Regulating the Nagoya Protocol: a Kat explains in simple words ...

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising (here) is still attracting far too little interest and attention within the IP professions, as evidenced by the low level of response to fellow Kat Darren's excellent post on this blog last month ("Onward march to Nagoya - UK and EU draft implementing regulations", here) which, as of the date of posting this item, has not received a single comment.

It occurred to this Kat that perhaps the lack of response to Nagoya-related posts is related to the fact that most people don't know about the Protocol and are too busy doing their day jobs to take time out to find out a little more about it.  Accordingly, the following is a short and easy piece that Darren has drawn to the attention of this Kat and which may help to put readers into the picture without inflicting too much pain and effort. It was published at the end of March in question-and-answer form as part of LexisNexis's PSL service, with Ioan Marc Jones providing the questions and Darren the answers and it reads like this (with links and emphases added and with some minor editing):

Regulating the Nagoya Protocol 

Environment analysis: What are the potential consequences of the Nagoya Protocol's recent compliance regulations? 

Original news

Nagoya Protocol (Compliance) Regulations 2015, SI 2015/821: Measures needed for the UK to implement the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their utilisation in the Union are put in place. Parts 1 and 2 come into force on 9 July 2015, parts 3-6 and the Schedule come into force on 12 October 2015.

What is the background to the regulations? Why were they introduced?

These regulations have been put in to place under the UK's obligations under Regulation 511/2014, and in particular art 11 thereof that states 'member states shall lay down the rules on penalties applicable to infringements of arts 4, 7 and shall take all the measures necessary to ensure that they are applied'. Regulation 511/2014 was enacted to enable the EU and its member states to ratify the Nagoya Protocol--which it did in Council Decision 2014/283. The Nagoya Protocol, which itself is a development of the Convention on Biological Diversity (CBD), entered into effect for the EU on 12 October 2014, but the provisions for which the UK is required to provide penalties do not come into effect until a year later, namely 12 October 2015. 

"I'm from the National Measurement Office
and I'm here to help you ..."

In addition, the regulations indicate the secretary of state as competent under Regulation 511/2014 for various functions, such as maintaining a register of trusted collections of genetic resources (Regulation 511/2014, art 5), monitoring user compliance (Regulation 511/2014, art 7), and encouraging awareness of and compliance with Nagoya Protocol (Regulation 511/2014, art 13). It has been announced that the National Measurement Office will in general be tasked with these functions. The EU is also enacting an implementing regulation and this will also be relevant when passed. In particular this will give more information about the declarations required pursuant to Regulation 511/2014, art 7(1)(2).

What do they cover? 

The main provision of the regulations is civil and criminal sanctions.

The civil sanctions are set out in the schedule to the Nagoya Compliance Regulations, and reg 8 indicates that these are for non-compliance with:

• Regulation 511/2014, art 4 (1)--this requires users to 'exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements, and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements'
• Regulation 511/2014, art 4 (3)--this requires users to seek, keep for 20 years, and transfer to subsequent users details about the genetic resources, their source and information about their access, and applicable access and benefit sharing agreements
• Regulation 511/2014, art 7(2)--this requires users to declare and submit evidence of compliance with the due diligence obligation (Regulation 511/2014, art 4) at the final stage of development of a product developed via the utilisation of genetic resources 

The main tools of civil sanctions are:

• a compliance notice found in para 1 of the schedule
• a variable monetary penalty in para 2 of the schedule
• a stop notice in paras 12, 13 of the schedule 

The criminal sanctions are set out in reg 16, referring to regs 13, 14, and relate mainly to failure to comply with a compliance notice or stop notice, or obstruction of an inspector.

There is also a criminal sanction in regulation 13c for noncompliance with Regulation 511/2014, art 4(6), which specifies that information must be kept for 20 years after cessation of utilisation, but this limited to a fine not exceeding £5,000. There are, however, also civil non-compliance penalties available, found in para 23 of the schedule.

Regs 10-12 give powers, subject to certain safeguards, for inspectors to enter premises to enforce Regulation 511/2014. Paragraph 26 of the schedule requires that guidance be published about the use of civil sanctions, but this is not yet available.

How do they affect existing civil sanctions? 

Functional units of heredity

These regulations are entirely unprecedented and impose on researchers who deal with genetic material--defined broadly as anything that contains 'functional units of heredity', including cells, seeds and whole organisms--an entirely new regulatory requirement. The regulations fall generally within the competence of the Department for Environment, Food and Rural Affairs as that is the department to whom responsibility for the Nagoya Protocol has been handed, but bears little relation to any existing regulatory requirements. The guidance that is to be published about how they will be deployed will be very welcome.

Are there any unintended consequences? 

It is hard to see how the increase in bureaucracy and record keeping by researchers in the UK will actually have much positive effect on helping sharing the benefit of genetic resources with the countries from which they have been obtained. There is a concern that the effect of the greatly increased bureaucratic hurdle will be to hamper and reduce research involving genetic resources from other countries that are signatories to the CBD. Also, since the US is notably not a signatory to the CBD, it may be attractive to move such research there, where these regulations will not apply. At the least US researchers will be at a significant advantage for not facing this additional regulatory burden.

Thanks, Darren!

Things to do in Nagoya here
Where to eat in Nagoya here