The Pharmaceutical Group of the European Union (PGEU) is the European association representing community pharmacists in 32 countries, including EU Member States, EU candidate countries and EFTA members. The IPU is a member of the PGEU, and in this article the IPU’s Head of Strategic Policy, Clare Fitzell, provides an overview of the work of the PGEU, and why it matters to Irish community pharmacists.
The IPU works closely with our colleagues in PGEU on individual policy issues and overarching public policy advocacy at an EU level. For the latter, the IPU provides the PGEU with information on current concerns in Ireland, which can be fed into their advocacy at a European level, and the PGEU provides support to the IPU on framing internal Irish policy issues and support on understanding and circulating information on developments from the European stage. Working with colleagues at the PGEU both informs the work of the IPU, and allows us to inform advocacy at a European level.
Overall, the PGEU represents 400,000 community pharmacists in Europe through their professional bodies and pharmacists’ associations. The vision of the PGEU is that community pharmacists are recognised and supported within national health systems as key health professionals, making a dynamic, sustainable, and evolving contribution to the health of individuals and communities whilst strengthening European health systems.
Nearly 70% of our national legislation in Ireland originates from EU Directives and Regulations, hence the requirement for us to participate and advocate for community pharmacy and community pharmacists at a European level, rather than waiting for transposition into Irish legislation. The PGEU maintains regular contact with the European Commission (including DG SANTE, DG GROW and DG CONNECT), the European Parliament, the Committee of Permanent Representatives (COREPER) and the Economic and Social Committee. The PGEU is part of a network of European healthcare professionals’ organisations through which the European Medicine Agency engages with the healthcare sector.
The PGEU are very active on a number of critical issues that impact all pharmacists across Europe, including these six main policy areas:
“Nearly 70% of our national legislation in Ireland originates from EU Directives and Regulations, hence the requirement for us to participate and advocate for community pharmacy and community pharmacists at a European level.”
The PGEU is a founding member and has a seat on the European Medicines Verification Organisation (EMVO) board, the organisation responsible for the developing and maintaining the European Medicines Verification System (EMVS). EMVO is responsible for the EU Hub, which is the system by which manufacturers upload product data and unique identifiers and from where manufacturers’ information is stored and transmitted to the relevant national systems (the IMVS, in our case). A focus at the EMVO level in 2022, was to reduce the number of system alerts and undertake a project involving representatives from all EMVS stakeholders on an Alert Management System (EAMS). In February 2023 the EAMS went live; interested national NMVOs are currently completing contractual agreements to connect their AMS national systems to the EAMS.
As part of the FMD legislation, the European Commission was tasked with carrying out an evaluation of the implementation of the Directive five years after it came into force in 2019. The European Commission has requested consultancy firm EY to carry out this study, and both the PGEU and the IPU have been interviewed as stakeholders in this evaluation.
The implementation of this legislation, the operational activities of EMVS/NVMS systems and the stakeholder model remain a focus for the PGEU. The key objective in this regard is to ensure minimal disruption for community pharmacists in implementing FMD legislation in order to comply with legal obligations.
Medicine shortages are of significant concern at a European level as they are at a national level in Ireland, with most European countries reporting significant constraints on their medicine supply chains. In December 2023, the PGEU conducted a survey of members to understand the worsening situation across Europe; the results of the survey were published early in 2024 and the significant statistic from this report is that each pharmacy across Europe now spends 9.5 hours per week managing shortages — this is a considerable increase on the 2022 figure, which was 6.7 hours.
The EMA invited the PGEU to speak at a stakeholder workshop in March to present the community pharmacists’ perspective on preventing medicine shortages. In October 2023, the European Commission adopted a communication on medicines shortages, which the PGEU members welcomed. This communication outlines a number of initiatives across the EU to help mitigate the problem of medicine shortages, some of which are listed below:
The European Commission is presenting a regulation to establish a European Health Data Space (EHDS) to allow for the full potential of health data to be realised. The EHDS is a central building block for a strong European Health Union, and it aims to empower people to control and utilise their health data in their home country or other Member States. It fosters a genuine single market for digital health services and products. It offers a consistent, trustworthy, and efficient framework for using health data for research, innovation, policy-making, and regulatory activities while ensuring full compliance with the EU’s high data protection standards. In response to developments in this, the PGEU published its Position Paper on the European Health Data Space, in which the PGEU advocates for the widespread adoption of electronic health records and e-prescribing systems and highlights the key role of community pharmacists in the development of these solutions across Europe. It outlines how community pharmacists are ideally placed to play a pivotal role in designing, developing, testing, implementing, evaluating, and ensuring the uptake of new ICT innovations and in confirming they are fit for practice. This is due to their significant proactive investments in information and communications technology (ICT) infrastructure over the past decades.
