A snapshot by yours truly while following the debate on synthetic biology.  As you can see, business gets a seat in a place far, far away – in the back of the room.

After two weeks of intense negotiations in Montreal, on 19 December 2022, the Conference of the Parties (COP) to the Convention on Biological Diversity (CBD) adopted the new Global Biodiversity Framework.  Covington partner Bart Van Vooren was on the ground as a business delegate to these talks. 

Brief Summary

This blog explains one the most consequential outcomes for companies from COP15: the decision to set up a global mechanism requiring the private sector to pay into a new Global Biodiversity Trust Fund.  The COP15 Decision was to decide to set up the mechanism immediately, and to tease out the details over the next two years.  In short, the new fund is expected to generate up to 15 billion USD per year from companies that “use digital sequence information on genetic resources“.  The revenue generated will then be disbursed in support of the four (4) Goals for 2050 and twenty-three (23) Targets for 2030 that together make up the Global Biodiversity Framework (GBF).  This new mechanism will no doubt impact most life sciences companies, but the COP15 Press Release hinted at two sectors that are being singled out (my emphasis):

Digital sequence information on genetic resources – a dominant topic at COP15 –  has many commercial and non-commercial applications, including pharmaceutical product development, improved crop breeding, taxonomy, and the monitoring of invasive species.

Reader beware, this blog is a long read.  I will first provide some insight on the political narratives and financial expectations underpinning the new system, and then deep dive into the legal nitty-gritty and (un)knowns of the Decision on Digital Sequence Information (DSI) adopted by COP15.

The new global mechanism on DSI is expected to generate 15 billion USD per year to support the new Global Biodiversity Framework (GBF)

Simplified, the negotiations in Montreal were driven by the following narrative.  Biodiversity is declining faster than at any time in human history.  We are on the verge of a mass extinction event.  All agree that urgent action is needed.  But what countries should shoulder what burden?  Who should pay – the public and/or private sectors?  And how much?   From the countries’ perspective, since biodiversity conservation and restoration would allegedly require more efforts from the more biodiverse but less wealthy ‘Global South’ (e.g. Brazil, Argentina, and the group of African countries); the ‘Global North’ (e.g. UK, the EU and its member states, Canada, but not the U.S. which is not a party to the CBD — though U.S. diplomats were present in droves in Montreal) is expected to ensure that sufficient funds are made available through public funds and private contributions.  This is known as “resource mobilization”, and the subject of a separate COP15 Decision on Resource Mobilization.  From the very start, the group of African countries had made clear that “a solution on benefit-sharing from digital sequence information” was a critical part of resource mobilization.  For them it was a deal-breaker.  They would refuse to approve the new Global Biodiversity Framework without  deal on sharing revenues generated from Digital Sequence Information. Of course, China – host and chair of the COP15 (taking place at the seat of the CBD Secretariat Montreal due to COVID), was not going to let that happen. 

The eventual grand bargain on biodiversity, resource mobilization and digital sequence information is clearly reflected in the four Global Goals for 2050.  Goals A and B are about the actions that need to be taken to rescue biodiversity.  Or, as one high level speaker put it, “it is not about saving the planet, but about saving ourselves.”  For instance, Goal A states e.g. that “[h]uman induced extinction of known threatened species is halted, and, by 2050, extinction rate and risk of all species are reduced tenfold and the abundance of native wild species is increased to healthy and resilient levels…“. 

Goals C and D are about mobilizing the resources to achieve the two previous goals.  We quote them in full, and highlight the language that is of direct relevance to the private sector. 

GOAL C

The monetary and non-monetary benefits from the utilization of genetic resources, and digital sequence information on genetic resources, and of traditional knowledge associated with genetic resources, as applicable, are shared fairly and equitably, including, as appropriate with indigenous peoples and local communities, and substantially increased by 2050, while ensuring traditional knowledge associated with genetic resources is appropriately protected, thereby contributing to the conservation and sustainable use of biodiversity, in accordance with internationally agreed access and benefit-sharing instruments.

GOAL D

Adequate means of implementation, including financial resources, capacity-building, technical and scientific cooperation,  and access to and transfer of technology  to fully implement the Kunming-Montreal global biodiversity framework  are secured and equitably accessible to all Parties, especially developing countries,  in particular the least developed countries and small island developing States, as well as countries with economies in transition, progressively closing the biodiversity finance gap of 700 billion dollars per year, and aligning financial flows with the Kunming-Montreal Global Biodiversity Framework and the 2050 Vision for Biodiversity.

