Incentives for new medicinal products: There are still few concrete proposals.

UM – 10/2024

The "silent pandemic"

Antimicrobial resistance (AMR) is considered one of the three greatest health risks. Every year, 35,000 people die of AMR in the European Union (EU). The fatality is more than one million worldwide. A gloomy forecast predicts doubling of this figure by 2050. Although the effects of AMR are devastating, there is little awareness of the problem among the general public. AMR is a "silent pandemic".

G7 deals with AMR

It is different in politics. On 10 October, the G7 health ministers met in Italy to discuss the challenge of AMR. The focus is on the responsible use of antibiotics in humans and animals, expansion of the access to antimicrobial medicinal products and support of research and development of new medicinal products. It is by no means certain that they will agree on concrete measures or even reach agreement to provide funds. The pharmaceutical industry not developing new antibiotics is one of the biggest problems. It is therefore hoped that the G7 will agree on a common course for market incentives for novel antibiotics by the end of the Italian Council Presidency at the end of November. The United Kingdom leads by example by introducing a subscription model in which developers of novel antibiotics receive a previously agreed fixed amount in return for a guaranteed supply.

UN General Assembly wants to mobilise money for developing countries

The date comes just over two weeks after the high-level meeting of the UN General Assembly, which ended with a political declaration (not available in German) that was considered rather disappointing by experts and healthcare NGOs. Significant reduction in AMR could be achieved by curbing the use of antibiotics in agriculture - one of the biggest drivers of antibiotic resistance. But there were also major differences of opinion in other areas, such as the obligations of the pharmaceutical industry, the shared use of new technologies, fair access to new medicines and funding. The focus here was less on incentive systems. A new independent committee has been tasked with developing ideas on how to raise €100 million for developing countries to support their fight against AMR.

What about Europe?

April last year, when it published its proposal for the revision of the general pharmaceutical regulations, the European Commission announced that the Health Emergency Preparedness and Response Authority (HERA) was also working on a "revenue guarantee". According to press reports, this is currently being examined in the form of a multi-country revenue guarantee scheme, in which participating companies receive compensation if their sales fall below a predetermined threshold. Conversely, the participating companies undertake to supply the Member States with antibiotics within 24 hours of an order being placed. In addition, the joint procurement of antimicrobials continues to be part of HERA's considerations.

EU States want to drastically reduce consumption

Nevertheless, in a recommendation dated 13 June 2023, the Council has already made the Member States more accountable for reducing human consumption of antibiotics by 20 per cent by 2030 and the EU-wide sale of antimicrobials for livestock and aquaculture by 50 per cent.