Art. 1 Subject matter
This Ordinance regulates access to and the utilisation of genetic resources and associated traditional knowledge as well as the fair and equitable sharing of benefits arising from their utilisation.
451.61
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
of 11 December 2015 (Status as of 1 January 2017)
The Swiss Federal Council,
based on Articles 23n paragraphs 5 and 6, 23o paragraph 3, 23q paragraph 1 and 26 of the Federal Act of 1 July 19661 on the Protection of Nature and Cultural Heritage (NCHA),
in application of the Nagoya Protocol of 29 October 20102 on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (Nagoya Protocol),
ordains:
This Ordinance regulates access to and the utilisation of genetic resources and associated traditional knowledge as well as the fair and equitable sharing of benefits arising from their utilisation.
In this Ordinance:
1 In meeting the due diligence requirement in accordance with Article 23n NCHA, users must in particular record, keep and pass on the following information to subsequent users:
2 If specific information under paragraph 1 letter b is unknown and cannot be obtained, the reasons must be recorded, kept and passed on to subsequent users.
3 If the name and address of the person under paragraph 1 letter b number 5 are subject to trade secrecy, this information need not be passed on to subsequent users.
4 In an internationally or nationally recognised emergency that threatens the health of humans, animals or plants or the environment, it suffices if the due diligence requirement for the utilisation of genetic resources that are pathogenic or harmful organisms is fully met at the time of the commercialisation of products developed on the basis of the utilised genetic resources.
5 All information specified in paragraphs 1 and 2 must be retained as follows and be made available on request to the implementing authorities:
1 Notification as defined in Article 23o paragraph 1 NCHA must be given by the user. It must contain the information specified in Article 3 paragraphs 1 and 2 that is available at the time of the notification.
2 Notification may also be given voluntarily, in particular if no commercialisation is intended.
3 The user receives a register number as evidence of the notification.
4 If compliance with the due diligence requirement has already been attested to under Article 7 of Regulation (EU) No. 511/20144 or is evident on the basis of information published through the international clearing house under Article 14 of the Nagoya Protocol, the user may notify the Federal Office for the Environment (FOEN) of the register number of the corresponding attestation or publication instead of providing the information under Article 3 paragraph 1.
5 As part of the market authorisation procedure, the user must specify to the competent authority under Article 11 whether the product to be commercialised has been developed on the basis of utilised genetic resources subject to due diligence and notification requirements, and where applicable, the register number.
4 Regulation (EU) No. 511/2014 of the European Parliament and of the Council of 16 April 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 Text, OJ L 150 of 20.5.2014, p. 59.
The requirements for recording, retaining and passing on information and for notification under Articles 3 and 4 apply, mutatis mutandis, to users of traditional knowledge associated with genetic resources in accordance with Article 23p NCHA.
1 The FOEN keeps a public register of practices that users may apply on the assumption that they meet the requirements under Articles 3-5 and 8.
2 A practice is included in the register if so requested by users or other interested parties and it is demonstrated that the practice meets the requirements under Articles 3-5 and 8. The FOEN must be informed of changes or updates to a recognised practice.
3 The FOEN may also, on its own initiative, include in the register a practice that meets the requirements under Articles 3-5 and 8.
4 If there are signs that through the application of a recognised practice the requirements under Articles 3-5 and 8 are no longer met, the FOEN sets a deadline by which the necessary measures must be taken. If the requirements are not met by the deadline, the FOEN removes the practice from the register.
1 The FOEN, taking account of Article 5 of Ordinance (EU) No. 511/20145, keeps a public register of recognised collections for which the holder guarantees that:
2 A collection is included in the register if requested by a holder and after the FOEN has verified and confirmed the compliance of the collection or a specific part thereof with the requirements under paragraph 1. The FOEN may commission third parties to perform this verification.
3 If there are signs that a collection or a specific part thereof no longer meets the requirements under paragraph 1, the FOEN sets a deadline by which the necessary measures must be taken. If the requirements are not met by the deadline, the FOEN removes the collection or the part concerned thereof from the register.
5 See also footnote to Art. 4 para. 4.
1 On accessing genetic resources in Switzerland, the user must record and retain and following information and pass it on to subsequent users:
2 If the name and address of the person under paragraph 1 letter d are subject to trade secrecy, this information need not be passed on to subsequent users.