The take-away: countries agreed to find 700 billion USD per year by 2050 to preserve biodiversity.  To do so, they want to substantially increase “benefit-sharing” from the new global mechanism on Digital Sequence Information, as well as from physical genetic resources under the already-existing Nagoya Protocol to the Convention on Biological Diversity.

The four Goals A through D for 2050 are then concretized in twenty-three (23) Targets to be achieved by 2030.  Target 19 is particularly relevant here.  It reads:

“TARGET 19

Substantially and progressively increase the level of financial resources from all sources, in an effective, timely and easily accessible manner, including domestic, international, public and private resourcesby 2030 mobilizing at least 200 billion United States dollars per year […]

In the next 8 years, Target 19 aims to find 200 billion USD per year for biodiversity.  Target 19 then continues to state that at least 30 billion USD per year should come from developed country parties.  That leaves 170 billion USD to be found elsewhere, including the private sector.  So how much do countries expect that the new global mechanism on Digital Sequence Information will generate?

There is no official figure on the expected contribution of new global mechanism on DSI to the 200 billion USD figure.  During the negotiations in Montreal, one country delegate whispered that there is an expectation up to 15 billion USD per year.  In view of this author, that is very optimistic.  The countries do not see it that way.  The final COP15 Decision on Digital Sequence Information made clear that expectations are “wide-ranging” – a slightly ominous term also reflecting the future scope of the global mechanism (my emphasis):

“Recognizing also that a solution for benefit-sharing from the use of digital sequence information on genetic resources is also a wide-ranging solution for the mobilization of resources to support the conservation and sustainable use of biological diversity,”

In the remainder of this blog, I deep-dive into what we know, and don’t know, on new global mechanism on DSI. 

First we had rain, then freezing cold, and towards the end: a nice blanket of snow. Photo Credit: Danny Grayales Perez-y-Soto, International Chamber of Commerce

The Decision to go for a Global Fund Now, and Hash out Details Later Demonstrates the High Stakes at COP15

COP15 started on 7 December 2022.  In the days leading up to it, there was an “Open-Ended Working Group” that drafted a “non-paper” on “a solution for Digital Sequence Information“.  At the start of the COP, that non-paper still opened with the following option:

The Conference of the Parties,

Decides that digital sequence information on genetic resources in not in the scope of the Convention on Biological Diversity.

By 12 December 2022, that first option had disappeared.  From what this author could gather, this was under significant pressure from the African group of countries.  Removing it was strongly opposed by e.g. Japan, but without backing from other Parties, they soon had to yield. As a compromise, the preamble to the final Decision on DSI now reads:

Recognizing that there are divergent views on digital sequence information on genetic resources with regard to its scope under the Convention on Biological Diversity

The second week of COP15 was thus dominated by the pressure to find a solution on DSI in a way that was intrinsically connected to “resource mobilization”.  Two options were on the table: Option A — Process for a Decision; or Option B — a Decision and a Process.  I quote the text in full, since the reader should also be aware of the path taken, as well as the path not taken.  It demonstrates the high political stakes surrounding benefit-sharing from DSI.

Option A was for the parties to establish a process to tease out a mechanism on DSI.  It would then be adopted by a Decision of the COP, in two years’ time at the COP16 in Turkey.  This option, in version 6 of the non-paper of 17 December 2022, read:

OPTION A

15.  Alt.1 Establishes a fair, transparent, inclusive, participatory and time-bound process to further analyse, [identify potentially most workable and practical options for] and define modalities to operationalize a mechanism for sharing benefits from the use of [biodiversity, including] digital sequence information on genetic resources for a decision [to be reported for consideration] at COP16 as set out in paragraphs 17 to 19 below. This process should take into account and build upon the outcomes of the work done by the informal Co-Chairs’ advisory group and the criteria laid out in paragraph 9 and 10

Option B was for the COP15 to take a Decision to establish a mechanism in Montreal.  The details would be hammered out over the next two years, again by COP16.  Option B read as follows, with my own emphasis:

OPTION B

15. Alt.2.a Decides to establish, as part of the post-2020 global biodiversity framework, a global mechanism for benefit sharing from the use of [biodiversity, including] digital sequence information on genetic resources, without prejudice to existing national legislative arrangements for sharing the benefits which arise from the use of digital sequence information on genetic resources [and as outlined in Annex III]

