Background to the complaint

1. The European Medicines Agency (EMA) is the EU agency responsible for the scientific evaluation, supervision and safety monitoring of medicines. In 2021, EMA launched a pilot project to support the repurposing of medicines.[1] The aim of the pilot project is to support not-for-profit organisations and academia to gather or generate sufficient evidence for the use of an established medicine in a new indication with the view to have this new use formally authorised by a regulatory authority. This is a way of making new treatment options available to patients.

2. The complainant contacted EMA about this project in May 2023, by e-mail, but did not receive a reply. In July, he used the online form on EMA’s website to ask about the state of play of the pilot project, when its results would be published, and if EMA could send him a list of the drug repurposing submission forms that it received.

3. EMA replied in August 2023 that it could not disclose this information as the pilot was still ongoing. It said that it would publish a report on the pilot once it is concluded. Dissatisfied, the complainant asked EMA to reconsider its refusal to disclose the list of the drug repurposing submission forms (by making a “confirmatory application” under the EU legislation on public access to documents, Regulation 1049/2001[2]).

4. On 11 September 2023, EMA contacted the complainant to clarify whether he was interested in receiving all repurposing submission forms submitted to EMA or a list of candidate products and indications. The complainant clarified that he was seeking access to a list of candidate products and indications.

5. EMA extended the deadline to reply to his confirmatory application twice. It adopted its confirmatory decision on 31 October 2023, that is, 11 days after the legal deadline for replying had expired.

6. In its reply, EMA granted partial access to the requested document, which contains a list of 35 candidate products and indications. EMA explained that the information provided in the document originates from third parties. After consulting those third parties, EMA decided that certain information in the document need to be redacted in order to protect the commercial interests of the consulted third parties. As a result, EMA redacted the names and therapeutic indications of five medicinal products.

7. Dissatisfied with how EMA had handled his request for public access to the document, the complainant turned to the Ombudsman on 22 November 2023.

The inquiry

8. The Ombudsman opened an inquiry into EMA’s refusal to provide full public access to the requested document, as well as the time taken by EMA to handle the complainant’s request.

9. In the course of the inquiry, the Ombudsman inquiry team inspected the document in question, and the documents related to the consultation with third parties. It also received EMA’s additional views on the complaint.

Arguments presented to the Ombudsman

The decision by EMA to refuse access to five medicinal products and their indications

10. EMA explained that the document requested includes a list of candidate products and indications, which originates from information provided by third parties. EMA consulted those third parties. While a majority of them agreed to disclosure, some failed to reply to the consultation and others objected to disclosure.

11. Following this consultation, EMA carried out its own assessment to establish whether access to the information could entail the disclosure of commercially confidential information received from these third parties. It concluded that information in relation to five medicinal products and their indications was commercially sensitive.[3] EMA explained that the information in question is not in the public domain and that its disclosure could seriously undermine the current and future economic interests of the concerned parties, linked to their investments in developing repurposing candidates, in connection with the prospective commercial viability of the candidate products.

12. In its reply to the Ombudsman, EMA further explained how it had carried out its assessment of the relevant medicines and indications. In line with its definition of “commercially confidential information”,[4] EMA assessed whether a link between the candidate products and the proposed indications had been sufficiently well established in clinical practice or in scientific literature regarding every candidate project for which a third party had not provided a reply in the context of the consultation.

13. EMA also explained that it had assessed whether there was a public interest that could be deemed more important than the need to protect the commercial interests of third parties. It did not identify any benefits that could arise from the release of commercially sensitive information in the requested list that would not be outweighed by the disadvantage that the third parties would suffer, in terms of disclosing their development plans and jeopardising the commercial viability of those projects. EMA said that, due to an administrative oversight, it failed to add this assessment in the confirmatory decision. In its reply to the Ombudsman, EMA said it would pay attention in future so that similar omissions would not reoccur.

14. The complainant considered that EMA had not explained in sufficient detail why, out of 35 products and indications, five had been redacted. After the opening of the inquiry, the complainant questioned how the redacted information could be commercially sensitive. He said that all products which are part of the pilot project had to “be an authorised medicine (containing the concerned active substance) out of data exclusivity and market protection periods and out of basic patent / supplementary protection certificate (SPC) protection”.[5] According to him, this meant that information related to the products should be in the public domain.

