We see this dynamic very positively and as an opportunity for patients in the EU. The pandemic has enormously accelerated certain developments in the healthcare sector - let‘s just take the example of digitalisation. At the same time, it has become clear how much cooperation in the EU network matters, for example, in that we can access shared data. Ultimately, new forms of collaboration have emerged that benefit everyone – such as the creation of a digital EU database around supply shortages, which facilitates exchange between the EMA and the national competent authorities. Our common goal is therefore to use this momentum to translate our insights into sustainable systems and processes.

Our regulatory network is a collaboration model, so whether we are in a crisis or not, the collaboration continues. During the pandemic, our work with EU partners and national regulatory authorities was astounding: we collaborated, adapted, and accelerated our processes, both proactively and when we were required to do so. The key is to make sure that the spirit and energy behind that collaborative effort across the EU doesn’t get lost as our work returns to ‘normal’. Medicines regulation is no less important now and new challenges are always emerging such as medicines shortages, antimicrobial resistance and more, which require the same collaborative effort. We know that we can achieve much more when we work effectively together.

The extended mandate has not changed the basic system for regulating medicines in Europe. In it, the EMA, just like the BfArM, is a member of the network of the heads of the national competent authorities, abbreviated as HMA. In it, we jointly use our resources and expertise to ensure good healthcare in Europe. As society changes and evolves, we must also evolve to fulfil this mission in the best possible way. For example, the fact that the EMA will play a coordinating role in defined crisis situations will benefit everyone. Ultimately, after all, the national experts work in the EMA‘s committees - including those that come into being as part of the extended mandate. So this is not about taking competencies away from national authorities. Rather, we are talking about how we can organize our work even better in the future, how we can coordinate optimally in times of crisis. In this way, the expanded mandate has a tangible effect on rapid and efficient exchange.

The pandemic showed the best side of our network in action: we pulled together all our expertise, adapted our processes and collaborated with our EU partners to roll out the largest immunisation program in European history. This couldn’t be done without a central coordinating body. The extended mandate recognises the way EMA adapted to the pandemic and took on new responsibilities such as the handling of medicines shortages and crisis coordination. It doesn’t remove decision-making powers at the national level, but enhances our ability as a network to collaborate and coordinate our efforts during ongoing crises and ensure we, collectively, are better prepared and ready for future crises.

AI has a broad spectrum of applications and the potential to impact EMA’s internal processes and the entire product lifecycle. As it plays a bigger role in the development of medicines, we anticipate changes to the content of the marketing authorisation applications of the medicines we approve, but also opportunities to improve the efficiency of our procedures and some of the associated administrative work. As regulators, our role is to ensure that the benefits of AI outweigh the risks and continuing to make sure we put patient’s health first. As we continue to see more AI usage in medicines development, patients will look to us for assurances. We will always need our national experts to help guide the uptake of AI to ensure safety is embedded as the technology evolves, and the benefits of AI are clear to everyone.

There are particular challenges around the use of AI. We are talking about the development of medicines and ultimately patient safety. The processes are characterized by a high degree of dynamism. Accordingly, we as national regulatory authorities are also constantly adapting our instruments and approaches. The BfArM is in dialogue with the relevant players, and we clearly see ourselves as a driver at the EU level. Of course, cooperation with the EMA is crucial. At the end of the day, we all have a common goal and want to achieve the best result for the care of the EU population. In the future, this will only be possible with the input of all national experts.

The use of AI in drug development is something new for all of us and brings with it a corresponding complexity. In order to act optimally at the EU level, early interaction with the national regulatory authorities and the EMA is an important building block. For example, in the “HMA-EMA joint Big Data Steering Group”, set up by the HMA and EMA. It advises on priority setting and action planning. The aim is to increase the benefits of data and AI in regulation - from data quality and study methods to evaluation and decision-making.

EMA is working with our partners in the EU, and internationally, to bring the full potential of AI tools to benefit all patients in the EU. Our national experts are central to this effort. We are working closely together as a network – using our full expertise – to make the most out of the opportunities it brings. Rather than waiting to see how AI disrupts our work; we are embracing the opportunities that AI can bring to our work and processes, and ultimately, to the lives of patients in the EU, while ensuring appropriate guardrails are in place. It is not a question of applying AI, but further developing AI and AI-specific capabilities across our whole network.

Our goal as regulators is to ensure patients have access to safe and effective medicines. The revision of the EU pharmaceutical legislation is a unique opportunity to reshape medicines regulation in the EU. It will help enable us to rationalise the use of the limited resources in the network and to deal more effectively with complex regulatory processes as a basis for a futureproofed system. What the European Commission has put forward is an EU regulatory framework that is fit for innovative medicines, promotes greater access to medicines for patients, and addresses the major public health challenges of the future.

Our current pharma legislation is not fit for purpose for the new challenges. So I fully agree with Mrs. Cooke that we must reshape medicines legislation to address adequately new approaches, new methods, and the use of big data and AI in all stages of drug development and surveillance to make the best out of this for patients. Working together on this will provide us with a competitive regulatory framework compared to other regions. It should also increase availability, access and affordability of medicinal products as well as fostering diversification of production and reducing risk of shortages – all in the interest of patients. So I can reassure you, we recognise the need for change and our network is eager to change to fulfil our mission even better – the new legislation should set the framework for this.