Today, the European Parliament approved a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) that will impose new additional costs on producers marketing pharmaceutical and cosmetic products in the European Economic Area by the end of 2027. Some studies suggest that the costs that producers would have to collectively pay could
Continue Reading New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic ProductsOn 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
Continue Reading EU Adopts New Rules on Greenwashing and Social Impact Claims
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)