OpenLobby.EU
Explore

The European Association of Hospital Pharmacists

EAHP

The European Association of Hospital Pharmacists represents 36 national hospital pharmacy associations to improve patient care in hospitals through science, research, education, and practice.

Lobbying Activity

Meeting with Romana Jerković (Member of the European Parliament, Rapporteur) and EU Coalition on Structural Heart Diseases

3 Dec 2025 · Cardiovascular Health

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur)

19 Nov 2025 · Health Policy

Response to Union prevention, preparedness, and response plan for health crises

28 Oct 2025

The European Association of Hospital Pharmacists (EAHP) welcomes the European Commissions initiative to strengthen the Unions prevention, preparedness and response for health crises. EAHP is a not-for-profit organisation representing over 30,000 hospital pharmacists from 37 European countries and developing the hospital pharmacy profession across Europe to ensure continuous improvement of care and outcomes for patients in the hospital setting. Hospital pharmacists play an essential role in prevention, preparedness and response. They are the healthcare professionals responsible for ensuring timely, effective and equitable access to safe medicinal product and medical devices and high-quality pharmaceutical care in hospitals. Hospital pharmacists are fundamental in supplying medicines, medical devices and providing pharmaceutical care in healthcare and geopolitical crisis situations such as earthquakes, wars, migration. During the COVID-19 pandemic, they were instrumental in managing shortages, coordinating medicines and vaccines distribution and stocks, developing contingency protocols to maintain continuity of care, supporting patients and healthcare teams in intensive care units, and finding innovative solutions to major shortages of medicines and medical devices. Their work strengthened Europes ability to deal with health threats and emergencies. Furthermore, due to their expertise in pharmacotherapy, hospital pharmacists are at the forefront of combating antimicrobial resistance (AMR) by promoting the prudent use of antibiotics and vaccination as a preventive measure. Within hospitals, they are active members of multidisciplinary antimicrobial stewardship (AMS) teams, and at national level, they are often consulted in AMR Committees. For this reason, hospital pharmacists are also involved in multiple fora at the European and international levels (e.g. AMR OHN, AMR Multi-Stakeholder Partnership Platform). EAHP supports the initiative aimed at adopting a coordinated Union approach, ensuring consistency among existing fragmented information, legislation and resources, and making them accessible in a single document to be consulted by crisis managers in times of need. EAHP also welcomes the plans emphasis on an all-hazard, whole-of-society and One Health approach. Nevertheless, EAHP encourages explicit recognition of the role of healthcare professionals -and hospital pharmacists in particular- as key stakeholders to be involved in governance for health crisis preparedness and response. Their participation will help identify bottlenecks in pharmaceutical logistics, promote evidence-based contingency planning and enhance the safe deployment of medical countermeasures. Furthermore, to optimise the effectiveness of this plan, EAHP recommends that it encompass the following aspects: -Address medicine and medical device shortages through improved coordination, information sharing, transparent supply chain monitoring, and reduced dependency on active pharmaceutical ingredients (APIs) produced outside Europe. -Ensure healthcare workforce preparedness by guaranteeing sufficient numbers of trained healthcare professionals, including hospital pharmacists. -Foster interoperability -while safeguarding patient- data by integrating immunisation systems with hospital information systems and ensuring all healthcare professionals can access vaccination records, and implement closed-loop logistic systems. -Prevent environmental contamination in all production sites, including those beyond Europes borders, as such contamination can trigger AMR in humans and animals. -Ensure strong coordination, avoiding duplication not only among EU institutions, agencies and national authorities, but also across different Commission services (e.g. DG SANTE, HERA, DG RTD, JRC). EAHP remains available for any further questions and looks forward to continued engagement with the Commission on the Union prevention, preparedness and response plan for health crisis.
Read full response

Meeting with András Tivadar Kulja (Member of the European Parliament, Shadow rapporteur)

18 Sept 2025 · Healthcare workforce

Meeting with Tiemo Wölken (Member of the European Parliament, Shadow rapporteur)

