3 August 2016
By Katie Beckett, ABS Project Manager at the Department for Business, Energy & Industrial Strategy
The world’s flora has been studied for millennia. The first plant records known to exist are from the Neolithic Revolution, about 1000 years ago, the same period that is often described as the Agricultural Revolution. Fast forwarding through history, from the work of Mendel to new drug discovery and advances in molecular biology, plant science is at the cutting edge of research and development (R&D) in many sectors around the world.
Pharmaceutical, food & beverage, cosmetic, textiles and agriculture are just a selection of those sectors that would not be where they are today without research into plants, their derivatives and by-products. Alongside industries researching plant material to develop innovative commercial products, the UK is home to several leading plant science university departments and research institutions, accessing plant genetic resources from around the world for their own research purposes.
The Nagoya Protocol
R&D forms the cornerstone of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation, an international agreement which was adopted in 2010 and addresses the third component of the Convention on Biological Diversity (CBD).
Until recently, plant material for research purposes was moved between countries often with little more than a Material Transfer Agreement (MTA) and phytosanitary certificate. However, with the entry into force of the Nagoya Protocol in 2014, those wishing to conduct R&D on plant genetic resources may have to consider additional requirements.
By promoting the fair and equitable sharing of benefits arising from these R&D activities, the Protocol aims to incentivise countries and communities to protect, conserve and sustainably use indigenous biodiversity. Benefit sharing can take many forms and of relevance to the plant science academic community, for example through the sharing of research results, capacity building or the training of plant scientists. Where the work goes beyond academic research, and commercialisation takes place, benefit sharing may take other monetary forms. Although there are no prescribed benefit sharing formats, Annex 1 of the Nagoya Protocol provides some suggestions.
Regulations and compliance
In the UK, and indeed across Europe, R&D conducted on plant material obtained from a country which is Party to the Nagoya Protocol, may be in scope of Regulation (EU) No. 511/2014 on compliance measures for users. This piece of European legislation outlines what those involved in such R&D activities must do in order to meet the provisions of the Nagoya Protocol and comply with the rules governing research in the EU.
Given the complexity of the topic and its relatively recent entry into force, there a number of tools that plant scientists should be aware of to help navigate the legislation and provide support in meeting the requirements. The ABS Clearing House is an online platform for exchanging information designed to facilitate implementation of the Protocol. Over time this platform will be increasingly populated with information including details of all the Parties to the Protocol, legislative and administrative measures in place and other supporting documentation.
More specific to those researchers in Europe, the European Commission have worked with Member States in the development of a guidance document, spanning all sectors and providing, amongst other information, scenarios of activities that fall in and out of scope. Complementary to the horizontal guidance, plans are afoot for the development of sector specific guidelines, addressing the intricacies of the sectors involved and how they use genetic resources.
It is understandable that the provisions under the Nagoya Protocol and the EU Regulation may be daunting despite the overall objectives largely falling in line with what plant scientists around the world are striving for; conservation and sustainable use. Regulatory Delivery, a Directorate of The Department for Business, Energy and Industrial Strategy (BEIS), is responsible for enforcing the regulation in the UK and supporting UK researchers, organisations and businesses to meet the requirements while facilitating innovation and the continued development of the UK’s science and research industry.
Those working with plant genetic resources in a R&D capacity, whether academic or commercial, are encouraged to assess their activities in relation to the relevant regulations and make use of the available tools to support compliance. For information regarding implementation and compliance in the UK, please contact Regulatory Delivery, on email@example.com