15. The complainant also noted that the pilot project was intended to support not-for-profit organisations and academia. In this sense, he found EMA’s arguments that disclosure would undermine the economic interests of the concerned parties, linked to their investments and commercial viability, to be flawed.

The time taken by EMA to handle the complainant’s request

16. The complainant said in his complaint that he had initially contacted EMA with a question on the pilot project to support the repurposing of medicines in May 2023, but never received a reply. He then contacted EMA again in July 2023 and, following EMA’s refusal to disclose the information requested, made a confirmatory application in August. EMA replied to his confirmatory application on 31 October and he did not receive the redacted document until 21 November. The complainant argued that this constitutes a delay of over six months.

17. EMA explained that, when the complainant initially contacted the agency in May 2023, he used an old e-mail address that EMA was no longer monitoring. Unfortunately, this meant that his e-mail was not processed.

18. When the complainant contacted EMA again in July, he used the contact form available on EMA’s website, which offers two options to visitors: “I want you to answer a question” and “I want an unpublished document”. The complainant chose the former. EMA therefore processed his request as a request for information, for which EMA set itself a time limit of two months to respond.

19. EMA said that, as soon as the complainant explicitly said that he wanted to file a confirmatory application under the EU legislation on public access to documents, it handled the request under the relevant rules, which set stricter time limits.[6]

20. On 11 September 2023, EMA requested the complainant to clarify the scope of his request. EMA acknowledged that the request for clarification occurred three weeks after the complainant’s confirmatory application. EMA explained that the delay was due to the fact that it had initially handled the complainant’s message as a request for information, which caused EMA to react less expeditiously than usual. In addition, EMA explained that it had to carry out an internal consultation in order to obtain more information on the status of the pilot project. EMA said that it provided this information to the complainant at the same time as the request for clarification.

21. EMA recognised that, in this case, it exceeded the time limits provided for under the EU legislation on access to documents by 11 days.

22. Finally, EMA explained that it had to wait 10 working days before disclosing the document after replying to the complainant’s confirmatory decision. EMA’s practice[7] is to provide the concerned third parties with an opportunity to make use of available remedies to secure effective judicial protection if a document they objected the disclosure of is nevertheless disclosed by EMA. EMA clarified that it had informed the complainant about this.

The Ombudsman's assessment

23. The Ombudsman inquiry team inspected the document at issue, which is a table comprising 35 rows and two columns. The first column contains the names of the candidate products in the pilot project, and the second column contains the indications of repurposing. The inquiry team also inspected the exchanges between EMA and the consulted third parties. The Ombudsman notes that, out of 35 third parties contacted, 20 agreed to disclose the name of their drug and its proposed indication. Three third parties objected to disclosure and twelve third parties did not reply to EMA’s consultation.

24. The inspection of documents confirmed that EMA had checked the available scientific literature for each product in relation to which it had doubts as regards a possible disclosure. EMA recorded its assessment for each product. The inspection also showed that EMA engaged with some of the third parties, in an effort to ensure the widest possible transparency.

25. Based on the consultations and its own assessment, EMA decided to redact the names and indications of five products on the list. EMA’s detailed explanations as to how disclosure of information related to these products could undermine the commercial interests of the third parties concerned appear reasonable. In view of this, the Ombudsman finds that EMA’s decision to rely on the exception for the protection of commercial interests was justified.

26. As regards the complainant’s argument that, as not-for-profit actors, the third parties concerned do not, or should not, have any commercial interests in repurposing medicinal products, the Ombudsman notes that the commercial interests exception can apply to “a natural or legal person”, irrespective of whether that person engages in commercial activities or not.[8]

27. The exception for the protection of the commercial interests of a third party must be set aside if there is a public interest in disclosure that is deemed more important.[9] In this case, the Ombudsman finds it regrettable that EMA did not explain in the confirmatory decision that it had balanced the public interest in disclosure against the commercial interests involved. EMA clarified, in its reply to the Ombudsman, that it had carried out this assessment and had found no overriding public interest in disclosure. The Ombudsman finds EMA’s clarification in this regard convincing, and trusts that EMA’s administrative oversight will not reoccur.

