The European Commission has a priori the support of MEPs for the creation of a “European Agency for Advanced Biomedical Research and Development” mentioned by Ursula von der Leyen in her State of the Union address (see EUROPE 12561/1). This idea is included in the own-initiative resolution adopted by the European Parliament on Thursday 17 September.
This dense report, which had already been voted on in the Committee on the Environment in July (see EUROPE 12527/10), proposes moving towards greater cooperation, coordination and harmonisation to prevent and combat the shortage of medicines in Europe. Its author, Nathalie Colin-Oesterlé (EPP, France), says that “ public health has become a geostrategic weapon capable of bringing a continent and beyond to its knees“.
Setting up a European reserve
In their resolution, adopted with 663 votes in favour, 23 against and 10 abstentions, MEPs support several key ideas, such as the creation of a European emergency pharmacopoeia. More specifically, they call for the establishment of a European emergency reserve of medicines of health and strategic interest, the fair distribution of which would be decided by a new European authority. They also call for health strategies at European level, with a common basket of medicines for cancer, infectious diseases, rare diseases and other areas particularly affected by shortages.
They then suggest setting up one or more European non-profit and general interest pharmaceutical laboratories in the absence of existing industrial production.
Finally, they ask the Commission to study and create an Orphan Drug Fund to be financed by the Member States in order to collectively acquire orphan drugs for the whole EU on behalf of the Member States.
Reviewing European rules
After the painful experience of Covid, MEPs call on the Commission, together with the Member States, to adopt a European pandemic preparedness plan.
They are also relying heavily on the future pharmaceutical strategy and the revision of the industrial strategy to address the shortage of medicines. They believe that both initiatives should include regulatory measures and encourage the production of active ingredients and essential medicines in Europe to ensure that medicines are available, affordable, sustainable and accessible to all. The Pharmaceutical Strategy should also examine the possibility of harmonising the rules on compulsory licensing of medicines.
As regards legislative initiatives, MEPs call for the creation of specific regulations for certain mature medicines. They propose that the idea of transparency of net tariffs and reimbursement of different treatments be reconsidered. They call on the Commission to include measures for the pharmaceutical sector in its proposal for legislation in 2021 on corporate due diligence and call for the revision of Regulation (EC) No 141/2000 on orphan medicinal products.
The text also contains several proposals to support industry by “introducing measures and financial incentives in line with State Aid rules and sustainable policies in return for commitments”. (Original version in French by Sophie Petitjean)