On Monday 26 April, MEP Dolors Montserrat (EPP, Spain) published her draft report on the new European Pharmaceutical Strategy (see EUROPE 12609/10), which is due to be presented to the Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) shortly. In particular, Ms Montserrat argues for some additional initiatives.
On unmet therapeutic needs initially, the MEP calls on the European Commission to promote the creation of a European framework that would guide the implementation by each State of plans to fight rare diseases, paediatric cancers, neurodegenerative diseases and antimicrobial resistance, and thus, in the long run, increase the development of medicines dedicated to these unmet needs.
“About 95% of rare diseases still have no treatment option” said the MEP, pointing out that of the 103 orphan drugs authorised by the European Medicines Agency in 2019, only half had reached the market, with an average delay of two years.
The main initiative promised by the Commission on unmet therapeutic needs is a revision of the legislation on medicines for rare diseases (141/2000) and medicines for paediatric use (1901/2006).
On this point, the rapporteur also calls for more investment in research on rare diseases.
Antimicrobial resistance. Another initiative that Montserrat calls on the Commission to consider is a “common EU therapeutic guide” for antimicrobials. She also calls for the coordination of communication campaigns on antimicrobial resistance (AMR) “through a single EU-wide timetable”.
“According to WHO figures, 33,000 people die each year in Europe because antibiotics are no longer effective” writes the MEP, calling AMR “a major global health problem”.
Her proposals seem to be in line with the rather vague promises made by the Commission: namely, “ the proposal of non-legislative measures” or “the optimisation of existing regulatory tools”.
Shortages and environment. Other issues highlighted by the rapporteur include the growing threat of shortages of essential medicines, and respect for the environment and the climate.
On the first point, Ms Montserrat calls on the Commission and Member States, for example, to promote more joint European public procurement, as has been done for Covid-19 vaccines.
On the second, she calls on the Commission to strengthen inspection throughout the pharmaceutical production chain and to ensure high standards of quality and durability of ingredients, including imported ingredients. “Pharmaceutical waste is also a serious concern that the Commission should address with measures to reduce wraps and packaging”, she writes.
To consult the draft report: https://bit.ly/3vzA9Cq (Original version in French by Agathe Cherki)