The European Commission has recently put forth a proposal to amend the EU pharmaceutical legislation on April 26, 2023 (available at https://health.ec.europa.eu/system/files/2023-04/com_2023_193_1_act_en.pdf). This proposed revision aims to establish a unified market for medicines across all EU member states, thereby promoting greater accessibility to novel and effective drugs while also tackling issues surrounding drug supply shortages.
Included in the package are specific measures aimed at developing new antibiotics, which are outlined in Chapter III. This section acknowledges that the current pipeline of effective antimicrobials that can combat antimicrobial resistance is impeded due to market failure. To encourage innovation in this area, new incentives have been proposed, particularly for priority antimicrobials. These will receive a transferable exclusivity voucher for one year, granting an additional year of regulatory data protection to the developer. The voucher can be used for any product in the developer’s portfolio, or it can be sold to another marketing authorization holder.
However, the developer must agree to supply the medicinal product in sufficient quantities to patients across the EU, as well as provide information on all funding received for research related to its development. This information is needed to account for the direct financial support given to the medicinal product. To provide early scientific and regulatory support to developers of new priority antimicrobials, the Priority Medicines (PRIME) scheme will be employed.
New incentives for priority antimicrobials
To be considered a ‘priority antimicrobial’, a medicinal product should “represent a real advancement against antimicrobial resistance and should therefore bring forward nonclinical and clinical data that underpin a significant clinical benefit with respect to antimicrobial resistance”. Also, «antimicrobial marketing authorization holders are required to develop a stewardship plan for antimicrobial resistance which includes information on risk mitigation measures, monitoring and reporting of resistance to the medicinal product».
HAPPY PATIENT celebrates this new initiative of the European Commission to actively fight against Antimicrobial Resistance and is optimistic about the potential of this new regulation to promote the development of novel antimicrobial agents and to address the issue of drug supply shortages that have been prevalent in Europe in recent times.