Brussels, 13 November 2023 – The European Lung Health Group (ELHG) has issued recommendations for the European Parliament discussion within the Health and Environment Committee (ENVI) on the legislative proposal updating the EU pharmaceutical framework, currently under review.

The ELHG welcomes the revision of the Regulation and Directive for medicines, which are impactful laws governing medical development and access in the EU. In particular, the ELHG is keen to inform legislation seeking to drive medical research, medicines innovation specially to underserved populations such as children and patients with rare diseases, broader and equal patient access and the involvement of patients and healthcare professionals’ organisations across the regulatory process.

In view of the current debate within the European Parliament, but also with regards to the foreseen inter-institutional negotiations, the European Lung Health Group calls the co-legislators to ensure that the newly proposed pharmaceutical package responds to the following patients and healthcare professionals’ expectations:

  • Retain the expertise of the paediatric and orphan committees at the EMA with similar involvement of patients and healthcare professionals’ representatives providing their unique experience in the regulatory process;
  • Reinforce the patients’ voice through financially compensated patients’ representatives for their contribution in the EMA Committees;
  • Include healthcare professionals as part of the European network, as key actors in care and treatment of patients;
  • Provide information regarding shortages of medicinal products, including the causes and measures expected on a publicly available website;
  • Have a patient-centred definition to address unmet medical needs, that takes into account the patients’ experience and the burden associated with the disease, assessed with input from both patients’ and healthcare professionals’ representatives;
  • Retain a mandatory paper package leaflet, which is to be complemented by an electronic version leaflet, to ensure access to information in an easy and effective manner;
  • Introduce information about the environmental impact of medicinal products, including the environmental footprint and guidance for product use and disposal on the package and/or leaflet.

The full ELHG recommendations on the pharmaceutical legislation on both the proposal for a Regulation 2023/0131 on the authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency, as well as the proposal for a Directive 2023/0132 on medicinal products for human use are available here.