The background to the complaint

1. The complaint concerns refusals of the European Medicines Agency (EMA) to grant access to various documents.

2. The complainant, Prescrire, is a non-profit continuing education organisation operating in the healthcare sector. Amongst its activities, the complainant provides independent scientific information to healthcare professionals. This includes providing systematic reviews of medicines. It bases these reviews on data collected from a variety of sources, including drug regulatory agencies such as EMA.

3. The complainant states that between 2005 and 2010, it submitted 142 requests for public access to documents or information to EMA. It states that EMA refused to grant access to many of the requested documents, or redacted much of what it eventually sent. The complaint concerns what the complainant considers the five most "unacceptable" cases of refusal to grant access.

The subject matter of the inquiry

Allegation

4. The complainant alleges that the European Medicines Agency wrongly refused to release documents in response to five requests for public access to documents, namely:

- A Reference Member State assessment report on the risk management plan for rimonabant[1];

- Periodic Safety Update Reports (PSURs)[2] held by EMA concerning a number of medicines;

- Mock-up packaging for medicines, held by EMA[3];

- A rapporteur's report and a co-rapporteur's report on the dextropropoxyphene[4] and paracetamol combination;

- A co-rapporteur report related to topical ketoprofen[5].

Claim

5. EMA should provide the complainant with public access to the documents requested.

The inquiry

6. The complaint was made on 30 August 2010.

7. EMA sent its opinion to the Ombudsman on 31 January 2011. The complainant submitted its observations on 30 March 2011.

The Ombudsman's analysis and conclusions

A. Allegation that EMA wrongly denied access to the requested documents

Arguments presented to the Ombudsman

A Reference Member State assessment report on the risk management plan for rimonabant

8. On 18 September 2008, the complainant requested EMA to provide it with diverse documents relating to rimonabant. Amongst these, the complainant requested documents relating to a risk management plan for rimonabant.

9. By email dated 23 September 2008, EMA informed the complainant that it required clarifications regarding the request for documents relating to a risk management plan for rimonabant.

10. The complainant replied that it sought access to "all other documents (non identified by us) made in relation with the risk management plan which contains safety data (sic)".

11. In response to the complainant's attempts to clarify its request, EMA identified what it claims were the relevant documents. Amongst others, in its email of 24 September 2008, it referred to "assessment reports on risk management plan and/or PSUR"

12. The complainant then clarified its request as being for access to "the assessment reports on risk management plan" and "all the PSURs for Acomplia[6]".

13. On 16 October 2008, EMA wrote to the complainant about its request for "all documents related to the Risk Management Plan for rimonabant."

14. EMA stated that it had decided to grant partial access to a document in response to the complainant's request for assessment reports on the Risk Management Plan. The document sent to the complainant was entitled "Acomplia/Zimulti, EU/1/06/344/001-009, Final Assessment Report ..."[7]. The letterhead of the document indicates that it was submitted to EMA by the Swedish national regulatory authority (Sweden acted as Reference Member State in the assessment procedure). It consists of 68 pages, of which 65 were fully redacted by EMA. Certain information was also redacted from the 3 pages to which the complainant was granted access. EMA justified the redaction of the 3 pages by simply stating that "confidential information was redacted."

15. In response, the complainant sent a confirmatory application, in which it asked EMA to reconsider its decision to redact extracts of the assessment reports on the Risk Management Plan.

16. In reply, EMA noted that the requested assessment reports "were part of wider documents, the PSUR assessment reports." EMA asked the complainant to clarify whether it also wanted access to the PSUR assessment reports, given that they did not form a part of the original request. As regards the information redacted from the 3 pages to which the complainant was granted access, EMA repeated its statement that confidential information had been redacted.

17. In its complaint to the Ombudsman, the complainant refers to the refusal of EMA to grant access to a fully legible version of the Swedish Report and its failure to give a clear justification for each deleted part of the report[8].

18. In its opinion sent to the Ombudsman, EMA notes that the assessment reports on the Risk Management Plan for Acomplia were contained in only a few paragraphs of a 68-page document. The reason for the extensive redaction of all other information contained in the document, including the date, was that the redacted information contained the assessment reports on diverse PSURs. EMA notes that the complainant had not requested access to PSURs.

19. EMA recognises that the redaction of all parts of the document not considered "relevant" by EMA is open to criticism. In particular, it acknowledges that the complainant was not made fully aware of the justifications for the redactions.

