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One Sample, One Share! A Proposal to Redress an Inequity with Equity

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Biobanks and Tissue Research

Part of the book series: The International Library of Ethics, Law and Technology ((ELTE,volume 8))

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Abstract

Biomedical research is built on the contributions of the trinity of donors (samples), universities (inventions) and industry (investments). While the law allows universities and industry to capitalize on their contributions, it denies donors of samples both the right to compensation for and the right to control the use of their contributions (Moore’s law).(Moore v. Regents of the University of California (51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479; Bovenberg, August 2005, Nature Biotechnology 37) To resolve this donor “cash and control inequity”, or donor “gains and governance deficit”, this paper explores a novel solution. Both universities and industry typically capitalize on their contributions by contributing these to a corporation in exchange for shares in the corporation’s capital. This form of capitalization triggers an obvious, but hitherto unasked question: if inventors and investors can contribute in exchange for shares, then why can’t donors? Issuing shares for samples may seem an awkward fit, but it is a proper way to give sample donors a say in both the gains and the governance of their samples. In view of the widespread use in the biopharmaceutical industry of stock option plans (for employees, suppliers, accountants, lawyers), a share issue (or sample donor stock options) to those who contribute indispensable material, does not seem out of place. Indeed, such a “shares for sharing” model would resolve all inequities ensuing from the double standard set by Moore’s law in one stroke. As an additional benefit, a share model, by definition, bestows rights (both to govern and to gain) that are commensurate to the value of the contribution. Rather than providing sample donors with a blanket power to unilaterally dictate the terms of commercialization of their samples, providing donors with equity allows for tailor made rights that reflect the proportionate value of this contribution relative to the contributions of the other contributors (inventors and investors). Notably, corporate law thus provides much more sophisticated instruments to resolve complex donor claims than the binary, one size fits all, informed consent doctrine has ever provided. The proposed corporate law instruments even fit the familial and genetic nature of the contributed sample. It allows sample shares to “stay in the family”, securing gains and governance for the donor’s descendants. In sum, the shares for samples model would redress the sample donor cash and control inequity, with equity.

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Notes

  1. 1.

    For example the story behind the HeLa cell line, in Skloot (2010).

  2. 2.

    Bovenberg (2005).

  3. 3.

    Laurie (2002, 318); Gitter (2004, 257).

  4. 4.

    Winickoff and Winickoff (2003, 349, 1181).

  5. 5.

    Bovenberg, supra note 3.

  6. 6.

    Kanellopoulou (2011).

  7. 7.

    Australian Law Reform Commission (2004).

  8. 8.

    Greely (2000); Potts (2002).

  9. 9.

    For example various public consultations for UK Biobank. Available at: http://www.ukbiobank.ac.uk/docs/perceptions.pdf (accessed 07 March 2011).

  10. 10.

    Dr David Cox, senior vice-president at Pfizer, in BBMRI: the Industry Perspective. Available at: http://www.pharmaceutical-technology.com/features/feature97506/ (accessed 07 March 2011).

  11. 11.

    Terry (2003, 377–93).

  12. 12.

    Laurie, supra note 3.

  13. 13.

    Bovenberg (2006), chapter 6.

  14. 14.

    Art. 2:175 Dutch Civil Code.

  15. 15.

    Art. 2:195 Dutch Civil Code.

  16. 16.

    Art. 2:191 Dutch Civil Code.

  17. 17.

    Art. 2:191a Dutch Civil Code.

  18. 18.

    Art. 2:191b Dutch Civil Code.

  19. 19.

    Art. 204a Dutch Civil Code. For contribution in kind after the incorporation, art.204b Dutch Civil Code provides for a similar mechanism.

  20. 20.

    Art. 2:3 Dutch Civil Code.

  21. 21.

    Article 21 Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine, Explanatory Report (ETS No. 164), no. 133.

  22. 22.

    Art. 2:217 (1) Dutch Civil Code.

  23. 23.

    Art. 2:217 (2) Dutch Civil Code.

  24. 24.

    Some commentators question, however, whether this right of the general meeting of shareholders extends automatically to a single shareholder or group of shareholders.

  25. 25.

    Art. 2:231 Dutch Civil Code.

  26. 26.

    Art. 2:19 Dutch Civil Code.

  27. 27.

    Art. 2:317 Dutch Civil Code.

  28. 28.

    Art. 2:18 Dutch Civil Code.

  29. 29.

    Ibid.

  30. 30.

    Art. 2:242 and 2:244 Dutch Civil Code.

  31. 31.

    Art. 2:210 Dutch Civil Code.

  32. 32.

    Art. 2:228 Dutch Civil Code.

  33. 33.

    Art. 2:243 Dutch Civil Code.

  34. 34.

    Crucell, Prospectus dated 28 October 2009, Dividend Policy, p.23.

  35. 35.

    http://www.sec.gov/answers/track.htm (accessed 07 March 2011).

  36. 36.

    Ibid.

  37. 37.

    Johnson & Johnson and Crucell in advanced negotiations for an all cash public offer of €24.75 per ordinary share of Crucell, New Brunswick, NJ, and Leiden, The Netherlands, Press release 17 September 2010.

  38. 38.

    Supra notes 8–12.

  39. 39.

    Press release, Johnson & Johnson Completes Tender Offer for Crucell and Declares Offer Unconditional, New Brunswick, NJ, and Leiden, the Netherlands, 22 February 2011.

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Correspondence to Jasper Adriaan Bovenberg .

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Bovenberg, J.A. (2011). One Sample, One Share! A Proposal to Redress an Inequity with Equity. In: Lenk, C., Sándor, J., Gordijn, B. (eds) Biobanks and Tissue Research. The International Library of Ethics, Law and Technology, vol 8. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-1673-5_6

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