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Legal Sources of Control Over and Access to Clinical Trial Data Under the EU Applicable Framework

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Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law

Part of the book series: Munich Studies on Innovation and Competition ((MSIC,volume 16))

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Abstract

This chapter examines the applicable legal framework at EU level that currently determines the conditions and scope of access to clinical trial data. First, the main sources of EU primary and secondary law applicable to clinical trial data throughout its lifecycle and particularly relevant for this study are outlined. Next, the legal determinants of trial sponsors’ control over and third-party access to individual patient-level trial data are surveyed and analysed. Finally, uncertainties and limitations of the current regulatory approach regarding the post-trial accessibility of non-summary data are identified.

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Notes

  1. 1.

    European Commission (8 Jul 2009) Pharmaceutical sector inquiry final report, p. 95. https://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf. Accessed 26 Mar 2021.

  2. 2.

    TFEU, art 4(2)(k).

  3. 3.

    Reg 536/2014/EU.

  4. 4.

    ibid rec 85.

  5. 5.

    ibid.

  6. 6.

    ibid.

  7. 7.

    ibid rec 82.

  8. 8.

    ibid.

  9. 9.

    ibid.

  10. 10.

    ibid.

  11. 11.

    See Explanations relating to the Charter of Fundamental Rights (2007) OJ C 303, C 303/18; Reg 536/2014/EU, rec 27.

  12. 12.

    Reg 536/2014/EU, art 3(a).

  13. 13.

    For a detailed discussion, see below at Sect. 4.3.3.

  14. 14.

    Reg 536/2014/EU, art 1.

  15. 15.

    Reg 536/2014/EU, art 99. On 21 April 2021, the EMA’s Management Board confirmed that the Clinical Trials Information System is ‘fully functional and meets the functional specifications, following an independent, successful audit’; at the time of writing, the European Commission is expected to consider ‘if the conditions set by the [EU Clinical Trials] Regulation are met and, once confirmed, [to] publish a notice in the Official Journal of the European Union’. EMA. Clinical trial regulation. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000629.jsp. Accessed 29 Jun 2021.

  16. 16.

    Dir 2001/20/EC.

  17. 17.

    European Commission, SWD(2012) 200 final, vol. I, pp. 17–27.

  18. 18.

    ibid.

  19. 19.

    Reg 536/2014/EU, rec 4, art 5.

  20. 20.

    European Commission, SWD(2012) 200 final, vol. I, pp. 35–38. Low-intervention studies are trials that involve investigational medicinal products that have been already authorised for marketing. See also Reg 536/2014/EU, art 2(2)(3).

  21. 21.

    Reg 536/2014/EU, rec 67; art 25(6).

  22. 22.

    Reg 536/2014/EU, rec 64; art 79. See also European Commission, SWD(2012) 200 final, vol. I, pp. 70–71 (concluding that the objective of addressing the global dimension of clinical trials and ensuring compliance with GCP would be ‘achieved reasonably well’ by combining the measures of mandatory trial registration and the inspections of non-EU countries’ regulatory systems for clinical trials).

  23. 23.

    Reg 536/2014/EU, rec 82 (emphasis added).

  24. 24.

    ibid.

  25. 25.

    Reg 536/2014/EU, art 3.

  26. 26.

    Reg 536/2014/EU, art 2(2)(30) (emphasis added).

  27. 27.

    ICH (10 Jun 1996) ICH Harmonised tripartite guideline. Guideline for good clinical practice. E6, para 1(24). Furthermore, the ICH guideline lists the types of documents that ‘individually and collectively’ allow to evaluate the conduct of a trial and the quality of the generated data. ibid paras 8.1–4.8.

  28. 28.

    Higgins et al. (2017), p. 8:4.

  29. 29.

    ibid p. 8:3. See also ICH (10 Jun 1996) ICH Harmonised tripartite guideline. Guideline for good clinical practice. E6, para 6.4 (stating that ‘scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design’).

  30. 30.

    European Commission, SWD(2012) 200 final, vol. I, p. 13.

  31. 31.

    Reg 536/2014/EU, rec 67.

  32. 32.

    Reg 536/2014/EU, art 81(4)(b). The EMA publication policy 0070 and the EU database are distinct instruments: the former applies to trial data submitted to the EMA through the centralised marketing authorisation procedure after 1 January 2015; the latter will apply to data generated in clinical trials approved after the EU Clinical Trials Regulation becomes applicable. EMA (21 Mar 2019) Questions and answers on the European Medicines Agency policy on publication of clinical data for medicinal products for human use. EMA/357536/2014, rev. 2, pp. 3, 6–7. https://www.ema.europa.eu/en/documents/report/questions-answers-european-medicines-agency-policy-publication-clinical-data-medicinal-products_en.pdf. Accessed 26 Mar 2021. Data disclosed under EMA’s publication policy 0070 can be accessed through the website launched and operated by the EMA: https://clinicaldata.ema.europa.eu/web/cdp/home. Accessed 26 Mar 2021.

  33. 33.

    Reg 726/2004/EC, art 57(1)(d). The EudraVigilance database is accessible to health-care professionals, marketing authorisation holders and the public, provided that personal data protection is guaranteed. ibid.

  34. 34.

    For further details regarding the functionalities of the EudraCT database, see https://eudract.ema.europa.eu/help/Default.htm. Accessed 26 Mar 2021.

  35. 35.

    Dir 2001/20/EC, art 11(1).

  36. 36.

    EudraCT. Overview of the EudraCT public and secure applications. https://eudract.ema.europa.eu/help/Default.htm#eudract/overview_eudract_public_secure.htm. Accessed 26 Mar 2021.

  37. 37.

    Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (30 Apr 2004) OJ L 136.

  38. 38.

    Reg 726/2004/EC, art 55.

  39. 39.

    Reg 726/2004/EC, art 57(1)(a).

  40. 40.

    European Commission, SWD(2012) 200 final, vol. I, p. 13.

  41. 41.

    ibid.

  42. 42.

    For a compilation of guidance documents applicable to clinical trials, see EudraLex – Volume 10 – Clinical trials guidelines. https://ec.europa.eu/health/documents/eudralex/vol-10_en#fragment0. Accessed 26 Mar 2021.

  43. 43.

    EMA (15 Oct 2018) External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. EMA/90915/2016, version 1.4. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data_en-3.pdf. Accessed 26 Mar 2021. Since its adoption in 2016, the procedural aspects were subsequently clarified in the revised versions of the guidance.

  44. 44.

    ibid p. 43 (emphasis added).

  45. 45.

