Regulatory News

EU Parliament Calls for Measures to Combat Antimicrobial Resistance

The European Parliament is calling for new measures to combat antimicrobial resistance (AMR) in Europe, where 25,000 die each year due to drug-resistant infections.

Background

Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance, the World Health Organization (WHO) called AMR "so serious that it threatens the achievements of modern medicine."

The rise of AMR is associated with the overuse and misuse of antimicrobial medicines such as antibiotics. When microbes targeted by a drug are not eliminated, treatment-resistant strains can be spread, which can have deadly consequences.

The problem is compounded by a significant decline in the development of new antimicrobial drugs in recent decades. The danger this can pose can be seen in the case of multidrug-resistant tuberculosis (MDR-TB), where over time strains of the bacteria have developed resistance to many previously effective treatments.

Taking on AMR

The proposal by the Members of European Parliament (MEPs) echoes previous calls for stricter control of the use of antibiotics in both human and veterinary populations.

For antibiotics used to treat humans, the MEPs propose to:

• "remind physicians of the paramount importance of ensuring that the prescription of antibiotics for treatment was appropriate and responsible;
• ensure that, whenever possible, appropriate microbiological diagnosis was systematically performed before prescribing antibiotics;
• regulate the prescription of antibiotics for treatment;
• encourage the development of new revenue models whereby economic returns for companies were de-linked from prescribed volumes of antibiotics, and at the same time, while encouraging pharmaceutical innovation;
• regulate the sale and distribution of antibiotics;
• intensify infection control, in particular from a cross-border perspective, and especially by carefully monitoring potential carriage of multidrug-resistant bacteria;
• improve safety standards, especially for medical devices that are resistant to sterilisation (e.g. endoscopes);
• launch awareness campaigns targeting a wide audience
• increase public funding and create new acade
   
  mic positions to focus on exploring and validating new approaches for treating bacterial infections.”

For animal populations, the MEPs point to new veterinary legislation currently under discussion, and urge companies to end prophylactic (preventative) antibiotic use and limit mass medication programs on farms.

Impact

Many of these measures reflect recent events, such as cases of carbapenem-resistant enterobacteriaceae (CRE) infections traced to insufficiently sterilized endoscopes and calls from the international community to delink the cost of antibiotics research and development from future sales. Stronger diagnostic requirements also have the potential to curb inappropriate antibiotic use in favor of more targeted treatment options that would reduce the need for retreatment.

In line with these measures, the MEPs are calling on the European Commission (EC) to adopt a new legislative framework to promote investment in new antibiotics. While the parliamentary proposal itself is not a legislative measure, it reflects increased awareness of the threat of AMR at a high level in EU politics.

European Parliament Press Release