Securing Europe’s medicine supply: envisioning a Critical Medicines Act

The Covid 19-pandemic has drawn attention to the role of the pharmaceutical industry and to production, availability and affordability of medicines and medicinal products on the European market.

Dependency on critical ingredients, such as active pharmaceutical ingredients (APIs), became obvious when China and India limited exports. According to current data, up to 80% of APIs used in Europe and about 40% of finished medicines sold in Europe come from China or India. The European Union's increasing dependence on API supplies has led to a partial loss of capability to manufacture active substances independently, which poses a potential threat to public health in the countries of the European Union.

The Pharmaceutical Strategy for Europe (published in November 2020) defined, among others, the goal to encourage the production of generic and biosimilar medicines while not discouraging research, development and innovation (R&D&I) of new pharmaceutical solutions in Europe. But current regulations are not conducive to supporting pharmaceutical production in Europe. European manufacturers are being pushed out of domestic and foreign markets due to higher labour costs and the need to meet stringent environmental standards, leading to a loss of price competitiveness and sales volumes. The cost of implementing the production of a single active substance, depending on the required synthesis technology, is estimated at EUR 50-180 million and the time needed for implementation is 3 to 6 years. Against this background, specific investments are required to restore API production in Europe on the scale required to ensure EU drug safety.

At the same time, we observe substantial changes in the pharmaceutical industry, e.g. growth of biotechnology or the move to personalised medicines. Policy makers have identified the need to address unmet needs and antimicrobial resistance.

The pharmaceutical industry has over the past years seen ample restructuring, mergers and acquisitions; recently a number of bigger players have closed or announced the closure of European production sites.

The relocation of pharmaceutical manufacturing to the EU would stimulate economic development and generate new jobs. Locating and supporting production in the EU would not only increase competitiveness of EU-based producers against their non-EU counterparts, but would also significantly reduce pharmaceutical production costs. In the longer term, this would increase the EU's resilience to future crises involving shortages of medicinal products and help restore Europe's status as an industrial leader.