New requirement for new applications for authorisation as a result of the Nagoya Ordinance


The Nagoya Protocol negotiated as part of the international Convention on Biological Diversity governs access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation. Accordingly, the Nagoya Protocol serves to implement the third objective of the Convention on Biological Diversity and contribute to the preservation of biodiversity and the sustainable use of its components. The Nagoya Protocol also applies to traditional knowledge associated with genetic resources and to the benefits arising from the utilisation of this knowledge. Switzerland ratified the Nagoya Protocol on 11 July 2014. The Protocol and the associated amendments to the Federal Act on the Protection of Nature and Cultural Heritage (NCHA; SR 451) came into force on 12 October 2014. The Federal Council passed the Nagoya Ordinance (NagO, SR 451.61) on 11 December 2015. As a result, it was subsequently necessary to amend Articles 3 and 7 of the Ordinance on Therapeutic Products (TPO; SR 812.212.21). With the exception of Art. 8 NagO, the amendments to the TPO and NagO came into force on 1 February 2016. Art. 8 NagO, which regulates access to genetic resources in Switzerland, including proof of compliance with the obligation to notify, will come into force on 1 January 2017.

Implications for new applications for the authorisation of medicinal products
According to the new Art. 3 para. 1bis TPO, a new application for authorisation of a medicinal product whose development is based on the utilisation of genetic resources or related traditional knowledge must include the registration number pursuant to Art. 4 para. 3 or 8 para. 5 of the NagO. The registration number is issued by the Federal Office for the Environment (FOEN) and provides the applicant with proof of compliance with the obligation to notify according to Articles 4, 5 or 8 of the NagO, and is a prerequisite for authorisation under Art. 7 paragraph 1bis of the TPO.

The new requirements arising from the NagO and the revised Articles 3 and 7 of the TPO must be satisfied for all new authorisation applications that involve substances (active substances or excipients) whose development is based on the utilisation of a genetic resource, if access to the genetic resource was gained after 12 October 2014 (see Art. 25d NCHA). If the use of traditional knowledge relating to genetic resources pursuant to Art. 23p NCHA is involved, the obligation to notify according to Art. 4 is similarly applicable. If the utilisation of a genetic resource from Switzerland pursuant to Art. 8 NagO is involved, evidence that the obligation to notify has been met will not have to be provided until Art. 8 NagO comes into force on 1 January 2017.

As a result of the new requirements, a passage dealing with the Nagoya Ordinance has been added to the Swissmedic forms for application submission. Applicants are now required to state whether the new application for authorisation is subject to the obligation to notify under Articles 4, 5 or 8 of the NagO. If so, the corresponding FOEN registration number must be stated on the form.