20. In its observations, the complainant considers EMA's redaction of much of the document difficult to justify.

21. The complainant also highlights the difficulties of requesting documents from EMA. In this particular instance, it notes that it was offered "assessment reports on risk management plan and/or PSUR". The complainant states that it originally thought that this referred to two documents: an "assessment report on risk management" and a document relating to "PSURs". This explains why it requested "all PSURs" and an "assessment report on risk management plan". The complainant stresses that it did not intend to refuse the "assessment report on PSUR", since it had asked for the entire document in its initial request.

22. The complainant notes that no public register lists the documents produced and held by EMA regarding the Risk Management Plan for rimonabant. This meant that it was obliged to trust that EMA would identify the relevant document.

23. The complainant therefore regrets that EMA does not currently provide public access, through its website, to a comprehensive register of all the documents it produces and receives.

24. The complainant also notes that it did not respond to EMA's further request for clarifications since a committee of EMA, the Committee for Human Medicinal Products (CHMP)[9], had recommended the suspension of the marketing authorisations for rimonabant a few days earlier. The complainant therefore decided to terminate what it considered to be a time-consuming and highly unproductive exchange with EMA.

Periodic Safety Updated Reports (PSURs)

25. The complainant states that it requested access to PSURs concerning rimonabant (see paragraph 13 above), telithromycin, memantine and ivabradine. All requests were denied on the grounds of the protection of commercial interests under Article 4(2), first indent of Regulation 1049/2001.

26. The complainant stresses the importance of obtaining information on medicines for all parties involved in health care, including patients.

27. The complainant notes that, according to EMA's rules, documents relating to clinical data cannot be considered confidential. It states that information about the adverse effects of drugs is scientific data, and EMA has no right to deny access to healthcare professionals.

28. In the opinion of EMA received by the Ombudsman, it notes that at the time of the request, the PSURs were considered to be confidential documents originating from marketing authorisation holders, and received by EMA in accordance with Article 24(3) of Regulation 726/2004. The requests for public access to the PSURs were thereby refused on the basis of Article 4(2), first indent of Regulation 1049/2001. EMA states that is has since revised its interpretation of Article 4 of Regulation 1049/2001, particularly with regard to documents originating from pharmaceutical companies in the framework of marketing authorization procedures. This includes PSURs. EMA notes that the complainant is aware of the new policy regarding requests for access to PSURs.

29. In its observations sent to the Ombudsman, the complainant notes that there has been a long history of refusals of access to PSURs. It also states that when it received its first public access to a PSUR, relating to travoprost, it only received half the PSUR. It later received the other half. EMA justified this as an oversight.

30. The complaint considers that EMA should make all drug PSURs available online immediately. It notes that EMA will continue to receive many requests, since the information about adverse effects (available online in the Summary of Product Characteristics and in EMA's "Steps taken after granting authorisation" tables) is too brief to enable independent drug evaluation teams to assess causality.

Mock-up packaging

31. On 23 April 2009, the complainant requested access to the colour mock-ups of packaging used for telbivudine[10] (including the primary and secondary packaging and leaflet). On 5 June 2009, EMA refused to grant access. It based its refusal on the need to protect commercial interests under Article 4(2), first indent of Regulation 1049/2001. The complainant resubmitted its request on 9 June 2009, which EMA again refused on 2 July 2009, citing the same reasons.

32. The complainant states that its reason for requesting the mock-ups is that well-designed packaging helps to minimise medication errors.

33. In its opinion, EMA notes that the mock-ups requested are presented at the time of submission of a marketing authorisation application, as part of the technical dossier. In accordance with published Guidelines on The Revised Checking Process of Mock-ups and specimens of outer immediate labelling and package leaflets of human medicinal products in the Centralized procedure,[11] "mock-ups must be submitted by the applicant/marketing authorisation holder to [EMA] for review, before commercialisation of the medicinal product." EMA then provides the applicant with an Opinion on the mock-ups received. After receiving an Opinion from EMA, the applicant is "responsible for the correct implementation of the agreed product information texts in their printed packaging materials, in line with the Commission Decision and relevant EU legislation".

34. EMA thereby highlights that the "mock-ups" presented by the applicant at time of filing the marketing authorisation application might not correspond to the commercialised packaging materials, and therefore might not be publicly available. Furthermore, they might contain information on colouring options and other design elements considered proprietary material.