17 Sept 2025 · Critical Medicines Act

Hospital Pharmacists Seek Central Role in EU Cardiovascular Plan

16 Sept 2025
Topic — This initiative targets cardiovascular disease prevention, treatment, and health industry competitiveness across Europe.
Message — The association requests formal recognition of hospital pharmacists' roles in medication safety and patient engagement. They urge the plan to address medicine shortages and workforce issues that limit patient care. Finally, they suggest providing practical case studies on using health data to improve outcomes.123
Why — Formal inclusion in the plan would increase the profession's influence and access to resources.4
Read full response

Meeting with Sandra Gallina (Director-General Health and Food Safety) and

16 Jul 2025 · Exchange of views on the state of play and next steps for the medical devices sector.

Response to Critical Medicines Act

4 Jul 2025

Medicine shortages remain a serious threat to patient safety and quality of care across Europe. The European Association of Hospital Pharmacists (EAHP), representing over 29,000 hospital pharmacists in 37 countries, was the first healthcare professional organisation to raise the alarm on medicine shortages at the European level over 12 years ago. Hospital pharmacists, responsible for medicine selection, storage, administration, dispensing, and monitoring, manage shortages daily to ensure patient safety and continuity of care. EAHP welcomes the Commissions proposal for a Critical Medicines Act to reinforce Europes supply chain resilience. To ensure real impact for patients, EAHP urges policymakers to consider the following: The Union list of critical medicines must cover all therapeutic classes, including antidotes and life-saving medicines. Excluded medicines should be reassessed with healthcare professionals' input. This list must align with outcomes of a regularly updated vulnerability assessment to detect risks across production and distribution of medicines and components. A published list of therapeutic alternatives should support clinical decision-making. Harmonised reporting, analysis, and communication must include all supply chain actors. Hospital pharmacists, as the link between suppliers, physicians, and patients, can provide real-time, evidence-based data forecasting medicine demand based on seasonality, consumption patterns, and epidemiology. Mandatory multi-stakeholder information sharing is vital for accurate, timely forecasting. Delayed or incomplete data causes late shortage detection and poor responses. Existing tools like the ESMP should coordinate efforts. Best practices in data reporting and monitoring exist in several Member States. The Act should strengthen hospitals ability to compound when authorised medicinal products are unavailable. Hospital compounding is a vital backup during shortages and must be supported via strategic projects. MEAT criteria in medicine procurement should better balance safety, quality, affordability, and availability. Criteria should not be price-only, and multi-winner approaches are preferred. Relying on a single supplier often increases shortages. Justification shall be mandatory when these criteria or approaches are not used, to promote accountability, prevent abuse, and strengthen health system resilience. Multidisciplinary procurement consulting hospital pharmacists and clinical experts is crucial. Centralised procurement excluding healthcare professionals risks worsening shortages, disconnecting clinical realities, and adding burdens. The Critical Medicines Coordination Group must not duplicate structures like MSSG. EAHP calls for healthcare professionals, especially hospital pharmacists, to be included as full stakeholders with voting rights or at least observer status, with mandatory consultation. Strategic projects addressing vulnerabilities shall be prioritised. Incentives shall come with clear supply obligations and performance clauses to safeguard public resources. A monitoring mechanism should assess if funding recipients meet regulation objectives, which focus on ensuring and strengthening patient access to medicines. Sanctions/penalties should apply if objectives are unmet. An improved, coordinated stockpiling approach is needed, including enhanced use of the Voluntary Solidarity Mechanism. For vulnerable and orphan medicines, EU stockpiling could improve preparedness and equitable access across Member States. The objectives of the Regulation shall be pursued ensuring transparency in each process and decision. EAHP calls on the European Parliament and Council to collaborate, placing patient interests, safety, and access to medicines at the core of the Act, including involvement of competent healthcare professionals.
Read full response

Meeting with András Tivadar Kulja (Member of the European Parliament, Shadow rapporteur)

3 Jul 2025 · Healthcare workforce shortage

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur) and Bureau Européen des Unions de Consommateurs and

