Implementation of the Nagoya Protocol
The collecting, obtaining and utilisation of seeds, plants and other living organisms from other countries are governed by international rules. The aim of the Nagoya Protocol is to properly regulate and simplify access to genetic resources and to promote the fair sharing of benefits arising from their utilisation. Nonetheless, implementation of policy in this field remains complex. What does the Nagoya Protocol cover (and what not), and how does this translate into practice?
From Convention on Biological Diversity to Nagoya Protocol
The Nagoya Protocol emerged from the Convention on Biological Diversity (CBD) which was opened for signature at the Earth Summit in Rio de Janeiro on 5 June 1992. Among other things, this Convention states that countries have sovereign rights to the genetic resources on their territory. This means that users such as researchers and breeders must check whether the country of origin of the genetic resources has introduced rules governing access to them. The CBD was signed by 196 parties and entered into force on 29 December 1993.
The three main aims of the CBD are:
- the conservation of biological diversity (or biodiversity)
- he sustainable use of its components
- the fair and equitable sharing of benefits arising from genetic resources
Since the utilisation of genetic resources can deliver knowledge or profit, countries rich in genetic resources – often developing countries – wish to share in the benefits obtained in countries in which the genetic resources are utilised. On the other hand, for countries such as the Netherlands, which make use of a lot of genetic resources from other countries for purposes such as breeding new plant varieties, it is crucial that the international exchange of genetic resources can take place without unnecessary hindrance.
Suitable financing for access to these genetic resources, known as Access and Benefit-Sharing (ABS), formed part of the arrangements made at the Earth Summit in Rio. However, no clear pointers were given as to how this was to be implemented. For this reason, a separate protocol, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising for their Utilisation (Nagoya Protocol), was drawn up in 2010. The purpose of this Protocol is to clarify, further concretise and promote the implementation of the third objective of the CBD, namely the fair and equitable sharing of the benefits arising from the utilisation of genetic resources. Although the Nagoya Protocol provides a clearer indication of the form ABS rules can take, they still require implementation at national level. The Nagoya Protocol entered into force on 12 October 2014. At present, 93 countries are signatories to the Nagoya Protocol, three have ratified the Protocol but are not yet party to it, and 105 are not yet participating, including the USA, since it has also not ratified the CBD (data from ABS Clearing House, 22 March 2017).
How does it work?
The Nagoya Protocol is based on Prior Informed Consent (PIC) of the country providing the resources, and Mutually Agreed Terms (MAT) on benefit-sharing between the user and the supplier. Users must always check whether a country requires PIC and/or MAT. MAT determine the conditions for the utilisation of genetic resources and the sharing of the benefits and are included in the agreement between the supplier and the user of the genetic resources.
The parties to the Nagoya Protocol must take measures themselves to ensure compliance with the ABS rules. Therefore, signature of the Nagoya Protocol is not enough on its own: national legislation and regulations are also needed. Of the 93 countries that have signed up, 31 have taken measures, at national level, to implement the ABS obligations of the CBD and/or the Nagoya Protocol (data from ABS Clearing House, 22 March 2017). However, this does not necessarily mean that PIC and MAT can be obtained in practice.
Forty-eight percent of countries in Europe are party to Nagoya, and of those, 76 percent have taken legislative, administrative or policy measures concerning ABS. In Asia, 35 percent of countries are party to the Nagoya protocol and 12 percent of those have taken national measures. Qatar has ratified the Protocol but is not yet party to it. In South America, five of the twelve countries (42 percent) are party to the Protocol and of those, only Peru has a national regulatory regime. Brazil is not a party but has also set up a national regulatory regime.
The ABS Clearing House (ABSCH) platform was set up as a place to exchange information on ABS regulations. It is designed to help users determine what rules apply in the countries that are party to the Nagoya Protocol and the CBD.
In 2014 the European Union adopted Regulation (EU) No 511/2014 in implementation of the compliance part of the Nagoya Protocol. All users of genetic resources in the EU must comply with this regulation, which, like the Nagoya Protocol, entered into force on 12 October 2014. ABS rules are not regulated by the EU per se; access and benefit-sharing are arranged by the member states themselves. To supplement the Regulation, a Commission Implementing Regulation (Regulation (EU) No 2015/1866) was also drawn up to provide additional clarification of some of the articles of the Regulation. The European regulatory regime requires users of genetic resources to make the necessary effort (“due diligence”) to demonstrate that the genetic resources they work with were obtained legally and may be applied for the user’s desired purpose. In addition, users must ensure that any benefits from the utilisation of these resources are shared fairly and equitably. EU member states are required to check that users are in compliance with this obligation and must ensure that infringements of the Regulation are rectified or punished. To achieve this, member states must set up a “competent authority”, a “national focal point” and a “monitoring authority”. In addition, they must define what corrective or disciplinary action will be taken if the Regulation is infringed. Because the regulatory regime does not as yet provide sufficient clarity, the European Commission and the member states are working on supplementary documents that will elaborate on the scope of the regulations. For example, in August 2016 a Horizontal Guidance document was issued in which cross-sectoral elements were explained. Work is also ongoing on sectoral Guidance Documents. The Guidance Document for the Plant Breeding Sector was completed by consultants and experts in early 2017 and is now entering the political process.
