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We Can Only Presume: Relationship between Protection of Commercial Interests and General Presumptions of Confidentiality Shrouded in Mist as Court of Justice Upholds European Medicines Agency Disclosure of Clinical Study Reports

Published online by Cambridge University Press:  05 April 2021

Eógan HICKEY Open the ORCID record for Eógan HICKEY [Opens in a new window]
Eógan HICKEY*
Affiliation:
Trainee solicitor (lawyer), William Fry, 2 Grand Canal Square, Dublin, Ireland; email: eoganh@gmail.com.
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Abstract

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Type
Case Notes
Information
European Journal of Risk Regulation , Volume 12 , Issue 4 , December 2021 , pp. 871 - 878
Copyright
© The Author(s), 2021. Published by Cambridge University Press

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Footnotes

The author would like to thank Shay Buckley for his comments. All mistakes are the author’s own.

References

1 Case C-175/18 P, PTC Therapeutics International v European Medicines Agency, ECLI:EU:C:2020:23 (PTC).

2 Case C-178/18 P, MSD Animal Health Innovation and Intervet International v EMA, ECLI:EU:C:2020:24 (MSD).

3 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents.

4 This obligation is codified and given further detail in the EMA’s External guidance on the implementation of the EMA policy on the publication of clinical data for medicinal products for human use, 2016, EMA/90915/2016.

5 PTC, ECJ, para 11.

6 ibid.

7 ibid, para 15.

8 T-729/15, MSD, ECLI:EU:T:2018:67 (MSD, GC), para 4.

9 MSD, ECJ, para 10.

10 MSD, GC, para 10.

11 MSD, AGO, ECLI:EU:C:2019:710 (MSD, AGO), para 3.

12 Case T-718/15, PTC, ECLI:EU:T:2018:66 (PTC, GC), para 39; MSD, GC, para 26.

13 PTC, GC, para 40; MSD, GC, para 28.

14 PTC, GC, paras 41 and 44; MSD, GC, para 29.

15 MSD, AGO, para 48.

16 C-57/16 P, Clientearth v Commission, ECLI:EU:C2018:660.

17 PTC, AGO, ECLI:EU:C:2020:23 (PTC, AGO) para 70; MSD, AGO, para 50. AG Hogan quoted directly from Clientearth, para 80.

18 PTC, AGO, paras 78–79; MSD, AGO, paras 52–56.

19 PTC, paras 60–62; MSD, paras 57–58.

20 PTC, para 67; MSD, para 64.

21 Author’s summary of arguments. See MSD, paras 120, 121.

22 Author’s summary of arguments. See PTC, para 117ff.

23 PTC, para 124.

24 PTC, para 127.

25 PTC, para 128; MSD, paras 124, 127.

26 MSD, para 126.

27 PTC, para 77; MSD, para 77.

28 Regulation 141/2000, Art 8(3)(c).

29 PTC, AGO, para 148.

30 Author’s rephrasing. PTC, para 74; MSD, para 70.

31 PTC, para 83; MSD, para 82.

32 PTC, para 93.

33 PTC, paras 81, 94 and 96.

34 PTC, para 82; MSD, ECJ, para 96.

35 MSD, para 93.

36 PTC, para 109; MSD, ECJ, para 95.

37 PTC, para 75; MSD, para 71.

38 PTC, para 107; MSD, ECJ, para 98.

39 In Clientearth, it was argued that the existence of specific rules limiting access was a common factor in cases that recognised a GP (see Clientearth, para 62). However, the ECJ declined to endorse this as a criterion, although it did not address the argument specifically.

40 See T-245/11, Clientearth/ICS, ECLI:EU:T:2015:675, para 173ff. Contrast with T-189/14, Deza, ECLI:EU:T:2017:4, paras 37–40.

41 Clientearth, para 81.

42 D Curtin & P Leino, “Openness, transparency and the right of access to documents in the EU: in-depth analysis”, Robert Schuman Centre for Advanced Studies Research Paper No. RSCAS 2016/63 <papers.ssrn.com/sol3/papers.cfm?abstract_id=2879315>, p 10 (accessed 7 January 2021).

43 J Mendes, “The Principle of Transparency and Access to Documents in the EU: For What, for Whom and of What?”, University of Luxembourg Law Working Paper No. 2020-004 <https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3557795>, pp 10, 13 (accessed 7 January 2021). See also Curtin & Leino, ibid, p 10; PP Craig, EU Administrative Law (Oxford, Oxford University Press, 2012) p 363.

44 Curtin & Leino, supra, note 42, p 11.

45 ibid, p 26.

46 See, generally, E Korkea-aho & P Leino, “Who Owns the Information Held by EU Agencies? Weed Killers, Commercially Sensitive Information and Transparent and Participatory Governance” (2017) 54(4) Common Market Law Review 1059.

47 ECHA, Access to documents at ECHA – 2017 Key figures: In Brief, ECHA-18-B-03-EN <https://echa.europa.eu/documents/10162/13604/adt_2017-key-figures_en.pdf/e35dd59d-0f5a-4393-d86d-7739a2c09dc5> (accessed 7 January 2021).

48 Under Regulation 1049/2001, Art 4(4), the agency must consult with MA holders to assess whether an exception to disclosure applies.

49 PTC, GC, paras 4–9.

50 MSD, paras 8–12.

51 See, generally, Korkea-aho & Leino, supra, note 46.

52 ibid, p 1074.