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Achieving Sustainable Drug Development Through CSR: Possibility or Utopia

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Bioeconomy for Sustainable Development

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Abstract

This book chapter looks into corporate social responsibility (CSR) and meta-regulation as legislative technique as a way to implement regulatory incentives of sorts aiming to foster sustainable drug development. The chapter pays particular attention to supplementary protection certificates, the recent manufacturing waiver in the EU, and PRIME. By reviewing these regulatory inccentives, the chapter reflects on the need to include CSR principles in future legislative reforms, which should not focus exclusively in recouping investments but instead in achieving a balance amongst stakeholders’ and patients’ interests, thus proposing meta-regulation as a means to achieve it.

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Notes

  1. 1.

    See PRIME: priority medicines, available at:<https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines> (accessed, 15 Feb 2019).

  2. 2.

    The term “legislator” is purposefully avoided, since the initiative although based in Law is not law.

  3. 3.

    Marrakesh Agreement establishing the World Trade Organization, Geneva, 15 April 1994, entered into force 1 January 1995, 1867 United Nations Treaty Series 3, annex 1C – Agreement on Trade-Related Aspects of Intellectual Property Rights (1994), ‘Art. 7: The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations’.

  4. 4.

    Idem Art. 8(1): ‘Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.

    (2). Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology’.

  5. 5.

    Or at the regional level, case in point the EU. In other words, allowing for the insertion of voluntary incentives to foster collaboration or even reduce R&D costs by assisting in clinical trials or waiving fees as foreseen within PRIME. See further section 2.3.

  6. 6.

    See Art. 33 TRIPS Agreement. At the EU level, patent protection is established at the Convention on the Grant of European Patents of 5 October 1973 as amended by the act revising Article 63 EPC of 17 December 1991 and by decisions of the Administrative Council of the European Patent Organisation of 21 December 1978, 13 December 1994, 20 October 1995, 5 December 1996, 10 December 1998, and 27 October 2005. See Art. 63.

  7. 7.

    These patent strategies focus on excluding competitors without pursuing innovative efforts. See Commission, ‘Pharmaceutical Sector Inquiry Final Report, Part I’ (8 July, 2009); and ‘Communication from the Commission – Executive Summary of the Pharmaceutical Sector Inquiry Report’ (8 July, 2009).

  8. 8.

    World Health Organization, Sixty-Eight World Health Assembly, Decision A68/DIV./3 (5 June 2015)

  9. 9.

    Regulation (Ec) No 469/2009 Of The European Parliament And Of The Council Of 6 May 2009 Concerning The Supplementary Protection Certificate For Medicinal Products (Codified Version)

  10. 10.

    Impact Assessment Accompanying the Document Proposal for A Regulation Of The European Parliament And Of The Council Amending Regulation (Ec) No 469/2009 Concerning The Supplementary Protection Certificate For Medicinal Products.

  11. 11.

    Idem

  12. 12.

    See Art. 7 and 8 TRIPS Agreement.

  13. 13.

    See Regulation (EC) No 469/2009 Of The European Parliament And Of The Council Of 6 May 2009, and amendment full quote.

  14. 14.

    See Preamble from Regulation (EC) No 469/2009 Of The European Parliament And Of The Council Of 6 May 2009.

  15. 15.

    See Council Conclusions on strengthening the balance in the pharmaceutical systems in the EU and its member states. European Union: European Commission, Commission Staff Working Document Impact Assessment: Accompanying documents for Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products, Brussels May 2018, SWD(2018) 240 Final.

  16. 16.

    Idem.

  17. 17.

    See Plomer, A. “A Unitary Patent for a (Dis)United Europe: The Long Shadow of History” in46 IIC – International Review of Intellectual Property and Competition Law 5, August 2015, pp. 508–533.

  18. 18.

    See European Union: European Commission, Commission Staff Working Document Impact Assessment: Accompanying documents for Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products, Brussels May 2018, SWD(2018) 240 Final.

  19. 19.

    Smart legislation is a terminology used by Mittra et al. (2011) requiring from regulators to design legislation implementation that is sensitive to opportunities emerging from life sciences and is not exclusively addressed to sustain multinational dominance.

  20. 20.

    Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p.1), last amended by Regulation (EC) No 596/2009 (OJ L 188, 18.07.2009, p. 14).

  21. 21.

    See SPC Dir granting two additional years of protection against unfair competition, note the term of protection is generally 8.

  22. 22.

    See Kimberley Process Certification Scheme (KPCS) available at: <https://www.kimberleyprocess.com>.

  23. 23.

    European Parliament, Options for improving access to medicines, European Parliament resolution of 2 March 2017 on EU options for improving access to medicines (2016/2057(INI)).

  24. 24.

    Art. 7 TRIPS Agreement.

  25. 25.

    Art. 8(1) TRIPS.

  26. 26.

    EU Medicines Agencies Network Strategy to 2020, Working together to improve health (EMA/MB/151414/2015, 17 December 2015).

  27. 27.

    EMA, Enhanced early dialogue to facilitate accelerated assessment of PRIority Medicines (PRIME) EMA/CHMP/57760/2015.

  28. 28.

    European Medicines Agency, Committee for Medicinal Products for Human Use, Enhanced early dialogue to facilitate accelerated assessment of PRIority Medicines (PRIME), 7 May 2018, EMA/CHMP/57760/2015, Rev. 1.

  29. 29.

    European Medicines Agency, Committee for Medicinal Products for Human Use, Enhanced early dialogue to facilitate accelerated assessment of PRIority Medicines (PRIME), 7 May 2018, EMA/CHMP/57760/2015, Rev. 1.

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Author information

Authors and Affiliations

  1. Faculty of Law, Turku Institute of Advanced Studies, University of Turku, Turku, Finland

    Dhanay M. Cadillo Chandler

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  1. Dhanay M. Cadillo Chandler
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Correspondence to Dhanay M. Cadillo Chandler .

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Editors and Affiliations

  1. Department of Biochemistry, Institute of Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India

    Chetan Keswani

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Cadillo Chandler, D.M. (2020). Achieving Sustainable Drug Development Through CSR: Possibility or Utopia. In: Keswani, C. (eds) Bioeconomy for Sustainable Development. Springer, Singapore. https://doi.org/10.1007/978-981-13-9431-7_15

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