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Personalised Medicine, Individual Choice and the Common Good
  • Edited by Britta van Beers, Sigrid Sterckx, Donna Dickenson
  • Published online:
    02 November 2018
    Print publication:
    22 November 2018
  • Hippocrates famously advised doctors 'it is far more important to know what person the disease has than what disease the person has'. Yet 2,500 years later, 'personalised medicine', based on individual genetic profiling and the achievements of genomic research, claims to be revolutionary. In this book, experts from a wide range of disciplines critically examine this claim. They expand the discussion of personalised medicine beyond its usual scope to include many other highly topical issues, including: human nuclear genome transfer ('three-parent IVF'), stem cell-derived gametes, private umbilical cord blood banking, international trade in human organs, biobanks such as the US Precision Medicine Initiative, direct-to-consumer genetic testing, health and fitness self-monitoring.Although these technologies often prioritise individual choice, the original ideal of genomic research saw the human genome as 'the common heritage of humanity'. The authors question whether personalised medicine actually threatens this conception of the common good.

  • Similar or the Same? Why Biosimilars are not the Solution

  • Lisa Diependaele, Julian Cockbain, Sigrid Sterckx
  • Journal:
    Journal of Law, Medicine & Ethics / Volume 46 / Issue 3 / Fall 2018
    Published online by Cambridge University Press:
    01 January 2021, pp. 776-790
    Print publication:
    Fall 2018

  • Advancements in the field of biotechnology have accelerated the development of drugs that are manufactured from cultures of living cells, commonly referred to as “biologics.” Due to the complexity of the production process, generic biologics are unlikely to be chemically identical to the reference product, and accordingly are referred to as “biosimilars.”

    Encouraging the development of biosimilars has been presented as the key solution to decrease prices and increase access to biologics, but the development and use of biosimilars continues to raise problems, none of which can easily be addressed. Developing a biosimilar requires considerable time and financial resources, and legitimate safety concerns necessitate elaborate clinical testing of biosimilars. As a consequence, the introduction of biosimilars onto the market has not resulted in significant price reductions, and concerns regarding the substitution and interchangeability of original biologics with biosimilars persist.

    This article will explain how the biologics production process distorts the trade-offs that traditionally guided both patent protection and regulatory exclusivities: disclosure as a key condition for benefiting from the corresponding monopoly position. Hence, we propose establishing a mechanism of mandatory deposit of the original biologic's cell line at the stage of the regulatory approval as the most effective remedy.

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