On Monday 1 September, MEP Tomislav Sokol (EPP, Croatian) will present to European Parliament’s Committee on Public Health his draft report aimed at strengthening certain provisions of the proposal relating to critical medicines’ availability and security of supply.
This proposal aims to address a growing number of medicine shortages in Europe due to vulnerabilities in supply chains, over-reliance on a limited number of global suppliers and a lack of production capacity in the EU (see EUROPE 13668/18).
Definitions and scope of application. The purpose of the amendments is to specify that critical medicines are those whose shortage causes serious harm to patients and healthcare systems. Medicines of common interest are defined as essential medicinal products not available in at least three Member States or meeting specific criteria (e.g. orphan medicines, innovative antimicrobials). The rapporteur also proposes broadening the definition of key inputs to include raw materials, feedstock, solvents and reagents. In addition, the draft report clarifies the differences between contingency stocks and national stocks.
Coordination and solidarity. Some amendments provide for the creation of a European coordination mechanism, administered by the Commission, to enable equitable redistribution of medicines in the event of a serious shortage, after national solutions have been exhausted. The remit of the Critical Medicines Group would also be strengthened.
Collaborative procurement is encouraged, but an amendment specifies that the participation of economic operators must remain voluntary.
Strategic projects. These projects aim to create or increase production capacity for critical medicines or medicines of common interest, modernise existing sites or develop innovative manufacturing processes.
An amendment specifies that the construction of production centres for medicinal products falling under the “medicines of common interest” definition must be considered a strategic project.
Priority support should be given to strategic projects, through European funds (‘EU4Health’, Horizon Europe, Digital Europe, STEP, etc.). Amendments further propose that these projects could also be financed with revenue generated by customs duties imposed by the EU on critical medicines or medicines of common interest in response to third countries’ restrictive customs or trade measures.
Certain conditions are provided to ensure the effectiveness of common procurement procedures for these medicinal products (flexibilities regarding electronic packaging information, harmonisation of pack sizes, labelling adjustments).
European stocks. The draft report supports the creation of contingency stocks for critical medicines, managed by the Commission. Member States should regularly report on their stockpiles and contingency stocks using a harmonised digital reporting system.
Provisions in the draft report aim to prevent environmental or chemical legislation from disrupting the production of critical medicines. The Commission should assess the impact of environmental legislation on the availability of medicines and, if necessary, propose mitigating measures.
In the event of major market distortions or a crisis, the Commission could temporarily suspend certain provisions of the regulation until appropriate corrective measures are taken.
Amendments also suggest including experimental medicines in certain mechanisms (such as contingency stocks) and providing a strict framework for State aid to avoid distortions of competition.
The draft report: https://aeur.eu/f/i6p (Original version in French by Lionel Changeur)