading data. The Agency stated that this was why the legislator had provided the general public with the possibility of obtaining only partial access to such data, and only following an evaluation by the Agency.
13. The Agency then stated that if the interest of protecting public health and informing civil society is to be properly pursued, and in a focused way, the data held in EudraVigilance should not be indiscriminately released, and the general public should not be granted direct access to raw data hosted by the system.
14. In the context of this argument, the Agency also stated that, in order to comply with Article 57(1)(d) and Article 26 of Regulation 726/2004, and with "the principle of transparency", it had drafted a policy which would regulate access to the EudraVigilance database by the various stakeholders. This policy provides the various stakeholders with three different levels of access to the system. In line with the relevant legal provisions, the following three categories of users would thus be granted appropriate rights of access: (i) the European Commission and Member States; (ii) pharmaceutical companies and sponsors of clinical trials, and (iii) the general public and healthcare professionals.
15. As a second argument, the Agency stated that Regulation 1049/2001 does not apply to the complainant's requests for access because the definition of "document" in Regulation 1049/2001 does not apply to data stored in the EudraVigilance database. It stated that it had applied the definition provided by the European Commission, according to which a document is produced as the result of a normal search of the database. The Agency also pointed out that, according to the Commission's recent legislative proposal to amend the definition of "document" contained in Regulation 1049/2001, electronically stored data, held in a processing retrieval system, are only "documents" for the purposes of that Regulation if they can be extracted in the form of a printout or electronic-format copy, using the available tools for the exploitation of the system. The Agency then argued that, under the currently applicable legislation, the suspected serious adverse reaction reports stored in the EudraVigilance database are not "documents", because the information is not immediately retrievable from the database. Instead, a complicated procedure is necessary in order to obtain "humanly readable data" from it. The Agency also stated that obtaining the requested reports from the EudraVigilance database would require a "tailor made" search of the database in accordance with the parameters set out in the complainant's application.
16. As a third argument, the Agency sought to justify its refusal to provide access to the requested suspected serious adverse reaction reports by referring to the principle of proportionality. The Agency stated that if it were to make the requested "ad hoc generated documents" available, this would result in its having to bear a disproportionate administrative burden in terms of time and resources. The Agency also pointed out that it did not have the necessary personnel to deal with access to document requests on a full-time basis. In this regard, the Agency stated that generating and making the requested reports available in a readable format would take eight working hours, excluding the time needed to redact personal data.
17. The Agency supported its third argument by referring to the judgment of the Court of the First Instance in Case T-2/03 paragraph 102[7], which stated the following:
"An institution must therefore retain the right, in particular cases where concrete, individual examination of the documents would entail an unreasonable amount of administrative work, to balance the interest in public access to the documents against the burden of work so caused, in order to safeguard, in those particular cases, the interests of good administration (see, by analogy, Hautala v Council, cited in paragraph 69 above, paragraph 86)".
18. The Agency stated that its third argument was supported and shared by the British Freedom of Information Act, which foresees the possibility for an institution to deny access whenever the cost of compliance would exceed appropriate limits[8].
19. In his observations on the Agency's reply to the further inquiries, the complainant recalled that he needed the information he had requested from the Agency in order to present that information in two court cases concerning deaths allegedly caused by the use of Septrin. He argued that a potential loss of life was more important that commercial confidentiality. As regards the Agency's argument that making the requested documents available would result in its having to bear a disproportionate administrative burden, the complainant argued that human health must take precedence over any administrative burden which might arise for the Agency's services in complying with his request.
20. The present case is similar to complaint 2493/2008/(BB)TS concerning public access to reports on the serious suspected adverse reactions to a medicinal product known as 'Roaccutane', which are also stored in the EU-wide EudraVigilance database. In the course of the (ongoing)[9] inquiry into that complaint, the Agency accepted the European Ombudsman's draft recommendation to reconsider providing public access to the requested serious suspected adverse reaction reports stored in the EudraVigilance database, in accordance with Regulation 1049/2001. The Agency thus revised its position on the confidentiality of the information contained in requested documents. It now agrees that:
(i) Regulation 1049/2001 applies to documents contained in the EudraVigilance database;
(ii) data stored in EudraVigilance do constitute "documents"; and
(iii) providing access to such "documents" does not impose a disproportionate administrative burden on the Agency's services.
21. Given that the Agency has already accepted the Ombudsman's draft recommendation[10] in the case referred to above, it is not necessary to carry out an analysis of the above arguments in the present case.