28. As regards the time taken by EMA to process the complainant’s access request, the Ombudsman understands the complainant’s concern that it took EMA a long time to reply to it. Having reviewed the supporting documents and the additional explanations provided by EMA, the Ombudsman understands that there was a series of unfortunate circumstances in this case, including the complainant’s initial use of an outdated email address and EMA’s initial categorisation of his request as a request for information, that led to delays.

29. The Ombudsman notes that, as soon as the complainant made a confirmatory application under Regulation 1049/2001, EMA handled the request under the relevant rules.

30. That said, it still took EMA three weeks to ask the complainant to clarify his request. The Ombudsman considers that, in general, it is good administrative practice for EU institutions to request clarification as soon as they realise, within a reasonable period of time (2-3 working days) after receiving a request, that the request is imprecise.[10] In this case, it took EMA longer to seek the necessary clarifications. Furthermore, EMA exceeded the extended time limit to reply to the complainant’s request by 11 days.

31. These delays are regrettable. The Ombudsman reiterates her view that failure to comply with the time limits laid down by the legislature cannot be good administration.[11] However, given that the Ombudsman has recently drawn EMA’s attention to the importance of dealing with public access requests as swiftly as possible, and is awaiting EMA’s follow-up reply to that case,[12] no further inquiries in this case are justified.

Conclusions

Based on the inquiry, the Ombudsman closes this case with the following conclusions[13]:

There was no maladministration by EMA when it refused public access to the five medicinal products and indications at issue.

No further inquiries are justified on the time taken by EMA to handle the request for public access to the document in question.

The complainant and EMA will be informed of this decision.

 

Rosita Hickey
Director of Inquiries

Strasbourg, 24/01/2024

 

[1] More information on the pilot project is available on EMA’s website at: https://www.ema.europa.eu/en/news/repurposing-authorised-medicines-pilot-support-not-profit-organisations-and-academia

[2] Regulation 1049/2001 regarding public access to European Parliament, Council and Commission documents: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32001R1049. Regulation 1049/2001 is applicable to EMA as laid down in Article 73 of EMA’s founding regulation (Regulation (EC) No 726/2004).

[3] In accordance with Article 4(2) first indent of Regulation 1049/2001.

[4] Set out in EMA’s Guidance Document on the Identification of Commercially Confidential Information and Personal Data, available at: https://www.ema.europa.eu/en/documents/other/heads-medicines-agencies-european-medicines-agency-guidance-document-identification-commercially-confidential-information-and-personal-data-within-structure-marketing-authorisation-application_en.pdf.

[5] The complainant referred, as a source, to EMA’s website: https://www.ema.europa.eu/en/news/repurposing-authorised-medicines-pilot-support-not-profit-organisations-academia

[6] 15 working days from registration of such an application. The time limit may be extended by an additional 15 working days in exceptional cases. See Article 8 of Regulation 1049/2001.

[7] EMA’s practice is set out in the agency’s policy on access to documents (POLICY/0043), paragraph 5.7 of the Annex, page 11, available at: https://www.ema.europa.eu/en/documents/other/policy-43-european-medicines-agency-policy-access-documents_en.pdf

[8] See the wording of Article 4(2) first indent of Regulation 1049/2001. See also the judgment of the General Court of 21 October 2010, Agapiou Joséphidès v Commission and EACEA, case T-439/08, concerning the commercial interests of a public university, available at: https://curia.europa.eu/juris/liste.jsf?language=en&num=T-439/08.

[9] According to Article 4(2) of Regulation 1049/2001.

[10] See the Ombudsman’s Recommendation on practices Frontex has in place for dealing with requests for access to documents (case OI/04/2022), paragraph 27, available at: https://www.ombudsman.europa.eu/en/recommendation/en/170366

[11] See the Ombudsman’s Special Report in case in her strategic inquiry concerning the time the European Commission takes to deal with requests for public access to documents (case OI/2/2022/OAM), paragraph 6, available at: https://www.ombudsman.europa.eu/en/special-report/en/175425

[12] Decision on how the European Medicines Agency (EMA) deals with requests for public access to documents (case 2243/2022/SF), available at: https://www.ombudsman.europa.eu/en/decision/en/179137

[13] This complaint has been dealt with under delegated case handling, in accordance with the Decision of the European Ombudsman adopting Implementing Provisions, available at: https://www.ombudsman.europa.eu/en/legal-basis/implementing-provisions/en#hl10