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Monday, 6 April 2015

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


NotMyProblem said...

Still no comments, but possibly because I wonder whether the issue relates to patents. As a patent attorney, I might be more interested if it can be a ground for invalidity of the patent, and if not thoroughly studying these rules can make me liable or face disciplinary sanctions. Otherwise, I prefer leave this matter for a client's in-house or general counsel.

Anonymous said...

Surely we are supposed to be able to advise clients in all aspects of their I P.. If we fail to advise them early on to keep proper records and it later comes back to bite then on the bum making their patent useless, haven't really failed?

Darren Smyth said...

I would add that although in this country and according to the EU Regulation non-compliance with Nagoya is not a ground for invalidation of patents, some countries have adopted disclosure requirements in patent applications as a mandatory requirement, so I don't think that it is sufficient for patent professionals to simply say "this is not my area".

Graham Spencer said...

Anonymous has it right - and it is, of course, especially important for that Cinderella of IP rights, the Plant Variety Right. In the plant breeding world where I live, some (but probably not enough) breeders and growers are very agitated by Nagoya. I would suggest that record keeping in much of the industry, especially amongst independent breeders, could best be described as "poor".

Brendan Tobin said...

Get ready things are going to get complicated.

The Nagoya Protocol is the culmination of a painfully slow process to implement the third objective of the Convention on Biological Diversity, the fair and equitable sharing of benefits arising from utilisation of genetic resources and the associated issue of protection of rights over traditional knowledge. Despite many flaws, it is a significant step toward the realization of equity and fairness in benefit sharing and greater opportunities for research and development.

Unfortunately the adoption by the European Union of very weak measures on the protection of traditional knowledge in its implementation of the Nagoya Protocol shows a lack of political will to take the necessary steps to protect the interests of indigenous peoples (largely poor and marginalised) against the interests of corporate wealth generation. When taken together with the collapse of negotiations at WIPO for development of international instruments on protection of traditional knowledge the European law leaves the burden for protecting traditional knowledge on developing countries and indigenous peoples themselves. This makes it likely that ever more stringent measures will be adopted to protect traditional knowledge and genetic resources from unapproved and uncompensated use. One way to lessen the need for stringent legislation in this area would be the adoption of a functional disclosure of origin system with obligations to provide evidence of prior informed consent for use of genetic resources and traditional knowledge, in patent, plant breeders rights and product approval processes.

At least 18 mainly megadiverse countries have already developed disclosure of origin requirements. The adoption by the Nagoya Protocol of a standardised international certification system to evidence compliance with national access and benefit sharing legislation makes the adoption of an international disclosure system ever more likely.

Efforts to move negotiations on disclosure forward in WIPO and the WTO have been frustrated by a small group of developed nations, their capacity to continue to block negotiations may be running out. Following the suspension of negotiations on disclosure of origin at WIPO the debate on this issue may be taken up again in the Convention on Biological Diversity, which has previously adopted a decision calling for states to encourage disclosure. The most practical forum for discussion of this issue would seem to be within the framework of the compliance negotiations at the Nagoya Protocol, where the European Union and most (if not all) states already support the adoption of some form of binding international disclosure of origin/source system. If this were to happen the question will no longer be if but rather when will disclosure of origin become obligatory and what form those obligations will take.

During the 20 years of negotiations that preceded and eventually led up to the adoption of the Nagoya Protocol, the primary input of most IP lawyers in the debate on access and benefit sharing has been to decry the possible adoption of disclosure measures, without the promotion of any functional alternative. It is time to change that focus and entice the IP community to play a more active role in helping develop a meaningful debate on how to secure fairness and equity in benefit sharing, implement a functional disclosure system and help secure the protection of rights over traditional knowledge. Now that would be a worthwhile use of effort.

For a critique of the implementation of Nagoya Protocol's provisions on traditional knowledge by the European Union see Brendan Tobin Biopiracy by Law: European Union Draft Law Threatens Indigenous Peoples’ Rights over
their Traditional Knowledge and Genetic Resources’, European Intellectual Property Review,
36(2), 124–136. 2014

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