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Zoé Bertrand

Zoé Bertrand is an associate in the Life Sciences Practice group. Zoé advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, with a focus on EU, Belgian, and French regulatory advice. She is a native French speaker and fluent in English.

The European Union has just published a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) in the EU’s official journal.  The UWWTD imposes important new Extended Producer Responsibility (“EPR”) obligations that will have a significant financial and administrative impact on companies marketing human medicines and cosmetic products in the EU.  Member States must implement the new UWWTD by July 31, 2027 and must apply the new EPR obligations to in‑scope companies by December 31, 2028. 

In a previous blog, we discussed the new EPR obligations in detail.  In this blog, we outline the key financial provisions of the EPR obligations and raise different questions concerning Member States’ discretion when transposing the EPR obligations into their national laws.

Extended Producer Responsibility under the UWWTD

The UWWTD requires Member States to ensure the treatment of urban wastewaters to remove micropollutants (so‑called fourth stage, or “quaternary” treatment).  Article 9 of the Directive also requires Member States to ensure that producers that market products listed in Annex III (i.e., human medicinal products and cosmetic products) have EPR obligations and pay, via producer responsibility organizations (“PROs”), for the costs of the quaternary treatment of urban wastewater, for data collection, and for other costs required to exercise their EPR. 

Specifically, Article 9 requires that producers subject to EPR obligations must cover:

  • At least 80% of the costs associated with quaternary treatment of wastewater to remove micropollutants.  This includes both capital investments for building or expanding urban wastewater treatment facilities and operational expenses for the treatment facilities.
  • 100% of the costs for gathering data on the products they place on the market.
  • 100% of other costs (e.g., administrative) required to exercise their EPR.

As noted above, Annex III currently lists human medicines and cosmetics as the product groups covered by the EPR obligations.  However, the UWWTD requires the Commission to assess the possible expansion of that list and to make the related legislative proposals by December 31, 2033.

National Implementation: Some Questions

The EPR obligations of the UWWTD will only apply to producers once Member States implement them into their national laws.  The Directive requires Member States to adopt their national implementing laws by July 31, 2027 and to apply the EPR obligations not later than December 31, 2028.  Member States may choose to apply the EPR obligations earlier.

The UWWTD leaves Member States with some discretion as to how they implement the EPR obligations, and also allows Member States to impose stricter and broader requirements.  Recital 3 of the Directive makes this clear, as it states that “[i]n line with Article 193 of the [TFEU] Member States can go beyond the minimum requirements set out in this Directive.  Member States could consider for instance […] imposing additional requirements for, or broadening the spectrum of the application of, their national extended producer responsibility systems.” Continue Reading The EPR Obligations of the New Urban Wastewater Treatment Directive Key Questions and Next Steps for Member States

October 12, 2024, marks the 10-year anniversary of entry into force of the Nagoya Protocol on Access to Genetic Resources and Fair Benefit-Sharing from their Utilization (“ABS”). This additional treaty to the Convention on Biological Diversity (“CBD”) has now been ratified by 142 countries. Over the past decade, Nagoya Protocol has resulted in the mushrooming of more than one-hundred thirty (130+) national ABS laws around the globe. All this time the Covington life sciences team has stood by its pharmaceutical, food and biotech clients to navigate this ever-more challenging Harlequin’s costume that is the global ABS legal regime. 

In this Client Alert we share lessons learned from our 10+ years of experience on ABS in the life sciences sector.[1] As an anniversary edition, this document is a long read. For ease of navigation, we have structured it as a Q&A. 

We first recall the basics of ABS. Then we cover key questions from clients such as e.g. compliance best practices and enforcement trends. Finally, we look to challenges in the near-future, focusing on emerging ABS regimes such as the global mechanism on benefit-sharing from Digital Sequence Information (“DSI”), the genetic resource disclosure requirement when filing patents under a new World Intellectual Property Organization (“WIPO”) treaty, the new “pathogen” ABS provisions of the World Health Organization (“WHO”) Pandemic Treaty, the High Seas Treaty on marine genetic resources, and last but not least, the new corporate due diligence obligations under the EU’s Corporate Sustainability Due Diligence Directive (“CS3D”).

If you have any questions or would like a meeting concerning the material discussed in this Client Alert, please contact our partner Bart Van Vooren at bvanvooren@cov.com.

The ABC of ABS

1. What is the purpose of the Nagoya Protocol?

The Convention on Biological Diversity of 1992 recognizes the sovereignty of countries over biological resources within their jurisdiction. The CBD has three main objectives: (1) the conservation of biodiversity, (2) its sustainable use, and (3) “the fair and equitable sharing of benefits from the arising from the utilization of genetic resources.” Although there are 196 Parties to the CBD, by 2014 very few countries had implemented rules on ABS. The Nagoya Protocol was therefore negotiated as a supplemental treaty to achieve the third objective of the CBD. It does so by empowering countries to impose prior authorization (Access) and payment requirements (Benefit-Sharing) on companies that commercialize products or processes that utilize biological materials. This supposedly creates a financial resources and incentive for countries to protect biodiversity.Continue Reading The Nagoya Protocol at Its 10th Anniversary: Lessons Learned and New Challenges from ‘Access and Benefit-Sharing’