13 Jun 2025 · Critical Medicines Act

Hospital Pharmacists Demand Central Role in Biotech Act

11 Jun 2025
Topic — The Biotech Act aims to create an environment that accelerates biotechnology innovation and deployment.
Message — The organization calls for hospital pharmacists to be recognized as central actors in the management and delivery of advanced therapy medicinal products. They demand that new legislation includes strong transparency requirements for public funding and the development of standardized European training programs.123
Why — This would solidify their professional authority over complex therapies and secure funding for necessary hospital staffing.45
Impact — Commercial biotech firms could lose control over product training and face more burdensome public disclosure rules.67
Read full response

Response to Communication on the EU Stockpiling Strategy

9 May 2025

The European Association of Hospital Pharmacists (EAHP) welcomes the intention of the Commission to propose a stockpiling strategy and coordination, though it wishes to highlight that the different fields impacted may require different approaches. A coordinated approach for medicines stockpiling should be ensured, alongside the effectiveness of medicines supply. If medicines are stockpiled, measures should be taken in order to avoid an unwanted increase of shortages, instead of a decrease of them, in either bigger or smaller countries. Some countries have implemented rolling stockpiles of medicines and essential materials in cooperation with the private sector. In these countries, this practice has proven helpful in reducing the risk of obsolescence and could be considered a potential example of best practices in certain scenarios. However, it should be noted that this approach may not be suitable or effective in all settings, and other solutions might be more appropriate in different contexts. EAHP calls for the incorporation of the recommendations of the Critical Medicines Alliance on stockpiling in the EU Stockpiling Strategy, and for exploring the way forward for a European stockpiling of medicines, that does not benefit some countries while leaving others behind. Coordination should be ensured among institutions and agencies, between the EU and Member States and among Member States. It would also be essential to have a regular dialogue and cooperation among the DGs involved. Coordination would also be needed with other relevant binding and non-binding acts, such as the existing EU legislation on public procurement and the EU guidance on public procurement of medicines currently under drafting, the future Critical Medicines Act, and the pharmaceutical legislation in its current and future version. An effective stockpiling cannot be achieved without promoting the exchange of information and best practices, as well as a high level of transparency. Keeping healthcare professionals in the information loop is essential to ensure an effective and patient-centred stockpiling. A comprehensive multi-stakeholder stock assessment should indeed precede the final stock arrangements. This should include competent authorities, manufacturers, suppliers, wholesalers, both hospital pharmacists and community pharmacists, and patients. These measures would be vital for creating a more responsive and resilient system that adjusts to fluctuating demands. A mechanism should be set in place to prevent unequal distribution of medicinal products from the available EU stocks, when a shortage of a particular medicine occurs and affects most of the EU countries. Finally, a mechanism should be put in place to modify the list of medicines stocked even throughout a year depending on the trends, so that the stock could be activated quickly and mitigate a shortage.
Read full response