In December 2023, MEPs adopted the report by an overwhelming majority, which will now serve as parliament’s negotiating mandate in talks with the Council on the final form of the legislation. The press release to announce the adoption stated: “The law would give patients the right to access their personal health data across the EU’s different healthcare systems (so-called primary use) and allow health professionals to access data on their patients, strictly based on what is necessary for a given treatment. Access would include patient summaries, electronic prescriptions, medical imagery and laboratory results. Each country would establish national health data access services based on the MyHealth@EU platform. The law would also set out rules on the quality and security of data for providers of Electronic Health Records (EHR) systems in the EU, to be monitored by national market surveillance authorities.”
On 24 February 2022, the Commission published an evaluation of the Directive on patient rights in cross-border healthcare in collaboration with Spark Legal Network and the Technopolis Group, which it then submitted to the European Council and Parliament. The evaluation assesses how the Directive’s objective to facilitate access to safe and high-quality cross-border healthcare in another Member State has been met and to what extent the Directive has promoted patient rights and cross-border cooperation between Member States for the benefit of EU citizens. On 6 June 2023, the European Commission published a report on data relating to the functioning of cross-border healthcare for the year 2021, as required under Article 20 of the Directive; this report indicated that Ireland reimbursed other States’ €7.8 million for the treatment of Irish citizens.
On 26 April 2023, the European Commission adopted a proposal for the revision of the General Pharmaceutical legislation, encompassing two main pieces of legislation: a new Directive and a new Regulation, which revise and replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases. The European Parliament approved a timeline for this dossier, which includes the presentation of a draft report, a vote in Plenary and the adoption of the position of the European Parliament expected in April 2024. The PGEU has prepared a Position Paper on the Reform of the Pharmaceutical Legislation, which encompasses the PGEU’s position on the different topics with relevance and impact on pharmacy practice.
In this position paper, the PGEU calls for the following:
In 2023, the European Commission prepared a Commission proposal for a Council Recommendation on vaccine-preventable cancers. The proposal aims to help EU Member States address vaccine-preventable cancers with a focus on increasing the uptake of vaccination against Human papillomaviruses (HPV) and Hepatitis B virus (HBV). The PGEU has contributed to the European Commission’s call for evidence for an initiative on Cancer prevention — action to promote vaccination against cancer-causing viruses, showcasing members’ best practices, including Ireland’s community pharmacy vaccination programmes and the contribution of European community pharmacists to this topic.
The PGEU developed a new Position Paper on The role of community pharmacists in vaccination, highlighting pharmacists’ contribution to increasing vaccination coverage and combating vaccine hesitancy, namely through advocating for the implementation of pharmacist-based vaccination programs in Europe.
In September 2018, the European Parliament resolution on a European One Health Action Plan against Antimicrobial Resistance (AMR) was adopted. This resolution acknowledged the key role of pharmacists in raising awareness of the appropriate use of antimicrobials and in the prevention of AMR. It encouraged Member States to expand pharmacists’ responsibilities by allowing the exact quantity of dispensing and enabling the administration of certain vaccines and rapid diagnostic tests within pharmacies. Each year, the PGEU and the IPU engage actively in the ECDC European Antibiotic Awareness Day (EAAD) and the WHO World Antibiotic Awareness Week. On 26 April 2023, the European Commission presented a proposal for a Council Recommendation containing complementary measures to combat AMR in human health, animal health and the environment through the so-called One Health approach, which was subsequently adopted on 13 June 2023.
The proposed measures set out in the recommendation include:
The PGEU published a new position paper on Antimicrobial Resistance, encompassing the Reform of the EU pharmaceutical legislation. The developments related to antimicrobial resistance as outlined in the EU Pharmaceutical Strategy, namely the inclusion of different models for funding the development of new antimicrobials. The PGEU will continue to promote its Position Paper, which showcases the contribution of community pharmacists in the fight against AMR and highlights the PGEU members’ initiatives. The position paper recommends a set of actions at the national and European levels to curb this “silent pandemic”, namely the implementation of pharmacy services for early detection and screening of bacterial infections, appropriate changes in the legislation for the adaptation of antibiotics packages to the duration of the treatment and support and funding for appropriate collection schemes for unused and expired medicines, which aligns to ongoing work in the IPU to seek the DUMP scheme be expanded to a national service.
We look forward to a productive year in 2024, working with our European colleagues on a number of areas, including harmonisation of medicine shortage reporting procedures, actively promoting the PGEU position papers on EHDS and the General Pharmaceutical Legislation at a local and Department of Health policy level.
For more information see pgeu.eu.
References available on request.
Clare Fitzell
Head of Strategic Policy, IPU
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