Ana Simões Ferreira and Ricardo Rocha analyse the impact of the new European pharmaceutical package

Ricardo Rocha and Ana Simões Ferreira contributed to a Jornal Económico special report on the EU Pharma Package, the most comprehensive reform of European pharmaceutical legislation in the past two decades.

Ricardo Rocha analysed the changes to regulatory protection periods and the extension of the Bolar exemption, which will allow manufacturers of generic and biosimilar medicines to begin preparing for market entry at an earlier stage. As he explains, the aim is to “ensure that patients have access to medicines that are less costly for healthcare systems as soon as legally possible”.

Ana Simões Ferreira highlighted the reform’s impact on contractual relationships across the sector. “Continuity of supply will no longer be a general obligation and will instead become a central element of the relationship between pharmaceutical companies, distributors, hospitals and public authorities,” she states.

Contracts will be expected to include more stringent obligations regarding stock levels, information sharing, the prevention of shortages and contingency plans. Ana Simões Ferreira nevertheless warns that “it will be necessary to ensure that these obligations do not become excessive or disproportionate”, particularly in a smaller market such as Portugal.