The background to the complaint

1. The complainant, who considers that a widely-used vaccine damaged his health, asked the European Medicines Agency (EMA) for public access to various documents it held relating to the vaccine. He was not satisfied with EMA's reply and thus turned to the Ombudsman in June 2014.

2. Following initial inquiries by the Ombudsman, EMA disclosed a number of documents it held related to the vaccine. The Ombudsman closed the case at that point.

3. The complainant disagreed with the Ombudsman's decision to close the case, arguing that EMA should provide him with documents relating to the production of the vaccine. EMA had refused to grant public access to these documents on the basis of Article 4(2) of Regulation 1049/2001[1], stating that the disclosure of the requested documents would damage the commercial interests of the pharmaceutical company holding the manufacturing rights of the vaccine.

The inquiry

4. The Ombudsman opened a further inquiry into the complaint on 30 September 2014 and identified the following allegation and claim:

1) EMA was wrong in refusing access to the Quality data (Module 3) and the OMCL production documentation concerning the vaccine in question.

2) EMA should grant access to the documents requested.

In opening this inquiry, the Ombudsman asked EMA to answer the following questions:

(i) How is EMA's decision of 12 December 2013, which appears to rely on the general presumption that disclosure would undermine the commercial interests of the owner of the information, compatible with the need, set out in the case-law, to undertake a specific and individual assessment of the documents requested?

(ii) If EMA did rely on such a general presumption, which Court judgment supports the approach that a general presumption applies in the case of the kind of documents at issue in this case?

(iii) The quality data appears to contain particulars on product composition and a description of the manufacturing processes. While it may be that the documents requested by the complainant do contain commercially sensitive information which should not be disclosed, it is also the case that the product composition and description of the manufacturing processes of some medicinal products are already publicly know. This is the case, for instance, with patented drugs. Could EMA thus provide more information on this case, explaining, for example, whether any details of product composition and of the manufacturing processes are already public?

(iv) Could EMA explain why it has not considered granting partial access to the documents requested, pursuant to Article 4(6) of Regulation No 1049/2001? In this regard, the Court's judgment in Terezakis is relevant; it held that "if all information relating to a company and its business relations were regarded as being covered by the protection which must be given to commercial interests in accordance with Article 4(2), first indent of Regulation 1049/2001, effect would not be given to the general principle of giving the public the widest possible access to documents held by the institution[2]." Hence, how is EMA's position compatible with the Court's judgment in this case?

5. In the course of the inquiry, the Ombudsman received EMA's opinion on the complaint and, subsequently, the comments of the complainant in response to EMA's opinion. The Ombudsman also inspected the documents concerned. At the request of the Ombudsman, EMA also produced, together with the requested documents, a table highlighting which exact information contained in Module 3 was included in the European Public Assessment Report (EPAR) (see paragraph 11 below). In conducting the inquiry, the Ombudsman has taken into account the arguments and opinions put forward by the parties.

Refusal to grant access to the Quality data (Module 3) and the OMCL production documentation

Arguments presented to the Ombudsman

6. Regarding the OMCL[3] production documentation, EMA argued that the complainant had been informed, on at least two occasions, that EMA does not hold documents relating to OMCL testing. EMA cannot provide access to documents which it does not hold.

7. In reply to questions (i) and (ii), [the Quality data (Module 3)], EMA stated that the Ombudsman's assumption, that it had relied on a general presumption that disclosure would undermine the commercial interests of the owner of the information, was incorrect. EMA stated that its decision clearly outlined the reasons for refusing access to the Quality data (Module 3). These reasons were formulated following a careful and individual assessment of the content of the Quality data (Module 3).

8. In reply to question (iii), EMA stated that the Quality data (Module 3) of the marketing authorisation dossier for the vaccine in question contains specific chemical-pharmaceutical and biological data concerning the active substance and the final product. This includes, among other things, the quantitative composition and information on residuals and impurities per dose. The Quality data (Module 3) also contains specific information concerning the lot and batch numbering system, as well as laboratory codes. In EMA's view, the release of this information would result in the disclosure of specific development and manufacturing information that is confidential to the pharmaceutical company which owns a vaccine that is the result of significant research and investment of human, time and financial resources. The disclosure of this information would permit other pharmaceutical companies to benefit, for free, from the research and investments made by the pharmaceutical company which owns the relevant vaccine, effectively giving a competitive advantage to these other companies. The disclosure would, therefore, undermine the economic interest and competitive position of the marketing authorisation holder.

9. For the reasons set out above, EMA considered the information contained in the Quality data (Module 3) to constitute commercially confidential information. It stated that this conclusion is in line with the provisions of the 'HMA/EMA guidance document on the identification of commercially confidential information and personal data within the structure of the marketing authorisation application: Release of information after the granting of a marketing authorisation', especially Section 3.1 thereof, which provides that detailed quality and manufacturing information is commercially confidential. At the time of assessing the complainant's request for access to the Quality data (Module 3) for the relevant vaccine, the information that was considered commercially confidential by EMA was not, to the best of EMA's knowledge, already in the public domain.

10. In reply to the Ombudsman's question (iv), EMA stated that, following the Ombudsman’s inquiry, it had reassessed the Quality data (Module 3) in order to analyse whether partial access could be granted to this document. EMA stated that it had identified only two sections of Module 3 for which partial access could be considered: section 3.2.5.1 Active Substance - general information, and section 3.2.P.1- Description and composition of the drug product. However, following an individual and specific assessment of these sections, EMA came to the conclusion that almost all the information was commercially confidential. The information contained in those two sections that is not commercially confidential is already publicly available in the European Public Assessment Report ("EPAR") for the vaccine in question, which can be found on EMA's website. EMA had referred the complainant to this information on several occasions.

