Protecting genetic resources – the future of the Nagoya Protocol

April 3, 2014 - Categorised in: - Tags: , , ,

IP & IT analysis: Will the Nagoya Protocol be effective in ensuring a fair distribution of the benefit derived from genetic resources? Brendan Coolsaet and Arianna Broggiato, research fellows at the Centre for Philosophy of Law (Catholic University of Louvain, Belgium), explore the challenges in implementing the Nagoya Protocol.

Controls requiring researchers who use genetic resources to be aware they only use resources that have been accessed in accordance with the laws of the country providing them must be implemented by both the EU and its member states in accordance with the Nagoya Protocol. The Department for Environment, Food and Rural Affairs (Defra) is proposing to implement these new rules through statutory instrument where required and administratively if legislation is not necessary. It plans to introduce a civil sanctions regime for breaches on the new rules. Those wishing to comment on these proposals should do so by 21 April 2014.

What are the broad principles of the Nagoya Protocol?

The Nagoya Protocol to the 1992 Convention on Biological Diversity (CBD) is based on the interdependent principles of ‘access to genetic resources’ and ‘the fair and equitable sharing of benefits arising from their utilisation’–in short, access and benefit-sharing (ABS)–as introduced by the CBD. According to the Nagoya Protocol, art 6, access to genetic resources shall be subject to the prior informed consent (PIC) of the party providing genetic resources (provider country), unless otherwise determined. Fair and equitable benefit-sharing is to be achieved through bilateral negotiations of mutually agreed terms (MATs) between provider and user of genetic resources. The right to determine the terms of access and benefit-sharing through PIC and MATs is derived from the sovereign rights of states to exploit their own resources, enshrined in CBD, art 15(1) and in the customary law.

The Nagoya Protocol further elaborates on and implements the basic principles of the CBD related to the rights of indigenous and local communities (ILCs) to determine the terms of access to their traditional knowledge.

What is the legal status of the Nagoya Protocol?

The Nagoya Protocol is a legally binding agreement aiming to further the implementation of the third objective of the CBD, namely the fair and equitable sharing of benefits arising from the utilisation of genetic resources. Being a subsidiary agreement to the CBD, the Nagoya Protocol’s objective is also to contribute to the first two objectives of the CBD:

  • the conservation of biological diversity, and
  • the sustainable use of its components

As regulated by CBD, art 32, only parties to the CBD can become parties to the Nagoya Protocol. More specifically, the Nagoya Protocol provides more detailed provisions on ABS and clarifies the rights and duties of the parties–with the view of implementing the obligations embedded in CBD, arts 8(j), 15, 16 and 19. It applies to:

  • genetic resources within the scope of CBD, art 15
  • traditional knowledge associated with genetic resource within the scope of the CBD, and
  • the benefits arising from the utilisation of such resources and knowledge

The Nagoya Protocol does not provide for retroactive application of access-related provisions. However, the ABS provisions of the CBD continue to apply to pre-Nagoya Protocol accessions.

The Nagoya Protocol will enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification by parties to the CBD (29 parties have ratified the Nagoya Protocol at the time of writing)

What are the challenges in implementing the Nagoya Protocol and the EU Regulation on compliance measures for users from the Nagoya Protocol (the Compliance Regulation)?

Challenges related to the implementation of the Nagoya Protocol and the Compliance Regulation are numerous. As addressing them all could fill a whole book, we only discuss two important aspects from a legal point of view.

One of the most challenging features of the ABS framework is that ABS is legally grounded in the state’s sovereign rights over genetic resources, while the transjurisdictional exchange of genetic resources is negotiated by private actors. The authority to grant access to genetic resources, for instance, is a prerogative of the state, but can be attributed by the state to well identified non-governmental entities such as research institutes and ex situ collections. In contrast, those acquiring and using genetic resources are in many cases non-state entities, mostly researchers and private companies.

Furthermore, the terms of the exchange (ie MATs) between these actors are normally set out in private law contracts (such as material transfer agreements). These contracts must comply with the rules and procedures for MAT established in the provider countries’ legislation and the rules for monitoring the establishment of MAT in the user countries’ legislation. Therefore, in practice, power over ABS implementation is shared between governmental and non-governmental entities situated both in the user and provider countries.

Another important challenge, in the European context, is the heterogeneity of existing ABS regimes. The Compliance Regulation only entails minimum features which are to be complemented with existing ABS systems and best practices left to the discretion of member states and of users/providers of genetic resources. However, as the EU’s impact assessments on ABS acknowledge, existing instruments strongly differ in terms of depth, scope and effectiveness as well as across different types of users. Furthermore, it is likely that access to and use of genetic material and traditional knowledge is already (indirectly) regulated by private and public law provisions–if not by specific ABS laws–which will impact or be impacted by the harmonisation at EU level. This is further complicated by the plurality of political structures and the division of competences within member states, as well as by the diverging interests of member states (user, provider or both) with the Nagoya Protocol.