35. In its observations, the complainant notes that packaging is crucial to the correct and safe use of drugs. It noted that, along with other interested parties, it works to shed light on numerous features of packaging that can create confusion between drugs and can cause medication errors. It points out that some packaging is dangerous.

36. The complainant recognises that EMA publishes the marketing authorisation annexes, pertaining to labelling and the package, on its website. However, this does not allow examination of the drug packaging itself. Furthermore, the public has no access to the results of the EMA's examination of packaging items, or to the results of the readability checks carried out on package leaflets.

37. The complainant clarifies that it does not desire access to packaging that predated the market introduction of the drug, but requests the most recent version held by the EMA. The complainant assumed EMA would have packaging materials from after the market introduction of the drug. After reading the Revised Checking Process of Mock-ups and specimens of outer immediate labelling and package leaflets of human medicinal products in the Centralized procedure, the complainant notes that it should have requested copies of the specimens[12] submitted to EMA, rather than the mock-ups.

38. In any event, the complainant believes EMA could have been more explicit in its explanations. It also suggests that EMA could have provided a photograph of the specimens EMA held, or a colour copy of the sides of the box and the blister labelling.

Rapporteur and Co-Rapporteur reports on the dextropropoxyphene and paracetamol combination

39. On 16 April 2009, the complainant requested access to the Rapporteur and Co-Rapporteur reports from the referral procedure involving the dextropropoxyphene and paracetamol combination. EMA responded on 8 May 2009, refusing to grant access on the grounds stating simply that, "[a]ccess to a document... which relates to a matter where the decision has not been taken, shall be refused if disclosure of the document would seriously undermine the decision-making process, unless there is an overriding public interest in disclosure." Furthermore, EMA started that it could not identify any overriding public interest in favour of disclosure.

40. The complainant notes that on 14 June 2010, the Commission endorsed a CHMP recommendation to withdraw the marketing authorisation for products containing dextropropoxyphene for safety reasons. The complainant notes that the procedure leading to this took more than 800 days. It argues that marketing authorisations should, in such circumstances, be revoked within 15 months.

41. On 29 August 2010, the complainant requested the documents again.

42. EMA granted access to the Co-Rapporteur and Rapporteur reports on 19 October 2010, as soon as the Commission issued a final decision on the referral procedure. EMA submits that it was justified to refuse access before this point in time, for the reasons outlined above.

A Co-Rapporteur report related to topical ketoprofen

43. The Ombudsman considers it useful to first set out the relevant factual background to this aspect of the complaint. Article 107 (2) of Directive 2001/83/EC provides that when EMA is informed of suspensions or revocations of marketing authorisations adopted at national level, the CHMP shall prepare an opinion. A decision made by the competent French authority (Afssaps), to suspend the marketing authorisation of all topical medicines containing ketoprofen in France, triggered this procedure of review by the CHMP. Whilst the CHMP prepared its opinion, a marketing authorization holder challenged the decision of Afssaps before the French courts. In this context, it should be noted that marketing authorization holders, whose products are subject to the Article 107 procedure, are provided with copies of the CHMP Rapporteur and the Co-Rapporteur reports, so as to enable them to exercise their right to be heard. One of the applicants in the judicial proceeding before the French courts appears to have used a document, received in the framework of this on-going referral procedure, to challenge the decision of Afssaps. As a result, the competent French court (the Conseil d'Etat) mentioned the Co-Rapporteur's assessment in its judgment (the court noted that the Co-Rapporteur felt the risk-benefit balance remained unchanged). The complainant became aware of this assessment when it read the judgment of the Conseil d'Etat. On 25 February 2010, the complainant requested that EMA grant it access to the Co-Rapporteur Assessment Report on topical ketoprofen, produced in the framework of a procedure under Article 107 of Directive 2001/83/EC.

44. EMA responded on 17 March 2010, refusing access on the grounds that the relevant decision-making process was ongoing. EMA considered the Co-Rapporteur Assessment Report and the Rapporteur Assessment Report preparatory acts, which did not constitute the final position of the scientific committee. EMA further noted that the document requested would become accessible once the Commission adopts a Decision for this referral procedure.

45. According to the complainant, there has long been evidence that ketoprofen gels are more harmful than beneficial to patients with mild disorders, and that less dangerous therapeutic alternatives exist. The complainant therefore requested the Rapporteur and Co-Rapporteur reports, in order to enhance its understanding of this issue and to explain EMA's conclusions to its readers.