    See e.g. Case C-389/13 EMA v AbbVie [2013] ECLI:EU:C:2013:794, para 18; Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 26; Case T-235/15 Pari Pharma v EMA [2018] ECLI:EU:T:2018:65, para 63. See also EMA (30 Apr 2013) Advice to the European Medicines Agency from the Clinical Trial Advisory Group on Legal Aspects (CTAG5) – final advice, lines 160–161 (referring to the arguments of the participants of the workshop on access to clinical trial data and transparency held by the EMA in 2012 that ‘clinical-trial data are commercially confidential […] as they contain information such as […] proprietary information regarding efficacy and safety measurements and statistical analysis’ (emphasis added)). https://www.ema.europa.eu/en/documents/other/ctag5-advice-european-medicines-agency-clinical-trial-advisory-group-legal-aspects-final-advice_en.pdf. Accessed 26 Mar 2021. See also EFSPI, European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) position on European Medicines Agency (EMA) access to clinical trial data initiative (referring to trial sponsors as ‘the owners of the data’ throughout the text). https://www.efspi.org/documents/publications/efspipositiononema250413.pdf. Accessed 26 Mar 2021.

  46. 46.

    On the contractual practice of obtaining exclusive control over clinical trial data, see below at Sect. 4.2.5 in this chapter.

  47. 47.

    See e.g. Drazen (2002); Vickers (2006).

  48. 48.

    Drazen (2002), p. 409.

  49. 49.

    Rathi (2012) (emphasis added) (with further references).

  50. 50.

    Dir 2001/83/EC, annex I, pt 4(B)(2)(c) (emphasis added).

  51. 51.

    Dir 2001/83/EC, annex I, pt 4(B)(2)(d) (emphasis added).

  52. 52.

    ibid (emphasis added).

  53. 53.

    Reg 536/2014/EU, art 58 (emphasis added). A clinical trial master file ‘shall […] contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated’. Reg 536/2014/EU, art 57.

  54. 54.

    The question is posed in view of the civil law tradition, given the study’s focus on EU law. On the fitness of the concept of ‘data ownership’ in civil law jurisdictions, see Drexl (2018), p. 89 ff.

  55. 55.

    Reg 536/2014/EU, art 56(1).

  56. 56.

    Reg 536/2014/EU, art 56(2) (emphasis added).

  57. 57.

    Hoof (2010), p. 27. See also van Erp and Akkermans (2010), p. 33.

  58. 58.

    See e.g. European Commission, SWD(2017) 2 final, pp. 34–35 (emphasising that the concept of ownership should be distinguished from de facto possession).

  59. 59.

    See e.g. OECD (2015), p. 195 (pointing out that the concept of ownership is ‘often misunderstood and/or misused’ by businesses).

  60. 60.

    See e.g. Coleman and Kraus (1989), p. 1339 (observing that ‘[a] perfectly natural way of characterizing what it means to have a right to a resource or to property is in terms of autonomy or control’). It goes beyond the scope of this study to examine jurisdictional differences regarding ‘ownership’.

  61. 61.

    Reg 536/2010/EU, rec 51.

  62. 62.

    Dir 2001/83/EC, annex I, pt 4(B)(2)(c).

  63. 63.

    Penner (1996), p. 743.

  64. 64.

    Above (nn 50–53) and the accompanying text.

  65. 65.

    Declaration of Helsinki, paras 9 and 24.

  66. 66.

    ICH (10 Jun 1996) ICH Harmonised tripartite guideline. Guideline for good clinical practice. E6, para 4.8.10(o), (p).

  67. 67.

    Additional protocol to the Oviedo Convention concerning biomedical research (25 Jan 2005) CETS No. 195, arts 25 and 26.

  68. 68.

    Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (4 May 2016) OJ L 119 [hereinafter the GDPR].

  69. 69.

    GDPR, art 4(1) (emphasis added).

  70. 70.

    GDPR, art 9(1). Article 4(15) defines ‘data concerning health’ as ‘personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status’.

  71. 71.

    GDPR, art 9(2)(a).

  72. 72.

    GDPR, art 9(2)(b)-(j).

  73. 73.

    Prins (2006), p. 234.

  74. 74.

    ibid. See also European Commission, SWD(2017) 2 final, p. 33 (pointing out that protection of personal data ‘is a fundamental right in itself’; therefore, the new ownership right ‘would not be conceivable’ with regard to personal data). But see Purtova (2011), p. 47 (arguing that the EU approach to personal data protection does not ‘adequately grasp the new structure of relationships within data flow’). She concludes that property rights in personal data could better manage the complexity of the relationships between the numerous actors involved in processing personal data due to their erga omnes effect and fragmentation. ibid p. 61.

  75. 75.

    GDPR, rec 1 (emphasis added) (invoking Article 8(1) of the CFR and Article 16(1) of the TFEU).

  76. 76.

    Recital 4 of the GDPR states that ‘[t]he right to the protection of personal data is not an absolute right; it must be considered in relation to its function in society and be balanced against other fundamental rights, in accordance with the principle of proportionality’. Recital 7 of the GDPR holds that natural persons ‘should have control of their own personal data’.

  77. 77.

    Lynskey (2015), p. 241.

  78. 78.

    GDPR, art 15.

  79. 79.

    GDPR, art 18.

  80. 80.

    GDPR, art 20.

  81. 81.

    GDPR, art 21.

  82. 82.

    GDPR, art 22.

  83. 83.

    GDPR, art 17.

  84. 84.

    Reg 536/2014/EU, art 56(1) (mandating that, when trial data is recorded, processed, handled and stored by trial sponsors and investigators, the confidentiality of records and the personal data of the subjects remain protected according to the applicable law on personal data protection).

  85. 85.

    Reg 726/2004/EC, art 57(d) (vesting in the EMA the responsibility to guarantee personal data protection while ensuring the dissemination of information regarding the adverse reactions to medicinal products authorised for marketing within the European Community).

  86. 86.

    Dir 2001/83/EC, art 54a(3)(a).

  87. 87.

    GDPR, rec 26.

  88. 88.

    ibid (emphasis added).

  89. 89.

    GDPR, art 4(1).

  90. 90.

    See e.g. CIOMS (2016), p. 51; Institute of Medicine of the National Academies (2015), p. 13. But see Cavoukian A, El Emam K (2011) Dispelling the myths surrounding deidentification: anonymization remains a strong tool for protecting privacy, p. 7 (finding that the re-identification of individuals in medical databases by using sophisticated de-identification tools and public information happens rarely). https://www.ipc.on.ca/wp-content/uploads/2016/11/anonymization.pdf. Accessed 26 Mar 2021. The authors point out that the re-identification is ‘a difficult and time-consuming task’ that requires technical skills. ibid.

  91. 91.

