Masterarbeit

The Nagoya Protocol - Background and impact on Pharmaceutical Industry ***

Dr. Anna Ernst (2019)

Summary
Language: English
In 1993, the Convention on Biological Diversity (CBD) entered into force aiming amongst others the fair and equitable sharing of benefits arising out of the utilisation of genetic resources. The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity is a supplementary, binding, international agreement to the CBD and is intended to further concretize and improve the implementation of the access and benefit-sharing (ABS) obligations already foreseen under the CBD. It applies to genetic resources and traditional knowledge associated with genetic resources as well as to the benefits arising from their utilisation. The Nagoya Protocol (NP) shall create greater legal certainty and transparency for providers but also for users by establishing more predictable conditions for the access to genetic resources. It was adopted on 20 October 2010 in Nagoya/Japan and entered into force on 12 October 2014. After ratification of the NP by the European Union, Regulation (EU) No 511/2014 was adopted in order to implement the required monitoring and compliance provisions. In Germany, the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014 regulates the institutional competencies, establishes enforcement powers and defines possible sanctions for violations.
The first years after implementation of the NP and Regulation (EU) No 511/2014, respectively, have already shown that it is a highly complicated task and a lot remains to be done by all involved actors. Until now, the number of countries with clear, transparent and functioning access measures in place are still limited. Instead, there is a multitude of intransparent and not-harmonised requirements among the Parties to the NP. This fact discourages users from complying with the due diligence obligations. Further challenges are rapid technological developments in research and development, which needs to be understood in order to decide upon their relevance regarding the scope of the NP. However, it has been shown that the NP already contributes to raise awareness of the value of conservation and sustainable use of biodiversity and ecosystem services. There are already several examples demonstrating that the basic concept and objective of the CBD and NP have been reached. Especially with respect to the current debates on climatic change and the loss of biodiversity, the conservation of the biological diversity and the sustainable use of its components should be of interest to all of us.
Pages: 64; Annex I, pages: 8