The European Union has been debating the new pharmaceutical reform for years, a package of regulatory changes that updates medicines legislation. In June this year, the Council of the EU adopted its general approach, which opened the trilogue negotiations with the Parliament and the European Commission. It is in this phase that the final text of the legislation will be defined.
One of the most relevant issues is the hospital exemption, a matter of particular concern to us at Salud por Derecho. If you have been following us, you already know that the Hospital Exemption is a mechanism that allows hospitals to develop tailor-made advanced therapies for specific patients in a non-industrial way. It is essential for rare or very specific diseases, in which the pharmaceutical industry invests very little because they are not as profitable as more common conditions. However, today each EU country applies different rules, which creates inequalities in access and limits cooperation among Member States.
For this reason, Salud por Derecho, together with the European Cancer Leagues (ECL), the European Hematology Association (EHA), Health Action International (HAI), and Médecins du Monde International Network, has published a joint position paper calling for this mechanism to be strengthened so that it is fairer, more transparent, and accessible throughout the European Union.
In the document, we welcome some progress, such as clearer requirements for data reporting, but we also warn that important safeguards are still missing. We call for support mechanisms for academic and non-profit institutions, the creation of a public and regularly updated data repository, the possibility of cross-border application, the harmonization of data collection, and the evaluation of clinical evidence.
It is also essential to establish a firm and binding commitment to transparency so that the costs and final prices of products developed under this model are public and accessible.
01102025_Statement_HE_EU (1)Imagen de DC Studio en Freepik
