CABI s Access and Benefit Sharing policy and practice for compliant use of biological material

Transcription

1 CABI s Access and Benefit Sharing policy and practice for compliant use of biological material Nagoya Protocol Access and Benefit Sharing (ABS) policy and practice Chile January 2017 David Smith CABI, Director Biological Resources

2 Summary What is the Nagoya Protocol and what does it require Examples of policy and practice Where can we get the information Impact of compliance getting the benefits without impeding the progress of science

3 Background to Access and Benefit Sharing (ABS): The Convention on Biological Diversity (CBD) 1992 is devoted to the conservation of biological diversity 3 main objectives: 1.The conservation of biological diversity 2.The sustainable use of the components of biological diversity 3.The fair and equitable sharing of the benefits arising out of the utilization of genetic resources The Nagoya Protocol (October 2014) requires countries to ensure users of genetic resources comply with national access legislation so benefits can be shared

4 Nagoya Protocol on Access and Benefit Sharing (ABS) 93 Parties to the Nagoya Protocol Chile has not yet joined Europe has enacted regulation UK has a statutory instrument to implement the EU Regulation 29 countries with regulations Some countries that have not become a Party have enacted regulation some associated with the CBD e.g. Brazil

5 Why should a country become a party To control access to national genetic resources Track use Support the effective implementation of fair benefit-sharing To provide legal certainty in the use of genetic resources and traditional knowledge Engender trust in sharing and using another country s genetic resources Some countries have chosen not to exercise sovereign rights and focus only on ensuring benefits are shared What should Chile do?

6 Alstroemeria Lily Originally from Chile are now part of the Netherlands Horticulture Industry who license their propagation to other growers Nagoya Protocol would now ensure Chile would receive fair and equitable benefits from such and activity The CBD recommends studies and development is carried out in the provider country Benefits to the economy, livelihoods and job provision

7 ABS-CH 93 Parties to Nagoya Protocol 29 countries have National Legislation

8 How ABS will work: some key elements National Focal Points (NFP) are the contact points in country, to provide advice and reassure material is accessed correctly Competent National Authority (CNA) to provide PIC and the necessary permits CNA publishes permit as an Internationally Recognised Certificate of Compliance (IRCC) on the ABS Clearing House. Access Benefit Sharing Clearing House Mechanism A knowledge base to provide key information, for example on: Which countries are Party to the Nagoya Protocol National legislation Contacts for the National Focal Points

9 How ABS will work: Example of process in Europe Obtain Prior Informed Consent (PIC) before accessing the resources [CNA] Negotiate Mutually Agreed Terms (MAT) - how subsequent benefits will be shared Gain an Internationally-Recognised Certificate of Compliance (IRCC) where applicable At the final stage of product development make a declaration to the CNA that ABS obligations are fulfilled Retain relevant information for a 20-year period after the end of the period of use

10 How ABS will work in Europe: genetic resource in hand Establish when the genetic resource was accessed Identify country of origin of genetic resource Visit the Clearing House Mechanism to check if the country of origin is a party to the Nagoya Protocol and has national legislation If the information on the Clearing House Mechanism is unavailable or is unclear contact the National Focal Point

11 29 Countries published 82 pieces of legislation; Total of 46 countries or regions with Legislative, Administrative or Policy Measures (MSR) Albania Austria Belarus Belgium Brazil Bulgaria Burundi Croatia Cyprus Czech Republic Denmark Dominican Republic Estonia Ethiopia European Union Finland France Germany Greece Guatemala Hungary India Ireland Italy Kenya Latvia Lithuania Luxembourg Malawi Malta Mexico Netherlands Norway Peru Poland Portugal Romania Slovakia Slovenia South Africa Spain Sweden Switzerland Uganda UK Vietnam

12 29 Countries published 82 pieces of legislation; Total of 46 countries or regions with Legislative, Administrative or Policy Measures (MSR) Albania Austria Belarus Belgium Brazil Bulgaria Burundi Croatia Cyprus Czech Republic Denmark Dominican Republic Estonia Ethiopia European Union Finland France Germany Greece Guatemala Hungary India Ireland Italy Kenya Latvia Lithuania Luxembourg Malawi Malta Mexico Netherlands Norway Peru Poland Portugal Romania Slovakia Slovenia South Africa Spain Sweden Switzerland Uganda UK Vietnam

