On 19 December 2022, the parties to the Convention on Biological Diversity (CBD) decided to create a new global mechanism requiring the private sector to pay into a new Global Biodiversity Trust Fund.
The new fund is expected to generate up to 15 billion USD per year, based on contributions from companies that “use
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.
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.
On 1st August 2022, the Italian Competition Authority (“AGCM”) published its decision where it ruled that the NutriScore labelling must be discontinued in Italy because it deceives consumers. The authority further held that products meant for the French market, where the NutriScore is allowed, and which are distributed also on the Italian market may keep the NutriScore labelling provided that this is sufficiently substantiated.
Continue Reading NutriScore Halted In Italy As Italian Competition Authority Deems It Misleading
On 14 July 2022, the European Commission published a proposal for a Regulation on “substances of human origin” (“SoHO”) intended for human application. The proposed Regulation is intended to replace the existing and largely outdated Directives on SoHO, respectively on Blood and on Tissues and Cells. These sets of rules govern the sourcing and use of starting materials for innovative therapies, such as blood, tissues and cells. Pharmaceutical companies active in the manufacturing of advanced therapy medicinal products (“ATMPs”) are therefore well advised to closely monitor the developments surrounding the proposed Regulation.
Continue Reading European Commission to Harmonize Rules on the use of Substances of Human Origin
In collaboration with Corporate Law Group, New Delhi, India
On December 16, 2021, India proposed amendments to the Biological Diversity Act, 2002 (the “BDA”) by introducing the Biological Diversity (Amendment) Bill, 2021 (the “Bill”). The process to amend the BDA was undertaken in response to long-standing complaints by stakeholders in the Indian systems of medicine, seeds, and research sectors, as well as industry, that existing access and benefit-sharing (“ABS”) processes in relation to Indian biological resources are too burdensome.
The Bill has several objectives. It seeks to attract foreign investment in Indian biological resources, to fast-track research, patent application processes, and transfer of research results, and to decriminalize non-compliance. The Bill also seeks to further the conservation of biological resources in line with objectives of the Convention on Biological Diversity (“CBD”) and Nagoya Protocol to the CBD, to encourage cultivation of medicinal plants, and to support the Indian system of medicines.
The Bill’s proposed amendments are extensive and touch on many different aspects of ABS, but focus mainly on access and access procedures. In this blog, we present the key proposed amendments, as well as next steps in the process for the adoption of the Bill.
From 25 to 29 January 2022, the 150th session of the World Health Organization’s (“WHO”) Executive Board (“EB”) took place in Geneva, Switzerland. Two years into the COVID-19 pandemic, a central theme for this session was the management of global health emergencies. This post briefly outlines the main take-aways for pharmaceutical companies.
Continue Reading Key Take-aways from the 150th Session of the WHO Executive Board
Between 29 November and 1 December 2021, all member states of the World Health Organization (WHO) will convene for an extraordinary session of the World Health Assembly (WHA). There is only one agenda item: whether or not to commence negotiations towards a legally binding, global instrument on pandemic preparedness and response. Since it was first proposed by the European Union (EU) in November 2020, significant momentum has built towards some kind of International Pandemic Treaty (IPT). The project is currently backed by the EU and more than 25 countries, though sceptics include the U.S., Russia, Brazil and China.
The IPT will be directly relevant to all pharmaceutical companies developing medical countermeasures (e.g. vaccines, diagnostics, and therapeutics) to most infectious diseases with epidemic or pandemic potential. This blog summarizes key points that pharmaceutical companies should be aware of.
On 6 May 2021, the European Food Safety Authority (“EFSA”) published its updated safety assessment on titanium dioxide as a food additive (E171). EFSA examined new evidence on nanoparticles and found that there was uncertainty about E171’s ability to accumulate in the body and damage genetic material in cells; i.e. genotoxicity. The agency could not calculate an Acceptable Daily Intake (“ADI”), nor could it determine a safe cut-off value for particle size and distribution. On that basis, it could not confirm the safety of E171 in food. However, since it found no evidence of acute toxicity, an immediate ban is not warranted. France previously initiated a national ban in 2019/2020; following EFSA’s revised opinion, the EU is likely to adopt an EU-wide ban early 2022. In this blog, we briefly review the planned EU-level response and the developments in the Netherlands, Germany and the UK.
On 1 July 2021, the new French rules on early access to unauthorized medicinal products and off-label use of authorized medicinal products entered into force. The rules were introduced by the Social Security Financing Law for 2021 (LOI n° 2020-1576 du 14 décembre 2020 de financement de la sécurité sociale pour 2021 or “LFSS 2021”, available here). The reform seeks to simplify existing rules, make early access and off-label use more predictable for all users, and ensure the sustainability of these programs for the public health insurance system. In this blog, we present an overview of the new rules.
Continue Reading New Early Access and Off-Label Use Rules in France
On May 24, 2021, the World Health Organization (WHO) announced it singed an MoU with Switzerland to host the WHO’s first BioHub Facility, which is part of the new BioHub System first announced at the World Health Assembly in November 2020.
The stated purpose of the WHO BioHub is to set up a system that guarantees the timely sharing of biological material (e.g., clinical samples, specimens, isolates, cultures) for emerging pathogens, so as to ensure their faster identification and characterization and enable risk assessments and the rapid development of countermeasures (e.g., vaccines, diagnostics and therapeutics).
Continue Reading WHO Launches Global BioHub for Pathogen Sharing