«The main issue is the need for a harmonized application of the GDPR-principles in the EU member states. The EHDS could offer a way out, based on a well-thought-out system to facilitate the availability of data, and not to make it more difficult».
This is the hope expressed by Frank Vandenbroucke, Deputy Prime Minister and Minister of Health and Social Affairs of Belgium, who is leading the last European semester before the June elections.
In an interview with TrendSanità, Vandenbroucke discussed the major challenges that the European Union will face in healthcare: in addition to data usage (for which an agreement was reached in mid-March), the shortage of drugs and personnel, the pharmaceutical reform, and the AI Act.
The European Health Data Space
Starting with safe use of patients’ data: why managing the GDPR is so complex for health data and what could be done in this field?
GDPR offers a legal framework for primary and secondary use of health data.
The conditions for primary use by healthcare professionals include healthcare, and therefore GDPR offers a proper ground for EHR systems of healthcare professionals and health care institutions.
However, sharing of data between healthcare professionals, also in a cross-border context, is difficult to realize on the basis of the informed consent by the person for a specific set of data, for a specific purpose and for a specific data user. A generic and ethical consent that applies in the context of the deontology of (health) care professionals would have offered more flexibility, with the extra condition that a treatment relationship (under control of the person concerned) is a condition qua non before the healthcare professional can have access to certain well defined, standardized and interoperable priority categories of shared health data.
For secondary use, there is the possibility to use anonymized or pseudonymized data for public interest and scientific research, and the right to object based on a proper motivation if a person doesn’t agree with the usage of his/her data. The main issue is the need for a harmonized application of the GDPR-principles in the EU member states. The EHDS could offer a way out, based on a well-thought-out system to facilitate the availability of data, and not to make it more difficult.
How can we balance the patients’ right to decide about the use of their personal data and the importance of these data for scientific research, for example in the rare diseases?
Based on the EHDS negotiations, it is the vision of the member states to make all health data available for scientific research and public interest statistics under the GDPR conditions of preserving the non-identification principle of a person. Also the EU Parliament adheres this vision, but additionally wants to offer a harmonized opt-out possibility for citizens, preventing their data being available for scientific research or for public interest statistics. Especially in case of rare diseases, this could limit the quality and volume of the research data. Therefore, the use case of rare diseases deserves our special interest and will be used as one of the most important examples of research that should be facilitated.
What do you think about the European Data Space? Does it help a better sharing of patients’ data?
Yes, the EHDS should help to ensure the availability of health data for primary and secondary use, while empowering EU citizens and healthcare professionals in having access to data and services necessary to offer high quality and continuity of healthcare also in a cross-border situations.
Ensuring standardization of data, harmonization of processes, interoperability of services and EHR-systems, infrastructure for the exchange of data, processing and permitting the data exchange, will contribute largely to the availability of health data, enabled by services put into place by the Commission.
Under the new rules, individuals will have faster and easier access to electronic health data, regardless of whether they are in their home country or another member state. They will also have greater control over how that data is used.
EU countries will be required to set up a digital health authority to implement the new provisions. Member States may allow patients to opt-out on the use of their health data being accessed by a healthcare professional.
The EHDS will also provide researchers and policy-makers with access to specific kinds of secure health data, enabling them to tap into the vast potential provided by the EU’s health data to inform scientific research in the public interest. Member States shall put an opt-out mechanism in place for the further processing (secondary use, always under strict conditions), except for purposes of public interest, policy making, statistics and research purposes in the public interest
Currently, the level of digitalization of health data in the EU varies from one member state to another, making it more difficult to share data across member-state borders.
The proposed regulation requires all electronic health record (EHR) systems to comply with the specifications of the European electronic health record exchange format, ensuring that they are interoperable at EU level.
The Belgian experience
Belgium has recently launched a national health data agency to facilitate access for secondary use of data: how does it work and what is your opinion about that?
In the coming years, the Health Data Agency (HDA) will focus on facilitating the availability of health(care)-related data and developing and implementing a policy strategy with regard to this data in order to support scientific and policy-supporting research and innovation. The framework for this is the EHDS regulation on the European Health (care) data space.
If our citizens make their data available, then they should get some return in better health and healthcare
This agency aims to be a unique point of contact for sharing and making health (care) data accessible in a GDPR-compliant manner. It will play a key role in a data-driven healthcare system. This will be done in a uniform, transparent and secure manner, in close collaboration with data suppliers and users.
We are investigating, together with the federal entities, how we can also give the Health Data Agency an interfederal role.
An integrated federal and interfederal initiative is really necessary to
- outline a vision and a long-term health care policy, focused on scientific evidence
- to organize a policy that focuses on sustainable changes in the way we organize our care
- to achieve a policy that focuses on healthcare investments that – both in the short and long term – contribute most to health gains, accessibility, quality and efficiency
Of course, all this can only be successful if citizens believe in this approach. But it doesn’t stop there: only by communicating transparently, providing information and explaining to citizens and patients why this is so important – for example for the development of new therapies – can a relationship of trust be built.
The industry, which is active in the field of life sciences, medical technologies, and digital health tools, bears a great responsibility to clearly demonstrate and help ensure that return on investment for our citizens and for the “common good”. That there is confidence in the use of their healthcare data.
If our citizens make their data available, then they should get some return in better health and healthcare.
The medicine shortages
What are your plans to cope medicine shortages in Europe? How having the Critical Medicines Alliance can help?
