Calls for a Crit­ical Medi­cines Act

There is a lot of talk about shortages in pharmaceutical products at the moment. Although the acute shortages are currently no longer as virulent as they were in the winter and spring of this year, there is political pressure for action - not only in the context of the amendment to the legislation on pharmaceutical products. 40 per cent of the medicinal products sold in the European Union come from third countries, and up to 80 per cent of the most important pharmaceutical active substances are produced in China and India. The European Union wants to become strategically more independent.

In a non-paper in May, 19 EU Member States call for policy measures to strengthen security of supply of medicines in Europe. Among other things, they are calling for a "Critical Medicines Act". The paper was prepared by the Belgian government and supported by 18 other Member States. In addition to Belgium, France and Germany, the paper was also signed by Austria, the Netherlands, Luxembourg, the Czech Republic, Spain, Estonia, Slovenia, Romania, Latvia, Lithuania, Greece, Malta, Poland, Italy and Portugal.

The idea

Member States are calling for a law that promotes EU production of essential medicines and more basic chemical agents and reduces dependence on large producers such as China and India. The non-paper states that the law should be seen as a toolbox of different instruments. Parallels can be drawn with the European Chips Act (EU Chips Act), which aims to strengthen the EU's autonomy in semiconductor technologies and applications. The EU Chips Act is built on three pillars: (1) Knowledge and competence building through chips for Europe initiative, (2) Financial incentives for public and private investments in building new production capacities, and (3) Monitoring and crisis management. The European Critical Raw Materials Act, a legislative proposal presented in March, could also be a model for a Critical Medicines Act. The law aims to strengthen domestic supply chains of critical raw materials for battery manufacturing, solar and wind technology, and the space and defence industries.

The time

According to the signatories, the submitted non-paper on medicinal products is detached from the proposals of the European Commission on the amendment to the legislation on medicinal products (cf. News 05/2023) and is intended to be a supplement. However, the initiative of the EU Member States puts pressure on the European Commission. The latter is currently examining the implementation of such a law. The co-signatories of the paper, Belgium and Spain will hold the upcoming Council Presidencies.

Another co-signatory, France, has already taken action. On 13 June, French President Emmanuel Macron announces his "Re-shoring initiative". For 50 medicinal products, the complete relocation or increase in production in France was announced. In a first phase, the French government will support eight projects to relocate the production of 25 medicines with 160 million Euros. France was the largest producer of pharmaceuticals in Europe until 2008.

The neces­sary

Regardless of whether, how and when a Critical Medicines Act is presented by the European Commission in parallel to the amendment to the legislation on medicinal products, the following applies to the German Social Insurance (DSV): In order to improve availability and supply reliability in the EU, it is important that diversification, stockpiling and an improved information and data basis are achieved. DSV will contribute in this sense.