The European Commission has proposed specific measures to increase the supervision and monitoring of the use of antimicrobial medicinal products (or “antimicrobials”), with the aim to counter the spread of antimicrobial resistance (“AMR”).  At the same time, the measures are also aimed at promoting and incentivizing the development of new priority antimicrobials through the use of transferable data exclusivity vouchers.

As we have discussed previously, the proposed changes to the regulation of antimicrobials are some of the more innovative aspects of the EU’s General Pharmaceutical Legislation amendment proposal and the Commission proposal for a Council Recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach (AMR), which were published on 26 April 2023 (“the Proposal”).  In this blog, we briefly explore some of these changes.

The growing AMR problem and EU response so far

AMR has become a growing concern worldwide.  The former Secretary-general of the World Health Organization (“WHO”), Margaret Chan warned that AMR is a “slow-moving tsunami” threatening to bring about “the end of modern medicine as we know it.”  In the EU alone, AMR causes around 35,000 deaths a year.

Multi-drug resistant bacteria, viruses, fungi, and parasites, are fast evolving mechanisms to resist the effects of existing antimicrobials (such as antibiotics, antivirals, antifungals, and antiparasitics).  At the same time, new antimicrobials are not keeping pace. Research and development, manufacture, and marketing of antimicrobials has significantly slowed down in the past 20 years, making infections harder to treat and increasing the risk of disease spread, severe illness, and death.

The Proposal tackles this rising threat to public health by introducing new measures building on strategies already implemented in 2017 and in 2022 to enhance R&D and the responsible use of antimicrobials (European One Health Action Plan against Antimicrobial Resistance and EU Global Health Strategy, respectively).  These measures focus on:    

  • Innovation: advancing research and development of new antimicrobials and antimicrobial diagnostics.
  • Reducing the spread of AMR: promoting responsible use of antimicrobials and enhancing surveillance and control measures.

Measures promoting antimicrobial innovation

To incentivize the development of priority antimicrobials, the Proposal introduces the possibility for developers to be granted a transferable data exclusivity voucher.

The transferable data exclusivity voucher offers an additional 12 months of regulatory data protection to the developer of the priority antimicrobial.   The developer can choose to use the voucher for any centrally authorized product in its own portfolio, or transfer it (e.g., through a sale) to another marketing authorization (“MA”) holder for a different centrally authorized product.  

This flexible regime and potential economic incentives are intended to promote antimicrobial innovation, linking the reward to another product than the new antimicrobial.  An extra year of regulatory data protection may be extremely valuable for certain medicinal products, especially in light of the potentially shortened market exclusivity periods under the Proposal (as we discussed here).  That being said, the regime will only remain in force for a limited time: 15 years from the date that the Regulation comes into force or until 10 data exclusivity vouchers have been issued, whichever date is the earliest.   As discussed below, there are also various restrictions involved in how the vouchers may be used.

Data exclusivity voucher requirements

Data exclusivity vouchers will not be granted for the development of all antimicrobials, but only for priority antimicrobials, which need to fulfil one of the following criteria:

  • represent a new class of antimicrobials;
  • have a distinctly different mechanism of action from that of any authorized antimicrobial in the EU; or
  • contain an active substance not previously authorized in a medicinal product in the EU that addresses a multi-drug resistant organism and serious or life threatening infection.

Vouchers may be revoked prior to their transfer if a request for supply, procurement or purchase of the priority antimicrobial in the EU has not been fulfilled.   Developers will also need to be transparent and publish information regarding any public contribution to the research and development costs of the priority antimicrobials.

Notably, the voucher can be transferred only once.  If the voucher is transferred, additional restrictions will apply.  The voucher can only be used:

  • once, and in relation to a single centrally authorized medicinal product;
  • during the first four years of data protection of the recipient medicinal product; and
  • if the MA of the priority antimicrobial that triggered the grant of the voucher has not been withdrawn. 

The commercial terms underlying the sale of any data exclusivity voucher will likely be complex and will involve the preparation and negotiation of bespoke contracts.

