Evelina Marchesoni
19 min
In this article we look at a ground-breaking decision of the Italian Supreme Court dealing with the compensation...
On April 10, 2024, the European Parliament voted to adopt a revised version of the European Commission’s proposed reforms to pharmaceutical legislation (the so-called “Pharmaceutical Package”), aimed at addressing pressing health challenges, notably antimicrobial resistance (AMR). This vote marks a significant step in the legislative process, setting the stage for further negotiations and potential enactment.
Key Reforms in the Pharmaceutical Package
The Pharmaceutical Package consists of a Directive and a Regulation proposal. These documents outline measures to incentivize the development of new antimicrobials and promote their prudent use to tackle AMR—a growing threat to public health in the EU. Please click here to read our previous article on AMR.
Incentive Scheme for Antimicrobial Development
A key element of the Pharmaceutical Package is the establishment of a voucher system to encourage the development of priority antimicrobials. The proposed incentive scheme has been revised by the Parliament, as briefly described below.
Under this revised scheme, developers can apply for transferable data exclusivity vouchers before obtaining marketing authorization.
These vouchers extend data protection for medicinal products for a maximum of an additional 12 months, with durations varying based on the priority of the pathogens they target:
- 12 months for critical pathogens
- 9 months for high-priority pathogens
- 6 months for medium-priority pathogens[1]
The conditions for the granting of the voucher have been strengthened by requiring the applicant:
- to demonstrate the capacity and to ensure the supply of the priority antimicrobial in sufficient quantities to meet the expected needs of the Union market, to be defined in a specific agreement with the Health Emergency Preparedness and Response Authority (HERA),
- to provide information on any financial support, including indirect support, received for research related to the development of the antimicrobial,
- to submit the stewardship and access plan in accordance with the revised Directive[2]; and
- to submit a global access plan to supply third countries in critical need.
The voucher can be transferred once to another marketing authorization holder (MAH), but it must be used within four years of issuance. The financial aspects of voucher transfers are carefully regulated, with proceeds channeled to ensure the continued supply of priority antimicrobials[3].
New Reward Schemes and Subscription Models
In addition to the voucher system, the Parliament introduced new reward schemes to promote antimicrobial development:
- Market Entry and Milestone Rewards: These rewards provide financial incentives for completing key stages of antimicrobial development.
- Subscription Model for the Joint Procurement of Antimicrobials: The Commission and any of the Member States may participate in a joint procurement procedure for the advance purchase of antimicrobials. The joint procurement agreement shall take the form of a multiannual subscription and will be subject to a number of conditions set out in the proposed Regulation.
Promoting Prudent Use of Antimicrobials
The Directive proposal includes measures to ensure the prudent use of antimicrobials. An amended Article 17 now requires, in addition to the stewardship plan[4], an antimicrobial access plan for MA applications. This access plan aims to ensure sustainable and effective distribution of antimicrobials, including in low- and middle-income countries.
Additionally, the text emphasizes the importance for MAHs of dispensing antimicrobials (where possible) on a per-unit basis, in quantities appropriate to the treatment duration and obliges Member States to establish appropriate disposal systems for antimicrobials and to educate the public on correct disposal methods for antimicrobials.
Next Steps
The Council of the EU will now review the Parliament’s proposals. The June European elections ushered in a new Parliament, which will engage in inter-institutional negotiations to finalize the reforms.
These measures represent a concerted effort by the EU to address the urgent issue of antimicrobial resistance, balancing the need for innovation with the necessity of responsible usage and access.
[1] On this point, the Commission should adopt delegated acts to set up the eligibility of pathogens for protection periods in accordance with the WHO list of priority pathogens (or an equivalent).
[2] Please find further details below on the stewardship and access plan.
[3] The Commission shall adopt delegated acts to supplement these provisions.
[4] As a reminder, the stewardship plan includes information on risk mitigation measures to limit AMR, monitoring and reporting of resistance to the medicinal product.
This article is part of our series that covers the amendments adopted by the European Union (EU) Parliament to the proposed reforms of the European pharmaceutical legislation on medicinal products for human use (the so-called “Pharmaceutical Package”) presented by the European Commission on 26 April 2023. To read our first article and the whole series, please click here.