Response to EU Strategy on medical countermeasures

9 May 2025

The European Association of Hospital Pharmacists (EAHP) welcomes the efforts for supporting medical countermeasures against public health threats through a comprehensive strategy aimed at improving health systems resilience and security. Hospital pharmacists (HPs) are the key stakeholders responsible for medicines, and in many countries, for medical devices management and safety in the hospital environment. They manage in- and out-patient services, support the seamless transition of care for patients moving within the healthcare system, and are involved in home care treatment of serious chronic diseases. HPs play a unique role in guaranteeing successful pharmacotherapy outcomes and in preventing avoidable iatrogenic medication and medical device risks. In addition, they are in charge of the procurement of medicines and medical devices, hospital drug expenditure, whilst ensuring that every patient within the hospital receives the necessary treatment - getting the appropriate medical device or the right dose of the right medicine, of the right quality, at the right time. Taking into account an ageing population and cardiovascular comorbidity resulting in polypharmacy, the role of hospital pharmacists in medication management is more important than ever. The COVID-19 pandemic led to an increase in medicines and medical devices shortages, posing risks for patient safety and access to medicines. In fact, the pandemic presented a particularly insidious challenge for hospital pharmacists and, more broadly, for healthcare systems across the board. Since 2013, EAHP has conducted a series of surveys with the aim of elucidating the main drivers of shortages, their impact on patient care, and mitigation pathways with a goal of minimising the impacts of the shortages. Medicine shortages -already a perennial concern- have developed recognisable patterns and in many countries commonly frequently reflecting the increased therapeutic demands associated with treating patients suffering from the legacy of COVID-19. According to a study conducted by EAHP during the COVID-19 pandemic, the primary strategies employed by HPs to manage medicine shortages included therapeutic substitution, the establishment of supplementary strategic stockpiles at local, regional, or national levels, and the transfer of medicines between hospitals. Additional measures such as importing pharmaceuticals from abroad and substituting with generic alternatives were also implemented to alleviate supply constraints. Amongst the medicines for which an increase of shortages was noticed in the last decade, are the preventative medicines, such as vaccines, which play an essential role in preventing the spread of infectious diseases and avoiding antimicrobial resistance (AMR). With regard to medical devices, while considering the general evaluation of the medical device regulation currently being performed by the Commission, short-term measures are necessary to address pressing issues to ensure that patients and healthcare practitioners continue to have timely access to the medical devices they need. To this aim, the availability of orphan and paediatric devices should be improved, as well as the access to well-established technologies for which no health risks have been identified. EAHP appreciates the objective of ensuring consistency from a policy perspective, linking this strategy to the Preparedness Union Strategy, the Global Health Strategy. the European Life Sciences Strategy, the White Paper on European Defense and the Strategy on Internal Security; the Critical Medicines Act, the EU Stockpiling Strategy and the Union Prevention Preparedness and Response Plan to be developed in 2025. EAHP strongly calls for also building on the recommendations developed within the Critical Medicines Alliance and for the continuous involvement of hospital pharmacists, bringing their unique competences to multi-stakeholder collaboration with a patient-centred holistic approach.
Read full response

Response to Implementing regulation for electronic instructions for use for medical devices

20 Mar 2025

The European Association of Hospital Pharmacists (EAHP) welcomes the proposed implementing act to increase the use of electronic instructions for use (eIFU), especially through its limitation to medical devices and their accessories intended only for professional use. However, EAHP would like to highlight several key concerns that must be addressed to ensure the safe and effective use of eIFUs by healthcare professionals: 1. It remains of utmost importance to guarantee the privacy and data protection of the user when accessing online instructions for use. Third-party applications or websites should not store any personal information linked to the request to access eIFUs which could indirectly lead to promotional activities. The appropriate application of European and national data protection legislation must be guaranteed and closely monitored; 2. There should be a clear process to ensure that healthcare professionals are made aware of any updates to eIFUs that significantly impact procedure for handling the medical device; 3. There should be a clear process in place to ensure that data are safe and there is no compromise to the information included in the eIFUs such as due to a cyberattack; and 4. Access to instruction for use must be ensured for all healthcare professionals, while many already use the digital version if accessible, not every healthcare provider has the necessary IT infrastructure to ensure a reliable and timely access to eIFUs. Therefore, to ensure an inclusive transition to eIFUs for professional use, businesses should still have to provide a paper manual if requested. EAHP remains available for any further questions from legislators and look forward to further engagement to ensure continued access to instruction for use for all healthcare professionals.
Read full response

