Background to the complaint

1. The complainant is a group of dairy farmers from the Netherlands whose cattle were, in the context of a mandatory vaccination campaign in the late 1990s, vaccinated against IBR[1]. According to the complainant, the vaccines they received were contaminated[2] and their cattle fell ill.

2. The complainant claims that, at that time, the European Medicines Agency (EMA) issued a CMVP[3] report, which suggested that mistakes had been made in the production process of the vaccines.

3. In July 2020, one of the complainants made a request for public access[4] to all documents underlying this CVMP report[5] to prove a causal link between the vaccine and the disease of their cattle. EMA replied that the request was placed in a queue and would be dealt with in chronological order from the time that it was received.

4. In May 2021, EMA informed the complainant that their public access request would shortly be dealt with.

5. In June 2021, EMA extended the time limit to reply to the complainant’s public access request. However, due to the very high workload of its ‘access to documents service’, EMA did not reply within this extended time limit and informed the complainant accordingly.

6. In July 2021, EMA released the first batch of documents to the complainant and refused access to the second batch of documents, arguing that their disclosure would harm the commercial interests of the pharmaceutical company.

7. Following the disclosure of the first batch of documents, the complainant contacted EMA with follow-up questions. In particular, the complainant wanted to know whether they could also receive public access to several attachments[6] that had been listed in one of the documents that EMA disclosed with the first batch.

8. EMA replied that the complainant would have to submit a new request for public access to the attachments listed in the disclosed document. EMA stated that it was currently operating under business continuity measures and that each public access request could not exceed two documents and that an applicant could have a maximum of five requests in the queue.

9. Dissatisfied with this reply, the complainant turned to the Ombudsman in December 2022.

The inquiry

10. The Ombudsman opened an inquiry. The inquiry focused on EMA’s practices of (i) queuing requests for public access to documents; and (ii) limiting the number of requests and the number of documents that individuals can request. The inquiry did not concern the complainant’s underlying public access request.

11. In the course of the inquiry, the Ombudsman asked EMA for a written reply on the complaint. In particular, the Ombudsman asked EMA to provide the legal basis for these two practices.[7] The Ombudsman shared EMA’s reply with the complainant, who did not provide comments.

Arguments presented to the Ombudsman

By the complainant

12. The complainant contended that individuals requesting access to documents (‘applicants’) may expect from a European agency, such as EMA, that it handle requests in their entirety and within a reasonable time.

13. The complainant argued that under EMA’s current two practices, it would take years to request and receive all the documents relevant to their case.

By EMA

On the ‘chronological queue’

14. EMA stated that it does not handle all requests for public access to documents immediately when it receives them. Rather, requests will be placed in a queue in the order in which they have been received (the ‘chronological queue’). The requests will then be handled on a ‘first-come first-served’ basis.

15. EMA clarified that, following a preliminary review of the scope of the requests, some of them will be processed immediately and not placed in the chronological queue. Requests will be prioritised for immediate processing, if they relate to

i. confirmatory applications;

ii. safety-related documents regarding ongoing/soon to start regulatory procedures;

iii. documents needed in connection with safety issues[8];

iv. documents in connection with litigation; or

v. documents that are not held by EMA.

The circumstances that allow for such a prioritisation are set out in EMA’s ‘Guide on access to unpublished documents’[9] (the ‘Guide’). EMA informs applicants in writing when their requests are placed in the chronological queue. If EMA subsequently, either on its own motion or following clarifications by the applicants, determines that the request should be handled immediately, it removes the request from the chronological queue.

16. EMA said that it introduced the practice of placing public access requests in a chronological queue in October 2019 as a temporary measure to safeguard its ability to perform its principal tasks related to the evaluation, supervision and pharmacovigilance of medicinal products. EMA explains this practice to applicants in its Guide.

17. EMA’s relocation from London to Amsterdam[10] and the COVID-19 pandemic kept EMA in a ‘business continuity status’ and undercut its capacity to start processing all requests for public access to documents upon receipt.

18. The relocation led to the resignation of staff[11], an increase in long-term leave and the loss of temporary agent workers[12]. The reduced resources led to an internal reallocation of staff, whereby several members of the ‘Documents Access and Publication Department’ were temporarily re-allocated to perform other core task activities related to marketing authorisation applications.

19. Following the COVID-19 pandemic, a significant number of resources were urgently shifted to activities related to the authorisation, supervision and pharmacovigilance of medicinal products related to the prevention or treatment of COVID-19. Several members of the public access team were re-allocated to perform tasks related to exceptional transparency measures for COVID-19 medicines and the management of requests for information. EMA stated that the requests for information almost doubled compared to the previous year.[13]

20. EMA considered that this practice of placing requests in the chronological queue is in line with the principle of proportionality[14], as it allows EMA to handle the numerous requests in a manner that takes into account its more urgent principal tasks and its available personnel. EMA explains this also to applicants in its policy on access to documents[15].

