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21 April 2022Alex Baldwin

Nagoya Protocol: ‘a masterpiece of ambiguity’

Since the Nagoya Protocol was implemented in October 2014, lawyers, academics, and the life sciences industry broadly have been calling upon institutions such as the European Union for guidance on how to best abide by the new regulations.

Now, more than seven years later, many are still unaware of what obligations the protocol puts on companies, how it is being implemented, as well as its broader implications on the life sciences community.

Broadly, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation is a supplementary agreement to the Convention on Biological Diversity (CBD) which looks to equitably share benefits arising out of the usage of genetic resources.

This framework was created to contribute to the conservation and sustainable usage of biodiversity.

Despite critics claiming that the protocol has adversely affected research and development efforts in biology, biotechnology and pharmaceutical sectors, some are pushing to broaden its coverage to other industries.

In March, five members of the subcommittee of the UK BioIndustry Association focused on the Nagoya Protocol met on LSPN Connect to share their personal views on the protocol and its impact on life sciences.

Summarising the response to the protocol’s introduction into the European Union, David Rosenberg, former consultant at GSK said: “At first sight, [the protocol seemed to be] a simple due diligence obligation that sounded quite reasonable.

“I think it's fair to say that at first sight, the licencing industry for example welcomed the regulation. However, it soon became clear that there were major problems, one of which is that nobody quite understood what it meant in practice.”

This caused concern for industries impacted by the regulation as failure to comply with certain provisions could potentially lead to jail time. However, following two new guidances—one published in 2016 and a follow-up, almost twice the length in 2021—uncertainty still remained in the life sciences community.

Many researchers that utilise genetic material in the development of vaccines for example need to ensure compliance with the protocol. Even material that would generally be considered exempt from the protocol, such viral or bacterial material extracted from the human body, can still be regarded as “non-human” and therefore subject to the protocol as it originated outside of the human body.

According to Rosenberg, Nagoya has hindered the development of vaccines for Ebola, Zika, and seasonal flu.

Failed collaborations

As well as delaying the development of key treatments, issues arising from the particulars of the Nagoya Protocol can lead to deals and projects collapsing altogether.

The panel turned to examples they have heard of organisations that have had deals and partnerships fall through due to the potential issues surrounding compliance with the Nagoya Protocol.

Diana Sternfeld, head of IP at LifeArc explained a situation where a deal biosynethetics collaboration between the John Innes Centre and a body in Vietnam fell through due to both parties not being able to reach an agreement on certain terms under the Nagoya Protocol.

Sternfeld said: “They could not agree on the mutually-agreed terms, so John Innes had to go elsewhere… Vietnam missed out. Both parties had tried very hard to make this work. But it simply was too complicated.”

A key recommendation from the panel was that any organisation that works with genetic materials, even those not covered by the Nagoya Protocol, should ensure that they can prove their accordance with, or their distinction from the regulations if they are ever audited.

Matthew Garner, head of IP at The Cell and Gene Therapy Catapult said: “It's your responsibility to be able to demonstrate that [you are exempt] and provide evidence if you are ever audited.

“It's a simpler and more satisfactory situation to have in place the relevant records and an assessment of the scope of the materials in question such that should we be audited, we are able to provide simple evidence fairly straightforwardly.”

What can change?

While the panel detailed the impact the protocol has had on the life sciences sector, it reinforced that positive steps could be taken to change the implementation of the protocol for the better.

Beatriz San Martin, partner, Arnold & Porter stressed that putting pressure on the governing bodies is necessary in order to bring greater clarity to their own interpretation of the protocol.

San Martin said: “We might disagree with what the EU guidance says for example, but the problem is that these are the bodies that are implementing their own a view or interpretation of the protocol. Unless you challenge that, then you're going to have to meet that higher threshold than perhaps is contained within the remit of the law.”

Varuni Paranavitane, senior associate at AA Thornton & Co also added that changes could be on the horizon for the UK’s implementation of the protocol in light of its departure from the European Union.

Paranavitance said: “There is a potential post-Brexit... for the UK to divert from the European Commission's guidance and provide some clarity and certainty for the stakeholders. So that's something that we are waiting on.”

Watch:  The Nagoya Protocol: why it increasingly matters to the life sciences community

LSPN Connect is the membership programme for the Life Sciences—for more information on joining, visit  www.lspnconnect.com

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24 November 2016   Benin yesterday accepted the 2005 protocol amending the World Trade Organization’s (WTO) agreement on TRIPS, a protocol intended to ease poorer WTO members’ access to affordable medicines.