Parliament pushes for a more ambitious and European approach to Critical Medicines Act
The European Parliament’s public health committee has endorsed compromise amendments to the Critical Medicines Act, setting out a more ambitious approach than member states
This evening (15 December), the European Parliament’s Public Health Committee (SANT) voted on compromise amendments that have been hammered out over recent weeks.
The amendments were adopted with 27 votes in favour, one against, and eight abstentions.
The Critical Medicines Act aims to improve the security of supply and availability of critical medicines in Europe. Originally, spurred by supply shortages during COVID, member states continue to experience shortages.
“Today’s vote is a defining moment for Europe’s health security. We are tackling persistent shortages and reducing our dependence on a limited number of external suppliers,” said MEP Tomislav Sokol (EPP, Croatia), the lead rapporteur.
The vote was also welcomed by MEP Tiemo Wölken (S&D, Germany) one of the rapporteurs on the Pharma Package: “I believe that the CMA will complement key measures such as the reporting obligations enshrined in the Pharmaceutical Regulation, providing a solid foundation to tackle shortages effectively.”
Over 50% of shortages are caused by manufacturing issues, including shortages in active substances. The Pharma Package goes some way in addressing this by requiring manufacturers to draw up shortage-prevention plans for prescription medicines, including not only preventive measures but also concrete risk-mitigation actions. Suppliers must also carry out a vulnerability assessment of their supply chains, including dependencies on third countries.
“The CMA will provide additional support by strengthening production capacity in the EU, diversifying supply chains, and reducing our dependence on third countries,” says Wölken.
Member states have become increasingly concerned by their dependency on countries outside the EU. A point recently underlined by the Danish Health Minister, Sophie Løhde: “In these uncertain times, security of supply cannot be taken for granted. We must make our supply chains more robust so that patients can access the medicines they need.”
Health ministers reached an agreement on a “general approach” to frame their negotiations with the Parliament in early December. Still, not all ministers were happy with the more limited ambitions of the Council, and will be hoping that the Parliament will push for measures that faced resistance from fellow ministers.
Catherine Feore
The MEPs want member states to prioritise financial support for strategic projects, through regional funds and through a dedicated “critical medicines security fund” to be established under the EU’s next multiannual financial framework (MFF).
Collaborative/joint procurement
While the Council’s general approach preferred “collaborative procurement” to “joint procurement”, the European Parliament’s SANT committee wants both. The Parliament says that for collaborative procurement this should only require the participation of three or more countries, three fewer than the minimum set by the Council. For joint procurement involving the Commission, the Parliament says that this should only require the participation of five countries and should go beyond critical medicines, including innovative, rare disease and high cost or specialized treatments, such as in the field of cancer treatments.
Stockpiling
Again, where member states were cautious about a centralized EU role on stockpiles, MEPs call for the creation of an EU co-ordination mechanism for national stockpiles and contingency stocks of critical medicines.
Going further, they want the Commission to have the power to decide, as a last resort, the redistribution of medicines from one national stockpile to one or more other countries, in instances where a shortage or a supply disruption of a critical medicinal product has been identified. At the moment there is a voluntary scheme that - by and large - works.
The SANT Committee also envisages the Commission having the power to decide on a Union Stockpile where voluntary mechanisms are insufficient through delegated legislation. MEPs agreed that the Union should be able to provide budgetary support for such a stockpile where appropriate.
The Parliament will vote on the report during its plenary session in January. Once their report is adopted, the negotiations with the Council will begin.