In the Netherlands, the Act Implementing the Nagoya Protocol (Wet Implementatie Nagoya Protocol) was introduced on 30 September 2015 and entered into force in April 2016. This law regulates the direct effect of the EU Regulations (EU No 511/2014 and EU No 2015/1866). The Dutch Food and Consumer Product Safety Authority (FCPSA) was designated as the monitoring authority and the Centre for Genetic Resources, the Netherlands, at the University of Wageningen Research Centre (Wageningen UR) as the national focal point for access and benefit-sharing. This means that Dutch users can now be monitored to ensure they exercise care when utilising genetic resources. The website of the Dutch ABS Help Desk offers information for users of genetic resources.
In 2016 the FCPSA immediately started consulting with companies on the interpretation of the regulatory regime. They realise that breeding companies already have a lot of knowledge and are actively working on systems to track their flows of genetic resources internally. The Netherlands was the first member state to start large-scale monitoring, which it introduced in the plant breeding sector. Most of the companies inspected utilise genetic material dating back to before 12 October 2014, which therefore lies outside the scope of the EU regulations. According to the FCPSA, companies find it difficult to access material from some source countries in practice: it may be problematic to contact the competent authorities, for instance, or negotiations may take many years. This could hamper innovation in the future.
Complexity of the ABS regulations
There are various other legislative and regulatory regimes besides the Nagoya Protocol, and this can cause confusion. The 2004 International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) uses the same system but with a more limited scope, as its name suggests. The ITPGRFA contains supplementary arrangements designed to make the exchange of genetic resources for food and agriculture easier and more efficient: the Standard Material Transfer Agreement (SMTA). If a particular genetic resource is governed by the ITPGRFA, it is not subject to the Nagoya Protocol as well. In addition, there are various regional and national legislative and regulatory regimes. For example, ABS measures may also apply in countries that are not party to the CBD and Nagoya. Furthermore, many institutes and companies have their own rules.
The Nagoya Protocol was developed to properly regulate access to genetic resources and to create a transparent legal framework for benefit-sharing and compliance. Although the need for rules governing access at the international level seems logical, the various conventions and associated regulatory regimes make access more complicated rather than less, and there is still a great deal of confusion surrounding their implementation and compliance. In practical terms, this makes it difficult to make concrete arrangements. The practicability of the international regulations and the implementation of the Nagoya Protocol and its regulation within the EU should become clear over the next few years.
Dümmen Orange complies with Nagoya
At Dümmen Orange we have a statutory obligation to comply with international, national and regional regulations in respect of ABS, such as the Nagoya Protocol. And we meet that obligation,’ says Hans van den Heuvel, Managing Director R&D at Dümmen Orange. Dümmen Orange operates in various countries and therefore has to deal with different regulatory regimes. For example, the Netherlands, Germany and Spain are party to Nagoya and have national laws governing enforcement. Kenya and Ethiopia are party to Nagoya but do not have relevant legislative structures, while the USA is not party to either the Nagoya Protocol or the CBD. These countries therefore do not fall within the scope of the Nagoya Protocol. ‘At Dümmen Orange we recognise the Nagoya Protocol and take it seriously. We keep a record of the genetic resources we use in the breeding process. Where necessary, we have adapted our internal policy to Nagoya, taking regional differences into account. We also respect the providing countries’ national regulatory regimes and requirements for ABS,’ Hans van den Heuvel emphasises.
Plantum, the Dutch industry organisation for plant breeders, actively promotes the preservation of access to genetic resources both nationally and internationally and is committed to making this as easy and efficient as possible. The organisation believes that the ITPGRTA has the most pragmatic approach to ABS. A standard contract such as the SMTA – the manner in which arrangements are made for the exchange of genetic resources for food and agriculture within the ITPGRFA – is very useful in this regard. Plantum is calling for such a contract to be used for all crops in the future.
Plantum, ESA (the European Seed Association) and CIOPORA (the International Community of Breeders of Asexually Reproduced Ornamental and Fruit Varieties) have provided input for the European Commission’s and member states’ European Guidance Documents. Plantum is working on the implementation of the European regulatory regime in the Netherlands and on policy at the national, European and international levels. Among other things, it is in discussions with the FCPSA about obtaining further clarification on the monitoring of businesses and how businesses should submit due diligence declarations in practice. Work is also being done to complete the Guidance Document and revise the SMTA.