EFA recently contributed to the European Medicines Agency (EMA) targeted stakeholder consultation which reviewed the first Union list of critical medicines – vital for improved access to medicines for patients with allergy, atopic eczema, asthma and COPD. The list is an important step for the EU to seek for supply, security and prevention of shortages of critical medicines, as it indicates the significant harm to patients and health systems that a potential shortage of medicine might cause.
At the moment, a medicine is considered critical if it is used for serious diseases and cannot be easily replaced by other medicines in case of a shortage. Medicines fulfilling those criteria will be included in the Union list of critical medicines, for which they also need to considered critical in more than one-third of EU/EEA countries.
How can the critical medicines list help address shortages in the EU?
The list is an important step for the EU to ensure supply security and prevention of shortages of critical medicines, as it indicates the significant harm to patients and health systems that a potential shortage of this medicine might cause.
The first Union list of critical medicines indicates the critical importance of averting shortages for strategic medicines, as their unavailability could cause significant harm to patients and pose substantial challenges to health systems.
EFA’s input to the criticality of medicines
The first version of the Union list of critical medicines was published in 2023 and contained around 240 critical medicines. In 2024 the list will be expanded and thanks to a thorough examination of over 1,500 substances.
EFA, an active member of the EMAs Patients and Consumers Working Party (PCWP) since 2013, welcomed the opportunity to inform the review process that EMA is conducting with Member States to update the 2023 list.
First-line medicines to treat allergy
While allergy is one of the most common chronic diseases in Europe, the first Union list of critical medicines did not identify as critical any antihistamines, which is first line medication for allergy patients. As such, EFA recommended the inclusion on the list of injectable first-generation antihistamines and oral second and third-generation antihistamines, in view of the increasing allergy prevalence in Europe.
Critical medicines and options for children
Children have less treatment options than adults. However, the first Union list of critical medicines does not categorise the critical medicines for specific populations (i.e. different dosage, age or degree of severity). Therefore, EFA recommended the EMA to add considerations that help with the assessment of the medicines which can be prescribed for newborn, infant, children and teenagers. Such detail will put a focus on the most vulnerable populations to a shortage: children who unfortunately need to get off-label use incurring highly under-reported patient safety risk.
Considerations of seasonality for sudden demand increase
The current shortages experienced by patients living with chronic airways diseases are sometimes due to a sudden increased demand for medicines also prescribed to treat respiratory infections, such as bronchodilators. Therefore, to account for the instances in which sudden remand might drive shortages, EFA recommended to also add seasonality indicators, as narrowing down the likelihood of a shortage at a given time, such as the peak periods for transmission, can serve to increase preparedness and vigilance earlier on.
Analyse criticality also within innovative medicines
EFA also highlighted the importance of including the newest, innovative medicines in the review and the updated version of the critical medicines list. Given that novel molecules allow for more personalised treatment, lesser side effects, and better health outcomes for patients, they should be considered for their potential shortage and included in the future versions of the critical medicines list.
Critical medicines for allergy, atopic eczema, asthma and COPD
EFA thoroughly reviewed the EMA list of over 1500 medicines that are under review this year and focused on identifying the essential medicines for patients with allergy, asthma, atopic eczema and COPD. With valuable clinical input from the relevant European level medical societies (EAACI, ERS and EADV) on the proposed medicines, EFA identified 48 substances/combinations as important for our patients’ communities.
Next steps for better access to medicines for patients in Europe
The review of the EMA proposed substances will continue throughout the year, and will conclude with the publication of the updated Union list of critical medicines in December 2024. Stakeholders who contributed to the consultation will be contacted again by the EMA in November 2024 with feedback from the consultation process and request for input on the preliminary outcome of the second version of the Union list for critical medicines.
Special thank you for the great input and advice we received from Prof Anita Simonds from the European Respiratory Society (ERS), Prof Ioana Agache from the European Academy of Allergy and Clinical Immunology (EAACI) and the leadership and Eczema/Atopic Dermatitis Task Force of the European Academy of Dermatology and Venerology (EADV).
EFA will continue its work on shortages of critical medicines as a member of the recently-launched Critical Medicines Alliance (CMA).
You may read EFA’s full reply here.