11. In his observations, the complainant disagreed with EMA's opinion and reiterated that he wished to be granted access to the complete OMCL production documentation and the Quality data (Module 3).

The Ombudsman's assessment

12. The complainant requested access to two types of documents: the Quality Data (Module 3) and the OMCL production documentation.

13. Regarding the Quality Data (Module 3), the Ombudsman notes that Marketing Authorisation dossiers submitted to EMA are composed of different sections, called “Modules”. The “Quality Data” Module (Module 3) contains information on the manufacturing process and the chemical composition of the product. Module 3 does not contain non-clinical or clinical data relating to the safety and efficacy of the product. This type of information is contained in Modules 4 and 5 of marketing authorisation dossiers.

14. Having read carefully the various communications from the complainant, the Ombudsman suspects that the complainant may have been misled by the term "Quality data", used to describe Module 3. This term may have misled the complainant into believing that Module 3 contained data relating to the safety of the product. The Ombudsman finds that it would have been citizen-friendly for EMA to have taken the initiative to clarify, in its first reply to the complainant, that the relevant information on the safety and efficacy of the product is contained in other sections of the Marketing Authorisation Dossier, but not in Module 3.

15. As regards EMA's refusal to grant the complainant full access to the Quality Data (Module 3), the Ombudsman notes that the documents contain data on how the product is produced and its chemical composition (see paragraphs 13 and 14 above). The Ombudsman accepts EMA's argument that the release of this information would allow a third party manufacturer to benefit from the research and investment of the relevant vaccine's marketing authorisation holder (such as a manufacturer of generics who might use that information to produce its own products). The disclosure of this information would therefore undermine the economic interest and competitive position of the marketing authorisation holder. Accordingly, the exception to public access set out in article 4(2) of Regulation 1049/2001 applies.

16. The Ombudsman considers EMA to have correctly identified sections 3.2.5.1 "Active Substance- general information" and "3.2.P.1- Description and composition of the drug product" as the only parts of the relevant documents containing information that could have been partially disclosed to the public without damaging the commercial interests of the relevant vaccine's marketing authorisation holder.

17. Regarding the possibility of granting partial access to the above information, it is necessary to take into account the administrative burden that the granting of such access would entail[1]. This is particularly the case when the granting of partial access would give so little information that it would be of no use to the applicant. In such a case, it is reasonable to consider partial access to be pointless^[2]. In the case at hand, the Ombudsman considers that the administrative effort required of EMA, in order to grant partial access to the few portions of the 1512-page document that is not covered by article 4(2) of Regulation 1049/2001, would have been disproportionate, particularly considering that partial access would have given information that is already publicly available in the European Public Assessment Report ("EPAR"), which is published on EMA's website in a much more understandable manner.

18. On the question of an overriding public interest, the Ombudsman considers that there are strong reasons for considering that an overriding public interest exists for the disclosure of Modules 4 and 5 of marketing authorisation dossiers since these Modules contain key information on the safety and efficacy of products. On the other hand, unless concerns exist regarding precisely how a product is made, there would not normally be any overriding public interest in obtaining access to Module 3 of marketing authorisation dossiers.

19. Regarding the documents relating to OMCL testing, EMA stated that it does not hold documents relating to OMCL testing and that it cannot, therefore, provide access to these documents. According to the relevant case-law, where an institution asserts that a particular document to which public access has been sought does not exist, there is a presumption that the document does not exist (unless this can be rebutted by the applicant with relevant and consistent evidence)[3]. The same applies by analogy to documents that the institution says it does not hold[4]. Given that the complainant has not put forward any argument questioning EMA's statement that it does not hold the documents concerned, its reply that it cannot give access to them must be accepted at face value.

20. On the basis of the above, the Ombudsman finds no maladministration by EMA in its handling of the complainant's request for access to documents.

Conclusion

On the basis of the inquiry into this complaint, the Ombudsman closes it with the following conclusion:

There has been no maladministration by EMA.

The complainant and EMA will be informed of this decision.

Emily O'Reilly

Strasbourg, 06/06/2016

 

[1] Judgement of the Court of First Instance of 19 July 1999 Hautala v Council T-14/98 ECLI:EU:T:1999:157 [paragraph 30]

[2] Judgement of the General Court of 20 March 2014 , Reagens v Commission T-181/10 ECLI:EU:T:2014:139 [paragraphs 172-175].

[3] Judgement of the General Court of 26 April 2005, Sison/Council, T-110/03, T-150/03 and T-405/03, ECLI:EU:T:2005:143 [paragraph 29].

[4] Judgement of the General Court of 19 January 2010, Co-Frutta/Commission, T-355/04 and T-446/04, EU:T:2010:15 [paragraph 155].

 

[1] http://www.europarl.europa.eu/RegData/PDF/r1049_en.pdf

[2] Judgment of the Court of first instance of 30 January 2008 Ioannis Terezakis v Commission of the European Communities T-380/04, ECLI:EU:T:2008:19, [paragraph 93]

[3] The European network of Official Medicines Control Laboratories is a network created in 1994 by the Council of Europe and the European Commission. Its aim is to support regulatory authorities in ensuring the quality of medicinal products for human and veterinary use available on the market - See more at: https://www.edqm.eu/en/General-european-OMCL-network-46.html#sthash.qj8bhEXn.dpuf