21. EMA stated that it is aware of the fact that effective access entails timely access. For this reason, EMA is actively exploring steps to reduce the chronological queue with the aim of reducing the reliance on it and ultimately phasing it out.

22. EMA stated that it has sought to reinforce its commitment towards proactive transparency and monitors and anticipates areas of work that may generate public interest from a public access to documents perspective. In particular, since October 2020, EMA has been publishing clinical data for COVID-19 medicines and has shared additional safety information on a regular basis in the form of monthly summary safety reports. Furthermore, EMA has identified the category of most frequently requested documents, which are ‘risk management plans’. Since September 2022, EMA has been proactively publishing these plans for centrally authorised products that contain new active substances and are considered to be of particular public interest. EMA considers that the implementation of these steps means that certain documents of major public interest are proactively made available, thus potentially reducing the number of requests for those documents. EMA said that the identification of documents that ought to be proactively published is an ongoing exercise.

23. EMA further stated that it has allocated additional interim administrative resources to the public access team to reduce the chronological queue. These resources are, however, only temporary and EMA will have to reconsider the matter of dedicating sufficient personnel to handle public access requests in its overall resourcing strategy, which is subject to the directives and approval of the European Commission.

24. EMA, together with external consultants, is also exploring the feasibility of additional measures that could potentially help reduce the chronological queue. In particular, EMA is considering the feasibility of a public register. However, the huge workload associated with a public register and other competing projects that are mandated by pharmaceutical law[16] complicate its implementation. In addition, EMA is reviewing its processes to optimise its efficiency. This includes the use of an automation tool that could help reduce the time needed to process a request for access to documents.

On the ‘5-2-rule’

25. In March 2021, EMA decided to limit the number of public access requests that applicants can make to five requests in the chronological queue at a given time. It also decided to limit the number of documents that an applicant can request to two documents per public access request.

26. EMA introduced these two limitations (the ‘5-2-rule’) to ensure a manageable flow of all requests from all applicants in a fair, timely and consistent way - in the context of the COVID-19 pandemic and the loss of staff due to its relocation to Amsterdam. This limitation has been applied to ensure fairness between all requesters, as, in EMA’s view, the same fair chance is offered to requesters to start processing their requests as soon as possible and to ensure they do not remain behind massive requests. EMA invites applicants to indicate the order in which they would like their requests to be processed. EMA explains this practice also in its Guide.

27. EMA stated that the basis for this practice rests on the principle of proportionality. It enables EMA to handle extensive numbers of requests that are submitted by a single applicant in a manner that does not undermine EMA’s principal tasks and that is consistent with the capacity of its available personnel. It also ensures fair treatment between applicants.

28. EMA said that it seeks to engage with applicants in a clear and transparent manner at all stages of the processing of the public access requests. It endeavours to ensure that applicants have all the necessary information to enable them to potentially clarify the scope of their requests. EMA’s public access team will take the initiative to contact applicants to understand better the scope of a request that concerns more than two documents.

29. EMA stated that it takes active steps to ensure that applicants know of the possibility to specify the documents and the requests they wish to receive. Upon receipt of a new request for public access from the same applicant, EMA will contact the applicant in writing to verify whether they wish to adjust the order of priority in which their requests will be processed. Exceptionally, EMA will make itself available for a phone or video call to provide clarifications to the applicant.

The Ombudsman's assessment

1. The ‘chronological queue’

30. Public access to documents is a fundamental right[17] that safeguards the transparency and legitimacy of the EU institutions. To ensure meaningful access, EU institutions should deal with all requests for public access as swiftly as possible.

31. According to the EU legislation on public access to documents (Regulation 1049/2001)[18], requests for public access should be handled “promptly”. Regulation 1049/2001 sets out a time limit of 15 working days for an institution’s decision, both on the initial access request and on requests for review where the institution has initially refused (full) access (a ‘confirmatory application’). Each time limit can be extended once, in “exceptional cases”, by another 15 working days, which means that EU institutions are expected to take a decision, at initial and at review stage, within a maximum of 30 working days. Failure to comply with the time limits laid down by the legislator cannot be good administration.

