The European Parliament’s Health Committee (ENVI) approved on Tuesday 12 October, by 62 votes to 8 with 8 abstentions, the draft report by Dolors Montserrat (EPP, Spain) on the new European pharmaceutical strategy (see EUROPE 12710/9).
The text, which will still have to go through the plenary at the end of November, has already been considerably fleshed out by the political groups.
Research and development. Several groups had expressed their intention to strengthen in particular the provisions concerning research and development of medicines (see EUROPE 12728/9).
In this respect, MEPs are now calling for more investment, both public and private, in pharmaceutical research.
They also call for the Clinical Trials Regulation (536/2014) to be fully implemented “to facilitate the launch of large clinical trials” at European level.
They also call for greater involvement of patients’ organisations in drug development and pharmaceutical research strategies, particularly with a view to addressing unmet therapeutic needs.
Transparency and access to medicines. The S&D, Greens/EFA, and The Left groups had indicated that they would demand guarantees on transparency.
The adopted text invites the Commission to work with the EU27 to “ introduce measures” to increase transparency in the development, manufacture, and pricing of medicines.
On this last point, MEPs recognise that pricing should remain a national competence, but call for publicly-funded research-based medicines to be “available throughout the EU at a fair price”. The pharmaceutical industries should also, in their opinion, comply with certain conditions regarding the prices of these medicines developed with public funds.
MEPs also consider it necessary to promote “collective negotiation of the price of medicines with pharmaceutical industries”.
They also suggest that the Commission should consider the creation of a European fund co-financed by the EU27 to negotiate and purchase orphan drugs in order to ensure equal access to these expensive treatments for patients in different Member States.
Shortages. In general, MEPs call in their report for measures to be taken to increase the availability of medicines and thus combat the problems of shortages.
In one of the adopted amendments, the importance of generics and biosimilars in this respect is emphasised. These would, according to MEPs, increase “equitable access for patients and ensure the sustainability of healthcare systems” in an EU where access to healthcare remains uneven.
The Commission also has a role to play here, say MEPs, who call on it to remove all barriers to competition and ensure that generic and biosimilar alternatives are available.
To see the compromise amendments incorporated in the final text: https://bit.ly/3BAHRzs (Original version in French by Agathe Cherki)