The EU’s New Regulation to Combat Biopiracy

A legislative system to address biopiracy

A lack of trust has emerged in countries used as sources of genetic resources. Some believe that foreign researchers have ignored sovereign rights to resources and communities’ traditional knowledge. This behaviour, termed “biopiracy”, has led to restrictions on access to genetic resources in some cases. One manifestation is a situation where a company has developed commercial products based on genetic resources from third world countries and filed patents using that material. The introduction of the proposed measures in the Regulation should create a ‘level playing field’ that allows both sides to show compliance with the relevant rules and thereby boost collaborative efforts.

The Protocol and the Convention on Biological Diversity

The Protocol is a legally binding international treaty that is expected to come into force in 2014. It came about as a result of international cooperation by signatories to the Convention on Biological Diversity (“CBD”). All 27 Member States are parties to the CBD, which aims to preserve biological diversity, ensure sustainable utilisation of its components and provide for equitable sharing of consequent benefits. The CBD is legally binding but it requires countries to develop national implementing legislation. Although many developing countries have established access laws, this is not generally the case with industrialised countries. This has meant that users of genetic resources in industrialised countries have so far had no legal obligation to share any benefits, particularly as access to genetic resources is generally via intermediaries and users are not involved in collecting genetic resources from developing countries.

The objective of the Protocol and the Regulation is therefore to deliver the practical element of the CBD’s aims.

In addition, there is currently no internationally agreed definition of “traditional knowledge associated with genetic resources” or of the “holding” of such knowledge by an indigenous local community. However, the international definitions of those terms and concepts are currently being negotiated in the Intergovernmental Committee of the World Intellectual Property Organization.

The Regulation

The proposed Regulation aims to implement and to enable the EU to ratify the Protocol and incorporates its three main objectives:

• Establishing predictable conditions for access to genetic resources;
• Ensuring benefit-sharing between users and providers; and
• Ensuring only legally acquired genetic resources are used.

Key provisions

Although Member States have considerable discretion as to how they regulate access to genetic resources, provisions relating to user-compliance are mandatory. The key elements are as follows.

Due diligence and information gathering

Obligations are imposed on all users of genetic resources. Users, which include researchers, collectors and manufacturers, would have a duty to exercise due diligence when accessing and using genetic resources and traditional knowledge. Users would be required to seek, keep and transfer to subsequent users information concerning (i) the date and place of access to resources; (ii) the description of the resources used; (iii) the direct source of the resources and subsequent users; (iv) any rights or obligations (or lack of) relating to access and benefit sharing; and (v) any mutually agreed terms. Relevant information must be retained for 20 years following the end of the period of use. Permits and evidence of decisions to grant prior informed consent/mutually agreed terms will be collated through an Access and Benefit-sharing Clearing House.

EU-wide register of collections

An easily accessible EU-wide register of trusted collections, for example seed banks, will be set up. To be registered, a collection owner must: have standardised procedures for exchanging samples; evidence compliance with all legal requirements for accessing genetic resources; keep records of resources supplied; have unique identifiers for samples; and use appropriate tracking and monitoring tools. However, the burden of ensuring compliance with the Regulation will rest with the relevant Member State. Acquiring a genetic resource from such a trusted collection discharges the due diligence duty.

Monitoring to reduce illegal access to genetic resources

Users must communicate to Member States and the Commission compliance with the due diligence requirements under the Regulation. This will create a system of checks on users of genetic resources. The Protocol requires signatories to designate national focal points and competent national authorities, who will be responsible for establishing the procedures and providing evidence of prior informed consent to access genetic resources. If a competent authority finds a user has not met its obligations it can issue sanctions which include seizure of illegally acquired genetic resources and suspension of use. It is for each Member State to lay down penalties which must be “effective, proportionate and dissuasive”.

Next Steps

The Regulation will now be considered by the European Parliament and the Council under the co-decision procedure and, if agreed, will become law. It is proposed that the Regulation shall enter into force on the 20th day following publication of a notice that the Protocol has entered into force.

Conclusions

Users in industrialised countries have thus far had no legal obligation to share benefits with resource owners. This has undermined global progress in conservation and sustainable use of biodiversity.

The proposed Regulation now clarifies and centralises the obligations for users, collection owners and Member States envisaged by the Protocol. The measures should increase transparency for those sourcing genetic material and those accessing it via a collection. They should also improve accountability to countries and indigenous and local communities supplying resources, and streamline access to resources. It is hoped that this will result in increased trust, certainty and access to genetic resources, thereby lowering transaction costs and enhancing further innovation.

For the full text of the Regulation click here