32. The Ombudsman has found in the past[19]  that, under certain circumstances, a queuing mechanism may constitute a “fair solution”[20] where the institution would otherwise have to refuse public access due to an excessive administrative burden. Specifically, the past cases concerned multiple requests for public access to documents made by a single applicant in close temporal proximity that could reasonably be considered as ‘one request’, the processing of which would entail an excessive administrative burden. The Ombudsman found that EMA has in such cases the right to seek a “fair solution” and that such a fair solution may entail the queuing of such multiple requests. In these specific circumstances, the Ombudsman considered that a queuing mechanism can be a viable instrument to ensure that as many individuals as possible can exercise their right of public access to documents and that all individuals are treated fairly and equally.

33. However, the Ombudsman considered that even in these specific circumstances the application of a queuing mechanism must comply with certain principles.[21] It should, first and foremost, not be applied automatically to every case of multiple requests made by the same applicant. Rather, the institution concerned should apply it in exceptional circumstances only. Furthermore, the queuing mechanism must be applied equally to all individuals requesting access to documents, and the institution concerned should give reasons in each case as to why it considers the application of the mechanism necessary. The institution should also properly inform applicants about how their requests will be handled and should allow them to (re-)determine in which order their multiple requests are processed. Moreover, the institution should continuously reassess its workload with a view to processing each request put in a queue as swiftly as possible. In cases where applicants do not agree to the queuing, the institution should also inform them about the possibility to propose an alternative solution.

34. The Ombudsman is aware of the increasing number and complexity of requests handled by EMA. She understands the challenges posed by this increase, together with the loss of staff and the need to re-allocate staff to perform other core tasks. The Ombudsman appreciates the efforts that EMA has undertaken to deal with all public access requests in a fair and transparent manner. She welcomes EMA’s commitment to proactive transparency and the steps EMA has taken to identify areas of work that may generate public interest.

35. This being said, the Ombudsman is very concerned that EMA now automatically places access requests in a queue, except where a first review shows that there are circumstances justifying immediate processing. These circumstances include if the request pertains to a confirmatory application, safety-related documents, documents claimed to be needed in connection with safety issues, documents requested in connection with litigation or documents not held by EMA. It appears that all other requests are placed in the chronological queue, independent of whether their processing would entail a disproportionate administrative burden that would allow EMA to seek a “fair solution”.

36. This practice cannot be good administration. It is also not in line with Regulation 1049/2001, in particular its requirement that access requests shall be handled “promptly” and, in any case, within the deadlines set out in that Regulation.

37. The Ombudsman recognises EMA’s awareness of the fact that “effective access entails timely access” and its related efforts to reduce the chronological queue with the aim of ultimately phasing it out. However, in view of her above assessment, the Ombudsman urges EMA to address this issue as a matter of priority in order to safeguard the fundamental right of public access to documents. She will ask EMA to report back by 30 March 2024 on the progress made.

2. The ‘5-2-rule’

38. EMA automatically and unilaterally restricts the number of documents individuals can request and the number of requests individuals can make to two documents per request and to five requests in the chronological queue at a given time. EMA considers that this ‘5-2 rule’ offers all applicants the same fair chance to have their requests processed as soon as possible and not to remain in the queue behind massive requests.

39. The Ombudsman is not aware of any statutory provisions or EU case-law that would allow an institution to limit automatically and unilaterally the number of documents applicants can request or the number of requests applicants can submit before even processing the request.

40. In accordance with Regulation 1049/2001[22] and EU case-law[23], an institution may exceptionally unilaterally restrict the scope of a request, if the following three cumulative conditions are met. First, the institution must show that the workload involved by the concrete, individual review of the documents requested, is unreasonable. Thus, an ‘unreasonable workload’ in general terms is not sufficient. Second, the institution must have attempted to consult with the applicant. Thirdly, the institution must have specifically considered alternatives to the specific and individual examination of the documents requested and must have concluded that these alternatives would be less favourable to the applicant or would also entail an unreasonable workload.

41. The Ombudsman takes the view that EMA’s ‘5-2-rule’ does not meet these three conditions. EMA does not start with an individual assessment of the documents requested until after it has already unilaterally limited the scope. While EMA contacts applicants to ask which two (out of several) documents are the subject of a request, it does not provide any other options to them.  

42. Limiting the number of requests to five in the chronological queue at a given moment and the number of documents to two documents per request is arbitrary. It does not take account of the length, complexity or total number of documents falling within the scope of individual requests, and thus the administrative burden involved in their processing.

43. Given the above considerations, the Ombudsman takes the view that the automatic and unilateral restrictions of the number of requests and the number of documents per request constitutes maladministration.

