Granting research funding and approving products

Guidance as to what you need to inform the users of in conjunction with the assignment of public or private research funding and the final approval of a product.

Guidance

Target group 

  • Actors that grant research funding and actors that approve products that involve genetic resources.

As research funding provider or product approval authority you play a key role as information disseminator and link to users of genetic resources. 

You can contribute to the effective implementation of the ABS Regulation by informing the users of the requirements imposed upon them in conjunction with the assignment of public or private research funding and the final stage of product development. 

Information to be disseminated

You may disseminate the following information in conjunction with the announcement of research funding and prior to the final approval of a product. Links can be found under the "Laws/Regulations" tab, above.

  • The ABS Regulation applies to all genetic resources except:
    - the human genome 
    - genetic resources for food and agriculture under the International Treaty on Plant Genetic Resources for Food and Agriculture,
  • The ABS Regulation applies on the condition that the access country is a party to the Nagoya Protocol and that the county has national access legislation.
  • The ABS Regulation is applicable to accesses to genetic resources carried out after 12 October 2014.
  • Further information regarding time and the procedure for making a declaration in conjunction with the assignment of research funding and in conjunction with the final approval of a product is given in Article 5 and Article 6, respectively, of the ABS Implementation Regulation (EU) 2015/1866.
  • Spot checks of users’ compliance will be conducted by the Swedish Environmental Protection Agency in accordance with a risk-based control plan.
  • The user must clearly mark, in his or her declaration, any information that is confidential. 

Declaring due diligence

You must show that you comply with the access legislation of the country in question. You must show this by obtaining prior informed consents (PIC) and establishing mutually agreed terms (MAT) and by declaring due diligence in accordance with the ABS Regulation.

You must submit a due diligence declaration on two occasions:

  1. after the first partial payment of research funding has been received or not later than the end of the project or when the final report is submitted. This applies even if no further product development occurs.
  2. in the final development stage of a product.

You must submit your declaration of due diligence using the data submission tool “DECLARE”. Articles 5-6 of the EU’s Implementation Regulation contain more detailed information about when to submit declarations. The procedure for submitting a declaration can be found in the User Guide for the DECLARE NAGOYA IT system.

NB: Concerning due diligence

The Swedish Environmental Protection Agency requests that all recipients of research funding (Article 7.1 of EU Regulation No. 511/2014), that pertains to the use of genetic resources and traditional knowledge concerning such resources, must declare due diligence.

On 12 October 2014 the Nagoya Protocol and the EU ABS Regulation came into effect. This implies that anyone who conducts research on genetic resources and traditional knowledge about such resources must have permission for the use of such material (PIC) and must have established an agreement (MAT) as to how the research will benefit the host country. Any user who has accessed genetic resources and traditional knowledge after 12 October 2014 is required to declare so-called due diligence.

Due diligence implies that the user must show that the genetic resource was obtained in accordance with applicable legislation in the country in question and that the potential benefit of the genetic resource must be distributed in a reasonable and fair manner. Exceptions are research on the human genetic heritage, pandemic influenza virus that is covered by the WHO’s PIP framework, genetic material that has been obtained from international waters, and plant genetic material that is included in Appendix 1* of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGFA). For any questions concerning the regulations and the declaration of due diligence, please contact the Swedish Environmental Protection Agency.

Use of links encouraged

We encourage the use of links from your website to the Swedish Environmental Protection Agency’s information.

Laws/Regulations

Definitions

Definitions

For the purposes of this Regulation, the definitions of the Convention and the Nagoya Protocol as well as the following definitions apply:

