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Final Conclusions and the Outlook

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

Abstract

This chapter synthesises the findings of the analysis de lege lata and de lege ferenda and highlights future research needs.

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Notes

  1. 1.

    Chapter 4 at Sect. 4.2.

  2. 2.

    Chapter 4 at Sect. 4.3.

  3. 3.

    As concluded in Chap. 4 at Sect. 4.2.1.2.

  4. 4.

    Chapter 4 at Sect. 4.3.1.

  5. 5.

    As summarised in Chap. 4, Table 4.1 ‘The relationship between the right of access to documents and reservations for CCI under sector regulations’.

  6. 6.

    Chapter 4 at Sect. 4.2.1.2, subheading ‘No Property Rights in IPD as Personal Data’.

  7. 7.

    As concluded in Chap. 4 at Sect. 4.4.

  8. 8.

    See Chap. 7 Sect. 7.1.1.1.

  9. 9.

    Chapter 7 at Sect. 7.1.1.3.

  10. 10.

    Chapter 7 at Sect. 7.1.1.2.

  11. 11.

    As concluded in Chap. 7 at Sect. 7.3.

  12. 12.

    As summarised in Chap. 7, Table 7.1 ‘Synthesis of theoretical assumptions about R&D externalities and their implications for the allocation of resources to R&D’.

  13. 13.

    Chapter 7 at Sect. 7.2.3.3, subheading ‘The (Controversial) Role of Patents as a Means to Coordinate Research Efforts’.

  14. 14.

    See Chap. 8 at Sect. 8.1.4.

  15. 15.

    As concluded based on the analysis in Chap. 5 at Sects. 5.3; 5.4.1 and 5.4.2, respectively.

  16. 16.

    See also conclusions in Chap. 5 at Sect. 5.5.

  17. 17.

    As discussed in Chap. 8 at Sect. 8.1.4.4, subheading ‘The Case of Drug Improvements’.

  18. 18.

    As shown by the primer on secondary analysis of IPD in Chap. 3 and the specific scenarios in Chap. 8 at Sect. 8.1.4.3.

  19. 19.

    For the reasons discussed in Chap. 8 at Sect. 8.1.4.4.

  20. 20.

    Chapter 8 at Sect. 8.1.4.4, subheading ‘Protection of Exploratory Endpoints as Intermediate Research Results’.

  21. 21.

    As examined in Chap. 9 at Sect. 9.3.

  22. 22.

    Chapter 8 at Sect. 8.2.3.

  23. 23.

    Chapter 8 at Sect. 8.3.5.

  24. 24.

    Chapter 8 at Sect. 8.3.4.

  25. 25.

    As presented in Chap. 9.

  26. 26.

    Chapter 9 at Sect. 9.6.3.2.

  27. 27.

    The intersection between IPD accessibility and patent protection is examined in Chap. 5 at Sect. 5.3.

  28. 28.

    On the proposal for the revision of the relevant provisions under the EU Clinical Trial Regulation, see Chap. 9 at Sect. 9.6.3.

  29. 29.

    Above (Chap. 8, nn 169–177) and the accompanying text.

  30. 30.

    Chapter 8 at Sect. 8.3.5.

  31. 31.

    Chapter 7 at Sect. 7.2.3.2, subheading ‘A Trade-off Between Knowledge Diffusion and Innovation Incentives’.

  32. 32.

    Chapter 2.

  33. 33.

    Chapter 8 at Sect. 8.1.4.4, subheading ‘Protection of Exploratory Endpoints as Intermediate Research Results’.

  34. 34.

    Chapter 7 at Sect. 7.1.2.

  35. 35.

    Chapter 7 at Sect. 7.3.1.

  36. 36.

    See Chap. 7, Table 7.1 ‘Synthesis of theoretical assumptions about R&D externalities and their implications for the allocation of resources to R&D’.

  37. 37.

    Above (Chap. 7, nn 145–148) and the accompanying text.

  38. 38.

    See Chap. 8 at Sects. 8.2.3.2 and 8.2.3.3.

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Kim, D. (2021). Final Conclusions and the Outlook. 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_10

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  • DOI: https://doi.org/10.1007/978-3-030-86778-2_10

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