46. The opinion that EMA sent to the Ombudsman states that it considers the decision to deny access to the documents justified. At the time that the request was made, the Article 107 referral procedure was still pending, and the documents were considered a preparatory act. It thereby refused access on the grounds of the preparatory nature of the document, combined with the fact that it formed part of an ongoing procedure.

47. EMA stresses that its refusal only remained in force while the procedure was ongoing. Therefore, it argued that there was no negative impact on the transparency of the process, as the documents became accessible as soon as a decision was taken.

48. In its observations, the complainant submits that waiting for the Commission's decision is unacceptable and simply another means of avoiding transparency. Furthermore, it claims that EMA's attitude towards its request detracts from its remit to safeguard public health. It states that topical ketoprofen remains available in Europe, which exposes patients to serious risks, without providing any particular advantage when compared with other drugs of the same therapeutic group.

The Ombudsman's assessment

49. The Ombudsman has repeatedly emphasised the importance of openness and transparency for EU institutions, bodies, office and agencies. EU administrative bodies will only enjoy greater legitimacy amongst citizens if they are open and transparent. A culture of transparency enables EU citizens to verify that decisions of the EU public administration are taken in the public interest. It also empowers citizens to participate more closely in EU decision-making. Public access to documents held by the EU institutions, bodies, office and agencies are essential components of openness and transparency, as such access empowers citizens to monitor, and scrutinise effectively, the exercise of their powers. In this context, it should be noted that the right of access to documents is now enshrined as a right under the Treaties and the Charter of Fundamental Rights[13].

50. When the actions of an EU institution, body, office or agency directly affect the interests of citizens, it is particularly important to enhance legitimacy by promoting a culture of openness and transparency[14]. This applies with particular force to EMA. EMA's decisions relating to the authorisation and supervision of medicines for human use, including the decisions relating to the safety and efficacy of such medicines, directly or indirectly affect all EU citizens.

51. The openness and transparency of EMA also serves to foster scientific discussion and progress, by enabling independent scientists to scrutinise the conclusions of EMA, and the data and arguments taken into consideration by EMA when reaching those conclusions.

52. Regulation 1049/2001 governs access to documents held by EMA[15]. Regulation 1049/2001 grants the widest possible access to documents. Any attempt to restrict this must be justified by one of the exceptions to the right of access contained in Article 4 of Regulation 1049/2001. These exceptions protect defined, objective public and private interests.

53. Exceptions to the right of access to documents must be strictly interpreted.[16] The mere fact that a document concerns an interest protected by an exception is not in itself sufficient to justify the application of that exception[17]. A refusal to grant access to a document is only justified if access undermines the protected interest[18]. The risk that the protected interest will be undermined must be reasonably foreseeable, and not purely hypothetical[19].

54. Even if it is determined that access to a document will undermine a protected interest, access must still be granted if there is an overriding public interest justifying disclosure of the document concerned.

55. The reasons set out in a decision refusing access to documents must prove that the above analysis took place.

56. The Ombudsman now turns to consider each aspect of the complaint.

Periodic Safety Update Reports (PSURs)

57. The Ombudsman notes that at the time of the requests for public access to the PSURs described by the complainant, EMA treated the PSURs as confidential documents. EMA has since revised its interpretation of Article 4 of Regulation 1049/2001, in particular with regard to documents originating from pharmaceutical companies in the framework of marketing authorization procedures. This includes public access to PSURs. Indeed, it appears from the observations of the complainant that it can now obtain copies of PSURs.

58. The Ombudsman commends EMA for changing its practice as regards public access to PSURs, which serves an important public interest. She notes that PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product. In order to ensure the effectiveness of EMA's pharmacovigilance role, it is vital that PSURs are accurate and complete, and that EMA's analysis of them is correct. As EMA's present willingness to make PSURs available to the public allows for third party scrutiny of PSURs, and the EMA analysis thereof, public trust in EMA is reinforced. When carrying out the important tasks assigned to it, EMA now enjoys greater legitimacy.