Measures aimed at reducing the spread of AMR

The Proposal also introduces various measures aimed at reducing the spread of AMR and ensuring the responsible use of antimicrobials.  Briefly, these include:

  • Refusing a Marketing Authorization due to AMR or Imposing Obligations

Developers of antimicrobials will need to include in their MA applications (as part of their Environmental Risk Assessment (“ERA”)) an evaluation of the risk for AMR selection during the entire manufacturing and supply chain inside and outside the EU, including the use and disposal of the antimicrobial.   If the ERA is incomplete, insufficiently substantiated, or shows that the environmental risks posed by the product outweigh the benefits, the European Medicines Agency (“EMA”) and national competent authorities may refuse the MA application for the antimicrobial.   Post-authorization obligations can also be imposed.  If you want to learn more about the key environmental measures under the Proposal, please see our Environmental blog.

  • Antimicrobials will only be available through prescription

Under the Proposal, antimicrobials will only be available under a relevant prescription.   Additionally, Member States can choose to introduce further restrictions, such as restricting the validity of prescriptions, requiring the mandatory use of diagnostic tests before prescription, or limiting the quantities prescribed to the amount required for the treatment course. 

  • Mandatory stewardship plan for antimicrobials

Developers are required to develop an AMR stewardship plan as part of any MA application for antimicrobials.   The AMR stewardship plan must include risk mitigation measures to limit AMR development related to the use of the antimicrobial, as well as relevant monitoring and reporting plans regarding AMR.   Competent national authorities may impose additional obligations on the developer where the AMR stewardship plan is unsatisfactory. 

  • Limited pack size of antimicrobials

The Proposal strengthens EU rules on package sizes, educational measures, and proper disposal of unused and expired antimicrobials.   The MA holder will be responsible for ensuring that the pack size of the antimicrobial is appropriate for its dosage and duration of treatment.   National rules should also ensure that antimicrobials are dispensed in quantities consistent with the prescription.   

  • Provide special information to healthcare professionals and users

Both MA holders and Member States have a joint responsibility to provide information to healthcare professionals (“HCPs”) and patients on the proper use, storage, and disposal of antimicrobials.   MA holders must create information materials for both HCPs and users, such as educational materials for HCPs, or an awareness card for patients with information on AMR and the appropriate use and disposal of the product (using standardized text to be developed by the EMA).   A warning about inappropriate disposal of antimicrobials contributing to AMR from should also be included. 

This blog is based on the wording of the EU’s proposal published on 26 April 2023.  This wording could significantly change during the legislative process.  Our Dublin, Brussels, Frankfurt and London teams will continue to monitor this legislation.  We will be hosting a webinar to discuss the impact on 9 May.  To sign up for the webinar please click here.


Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the EU Courts in Luxembourg and in local…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the EU Courts in Luxembourg and in local litigation in Belgium. Peter’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations.

Chambers Global notes that a client said: “He is an extremely experienced professional with broad expertise and provides sensible and well-balanced solutions.” He is consistently ranked by PLC as one of the leading life sciences lawyers globally and Legal 500 EMEA and Chambers Europe note Peter’s prominent regulatory pharmaceutical and environmental practice. Legal 500 EME noted that he is “a superb lawyer who is very pleasant to work with.” Peter regularly writes and speaks on life sciences issues. He is a founding member of the Brussels Pharma Law Group and also served for fifteen years as Managing Partner of the firm’s Brussels office.

Photo of Ellie Handy Ellie Handy

Working with companies in the life sciences and technology sectors, Ellie Handy focuses on EU, Irish, and UK life sciences regulatory and commercial matters.

Ellie advises clients on regulatory issues including classification, biologics, orphans, paediatrics, GxP, market and data exclusivity, clinical research, labelling…

Working with companies in the life sciences and technology sectors, Ellie Handy focuses on EU, Irish, and UK life sciences regulatory and commercial matters.

