The Nagoya Protocol might ring a bell, but few people know exactly what it stands for. Many biotech companies develop products and processes in which a specific kind of microbe, seed or enzyme (or, in some cases, a specific plant or animal species) is used. These genetic resources all originate or are derived from an organism, somewhere in the world. The country where it was found, is entitled to certain (financial) rights concerning these resources. However, it can be difficult to keep track of the origin of a genetic resource. For example, some were first used in a lab, then transferred to another lab, used in a startup and subsequently sold to a bigger company. This can make remuneration of the country of origin very complex. The Nagoya Protocol provides a legal framework to protect the rights associated with the use of a country’s genetic resources.
Carefully establishing the rules
The Earth’s biological resources are an invaluable asset that should be conserved for future generations and are protected by the UN Convention on Biological Diversity. Nagoya was established as a part of this Convention to protect ‘Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization’ (ABS). It entered into force on October 12, 2014. Many countries, including Belgium, have enacted or are currently developing national ABS laws. This legislation makes use of tools such as prior informed consent (PIC) and mutually agreed terms (MAT) to issue permits and arrange monetary/non-monetary benefits, respectively. Compliance rules are established in the country of use. For the EU member states, these rules are also managed on the EU level. Nagoya describes the due diligence obligation to remunerate the country from which genetic resources originate, used for R&D and commercialization.
A lot of fine-tuning of the protocol is still necessary. Different authorities are working hard to put this protocol in place. – Cathy Plasman, Secretary General, Bio.be
Bio.be gives you guidance
The Belgian Association for Bioindustries (Bio.be) organized a conference during European Biotech Week 2015 on the impact of this new regulatory framework on R&D activities. Cathy Plasman, Secretary General of Bio.be, provides some background information: “Advocacy is one of our priorities, and in this case we saw a lot of hurdles for our member companies, but also for the universities and knowledge centers (e.g., VIB).
First, there is a lot of uncertainty about the scope of Nagoya, due to different interpretations of definitions; nevertheless, it is always up to the user to prove due diligence. A very difficult exercise, knowing that each stakeholder can introduce a complaint. During the conference, several cases (GSK, Bayer CropScience, Ecover, BCCM) were presented. The aim was to show the invited European and Belgian authorities where more clarification is needed and how compliance facilitation tools such as the ‘registered collections’ and ‘best practices’ could be optimized. We are also closely involved in the EC work on the complementary measures described in the guidance documents (horizontal guidance on the scope and sector-specific –for biotechnology– guidance on utilization).
Secondly, we want an efficient system for submission in Belgium, preferably with one ‘front office’ and no extra administrative costs. The federal state as well as the regions are involved in the implementation, which is still underway. We already received support from the Secretary of State for Science Policy, Mrs. Sleurs, during the conference. She stated that her services acknowledge the importance of cooperation between industry and academia and stressed that access to genetic resources is essential for innovation.
SMEs are not always aware of their compliance requirements.
Finally, it is our role to inform the biotech companies of their obligations under the Nagoya Protocol. These companies, especially biotech SMEs, are not always aware of their compliance requirements. We therefore support training sessions by ABS-int (Zwijnaarde) on the legal and IP aspects.”
Exceptions prove the rule
There are some exceptions regarding which genetic resources are covered by the Nagoya Protocol. For example, this framework is not appropriate for crops, as they are widely used. For the use and exchange of crops, multilateral international contracts have been put into place. Another exception is made for certain influenza viruses, which can be exchanged in order to facilitate the development of vaccines, outside the Nagoya scope. Cathy Plasman comments: “During the Ebola outbreak, no exception to the Nagoya Protocol had been established for the exchange of Ebola particles. This slowed down the process to develop a vaccine. A lot of fine-tuning of the protocol is still necessary. Different authorities are working hard to put this protocol in place.”
In the coming months, BioVox will present a series of case studies in which different companies share their experiences concerning Nagoya.
(Image courtesy of criminalatt at FreeDigitalPhotos.net)