59. While the Ombudsman considers that EMA was not justified in refusing access to PSURs at the time that the requests for public access were made, in light of its new legal interpretation, which allows for access to PSURs, the Ombudsman accepts that EMA has settled this aspect of the complaint. [20]

Mock-up packaging and specimen packaging

60. The Ombudsman notes that the safe and correct use of all medicines depends (amongst other factors) on users reading the labelling and packaging accurately, and being able to understand and act on the information provided. The primary purpose of labelling and packaging should be the clear, unambiguous identification of the medicine and the conditions for its safe use. Important information for safe use of the medicine must be legible, and clearly mentioned on the packaging and in the leaflet, so that confusion and medication errors are minimised. In terms of the public interest, it is important that third parties can review the packaging of medicines for human use, as well as the analysis of EMA in relation to that packaging.

61. However, this public interest is served only in relation to the packaging that is actually used to market a product. It is not necessarily served by granting access to provisional mock-ups of packaging. In this context, it should be noted that applicants for marketing authorisations must provide an English and multi-lingual colour "mock-up" of outer and immediate packaging for each pharmaceutical form in each container type (for example, blister, bottle, vial, pen ...). Mock-ups must also be provided for each strength or for each different total content per total volume. As far as possible, applicants should submit mock-ups which are considered final drafts. However, EMA may provide applicants with provisional comments on the mock-ups, which the applicant should take into account when further developing its packaging proposals. The mock-ups will subsequently be reviewed in detail by the EMA, in parallel to the scientific assessment, and any comments about the mock-ups will be sent to the applicant. The above analysis highlights the fact that mock-ups originally presented to EMA do not necessarily reflect the eventual packaging used to market a product.

62. In contrast, marketing authorisation holders are required to provide EMA with a set of relevant example "specimen" of outer and immediate packaging and package leaflet for review, at the latest 15 working days before their launch. Applicants should allow sufficient time for the review process of specimens, including any subsequent changes which may exceptionally have to be introduced to the specimens before launch. Therefore, EMA will receive and review a set of specimens for each different product presentation before their first introduction to the EU market.

63. The Ombudsman agrees that there may be an impact on the commercial interests of a marketing authorisation holder if mock-ups, which are not eventually used when marketing the product, are disclosed to the public. Such disclosure may reveal valuable packaging designs, which would not otherwise be in the public domain. It is reasonably foreseeable, and not purely hypothetical, that such disclosure could benefit competitors. In contrast, there would be no impact on the commercial interests of a marketing authorisation holder if examples of specimens held by EMA were disclosed, given that these specimens should be identical to the packaging and leaflets actually used by the marketing authorisation holder when marketing its product. Their design features are therefore already in the public domain.

64. As regards whether there exists an overriding public interest in disclosure of the mock-ups, the Ombudsman notes that the mock-ups do not necessarily reflect the packaging that is used to market the product. In her view, there is no overriding public interest in disclosure of the mock-ups. However, there is an important public interest in the disclosure of the specimens held by EMA, and the EMA analysis of these specimens.

65. The Ombudsman notes the complainant's statement that it may have requested the wrong documents. Rather than requesting mock-ups, it should have requested the packaging of specimens held by EMA. EMA's opinion on this issue seems to indicate that, if the complainant were to make a new request to EMA for public access to specimens (both packaging and leaflets) in its possession, public access would be granted.

66. In light of the above, the Ombudsman finds that there was no maladministration by EMA in relation to these aspects of the complaint.

Reports on the dextropropoxyphene and paracetamol combination and on topical ketoprofen

67. The Ombudsman considers it appropriate to simultaneously address the aspects of the complaint relating to access to reports on the dextropropoxyphene and paracetamol combination, and access to reports on topical ketoprofen, since similar issues arises in relation to both requests.

68. The complainant contests the decision of EMA to refuse access to Rapporteur and/or Co-Rapportuer reports, prepared in order to allow the CHMP to form an opinion on issues arising in relation to the safety/effectiveness of medicinal products, until the Commission had made a final decision on the review of the marketing authorisations for the products concerned (namely the dextropropoxyphene and paracetamol combination and topical ketoprofen).

69. EMA refused access to these reports, while the referral procedure was ongoing, on the grounds of Article 4 (3), first paragraph of Regulation 1049/2001. Article 4 (3), first paragraph of Regulation 1049/2001, permits an institution to refuse access to a document, drawn up for internal use or received by an institution, which relates to a matter upon which a decision has not been taken, if disclosure of the document would seriously undermine the institution's decision-making process. However, even if disclosure of the document would seriously undermine the EMA's decision-making process EMA should still disclose the document if there is an overriding public interest in disclosure.

70. The Ombudsman recognises that the review of the safety and effectiveness of medicines for human use is a particularly important and sensitive matter. It is vital that the review by EMA of the safety and effectiveness of medicines for human use is complete and accurate.

