he draft European Medicines Agencies Network Strategy EMANS to 2028 has recently been through a public consultation and is expected to be finalized in March 2025, with a workshop with stakeholders planned for February 2025.

In this interview, Melanie Carr and Rui Santos Ivo share their thoughts on why the EMANS is critical for the success of the EU regulatory network and how it will contribute to fostering EU innovation and competitiveness.

The strategy aims to prepare the European medicines regulatory network to handle changes in the field of medicines regulation and focuses on:

• Accessibility: Facilitating access to medicines in the EU
• Leveraging data, digitalization, and artificial intelligence: Improving decision-making, optimizing processes, and increasing efficiency
• Regulatory science, innovation, and competitiveness: Helping improve innovation and competitiveness in the EU healthcare sector
• Antimicrobial resistance and other health threats: Preparing the EU for potential threats including antimicrobial resistance
• Availability and supply: Strengthening availability of medicines to protect public and animal health
• Sustainability of the European medicines agencies network: Ensuring available resources to support its scientific and regulatory decision-making.

Strategy Development

Why is a comprehensive European Medicines Agencies Network Strategy (EMANS) critical for the success of the European Union (EU) regulatory network?

Melanie Carr: Thank you for this question. I think it’s the perfect place to start.

One way to understand the importance of a strategy like this is to look at how the EU medicines agencies network operates.

We are a network of medicines regulators from 27 EU Member States plus EMA. We have thousands of experts working together across the EU, who (among other things) evaluate and monitor medicines, inspect clinical trial and manufacturing sites across the globe, manage shortages, and implement policies to help patients in all EU countries to gain access to medicines they need. And not only do we work together as a network of medicines regulators; we also work in concert with the European Commission and other EU agencies concerned with public and animal health.

And the stakes are tremendously high: The network serves over 450 million citizens in the European Union and the wider European Economic Area. But its impact stretches even further. Our engagement with international partners, including the World Health Organization, means that what happens in the network has global implications.

It is, therefore, important that European medicines agencies work collaboratively on a comprehensive strategy so this unique network of regulators can—as a whole—seize the opportunities we have to promote public and animal health in this changing pharmaceutical landscape.

In fact, the first network strategy was developed back in 2015. Our aim is to ensure a transparent, structured, forward-looking approach to managing the network’s public health priorities. Along with setting measurable goals and objectives, the strategy will keep us accountable and aligned with the evolving healthcare needs within the EU.

Also, this strategy is the result of input from our key stakeholders, which is why it has been released for public consultation. This ensures it genuinely takes into account and addresses the needs of those for whom we work.

And there are several opportunities that would interest our stakeholders: Exciting innovations in research and development, such as advances in precision/personalized medicines; the increasing use of technologies, like artificial intelligence, across a range of functions; opportunities to accelerate access to medicines by working closely with health technology assessment (HTA) bodies; new legislation for public health emergencies enacted in the wake of COVID-19; and the proposed revisions to pharmaceutical legislation in what will be the largest reform of EU medicines regulation in decades. To name a few.

Rui Santos Ivo: These opportunities are, in a sense, a fuel for this strategy which, as you well know, is a review and update of the one which we published four years ago.

In the draft out for consultation, we lay out a vision for 2028 and beyond of an EU where medicines are more accessible and fewer patients and users of animal medicines face shortages or disruptions in supply of their medicines. It is also a vision where the network has kept abreast of advances in digitalization and AI, fostered innovation and competitiveness, and is on a better footing with respect to resources and productivity.

To achieve all this, it is crucial that we harness the skills and resources of the network to the fullest. This is what this strategy enables us to do.

When we started to work on the strategy, we engaged early on with our stakeholders. We genuinely want to ensure that across the six focus areas covered in the strategy we take into account and address the needs of those who have an interest in or are involved in our work.

What has been the most important driver for this strategy update? What are the key new topics?

Rui Santos Ivo: I think it all goes back to opportunities. If we had to pinpoint one, it would likely be the proposed new pharmaceutical legislation. But as mentioned, we have seen important scientific and technological changes over the past few years, and there are opportunities from the HTA Regulation to facilitate access to medicines as well as regulatory changes brought about by the COVID-19 pandemic.

Overall, the focus areas or themes of this strategy are similar to those in the previous one: accessibility; leveraging data, digitalization and AI; regulatory science, innovation, and competitiveness; antimicrobial resistance and other health threats; availability and supply of medicines; and, lastly, sustainability of the network.

But there are a number of important changes of emphasis rather than of content: an increased focus, for example, on competitiveness of the EU in the development and manufacture of medicines; more goals and objectives for artificial intelligence, use of which has recently surged across all industries; and more emphasis on the One Health Approach, which takes account of the fact that the health of humans, domestic and wild animals, plants, and the wider environment (including ecosystems) are closely intertwined.

We should also not forget that we drafted this strategy in a post-pandemic setting and had the chance to draw on the lessons learned from tackling COVID-19 and from the new regulatory tools that emerged.

Melanie Carr: Indeed. One area where the pandemic left its mark in this updated strategy is in public engagement and communication.