Response to Critical Medicines Act

27 Feb 2025

The European Association of Hospital Pharmacists (EAHP) has been at the forefront for addressing medicines shortages and ensure patients access to medicines for over a decade. The Critical Medicines Act has the potential to constitute a major step forward in ensuring access to medicines. Nevertheless, in order to effectively achieve the objective, the Critical Medicines Act should: Incorporate the recommendations of the Critical Medicines Alliance in the Critical Medicines Act. The drafting groups included representatives of civil society, healthcare professionals associations, Member States and industries -coordinated by the European Commission- that worked together to find a consensus. Incorporating the recommendations in the Act, may constitute the basis for a draft that represents more widely shared positions and, consequently, facilitates negotiations and the legislative process thereafter. Adopt a patient-centred holistic approach to ensure that policies and initiatives prioritise patient needs and that are grounded in the improvement of public health services delivered by healthacare professionals, by securing access to at least critical medicines. Deliver tangible results in timely manner in addressing shortages of all medicines, not just critical ones, to ensure comprehensive healthcare resilience. Emphasize effective, transparent and trustworthy information sharing among all relevant stakeholders as to enhance and strenghten coordinated and collaborative actions and solutions across healthcare settings. Rethink procurement models, avoiding the "single winner takes all" approach and procurement decisions based solely on price. Promote the use of MEAT (Most Economically Advantageous Tender) criteria, incorporating environmental and social aspects in procurement processes. Ensure the involvement of key stakeholders, including hospital pharmacists, in public procurement procedures at all levels (European/national/regional/hospital). Hospital pharmacists act as a bridge between patients and suppliers and are often responsible for hospital medicine procurement in many European countries. Their expertise allows them to provide hospital practice data-driven insights based on patient needs, available therapeutic and generic alternatives and on ongoing and past shortages, that could improve procurement efficiency while ensuring compliance with good clinical practices. Strengthen European harmonised and coordinated policies on stockpiling of medicines, in order to enhance supply security. Remove barriers to replacement compounding when a licensed medicine is unavailable on the market, ensuring swift responses to urgent shortages. Enhance API (Active Pharmaceutical Ingredient) production in Europe to secure supply chains and ensure the availability of finished pharmaceutical products. Include concrete measures to implement the List, in order to guarantee the access to the essential treatments. Provide for the development of a list of possible substitutions to support healthcare professionals in managing shortages effectively, ensuring alternative therapeutic options when treatments are unavailable. Include measures to address severe shortages of oncological drugs and other life-saving treatments, by implementing strategies to increase their availability, such as expanding production capacity; providing incentives for pharmaceutical companies considering many of these medicines (e.g., etoposide, fluorouracil) are low-cost and not financially appealing for manufacturers; identifying alternative sites of production and creating a faster approval system for new production sites. In addition to the attached files, the overview of EAHP shortages survey reports are available at the following link: https://eahp.eu/eahp-medicines-shortages-surveys/
Read full response

Meeting with András Tivadar Kulja (Member of the European Parliament)

27 Jan 2025 · European Health Data Space, European healthcare

Meeting with Ariane Vander Stappen (Head of Unit Health and Food Safety)

14 Jan 2025 · Discussion on Antimicrobial Resistance

Meeting with Catherine Amalric (Member of the European Parliament, Shadow rapporteur)

23 Oct 2023 · Reform of the EU pharmaceutical legislation

Meeting with Tilly Metz (Member of the European Parliament) and European Patients' Forum (EPF) and

10 Oct 2023 · Pharma Package

Hospital pharmacists urge preserving information in medicine rule changes

21 Sept 2023
Topic — The European Commission is updating the rules for changing existing medicine marketing authorisations.
Message — The association requests that streamlining regulations does not reduce the data available to healthcare professionals. They emphasize that maintaining detailed product information is critical for patient safety.12
Why — Retaining comprehensive records helps pharmacists avoid increased workloads and ensures treatment accuracy.3
Impact — Patients risk safety issues if streamlined procedures lead to insufficient medicinal information.45
Read full response

Hospital pharmacists urge stronger safety rules and shortage controls

4 Sept 2023
Topic — The European Commission is revising the legislative framework for pharmaceutical products.
Message — The association requests barcodes on primary packaging to reduce errors and warns against removing paper leaflets for out-patients. They also advocate for hospital pharmacists to produce essential medicines during supply shortages.123
Why — This would expand the clinical role of pharmacists and improve safety for healthcare staff.45
Impact — Drug manufacturers would face new burdens regarding mandatory safety plans and shortage reporting.67
Read full response

