On Tuesday 3 October, MEP Pernille Weiss (EPP, Danish) submitted her draft report amending the proposed directive on pharmaceutical products. It will shortly be discussed by the European Parliament’s Environment Committee.
This directive contains all the requirements for authorisation, monitoring, labelling and regulatory protection, marketing and other regulatory procedures for all medicines authorised at EU level (see EUROPE 13201/23).
The draft report by Tiemo Wölken (S&D, German) concerns the proposed regulation on medicines.
Ms Weiss believes that innovation to address unmet medical needs must be sufficiently encouraged, while the definitions used to decide which medicines address an unmet medical need must take account of the patient’s point of view. In this respect, the rapporteur believes that the concept of patients’ ‘quality of life’ should be taken into account.
The rapporteur also proposes to increase the rewards for completing a paediatric investigation plan when it is carried out for a different disease than the one for which a medicine is intended for the adult population.
Access to medicines. The Commission has proposed an incentive that will grant an extension of data protection if a medicine is supplied in accordance with the needs of the Member States concerned within 2 years of the market authorisation (or within 3 years in certain cases).
Ms Weiss is opposed to this measure and proposes instead that market authorisation holders should be required to submit an application for pricing and reimbursement in each Member State that so requests.
Finally, the rapporteur believes that in the event of serious risks to the environment, a market authorisation may be suspended or modified, but should only be revoked in cases where these risks clearly outweigh the loss of the positive therapeutic effect of the medicine.
Link to the draft report: https://aeur.eu/f/8w4 (Original version in French by Lionel Changeur)