European Medicines Agency executive director Emer Cooke speaks to Gerry Hughes about the areas where hospital pharmacists can have the greatest synergy with the European medicines regulator and reflects on the regulatory structures in place to support that contribution and optimise patient care across the continent.
Set within the continuously evolving medicines and therapeutics landscapes, the interface between regulation and service delivery in secondary healthcare has never been so important. Hospital pharmacists sit squarely at this interface, shaping medicines stewardship, and acting as trusted conduits of real-world medicines use data back to regulators.
The pipeline of advanced therapy medicinal products (ATMPs) is expanding rapidly, and hospital pharmacists are expected to play a central role in their safe and effective use. Emer Cooke, pharmacist and executive director of the European Medicines Agency (EMA), emphasises the need for proactive preparation in this area, particularly in education and workforce development.
‘This is something where I think training is definitely going to be needed,’ she says. ‘There is a position paper from the European Association of Hospital Pharmacists (EAHP) on ATMPs, which really calls for better education and training – and training materials – and calls on pharmacy schools and professional body bodies to offer this education.’
Meeting the challenge of ATMPs in hospital pharmacy
Hospital pharmacies are already encountering ATMPs in practice, and the trend is set to continue. ‘We’ve authorised 30 of those so far and we’re expecting around 20 more between 2025 and 2027,’ Ms Cooke notes.
To prepare, hospital teams are being encouraged to align their training and operational planning with European initiatives. Ms Cooke highlights the importance of hospital pharmacy representation in shaping readiness for ATMPs. She cites the European Society of Oncology Pharmacy as an active stakeholder in the Accelerating Clinical Trials in the EU (ACT EU) multi-stakeholder platform.
This initiative is part of the EU’s broader effort to modernise and streamline clinical trials across the region. ACT EU serves as a collaborative vehicle for regulators and clinical trial stakeholders, including hospital pharmacists, to share perspectives and co-develop improvements to the research environment.
It aims to transform the EU into a region that supports clinical trial development and fosters innovation at every stage of the research lifecycle, ultimately delivering more impactful trials and better outcomes for patients and healthcare systems.
‘The eyes and ears of medicines performance’
Hospital pharmacists’ proximity to complex patients and multi-drug regimens places them in a unique position to contribute to post-marketing safety and effectiveness. As Ms Cooke explains, ‘hospital pharmacists are probably the best contributors, or should be the best contributors, to our pharmacovigilance system because they see a broad range of products and have direct patient contact’.
This perspective is already being embedded into regulatory structures, with the EMA’s Pharmacovigilance Risk Assessment Committee Risk Minimisation Alliance working to make risk minimisation measures more effective.
‘Again, we have an EAHP representative in this group, and it really helps us to ensure that we’re getting the feedback from the hospital pharmacy perspective to inform our regulatory thinking,’ Ms Cooke explains.
In many ways, she sees hospital pharmacists as the eyes and ears of medicines performance in the real world. ‘We would like to see what’s happening in practice,’ she says. ‘Safety information is one thing, but experience on the real-world use is also very valuable.’
This is where data standards are emerging as a critical element to pharmacovigilance. The Data Analysis and Real-World Interrogation Network – known as DARWIN EU – delivers real-world evidence from across Europe on diseases, populations and the use and performance of medicines. It enables the EMA and national competent authorities to access high-quality, validated data throughout the lifecycle of a medicinal product.
Ms Cooke advises that hospital pharmacy teams preparing to contribute to this work should ensure that local electronic health record systems are aligned with recognised common data models and metadata standards. She notes: ‘I think it’s important that hospital pharmacists are aware of this and also of the importance of data standardisation, because the real challenge for us is, if you want to collate the data and you want to analyse it, you have to have it in a compatible data format.’
Hospital pharmacists and medicines shortages
The Covid‑19 pandemic exposed the urgent need for coordinated action on medicines shortages, not only across Europe, but globally. Under new EU regulations, the EMA now holds expanded responsibilities to monitor and respond to critical shortages that could lead to crisis situations.