How will the protocol affect research and businesses?

Users of genetic resources and/or traditional knowledge accessing such resources and/or knowledge for utilisation will have to consider the following.

If access concerns genetic resources

Users will have to obtain authorisation for access from the competent national authority, if required by the provider country–additional permits may be required if the resources are protected or located in protected areas

If access concerns traditional knowledge

Users will have to obtain authorisation for access from ILCs, if required by the provider country and according to domestic law of the provider country.

Terms of utilisation

Users will have to establish the terms of utilisation, including the conditions of transfer of biological material/traditional knowledge to subsequent users and the benefit-sharing agreements through MATs.

In-country assistance

In some cases the provider country might require foreign users to apply jointly with a legal personality registered within that country–where this is the case, users will have to establish cooperation contracts with local users.

Local rules

Users will have to inquire about, and comply with, the relevant rules of the user country concerning monitoring and user measures (ie due diligence in Europe).

MATs

Users will have to utilise genetic resources in accordance with MATs if they are required by applicable legislation or regulatory requirements, including the sharing of benefits.

What would constitute ‘due diligence’ under the Compliance Regulation?

The Compliance Regulation understands due diligence as seeking, keeping and transferring the internationally-recognised certificate of compliance (ie the permit issued at the time of access) and information on the content of the MATs. If no certificate of compliance exists user shall seek, keep and transfer information related to:

  • the date and place of access of genetic resources or of traditional knowledge associated with genetic resources
  • the description of the genetic resources or of traditional knowledge associated with genetic resources utilised
  • the source from which the genetic resources or traditional knowledge associated with genetic resources were directly obtained, as well as subsequent users of genetic resources or traditional knowledge associated with genetic resources
  • the presence or absence of rights and obligations relating to access and benefit-sharing including rights and obligations regarding subsequent applications and commercialisation
  • access permits (where applicable)
  • mutually agreed terms, including benefit-sharing arrangements (where applicable)

Due diligence is to be exercised when genetic resources and traditional knowledge associated with genetic resources are being exchanged between users of such resources/knowledge.

How will ‘traditional knowledge’ be defined?

There is currently no internationally-agreed definition of ‘traditional knowledge associated with genetic resources’ (TKaGR). The Compliance Regulation defines TKaGR held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the MATs. The definition of TKaGR will thus depend upon the content of the benefit-sharing agreement. In its preamble, the Compliance Regulation indicates that relying on such a dynamic approach ensures flexibility and legal certainty for providers and users.

It should be noted that the Nagoya Protocol, art 17 does not compel parties to monitor the utilisation of traditional knowledge.

What sanctions would an organisation face for breach of the Nagoya Protocol/Compliance Regulations?

The Nagoya Protocol is an international agreement, which applies to states or regional economic integration organisations which are parties to the Nagoya Protocol. As regulated by the Nagoya Protocol, arts 15(2) and 16(2), parties are responsible for the adoption of measures to address situations of non-compliance. Such measures shall be effective, proportionate and dissuasive. Examples of sanctions voiced during the negotiations on the Nagoya Protocol included fines, criminalisation and prohibition of utilisation of the accessed materials in cases of non-compliance.

The initial proposal for the Compliance Regulation included the following examples of penalties (art 11 of the initial proposal COM(2012) 576, published on 4 October 2012):

  • fines
  • immediate suspension of specific use activities
  • confiscation of illegally acquired genetic resources

The Environmental Committee of the European Parliament proposed the following amendments to the Commission’s proposal (Amendments 62 and 63, Draft Report by the Committee on the Environment, Public Health and Food Safety on the proposal for a regulation, published on May 6, 2013):

  • fines proportional to the value of the activities related to genetic resources con-cerned–effectively depriving those responsible of the economic benefits derived from the infringement–and increasing for repeat infringements
  • immediate suspension of specific use activities including commercialisation of products based on genetic resources and associated traditional knowledge

Neither the initial proposals nor the amendments on sanctions were sustained in the final text of the Compliance Regulation. As in the Nagoya Protocol, the Compliance Regulation, art 11 calls upon member states to establish effective, proportionate and dissuasive penalties applicable to non-compliance of users with obligations under art 4 (Obligations of users). Article 11 does not define the terms ‘effective, proportionate and dissuasive’, nor does it specify specific sanctions or penalties related to non-compliance. The EU leaves the responsibility of sanctioning non-compliance to the member-states.

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