Ellie advises clients on regulatory issues including classification, biologics, orphans, paediatrics, GxP, market and data exclusivity, clinical research, labelling and promotion, reporting obligations, medical devices, and digital health. Ellie also advises companies in the food, cosmetic and consumer products sectors regarding regulatory compliance and borderline issues. Ellie provides advice in relation to corporate transactions and restructuring, in particular performing regulatory due diligence.

Ellie represents and works with a wide range of clients working in the life sciences and technology sectors on both contentious and non-contentious regulatory matters.

Ellie’s pro bono work includes assisting charities. In addition to her role at Covington, Ellie spent three years working life sciences regulatory practice in London.

Photo of Roderick Dirkzwager Roderick Dirkzwager

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a…

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

  • EU, Irish, and UK regulatory issues relating to pharmaceutical products and medical devices;
  • commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
  • regulatory and commercial due diligence for life sciences transactions; and
  • intellectual property issues arising in corporate transactions and IP-related contracts.

Roderick is also a member of Covington’s Life Sciences in Africa team and advises clients on regulatory and commercial strategies for the supply of medical products across Africa, including through international recognition procedures such as WHO pre-qualification. Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.

Photo of Anna Wawrzyniak Anna Wawrzyniak

Anna Wawrzyniak is a senior scientific and regulatory advisor in the Life Sciences team. As a non-lawyer with a Ph.D. in biomedical sciences, Anna provides detailed scientific and regulatory advice to the firm’s pharmaceutical, food and feed clients. She draws on her technical…

Anna Wawrzyniak is a senior scientific and regulatory advisor in the Life Sciences team. As a non-lawyer with a Ph.D. in biomedical sciences, Anna provides detailed scientific and regulatory advice to the firm’s pharmaceutical, food and feed clients. She draws on her technical and regulatory expertise to help clients in strategic planning and in navigating regulatory proceedings, especially in areas where a deep understanding of the underlying science is important. In particular, she advises pharmaceutical clients on regulatory issues relating to product classification, biologics, advanced therapies, orphans, paediatrics, market and data exclusivities.

Anna has deep expertise in the following areas:

  • The development and approval of medicinal products;
  • Strategies for obtaining and maintaining regulatory exclusivities, including orphan market exclusivities, regulatory data exclusivities (new active substance status) and paediatric incentives;
  • Support to high stake litigation on regulatory aspects;
  • PRIME, accelerated approvals, conditional and exceptional marketing authorisations;
  • Advanced therapies, biologic and substances of human origin;
  • Borderline classification;
  • Regulatory due diligence;
  • Novel foods and food supplements; and
  • Feed.
Photo of Yuliya Gevrenova Yuliya Gevrenova

Yuliya Gevrenova is an associate in the Life Sciences Practice Group. She advises clients across a wide range of regulatory, compliance and procedural issues, focusing on EU and Public International law.

Yuliya assists multinational companies in the food, feed, pharmaceutical and cosmetics sectors…

Yuliya Gevrenova is an associate in the Life Sciences Practice Group. She advises clients across a wide range of regulatory, compliance and procedural issues, focusing on EU and Public International law.

Yuliya assists multinational companies in the food, feed, pharmaceutical and cosmetics sectors to navigate complicated legal frameworks, including:

  • International Health law, including the impact of the WHO Pandemic treaty, the application of the International Health Regulations and the Pandemic Influenza Preparedness Framework.
  • International Environmental law, including issues of access and benefit sharing under the Convention on Biological Diversity and the Nagoya protocol.
  • Food law, including labelling and claims; coordination with national authorities during withdrawals and recalls; special rules on flavorings and enzymes, as well as GMOs and NGTs.
  • Chemicals (REACH, plastics, pollutants, etc.) and Environmental regulations (CSDDD, Wastewater Directive, green washing, etc.).
  • Animal health issues, including animal testing, transportation and feed.

As part of her pro bono practice, Yuliya advises on complex litigation strategies aimed at defending the rights of people with mental disabilities.