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Friday, September 15, 2017

Biotechnology law in the European Union up for debate

European legislation guarantees neither the conservation nor sustainable use of biological resources and their components, according to a study by the UPV/EHU-University of the Basque Country

A study conducted in the UPV/EHU's Department of Constitutional Law, Administrative Law and the Philosophy of Law has concluded that European Union Legislation on protecting biological material is insufficient and strengthens the position of large biotechnology companies.

The conservation and sustainable use of biological diversity in the face of biotechnological applications is an aim stipulated in European Union legislation. The researcher Ricardo Ignacio Bachmann-Fuentes has analysed EU law applicable in these matters starting from an initial hypothesis that "there is a high standard of protection in the European Union. Oddly enough, this hypothesis was rejected. Many doubts are raised, above all with respect to risk analysis in biosecurity, since much of European and international law in this matter seems to be conceived in a way that is tailored to the transnational biotechnology companies," he pointed out. In other words, according to the author of the study, "there is no appropriate legislation with respect to the conservation and sustainable use of resources".

He also explored the appropriating of biological resources through intellectual property rights. "For example, a biotechnology company incorporates a gene from an insect into a variety of maize and then proceeds to patent it, as well as protecting it by means of breeder's rights. So by means of these rights the company appropriates itself of the genetic resource and the associated traditional knowledge," confirmed Ricardo Ignacio Bachmann. All this has a bearing "on the loss of the planet's biological diversity, and jeopardises the environment and the population's food security because biological diversity is decreasing," he added.

Change of direction

The researcher has put forward various proposals designed to change the direction of the current policies and reverse this situation. "My main proposals relate to the incorporating of biosecurity principles into the law on intellectual property, as in the case of the precautionary principle". He defends the position that there has to be a risk assessment with respect to biological diversity before granting protection to a biotechnological innovation, "in other words, if the intention is to patent a variety of maize, the interested party has to prove beforehand that this variety of maize is not going to have a negative impact on the existing biological diversity".

He also proposes that a system be set up to protect biotechnological innovations that is of a lower rank than the current one, "which constitutes overprotection that restricts the rights of traditional farmers and stockbreeders.  If a farmer keeps traditional seeds, he/she cannot use them because there is an owner to whom a levy has to be paid for the intellectual property rights. All this has been gradually eroding the European Union's genetic diversity," explained Bachmann.
Finally, he stresses the validity of the compulsory mechanisms of public participation and information involving farmers, stockbreeders, ecologists, and experts in all the areas, and which results in the specification of a directive, "whereby the right resulting from this process is the product of deliberative democracy". 

Additional information

This research has been conducted within the PhD thesis of Ricardo Ignacio Bachmann-Fuentes (Chile, 1975), entitled Derecho de la biotecnología de la Unión Europea. Nuevas perspectivas jurídicas sobre conservación y utilización sostenible de la diversidad biológica y sus components (Biotechnology Law in the European Union. New legal perspectives on the conservation and sustainable use of biological diversity and its components). His supervisor was Iñigo Urrutia-Libarona, adjunct lecturer in Administrative Law in the UPV/EHU's Department of Constitutional Law, Administrative Law and the Philosophy of Law.

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