    See e.g. PhRMA and EFPIA (18 Jul 2013) Principles for responsible clinical trial data sharing. Our commitment to patients and researchers, p. 4 (stating that drug companies would not share patient-level data ‘when there is a reasonable likelihood that individual patients could be re-identified’). https://www.efpia.eu/media/25189/principles-for-responsible-clinical-trial-data-sharing.pdf. Accessed 26 Mar 2021.

  92. 92.

    See also above (nn 61–63) and the accompanying text.

  93. 93.

    European Commission, SWD(2017) 2 final, p. 19. With regard to the eligibility for the trade secret protection, the Commission doubted whether ‘individual data generated by interconnected machines and devices could be regarded as “trade secrets” in the sense of [the Trade Secrets] Directive, mostly because of its lack of commercial value as individual data; however, combination of data (datasets) can be trade secrets under [the Trade Secrets] Directive if all the criteria are met’.

  94. 94.

    ibid p. 33.

  95. 95.

    European Commission, COM(2017) 9 final, p. 9 (emphasis added). As pointed out by the Commission, sensor-generated data can be personal or non-personal, whereby the differentiation depends on whether a natural person can be identified. ibid.

  96. 96.

    Reg 536/2014/EU, art 47.

  97. 97.

    Reg 536/2014/EU, art 48.

  98. 98.

    European Commission, SWD(2017) 2 final, p. 19. See also Max Planck Institute for Innovation and Competition (2017) Arguments against data ownership: ten questions and answers, p. 1 (pointing out that ownership rights ‘can only be recognised and provided by law’ and that ‘a “data ownership right” does not currently exist either at EU or Member State level, or any other industrialised country’). https://www.ip.mpg.de/fileadmin/ipmpg/content/forschung/Argumentarium-Dateneigentum_eng.pdf. Accessed 26 Mar 2021.

  99. 99.

    van Erp S (2017) Ownership of data and the numerus clausus of legal objects. Maastricht European Private Law Institute Working Paper No. 2017/6 1-23, p. 13. https://cris.maastrichtuniversity.nl/en/publications/ownership-of-data-the-numerus-clausus-of-legal-objects. Accessed 26 Mar 2021. The question of how property law of EU Member States applies to clinical trial data goes beyond the scope of this study.

  100. 100.

    See Drexl (2018), p. 90 (noting that ‘reliance on property in the physical carrier will not provide sufficient protection where the person who has a legitimate interest in protection is different from the person owning the physical career’).

  101. 101.

    At EU level, criminal penalties for offences against information systems were harmonised by the Directive 2013/40/EU of the European Parliament and of the Council of 12 August 2013 on attacks against information systems and replacing Council Framework Decision 2005/222/JHA (14 Aug 2013) OJ L 218.

  102. 102.

    While the relationship between trade secrets and IP has been debated, this study adheres to the view that trade secrets can be regarded as a subset of IP law, albeit they are not protected by exclusive rights. See European Commission (28 Nov 2013) Impact assessment accompanying the document proposal for a Directive of the European Parliament and of the Council on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure, SWD(2013) 471 final, p. 66.

  103. 103.

    As for other fields of IP law, copyright protection can apply to the scientific publications based on the IPD analysis, but not to ‘raw’ IPD as such; patents can be obtained for inventions that might be developed on the basis of IPD analysis (e.g. therapeutic applications). See Chap. 8 at Sect. 8.1.4.3 (discussing how secondary analysis of historical IPD might contribute to drug development).

  104. 104.

    Directive 2016/943/EU of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (15 Jun 2016) OJ L 157/1.

  105. 105.

    Dir 2016/943/EU, art 4.

  106. 106.

    Dir 2016/943/EU, art 2(1).

  107. 107.

    EMA, External guidance on the publication of clinical data (n 43), pp. 53–54.

  108. 108.

    Case T-235/15 Pari Pharma v EMA [2018] ECLI:EU:T:2018:65, para 57. In that case, the applicant failed to show that, ‘in itself, the compilation of all the information consisted, for example, of new scientific conclusions or considerations relating to an inventive strategy which gives the undertaking a commercial advantage over its competitors and that it therefore provided added value’. ibid para 107.

  109. 109.

    ibid para 113 (emphasis added). As a side note, it is worth noting that the criterion of ‘inventiveness’ is irrelevant for the question of the eligibility for trade secret protection. The reports at issue contained the results of the market survey conducted by Pari Pharma. See also EMA, External guidance on the publication of clinical data (n 43), p. 49 (stating that, in many cases, clinical study reports build on ‘logic and common sense in line with the content of publicly available documents’, including scientific and regulatory guidelines and guidance documents and, therefore, should be deemed as common knowledge).

  110. 110.

    ibid paras 113–114.

  111. 111.

    At the time of writing, the EMA does not disclose IPD.

  112. 112.

    The coexistence of data protection and trade secrets is not excluded. For instance, Recital 35 of the EU Trade Secrets Directive emphasises that the trade secret holder, when taking measures to protect a trade secret, should respect the right to protection of personal data of individuals whose personal data may be processed. Recital 63 of the GDPR states that, where possible, ‘the controller should be able to provide remote access to a secure system which would provide the data subject with direct access to his or her personal data’ and that such right ‘should not adversely affect the rights or freedoms of others, including trade secrets’. See also Article 29 Data Protection Working Party (13 Dec 2016) Guidelines on the right to data portability. WP 242 rev.01, p. 10 (emphasising that ‘[a] potential business risk cannot […] in and of itself serve as the basis for a refusal to answer the portability request and data controllers can transfer the personal data provided by data subjects in a form that does not release information covered by trade secrets or intellectual property rights’). https://ec.europa.eu/information_society/newsroom/image/document/2016-51/wp242_en_40852.pdf. Accessed 26 Mar 2021. On the relationship between trade secret protection and personal data protection, see e.g. Graef et al. (2018).

  113. 113.

    Above at Sect. 4.2.1.2, subheading ‘The Obligation to Protect Data Against Unauthorised Access as the Source of de facto Exclusive Control’ in this chapter.

  114. 114.

    As discussed in Chap. 3.

  115. 115.

    The duty of confidentiality of EU institutions—thus, the EMA—is guaranteed under Article 339 of the TFEU.

  116. 116.

    See Chap. 5 at Sect. 5.1.3.

  117. 117.

    See CIOMS (2016), p. 51 (emphasising that researchers, sponsors and research ethics committees ‘must share data for further research where possible’); Krumholz (2015).

  118. 118.

    Above (n 55) and the accompanying text.

  119. 119.

    Above (nn 61–62) and the accompanying text.

  120. 120.

    For a review of evidence, see Chap. 6 at Sect. 6.3.2.

  121. 121.

    EMA publication policy 0070, p. 4.

  122. 122.

    Dir 2016/943/EU, art 2(1)(b).

