Insights

After a somewhat turbulent adoption process, on 25 July 2024 the Corporate Sustainability Due Diligence Directive (“CS3D”)[1] finally entered into force.  The CS3D requires certain companies operating in the EU/EEA, to identify and address adverse impacts on human rights and the environment as regards their actions both inside and outside of Europe. This includes obligations for companies to issue publicly available annual statements on human rights and environmental issues, and to adopt and put into effect transition plans for climate change mitigation.

The EU Institutions are in the process of agreeing new rules to further prevent greenwashing.  On 17 June 2024, the Council adopted its general approach to the proposed Green Claims Directive (“GCD”). The GCD is focused primarily on how companies would need to substantiate and verify green claims which are potentially permissible in the EU.  It complements the Directive on Empowering Consumers of the Green Transition (“ECGT Directive”) which entered into force in March 2024.  That Directive focuses primarily on blacklisting and prohibiting certain greenwashing practices. Together these two Directives will create a single regulatory framework concerning environmental, and to some extent, social claims.       

The EU legal and policy framework regarding critical medicines and medicine shortages is rapidly changing.  In the past 12 months alone, there have been numerous developments: from the ‘Non-Paper’; to the Communication on ‘Addressing medicine shortages’; and the launch of the Critical Medicines Alliance.  In the next 12 months, there is likely to be similar developments – including a possible draft proposal for a ‘Critical Medicines Act’.  As the new regulatory framework becomes clearer, pharma companies will need to understand it, and prepare for the impact it will have.