Response to Unique Device Identification assignment for highly individualised devices

13 Apr 2023

Feedback of the European Association of Hospital Pharmacists (EAHP) to the Commission Delegated Regulation on the assignment of Unique Device Identifiers for contact lenses.
Read full response

Hospital pharmacists urge risk assessment before listing pharmaceutical pollutants

14 Mar 2023
Topic — The European Commission is updating the lists of priority pollutants in surface and groundwaters.
Message — EAHP requests a prospective risk inventarisation before listing medicines to prevent unexpected therapy failure. They also advocate for waste measures and including toxicity information in package leaflets.12
Why — This would empower hospital pharmacists as policy advisors while unlocking EU financial support for their activities.3
Impact — Patients may face health risks if restricted medications cause a shift toward broad-spectrum antibiotics.4
Read full response

Hospital pharmacists urge wastewater rules to protect medicine access

14 Mar 2023
Topic — Revision of EU rules for treating urban wastewater and removing micro-pollutants.
Message — The group requests that hospital pharmacies be exempted from the definition of distributors to avoid liability. They also call for safeguards to prevent wastewater regulations from causing further medicine shortages.123
Why — Exempting pharmacies would protect their budgets from new costs and administrative liabilities.45
Impact — Drug manufacturers would face higher costs and stricter global supply chain reporting.67
Read full response

Response to Vaccine-Preventable Cancers

1 Feb 2023

Feedback from the European Association of Hospital Pharmacists to the call for evidence for an initiative on Proposal for a Council Recommendation on Cancer prevention action to promote vaccination against cancer-causing viruses.
Read full response

Response to Extension of the transition period for medical devices

18 Jan 2023

Feedback of the European Association of Hospital Pharmacists (EAHP) to the Proposal for a Regulation on the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
Read full response

Response to Improving the provision of digital skills in education and training

9 Sept 2022

Feedback of the European Association of Hospital Pharmacists to the call for evidence for an initiative on “Proposal for a Council Recommendation on improving the provision of digital skills in education and training”.
Read full response

Response to Enabling factors for digital education

9 Sept 2022

Feedback of the European Association of Hospital Pharmacists to the call for evidence for an initiative on “Proposal for a Council Recommendation on Digital education – enabling factors for success”.
Read full response

Response to Revision of the Union legislation on blood, tissues and cells

5 Sept 2022

Feedback of the European Association of Hospital Pharmacists to the “Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application”.
Read full response

Hospital pharmacists urge stronger privacy safeguards in health data plan

22 Jul 2022
Topic — The proposal aims to create a secure framework for exchanging electronic health data.
Message — EAHP demands stricter oversight for secondary data use to prevent commercial exploitation. They argue hospital pharmacists must have direct access to patient health records. The association also calls for involving healthcare professionals in the implementation process.12
Why — Universal access to patient records allows pharmacists to improve medication safety and adherence.3
Impact — Patients risk discrimination if data privacy safeguards fail to prevent commercial misuse.4
Read full response

Hospital Pharmacists seek expansion of human-only drug list

13 May 2022
Topic — This policy creates a list of antimicrobials reserved exclusively for human medical treatment.
Message — The group requests expanding the list to include several more antiviral and antibiotic medicines. They argue that restricting these treatments to humans is necessary to fight drug resistance.12
Why — Pharmacists would maintain the clinical effectiveness of critical drugs used for serious hospital infections.34
Impact — Industrial livestock farmers would lose access to specific antibiotics currently used in food production.5
Read full response

Response to Recommendation for strengthened actions against antimicrobial resistance

21 Mar 2022

Attached please find the feedback of the European Association of Hospital Pharmacists to the call for evidence for an initiative on “Antimicrobial resistance – recommendation for greater action”.
Read full response

