Published November 2016
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 (Nagoya Protocol), which was adopted in 2010 and entered into force on 12 October 2014, is a supplementary agreement to the Convention on Biological Diversity (CBD). It provides a legal framework that governs access to non-human genetic resources and traditional knowledge.
Are there recent scientific, legal or social developments?
The Nagoya Protocol was brought into EU law by the adoption of Regulation EU No 511/2014 on 16 April 2014, although some of the key provisions only became applicable on 12 October 2015. In the UK, this EU regulation has been implemented by the Nagoya Protocol (Compliance) Regulations 2015. In particular, the Nagoya Protocol details information that must be included in the prior informed consent given by the provider country, and a general obligation to establish a benefit sharing agreement between the provider and user.
Are there complex ethical issues?
One of the fundamental elements underpinning the Protocol is the equitable sharing of benefits. In practice, the majority of the agreements are expected to be signed between biodiversity-rich, and often developing, countries, and users from more advanced countries. Access and benefit sharing for the utilisation of genetic resources has been a controversial issue in the past, and it was felt that the CBD did not offer sufficient legal clarity to protect the rights of states and indigenous communities over their local resources. Companies and scientists sometimes developed and patented commercial products based on genetic resources, resulting in accusations of biopiracy. The Nagoya Protocol aims to combat this by ensuring that developing states benefit from the use of their genetic resources by foreign institutions. A question that could be explored is whether the protocol succeeds in these aims, and whether there are further issues concerning respect for autonomy, the recognition of human rights, and justice for indigenous peoples and citizens of developing countries that cannot be addressed through legislation, and might be better addressed by education and codes of ethics and best practice. Additionally some institutions, including the Wellcome Trust, have raised concerns about the potential negative impact on international research efforts (e.g. monitoring of drug resistance and responding to disease outbreaks), which rely on open and comprehensive databases that source information from many countries. The concern is that the requirements contained within the protocol will restrict the efficient sharing of information, or that research institutions might migrate to countries that have not ratified the Protocol, such as the USA or China.
Is there a potential policy impact?
DEFRA’s Consultation on implementing the Nagoya Protocol (CINP) highlighted the need for clarification on a number of aspects of the EU Regulation and UK implementation. These included:
- what constitutes due diligence (which users must exercise when ascertaining whether a genetic resource has been accessed in accordance with regulatory requirements);
- whether the Protocol applies to derived materials (e.g. DNA sequences); and
- how to collaborate with organisations from countries that are not signatories.
The government response detailed in the CINP does clarify some issues and there is minimal guidance on the ABS: compliance and guidance webpage with links to the CBD’s Access and Benefit-Sharing Clearing-House, and the EU’s Commission Implementing Regulation for Article 5 on the register of collections, Article 7 on making declarations of due diligence, and Article 8 on best practices. DEFRA and the National Measurement and Regulation Office (NMRO) have responsibility for producing guidance relating to the UK implementation and raising awareness of the protocol and its implementation.
Is it a subject of public concern?
It would appear that the existence of the Nagoya Protocol has remained largely outside of the public’s awareness thus far. However, the ability of the international community to prevent and respond to potential epidemics or pandemics is likely to be a subject of significant public concern.
Is consideration timely?
The UK government will conduct a review within five years to address any concerns that arise from the implementation of the EU Regulation. In addition, the EU Regulation requires Member States to provide a report on its application by 11 June 2017, and so a review of some type is likely to be carried out before this date.
Can the Council offer a distinctive contribution?
The Nagoya Protocol is essentially a legal development, albeit one with important implications for future biological and medical research. However, it may be that the Council can offer a neutral perspective on some of the raised concerns, or provide a platform for involved parties to debate the potential impact of this Protocol on research. In addition, this topic might provide the opportunity to explore some of the ethical challenges that were highlighted in the previous background paper on pandemics and the global response to disease outbreaks.
Possible future work topics
This is one of the topics that have been suggested as possible project areas for further investigation by the Council. These topic summaries do not aim for comprehensiveness; rather, they are intended to sign-post some of the key considerations and to provide a starting point for discussion. Each summary includes links to relevant publications on the topic.