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 litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Bart 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, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.

During his previous professional career, Bart was a professor of EU law at the University of Copenhagen and published a couple of books with Oxford and Cambridge University Press. His academic swan song was the (now leading) textbook republished in 2020 by his former academic colleagues in 2nd edition: EU External Relations Law, available from Hart Publishing.

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European Union Law Scales of Justice

EU Court Overturns EU-wide Botanical Food Ban

By Brian Kelly, Katharina Ewert, Bart Van Vooren & Peter Bogaert on November 15, 2024

Posted in European Union, Food & Beverage, Food & Drug Regulatory, Life Sciences

In a precedent decision, on 13 November 2024, the EU General Court annulled significant parts of a Commission Regulation, which sought to restrict or place under scrutiny the addition of certain botanicals containing hydroxyanthracene derivatives (“HADs”) to foods. The Court held that the Commission had exceeded its powers by seeking to regulate botanical “preparations.” Moreover, the Commission, in relying on the scientific opinion of the European Food Safety Authority (“EFSA”), had failed to demonstrate that the relevant substances would be ingested in amounts greatly exceeding those consumed from a normal diet or otherwise represented a potential risk to consumers. Continue Reading EU Court Overturns EU-wide Botanical Food Ban

EU Adopts New Rules on Greenwashing and Social Impact Claims

By Bart Van Vooren, Cándido García Molyneux, Seán Finan, Paul Mertenskötter & Hannah Edmonds-Camara on January 31, 2024

Posted in Cosmetics, Environmental, Social and Governance (ESG), European Union, Food & Beverage, Greenwashing, Life Sciences

On January 17, 2024, the European Parliament formally endorsed its provisional agreement with the Council on the Directive Empowering Consumers for the Green Transition through Better Protection against Unfair Practices and Better Information (“Greenwashing Directive”). The Council is now expected to endorse the provisional agreement after which the…

Pathogen Access and Benefit-Sharing (P-ABS) under the draft WHO Pandemic Treaty: Why Many Vaccine, Therapeutic, and Diagnostic Companies will be in Scope

By Bart Van Vooren & Yuliya Gevrenova on July 12, 2023

Posted in Access and Benefit-Sharing, COVID19, Life Sciences, Pharma, Pharmaceutical companies

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…

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)

By Bart Van Vooren on June 22, 2023

Posted in European Union, Food & Drug Regulatory

In short

We 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…

Historic Marine Biodiversity Treaty creates new Access and Benefit-Sharing obligations for life sciences companies

By Bart Van Vooren, Yuliya Gevrenova & Seán Finan on June 21, 2023

Posted in Cosmetics, Environmental & Clean Technology, Environmental, Social and Governance (ESG), Food & Drug Regulatory, Global Supply Chain, Life Sciences, Pharma, Uncategorized

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…

EU Pharma Legislation Review Series: GMO Medicines

By Seán Finan, Grant Castle, Bart Van Vooren & Yuliya Gevrenova on April 28, 2023

Posted in Clinical Trial Applications, Environmental & Clean Technology, Environmental, Social and Governance (ESG), EU Pharma Law Revision, European Union, Food & Drug Regulatory, Gene Editing, GMOs, Medicinal Products, Medicinal Products

“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

EU Pharma Legislation Review Series: Addressing Environmental Risks

By Seán Finan, Grant Castle, Bart Van Vooren & Yuliya Gevrenova on April 28, 2023

Posted in Environmental & Clean Technology, Environmental, Social and Governance (ESG), EU Pharma Law Revision, European Union, Food & Drug Regulatory, Gene Editing, Greenwashing, Life Sciences, Medicinal Products, Medicinal Products

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:

Pre-authorization — Environment-related refusals: The European authorities will be able to refuse a marketing authorization application where the accompanying Environmental Risk Assessment (“ERA”) is not adequate, or if the environmental risks have not been sufficiently addressed.
Post-authorization — Environment-related monitoring and conditions of use: The European authorities will be able to impose environment‑related conditions of use on authorized medicines, including limiting the product to prescription-only or requiring additional post-authorization ERAs. They will also be able to suspend, revoke or vary marketing authorizations where a medicine presents a serious risk to the environment.
Awareness and knowledge building — Warnings and environmental risk databases: Companies will be required to include additional information on environmental impact in a medicine’s EPAR, and additional awareness‑raising information in the product packaging of antimicrobials.

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

Green Groceries: Key ESG Issues for the FMCG Industry (including FBOs)

By Seán Finan, Cándido García Molyneux, Paul Mertenskötter, Bart Van Vooren, Richard Rowlands & Hannah Edmonds-Camara on April 25, 2023

Posted in Corporate Reporting and Disclosures, Environmental & Clean Technology, Environmental, Social and Governance (ESG), Extended Producer Responsibility, Food & Beverage, Greenwashing, Life Sciences, Supply Chain Due Diligence

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)

Inside EU Life Sciences

Bart Van Vooren

EU Court Overturns EU-wide Botanical Food Ban

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)

In short

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