13 29 Countries published 82 pieces of legislation; Total of 46 countries or regions with Legislative, Administrative or Policy Measures (MSR) Albania Austria Belarus Belgium Brazil Bulgaria Burundi Croatia Cyprus Czech Republic Denmark Dominican Republic Estonia Ethiopia European Union Finland France Germany Greece Guatemala Hungary India Ireland Italy Kenya Latvia Lithuania Luxembourg Malawi Malta Mexico Netherlands Norway Peru Poland Portugal Romania Slovakia Slovenia South Africa Spain Sweden Switzerland Uganda UK Vietnam

14 2nd Meeting of the Parties to the Nagoya Protocol (COPMOP2) In December 2016 Antigua and Barbuda, Cameroon and Argentina ratified the NP Special conditions for public health and pathogen-sharing on agenda for 2018 Seeking recognition that digital and physical genetic resources are legally equivalent Measures to assist in capacity-building and capacity development Need for a global multilateral benefit-sharing mechanism Such decisions impact on the way we work with biodiversity important for countries to participate

15 EU Regulation (no. 511/2014) on ABS compliance Users and utilisation Requires a user of genetic resources or the associated traditional knowledge to: Declare that benefit sharing mechanisms are in place when Securing funding for the research A product goes to market. Applicable when conducting research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology

16 EU Regulation (no. 511/2014) on ABS compliance Scope of ABS Some reasons why genetic resources may be out of scope The EU Regulation applies: a) to genetic resources from countries that exercise sovereign rights b) to genetic resources when countries have established applicable access measures and ratified the Nagoya Protocol c) if genetic resources were accessed after 12 October 2014 d) to genetic resources that are not already governed by specialised international instruments

17 Guidance for compliance with EU Regulation The EC have drafted sector specific guidance on the final stage of utilisation Involved in-depth stakeholder engagement e.g. Biotechnology Food and Beverage Biocontrol and Biostimulants Cosmetics

18 Example system: New Brazilian ABS regulations: Biodiversity Law (Law13.123) Brazil not yet Party to Nagoya Protocol The key steps for compliance in Brazil are: To collect, a foreign scientist must be registered working with a partner in Brazil and have an Authorization Request for Collecting and Research (Scientific Expeditions) from the National Council for Scientific and Technological Development The Brazilian collaborator can seek a permit for collecting from ICMBio - Instituto Chico Mendes de Conservação da Biodiversidade (ICMBio) through the electronic system SISBIO

19 Brazilian process Implementing, managing and monitoring conservation is through SISBio Sisbio allows researchers to request permits for collection of biological material and conducting research in federal conservation units and caves Researchers must meet Instruction ICMBio No. 03/2014 which establishes and regulates SISBio. In accordance with the Law /2015 and Decree 8.772/2016 samples sent out of the country constitutes a shipment and must be registered with the Genetic Heritage Management Council (CGEN) via the electronic system SisGen, (not yet available)

20 Brazilian process A sample with a shipment registration can leave the country. The user, through the Brazilian collaborator, must then notify Brazil if a product is put on the market. This will trigger benefit sharing. Materials can be sent out of the country to carry out a service such as sequencing or identification. This, in Brazilian terms, is not access i.e. research and development (utilisation); Normally under such circumstances the entity carrying out the service will be required to return or destroy the samples.

21 CABI in Brief At the institutional or organisational level Not-for-profit intergovernmental organisation established in 1910 by a UN treaty Provides scientific expertise and information about agriculture and the environment Expertise in: scientific publishing and international development Owned by 48 member countries 400 staff worldwide in 21 locations Annual turn-over 28m (2013) Compliant with requirements for Joint Management of strategic EC programmes, following successful 4-pillar audit in 2011

22 We work on behalf of 48 member countries

23 Global reach We have 480+ staff across 21 locations worldwide USA 3 UK 215 Netherlands 3 Switzerland 27 Hungary 1 Bulgaria 1 Bangladesh 1 Trinidad & Tobago 4 China 8 Costa Rica 1 Malaysia 25 Brazil 4 Australia 1 Chile 1 India 28 Ghana 6 Niger 1 Uganda 1 Kenya 40 Ethiopia 1 Pakistan 115

24 Our work with Biodiversity Includes sampling/collection of biological materials for all uses Diagnosis of disease Biodiversity studies Bioprospecting for useful properties CABI is both a provider (as a collection it is an intermediary) and user in the context of the Nagoya Protocol CABI s Policy To perform due diligence regarding access and benefit sharing To put in place best practices to comply with national legislation Driver is not just regulatory CABI aims to engender trust, to facilitate science, and to ensure that benefits are shared

25 Tools to help The CBD web site provides information on all signatory/ratified countries National Authority Contact point National Biodiversity Strategy and Action Plan ABS Measures Regulations where in place