44. The Ombudsman would normally, in these circumstances, issue a recommendation. However, as set out in paragraph 37 above, EMA is actively exploring steps to reduce the use of the chronological queue with the aim of ultimately phasing it out. Given EMA’s commitment to phasing out this practice, the Ombudsman again asks EMA to report back by 30 March 2024 on the progress. The Ombudsman will then determine if she needs to pursue these matters on her own-initiative.

Conclusions

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

The practice of automatically placing certain categories of requests for public access in a chronological queue, independent of whether their handling would entail an excessive administrative burden, cannot be good administration.  

The practice of limiting the number of requests applicants can submit to five in the chronological queue and the number of documents to two documents per request constitutes maladministration.

As EMA is already taking proactive steps to phase out the practice of the chronological queue, the Ombudsman refrains from making a recommendation in this case and instead asks EMA to report back by 30 March 2024 on the progress made. The Ombudsman will then determine if she needs to pursue these matters on her own-initiative.

The complainant and EMA will be informed of this decision.

Emily O'Reilly
European Ombudsman

Strasbourg, 13/12/2023

 

[1] Infectious Bovine Rhinotracheitis is a highly contagious, infectious respiratory disease.

[2] The complainant claims that the vaccines were contaminated with ‘Bovine Virus Diarrhea’ and that they may have been contaminated with other pathogens as well.

[3] The Committee for Veterinary Medicinal Products, is the committee, within EMA, that is responsible for veterinary medicines. It plays a vital role in the authorisation of veterinary medicines within the EU. More information available at: https://www.ema.europa.eu/en/committees/committee-veterinary-medicinal-products-cvmp#:~:text=The%20Committee%20for%20Veterinary%20Medicinal,Use%20before%2028%20January%202022.

[4] Under Regulation 1049/2001 regarding public access to European Parliament, Council and Commission documents; https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32001R1049.

[5] ‘EMA/CMVP/768/99.

[6] One of the documents disclosed referred to over 60 documents that were not disclosed.

[7] The Ombudsman addressed six specific questions to EMA; available at: https://www.ombudsman.europa.eu/en/case/en/63009

[8] Such documents are principally requested by patients or healthcare professionals.

[9] Available at: https://www.ema.europa.eu/en/documents/other/guide-access-unpublished-documents_en.pdf

[10] Following the withdrawal of the United Kingdom from the European Union, EMA relocated its headquarters from London to Amsterdam.

[11] EMA said that 56 members of staff left the agency.

[12] These temporary agent workers had a contract with an UK-based recruiter and not with EMA directly.

[13] In 2020, EMA received 7055 requests for information and in 2021, EMA received 12500 requests for information.

[14] In this context, EMA also refers to the opinion of Advocate General Kokott in case C-139/07 P, Commission v Technische Glaswerke Ilmenau, para 67; available at: https://curia.europa.eu/juris/document/document.jsf?text=&docid=77075&pageIndex=0&doclang=EN&mode=req&dir=&occ=first&part=1&cid=195736

[15] Available at: https://www.ema.europa.eu/en/documents/other/draft-policy/0043-european-medicines-agency-policy-access-documents_en.pdf

[16] Such as the creation of a European shortages monitoring platform.

[17] The right to access documents held by the EU institutions is enshrined in Article 15 of the Treaty on the Functioning of the European Union (https://eur-lex.europa.eu/eli/treaty/tfeu_2016/art_15/oj) and also recognised in Article 42 of the Charter of fundamental Rights of the EU (https://eur-lex.europa.eu/eli/treaty/char_2012/oj)

[18] Regulation 1049/2001 regarding public access to European Parliament, Council and Commission documents; available at: https://eur-lex.europa.eu/eli/reg/2001/1049/oj

[19] See Ombudsman’s decision in case 1608/2017/MIG on the European Medicines Agency’s handling of multiple requests for public access to documents made by a single applicant and its extension of deadlines; available at: https://www.ombudsman.europa.eu/en/decision/en/111254; and decision in case 2067/2020/MIG on the European Border and Coast Guard Agency’s (Frontex) handling of multiple requests for public access to documents made by a single applicant; available at: https://www.ombudsman.europa.eu/en/decision/en/143154

[20] In line with Article 6(3) of Regulation 1049/2001.

[21] See Ombudsman’s decision in case 2067/2020/MIG on the European Border and Coast Guard Agency’s (Frontex) handling of multiple requests for public access to documents made by a single applicant; available at: https://www.ombudsman.europa.eu/en/decision/en/143154

[22] Article 6(3).

[23] T-597/21, Basaglia v Commission, para 57; https://curia.europa.eu/juris/document/document.jsf?text=&docid=271304&pageIndex=0&doclang=FR&mode=req&dir=&occ=first&part=1&cid=2872359