71. When a Rapporteur and/or Co-Rapportuer report raises issues in relation to a product, it is important that the CHMP, and if applicable thereafter, the Commission, can review fully the findings in the reports. Until such reviews are carried out, the findings in the reports are provisional. The Ombudsman notes that the assessments in the two reports may differ from each other, and they may not represent the same position as that which is eventually adopted by the CHMP or the Commission.

72. It is important, for public health considerations, that the CHMP and the Commission carry out their reviews properly, reviews which are intended to determine if there is a need to modify or revoke a marketing authorisation for the product concerned. If it were reasonably foreseeable, and not purely hypothetical, that publication of a such reports before the CHMP or the Commission had taken a decision would put undue pressure on those decision making processes, to such an extent that an eventual decision may be based on a precipitated and incomplete analysis, disclosure could be withheld until those decisions were taken[21].

73. Whether or not it is in fact reasonably foreseeable, and not purely hypothetical, that publication of a such reports, before the CHMP or the Commission take a decision thereon, would put undue pressure on those decision making processes, to such an extent that the eventual decisions may be based on a precipitated and incomplete analysis, is a complex issue, which depends on factors including the specific content of those reports, the specific nature of the decision-making in the CHMP and the Commission and the specific nature, relevance and extent of the undue pressure that EMA considers would put on those decision-making bodies as a result of the public disclosure of the reports. The Ombudsman notes, however, that instead of engaging with the complainant on these issues, EMA limited itself to making the cursory conclusion that the release of the reports would seriously undermine its decision making process. By doing so, EMA failed to properly reason its decisions refusing access.

74. In light of the above, and taking into account the fact that the reports have now been released, the Ombudsman will close this aspect of his inquiry by making a critical remark.

Reference Member State assessment report on the risk management plan for rimonabant

75. In the course of the Ombudsman's inquiry, it emerged that the document requested by the complainant, and identified following clarifications, was drafted by the Swedish regulatory authority and entitled "Acomplia/Zimulti, EU/1/06/344/001-009, Final Assessment Report". The complainant wishes to gain access to a non-redacted copy of this document, or for any redactions to be specifically justified.

76. The Ombudsman first notes that the complainant's request of 18 September 2008 included a broad request for all other documents related to the risk management plan for rimonabant. EMA informed the complainant that it required clarifications regarding this broad request, and provided a list of documents that it thought might be of interest to the complainant.

77. The Ombudsman notes that Article 6.2 of Regulation 1049/2001 provides that "if an application [for public access to a document] is not sufficiently precise, the institution shall ask the applicant to clarify the application and shall assist the applicant in doing so, for example, by providing information on the use of the public registers of documents." Once such a clarification is made, and the applicant requests a specific document, the procedure under Article 7 of Regulation 1049/2001 applies.

78. The complainant responded to the requests for clarifications, stating that it sought access to "all other documents (non identified by us) made in relation with the risk management plan which contains safety data (sic)". The Ombudsman notes that this response was also very broadly worded. The Ombudsman considers this approach understandable, as the complainant did not, at that stage, have any comprehensive information as to which relevant documents EMA held.

79. In response to the complainant's effort to clarify its request, EMA then identified what it claims were the relevant documents. This included "assessment reports on risk management plan and/or PSUR". It appears the complainant then clarified that it wanted access to the following: "the "assessment reports on risk management plan" and "all the PSURs for Acomplia." (PSURs are dealt with separately above).

80. On 16 October 2008, EMA granted partial access to a document entitled "Acomplia/Zimulti, EU/1/06/344/001-009, Final Assessment Report". The document received by the complainant consisted of 68 pages, 65 of which were fully redacted. EMA also redacted certain information contained in the 3 pages to which access was granted.

81. In its opinion sent to the Ombudsman, EMA noted that the assessment report, requested by the complainant, was contained in only a few paragraphs of the 68-page document sent to the complainant. EMA explained that it had redacted extensive parts of that document because it contained information not requested by the complainant. Unfortunately, EMA failed to explain this to the complainant at the time.

82. The Ombudsman notes that Regulation 1049/2001[22] clearly provides that access to a part of a document can only be refused if one or more of the exceptions, as set out in Article 4 of the Regulation, are applicable. When faced with very broad requests for access to undefined documents (which was the situation in the present case), the Ombudsman acknowledges that it may be necessary for an institution to check many documents. In order to direct applicants to documents that are useful to them, it may be acceptable for the institution to provide partial access to the relevant parts of a document, in order to assist applicants and enhance transparency.

