Microbiology is an interconnected discipline, with researchers all over the world sharing samples and genetic data at an ever increasing pace. But how can we ensure that everyone can also benefit from any discoveries made? In this post, Katie Beckett from the UK Government’s Department for Business, Energy and Industrial Strategy (BEIS) tells us about the Nagoya Protocol, which aims to ensure that research benefits are shared in an equitable way.
Throughout human history, micro-organisms have played a critical role in the development of human society. From brewing beer to the Black Death, their impact has been significant, and microbiologists such as van Leeuwenhoek and Fleming have earned their place in history. Today, microbiology is a fundamental discipline in driving forward innovative research and new product development, such as producing new antibiotics to combat increasing drug resistance or studies into the effects of microbial communities on carbon and nitrogen cycles and resulting impacts on climate change. Microbiology is applied across a whole host of sectors and research areas with the micro-organisms themselves often being sourced from specialist collections around the world. In the first instance however, these genetic resources come from nature, existing in every part of the global biosphere – from the soil, atmosphere, and ocean, to hot springs and rock formations.
The protection and use of biological resources is of international concern. The Nagoya Protocol on access and benefit sharing (ABS), which entered into force in October 2014, is an international agreement that supplements the UN Convention on Biological Diversity (CBD). The agreement aims to ensure that benefits arising from research and development of genetic resources are shared in a fair and equitable way, thereby contributing to the conservation and sustainable use of biological diversity.
To date, 100 countries have ratified the Nagoya Protocol including the UK, which became a Party to the Protocol in May 2016. Under the Nagoya Protocol, Parties are obliged to take measures in relation to access to genetic resources and benefit sharing, with the aim of creating legal certainty for those seeking to access these resources for research and development programmes.
Through the adoption and implementation of effective access measures, countries can capture benefits that result from research and development of genetic resources over which they exercise sovereign rights. For this to be successful, legislation must facilitate access to the genetic materials, as without access there would be no opportunity for benefits. Benefits can be monetary or non-monetary with the conservation of biological diversity being of paramount concern. The concept of benefit sharing is not new, particularly for those working in academia and public institutions where results are routinely shared, papers are co-authored and knowledge is transferred between institutions and across geographical borders.
The Nagoya Protocol also requires Parties to establish compliance measures for users of genetic resources within their jurisdiction. In the UK, Nagoya Protocol obligations are implemented through Regulation (EU) No. 511/2014 on compliance measures for users. Regulatory Delivery, a directorate within the Department for Business, Energy and Industrial Strategy has been appointed by The Department for Environment, Food and Rural Affairs (Defra), the policy lead, as the competent authority responsible for UK implementation. Under the EU Regulation, users of genetic resources must ensure these resources have been accessed in accordance with the legislation of the provider country.
Over the past 18 months, Regulatory Delivery has focused on raising awareness and supporting compliance of UK users across a broad range of sectors including academia and pharmaceuticals, as well as cosmetics, food & beverage, bio-control, collections and others. There are also a number of tools available to support implementation and compliance, with the primary example being the Access and Benefit Sharing Clearing House (ABS-CH), an online platform acting as an information portal for details on country status, national contacts, legislation and administrative measures and examples of codes of conduct and best practices. In relation to measures for users in the EU, a cross-sector guidance document is available and sector-specific guidelines are currently under development to compliment this.
There will always be challenges when embedding new processes such as ABS into diverse areas of work as found within the microbiology community, but it is important not to lose sight of the overarching objectives, the conservation of biological diversity, and the opportunities that it presents both providers and users of micro-organisms.
Katie is the Enforcement Team Leader for Access and Benefit Sharing at Regulatory Delivery, The Department for Business, Energy and Industrial Strategy (BEIS). If you’ve any queries about how the Protocol might affect your work, please contact her via email.