This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the whole series, please click here.

As mentioned in our previous article, the European Commission finally presented on 26 April 2023 its long-awaited plan revising the European pharmaceutical legislation, the so-called “Pharmaceutical Package“, including both a Directive and a Regulation proposal. The legislative proposals are accompanied by a Recommendation from the Council of the European Union (EU) addressing antimicrobial resistance, one of the main focuses of this new legislative framework.

Indeed, “antimicrobial resistance” (AMR) has been identified as one of the three main health threats targeting the EU[1]. AMR is the ability of a micro-organism to survive or to grow in the presence of an antimicrobial agent that is usually sufficient to inhibit or kill that micro-organism; in other words, the ability of micro-organisms, such as bacteria, to become increasingly resistant to an antimicrobial to which they were previously susceptible.

Referred to as the “silent pandemic”, AMR is thought to be responsible for 35,000 deaths a year in the EU/EEA[2] and entails considerable expenses for healthcare systems. The number of new, more effective anti-microbials in development is concerningly low and there has been much debate about the best format for EU-wide structured incentives (as have been adopted in some Member States) to help encourage companies to invest in developing anti-microbial products.

The draft revision of EU pharmaceutical legislation sets out several complementary measures to tackle the rising problem of AMR:

The Regulation proposal: a voucher system granting transferable data exclusivity rights to encourage the development of antimicrobials

Chapter III of the draft regulation (articles 40 to 43) introduces a system of financial rewards for developers of new “priority” antimicrobials, through the granting of a transferable data exclusivity voucher.

Subject to strict eligibility criteria, this voucher grants its holder an additional year of regulatory data protection for a centrally authorised product, and may be used for the priority antimicrobial, for another product of the MAH, or transferred to another MAH in full transparency (the beneficiary notifies the European Medicines Agency of this transfer, as well as of its value, which is made public). The voucher must be used within 5 years from the date of grant.

It should be noted that this is a temporary mechanism to be tested for a period of up to fifteen years. The number of vouchers granted over this period is restricted to a maximum of ten, to curtail the potential burden this scheme could have on healthcare systems.

The Directive proposal: various measures to promote the prudent use of antimicrobials

Related measures are introduced within the framework of the Directive, including:

• inclusion of an “antimicrobial stewardship plan” when applying for a marketing authorization and adaptation of the pack size of the antimicrobial to the usual posology and duration of treatment (article 17);
• extension of the scope of the environmental risk assessment (required for the granting of a marketing authorisation)[3] to cover the risk of AMR selection in the environment due to the manufacturing, use and disposal of the medicinal product (article 22);
• classification by default of antimicrobials as prescription-only medicinal products (article 51);
• inclusion in the packaging of an “awareness card” containing specific information on the antimicrobial, AMR and the appropriate use and disposal of antimicrobials (article 69).

The Council recommendation: a coordinated response to the cross-cutting, cross-border issue of AMR

On 13 June 2023, the Council adopted a recommendation aimed at combating AMR in the fields of human health, animal health and the environment. This recommendation is an extension of the EU “One Health” action plan, and provides Member States with concrete objectives and means of action, in particular to:

• implement national action plans against AMR;
• strengthen surveillance and monitor AMR and antimicrobial consumption;
• improve infection prevention and control – in particular via the health and welfare of food-producing animals to reduce the spread of infectious diseases in farms;
• ensure prudent use of antimicrobials;
• reduce the use of antimicrobials by 2030 by 20% in terms of total human consumption of antibiotics and by 50% in terms of total sales of antimicrobials used in the EU for farm animals and aquaculture;
• raise awareness, educate and train the public and professionals in the human and veterinary health sectors.

[1] HEALTH UNION: Identifying top 3 priority health threats, https://health.ec.europa.eu/system/files/2022-07/hera_factsheet_health-threat_mcm.pdf

[2] Assessing the health burden of infections with antibiotic-resistant bacteria in the EU/EEA, 2016-2020, https://www.ecdc.europa.eu/sites/default/files/documents/Health-burden-infections-antibiotic-resistant-bacteria.pdf

[3] For further developments on the Environmental Risk Assessment requirements under the proposed new Directive on medicinal products for human use, please read our article here