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BIOTEK2021-Bioteknologi for verdiskaping

Exploring Legal Conditions and Framework for Marine-based Bioprospecting and Innovation

Awarded: NOK 5.3 mill.

Marine bioprospecting means searching for and collect the genes, biomolecules and organisms from the marine environment. This can be bacteria, algae and animals living on the seabed or in the water column and that have adapted to the extreme conditions. There are great expectations that bioprospecting could lead to development of new drugs and compounds that can be used in food, feed and in industrial processes. The project Exploring Legal Conditions and Framework for Marine-based Bioprospecting and Innovation is about exploring legal regulations of bioprospecting on three levels: at the global level in Law of the Sea and the rules on the harmonization of patent law; at the national level about how Norway chooses to regulate access to genetic resources in the marine area; and between private parties through the design of contracts for access and benefit sharing from biotechnology research and development. Under the Law of the Sea there is an ongoing negotiation about how access to genetic resources in the area beyond national jurisdiction shall be regulated. The project analyze the current legal situation and come up with proposals to require sharing of samples so that more researchers can get access to research this material. Since a cruise on the open sea is expensive, making samples available to more researchers is a way to boost research and innovation. During the autumn 2015 the UN gave a mandate to continue negotiations on the way towards a binding international regime. How Norway will regulate bioprospecting is also unclear, although the Government in 2009 presented its strategy for marine bioprospecting. It emphasized that bioprospecting will be increased and that marine genetic resources will be utilized in a sustainable manner. Benefit sharing or cost sharing can help to ensure and promote Norwegian value creation. Cost sharing is based on the drives innovation at Norwegian biological material must help pay the cost of Norway has to make the material available. One of the central questions is who owns the genetic resources in the sea. Within Norwegian exclusive economic zone and continental shelf the Biodiversity Act (2009) and the Marine Resources Act (2008) regulate the rights to marine resources. Both laws establish that the resources belong to the community in Norway. How Norway shall regulate bioprospecting is being considered in the Ministries and there is a draft administrative regulation on the table which suggests that regulating access to the collected material and benefit distribution by commercial use will ensure and promote Norwegian value creation. Until regulations are adopted, bioprospecting is unregulated in Norway. This creates a legal uncertainty for commercial and non-commercial operators who want to leverage the resources and means that the research institutions and national initiatives Marbank perform their duties in a legal vacuum. One possible reason that the Norwegian Government has not crossed the finish line with a regulation may be uncertainty about whether one should impose industry to share profits generated by the use of marine material. If the government concludes that it should not require payment for use of the collected material, a difficult financial situation may arise for Marbank and other research institutions. This becomes particularly problematic if it is simultaneously signaled that these institutions are expected to become self-financing. An important question that then needs to be clarified is: Who should be responsible to contribute funds for exploration (requiring expensive research cruises and infrastructure), collecting, screening and availability of marine material? Along the Norwegian coast and in the ocean there are demanding conditions. Much of the collection takes place in deep water and in cold conditions, the collection is time-consuming and requires costly infrastructure. The material offered by collections like Marbank is much more than raw material straight from the sea; it is screened and tested for interesting properties. Today, Norwegian and foreign institutions and companies freely access this material. Value added by foreign operators will thus be partly financed by the Norwegian research budgets without Norway getting anything back. Since results can be patented, Norway may ultimately have to pay monopoly prices for the products developed based on Norwegian genetic resources. Such product development will not create jobs in Norway. Public funding is and will be required through all stages of the value creation chain, from collection to final products. Long-term financing is therefore important to promote the mapping and analysis of the samples collected. An element in securing such funding is to develop good contracts to balance the rights and obligations relating to utilization of such material commercially. This project has discussed how Marbank can design their contracts to meet future challenges.

