Innovation on genetic resources as an instrument for (Sustainable) Development. Patent disclosure and other new requirements.

Transcription

1 Innovation on genetic resources as an instrument for (Sustainable) Development. Patent disclosure and other new requirements. Dr. Alejandro Lago Manager UNDP-GEF Global ABS Project

2 STRUCTURE OF THE INTERVENTION 1 0. Background: Quick glance to the UNDP-GEF Global Project on ABS 1. What is ABS and why is important in regard to blue innovation? 2. Key features of the Nagoya Protocol, the EU Regulation and related legislation 3. What is the function of the checkpoint and which ones are in the EU? 4. Checklist: how to ensure that we are ABS proof! 5. Innovation on Genetic Resources for Sustainable Development

3 UNDP-GEF GLOBAL ABS PROJECT Strengthening human resources, legal frameworks, and institutional capacities to implement the Nagoya Protocol

4 UNDP-GEF ABS GLOBAL PROJECT Participating project countries: Albania, Belarus, Botswana, Colombia, Comoros, Dominican Republic, Ecuador, Egypt, Ethiopia, Honduras, India, Jordan, Kazakhstan, Kenya, Mongolia, Myanmar, Panama, Rwanda, Samoa, Seychelles, South Africa, Sudan, Tajikistan, Uruguay ABS and the Global ABS Project

5 24 countries at the global level (6 per region) DURATION: 3 years (end of the project August 2019) GEF FUNDING PER COUNTRY: USD COUNTRY CO-FUNDING: average around USD OBJECTIVE OF THE PROJECT: Assisting countries in the development and strengthening of their national ABS frameworks, human resources, and administrative capabilities to implement the Nagoya Protocol

6 Components of the Project 1. Strengthening the legal, policy, and institutional capacity to develop national ABS frameworks 2. Building trust between users and providers of genetic resources to facilitate the identification of bio-discovery efforts 3. Strengthening the capacity of indigenous and local communities to contribute to the implementation of the Nagoya Protocol 4. Implementing a Community of Practice and South-South Cooperation Framework on ABS

7 1. What is ABS? ACCESS TO GENETIC RESOURCES (AND TRADITIONAL KNOWLEDGE ASSOCIATED TO GENETIC RESOURCES) AND THE FAIR AND EQUITABLE SHARING OF THE BENEFITS DERIVED FROM THEIR UTILIZATION LET S SEE AN EXAMPLE

8 1. Why is ABS important in regard to blue innovation (for your research institution)? SOME KEY QUESTIONS Does your research institution utilize genetic resources? Do you know the origin of the genetic resources that you utilize? Do you know if they have been legally obtained (in compliance with the legislation of the provider country)? Do you know the Nagoya Protocol and how the European and national legislations can affect you?

9 2. Key features of the Nagoya Protocol, the EU Regulation and related legislation NAGOYA PROTOCOL Adopted 29 th October 2010 Entry into force 12 th October 2014 Truly international system to monitor and control the utilization of genetic resources: Checkpoints and sanctions to users in user countries Why article 15 of the Convention on Biological Diversity was not enough? (Based on the sovereignty of countries- national legislations on access to genetic resources)

10 2. Key features of the Nagoya Protocol, the EU Regulation and related legislation 104 Parties to the Nagoya Protocol Source The Access and Benefit-Sharing Clearinghouse

11 2. Key features of the Nagoya Protocol, the EU Regulation and related legislation EU REGULATION 511/2014 European Union has ratified the Nagoya Protocol Main obligation of users- Due Diligence Main obligation of Member States- Collect information from users and send it to the ABS-CH, and sanction national users in case of violations of ABS legislations of provider countries EU registered collections Commission Implementing Regulation 2015/1866 Member States of the European Union need to establish specific national measures to make operational the EU system (Portugal- decree-law 122/2017; Spain- Royal Decree 124/2017)

12 3. What is the function of checkpoints and which ones are in the EU? To collect information related to the legal access to the genetic resources and submit it to the ABS-CH 1. Beneficiaries of research funding involving the use of genetic resources or the use of traditional knowledge associated with such resources. 2. Users of genetic resources or traditional knowledge associated with such resources at the final stage of a product's development.

