Objectives of the protocol

Objectives:

1. Article 1 of the Protocol addresses the “fair and equitable sharing of the benefits arising from the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components”.
2.  Creating greater legal certainty and transparency for both providers and Users of genetic resources by:

• Establishing more predictable conditions for access to genetic resources.
• Helping to ensure benefit-sharing when genetic resources leave the contracting party providing the genetic resources.
• Ensuring benefit-sharing by creating incentives to conserve and sustainably use genetic resources, and therefore enhance the contribution of biodiversity to development and human well-being.

The Protocol outlines enforceable procedures for ensuring that genetic resources taken from a country of origin is done with the Prior Informed Consent (PIC) of that country and that Users have appropriate legislative, administrative or policy measures to ensure that benefits from the utilization of genetic resources (including subsequent applications and commercialization) are equitably shared upon Mutually Agreed Terms (MAT).

Nagoya Protocol (Compliance) Regulations 2015, SI 2015/821 [pdf]

Implementation of the Regulations (part 1 and 2) came into force in the UK on 9 July 2015, parts 3-6 and the Schedule came into force on 12 October 2015. In the UK, the office of Secretary of State is responsible for maintaining a register of trusted collections of genetic resources, monitoring User compliance, and encouraging awareness of, and compliance with the Protocol. The Department for Environment Food and Rural Affairs (DEFRA) is responsible for implementing the EU Regulation relating to the Protocol. The competent authority enforcing the legislation in the UK is the National Measurement Office.

Sanctions

The duties on all Users of genetic resources will be enforced in the UK by a range of civil penalties, from fines to injunctions on the use of the resources in question. DEFRA indicates that fines of up to £250,000 and a maximum of two years in prison will be appropriate penalties for the most severe cases of wilful non-compliance. Note that the requirement for a User to demonstrate that it has complied with the requirements of the Protocol commenced on 12^th October 2015.

Universities (and their members of staff) are “Users” if they conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology. Further, the award of research funding is seen under the Regulation as one of the key check points for establishing and monitoring compliance of Users with the Protocol.   Therefore appropriate due diligence should be carried out.

The Regulations also applies to collections collected and held by Universities. Recital (18) of the Regulation states: “The collection of genetic resources in the wild is mostly undertaken for non-commercial purposes by academic, university and non-commercial researchers or collectors.  In the vast majority of cases and in almost all sectors, newly-collected genetic resources are accessed through intermediaries, collections, or agents that acquire genetic resources in third countries”.

Relevance to the College

Universities (and their members of staff) are “Users” if they conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology. Further, the award of research funding is seen under the Regulation as one of the key check points for establishing and monitoring compliance of Users with the Protocol.   Therefore appropriate due diligence should be carried out.

The Regulations also applies to collections collected and held by Universities. Recital (18) of the Regulation states: “The collection of genetic resources in the wild is mostly undertaken for non-commercial purposes by academic, university and non-commercial researchers or collectors.  In the vast majority of cases and in almost all sectors, newly-collected genetic resources are accessed through intermediaries, collections, or agents that acquire genetic resources in third countries”.