Preparing for the future
In 2020, EMA made preparations to ensure that it was fit to tackle future scientific and technological challenges and able to deal with new responsibilities.
Regulatory Science Strategy to 2025
EMA published its Regulatory Science Strategy to 2025 in March 2020, following its adoption by the Management Board. Developed over two years in consultation with a wide range of stakeholders, including healthcare professionals, patients, the pharmaceutical industry, academia and regulatory bodies, the strategy aims at advancing regulatory science over the next five years, covering both human and veterinary medicines. It is the Agency’s response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines that combine different technologies.
The COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the EU and globally, which is one of the fundamental principles of this strategy. The learnings from this public health crisis and how the European medicines regulatory network dealt with it will be incorporated so that processes can be adapted in real time, where needed.
The strategy sets out key areas where new or enhanced engagement of the EU network is essential and where advances in regulatory science are necessary. It identifies strategic goals for such engagement for human and veterinary medicines and includes core recommendations and underlying actions to support these.
The five key goals of the strategy include:
- catalysing the integration of science and technology in medicine development;
- driving collaborative evidence generation – improving the scientific quality of evaluations;
- advancing patient-centred access to medicines in partnership with healthcare systems;
- addressing emerging health threats and availability/therapeutic challenges;
- enabling and leveraging research and innovation in regulatory science.
The goals, and the recommendations and actions stemming from them, aim to ensure that regulators can advance public health and that medicine regulation in the coming years is designed in a way that delivers optimal outcome for the European citizens.
Deliverables of the Regulatory Science Strategy continue to be embedded in EMA’s multiannual work programmes and implementation plans of EMA’s scientific committees, working parties and other groups involved in medicine evaluation.
Future-proofing EMA – organisational changes that came into effect in 2020
One of the first concrete outcomes of the Regulatory Science Strategy was the implementation of a new, more agile organisational structure to ensure that the Agency operates as efficiently as possible to deliver high-quality outputs for public and animal health. The changes were implemented in March 2020 and took into account the rapidly evolving landscape for pharmaceutical research and development that requires regulators to keep up with advances in science and technology and prepare for future challenges at an ever-accelerating pace. They were also driven by the need to recalibrate to a reduced workforce following the relocation of the Agency to Amsterdam in 2019, while also dealing with an increased workload due to the pandemic and the implementation of various new pieces of legislation extending the scope of EMA’s activities.
The main, high-level changes were as follows:
Operations in the area of human medicines have been integrated into one Human Medicines Division, which is now led by Alexis Nolte. The structure of the Veterinary Medicines Division, under the leadership of Ivo Claassen, remains unchanged.
In addition, four mission-critical task forces were established to support the human and veterinary medicines divisions, bringing together expertise to drive transformational change in the following high-priority areas:
- The Digital Business Transformation task force is responsible for driving complex, digital change initiatives that have a profound impact on the strategy of EMA, its structure and operations in relation to the network, its partners and stakeholders. It includes adapting EMA operations to fundamental changes brought by legislative initiatives, digital technologies and global trends to meet stakeholders’ needs and expectations throughout the phases of digital business transformation. Zaide Frias leads this taskforce.
- The Data Analytics and Methods task force is responsible for building up capability and capacity within EMA and across the network to deliver robust evidence for benefit-risk decision-making. This will be achieved through a series of projects and initiatives in line with the Big Data Steering Group workplan. These will strengthen scientific advice on products under development, underpin support to marketing authorisation assessments and deliver expert methods advice and data analysis for medicines on the market. All this will be pursued in close cooperation with legal and data protection internal experts to guarantee compliance with data protection ‘by design’ and ‘by default’ principles. Peter Arlett heads this task force.
- The Regulatory Science and Innovation task force enables the continuous ‘future-proofing’ of the Agency and the network by addressing key scientific and technological trends and their translation through the development of EMA’s regulatory science strategy (see above), planning and governance. It also seeks to offer an enhanced first point of contact service to developers, in particular SMEs and academia. This task force is led by Anthony Humphreys.
- The Clinical Studies and Manufacturing task force is responsible for developing and guiding Agency strategy at EU and global level to support the facilitation of clinical studies and manufacturing. Fergus Sweeney leads this task force.