13 3. What is the function of checkpoints and which ones are in the EU? Member States can establish additional checkpoints SPAIN Patent application: Law 24/2015 and Royal Decree 124/2017

14 3. Practical example (Spain) LAYOUT OF DUE DILIGENCE DECLARATION- BENEFICIARIES OF RESEARCH FUNDS (SPAIN) When? How? No declaration Lack of compliance due diligence After the reception of the first payment Electronic platform Ministry of Environment No transfer of the last payment of funds Total or partial return of the research funds granted Before the reception of the last payment Economic Sanctions (from million euros)

15 3. Practical example (Spain) LAYOUT OF DUE DILIGENCE DECLARATION- PATENT APPLICATION (SPAIN) When? How? Lack of compliance due diligence Before requesting a patent application Electronic platform Ministry of Environment No consequences in regard the validity of the patent Economic Sanctions (from million euros)

16 This invention is based on the extraction and use of a blue dye with edible properties from the fruit of the Genipa americana tree. This tree grows in a variety of rainforests of Colombia. In compliance with the principles of ABS of the Convention of Biological Diversity and its implementing Nagoya Protocol, access to the genetic resources was obtained through agreements with ethnic communities and the authorities charged by Colombian legislation with administering their collective territories. The assignee has also entered into agreements with several community entrepreneurial initiatives that coordinate local production and supply dynamics with commercial partners. Through a shareholding agreement, these communityowned suppliers share in the financial benefits of commercialization of the genetic resources. Additional benefit sharing is provided through Fundacion Espave, a nonprofit organization that But also examples in patents, via ABS contract obligations United States Patent 9,376,569 Cano, et al. June 28, 2016 Colorant compounds derived from genipin or genipin containing materials Abstract The present disclosure provides colorant compounds and methods of isolation of the colorant compounds derived from a reaction of genipin and an amine. The colorant compositions comprise purified compounds (e.g., a purified polymer or a purified dimer) obtained from multiple fractioning by chromatography of the reaction resulting material. The purified polymer or dimer can be used as a colorant by itself or in combination with another colorant for imparting color to a food, a drug, a cosmetic, a medical device, and textile products. Description BACKGROUND OF THE INVENTION Statement of Access and Benefit Sharing (ABS)

17 4. Checklist: how to ensure that we are ABS proof! 1. We need to go back to the origin: What is ABS for and how to comply with national legislations in the countries where we obtain the genetic resources? Research and researchers are at the center of the ABS system Convention on Biological Diversity Art Each Contracting Party shall endeavour to develop and carry out scientific research based on genetic resources provided by other Contracting Parties with the full participation of, and where possible in, such Contracting Parties.

18 WORLD S BIODIVERSITY IS DISTRIBUTED IN INVERSE PROPORTION TO THE SCIENTIFIC AND TECHNOLOGICAL CAPACITY A B S REVERT THAT SITUATION: INCENTIVE FOR TECHNOLOGY TRANSFER + FUNDS FOR BIODIVERSITY CONSERVATION

19 4. Checklist: how to ensure that we are ABS proof! 1. If we access the genetic resource in situ: 1. Before going to the country check if there is ABS legislation in place and procedures 2. Check with your national counterparts 3. Comply with the national legislations- obtain PIC, negotiated mutually agreed terms to share benefits and obtain the national access permit= Internationally Recognized Certificate of Compliance 4. Transfer genetic resources (if allowed) in the same conditions as you have received them 5. Comply with the terms of your agreements and share benefits with provider countries

20 4. Checklist: how to ensure that we are ABS proof! 1. If we access the genetic resource ex situ: 1. Request the origin of the genetic resources and the corresponding documentation (PIC, MAT, permit or IRCC) 2. If there is an Internationally Recognized Certificate of Compliance check its terms 3. Use the genetic resources within the conditions they have been accessed 4. Share benefits with the provider country

21 Highly recommended incoming event in Porto Marco Rebelo, ICNF, IP, Portugal THE REGIME ON THE UTILIZATION OF GENETIC RESOURCES - RIGHTS AND OBLIGATIONS OF USERS (in English) 29 th November hours CIBIO- Research Center on Biodiversity and Genetic Resources CIBIO-InBIO s Auditorium, Campus de Vairão

22 If INNOVATION is not for Sustainable Development, What is it for?

23 Thank you for your kind attention