Until the very end of the Montreal summit, it was not clear whether Option A or Option B would be chosen.  During the last three days of COP15, there was a so-called “High Level Segment” (HLS).  The HLS is the part where the highest government officials fly in to decide on issues that require political guidance.  Negotiations at the HLS continued into the early morning of Sunday to Monday on 18 to 19 December 2022.  Eventually the global South won the day. It was decided to establish the mechanism immediately, and hash out the details over the next two years.  The choice for the ‘maximalist’ option on the table is significant.  A process can easily drag out and more easily fail. A decision on the global mechanism now, and figuring out the details later, creates more pressure on countries to succeed within a set time-frame (though it too, can drag out and eventually fail, but less likely).  

Paragraph 16 of the final Decision on Digital Sequence Information eventually reads:

Decides to establish, as part of the post-2020 global biodiversity framework, a            multilateral mechanism for benefit-sharing from the use of digital sequence information           on genetic resources, including a global fund”

Between the text of 17 December and the final version, a number of important deletions took place.  First, it was not accepted that DSI on “biodiversity” as such would be trigger for payments into the global fund.  Instead, the more narrow “genetic resources” was used.  Second, the reference to “without prejudice to national laws…” was moved to another paragraph where it is somewhat less prominent.  This was a hotly negotiated and important legal issue to which I will return separately below. Third, the text refers to a “global” fund rather than a “multilateral” one, to underscore the transnational, above-country nature and importance of the fund.  Fourth, Annex III was deleted in its entirety.  It contained quite a bit of detail on what the global mechanism would look like.  For that reason I reproduced it at the end of this blog.  No doubt some of its contents will be revived over the next two years. 

Next, I turn to the question that readers who made it this far must have been wondering about: what does “digital sequence information” actually mean?

The 15 billion US dollar question: what is “digital sequence information” (DSI)?

Despite calls from industry to provide clarity on what to expect from the new mechanism, there is no definition in the COP15 Decision.  The first paragraph of the final COP Decision on DSI simply reads that the conference of the parties: “[a]grees on the continuing use of the term “digital sequence information” for further discussions.”  Hidden away in the preamble, however, are hints on how DSI might be defined over the next few years.  The Decision’s preamble refers to the preparatory work that had been done in the period between COP14 and COP15.  Specifically, the note from the Open Ended Working Group of 3-5 December 2020 on policy options to regulate digital sequence information and the report from the Ad Hoc Technical Expert Group on Digital Sequence information on Genetic Resource.  A discussion of these two documents would make this blog ‘the longest read’ ever.  But they are nevertheless a highly recommended deep dive, since these two documents will very much shape the global mechanism over the next two years.  Of course, I am happy to draft the longest memo ever, if there are any takers.

Building on the above-mentioned documents, certain parties at COP15 did attempt to include a definition of DSI.  On 17 December 2022, already during the High Level Segment, a draft of Goal C of the Global Biodiversity Framework still read (my emphasis):

GOAL C

[The monetary and non-monetary benefits from the utilization [of genetic resources [in    any form] including digital sequence information] [, only including nucleotide sequence data and excluding any information and data belonging to the group 1, 2, 3 contained in the outcome of the 2020 DSI AHTEG] [including digital sequence information]/[biological diversity, including digital sequence information], and traditional knowledge associated with genetic resources, as applicable are shared fairly and equitably, and, as appropriate, with indigenous peoples and local communities, [and [substantially] increased,] and traditional knowledge associated with genetic resources is appropriately protected, thereby contributing to the conservation and sustainable use of biodiversity, and in accordance with internationally agreed access and benefit-sharing instruments.

The highlighted language was eventually deleted from the text of Goal C.  But it was an important attempt to define DSI in a limited way that provides some degree of legal certainty.  With that language, it would comprise genomics and transcriptomics only, and exclude “higher” levels of information such as proteomics or metabolomics.   The following table from the report of the “Ad Hoc Technical Working Group” clarifies the different groups, referred to in the draft Goal C cited above. 