Let me begin by taking a step back. One year ago Belgium was facing a dangerous shortage of thrombolytics. We could no longer guarantee availability at all hospitals. We needed to centralise stock. At one point, we only had enough supplies for the next two weeks because there were no thrombolytics on the market that money could buy. I’m not sure if you know this, but thrombolytics must be administered within four hours of thrombosis. If a hospital must wait for the thrombolytic to arrive from another location, it may be too late and the patient could die. This is what we were scared of at that time: patients dying because of medicine shortages.
Our medicines agency was working day and night to contact companies and other member states to find even the smallest supply of thrombolytics. Finally, France stepped in to help us out. The European Medicines Agency (EMA) helped us look for alternative suppliers, for which we are eternally grateful. We are now one year since that crisis moment, and we are still not safe. We are no longer in an acute situation, but we also do not have the long term security we need. This is the reality that most health ministers face today.
We all want the same thing: more security for our citizens. And we all know the same thing: we cannot achieve this alone
What I want to convey is this: Europe has changed tremendously in the past year. One year ago, the EU was not a big player in the issue of shortages. Medicines are mostly national competency. It were mostly the national medicines agencies who had to solve the issues, with the EMA and the Commission playing interlocutor roles.
Since then, we have seen that Health ministers, the Commission and the EMA really come together to address common issues. It’s one of the good things that came out of the pandemic. During the anti-Covid vaccine race, we saw that the EU has the potential to achieve great things. There is a high level of solidarity between governments and a willingness to think outside the box. Most importantly, traditional differences between small and large countries, as well as East and West, hardly matter in the discussion on shortages. We all want the same thing: more security for our citizens. And we all know the same thing: we cannot achieve this alone.
In the run-up to its Presidency, Belgium wrote a non-paper supported by 23 member States that contained three action points:
- to establish a voluntary solidarity mechanism
- to create an EU list of critical medicines and to map vulnerabilities in supply chains
- to launch a Critical Medicines Act
The Commission and the European Medicines Agency reacted quickly, and came forward with a Communication which announced a whole battery of actions. The difference this made already shows today.
You’ll remember from my thrombolytics example that last year, our medicines agency had to call every member state separately to find thrombolytics. Today we have a solidarity mechanism in place, to prevent citizens from suffering serious damages because of shortages. Any member states who faces an acute problem now contacts the EMA, and within 5 days you will have the first reactions from other member states. Within the first 10 days, you should have had some help. This is how the EU protects people: by organizing collective action.
Last year, we were still discussing at the European level in what circumstances a medicine should be seen as critical. Today, we have an EU list of around 200 critical medicines. The vulnerability analysis for the medicines on this list is well underway; the Commission and the MSSG have selected the first few medicines that will be analyzed.
Last but not least, the Belgian Presidency and the European Commission will launch a Critical Medicines Alliance on 24 April, which will prepare concrete action plans to diversify supply chains and support European production, based on the evidence provided through the vulnerability analysis.
This Alliance is the world’s first major partnership between governments, industry and civil society to address the structural issue of medicine shortages, and the question of overdependence.
Not even the US, a country which is traditionally quite advanced when it comes to health security, has a partnership like this. We are regularly in contact with US counterparts and they are keen on what we are doing. I would say Europe now really has taken charge of the problem of medicine shortages.
The pharmaceutical reform and the AI Act
The review of pharmaceutical legislation will not be approved before the end of the legislature. Is it a problem for European citizens? And for industry?
We knew that the co-legislators would not be able to finish negotiations on the pharmaceutical legislation before the end of the legislation. The legislation is simply too important and too complex to rush through in a mere few months. It’s better for European citizens and industry to have a good piece of legislation that ensures the quality, availability and affordability of medicines than to have legislation that was written hastily and for which we discover all sorts of problems afterwards.
Europe is approving the AI Act: what do you think about it, regarding consequences on health field?
Medtech Europe claims that it is shown that AI in healthcare could save around 400 000 lives annually and up to 200 billion Euros in Europe. We also believe that safe, high-quality, and trustworthy AI in medical technologies, decisions support systems, wearables and other devices and applications will improve healthcare, prevention and patient outcomes. A regulatory framework that supports innovation and research and the availability of data to train AI systems is hence necessary.
The AI Act should facilitate innovation, create a level-playing field and maintain our international position while ensuring the protection of fundamental rights.
The health workforce shortage
An other big problem is the doctors and nurses’ shortage: after pandemic all Europe is facing a problem with their number but also with their salary and work-life balance. A lot of them are migrating: how do you see the issue and what might be the solutions to safeguard both the reward of professionals and the right to care of patients?
To face the health workforce crisis, we need policy action at all policy levels: national, European and international. Providing high quality healthcare services to the population is primarily a responsibility of Member States. This includes ensuring that sufficient health professionals with the right skills are available. But Europe has also a role to play.
To address the challenges, the Belgian presidency intends to put on the EU agenda the development of a comprehensive EU health workforce strategy. This strategy should encompass two broad areas:
- Initiatives to support national health workforce strategies, for instance on: recruitment, training, continuous professional development, skill mix, retraining, working conditions and retention
- Secondly, an evaluation and possibly a revision of the EU legal frameworks regulating health professionals, in particular the Professional Qualifications Directive (PQD), in order to better adapt them to the changing needs of health systems. Even the EU legal frameworks offer a series of solutions, they also limit the policy space of national authorities, e.g. by overlooking variations in training programs, professional competencies, and the specific demands of different healthcare systems. If portability of new tasks, roles and specializations is restricted for certain professions, this may diminish the attractiveness of these professions. The assessment should in particular focus on the impact of these legal frameworks on national health workforce strategies.
During the Belgian presidency, we want to explore what should be the scope, content and priorities of such an EU health workforce strategy. Where can the EU comparatively offer most advantage when it comes to supporting national health workforce policies? How