83. However, it is important that such an approach does not lead to abuse of Regulation 1049/2001. In particular, it should not lead to the evasion of the requirement to fully justify any non-disclosure of a requested document. If an applicant, after receiving partial access, insists on obtaining a document in its entirety, that should be provided to the applicant, unless the institution shows that an exception set out in Article 4 applies to all or part of the document.

84. In the present case, the Ombudsman notes that the complainant expressly asked EMA for a full copy of the 68 page report after receiving the redacted version, or for justifications for the redaction of parts of the document. It was not for EMA, at that stage, to question why the complainant wanted access to the full report.

85. The Ombudsman notes that EMA recognises that the redaction of parts of the document, not considered "relevant" by EMA, leaves it open to criticism. EMA also admits that the complainant was not made fully aware of the justifications for the redactions when it first received the redacted document. The Ombudsman considers that it would always be useful, when sending a redacted document to an applicant, for EMA to state expressly whether or not the document has been redacted because an exception to public access applies. If EMA considers that an exception to public access applies, it should explain clearly why this is the case. In addition, if, EMA has redacted a very large document in order to provide a complainant with an answer to a broad and unclear request, and to empower the complainant to make a more precise request, EMA should state that the applicant has a right to request access to the entire document.

86. In the present case, it is understandable that the complainant was frustrated by the steps taken by EMA. Rather that being helpful, EMA's behaviour was confused and confusing.

87. The Ombudsman notes that very soon after the aforementioned EMA failures, the CHMP recommended the suspension of the marketing authorisations for rimonabant. The complainant states that as a result of this decision, it decided to terminate what it considered to be a time-consuming and highly unproductive exchange with EMA. Therefore, the Ombudsman considers that a friendly solution to this aspect of the complaint is not now of any practical use to the complainant. She will thus close this aspect of the complaint by making a critical remark.

88. In its observations, the complainant highlights the difficulties it encountered when formulating its requests for documents from EMA. It notes that no comprehensive public register listed the documents produced and held by EMA regarding rimonabant. This meant that it was obliged to trust that EMA would indentify the relevant documents. The complainant calls on EMA to provide public access, through its website, to a comprehensive register of all the documents it produces and receives. The Ombudsman agrees that the complainant's suggestion would help improve the transparency of EMA. She considers that EMA has a positive duty to ensure records are kept in a manner that allows for more effective public access. She points out that the aim of a public register is to enable the public to gain detailed and up-to-date knowledge of the documents, or at least the type of documents, that an institution holds. This knowledge facilitates members of the public to exercise their fundamental right to request access to documents.[23] The Ombudsman thus encourages EMA to establish a better document archive, including a comprehensive and useful database, in order to assist citizens in making requests for access to documents in its possession. The Ombudsman will also make a further remark.

C. Conclusions

On the basis of her inquiry into this complaint, the Ombudsman closes it with the following two conclusions and two critical remarks:

As regards the failure to give public access to PSURs, the Ombudsman considers that EMA was not justified in refusing access to PSURs at the time the requests for public access were made. However, in light of the change in practice of the EMA in relation to granting access to PSURs, the Ombudsman finds that EMA has now settled this aspect of the complaint.

As regards the alleged failure to grant public access to mock-up packaging, the Ombudsman finds that there was no maladministration by EMA.

As regards the failure to grant public access to reports on the dextropropoxyphene and paracetamol combination and on topical ketoprofen, the Ombudsman considers that EMA failed to reason properly its decisions refusing access.

As regards the failure to grant public access to a reference Member State assessment report on the risk management plan for rimonabant, EMA erred when it failed to provide a valid justification for the redaction of an assessment report requested by the complainant.

The complainant and the European Medicines Agency will be informed of this decision.

Further remark

By establishing a comprehensive publicly accessible register of documents, EMA would assist citizens who request access to documents in the possession of EMA.

 

Emily O' Reilly

Done in Strasbourg on 2 December 2013

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[1] Rimonabant is an anti-obesity drug.

[2] PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product. They are submitted by marketing-authorisation holders at defined time points during the post-authorisation phase.