The choice between groups 1, 2 or 3 for the definition of DSI will be the battleground when setting up the global mechanism.  An example of how this would impact public and private research entities.  A university decodes and examines the genome of a wild drought resistant plant, and uses that information to improve a food crop’s resilience to climate change.  That would likely be covered by group 1 – genomics.  But if that same entity were to run mass spec on the biochemical composition of that plant to examine whether it contributes to its drought-resistant properties then this activity could be within scope of group 3 – metabolomics.  And no doubt, scientists might then ask – is the plant microbiome – just one of many dozens of questions and uncertainties the definition of DSI will generate. 

Since the ambition is to generate up to 15 billion USD/year, and since the COP decision refers to “a wide-ranging” solution, a push for a wide definition of DSI comprising all three groups is likely.

How Much, and When, are Users of Digital Sequence Information Expected to Pay?

Unsurprisingly, the final COP Decision does not provide an answer to this question.  In annex to the COP Decision there is a list of “issues for further consideration” over the next two years.  It includes the “triggering points for benefit-sharing” and “contributions to the fund.”  However, prior drafts that were negotiated at COP15 contained much more detail on these points.   I mentioned earlier that the High Level Segment was presented on 17 December 2022 that contained an Annex III.  It was eventually deleted because too much bracketed language remained.  On the expected levy, and the triggering point, it stated:

“…

b)  Contributions to the fund

(i)  Each [developed-country] Party will take measures to ensure that 1% of the [retail price of all commercial income][net revenue from products] resulting from all utilization of [genetic resources, traditional knowledge associated with genetic resources and] digital sequence information on genetic resources is contributed to the multilateral fund, subject to the exceptions set out below.

(i) alt. Funds should be deposited into the fund by users of digital sequence information on genetic resources at the point at which they commercialise a product derived from the use of digital sequence information on genetic resources

(ii) The multilateral fund will also be open for voluntary contributions from all sources.

The “one percent of the retail price” was discussed by many at COP15.  To some degree, it reflects the national ABS law of Brazil, and the group of African countries has been broadly supportive.  The proponents consider one percent to be a small percentage that developed countries and their companies should easily be able to afford. There is no impact assessment or any study that supports this assumption.  Some back-of-the-envelope math, using the draft text, makes clear why the High Level Segment of COP15 could not yet agree on this crucial element. 

Lawyer does math: The global mechanism on DSI is expected to generate up to 15 billion USD/year.  The one percent would be levied by developed-country parties only, on the retail price or net revenue from products.  That means that ‘the Global North’ (excluding the United States that is not a party to CBD), somewhere, should find 1,5 trillion USD/year “taxable base” to generate these funds.  That’s a lot.  For comparison, according to World Bank data, the EU’s GDP in 2021 stood at 17 trillion USD. A “wide-ranging” global mechanism indeed.

What is the Relationship between the Global Benefit-Sharing Mechanism of CBD and National Benefit-Sharing Laws under the Nagoya Protocol to CBD?

Readers that are in the weeds on Access and Benefit-Sharing (ABS) will no doubt have thought: “and what about the Nagoya Protocol?” Will there be two payment obligations for use of Digital Sequence Information, one under national ABS laws, and one under the global mechanism?  This has been negotiated at COP15, but the jury is still out.

The “multilateral mechanism for benefit-sharing from the use of digital sequence information on genetic resources, including a global fund” decided at COP15 was an essential pre-condition for the Parties to agree on the 2030 Global Biodiversity Framework.  A similar bargain was struck back in 2010.  At that time, the parties to the Biodiversity Convention agreed the 2011-2020 “Aichi Biodiversity Targets“.  Back then, a pre-condition to the Aichi Targets was the conclusion of the “Nagoya Protocol Access to Genetic Resources and Fair and Equitable Benefit-Sharing” to the Biodiversity Convention.  This additional international agreement attached to the Biodiversity Convention essentially allows the -by now- 135 countries that signed up to the Nagoya Protocol, to require a permit to access the provider country’s biological riches, and agree to benefit-sharing in return for the permit.  In the decade since the Nagoya Protocol was concluded, it has spawned more than one hundred (+100) national Access and Benefit-Sharing laws, by Covington’s last count in October 2022.  According to our database, thirty-nine (39) of those national laws already apply to Digital Sequence Information in some form.  As with many rules in the environmental law domain, non-compliance is sanctioned by severe administrative and criminal penalties.  The result has been a massive compliance headache for global life sciences companies.

