Francisca Paulouro, Head of Practice Partner for Health, analyses in Jornal Económico the impact of the new European pharmaceutical framework on contractual arrangements and continuity of medicines supply.

In the article ‘New pharmaceutical legislation requires contracts to be reviewed’, she examines the changes introduced by the EU Pharma Package, alongside the Critical Medicines Act, and the strengthened obligations aimed at preventing shortages and ensuring continuity of supply.

The new rules are expected to have a direct impact on contracts between manufacturers, distributors, hospitals and public bodies, particularly through requirements relating to safety stocks, supplier diversification, reporting and information-sharing mechanisms, contingency planning and supply chain monitoring.

‘The EU legislator is now turning a number of best practices in security of supply, redundancy and risk management into binding legal obligations,’ she notes, adding that legal compliance will no longer be limited to maintaining supply, but will also require compliance with the conditions needed to ensure that supply remains adequate and continuous.

In the context of public procurement, Francisca Paulouro also highlights the possibility for contracting authorities to introduce supply resilience criteria, including requirements relating to safety stocks, supplier diversification and supply chain monitoring, as well as performance clauses concerning delivery times.