22. However, in the case subject to the present inquiry, the Agency argued that access to the documents could not be given, because:
(i) the documents contain data that cannot be released due to data protection rules;
(ii) the documents contain data that are commercially confidential; and
(iii) it is the applicant who must bear the burden of proof to show that there is an overriding public interest in public access, and the applicant has not succeeded in doing so.
23. The Agency argued that personal data contained in the requested documents would need to be redacted. This included personal data of patients and of the persons reporting the adverse reactions ('reporting doctors').
24. Personal data is any information relating to an identified or identifiable natural person[11]. Based on the results of the inspection of the file carried out by his services on 4 December 2008, the Ombudsman notes that the reports on the suspected serious adverse reactions to Septrin contain some personal data of patients and reporting doctors. Deleting the names of natural persons and data on the basis of which natural persons could be identified is clearly justified under Regulation 1049/2001.
25. According to Article 1(a) of Regulation 1049/2001, the purpose of Regulation 1049/2001 is to ensure the widest possible access to documents. Thus, the exceptions to the general right of access to documents must be interpreted and applied strictly[12]. As such, public access can only be denied if it is demonstrated that such access would specifically and actually undermine the interest protected by the exception[13]. In the present case, relying on Article 4(2) of Regulation 1049/2001 regarding access to documents, the Agency simply argued that certain sets of data stored in EudraVigilance are commercially confidential and, as such, cannot be disclosed. The Agency did not in any way substantiate this argument. After examining the sample report on the serious suspected adverse reactions to Septrin, provided by the Agency in the context his inspection of 4 December 2008, the Ombudsman also notes that it is not evident that such reports contain commercially confidential information or other information which would damage any legitimate business interests of a third party. Thus, in the Ombudsman view, the Agency failed to establish that the requested documents fall within the scope of the exception concerning the protection of commercial interests, as provided for in Regulation 1049/2001.
26. The Agency argued that the burden of proof regarding the possibility of an overriding public interest lies with the complainant, and that the evidence provided by the latter concerning the overriding public interest was not sufficient to justify the disclosure of the requested documents. The Ombudsman does not agree. Article 4(2) and Article 4(3) of Regulation 1049/2001 provide that an institution must not release a document to the public if one of the interests set out in those provisions applies, unless there is an overriding public interest in public disclosure. The Ombudsman notes that an institution to which a request is made pursuant to Regulation 1049/2001 is required to apply the Regulation in full. This involves carrying out a full analysis to determine whether an overriding public interest in disclosure exists. The Ombudsman underlines that, in this respect, it is certainly correct for the institution, to which a request for public access is made, to examine arguments put forward by an applicant in relation to overriding public interests. However, the Ombudsman notes that the institution concerned should also, ex officio, carry out its own examination to establish whether there is an overriding public interest in disclosure.
27. In the present case, the Agency did not even demonstrate that the disclosure of the documents falls within the exceptions set out in Article 4(2) or Article 4(3) of Regulation 1049/2001. Thus, it is not necessary to examine, in concrete terms, whether there is an overriding public interest in disclosure. However, the Ombudsman considers that, in future, the Agency should, ex officio, determine whether there may be an overriding public interest in disclosure by balancing the interests protected under Article 4(2) and Article 4(3) of Regulation 1049/2001 with the public interest in disclosure.
28. In light of the above, the Ombudsman will make a draft recommendation to the Agency. In making this draft recommendation, the Ombudsman notes that the Agency has recently published its new policy on access to documents concerning medicines for human and veterinary use[14]. This policy clarifies that, in line with Article 15 of the TFEU, the Agency is committed to granting the widest possible access to documents according to the principles and further conditions as defined by Regulation 1049/2001. The European Ombudsman has applauded this constructive approach to improving the Agency's transparency policy.
On the basis of his inquiries into this complaint, the Ombudsman makes the following draft recommendation to the Agency:
The Agency should review the possibility of granting the complainant the access he requested to the reports on suspected serious adverse reactions to Septrin, in accordance with Regulation 1049/2001, and in light of the Agency's new policy on access to documents.
The Agency and the complainant will be informed of this draft recommendation. In accordance with Article 3(6) of the Statute of the European Ombudsman, the Agency shall send a detailed opinion by 31 March 2011. The detailed opinion could consist of the acceptance of the draft recommendation and a description of how it has been implemented.