  123. 123.

    See Chap. 2 at Sect. 2.1.2.

  124. 124.

    Anson (2005), p. 32 ff.

  125. 125.

    ibid p. 33 (noting that historical costs provide ‘an absolute minimum value for the asset’).

  126. 126.

    Anson (2005), p. 34.

  127. 127.

    ibid.

  128. 128.

    Jager (2002), p. 135 ff.

  129. 129.

    See below (Chap. 9, nn 29–32) and the accompanying text.

  130. 130.

    See e.g. Data use agreement, para 1.2. http://yoda.yale.edu/data-use-agreement. Accessed 26 Mar 2021. See also CSDR standard contract template for clinical trial data sharing (10 Apr 2017). https://www.clinicalstudydatarequest.com/Documents/CSDR%20DATA%20SHARING%20AGREEMENT%20Version%201%204.10.2017.pdf. Accessed 26 Mar 2021.

  131. 131.

    Anson et al. (2005), p. 84 (emphasis added).

  132. 132.

    ibid (emphasis added).

  133. 133.

    Dir 2016/943/EU, rec 14 (emphasis added).

  134. 134.

    For an analysis of how IPD disclosure might affect regulatory incentives that delay the marketing authorisation of generic products, Chap. 5 at Sect. 5.4.

  135. 135.

    As the CJEU held in EMA v AbbVie:

    The extent to which the disclosure of [clinical study reports] causes serious and irreparable harm depends on a combination of circumstances, such as, inter alia, the professional and commercial importance of the information for the undertaking which provides it and the utility of that information for other undertakings which are liable to examine and use it subsequently.

    Case C-389/13 EMA v AbbVie [2013] ECLI:EU:C:2013:794, para 42 (emphasis added).

  136. 136.

    For a more detailed discussion of implications of IPD disclosure for competition in R&D, see Chap. 8 at Sect. 8.1.4.

  137. 137.

    On the potential re-use of IPD for obtaining marketing approval for generic drugs, see Chap. 5 at Sect. 5.4.1.

  138. 138.

    Dir 2016/943/EU, art 2(1)(c) (emphasis added).

  139. 139.

    Reg 536/2014/EU, art 56(2).

  140. 140.

    Reg 536/2014/EU, arts 56, 81(4) and 93.

  141. 141.

    On the implementation of the EMA publication policy 0070, see Chap. 2 at Sect. 2.3.1.2.

  142. 142.

    Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases (27 Mar 1996) OJ L 77.

  143. 143.

    Dir 96/9/EC, art 1(2).

  144. 144.

    A trial protocol describes the methodology for answering a research question in a credible way. Reg 536/2014/EU, art (2)(22) and annex I(D).

  145. 145.

    See ICH (10 Jun 1996) ICH Harmonised tripartite guideline. Guideline for good clinical practice. E6, para 1.11 (defining a case report form as a ‘document designed to record all of the protocol required information to be reported to the sponsor on each trial subject’).

  146. 146.

    ICH (5 Feb 1998) ICH Harmonised tripartite guideline. Statistical principles for clinical trials. E9, p. 7 ff.

  147. 147.

    The power of a trial means the statistical significance of the trial evidence. More specifically, it refers to the statistical probability that the null hypothesis will be rejected if it is not true. Day (2007), p. 160.

  148. 148.

    The trial sample size refers to the number of trial participants and is estimated based inter alia on calculating the power of a trial.

  149. 149.

    ICH (5 Feb 1998) ICH Harmonised tripartite guideline. Statistical principles for clinical trials. E9, p. 16.

  150. 150.

    An ‘outcome of interest’ is defined as a measurable effect of a medicinal intervention on the disease clinical manifestations.

  151. 151.

    The ‘effect size’ of a health intervention refers to the measure that correlates with the outcome of interest and statistically characterises the trial hypothesis.

  152. 152.

    Case 490-14 Freistaat Bayern v Verlag Esterbauer [2015] ECLI:EU:C:2015:735.

  153. 153.

    Drexl (2018), p. 74.

  154. 154.

    Case 490-14 Freistaat Bayern v Verlag Esterbauer [2015] ECLI:EU:C:2015:735, para 24 ff.

  155. 155.

    ibid para 27.

  156. 156.

    Dir 96/9/EC, art 3(1).

  157. 157.

    Case C-604/10 Football Dataco and Others [2012] ECLI:EU:C:2012:115, para 38 (and case law cited) (emphasis added).

  158. 158.

    For a detailed discussion, see Chap. 6 at Sects. 6.4.2.2 and 6.4.2.3.

  159. 159.

    CSRs follow the structure specified in Directive 2001/83/EC, annex I, part I, module 5. See also Chap. 3 at Sect. 3.1.2.

  160. 160.

    Case C-604/10 Football Dataco and Others [2012] ECLI:EU:C:2012:115, para 39 (and case law cited).

  161. 161.

    Dir 96/9/EC, art 7(1). Recital 40 specifies that ‘such investment may consist in the deployment of financial resources and/or the expending of time, effort and energy’.

  162. 162.

    Established case law of the CJEU: Case C-203/02 BHB Horseracing [2004] ECLI:EU:C:2004:695, para 35; Case C-444/02 Fixtures Marketing [2004] ECLI:EU:C:2004:697, para 45. As held by the CJEU, the ‘purpose of the protection by the sui generis right provided for by the [database] directive is to promote the establishment of storage and processing systems for existing information and not the creation of materials capable of being collected subsequently in a database’. ibid para 40.

  163. 163.

    See e.g. Drexl (2018), p. 70 ff; Leistner (2017), p. 28.

  164. 164.

    See Fisher et al. (2018), p. 61 (reporting that it is mainly database producers, who often encounter difficulty in making the distinction between creating and obtaining data as it is ‘sometimes impossible for database producers to separate [the costs] and, therefore, to prove the investment in these two types of effort’).

  165. 165.

    See Drexl (2018), p. 70 (noting that, ‘[b]y excluding investment in the creation of data, the case law [of the CJEU] considerably reduces the likelihood that a sui generis right will exist in so-called “sole source” databases’).

  166. 166.

    Cummings et al. (2007), p. 20.

  167. 167.

    This is likely to be the case with scientific data in general. See Beunen (2007), p. 233 (noting that scientists discovering factual data become single-source producers of information holding ‘a de facto monopoly on their materials’).

  168. 168.

    See Drexl (2018), p. 71 (pointing out that ‘the distinction between creating and obtaining data can easily be applied where the underlying data were created by a person or entity that is different from the database maker’).

  169. 169.

    The substantiality criterion is unlikely to present a hurdle, given that the case law set a rather low threshold. Leistner (2017), p. 30.

  170. 170.

