On 14 July 2014, Uruguay signed the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization, accepted on 29 October 2010 in Nagoya (the "Nagoya Protocol") after intensive negotiations. It is the 50th state to sign up to the Protocol and so, in compliance with its Article 33, the Protocol will now enter into force on 12 October 2014 - the ninetieth day after the deposit of the 50th instrument of ratification, acceptance, approval or accession.
This article explains what the Nagoya Protocol is intended to achieve.
What is biopiracy?
By common definition, biopiracy is the commercial development of biological compounds or genetic sequences by a technologically advanced country or organization without obtaining consent from, or providing fair compensation to, the peoples or nations in whose territory the materials were discovered.
One example of biopiracy is "devils claw" (Harpagophytum procumbens), an herbaceous plant native to the savannah of Southern Africa and known for generations by the San people, who are indigenous to southern Africa, to relieve arthritis. Today numerous herbal medicinal products based on devils claw and promoted as relieving arthritis are marketed in Europe; however, the San people do not benefit from the commercialisation of their traditional knowledge.
In another case, the San people had to sue the patentee of the appetite suppressant derived from the succulent plant hoodia – used by the San for centuries to suppress appetite during their walks through the savannah – in order to obtain an agreement which grants them a certain revenue from the sale of hoodia products.
Aims of the Nagoya Protocol
To prevent such exploitation and disputes, the Nagoya Protocol aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way, including by appropriate access to genetic resources and transfer of relevant technologies.
To achieve this, the Protocol sets out core obligations for its parties to take the necessary legislative, administrative or policy measures in relation to access to genetic resources, benefit-sharing and compliance.
Obligations on the Parties
According to Article 6 of the Protocol, the national access measures must create: legal certainty, clarity and transparency; provide fair and non-arbitrary rules and procedures; establish clear rules and procedures for prior informed consent and mutually agreed terms; provide for issuance of a permit or equivalent when access is granted; and create conditions to promote and encourage research contributing to biodiversity conservation and sustainable use.
National benefit-sharing measures must provide for the fair and equitable sharing of benefits arising from the utilization of genetic resources. In this context, utilization means research and development on the genetic or biochemical composition of genetic resources, as well as subsequent applications and commercialization. According to the Nagoya Protocol, sharing must be subject to mutually agreed terms. The benefits maybe monetary or non-monetary; therefore benefits can be royalties, sales revenue or the sharing of research results.
The Nagoya Protocol also provides specific obligations to support compliance with the national legislation or regulatory requirements of the party providing the genetic resources, and contractual obligations reflected in mutually agreed terms. The compliance obligations were subject to extensive discussions and the compromise, now in Articles 15 to 18, obliges the parties to the Protocol to:
- take measures providing that genetic resources utilized within their jurisdiction have been accessed in accordance with prior informed consent, and that mutually agreed terms have been established;
- cooperate in cases of alleged violation of another party's requirements;
- encourage mutually agreed contractual provisions on dispute resolution;
- ensure an opportunity is available to seek recourse under their legal systems when disputes arise from mutually agreed terms;
- take measures regarding access to justice; and to
- take measures to monitor the utilization of genetic resources after they leave a country including the designation of effective checkpoints at any stage of the value-chain: research, development, innovation, pre-commercialization or commercialization.
In addition, Article 14 of the Nagoya Protocol establishes the Access and Benefit-Sharing Clearing-House (ABS-CH), a web based platform to share information to support the implementation of the Protocol. The Protocol also includes the obligation to Parties to make certain types of information available through the ABS-CH. Moreover, the Parties have to continuously provide and update the information required under the Protocol.
To ensure a proper application of the Protocol within the EU, Regulation (EU) No 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union was adopted on 16 April 2014. With the exception of Articles 4, 7 and 9, this Regulation will apply from the date that the Nagoya Protocol comes into force.
Once the Protocol's provisions are implemented, a company seeking access to a genetic resource in another country, for example plants which are known to have medicinal properties will have to comply with the national provisions of the country providing the plant, in order to conduct research with the intention of developing a new medicinal product. Therefore, the company will have to conclude an agreement which gives the country providing the resource and – if applicable – the indigenous or local community providing the related traditional knowledge, fair and equitable benefits arising from the utilisation of this resource and knowledge.