Unfortunately, the world failed to meet any of the twenty (20) Aichi Targets.  A similar conclusion arguably applies to the Nagoya Protocol, if measured by the funds for biodiversity generated by national ABS laws.  In one side event at COP15 supported by the Brazilian government (see photo of slide to your left), the speakers explained that the Brazilian ABS law (that requires benefit-sharing to the amount of 1% of annual net revenue obtained from economic exploitation of finished products from access to Brazilian genetic heritage) had generated about 1.2 million USD in the three-year period of 2020 to 2022.  In my personal view, that is surprisingly low.  Especially since Brazil has had an ABS law for two decades, and hence is one of the most prominent and experienced jurisdictions in the world on this topic.  In fact, a recent study has shown, that the Brazilian ABS law has generated more monies from fines for non-compliance, than monies from equitable benefit-sharing under the Brazilian ABS law.  Apparently, the funds from those fines were also not attributed to biodiversity projects, though that is legally possible. 

Hence I was pleasantly surprised at COP15, when even the most fervent proponents of the Nagoya Protocol, acknowledged that its Harlequin’s costume of national ABS laws created massive transaction costs and failed to meet its goal of equitable benefit-sharing for biodiversity. Yet astonishingly, many countries were not willing to give up on their national ABS laws in favor of the global mechanism. At the very end of the High Level Segment of COP15, on Sunday 18 December 2022, the draft Decision still read (my highlights in underline and bold):

16.       Decides to establish, as part of the post-2020 global biodiversity framework, a global mechanism for benefit-sharing from the use of digital sequence information on genetic resources, including a multilateral fund, without prejudice to existing national legislative arrangements, for sharing the benefits which arise from the use of digital sequence information on genetic resources

Industry had strongly opposed a “hybrid system” where national benefit-sharing laws would co-exist with a global benefit-sharing system.  A number of countries agreed, but a compromise was difficult to find at COP15.  In a flurry of late-night negotiations during the High Level Segment, the text in bold was eventually deleted.  But given the need for “beautiful constructive ambiguity” (an actual quote from one of the delegates), the final COP Decision also contains paragraphs 6 and 7 that allow exceptions to the multilateral system, and paragraph 11 that reads (my highlights):

“Agrees that the approach set out in this decision to fair and equitable benefit-sharing from the use of digital sequence information on genetic resources does not affect existing rights and obligations under the Convention and the Nagoya Protocol, including, as applicable, those related to traditional knowledge and the rights of indigenous peoples and local communities, and is without prejudice to national access and benefit-sharing measures

Hence, national ABS laws remain unaffected by the global mechanism.  The Annex on “issues for further consideration” states that parties will need to further align on the “Interface between national systems and the multilateral mechanism on benefit-sharing” as well as the “Relationship with the Nagoya Protocol.” There is a glimmer of hope, however.  Neatly tucked away in that same Annex is the possibility for Parties to the CBD to potentially “voluntarily extend the multilateral mechanism to genetic resources or biological diversity.”  Taken together, in theory, this could mean that countries that have national ABS laws can decide to give them up altogether.  It is possible for countries to adopt the position that benefit-sharing from both physical genetic resources, as well as DSI should be managed at global level only.  That is the optimistic view.  Conversely, it is equally possible national ABS systems that apply to DSI (such as the Brazilian rules) continue to exist concurrently with the global mechanism on DSI, creating legal uncertainty and/or double payment obligations.

Next Steps and Timeline: Two Years is Incredibly Short

Currently the global mechanism on DSI exists in name only and a host of issues need to be fleshed out.  At paragraph 9, the final Decision on Digital Sequence Information contains the following principles that the mechanism should follow: 

  • Be efficient, feasible and practical;
  • Generate more benefits, including both monetary and non-monetary, than costs;
  • Be effective;
  • Provide certainty and legal clarity for providers and users of digital sequence information on genetic resources;
  • Not hinder research and innovation;
  • Be consistent with open access to data;
  • Not be incompatible with international legal obligations;
  • Be mutually supportive of other access and benefit-sharing instruments;
  • Take into account the rights of indigenous peoples and local communities, including with respect to the traditional knowledge associated with genetic resources that they hold;”

These are encouraging criteria, but the devil will be in the detail.  According to paragraphs 17 to 22 of the final Decision on Digital Sequence Information, there will now be a “fair, transparent, inclusive, participatory and time-bound process to further develop and operationalize the mechanism… to be finalized” in two years’ time, at the next COP16 to be held in Turkey.  As part of that process, paragraph 20 invites “relevant organizations” to submit views on the following issues, referenced in an annex:

