In February, the Council of Europe’s Committee of Ministers adopted a Recommendation seeking to promote equitable access to medicinal products and medical equipment in a situation of shortage and to safeguard the fundamental rights of individuals who need them for serious or life-threatening health conditions in the 46 Council of Europe member states.
Recommendation CM/REC(2023)one on ‘Equitable access to medicinal products and medical equipment in a situation of shortage’ was prepared as a response to the lessons learnt from the COVID-19 pandemic and the increasing shortages of medicines and medical devices across Europe. It calls for ensuring that there is a system in place to prevent and mitigate situations of shortage and to better prepare for such shortages.
HMA/EMA multi-stakeholder workshop on shortages
At the beginning of March, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) organised a two-day workshop focused on medicine shortages. EAHP’s Director of Professional Development Despoina Makridaki represented the views of hospital pharmacists.
Workshop participants were informed about the HMA/EMA Task Force activities on medicines shortages and availability and interfaces with other initiatives, received updates on the progress with the Task Force deliverables and identify areas of agreement as well as areas for further discussion and had the possibility to share their perspectives and activities seeking to address availability issues.
Swedish Council presidency
In January Sweden took over the Council Presidency. Healthcare support for Ukrainian refugees, tackling shortages of medicines, access to medical devices, the European Health Data Space (EHDS), antimicrobial resistance (AMR), mental health, fight against cancer and preparedness for future health crises are among Sweden’s priorities.
Similar to its predecessor, the Swedish Council Presidency plans to build on the lessons learnt from the COVID-19 pandemic. In addition, it will be responsible for negotiating a number of key proposals, including the Regulation for a European Health Data Space, the proposal concerning a Regulation on standards of quality and safety for substances of human origin intended for human application and the long-awaited revision of the general pharmaceutical legislation of the EU, including proposals on new regulations concerning orphan medicinal products and paediatric medicines. Also, the international pandemic treaty and the EU’s Global Health Strategy fall within the work programme of the Presidency.
Linked to the AMR health threat the Presidency will focus on maintaining the possibility of effective treatment of bacterial infections in humans and animals, and keeping the issue at the top of the international agenda. Both ensuring sustainable access to effective antimicrobials and reducing the EU’s contribution to AMR will play a key role.
Feasibility study on stockpiling of antimicrobials against AMR
The Health Emergency Preparedness and Response (HERA) Directorate General commissioned a study that looked at the threat of antimicrobial resistance (AMR) and stockpiling efforts for medical countermeasures.
The study was carried out in two phases. The first phase focused on an extensive mapping which looked into the identification of antimicrobials with a critical need for undisrupted access, analysed supply chain vulnerabilities for the selected antimicrobials and reviewed existing antimicrobial stockpiling systems at the EU and global levels. The second phase focused on finding means to overcome the vulnerabilities. Also, different options for stockpiling antimicrobials at the EU level, both physically and virtually, were looked at.
The study showed that 32 classes of antibiotics require continued availability in all EU Member States to ensure a continuous basis of therapeutic and prophylactic options for healthcare professionals and patients. Limited EU self-sufficiency for the production of APIs and the lack of buffer manufacturing capacity for critical intermediates were identified as key vulnerabilities.
Multistakeholder event on Biosimilar medicines – Watch the recording
On 13 December 2022, the European Commission organised a multistakeholder event focused on biosimilar medicines. Different stakeholders contributed, including EAHP’s Director of Professional Development Despoina Makridaki.
The event focused on biosimilar competition, interchangeability, switching and substitution of biosimilars and national biosimilar policies. In addition, oncology biosimilars and trust in them were explored further. The event was concluded by a panel discussion to which patients, healthcare professionals, payers and industry representatives contributed. In case you missed the event, you can access all presentations as well as the recording online.
Coalition for vaccination brings together European healthcare professionals
In mid-January, close to a hundred experts from across Europe gathered to discuss European and national vaccination policies and healthcare professionals' role in increasing vaccine confidence and uptake. EAHP was represented at the Coalition for Vaccination conference by its Director of Finance Nenad Miljković.
The event followed the adoption of Council Conclusions in December 2022 which reaffirmed that vaccination is one of the most effective tools in the prevention of infectious diseases, highlighted the importance of communication training for healthcare professionals and reinforced the role of the Coalition. Those participating in the conference reiterated the need for all actors to work together to close vaccination gaps.
With its deliverables in the finalisation stage, the IMMUNION project presented its work during the conference. The aim of the project that was set up in 2021 was to strengthen collaboration between healthcare professionals and other stakeholders, addressing issues of access to accurate, evidence-based information about vaccination. This was primarily achieved through strategies focused on communication and training. In addition, tools and resources were developed to increase vaccine coverage, in particular among underserved populations.
EMAs new role during public health emergencies
Since the beginning of February, the additional responsibilities regarding the monitoring and mitigation of shortages of critical medical devices during public health emergencies of the European Medicines Agency (EMA) are applicable. The Agency is now responsible for coordinating responses of EU / EEA countries to shortages of critical medicines and medical devices including in-vitro diagnostics during public health emergencies.
The work of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – which was set up almost a year ago – will from now be complemented by the Medical Devices Shortages Steering Group (MDSSG). The MDSSG is tasked with coordinating urgent actions within the Union in relation to the management of supply and demand issues of critical medical devices and making recommendations to relevant stakeholders, including the European Commission, Member States and notified bodies.
The MDSSG will be composed of a representative of the Agency, a representative of the European Commission and one representative appointed by each Member State. The MDSSG will be co-chaired by the Agency and by a representative of a Member State. A representative of the Agency’s Patients' and Consumers' Working Party ('PCWP') and Healthcare Professionals' Working Party ('HCPWP') may attend meetings of the MDSSG as observers.
Footnotes
Competing interests: None declared.
Provenance and peer review: Commissioned; internally peer reviewed.