Response to Requirements for Artificial Intelligence

2 Aug 2021

The European Association of Hospital Pharmacists (EAHP) welcomes this legislation proposal on the ethical and legal requirements on Artificial Intelligence (AI). The proposed regulation lays down a set of harmonised rules for the development, placement on the market and use of AI systems in the Union, this is particularly important (as explained in the proposal) for systems that can pose signifiable risks on the health of citizens. EAHP also recognizes the importance of labelling as high-risk AI systems that can have a significant impact or risk on the health of the user (like medical devices) and the importance of having a set of ethical and legal requirements on the development, placement and use of these devices in the market (adding to all requirements established in the medical devices regulation). However, despite these positive features, EAHP believes that the legislative proposal should be more specific for health-related AI systems and include as high-risk systems all those that interact with patients and are linked with patient’s treatments and research ..or are being used to generate treatment suggestion based on misinformation.. For instance, AI systems that analyse health data to better diagnose diseases. All AI systems that imply the use of health data or have an impact on patients’ treatment whatsoever should be considered as high risk not only the ones that according to the draft regulation can harm or cause a threat to the health of the users. All health-related AI systems should be included as high-risk system or should have a separate set of rules to ensure the correct use of these systems. In addition, the legislation should include a mention to nanomedicine and nanotechnology, when being used to effectively diagnose, treat, and prevent various disease with the support of AI. The proposed legislation does not treat the algorithms used on mobile apps or mobile operating systems as high risk, and it’s important to keep in mind that there are health apps and m-health application that could be linked with AI systems and that should also include as high risk to protect patients and the safety of their data. It is possible that some algorithms used in ad tracking or recommendation engines might be prohibited as manipulative or exploitative practices. The legislative proposal lacks detailed legal requirements on the right for patients to have access to the information processed by the AI systems and to understand the use of their data. The draft regulation is not very concise on the information that must be disclosed to the people who are affected by AI systems. The draft regulation requires that people be informed when they “interact with” an AI system or when their emotions or gender, race, ethnicity or sexual orientation are “recognised” by an AI system. This doesn’t not include all data and interactions that patient can have and provide to AI systems. This shortcoming should be addressed. The proposal allows providers of AI systems to use sensitive data to ensure that there is no bias on the data used and the results provided by the AI systems, but this information and the use of this data is only accessible to regulators upon request. In our opinion the legislative proposal should, however, have a stronger definition and better requirements when it comes to using data from the AI systems, especially for sensitive data like health information. Regarding more technical comments, From EAHP we believe that in page 33 paragraph 68 the conformity assessment needs to be done at the latest 3 months prior the AI system is places in the market. In addition, we believe that the legislation should also apply to AI systems developed for military purposes. Finally, a guidance needs to be included on chapter 1 article 57 to describe the background required for the Board.
Read full response

Response to Commission Implementing Regulation on EUDAMED

22 Jun 2021

The European Association of Hospital Pharmacists (EAHP) welcomes the proposal for the Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed). For healthcare professionals, a swift implementation would be important. Also, it would be interesting and useful to know which modules (or parts of which modules) would be accessible to healthcare institutions.
Read full response

Meeting with Margaritis Schinas (Vice-President) and

16 Jun 2021 · Supply chains for medicines

Response to Electronic instructions for use for medical devices

25 May 2021

The European Association of Hospital Pharmacists (EAHP) welcomes the European Commission’s proposal for the Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices. For healthcare professionals working with this information, it is very useful to have it available electronically. Similar to the procedures established for medicines, any electronic instructions for use of medical devices need to be assessed and accepted by regulatory authorities in the same way that happens with paper instructions.
Read full response

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

Please find attached the feedback of the European Association of Hospital Pharmacists (EAHP) on the combined evaluation roadmap/inception impact assessment for the evaluation and revision of the general pharmaceutical legislation.
Read full response

Response to European Health Emergency Response Authority

24 Feb 2021

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on the Inception Impact Assessment for the European Health Emergency Preparedness and Response Authority (HERA).
Read full response

Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on the “Proposal for a Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices”.
Read full response

Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on the “Proposal for a Regulation seeking to reinforce the mandate of the European Centre for Disease Prevention and Control”.
Read full response

Response to A European Health Data Space

2 Feb 2021

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on "Digital Health data and services-the European health data space".
Read full response