    Case C-203/02 BHB Horseracing [2004] ECLI:EU:C:2004:695, para 42.

  171. 171.

    Reg 536/2014/EU, art 3(b). On the concepts of reliability and robustness of clinical trial data, see this chapter at Sect. 4.1.2.1, subheading ‘Data Reliability and Robustness’. On systematic errors in design and methodology of clinical trials that can impair the reliability and robustness of trial data, see Chap. 6 at Sects. 6.4.2.2–6.4.2.4.

  172. 172.

    Reg 536/2014/EU, art 48 (providing inter alia for the obligation on trial sponsors to ensure reliability and robustness of trial data).

  173. 173.

    Case C-203/02 BHB Horseracing [2004] ECLI:EU:C:2004:695, para 42.

  174. 174.

    See e.g. Institute of Medicine of the National Academies (2015), p. 68 (reporting that the costs of de-identifying a data-set can range from 10,000 to 100,000 US dollars, and the costs of developing the in-house capacity to automate data de-identification range from 100,000 to 500,000 US dollars). Such costs can easily meet the ‘substantiality’ threshold, which is viewed to be rather low. See Leistner (2017), p. 30; Fisher et al. (2018), p. 53 (noting that ‘commentators are split on the issue [of the threshold of the investment eligible for the sui generis protection] but generally, national courts have been generous and granted protection for relatively low-level investments’).

  175. 175.

    https://clinicalstudydatarequest.com. Accessed 26 Mar 2021.

  176. 176.

    Once a data-sharing agreement is signed, ‘a research area is created in the secure data access system’ where the trial sponsor can upload anonymised data and supporting documentation. Frequently asked questions. https://clinicalstudydatarequest.com/Help/Help-FAQS.aspx. Accessed 26 Mar 2021.

  177. 177.

    On the restrictive data-sharing policies and practices of drug companies, see Chap. 5 at Sect. 5.1.3.

  178. 178.

    For an overview of data exclusivity regimes in 44 jurisdictions, see IFPMA (2011) Data exclusivity: encouraging development of new medicines. https://www.ifpma.org/wp-content/uploads/2016/01/IFPMA_2011_Data_Exclusivity__En_Web.pdf. Accessed 26 Mar 2021. The international proliferation of test data exclusivity can be attributed to the protection obligations under Article 39(3) of the TRIPS Agreement and the FTAs. For a detailed account, see de Carvalho (2018) and Shaikh (2016).

  179. 179.

    For a critical account, see Chap. 5 at Sect. 5.2.4.2.

  180. 180.

    Council Directive 87/21/EEC of 22 December 1986 amending Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (17 Jan 1987) OJ L 15.

  181. 181.

    Dir 2001/83/EC, art 8(3)(i). Annex I lists the particularities of an application dossier.

  182. 182.

    Dir 2001/83/EC, art 10(2)(b) (emphasis added). Furthermore, the provision clarifies that

    different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant (emphasis added).

  183. 183.

    The ‘reference medicinal product’ means the originator drug authorised on the basis of full efficacy and safety data. Dir 2001/83/EC, art 10(2)(a).

  184. 184.

    Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products (9 Feb 1965) OJ 022.

  185. 185.

    As affirmed by the CJEU, the purpose of the abridged procedure is ‘to relieve applicants for marketing authorisation of the obligation to carry out pharmacological and toxicological tests and clinical trials’ and, in so doing, avoid the repetition of tests on humans or animals, ‘unless absolutely necessary’. Case C-368/96 The Queen v The Licensing Authority [1998] ECLI:EU:C:1998:583, paras 69, 71. See also Dir 2001/83/EC, rec 10; Dir 87/21/EEC, rec 4.

  186. 186.

    Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (30 Apr 2004) OJ L 136.

  187. 187.

    Dir 2001/83/EC, art 10(1), para 4.

  188. 188.

    Dir 2001/83/EC, art 10. For a lay summary of these rules, see European Commission (2018) Notice to applicants, vol. 2A, rev 9, p. 42 ff.

  189. 189.

    On the potential impact of CSRs and IPD disclosure on this type of protection, see Chap. 5 at Sect. 5.4.1.

  190. 190.

    In the case of the EMA, the primary source of the duty ‘not to disclose information of the kind covered by the obligation of professional secrecy’ is Article 339 of the TFEU. See also below at Sect. 4.3.3 in this chapter.

  191. 191.

    See above at Sect. 4.2.4.1 in this chapter.

  192. 192.

    Dir 2001/83/EC, rec 9 (pointing out the need to ensure that ‘innovative firms are not placed at a disadvantage’).

  193. 193.

    Case C-368/96 The Queen v The Licensing Authority [1998] ECLI:EU:C:1998:583, para 81 (emphasis added).

  194. 194.

    ibid para 83.

  195. 195.

    It is worth pointing out that the decision in The Queen v The Licensing Authority has been criticised for not addressing the issue of test data protection form a ‘proper dogmatic’ perspective. Cottier et al. (2000), p. 60.

  196. 196.

    Case C-368/96 The Queen v The Licensing Authority [1998] ECLI:EU:C:1998:583, para 81.

  197. 197.

    Dir 2001/83/EC, art 10(1)(a)(i) (emphasis added).

  198. 198.

    See Chap. 6 at Sect. 6.5.1.2.

  199. 199.

    GDPR, art 9(1). ‘Data concerning health’ is defined as ‘personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status’. GDPR, art 4(15).

  200. 200.

    GDPR, art 9(2)(a).

  201. 201.

    Reg 536/2014/EU, art 28(1)(c).

  202. 202.

    Reg 536/2014/EU, art (2)(21).

  203. 203.

    Reg 536/2014/EU, art 28(2) (emphasis added). Furthermore, Recital 76 states that, to ensure ‘the robustness and reliability of data from clinical trials used for scientific purposes’, the withdrawal of informed consent ‘should not affect the results of activities already carried out, such as the storage and use of data obtained on the basis of informed consent before withdrawal’ (emphasis added). For an analysis of the GDPR provisions relevant for clinical trial data processing for primary and secondary research purposes, see European Data Protection Board (23 Jan 2019) Opinion 3/2019 concerning the questions and answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR) (art. 70.1.b)).

  204. 204.

    Osborne Clarke LLP (2016).

  205. 205.

    ibid p. 154 (emphasis added).

  206. 206.

    ibid (emphasis added).

  207. 207.

    Mattei (1998), p. 160.

  208. 208.

    ibid p. 161. See also von Bar and Drobnig (2004), p. 320 ff.

  209. 209.

    Above at Sect. 4.2.1.2, subheading ‘No Property Rights in IPD as Personal Data’.

  210. 210.

    European Commission, SWD(2017) 2 final, p. 19 (emphasis added).

