Written by Gianluca Quaglio with Virginia Mahieu,
Across the board, the message is clear: the Covid‑19 pandemic has shone a spotlight on the need for better EU policies for public health, especially in relation to diagnostic testing and the sharing of healthcare data. Indeed, this was the subject of a recent STOA workshop, which featured discussions on – but not limited to – the impact and challenges of the new in vitro diagnostics regulation (IVDR) and the Commission’s proposal for a European Health Data Space (EHDS).
The event, held online on 22 April 2021, was jointly organised by STOA, the Biomedical Alliance in Europe (BioMed Alliance), the European Hematology Association (EHA), the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), and the European Society of Cardiology (ESC). It included speakers from a range of backgrounds, including policy-makers, experts from the European Commission and health professionals representing medical associations.
Alexandra Geese, Member of the European Parliament (Greens, Germany) and STOA Panel member, opened the workshop, noting that the coronavirus pandemic has highlighted the importance of science in public life, and the need for policy decisions and regulatory systems to be guided by scientific and clinical evidence. Scientific input is crucial to ensure that health policy initiatives can lead to better public health and enhance resources for patients. The trend has been accelerated greatly by the need for a shared response to the Covid‑19 pandemic, and by the unprecedented investment announced for the EU4Health programme.
Andrzej Rys, Director for Public Health and Risk Assessment at the Directorate-General for Health and Food Safety (DG SANTE) of the European Commission then outlined the current and future EU health agenda. He introduced the two new implementing regulations on medical devices and in-vitro diagnostics (MDR and IVDR), as well as the main initiatives currently in progress: the EU Pharmaceutical Strategy, pointing out the need for a holistic approach covering the full lifecycle of medicines, the new EU framework for cooperation on Health Technology Assessments (HTA), and the Health Union Package. The main goal of this last initiative is to strengthen the EU’s health security framework, and reinforce the crisis preparedness and response capacity of key EU agencies, the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA).
He also introduced some items from the Commission’s upcoming legislative agenda, highlighting the plans for the EHDS, which aims at implementing a timely and simplified exchange of and access to health data for different uses (healthcare provision, digital health services, pharmacovigilance, public health, research etc.). He also emphasised the need to put the Beating Cancer Plan into practice, strengthening the EU approach at every key stage of the disease: prevention, diagnosis, treatment and survivorship.
Impact of changes under the new in vitro diagnostic medical device regulation (IVDR)
The first part of the online meeting focused on the new medical devices regulation (MDR) and IVDR and how they differ from the previous directives in place. Olga Tkachenko, from the DG SANTE Unit for Medical Devices and Health Technology Assessment and chair of the In vitro Diagnostics Working Group, described the three themes that the new IVDR brings to diagnostic devices used in clinics: higher standards of evidence, transparency and traceability, and harmonisation. She explained the current state of authorisation of the notified bodies (i.e. the companies that are designated to perform conformity assessments) needed to support the stricter requirements of this new regulation, but noted a thus far worrying lack of applications from manufacturers for their IVD devices to be evaluated under the new regulation.
Perspectives from physicians representing medical associations were then shared as to how the IVDR will affect patients and diagnostic specialists, with particular emphasis placed on the provisions for in-house diagnostic devices, also referred to as lab-developed tests (LDTs). Christa Cobbaert, from EFLM, supported the overall goal of the IVDR, which is to improve the clinical effectiveness and safety of medical tests for improved patient outcomes. She noted that the stricter requirements for medical device registration will put an administrative and financial burdens on both manufacturers and end-users and may impact the timely delivery and availability of these tests in clinics. It could also hinder testing innovation and precision diagnostics, especially for rare diseases. She added that, although LDTs are exempt from evaluation by a notified body under the IVDR, labs will be required to use commercially-approved (CE) tests when available and this could endanger the flexibility of labs to repurpose their own tests when needed, which was a cornerstone of the early stages of Covid‑19 testing. Christa Cobbaert asked that the Commission provide a transparent contingency plan, with EU-wide flexibility for derogations.
Elizabeth MacIntyre from EHA, explained that high-complexity diagnostic assays are frequently developed in-house, and that, as these tests are rarely used, they are less interesting to the commercial sector and as a result only a few are CE-marked. However, when they are needed, they are vital for patients. She expressed concern that, due to the strictness of the IVDR, some of these tests will disappear from the commercial market. As the use of LDTs must be justified if no alternative CE-marked test is available, this will increase workload and potentially delay patient treatment. She commented that she hoped the increased costs and workload will be offset by the benefits of the IVDR.
More evidence-based EU policies for health: the cases of the European Health Data Space, Health Technology Assessment and artificial intelligence in medicine
In the second part, several EU initiatives relevant to health policy were presented within specific case studies providing examples of how these initiatives are viewed by European medical professionals and how they may impact clinical practice.
Iona-Maria Gligor, Head of Unit at DG SANTE and responsible for Digital Health and European Reference Networks, presented the draft plans for the European Health Data Space (EHDS), the public consultation for which will be launched soon. She described the Commission’s legislative proposal in four pillars: (i) sharing of health data for healthcare, and improving the limited interoperability between healthcare providers; (ii) consolidating the use of health data in research and policy-making, refining cross-border access to health data, and strengthening digital infrastructures; (iii) supporting a single market for digital health services; and (iv) promoting the development and rollout of artificial intelligence (AI) in health and medicine and supporting regulators to evaluate AI algorithms.
In relation to this issue, Frank Rademakers, from University Hospital Leuven, discussed the role of AI in healthcare policy, which is increasing due to the massively increasing amount of data becoming available. He stressed that one of the most important aspects of the upcoming EHDS proposal will be the interoperability of the system. Similarly, data ownership and standardisation will be paramount to training AI algorithms, and involving stakeholders in developing these working guidelines to mitigate risk. Aldo Maggioni, Director of the Research Center of the Italian Association of Hospital Cardiologists (ANMCO), discussed several real-world case studies in which the EHDS could support clinical practice and thereby guide policy-making, by defining target populations for new therapeutic approaches, undertaking post-market surveillance of drugs and devices, and providing a platform to conduct randomised clinical trials.
Another topic where more evidence-based EU policies for health are needed, was presented by Piotr Szymański, from ESC. He discussed the scientific and clinical rationale for a health technology assessment (HTA) tool to support clinical decision-making – HTA is an evidence-based process to evaluate the effectiveness of new and existing medical technologies from both a physician’s and a patient’s perspective, in order to guide correct decisions on pricing and reimbursement. It is active over four clinical domains: diagnosis, technical characteristics, clinical effectiveness, and safety. The EU-wide implementation of this process will avoid duplication of efforts and improve the functioning of the EU single market.
In his closing remarks, Member of the European Parliament and STOA Panel member Tiemo Wölken (S&D, Germany), reiterated the timeliness and importance of the topics discussed in the workshop, and noted the full and ambitious EU legislative agenda in this field. He commented that, although the new IVDR will involve stricter requirements aimed at improving patient care, policy-makers are aware of the concerns regarding the challenges in its implementation. He argued that the EHDS will promote better exchange and access to data, but clear rules on liability and interoperability will be key to ensuring the benefits of digital health. Finally, he noted his appreciation for the upcoming HTA proposal, which will speed up and improve access to new medicines and medical devices for patients, ensuring equal access across the EU.
The full recording of the workshop is available here.