Response to Proposal for a Regulation on serious cross-border threats to health

1 Feb 2021

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on the “Proposal for a Regulation on serious cross-border threats to health”.
Read full response

Response to Revision of the EU legislation on medicines for children and rare diseases

6 Jan 2021

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on the “Inception Impact Assessment for the Revision of the EU legislation on medicines for children and rare diseases”.
Read full response

Response to Green Paper on Ageing

14 Dec 2020

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on the “Roadmap for the Green Paper on Ageing”.
Read full response

Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on the “Inception Impact Assessment for the Revision of the Union legislation on blood, tissues and cells”.
Read full response

Meeting with Stella Kyriakides (Commissioner) and

30 Sept 2020 · Call with pharmaceutical and medical device supply Chain on COVID-19

Meeting with Stella Kyriakides (Commissioner)

22 Sept 2020 · Exchange of views on the upcoming Pharmaceutical Strategy, shortages of medicines and the role of health workforce in the health systems

Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

3 Jul 2020

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on the “Roadmap for the Pharmaceutical Strategy - Timely patient access to affordable medicines”.
Read full response

Response to Europe’s Beating Cancer Plan

2 Mar 2020

The European Association of Hospital Pharmacists (EAHP) welcomes the roadmap for Europe’s Beating Cancer Plan and the goals and objectives outlined within it. Tackling cancer is an important goal to achieve better health and wellbeing in Europe and EAHP appreciates the opportunity to give feedback on the roadmap. Furthermore, EAHP would like to highlight the importance of involving all stakeholders and healthcare professionals in all stages of the process, in order to achieve these objectives as laid out in the roadmap. Both access to treatment and the growing burdens on European health systems are identified in the roadmap as issues which need to be tackled. The involvement of hospital pharmacists in procurement supports the functional, safe, cost-effective and reliable design of the hospital formulary which is essential in order to achieve the goals of the Europe’s Beating Cancer Plan of access to treatment and care as laid out in the roadmap. Hospital pharmacists are also the healthcare professionals who are the most involved in managing medicines shortages in hospitals. As mentioned on page 2 of the roadmap under the heading ‘Problem the initiative aims to tackle’, medicines shortages, including shortages of oncology medicines, can have disastrous consequences, such as delay in treatment, for cancer patients as well as laying unnecessary burdens on healthcare systems as the use of alternatives can be costly and may have detrimental effects on patient outcomes. In light of this, EAHP proposes that Europe’s Beating Cancer Plan should actively address the issue of medicines shortages. Furthermore, EAHP appreciates the emphasis on increased collaboration and teamwork within the health sector and different health professionals. As well as the importance of training of healthcare workers. EAHP would like to highlight the need to ensure that such collaboration includes all health professionals and health actors, including hospital pharmacists, to truly achieve seamless, efficient and patient orientated care. The involvement and recognition of all healthcare professionals in all stages of the process of formulating and implementing Europe’s Beating Cancer Plan is essential in order to achieve the objective of access to the best treatment for all, as outlined in the roadmap. EAHP also welcomes that the roadmap recognises the interconnectivity of the issue with other policies, such as eHealth. Furthermore, EAHP would like to draw attention to the issue of occupational health. Oncological medicines present certain dangers to both patients and to the healthcare professionals who handle them. This should be taken into account when considering the issue of occupational health in relation to Europe’s Beating Cancer Plan.
Read full response

Meeting with Vytenis Andriukaitis (Commissioner) and

22 Jul 2019 · Access to medicines

Meeting with Anne Bucher (Director-General Health and Food Safety)

1 Jul 2019 · • The current medicines shortages situation in Europe; • Our request for an investigation into the causes of shortages; and, • The general need for better information sharing about shortages.

Response to European Electronic Health Record (EHR) Exchange Format

20 Dec 2018

Please find the EAHP's feedback enclosed in the PDF file.
Read full response

Meeting with Vytenis Andriukaitis (Commissioner) and

3 May 2018 · HTA