  211. 211.

    See above (nn 98–100) and the accompanying text.

  212. 212.

    Above (n 56–60) and the accompanying text.

  213. 213.

    See generally Chap. 3.

  214. 214.

    EMA. EU Clinical Trials Register. About the EU Clinical Trials Register. https://www.clinicaltrialsregister.eu/about.html.

  215. 215.

    Reg 536/2014/EU, rec 39; art 37(4). The contents of both types of summaries are specified in Annexes VI and V, respectively.

  216. 216.

    Above at Sect. 4.1.2.1, subheading ‘The EU Database for Clinical Trial Data’.

  217. 217.

    Dir 2001/20/EC, art 17(3)(a); rec 9.

  218. 218.

    Reg 536/2014/EU, art 37(4).

  219. 219.

    European Commission (2015), p. 27 (citing Glenis Willmott, Member of the European Parliament and Rapporteur for the EU Clinical Trials Regulation).

  220. 220.

    Hervey and McHale (2015), p. 319.

  221. 221.

    ibid 320.

  222. 222.

    Reg 536/2014/EU, art 37(4) (emphasis added).

  223. 223.

    EMA publication policy 0070, p. 7.

  224. 224.

    Reg 536/2014/EU, art 81(7).

  225. 225.

    Reg 536/2014/EU, art 81(4)(b).

  226. 226.

    Reg 536/2014/EU, art 81(4)(b).

  227. 227.

    ibid.

  228. 228.

    EMA’ access policy 0043, p. 4 (emphasis added).

  229. 229.

    EMA publication policy 0070, p. 3.

  230. 230.

    ibid p. 4. The following appendices of a CSR are subject to mandatory publication: the protocol and its amendments, statistical methods and a sample case report form. EMA, External guidance on the publication of clinical data (n 43), p. 88.

  231. 231.

    EMA (30 Apr 2013) Advice to the European Medicines Agency from the Clinical Trial Advisory Group on Legal Aspects (CTAG5) – final advice, lines 8–10, 21 (putting forward arguments for and against). https://www.ema.europa.eu/en/documents/other/ctag5-advice-european-medicines-agency-clinical-trial-advisory-group-legal-aspects-final-advice_en.pdf. Accessed 26 Mar 2021.

  232. 232.

    EMA publication policy 0070, pp. 17–18.

  233. 233.

    ibid pp. 17, 19.

  234. 234.

    EMA, External guidance on the publication of clinical data (n 43).

  235. 235.

    ibid p. 52.

  236. 236.

    ibid p. 54 (emphasis added).

  237. 237.

    ibid p. 53 (emphasis added). See also EMA publication policy 0070, annex III (listing specific sections of CSRs that can be redacted as CCI).

  238. 238.

    EMA, External guidance on the publication of clinical data (n 43), p. 47.

  239. 239.

    GDPR, art 15.

  240. 240.

    Explanations relating to the Charter of Fundamental Rights (2007) OJ C 303, C 303/28.

  241. 241.

    See e.g. Curtin and Mendes (2014), p. 1104; Case C-52/05P Sweden and Turco v Council [2008] ECLI:EU:C:2008:374, para 45.

  242. 242.

    TFEU, art 15 (3).

  243. 243.

    Council Regulation (EC) 1049/2001 regarding public access to European Parliament, Council and Commission documents (31 May 2001) OJ L145/43.

  244. 244.

    Reg 726/2004/EC, art 73. National laws usually have analogous rules on transparency and access to documents held by public authorities. For an overview of transparency regimes and their application to clinical trial data in several EU Member States, see Pugatch Consilum (2015). Overall, the study finds that transparency regulations vary greatly among the examined EU Member States with some considerable ‘grey areas’. Even though drug authorities in Germany, Italy, Spain and Sweden ‘are committed to […] increased transparency, none of them have a policy of proactively publishing submitted clinical [trial data]’. ibid p. 4.

  245. 245.

    EMA publication policy 0070, p. 4.

  246. 246.

    ibid p. 1.

  247. 247.

    ibid p. 2.

  248. 248.

    ibid p. 1.

  249. 249.

    Reg 726/2004/EC, art 80.

  250. 250.

    Reg 1049/2001/EC, rec 4.

  251. 251.

    C-365/12 P Commission v EnBW [2014] EU:C:2014:112, para 85.

  252. 252.

    Reg 1049/2001/EC, art 4(1)(b).

  253. 253.

    Reg 1049/2001/EC, art 4(2), first indent.

  254. 254.

    Reg 1049/2001/EC, art 4(4). In general, access can be granted to any document irrespective of whether it is drawn up or received by an institution in any area of its activity. Reg 1049/2001/EC, art 2(3).

  255. 255.

    Joined cases T-355/04 and T-446/04 Co-Frutta v Commission [2010] ECLI:EU:T:2010:15, para 123.

  256. 256.

    Case C-365/12 P Commission v EnBW [2014] ECLI:EU:C:2014:112, para 63.

  257. 257.

    Reg 536/2014/EU, rec 67 (emphasis added).

  258. 258.

    Explanations relating to the Charter of Fundamental Rights (2007) OJ C 303, C 303/32-33 (and case law cited).

  259. 259.

    Above at Sect. 4.3.3.1.

  260. 260.

    As argued below at Sect. 4.3.3.4.

  261. 261.

    Reg 1049/2001/EC, art 4(4) (emphasis added).

  262. 262.

    EMA publication policy 0070, p. 3.

  263. 263.

    ibid p. 4. The following appendices of a CSR are subject to mandatory publication: the protocol and its amendments, statistical methods and a sample case report form. EMA, External guidance on the publication of clinical data (n 43), p. 88.

  264. 264.

    For a detailed analysis of these cases, see Kim (2017).

  265. 265.

    Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 28; Case T-73/13 R InterMune v EMA [2013] ECLI:EU:T:2013:222, paras 14, 16; Case T-44/13 R AbbVie v EMA [2013] ECLI:EU:T:2013:221, paras 18, 24; Case T-235/15 Pari Pharma v EMA [2018] ECLI:EU:T:2018:65, para 34.

  266. 266.

    Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, paras 21, 22; Case T-718/15 PTC Therapeutics International v EMA [2018] ECLI:EU:T:2018:66, para 26; Case T-235/15 Pari Pharma v EMA [2018] ECLI:EU:T:2018:65, paras 34, 36, 38. In the latter case, the dispute arose over the CHMP assessment report, which comprised the similarity and superiority reports submitted by Pari Pharma.

  267. 267.

    Case C-513/16 EMA v PTC Therapeutics International [2018] ECLI:EU:C:2017:148, para 45.

  268. 268.