26 Tools to help Clearing House Mechanism ABS-CH is a platform for exchanging information on access and benefit-sharing Each Party to the Nagoya Protocol is required to make available (a) Legislation ; (b) national focal point and competent national authority; and (c) Permits or their equivalent issued (PIC and MAT) IRCC Little in place one year in

27 Examples of Information sources Regulator National Measurement & Regulation Office Defra UK Stakeholders Group Contact: Participants: UK Government; Research Community; Companies; NGOs; Research funders.. European Commission Workshops ABS Consultation Forum International Chamber of Commerce Workshops events/events/2015/icc-conference-on-access-and-benefit- Sharing-Working-out-ABS-2015/ Science an research communities best practice Microbial Resources Research Infrastructure (MIRRI) Consortium of European Taxonomic Facilities (CETAF) Global Genome Biodiversity Network (GGBN)

28 Mutually Agreed Terms (MAT) in CABI context CABI accesses and collects biological materials for: diagnosis and identification of pests and diseases to advise on management recommendations; rapid identification of newly introduced alien species to facilitate containment and management; studies to assess impact of land-use and climate change on biodiversity and ecosystems services; long-term conservation to protect investment microbial solutions to improve health and nutrition; combatting threats to livelihoods, agriculture and the environment from pests and diseases; biological control agents for the management of invasive species, reduction of crop losses and minimisation of pesticide use; and increasing and improving scientific knowledge. Need to avoid administrative burden

29 CABI s non-monetary benefits and contributions to the local economy include: sharing of R&D results relevant to country needs; collaboration in education, training, research, development programmes and individual training; joint authorship of publications and joint ownership of intellectual property rights; access to ex situ facilities and to databases; transfer of scientific information, knowledge and technology; and institutional capacity-development to help build or maintain local collections The CABI offer - Mutually Agreed Terms (MAT)

30 Registered collections opportunity or not Not all control will be regulatory and there will be scope for improving compliance through demonstrating due diligence in sampling and use There is scope for a global registry of collections The five requirements of a registered collection are: Apply standard procedures for exchange between collections and supply to users Supply materials that are in compliance Keep records of supply Establish unique identifiers Use appropriate tracking and monitoring tools Still not clear what this means for collections: administration; data retrieval; liability etc.

31 We work on behalf of 48 member countries

32 CABI Nagoya Country Information Resource

33 Countries CABI has feedback from Brazil Kenya Switzerland UK In discussion with Canada China Pakistan India Malaysia Myanmar Vietnam Common factors Work through in-country partners Deposit samples in-country Deliver CABI benefits Implement best practices in a transparent way Next Steps Negotiations with targeted countries Produce common agreements to adapt country to country

34 CABI best practices If a CABI member country granting access through common agreement Record sample details Check that intended use of genetic resources accessed falls within the scope of CABI s work and ABS policy If a marketable product is intended special terms must be negotiated before the project starts Renegotiate new benefit sharing arrangements if applicable

35 CABI best practices If not a country where CABI has negotiated access: Check the ABS measures to ensure correct practice; Where possible acquire PIC and MAT or Internationally Recognised Certificate of Compliance (IRCC) before submitting project proposals; Acquire PIC and MAT before collecting or exporting CABI intends to negotiate open access under a standard MAT

36 CABI best practices Where there is no national legislation in place Work with the National Focal Point (NFP) to establish MAT If there is no NPF, work with an appropriate Ministry and/or government agency Where national legislation does not regulate access to the genetic resources CABI will still document what is done for future accountability

37 CABI best practices Where national legislation does not regulate access Work through a local national partner Register all collections with details of where collected, permit and other legal agreements, who is using them and for what CABI will introduce reporting mechanisms back to provider countries Deposit samples in the provider country or make them available If there is a change in intended use, change of use will be negotiated with the National Authority

38 Summary CHILE: Work with authorities to establish procedures Learn lessons from other countries Genetic resource use: When was the material isolated and from where? CBD and Access and Benefit Sharing Clearing House (ABS-CH) websites for advice; Contact the Country s National Focal Point (NFP) or Competent National Authority (CNA) When materials are not (yet) subject to legislation, follow best practice Ensure you are aware of the provider country requirements The Microbial Resources Research Infrastructure (MIRRI) ABS Manual provides best practice Acknowledgements: UK Regulator Katie Becket; The CABI Development Fund and the European Union s Seventh Framework Programme (FP7/ ) under grant agreement no

39 Assalamualikum merci ありがとう श क र य zikomo xie-xie thank you tak kiitos asante sana ke itumetse danke urakoze terima kasih CABI Europe - UK d.smith@cabi.org gracias efharistó zikomo dhanyawaad