The European Commission’s Critical Medicines Act, to be presented by European Health Commissioner Olivér Várhelyi and Commission Vice-President Teresa Ribera in Strasbourg on Tuesday, the 11th of March, includes medicines procurement, production subsidies and the creation of new global partnerships. The aim is to reduce dependence on supplies, according to a document project, obtained by Politico.
Europe has a plan to tackle the shortage of medicines – to produce more medicines and to tie contracts to their availability.
Europe relies heavily on India and China for the supply of medicines and ingredients, especially cheaper generic medicines. Reuters reports that, for example, 80% to 90% of antibiotics are produced in Asia, mainly in China.
“Foreign actors can easily turn this dependency into a serious vulnerability that threatens Europe’s security and defence capabilities,” said the letter signed by 11 European health ministers.
The European Commission’s proposal is based on a review of procurement rules to ensure that countries do not just choose the cheapest product available, but prioritise security of supply, the draft document says.
Under the legislation, countries will buy medicines not only on the basis of price, but also on the basis of new criteria, including stockholding requirements, supplier diversity, supply chain monitoring, transparency and performance clauses. Where appropriate, procurement could be from multiple suppliers.
Where the EU is dependent on a single third country for the supply of a critical product, the authorities should give preference to suppliers that produce a significant proportion in Europe. The legislation also provides for joint procurement of critical medicines by countries or on their behalf by the Commission.
As regards subsidies, the proposal specifies that countries may financially support “strategic projects” – those located in the EU that contribute to the establishment, expansion or modernisation of production capacity for essential medicines or their components. In such cases, priority should be given to supplying the EU market and these manufacturing projects could be financed by both countries and the EU.
State aid is usually granted to “first of a kind” projects, which means that many manufacturers of critical medicines – widely prescribed on a daily basis – would not normally qualify.
A new Critical Medicines Coordination Group, with two representatives from each country, would share information on drug production, government-backed projects and supply chain risks.
The draft contains few details on new international partnerships. It says that the Commission will “explore opportunities” to diversify supplies of key medicines, active substances and raw materials.
The Critical Medicines Act is an attempt by the Commission to reduce the vulnerability of manufacturing supply chains to dependence on India and China. It aims to complement the review of pharmaceutical legislation to strengthen the EU’s independence and competitiveness in this sector, while ensuring access to medicines for patients.