The sheer volume of information about COVID-19 circulating in the public sphere showed how much the network must reach out to the public and healthcare professionals. The strategy document makes it clear that public engagement is crucial for the network to deliver on its priorities. People have a right to be adequately informed about the medicines they take, and reinforcing trust in the regulatory system is necessary to counter mis/disinformation and “antiscience” narratives.

How did you manage to align all the stakeholders on the priorities? Were there any specific alignment challenges you wish to share?

Melanie Carr: As this is an update, we are aware and are taking into account the useful feedback we had received during the course of implementation of the previous strategy. We are also aware that many things may have changed over the past years, as may the priorities of some of our stakeholders.

Rui Santos Ivo: Which, of course, is why this public consultation is particularly important. As noted earlier, we are living in a post-pandemic world with new technologies and a changing regulatory landscape. We want to find out from our stakeholders what their priorities are and what has changed over the past few years.

We are interested to see what different stakeholders think about the focus areas of the strategy. We would also be interested to hear in general terms how we can best support the development and manufacture of medicines with the regulatory framework, whilst continuing to uphold the highest standards.

One of the challenges is that different stakeholders can bring different perspectives, and it is not always straightforward to align them. For example, there are sometimes contradictory views on how to facilitate access to medicines and how to meet unmet medical needs. We are planning a workshop with stakeholders early next year to discuss the feedback received during the consultation phase and to provide an opportunity to clarify our views as we finalize the strategy.

On a more practical note, another challenge is keeping the strategy at a high level and focused on those areas that we consider a priority in the coming three years. There will doubtless be requests to include additional elements and more granular/operational information.

The Vision: What Will the Future Look Like After Implementation?

How will the strategy contribute to fostering EU innovation in the global medicines market?

Melanie Carr: The key plank of our strategy to boost innovation in the EU is increasing the support we provide to developers. Not only large companies but particularly smaller developers: clinicians, academics, small and medium-sized enterprises (SMEs), research groups, incubators, and others.

The EMA has established a dedicated workstream to accelerate the development and innovation of medicines and related enabling technologies via its Innovation Task Force (ITF), working in close collaboration with the network. Dedicated offices for SMEs and academia further ensure targeted support for specific stakeholders. The network also provides many other tools to facilitate and promote innovation and collaboration in a regulatory context, such as the Quality Innovation Group, the EU-Innovation Network (EU-IN).

We will also continue with the PRIME program through which we specifically support the development of medicines that target unmet medical needs. Accelerating Clinical Trials in the European Union (ACT EU) is another initiative that will support smarter clinical trials.

New areas in the EMANS 2028 include regulatory science and competitiveness where further investment and development support is expected.

There are also opportunities in the proposed new pharmaceutical legislation to boost innovation through the use of adaptive frameworks, establishment of sandboxes, and implementing platform technology approaches.

You see that we have a number of ways to provide support, and this support will increase in the coming years as part of our innovation drive.

The strategy aims to create a supportive environment that not only drives scientific progress and innovation but also ensures that innovative treatments are accessible, safe, and beneficial to the EU population.

How will the strategy contribute to fostering EU competitiveness in the global medicines market?

Rui Santos Ivo: Competitiveness is inextricably linked to innovation. If we innovate more in the EU in terms of medicine development and manufacturing, we can better ensure that patients can access the medicines they need.

In addition to supporting individual developers, we can improve EU competitiveness by looking to see how we can create a more conducive environment for developers, one in which there is more predictability, which encourages the long-term investments required for medicines development. This is also an important part of the strategy.

How do you see it changing the pharmaceutical R&D landscape in the EU?

Rui Santos Ivo: I think the EU is in a good position, actually. Globally, we are a leader in the development and regulation of medicines, and we have a strong research base. Our strategy to boost innovation and create an optimal environment will, we hope, further improve the EU’s position. We also hope to better nurture talent here in the EU while attracting investment from outside the EU.

Ultimately, from the network’s perspective, the push for innovation and competitiveness is a public health objective that will lead to better health outcomes for patients in Europe and around the world.

Next Steps

How will EMA and Heads of Medicines Agencies (HMAs) consider feedback from other stakeholders?

Melanie Carr: When the consultation ends, EMA and HMA will consider the feedback from the public carefully, looking at common themes and specific recommendations as well as the general criticisms (or praise!) about the strategy.

We have a group of HMA/EMA experts who developed the strategy. The group will see what changes should be made based on the comments received. In terms of how we will consider them, it really comes down to how the suggestions can promote public and animal health, how relevant the recommendations are to the focus areas covered, and, of course, how feasible they are to implement.

How will the EMA and HMAs prioritize next steps and ensure resources to execute them?

Rui Santos Ivo: You raise important points here. While the strategy outlines the network’s main goals and objectives, some of which may be amended after the public consultation, we are working on an action plan for implementing them via our respective multi-annual work programs.

The current goals and objectives are all priorities, as they impact public health in different ways. But some of them can be achieved early, while others require work with other organizations, like HTA bodies, or will be finalized as part of the new pharmaceutical legislation. We can say that our action plan will consider what can be done at an early stage and what needs preparatory work for longer-term implementation.

As for resources, the need for more resources but also the need to deploy them effectively, streamlining our procedures and making the most of new technologies, is highlighted in the strategy. Implementation of the strategy will be closely monitored by our HMA/EMA coordination group.