    As claimed by the pharmaceutical companies in Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 7; Case T-718/15 PTC Therapeutics International v EMA [2018] ECLI:EU:T:2018:66, paras 4, 26.

  269. 269.

    Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 36; Case T-718/15 PTC Therapeutics International v EMA [2018] ECLI:EU:T:2018:66, para 40.

  270. 270.

    Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 35 (emphasis added).

  271. 271.

    ibid (emphasis added).

  272. 272.

    ibid. See also Case T-718/15 PTC Therapeutics International v EMA [2018] ECLI:EU:T:2018:66, para 39.

  273. 273.

    Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 37 (and case law cited); Case T-718/15 PTC Therapeutics International v EMA [2018] ECLI:EU:T:2018:66, para 41.

  274. 274.

    Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 46.

  275. 275.

    Case T-718/15 PTC Therapeutics International v EMA [2018] ECLI:EU:T:2018:66, para 48; Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 43.

  276. 276.

    Case T-718/15 PTC Therapeutics International v EMA [2018] ECLI:EU:T:2018:66, para 50; Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 45.

  277. 277.

    Case T-718/15 PTC Therapeutics International v EMA [2018] ECLI:EU:T:2018:66, para 52; Case T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 70.

  278. 278.

    Case T-235/15 Pari Pharma v EMA [2018] ECLI:EU:T:2018:65, para 57; Case T-718/15 PTC Therapeutics International v EMA [2018] ECLI:EU:T:2018:66, para 53; T-33/17 Amicus Therapeutics v EMA [2018] ECLI:EU:T:2018:595, para 47.

  279. 279.

    Above at Sect. 4.1.2.1, subheading ‘The EU Database for Clinical Trial Data’.

  280. 280.

    Such as in the case of the EMA; see Chap. 6 at Sect. 6.5.1.2.

  281. 281.

    As discussed in Chap. 8 at Sect. 8.2.3.2.

  282. 282.

    EMA publication policy 0070, p. 4.

  283. 283.

    For a detailed analysis, see Chap. 5 at Sect. 5.3.2 and Chap. 8 at Sect. 8.1.4.

  284. 284.

    Such responsibilities are vested in the EMA under Reg 726/2004/EC, art 55.

  285. 285.

    EMA publication policy 0070, pp. 3–4.

  286. 286.

    As shown in Chap. 3, exploratory IPD analysis can address questions beyond the benefit-risk balance of an investigational product.

  287. 287.

    European Commission (24 Feb 2009) Communication from the Commission – Guidance on the Commission’s enforcement priorities in applying Article 82 of the EC Treaty to abusive exclusionary conduct by dominant undertakings. OJ C 45/7 [hereinafter Enforcement priorities guidance], para 75.

  288. 288.

    On data-sharing policies of pharmaceutical companies, see Chap. 5 at Sect. 5.1.3 and Chap. 6 at Sect. 6.3.2.

  289. 289.

    On the reverse ‘information paradox’, see Chap. 9 at Sect. 9.3.2.5.

  290. 290.

    For a discussion, see Chap. 9 at Sect. 9.3.2.3.

  291. 291.

    For instance, in Microsoft the proceedings last over 14 years and in Magill almost 10 years.

  292. 292.

    On the role of competition law as an instrument of access to data in the context of data-driven innovation, see Drexl (2017b, c, d); Crémer et al. (2019), p. 73 ff.

  293. 293.

    The refusal-to-supply category encompasses IP-related cases (e.g. refusal to license IP rights) and refusal to grant access to an essential facility or a network. Enforcement priorities guidance (n 287), para 78.

  294. 294.

    ibid para 1.

  295. 295.

    ibid paras 75, 87.

  296. 296.

    Joined Cases C-241/91 and C-242/91 [1995] RTE and ITV v Commission (‘Magill’) ECLI:EU:C:1995:98.

  297. 297.

    Case C-418/01 IMS Health [2004] ECLI:EU:C:2004:257.

  298. 298.

    Case T-201/04 Microsoft v Commission [2007] ECLI:EU:T:2007:289.

  299. 299.

    ibid para 332.

  300. 300.

    See Drexl J, Hilty RM et al. (2016) Data ownership and access to data – position statement of the Max Planck Institute for Innovation and Competition as of 16 August 2016 on the current European debate. Max Planck Institute for Innovation & Competition Research Paper No. 16-10 [hereinafter MPI position statement on data ownership and access to data], para 34 (emphasising that the exceptional circumstances test was developed ‘under the assumption of IP protection for the subject matter at issue[, and] whether and how these findings can be applied to situations involving unprotected raw data is yet to be clarified’). https://www.ip.mpg.de/fileadmin/ipmpg/content/stellungnahmen/positionspaper-data-eng-2016_08_16-def.pdf. Accessed 26 Mar 2021.

  301. 301.

    Microsoft (n 298), para 289.

  302. 302.

    As concluded at Sect. 4.2.2 in this chapter.

  303. 303.

    Drexl (2017a), para 125 (further noting that the Magill case ‘laid the foundations for dealing with the issue of information-based dominance’).

  304. 304.

    Microsoft (n 298), para 332 (emphasis added).

  305. 305.

    ibid para 333.

  306. 306.

    Microsoft (n 298), para 335.

  307. 307.

    Enforcement priorities guidance (n 287), para 76. See also Drexl (2017a), para 137 (noting that, in light of the CJEU’s decision in Huawei, ‘the question may be asked whether a refusal to license or a refusal to deal can also be considered abusive if the dominant frm is not vertically integrated’).

  308. 308.

    ibid para 36. See also Drexl (2017a), paras 117, 130 (arguing that ‘control over big data should play a more prominent role in assessing market power and dominance’, and that ‘the collection of datasets for the purpose of enabling big data analysis may […] enhance market power of the firm that controls access to the larger dataset’).

  309. 309.

    Crémer et al. (2019), p. 100. MPI position statement on data ownership and access to data (n 300), para 33 (noting that ‘it is by no means clear how the relevant market for data should be defined when access concerns not individual data, but large data sets for data-mining purposes, and under what conditions different data sets can be considered as substitutable’).

  310. 310.

    MPI position statement on data ownership and access to data (n 300), para 33.

  311. 311.

    In Magill, the CJEU found for the dominant position of the TV stations, which ‘by force of circumstance’ enjoyed ‘a de facto monopoly over the information used to compile listings for the television programmes’. Magill (n 296), para 47.

  312. 312.

    Cummings et al. (2007), p. 20.

  313. 313.

    Drexl (2017a), para 128.

  314. 314.