[3] EMA operates a checking process of the printed materials used in the packaging and labelling of centrally authorised medicines. The aim of this checking process is to improve the quality of the printed materials that patients and healthcare workers receive with a medicine. This includes the outer and inner packaging of the medicine, and the printed package leaflet. "Mock-ups" are copies of the flat artwork design.

[4] Dextropropoxyphene is a painkiller. It has now been taken off the market due to concerns relating to safety and effectiveness. It was regularly used in combination with paracetamol.

[5] Ketoprofen is an anti inflammatory prescribed for arthritis-related inflammatory pains or severe toothaches.

[6] Acomplia was a tradename used to market rimonabant.

[7] The final words of the title are redacted.

[8] The final words of the title are redacted.

[9] The CHMP is the committee at the European Medicines Agency that is responsible for preparing opinions on questions concerning medicines for human use. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP). The members and alternates of the CHMP are nominated by European Union Member States in consultation with the EMA's Management Board. They are chosen on the strength of their qualifications and expertise with regard to the evaluation of medicines. They serve on the Committee for a renewable period of three years. The CHMP is composed of: a chair, elected by serving CHMP members; one member and an alternate nominated by each of the 28 Member States; one member and an alternate nominated by both Iceland and by Norway; up to five co-opted members, chosen among experts nominated by Member States or the EMA and recruited, when necessary, to provide additional expertise in a particular scientific area.

[10] Telbivudine is an antiviral drug used in the treatment of hepatitis B infection.

[11] Doc. Ref. EMEA/305821/2006, available at: http://www.ema.europa.eu/docs/en._GB/document._library/Regulatory_and_procedu raLguideline/2009/10/WC500004891.pdf

[12] "Specimens" are samples of the actual printed outer and immediate packaging materials and package leaflet (that is the 'sales presentation').

[13] See Article 15 TFEU and Article 42 of the Charter of Fundamental Rights of the European Union.

[14] Decision of the European Ombudsman closing his inquiry into complaint 2493/2008/(BB)(TS)FOR.

[15] Article 73 of Regulation 726/2004 (which is the Regulation establishing the European Medicines Agency) states that Regulation 1049/2001 shall apply to documents held by the European Medicines Agency.

[16] Case C-64/05 P Sweden v Commission [2007] ECR I-11389, paragraph 66, and Case C-266/05 P Sison v Council [2007] ECR I-1233, paragraph 63.

[17] Case T-20/99 Denkavit Nederland v Commission [2000] ECR II-3011, paragraph 45.

[18] Whereas the exceptions provided for in Article 4(1) and 4(2) of Regulation 1049/2001 apply if the protected interest would be "undermined" by the disclosure of the document, Article 4(3) of Regulation 1049/2001 only applies if the interest in question, which is the institution's decision-making process, would be "seriously undermined".

[19] Case T-211/00 Kuijer v Council [2002] ECR II-485, paragraph 56.

[20] EMA now evaluates PSURs through its Pharmacovigilance Risk Assessment Committee (PRAC), which is the EMA committee responsible for assessing all aspects of the risk management of medicines for human use. If the PRAC adopts a recommendation on the maintenance of the marketing authorisation for a centrally authorised product, there is no requirement to transmit this recommendation to the CHMP and the procedure ends with the adoption of the PRAC recommendation. However, if PRAC recommends any regulatory action, such as the variation, suspension or revocation of a marketing authorisation, the PRAC recommendation will be transmitted to the CHMP. The CHMP then adopts an opinion. The European Commission shall then take the necessary measures to vary, suspend or revoke the marketing authorisations, in accordance with the outcome of the assessment. The outcome of the PSUR assessment results in a legally binding decision to vary, suspend, revoke the marketing authorisations of the medicinal products containing the concerned active substance. The timelines for assessment of a PSUR are up to 134 days by the EMA (12O days if the process ends with the PRAC recommendation), followed by 67 days for the European Commission's decision-making process (if applicable).

[21] Once a definitive decision is taken in relation to the issues raised in the Rapporteur and Co-Rapportuer reports, this justification for non-disclosure would certainly cease to exist. At that stage, public access to the reports would serve to allow the public, which includes informed third parties, to determine if the decision-making process has arrived at satisfactory conclusions.

[22] See Decision of the European Ombudsman closing his inquiry into complaint 277/2012/RA against the European Commission.

[23] Decision of the European Ombudsman, closing his own initiative inquiry OI/11/2011/PB, concerning the European Environmental Agency, paragraph 13.