  • (a) Governance of the fund;
  • (b) Triggering points for benefit-sharing;
  • (c) Contributions to the fund;
  • (d) Potential to voluntarily extend the multilateral mechanism to genetic resources or biological diversity;
  • (e) Disbursement of monetary benefits, including information on geographical origin as one of the criteria;
  • (f) Non-monetary benefit-sharing, including information on geographical origin as one of the criteria;
  • (g) Other policy options for the sharing of benefits from the use of digital sequence information on genetic resources;
  • (h) Capacity development and technology transfer;
  • (i) Monitoring and evaluation and review of effectiveness;
  • (j) Adaptability of the mechanism to other resource mobilization instruments or funds;
  • (k) Interface between national systems and the multilateral mechanism on benefit-sharing;
  • (l) Relationship with the Nagoya Protocol;
  • (m) Role, rights and interests of indigenous peoples and local communities, including associated traditional knowledge;
  • (n) Role and interests of industry and academia;
  • (o) Linkages between research and technology and the multilateral mechanism on benefit sharing;
  • (p) Principles of data governance.

The COP15 Decision on DSI also requested that three studies would be commissioned, including one on lessons learned from other international mechanisms such as the International Plant Treaty and the WHO Pandemic Influenza Preparedness Fund…  Agri and pharma, watch out. The next two years will be interesting, no doubt.

 I leave you with this snowy picture from Montreal, taken at the end of COP15.  I am wishing you all a very Happy Holiday and a Wonderful, Happy, Healthy, and Fruitful New Year.  Let’s chat in 2023!

Bart

Walk in the snow: taking a break during the High Level Segment.

Below is the Annex III with some more details on the global mechanism.  This was the latest text as it stood in version 6 of the non-paper on DSI on 17 December 2022, before it was deleted during the High Level Segment.

[Annex III

Global mechanism for sharing benefits from the use of digital sequence information on genetic resources

1.   The global mechanism for the sharing of benefits arising from the use of digital sequence information on genetic resources established in paragraph 16.Alt.2.a of this decision includes a multilateral fund which will operate according to the provisions below.

a)   Governance of the fund

(i)   The monetary benefits to be shared under the global mechanism for benefit-sharing will be deposited in a multilateral fund [operated by the Global Environment Facility as the financial mechanism of the Convention][operated by the Global Biodiversity Fund].

(ii)  The multilateral fund will be governed by a steering committee, which will include, inter alia, representatives of indigenous peoples and local communities. 

b)   Contributions to the fund

(i)   Each [developed-country] Party will take measures to ensure that 1% of the [retail price of all commercial income][net revenue from products] resulting from all utilization of [genetic resources, traditional knowledge associated with genetic resources and] digital sequence information on genetic resources is contributed to the multilateral fund, subject to the exceptions set out below.

(i) alt. Funds should be deposited into the fund by users of digital sequence information on genetic resources at the point at which they commercialise a product derived from the use of digital sequence information on genetic resources

(ii) The multilateral fund will also be open for voluntary contributions from all sources.

c)   Disbursement of monetary benefits

(i)   The global mechanism on benefit sharing will operate in an open, competitive, project-based manner to support on-the-ground activities aimed at the conservation of biological diversity and the sustainable use of its components, in line with the ecosystem-based approach, in pursuit of spending priorities identified from time to time by the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services through scientific assessments.

(ii)  Indigenous peoples and local communities will be the primary beneficiaries of the fund.

d)   Monitoring and evaluation

(i)   The global mechanism for benefit sharing will be subject to monitoring and evaluation as part of the monitoring and reporting framework of the post-2020 Global Biodiversity Framework to enable the mechanism to be adapted as necessary according to the results of such evaluations.

e)   National systems

(i)   In some exceptional cases, the sharing of benefits from the use of digital sequence information on genetic resources may be directly with the respective source country or indigenous peoples and local communities. This will be considered in cases where:

a)   The user of the digital sequence information is the same person or entity engaged in the mutually agreed terms that regulate the genetic resource from which it was extracted, and these mutually agreed terms include the use of digital sequence information and the sharing of the benefits resulting from its use;

b)   The product is derived from the use of digital sequence information from a single known source country; or

c)   The product is derived from well-defined traditional knowledge.

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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive…

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Mr. Van Vooren has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

Finally, Mr. Van Vooren has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.