P. Nikiforos Diamandouros
Done in Strasbourg on 8 February 2011
[1] Decision of the European Parliament of 9 March 1994 on the regulations and general conditions governing the performance of the Ombudsman's duties (94/262/ECSC, EC, Euratom), OJ 1994 L 113, p. 15.
[2] Medicinal products cannot be placed on the market of a Member State unless a marketing authorisation has been issued in relation thereto.
[3] Septrin is used to treat bacterial infections.
[4] In addition, the complainant requested access to information on whether this product had ever gone through a re-evaluation and re-authorization procedure; information on whether the Agency has ever noted any changes in the product leaflet concerning Septrin; and copies of the consumer's instructions leaflet regarding Septrin, for the years 1998 up to 2007, as marketed in the UK or US markets. As regards these requests for information, the Agency replied that it was not in the position to provide him with the information he had requested because Septrin had only been authorised through national procedure in the UK, and not at the EU level. The Agency advised him to address these questions to the competent national authority in the UK (MHRA).
[5] Rules for the implementation of Regulation (EC) No 1049/2001 on access to European Medicinal Agency's documents (EMA/MB/203359/2006 Rev 1 Adopted), adopted on 19 December 2006 (http://www.EMA.europa.eu/pdfs/general/manage/mbar/20335906en.pdf). The Rules were adopted pursuant to Article 73 of Regulation (EC) No 726/2004 (that establishes the European Medicines Agency), which foresees that Regulation 1049/2001 shall apply to documents held by the European Medicines Agency. Article 73 of Regulation 726/2004 also obliges the Agency to adopt "implementing arrangements", which it has done through adoption of the above rules. Article 3(2) of the Agency's Implementation Rules for Regulation 1049/2001 is essentially identical to Article 4(2) of Regulation 1049/2001 which, anyhow, applies per se to the Agency.
[6] The legal term "lex specialis" is used to describe the principle whereby a law governing a specific subject matter (that is, a lex specialis) overrides a law which only governs general matters (that is, a lex generalis).
[7] Case T-2/03 Verein für Konsumenteninformation v Commission [2005] ECR II-1121, paragraph 102.
[8] The Agency noted that, in particular, The Freedom of Information and Data Protection (Appropriate Limit and Fees) Regulations 2004 (Statutory Instrument 2004 no 3244) provide for a limit of GBP 600 per request in the case of certain public bodies (including governmental departments), and GBP 450 in the case of other public authorities. The Statutory Instrument also foresees that the costs are to be estimated at a rate of GBP 25 per person per hour.
[9] Following EMA's reply to the draft recommendation, the Ombudsman asked EMA to complement its detailed opinion in order to help the Ombudsman complete his assessment by providing the following clarifications:
"1. Can EMA expressly confirm that, in its reply ... to the complainant's request for access, EMA provided the complainant with access to all reports of suspected serious adverse reactions to the medicinal product Roaccutane (isotretinoin) in its possession. In this respect, I note that the reports provided to the complainant date from 1995. I request EMA to inform me whether it holds, either in electronic or paper form, reports dating from before 1995.
2. Can EMA explain in more detail the reasons for not disclosing the name of the country from which the reports of suspected serious adverse reactions originate.
3. Can EMA explain the reasons for not disclosing the product name corresponding to each report..."
[10] The Ombudsman's draft recommendation is available at his website: http://www.ombudsman.europa.eu/cases/home.faces
[11] See Article 2(a) of Regulation 45/2001 Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ 2001 L 8, p. 1).
[12] See, for instance, Case T-403/05 MyTravel Group v Commission [2008] ECR II-2027, paragraph 32.
[13] Furthermore, the risk of a protected interest being undermined must, to be relied upon, be reasonably foreseeable and not purely hypothetical. It has also been acknowledged in the case-law that an EU institution may, in principle, base its decisions in this regard on general presumptions which apply to certain categories of documents, since considerations of a generally similar kind are likely to apply to requests for disclosure relating to documents of the same nature. However, it is incumbent on the institution to establish in each case whether the general considerations normally applicable to a particular type of document are in fact applicable to a specific document which it has been asked to disclose. Joined Cases C-39/05 P and C-52/05 P Kingdom of Sweden and Turco v Council [2008] ECR I-4723, paragraph 50.
[14] European Medicines Agency policy on access to documents concerning medicines for human and veterinary use (ref EMA/110196/2006), adopted on 30 November 2010, effective as from 1 December 2010.