Ms Cooke describes the EMA’s early work on drug shortages as an ad‑hoc network formed during the pandemic to share intelligence on essential products and cross‑border stock movement. This has since evolved into a formal structure, the Executive Steering Group on Shortages and Safety of Medicinal Products, designed to ensure a robust and timely response to supply issues caused by major events or public health emergencies.
Shortages remain a persistent concern for hospital pharmacy practice. Ms Cooke outlines how the EMA is working proactively with pharmaceutical companies to develop shortage prevention and mitigation plans.
‘If there are more embedded shortage problems across many member states, the EMA will do a deeper dive and come up with recommendations, which could be, for example, regulatory flexibilities, it could be to increase the manufacturing capability of the suppliers, it could be to look for sources outside the EU,’ she says.
One mechanism designed to support EU member states facing acute shortages is the voluntary solidarity mechanism. ‘If one country has a shortage of a particular product, they can request us to launch this procedure to see if stocks might be available and might be able to be moved from another country to their own country,’ Ms Cooke explains.
A collaborative medicines shortage response
The EMA’s approach is rooted in collaboration with interventions being co‑designed with stakeholders, including patient organisations. They recently held a public webinar for patients, consumers and healthcare professionals to explain EU regulatory processes for managing shortages, provide access to reliable information, explore collaborative prevention strategies, and gather stakeholder feedback.
In parallel, the EMA has launched a new awareness campaign, with the tagline #ItTakesATeam, in conjunction with various European healthcare professional and consumer organisations including EAHP and its community pharmacy counterparts. The campaign highlights the shared responsibility for preventing and managing shortages across the EU.
Commenting on its launch, Ms Cooke says: ‘The campaign aims to showcase the coordinated system that is needed at EU level to address shortages, but it also represents a step forward in how we engage with healthcare professionals and patients.’
She also emphasises the vital role pharmacists play in supporting patients during shortage periods. ‘Pharmacists can reduce stress for patients by reassuring them when their usual product is not available and they need to change, saying “this may not be what you’re used to, but it still works”.’
Hospital pharmacists and antimicrobial resistance
Antimicrobial resistance (AMR) remains a pressing healthcare challenge, and hospital pharmacists are uniquely positioned to support stewardship efforts through education, surveillance and regulatory feedback.
‘AMR is one of the examples where it is not so much a regulatory issue, [but] pharmacists, prescribers and patients need to work in a synchronised way,’ says Ms Cooke. ‘The big role in hospital pharmacy is education and awareness of the risks.’
This includes not only promoting appropriate use but also contributing to the development and evaluation of new agents, which is where the EMA comes in.
The European medicines agencies network strategy to 2028, titled ‘Seizing opportunities in a changing medicines landscape’, includes AMR as a priority theme. It highlights the need to refine preparedness activities, coordinated through the network’s Emergency Task Force, to avoid public health emergencies.
Given the limited commercial viability of last-resort antibiotics, the European Commission, through the upcoming revision of the pharmaceutical legislation is exploring incentive models such as a ‘transferable voucher’ system, which would allow developers to extend patent protection on other products.
International collaboration is also underway, with the EMA working with Japan, Health Canada and the FDA in the US to look ‘at guidance in some specific areas of development of antimicrobials’.
Hospital pharmacists are central to this effort and Ms Cooke says their contributions cannot be overstated. ‘They know what AMR does in practice and they have a key role in translating stewardship into regulatory intelligence that can help us do what we need to do,’ she says.
A strategic partner in medicines regulation
Hospital pharmacists are at the vanguard of translating medicines regulation and policy to safe and effective practice and bridging frontline insight into the heart of the EMA. Their proximity to patients, clinical teams and operational realities makes them uniquely positioned to do so.
As Ms Cooke puts it, ‘hospital pharmacists have a critical role to play in helping us shape the regulatory environment’ and in ensuring that first-use experience informs future policy and product development’.
Hospital pharmacy is increasingly recognised as a strategic partner in medicines regulation. The next five years will demand even closer alignment between regulators and patient care and hospital pharmacists are already leading the way.
