b"its interaction with the ITPGRFA mayshould be avoided. The second is that affect the seed business itself. governments should adopt a harmonized Another key issue is the tension aroseapproach to the approval of these prod-in connection with the access to plantucts to facilitate their use to farmers and genetic resources and their relationshipaccess to consumers.with intellectual property rights, and par- For example, the regulation in force in ticularly with the regimes for the protec- Argentina is an inclusion/exclusion pro-tion of plant varieties under the UPOVcess, which establishes the following: 1) To Convention and biotechnological inventiondetermine whether a product obtained patenting. Among the unresolved mat- by NBT could be reached by the GMO ters, is the definition of synthetic biol- regulation or not; 2) The analysis is carried Never have plant breedersogy (a topic that had been discussedout case by case; 3) It is not restricted for the last eight years), and the poten- to a specific list of techniques; 4) It gives had such a powerful tool intial consideration of the use of Digitalpredictability to the developer, since it their hands.Sequence Information (DSI) on plantallows consultation on a hypothetical genetic resources.While some countriesproduct or when the product is in theMiguel Rapela alleged that the DSI is not within the scopedesign stage through an Instance of Prior of the Nagoya Protocol, other countriesConsultation (ICP); 5 The authority must considered that the DSI is equivalentgive a response to the applicant within 80 to accessing a plant genetic resource.working days; 6) It uses the definition of The argumentation is that the value ofGMO of the Cartagena Protocol.the genetic resource lies in the informa- Although the evaluation process is tion transported by the DNA sequence. Aconfidential, the authorities of Argentina great question to be resolved. have released some very relevant data. Finally, for some important challenges,For example, from 2015 to December things are much better, as for example2021, 35 ICPs for plants, microorganisms in regulatory matters regarding NBTs.and animals have been evaluated. From After the pioneering regulation fromthe experience it could be observed that Argentina, so far, the region is opting tothe innovation speed of NBT-derived regulate crops produced through geneproducts is higher than that of GMOs. On reserved this power for provinces), whileediting SDN-1 and SDN-2, as conventionalthe other hand, the proportion of tech-introducing the concept of fair andcrops so long as the final product doesniques used is 86% for genome editing shared benefit between the one whonot contain a foreign DNA sequence intechniques and 14% for other NBTs. The delivers and the one who receives theits genome. This status is determined byconsultations were carried out 59% by resource. Then, the Nagoya Protocol onnational regulatory bodies, through a fastpublic institutions, 32% by local small and Access to Genetic Resources and the Faircase-by-case analysis of each new crop. medium size seed companies, and 9% and Equitable Sharing of Benefits Arisingby multinational companies. Such figures from their Utilization to the ConventionSW: What regulations have you seenreverse the situation observed in the on Biological Diversity was adopted andcome into play due to new breedingdevelopment of GMOs, where multina-became effective on October 12, 2014. techniques in the area? What dotional companies largely dominate.But the CBD and the Nagoya Protocolseed companies in Latin America are not the only international instru- need to be aware of? SW: In your opinion, what needs to ments that have dealt with geneticMR: In this regard, use was made of thebe updated in the current IP system resources. The FAO International Treatylong and excellent experience of morein Latin America? on Plant Genetic Resources for Food andthan twenty years in the regulation ofMR: To answer this question, it is neces-Agriculture (ITPGRFA) also covers thosetransgenic products of the regulatorysary to divide whether we are talking topics. This instrument became effectiveagencies of Argentina, Brazil, Chile,about Plant Breeders' Rights (PBR) to on June 29, 2004, and so far, has beenColombia, Mexico, and several otherprotect plant varieties or talking about ratified by 33 countries in Latin Americacountries, in addition to the century-oldPatents on biotechnological inventions.and Caribe. It has been stated that theexperience in crops obtained throughThe landscape of Plant Breeders' interaction between these internationaltraditional mutagenesis.Rights in the Americas is not only not instruments is ambiguous on many pointsTwo conclusions were reached; theuniform, but also difficult to understand. and, for the time being, it is difficult tofirst is that unnecessary regulation ofAlthough there are 18 UPOV member foresee how the validity of the CBD andproducts developed through gene editingcountries, only seven of them have rati-114/ SEEDWORLD.COMDECEMBER 2022"