Rys had spent 18 years working in the EU Commission’s Directorate-General for Health and Food Safety (DG SANTE). The Commission’s response to the Covid-19 crisis was the most interesting development for him due to the collective commitment and cooperation to react to the crisis and establish rather quickly new policies in place. Rys outlined the Commission’s legal and operational approaches to respond to the crisis.
He noted that despite the tension between the Member States regarding EU’s role on health policy, it is becoming a policy area where the EU is having an increasingly greater role. The EU can adopt health legislation under Article 168 (protection of public health) and the Article 114 (single market) and Article 16 (social policy) of the Treaty on the Functioning of the European Union (TFEU). Similarly, Articles 16 (data protection) and 179 (strengthen scientific and technological bases) have been relevant. In the context of the Covid-19 pandemic, Articles 122 and 222 (solidarity) and 196 (civil protection) have also been relevant because they allowed the Council to act.The EU’s approach to the pandemic response built on some lessons learned from the H1N1 (swine flu) through improved communication, detection and response; improved coordination, preparedness and planning; joint procurement; vaccine research and development, production capacity and distribution; and global governance. While some health-related regulations were already in place and did not need to be changed, others were amended to address the response needs of the Union.
The directive on patients’ rights was already in place and there was a framework to share patients’ data, but it was used also when some countries proposed to transfer patients across borders (e.g. from France to Germany). In the health data area, two articles on data protection were added. Regulations on the pharmaceutical package and medical devices were amended during Covid-19 so that masks could be used for the general public. The regulations on organs, blood, tissues and cells changed as well.
Additional regulations were passed to revise the mandates of the European Centre for Disease Control (ECDC) and the European Medicines Agency (EMA). Furthermore, the Commission established a new agency, HERA (Health Emergency Preparedness and Response Authority) to anticipate threats and potential health crises through intelligence gathering and by building response capacities.
Rys also highlighted the success of the Covid-19 vaccine strategy, and he argued that the success was due to EU solidarity – purchasing vaccines together and ensuring equitable distribution to all citizens of the EU at the same moment, whilst ensuring their quality, safety, and efficacy. Rys further discussed the importance of the Digital Covid Certificate (DCC) Regulation and the Regulation on European Health Data Space as fundamental tools to ease travel and establish a framework to use the individual’s health data for research, innovation, policy development and regulatory activities.
Kalra reiterated the argument that the EU’s pandemic response was built on existing regulatory tools, but it required a multifaceted preparedness framework that had not been in place. He further highlighted the Commission’s success in responding to the health crises, but lamented that the pandemic lessons had to be learned a second time, since the 2009 swine flu pandemic did not lead to significant changes to pandemic response strategies. Future challenges, he argued, are related to lack of sufficient funding and the backlog of unmet needs. This means that the EU would need to be more skillful in structuring a healthcare system that is able to do more with less money. Sharing surveillance data, monitoring vaccine uptake, cooperating after the outbreak of a pandemic, and sharing lessons learned are essential for such system.
Kalra argued that data will enable the EU to meet its future challenges on pandemic response. He described the EU Health Data Space as a pair of superhighways on patient data. The first highway entails developing applications to share patient data to enable an effective response to medical emergencies in locations outside of the patient’s country residence and to provide patient data to European citizens to track their health records. The second superhighway entails the establishment of a European platform to share country-level datasets with strict rules for permitted and prohibited users. Kalra asserted that the Health Data Space would spur research and innovation and address the problem of the lack of EU representativeness in artificial intelligence (AI), since innovators use American data for European innovations. He also emphasised the need to investing in digital skills for medical personnel and negotiate and agree on permissions to share data to enable the effectiveness of this data-driven approach.
The discussion focused broadly on the balance between efficiency in the delivery of healthcare services and civil liberties. Challenges to healthcare delivery in the EU, citizen distrust of governments, privacy and data control, and citizen involvement in the decision-making process to shape and deploy new healthcare monitoring and delivery policies were key discussion topics.
by Alban Dafa (ESC Research Assistant)
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