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The Nagoya Protocol

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Nagoya – What every UK Biotech company should know

The Nagoya Protocol is here to stay and its requirements will fundamentally affect biotech research in the UK.

Arising as part of the implementation of the Convention on Biological Diversity, with aims and objectives that are laudatory, in practice Nagoya may be emerging as a very heavy sledge hammer to crush a very puny nut.

The Convention on Biological Diversity (CBD) intended to put an end to ‘biopiracy’, the unfair appropriation of genetic resources and traditional knowledge from developing countries by research and commercial activities elsewhere. A CBD press release stated, “The entry into force of the Nagoya Protocol will provide greater legal certainty and transparency for both providers and users of genetic resources, creating a framework that promotes the use of genetic resources and associated traditional knowledge while strengthening the opportunities for fair and equitable sharing of benefits from their use.” It would be hard to argue against this objective, but the effect of the Nagoya Protocol on the biotech industry in its signatory countries is causing some concern.

The Nagoya Protocol entered in force on 12 October 2014. The EU is a signatory and so the effects of Nagoya will resonate within the UK through the implementing EU legislation, Regulation no. 511/2014 which will apply from 12 October 2015. The Nagoya Protocol requires that informed consent is obtained from the country of origin of a genetic resource for research or commercialization involving that resource. The Protocol envisages that the agreement for that consent will be on mutually agreed terms and will provide for “benefit sharing”, not just in terms of a royalty, but possibly also including the sharing of R&D results. Exactly how this will work out in practice is somewhat unclear. What is clear is that compliance with Nagoya will impose a significant administration burden on all biotech research involving a non-human genetic resource. And there is a requirement for that information to be retained for 20 years after the end of the period of utilization. Further, there are significant levels of penalties for non-compliance – both civil and criminal sanctions can be imposed, with the maximum levels being a fine of £250,000 and up to 2 years in prison. And, despite the Nagoya Protocol now being in force, there is a lot of confusion about exactly what is required since the implementing regulations are still being drafted, even though the 12 October 2015 date for the application of EU Regulation 511/2014 is fast approaching.

However, one issue is abundantly clear: there is a low level of understanding within the UK biotechnology industry of what needs to be done.

So here are our practical tips about what you should be doing now:

Audit all of your genetic resources:

That’s DNA, plasmids, bacteria, viruses, cells, tissue samples. They are all covered by the Nagoya Protocol. Document each sample noting in particular whether it is:

• a purely human sample (if so it is not covered by the Nagoya Protocol); or
• a sample which was obtained before 12 October 2014 (if so it is not covered by the Nagoya Protocol providing you have evidence of its date of acquisition).

Anything left falls under the provisions of the Nagoya Protocol and you will need to show due diligence in finding its country of origin and obtaining an Access and Benefit Sharing Agreement with that country.

Start putting in place a system for genetic resource administration

At the very least you will need a robust and reliable system able to record the date and place of access and a description of each genetic resource, together with information on the source of the genetic resource, of any subsequent users, plus copies of any benefit sharing agreement, certificate of compliance and access permits.

Where possible consider obtaining future genetic resources from UK sources

If that’s not possible, consider sourcing from a country which is not a party to the Nagoya Protocol (such as US). A further alternative is to source through a registered culture collection as then the regulatory burden will be eased somewhat. But ‘registered’ here means registered under the provisions of Nagoya – so check whether the culture collection you’re intending to use is registered under the Nagoya Protocol.

Register with the ABS-CH

The website address is https://absch.cbd.int/dashboard. Registration is free and easy and there’s a wealth of information about the Nagoya Protocol and the various signatory countries.

Keep an eye out for further updates

We will be posting about further updates as more becomes known!