    See Drexl (2017a), para 128 (observing that substitutability of datasets ‘will depend on the concrete circumstances, including the very nature of the information contained in the data’). Applying the concept of substitutability in the assessment of dominance ‘in a world of big datasets […] remains a most difficult task, since even the petitioner for access, such as a big data analyst, will often only have a vague understanding about the kind of data contained in the dataset and about which data will produce the most valuable new information based on observable correlations’. ibid para 129. See also MPI position statement on data ownership and access to data (n 300), para 33.

  315. 315.

    See Drexl (2017a), para 127. See also MPI position statement on data ownership and access to data (n 300), para 37.

  316. 316.

    Below (nn 330–331) and the accompanying text.

  317. 317.

    For an analysis, see Chap. 8 at Sects. 8.1.4.3 and 8.1.4.4.

  318. 318.

    To define a relevant market, competition law analysis of pharmaceutical cases often applies the Anatomical Therapeutic Chemical (ATC) classification, an international classification system developed by the WHO based on the chemical, pharmacological and therapeutic properties of medicines and organs or systems that they affect. WHO Collaborating Centre for Drug Statistics Methodology, ATC, structure and principles. https://www.whocc.no/atc/structure_and_principles/. Accessed 26 Mar 2021. The third ATC level, which groups medicines by their therapeutic indications (intended use), is usually used define the relevant drug market. Case COMP/A. 37.507/F3 – AstraZeneca, Commission Decision of 15 June 2005, para 371.

  319. 319.

    For a detailed analysis of this scenario, see Chap. 8 at Sect. 8.1.4.4, subheading ‘The Case of Drug Improvements’.

  320. 320.

    Such scenarios are analysed in Chap. 8 at Sects. 8.1.4.3 and 8.1.4.4.

  321. 321.

    Above at Sect. 4.3.4.2, subheading ‘The Dominance of the IPD Holder’.

  322. 322.

    Case C-7/97 Bronner [1998] ECLI:EU:C:1998:569, para 41.

  323. 323.

    ibid para 44.

  324. 324.

    See Chap. 5 at Sect. 5.4.1.2.

  325. 325.

    Chalmers and Glasziou (2009), p. 87.

  326. 326.

    Gøtzsche (2012), p. 237.

  327. 327.

    On this point, see Chap. 8 at Sect. 8.2.3.

  328. 328.

    Tierney et al. (2015).

  329. 329.

    An ‘effect size’ of medical intervention refers to a measure correlating with the outcome of interest, a measurable effect of a health intervention on the clinical manifestations of a disease (e.g. relief of symptoms).

  330. 330.

    Massaro (2009), p. 46.

  331. 331.

    ibid.

  332. 332.

    See Drexl (2017a), para 179 (drawing an analogy with the REACH Regulation and noting that it ‘facilitates access to information beyond the remedies available under competition law’ and pointing out that, while the obligation to share information under the REACH Regulation is motivated by a public interest in avoiding duplicative testing on animals, ‘EU competition law does not exempt the petitioner from making the same investment as the holder of the essential facility’).

  333. 333.

    Crémer et al. (2019), p. 101.

  334. 334.

    For a detailed analysis of this scenario, see Chap. 8 at Sect. 8.1.4.4, subheading ‘The Case of Drug Improvements’.

  335. 335.

    DiMasi and Faden (2011).

  336. 336.

    See Crémer et al. (2019), p. 100 (noting that refusals to grant access to data sought ‘for analytics purposes unrelated to the market in which the data holder is active […] are difficult to bring under the scope of Article 102 TFEU’).

  337. 337.

    Drexl (2012), p. 507.

  338. 338.

    Charles River Associates (2004) Innovation in the pharmaceutical sector, p. 63. https://www.crai.com/insights-events/publications/innovation-pharmaceutical-sector/. Accessed 26 Mar 2021.

  339. 339.

    On innovation as the key parameter of competition in the pharmaceutical sector, see Chap. 8 at Sect. 8.1.2.4.

  340. 340.

    Drexl (2012).

  341. 341.

    See e.g. Ben-Asher (2000), p. 292 (pointing out that the concept of competition in innovation ‘lacks a proper theoretical and empirical foundation because no economic theory or empirical basis conclusively links less research and development competition to less research and development, or less research and development to welfare losses’ (with further references)); Drexl (2012), p. 507 (noting that ‘modern competition law, which strongly focuses on market analysis, may face a major problem in addressing restraints of competition in innovation appropriately’).

  342. 342.

    As emphasised by the Commission, the methodology for assessing refusals to supply set out in its Guidance on enforcement priorities ‘deals only with this type of refusal’. Enforcement priorities guidance (n 287), para 76.

  343. 343.

    As in information-related cases Magill, IMS Health and Microsoft.

  344. 344.

    Institute of Medicine of the National Academies (2015), p. 141.

  345. 345.

    Besides, it is uncertain whether a new product criterion is ‘the only parameter which determines whether a refusal to license an intellectual property right is capable of causing prejudice to consumers within the meaning of Article 82(b)’. See Microsoft (n 298), para 647. Recall that the CJEU proceeded based on a presumption that trade secrets ‘must be treated as equivalent to intellectual property rights’. ibid para 289. It remains to be seen whether the ‘new-product rule’ should be applied to data not protected either under exclusive IP rights or as trade secrets. Drexl (2017a), para 140.

  346. 346.

    For a detailed analysis, see Chap. 8 at Sect. 8.3.

  347. 347.

    This is likely to be the case when access to ‘big data’ is sought for exploratory analysis. See MPI position statement on data ownership and access to data (n 300), para 37 (noting that when ‘access concerns data that are much larger in volume and of unknown or unspecified contents [and when] products or services that might be developed on the basis of such data cannot be readily ascertained at the time when access is granted […] it is not (yet) possible to adequately evaluate the dynamic effects on competition of the refusal to grant access in such cases’).

  348. 348.

    This finding is consistent with the view on competition law as an instrument of access to data in the context of data-driven innovation. See MPI position statement on data ownership and access to data (n 300), paras 31–32.

  349. 349.

    On the potential limitations of applying competition law to unilateral practices in the context of competition in innovation, see generally Drexl (2012). See also Drexl (2013), pp. 317–318 (observing that ‘it may well be that EU competition law lacks any remedy against unilateral restraints that obstruct R&D efforts of competitors prior to the emergence of a new technology or product market or the entry of the firms concerned into existing technology and product markets’).

  350. 350.

    See Chap. 6 at Sect. 6.5.1.2.

  351. 351.

    Currently, only summary results from such trials are required to be submitted to the EU database. Reg 536/2014/EU, art 37(4).

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    Daria Kim

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Kim, D. (2021). Legal Sources of Control Over and Access to Clinical Trial Data Under the EU Applicable Framework. In: Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law. Munich Studies on Innovation and Competition, vol 16. Springer, Cham. https://doi.org/10.1007/978-3-030-86778-2_4

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