Abstract
The rapid pace in the progression of life sciences pushes law in one of its most significant intrinsic features : the principle of certainty . While uncertainty and the modifiability of its results are of normal currency in life sciences , they are especially problematic in law , jeopardizing the very essence of equality and non-discrimination . It is also worth mentioning that life sciences work on a very diverse set of materials and cases that usually differ from each other. Any even minimum specific traits of bio-objects must be considered so as to avoid an undifferentiated and therefore unreasonable legal regulation . Law as a codified set of general principles also suffers from this perspective . Taking the above into consideration, this chapter proposes a number of coordinates, which can give biolaw the necessary features to cope with a difficult, ever-changing and very specific dimension of human knowledge —building, in this way, an open, updated and attentive biolaw for 21st Century life sciences .
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Notes
- 1.
The online version of the New Oxford American Dictionary defines Life Sciences as “the sciences concerned with the study of living organisms , including biology , botany, zoology, microbiology, physiology, biochemistry, and related subjects”. The Life Sciences page of Wikipedia lists 31 entries under the heading Biology and its branches, 29 entries under the heading Medicine and its branches and 34 entries under the heading New and other life science types. For the purposes of this chapter, the main reference goes to sciences dealing with physical and psychological human wellbeing.
- 2.
In a century, life expectancy at birth in a number of countries has risen from around 50 years to more than 80. The main problem , due to causes ranging from the spread of HIV to poor availability of drinking water, consists in the lack of homogeneity at the global level.
- 3.
We are not mentioning Nuremberg or Tuskegee. We are referring to much more current unethical and illegal conducts such as ‘evergreening’ (Novartis AG v. Union of India and Others, 2013, 6 SCC 1), ‘pay-for-delay’ (the Fentanil case in which J&J and Novartis were fined 15 million Euro by the European Commission ) or ‘non-disclosure agreement’. See, for instance Garattini et al. (2013).
- 4.
Other details on the website of the US Department of Justice : https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report.
- 5.
The inclusion goes back to 1994, modified in 2011: https://www.legifrance.gouv.fr/affichCode.do?cidTexte=LEGITEXT000006072665.
- 6.
In September 2009, when the Director of Public Prosecutions for England and Wales was debating the severity of the crime of abetting suicide, he opened an online public consultation, with nine questions. The consultation received more than 5000 replies, from individuals and associations on both fronts, which were taken into account by the office in issuing a new Policy for Prosecutors in Respect of Cases of Encouraging or Assisting Suicide, which now recognizes a not always overriding public interest in favour of the prosecution.
- 7.
In general terms, Ranchordás (2014) sees absolute stability as “impossible (and even undesirable) to achieve since, first, legislators and regulators do not possess complete information about all the required elements which can cause or solve the social problems requiring legislative or regulatory intervention; secondly, legislators are unable to eliminate the risk-factor which underlies legislation ; thirdly, legislators are constantly confronted with the obsolescence of laws and the possible occurrence of mistakes in lawmaking. In addition, absolute certainty in legislation or regulation does not have a place in a world characterized by constant change”.
- 8.
On the contrary, the Italian Act no. 40/2004 on artificial reproduction techniques does not contain any temporary clause. Only the Guidelines provide for an invitation to periodic reconsideration, which, however, does not refer to a possibly changed cultural climate, but only to technical and scientific progress: “The guidelines are periodically updated, at least every three years, in relation to technical-scientific evolution ”.
- 9.
The Guidelines go as follows: “the high risk of infection for the mother or the foetus is in fact , in objective terms, an impediment of procreation, by requiring the adoption of precautions that result necessarily in cause of infertility, to be included among the cases of severe male infertility to be ascertained and certified by medical act”.
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Casonato, C. (2019). The Essential Features of 21st Century Biolaw. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_6
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