Søren Flensted Lassen, Novozymes A/S 07 June 2016

Transcription

1 Brazil and European Dialogue on the Implementation of the Nagoya Protocol - Exchange of Genetic Resources - Private sector: Consideration and expectation in handling GR in product development, Incl. procedures and standards Søren Flensted Lassen, Novozymes A/S 07 June 2016

2 Novozymes A/S is a user Novozymes A/S is doing Bioprospecting for a commercial purpose. Novozymes A/S respect and strives to be in compliance with the Convention on Biological Diversity and the Nagoya protocol. And guided by User compliance article 4.5 Regulation (EU) No 511/2014: When the information in their possession is insufficient or uncertainties about the legality of access and utilisation persist, users shall obtain an access permit or its equivalent and establish mutually agreed terms, or discontinue utilisation

3 Back ground - Convention on Biological Diversity (CBD) The CBD entered into force on 29 December 1993 and 194 countries/states have ratified the Convention (In reality it means all countries except USA). The CBD acknowledge the sovereign rights of states over their natural resources And states that local law shall regulate: Conservation of biological diversity Sustainable use of its components Fair and equitable sharing of benefits arising from the use of genetic resources, based on mutually agreed terms.

4 Back ground the Nagoya Protocol on Access and Benefit-sharing Article 17. Monitoring the Utilization of Genetic Resources i. To support compliance, each Party shall take measures, as appropriate, to monitor and to enhance transparency about the utilization of genetic resources. Such measures shall include: a. The designation of one or more checkpoints, as follows: i. Designated checkpoints would collect or receive, as appropriate, relevant information related to prior informed consent, to the source of the genetic resource, to the establishment of mutually agreed terms, and/or to the utilization of genetic resources, as appropriate; ii. iii. iv. Each Party shall, as appropriate and depending on the particular characteristics of a designated checkpoint, require users of genetic resources to provide the information specified in the above paragraph at a designated checkpoint. Each Party shall take appropriate, effective and proportionate measures to address situations of non-compliance;

5 Regulation (EU) No 511/2014) of The European Parliament and 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 Users shall exercise due diligence to ascertain that : genetic resources have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements. AND At the stage of final development of a product developed: users shall declare to the competent authorities referred to in Article 6(1) that they have fulfilled the obligations under Article 4 and shall simultaneously submit: the relevant information from the internationally- recognized certificate of compliance; or the related information as referred to in Article 4(3)(b)(i)-(v) and Article 4(5), including information that mutually agreed terms were established, where applicable. Users shall further provide evidence to the competent authority upon request.

6 Information to have (seek, keep and transfer to subsequent users) Exsample in situ sampling User compliance (Article 4.3) seek, keep and transfer to subsequent users i) Date and place of access ii) Description of genetic resource in situ sampling microorganism, no TK Data and GPS coordinate on the spot for sampling Environmental sample iii) The source where directly obtained As i) iv) Rights and obligations relating access and benefit sharing (ABS) MAT/ABS clarified before sampling. Including right and terms for commercialization v) Access permits Depending on local legislation vi) Mutually agreed terms (MAT), incl ABS As iv)

7 Private sector Procedure and Standards Policy: Novozymes A/S respect and strives to be in compliance with the Convention on Biological Diversity and the Nagoya protocol. Traceability - Need to keeping track of GR origin throughout the R&D process to market. Novozymes A/S: To secure timely availability of information to document CBD/ABS compliance. Lack of information must not be a limitation or a hindrance for a product going into the market. Our solution. In house it-system to keep track of process. Each step in the development has its own unique identifier with link both back and forth in the development chain. Legal certainty and obligations: Capture international certificate of compliance or ABS-agreement (PIC and MAT) from country of origin if needed. As users we shall provide evidence to the competent authority upon request.

8 Consideration & perspective for embarking on a project Product development considerations: Is it possible to make business out of its fundamental conditions? Legal certainty for commercial utilization? Access Benefit Sharing conditions needs to be know up front Is the potential product within or outside CBD/Nagoya? Cases where information are from literature and/or public available databases e.g.. access was not needed? Source not traceable back to country of origin? When is there done enough? Synthetic biology the resulting GR is not from Nature? No country of origin? Clearly within CBD & Nagoya Unclear if within CBD & Nagoya

9 What would facilitate a bioprospecting development project with commensal purpose? Local legislation is the foundation for being in compliance! Direct communication with competent authorities in Country of origin ; the only authority able to grant legal certainty for utilisation! We are looking for simplicity, transparency, and an open dialog with officials

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11 Traceability Soil sample with PIC/MAT Isolate microorganism Cloned genes Protein engineering / artificial evolution A product Biotechnology uses Biological systems.or derivative thereof to make or modify for specific use