  • access  means the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol
  • association of users  means an organisation, established in accordance with the requirements of the Member State in which it is located, that represents the interests of users and that is involved in developing and overseeing the best practices referred to in Article 8 of this Regulation
  • collection means a set of collected samples of genetic resources and related information that is accumulated and stored, whether held by public or private entities
  • genetic material  means any material of plant, animal, microbial or other origin containing functional units of heredity
  • genetic resources  means genetic material of actual or potential value
  • illegally accessed genetic resources  means genetic resources and traditional knowledge associated with genetic resources which were not accessed in accordance with the national access and benefit-sharing legislation or regulatory requirements of the provider country that is a Party to the Nagoya Protocol requiring prior informed consent
  • internationally recognised certificate of compliance means a permit or its equivalent issued at the time of access as evidence that the genetic resource it covers has been accessed in accordance with the decision to grant prior informed consent, and that mutually agreed terms have been established for the user and the utilisation specified therein by a competent authority in accordance with Article 6(3)(e) and Article 13(2) of the Nagoya Protocol, that is made available to the Access and Benefit-sharing Clearing House established under Article 14(1) of that Protocol
  • traditional knowledge associated with genetic resources  means traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources
  • user means a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources
  • utilisation of genetic resources  means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention
  • prior informed consent (PIC) a permit or an equivalent document that has been issued at the time of access as proof of the compliance of applicable laws and regulations
  • mutually agreed terms (MAT): a contract between a provider of genetic resources or associated traditional knowledge and a user, within which the obligations are described that ensures that any potential benefit is shared fairly and equitably. Additional requirements may exist for subsequent users or at the time of product release to market

Background

Background

The aims of the UN Convention on Biological Diversity (CBD) are the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. At the Conference of the Parties to the Convention on Biological Diversity (CBD) in 2010, the Nagoya Protocol governing access to genetic resources and fair and equitable sharing of their use was adopted.

In the EU, the Nagoya Protocol is implemented by Regulation (EU) No 511/2014 of the European Parliament and of the Council 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 (also called the ABS Regulation).

This Regulation entered into force in October 2014. On 12 October 2015, one year after its entry into force, the Regulation’s provisions on the obligations of users of genetic resources began to apply within the EU.

Sweden is a signatory to the Nagoya Protocol, but has not yet ratified it. According to the Government Offices of Sweden, Sweden plans to ratify the Nagoya Protocol at the latest 90 days before the first meeting of the Parties to the Nagoya Protocol on Access and Benefit-Sharing in December 2016, in order to be a full member at this meeting. Before it can ratify the Protocol however, Sweden must have penalty provisions in place and a regulatory framework for access to traditional knowledge that is not acquired in the context of access to genetic resources. These provisions are likely to be decided on before the summer of 2016.

Tasked with the implementation of the ABS Regulation

In February 2015, the Swedish Environmental Protection Agency was tasked by the Government of Sweden with preparing for the implementation of the EU Regulation 511/2014 (ABS Regulation) on the implementation of the Nagoya Protocol. This task entailed:

  • Suggesting how best to organize and exercise national supervision of the ABS Regulation cost-effectively
  • Setting up a national focal point in the Internet-based Access and Benefit-Sharing Clearing House (ABS Clearing House) that has been established to provide information about access to genetic resources and benefit-sharing from the utilization of these resources
  • Initiating dialogue with representatives of users of genetic resources in both private and public sector activities in order to materially assist the implementation and facilitate compliance with the ABS Regulation.

How the Swedish EPA has been working on this task

In June 2015, the Swedish Environmental Protection Agency submitted a proposal to the Government concerning the supervision organization. This proposal suggested that both the Swedish Environmental Protection Agency and the Swedish Board of Agriculture should be competent authorities and share supervisory responsibility for the implementation. However, in January 2016 it became clear that the Swedish EPA needed to shoulder the entire responsibility for supervision, and therefore remains the only competent authority in Sweden. Since January, the Swedish EPA has been preparing in various ways to take on this responsibility, for example by developing a risk-based supervision plan and Guides for users.

The Swedish EPA has set up a national focal point by publishing Guides and other information on the Web.

The Swedish EPA now also has an organization for dealing with questions from stakeholders, and is ready to accept declarations from users.

Dialogue has been initiated through a hearing in the spring of 2015, and via e-mail communications with users of genetic resources.

On 22 April 2016, a seminar will be held to communicate the application of the ABS Regulation to different categories of users.

A report on this task was presented on 31 March 2016, at which time the Guides were also published.