3 The user must notify the FOEN of the information specified in paragraph 1 before market approval or, if such approval is not required, before the commercialisation of products developed on the basis of utilised genetic resources.
4 Notification may also be given voluntarily, in particular if no commercialisation is intended.
5 The user receives a register number as evidence of the notification and, on request, an attestation to the effect that the Swiss provisions on access and sharing of benefits have been complied with.
6 The information specified in paragraph 1 must be retained in accordance with the requirements set out in Article 3 paragraph 5 and be made available on request to the implementing authorities.
7 Genetic resources in respect of which the information specified in paragraph 1 has already been recorded and made available to the FOEN in global form in connection with a different procedure are exempt from the notification requirements under paragraph 3.
1 Applications for financial assistance for the conservation and sustainable use of genetic resources in accordance with Article 23q paragraph 2 NCHA must be submitted to the FOEN.
2 Support may be given in particular to the activities of institutions or organisations that engage in in situ or ex situ conservation, characterisation, or sustainable use of genetic resources or employ benefits arising from the utilisation of genetic resources for the conservation of biodiversity and the sustainable use of their components.
3 Information on genetic resources relating to supported activities must be made available on request to the FOEN.
1 The FOEN is the competent authority and focal point for the Nagoya Protocol. It has the following specific tasks:
2 The FOEN encourages users to voluntarily share the benefits arising from the utilisation of genetic resources or associated traditional knowledge in a fair and equitable way even when there is no legal obligation to do so. It aims to ensure that the benefits are used to conserve biological diversity and the sustainable use of their components.
1 As part of the market authorisation procedure in accordance with the ordinances listed below, the competent authorities verify whether evidence of compliance with the notification requirement as specified in Articles 4, 5 and 8 exists for products developed on the basis of utilised genetic resources or associated traditional knowledge:
Product |
Competent authority |
Applicable regulation |
---|---|---|
|
Swiss Agency for Therapeutic Products (Swissmedic) |
Ordinance of 21 September 20187 on Therapeutic Products |
|
Federal Food Safety and Veterinary Office (FSVO) |
Ordinance of 21 September 20188 on Therapeutic Products |
|
FSVO |
Ordinance of 23 November 20059 on Foodstuffs and Utility Articles |
|
Federal Office for Agriculture (FOAG) |
Ordinance of 12 May 201010 on Plant Protection Products |
|
FOAG |
Ordinance of 10 January 200111 on the Placing on the Market of Fertilisers |
|
FOAG |
Ordinance of 26 October 201112 on the Production and Marketing of Feedstuffs |
|
FOEN |
Ordinance of 10 September 200813 on the Handling of Organisms in the Environment |
|
FOAG |
Ordinance of 7 December 199814 on the Production and Placement on the Market of Plant Propagation Material |
|
Federal Office of Public Health (FOPH) |
Ordinance of 18 May 200515 on Biocide Products |
|
FOPH |
Ordinance of 5 June 201516 on Protection against Dangerous Substances and Preparations |
|
FOEN |
Ordinance of 10 September 2008 on the Handling of Organisms in the Environment |
2 If no evidence of compliance with the notification requirement is submitted at the beginning of the process, the competent authorities require users to submit evidence of compliance before the authorisation process is completed.
3 The competent authorities refuse authorisation if the user or users fails to submit evidence of compliance with the notification requirement.
4 The competent authorities forward to the FOEN the information from the user or users concerning compliance with the notification requirement at its request.
7 SR 812.212.21. The reference was adjusted to 1 Jan. 2019 in application of Art. 12 para. 2 of the Publication Act of 18 June 2004 (SR 170.512).
8 SR 812.212.21. The reference was adjusted to 1 Jan. 2019 in application of Art. 12 para. 2 of the Publication Act of 18 June 2004 (SR 170.512).
The amendment of other legislation is specified in the Annex.
1 Subject to paragraph 2 below, this Ordinance comes into force on 1 February 2016.
2 Article 8 comes into force on 1 January 2017.
The legislation below is amended as follows:
...17
17 The amendments may be consulted under AS 2016 277..