Bioprospecting can be understood as the search for and collection of biological resources; marine indicates that the resources are found in biotopes in the sea or ocean. The project will use legal analysis combined with biological and technical competence to further develop tools to capture and increase value from these resources and activities. The project consists of three work packages. WP 1: International regulation of bioprospecting in two on-going international negotiations as study object: the wor k undertaken by the Ad Hoc Open-Ended Informal Working Group on the topic bioprospecting on the oceans outside national jurisdiction (under the UN General Assembly), and the Antarctic Treaty Consultative Meeting (ATCM). In this WP the project will investi gate the current regulations in these areas relevant for marine bioprospecting, analyse options for how right and access to genetic resources in these areas can be regulated. WP 2: Open source for marine-based innovation: takes as its main research approa ch to explore how legal systems can be designed in the future (de lege ferenda). As background for the de lege ferenda discussions here, two issues needs to be explored: an empirical interdisciplinary study of the needs among core actors for legal regulat ion of their innovative activities, and a de lege lata study of the current patent law setting frameworks for an Open Source system. WP 3: Regulation of collections of marine genetic resources: It concerns options and limitations for contracts, with the aim of contributing to the management of collections of marine material from bioprospecting, in particular Marbank and other Norwegian actors. This includes the perspective of analysing the draft sMTA of Marbank against the relevant background law, and wi ll build knowledge about how the legal and institutional design of such collections. There are linkages among these three study objects which is a strong argument for doing research on them in context.

Funding scheme:

BIOTEK2021-Bioteknologi for verdiskaping

Thematic Areas and Topics

LTP3 Samfunnsikkerhet, sårbarhet og konfliktInnovasjon i offentlig sektor (utgår 2014)Forskning og innovasjonMarinØkosystem (utgår 2014)MatGlobal matsikkerhetPolitikk- og forvaltningsområderFiskeri og kystLTP3 Innovasjon i stat og kommuneGlobale utfordringerGlobal matsikkerhetPolarSvalbardNaturmangfold og miljøForurensning luft,vann, jord, biologiske systemer (utgår 2014)InternasjonaliseringInternasjonalt prosjektsamarbeidPolarAntarktisPolitikk- og forvaltningsområderNæring og handelNordområdeneArktisGlobale utfordringerGlobale miljøutfordringerInternasjonaliseringNordområdeneKunnskapsbasert næringsutviklingPolarNaturmangfold og miljøGlobale miljøutfordringerNaturmangfold og miljøBransjer og næringerFiskeri og havbrukPortefølje Klima og miljøPolarArktisNaturmangfold og miljøAnnen miljøforskning (utgår 2014)Globale utfordringerMarinHavbrukBransjer og næringerNaturmangfold og miljøØkosystemer, mangfold, friluftsliv (utgår 2014)LTP3 Et kunnskapsintensivt næringsliv i hele landetNordområdeneSamfunnsutvikling i nordområdeneLTP3 Global utvikling, ulikhet, og demokratibyggingNordområdeneSvalbardLTP3 Fagmiljøer og talenterPolitikk- og forvaltningsområderLTP3 Klima, polar og miljøInnovasjon i offentlig sektor (utgår 2014)LTP3 Høy kvalitet og tilgjengelighetPolitikk- og forvaltningsområderUtenrikspolitikkLTP3 Muliggjørende og industrielle teknologierInnovasjon i offentlig sektor (utgår 2014)Innovasjoner i virksomheter innenfor offentlig forvaltning og tjenesteytingLTP3 Klima, miljø og energiLTP3 Nano-, bioteknologi og teknologikonvergensBioteknologiMarinLTP3 Samfunnssikkerhet og beredskapBransjer og næringerHelsenæringenMatNordområdeneEtiske, juridiske og samfunnsmessige aspekterMatMat - Blå sektorPolitikk- og forvaltningsområderJustis og rettsvesenGrunnforskningNordområdeneGeopolitikk, internasjonal sikkerhet og folkerettPolitikk- og forvaltningsområderOffentlig administrasjon og forvaltningLTP3 Hav og kystNordområdeneUnike forskningsmuligheterPortefølje Banebrytende forskningLTP3 Marine bioressurser og havforvaltningPolitikk- og forvaltningsområderLæring, skole og utdanningPortefølje Demokrati og global utviklingLTP3 Styrket konkurransekraft og innovasjonsevnePortefølje ForskningssystemetPortefølje Mat og bioressurserNordområdeneKlima, miljø og biologiske ressurserPortefølje InnovasjonPortefølje Muliggjørende teknologierFornyelse og innovasjon i offentlig sektorForskning og innovasjon