Nagoya Protocol - Implementation in the European Union

It is a requirement of the Nagoya Protocol that if a researcher is to perform R&D (whether commercial or non-commercial) on a non-human genetic resource or derivative thereof (this extends to protein, RNA, metabolites of micro-organisms, etc) or the use of traditional knowledge associated with genetic resources, then it must be shown that the genetic resource has been accessed in accordance with the provisions of the Nagoya Protocol. The burden will be on the researcher to perform due diligence to establish this fact, in the absence of which all work must be halted. The protocol criteria are that:

• Prior informed consent has been obtained from the provider country (ie the place where the genetic resource exists in situ); and
• Mutually agreed terms for the sharing of any benefit arising form the utilisation of the resource have been set up.

Benefits can be either commercial or non-commercial and can include inter alia sharing data, or IP rights.

The Nagoya Protocol makes it illegal to perform R&D on a genetic resource that has not been accessed in accordance with the Nagoya Protocol.

Implementation of the Nagoya Protocol in the European Union

The EU Regulation implementing the Nagoya Protocol was published on 20 May 2014 and requires member states to provide guidance on due diligence and specify penalties associated with non-compliance.

Importantly, enforcement will be dependent on a member state's interpretation of the regulation. For example Brazil are considering implementing retroactive provisions, meaning that all genetic resources accessed even before 12 October 2014 must have the appropriate mutually agreed terms / benefit sharing agreement associated with them. However, even if a user in a EU member state has not complied with the Nagoya Protocol to Brazil's standard the individual will not be penalised, as the EU Regulation does not recognise retroactive enforcement of the Nagoya Protocol. Notably though, such a scenario could be problematic where a company has vested interests in Brazil and in any regard could be difficult from a PR perspective.

Scope of the Nagoya Protocol

There have been discussions whether the terms 'research' and 'development' are to be construed as being cumulative, however it would appear from the comments of the EU Commission's representative that performing either research or development on a genetic resource is enough to bring a researcher's activities within the scope of the regulation.

One implication of this is that performing research on a genetic resource solely in a non-Nagoya country (eg US) and then putting a product onto the market in the EU could fall within the scope of the regulation. This was purely the Commission's opinion, however arguably this takes a very broad view of the term 'development' and does not comply with the regulation which specifically refers to 'research and development'. We await further definition as to how to interpret 'research' and 'development'.

The scope of the Nagoya Protocol and regulation are such that at present they would appear to apply to the use of genetic resources ancillary to a main product. As an example, if a plant breeder is working to produce a new variety of potato that is resistant to a particular fungus and that fungus has been accessed after October 2014 from, eg Brazil, the fungus having been merely used to screen potato variants produced, mutually agreed terms will still need to be negotiated with Brazil even though the fungus is not the primary product or object of research.

Enforcement

In the UK the Department for Environment, Food and Rural Affairs (DEFRA) is responsible for implementing the regulation and the National Measurements Office will be performing checks and monitoring compliance. 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. Other member states such as Denmark and France are also planning to introduce hefty fines and criminal sentences.

Compliance with the provisions will be assessed at two key points:

1. Receipt of research funding; and
2. Commercialisation of a product (including applying for market approval in the EU).

The regulation indicates that the provisions will not be retroactive and will only apply to genetic resources accessed after 12 October 2014.

A question arises however with regard to the burden of proof that a genetic resource was accessed prior to the Nagoya Protocol coming into force. At present the safest thing to do would be for researchers to ensure that they keep detailed records concerning the date of access of a resource and documentary proof confirming this, if available. Difficulties are envisaged to arise in the case of companies having internal collections of genetic resources.

Compliance

An international body known as the Access and Benefits Sharing (ABS) Clearing House is to be set up to act as an intermediary to co-ordinate the implementation of the Nagoya Protocol. In principle the system should work as follows:

1. A provider country informs the clearing house of its national access and benefits sharing (ABS) information which the clearing house will keep up-to-date.
2. If a user wishes to access a genetic resource from provider country A, the user contacts the clearing house for details of how to agree mutually agreed terms with country A.
3. The user contacts the relevant government department in country A and obtains permission for either non-commercial or commercial use (the terms can be re-negotiated later if commercialisation appears likely).
4. Country A issues to the user a national permit and additionally country A files this at the clearing house.
5. The clearing house issues an internationally recognised certificate of compliance (IRCC) which is proof that the resource has been accessed in accordance with the Nagoya Protocol.
6. When a checkpoint is triggered (eg upon commercialisation) the IRCC will need to be presented.
7. The user communicates details back to the clearing house which in turn contacts provider country A to report on the progress in the R&D on their genetic resources. If necessary country A can use this as an opportunity to negotiate new terms (eg pertaining to a commercialisation agreement).

For point 3, it would appear that details of the use will need to be provided to the provider country. However, when submitting documentation to the ABS Clearing House it is planned that specific details can be made confidential and thus not open to inspection by third parties.

Consequently there are serious concerns about the confidentiality of information shared with government bodies of the provider countries and much care will need to be taken to determine the minimum level of disclosure required to comply with a provider country's requirements without giving away valuable commercial information.

Best practice

The regulation for implementing the Nagoya Protocol allows for the setting of 'best practices' to serve as a 'gold standard' for compliance. The intention is that if a researcher can show that they have carried out their due diligence as required by the best practice, any investigation as to their compliance when putting a product onto the market, for example in the EU, will be superficial.

Open issues

• There is no detailed guidance as to the scope of the legislation.
• There are still no specific details as to what constitutes an appropriate level of due diligence.
• An Implementing Act will be published by the EU Commission (final draft expected October 2015 – the first month in which compliance with the Nagoya Protocol will be checked).