By May 2024, the 194 countries of the World Health Organization (“WHO”) aim to finalize negotiations on a new international treaty on pandemic prevention, preparedness and response (“Pandemic Accord”). At the center of the negotiations is the contentious issue of Pathogen Access and Benefit-Sharing (“P-ABS
Continue Reading Pathogen Access and Benefit-Sharing (P-ABS) under the draft WHO Pandemic Treaty: Why Many Vaccine, Therapeutic, and Diagnostic Companies will be in ScopeWe won Case T-201/21 Covington & Van Vooren vs European Commission. But why did we litigate? Why did we ask to see how the member states voted on an EU implementing act? A short background story, worth a few minutes of your time if interested in the
Continue Reading The EU member states’ votes banning a product cannot be presumed confidential: Why we litigated Case T-201/21 Covington & VanVooren vs European Commission (and won)
On 19 June 2023, after almost 20 years of negotiations, the United Nations (“UN”) member states adopted a landmark treaty to ensure the conservation and sustainable use of marine Biodiversity of areas Beyond National Jurisdiction (the “BBNJ” treaty).
One of the cornerstones of the BBNJ treaty
Continue Reading Historic Marine Biodiversity Treaty creates new Access and Benefit-Sharing obligations for life sciences companies
“Delays in clinical trials result in delays of potentially life-saving treatments”
The European Commission is streamlining the rules for clinical trials of medicines consisting of, or containing genetically modified organisms (“GMOs”). Under the current EU GMO framework, getting authorization for clinical trials of GMO medicines is a long and costly process. Industry groups have vocally criticized it; and the Commission itself has voiced the need for change.
The Commission proposes a single, centralized application for clinical trials of GMO medicines. The sponsor will include a detailed environmental risk assessment with the application. In turn, the Commission will exempt clinical trials from the scope of many GMO rules. The new system will be leaner, greener and will get potentially life-saving treatments to patients with less administrative delay.
The changes are part of the EU’s new package of revisions to the bloc’s common pharmaceutical regime, set out in a draft Regulation and a draft Directive, published by the Commission on 26 April 2023. The new GMO medicines rules are just one part of a range of environment‑focused reforms to EU pharmaceutical law set out in the proposals — for more information, see our post here.Continue Reading EU Pharma Legislation Review Series: GMO Medicines
Pharmaceutical companies take note: the EU plans to refuse marketing authorizations for environmentally-unfriendly medicines.
The EU has published a package of revisions to the bloc’s common pharmaceutical regime. Many revisions aim to reduce the environmental impact of human medicinal products. The key environmental measures include:
In this post, we lay out what pharmaceutical companies need to know about the key environmental measures.Continue Reading EU Pharma Legislation Review Series: Addressing Environmental Risks
Those in the business of fast‑moving consumer goods (“FMCGs”) are likely aware of the plethora of environmental and product stewardship regulations applicable to the FMCG sector. These laws are set to increase and expand in application. What FMCG companies also need to get to grips with are a range of broader (and also fast‑moving!) environmental, social and governance (“ESG”) developments and consequent risks and opportunities. Companies need to understand how the new world of ESG impacts their supply chains, key ingredients and components, consumer choice and confidence, competitive advantage, market accessibility, and marketing.
Designed as a ‘primer’ for FMCG companies, in this piece, we cover a range of key trends in the emerging UK and EU ESG legal landscape as relevant for the FMCG sector, from farmers to Food Business Operators (“FBOs”) and from manufacturers to retailers. We also discuss some key legal and reputational risks; as well as pointers to help companies decipher and prepare for the ESG storm.
We focus on the UK and the EU (first movers on many ESG issues), but the landscape in other jurisdictions (including, for example, the US) is also evolving and becoming more complex.
Key ESG Issues for FMCGs
We think there are four categories of key ESG developments for FMCGs to watch: (I) corporate reporting and disclosure regimes; (II) green/sustainability claims and labelling; (III) supply chain obligations; and (IV) product packaging and presentation.
Many emerging ESG frameworks cut across sectors. This may be efficient for regulators, but can make identifying sector-specific risks and opportunities more challenging. We have sought to do that below.Continue Reading Green Groceries: Key ESG Issues for the FMCG Industry (including FBOs)
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
Continue Reading Submit your views! Consultation on the New Global Biodiversity Fund Paid For by Life Sciences Companies that “Use Digital Sequence Information on Genetic Resources”
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.Continue Reading Outcome from COP 15: a New Global Biodiversity Fund Paid For by Life Sciences Companies that “Use Digital Sequence Information on Genetic Resources”
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