Further reviews and operational changes were introduced in the course of 2020, with the aim of continually improving the quality of EMA’s regulatory and scientific output and level of service for its stakeholders. This included the new structure of the Information Management Division, which came into effect on 1 July and aims to evolve the delivery and maintenance of information systems to be more customer-focused, agile, integrated and innovative and to provide stakeholders with the right information management tools, technologies and services to deliver quality medicines to EU citizens. The division is led by Hilmar Hamann.
Future-proofing: Legal aspects
Regular contacts with the European Data Protection Supervisor (EDPS), DG JUST and DG SANTE’s Data Protection Coordinator were intensified in the second half of the year in respect of topics such as secondary uses of health data, use of real-world data in regulatory activities and use of cloud-based platforms and software.
European medicines agencies network strategy to 2025
The Regulatory Science Strategy also fed into the overarching ‘European medicines agencies network strategy to 2025’, which was developed together with the Heads of Medicines Agencies (HMA), and in consultation with the European Commission and stakeholders to guide the work carried out by the European medicines regulatory network in the coming years.
The strategy was published in December 2020, following its adoption by the EMA Management Board and HMA. The strategy details how the network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.
The COVID-19 pandemic has highlighted the pivotal role of medicine regulation for the protection of public health. Lack of availability of medicines, either because they are not marketed or due to supply disruptions, has shown to pose serious threats to patient and animal health, animal disease control programmes and sustainable livestock production. This strategy ensures that we join forces across the EU to effect tangible improvements for citizens.
The ‘European medicines agencies network strategy to 2025’ outlines six priority areas for the network:
- the availability and accessibility of medicines;
- data analytics, digital tools and digital transformation;
- innovation;
- antimicrobial resistance and other emerging health threats;
- supply chain challenges;
- the sustainability of the network and operational excellence.
It identifies strategic goals for each of these areas, which will be translated into concrete actions in the detailed work plans of EMA and the national competent authorities in EU Member States in the coming five years. Lessons from some recent developments related to the COVID-19 pandemic have been incorporated and further learnings will continue to be taken into account in subsequent work plans on an ongoing basis.
The strategy was open for public consultation from July to September. The extensive and helpful feedback from the consultation, which captured input from a broad range of stakeholder groups, was carefully analysed and reviewed in order to refine and finalise the strategy. Details on the comments received and the network’s analysis of these comments were also published.
The strategy was developed in close collaboration with the European Commission and its key themes are aligned with those covered in the Commission’s Pharmaceutical Strategy (see below), which will provide direction for future pharmaceutical policy for human medicines in the EU.
The network will review the strategy in 2022 to assess whether the goals and objectives remain appropriate, and to adjust them if necessary in the light of the changing environment and ongoing engagement with stakeholders.
Building a European Health Union: EMA’s new role in crisis preparedness and management
In 2020, EMA welcomed the European Health Union package proposed by the European Commission to strengthen the EU’s preparedness for crisis situations and response. The proposals included a possible extension of EMA’s mandate.
The Commission’s proposal for an extended EMA mandate reflects and strengthens several of the structures and processes that the Agency had voluntarily and proactively established to respond to the COVID-19 crisis, for example the coordination of the monitoring of shortages of critical medicines and the creation of a scientific Emergency Task Force that can swiftly advise clinical trial sponsors and medicine developers during public health emergencies. The proposal acknowledged that the work done so far by the Agency together with the national medicines authorities has been effective.
The Commission also proposed a new role for EMA in the medical devices area, including two very specific tasks building on EMA’s experience in setting up systems for the monitoring of medicines and working with scientific experts in various clinical areas, as well as EMA’s important role within the network in the implementation of the medical device legislation. These new tasks include monitoring and management of shortages of critical medical devices and the management of expert panels responsible for conducting the clinical evaluation of and providing advice with respect to high-risk medical devices and in vitro diagnostics.
Finally, the Commission proposed to strengthen the mandate of EMA by providing an explicit legal basis to access and analyse real-world healthcare data and by establishing, jointly with the European Centre for Disease Prevention and Control (ECDC), a vaccine safety and effectiveness monitoring platform.
An Extended Mandate Task Force (EMTF) was set up by the Agency's Executive Board in December 2020 to define the scope of the changes that EMA will have to introduce to implement the new legal mandate foreseen, to analyse the consequences of these changes and to draft a high-level roadmap for its implementation.