Social Structures
Author: Dr Emma McEvoy, Postdoctoral Researcher, SHAPES Project, ALL Institute, Department of Law, Maynooth University.
Less than a year ago, the sudden and somewhat unpredicted outbreak of the Covid-19 pandemic across Europe pushed most national health systems to their limits. Healthcare workers faced the brunt of the pandemic, dealing with shortages of Personal Protective Equipment (PPE), medical supplies, medicines and coping with Intensive Critical Units (ICU) bed shortages. The European Union (EU) as a whole was not prepared for the Covid-19 outbreak, and neither were any of the Member States. Society and the economy appeared to pause in time to support and allow front-line workers to navigate through the early chaos of the first wave of the pandemic. Many areas of society and the economy have yet to recover and re-start from this initial pause. This is also true of health systems. All EU countries, to some extent, paused or limited normal hospital operations, ranging from postponing routine cancer checks, to cancelling elective surgeries to some hospital day services.
It quickly became clear that the Covid-19 outbreak was a cross-border issue, and failure to deal with the crisis through a Pan-European approach was a threat to public health. The EU has traditionally stepped aside from coordinating European health related legislation and policies, leaving Member States to implement health and care systems as they see fit. Exceptions to this include regional regulation on the supply of safe medicines, product liability assurances, and more recently the promotion of cross-border health services. The outbreak of Covid-19 has caused policy makers and EU representatives to question this approach, the solidarity displayed between Member States has shown that a coordinated European approach is required to find a solution and exit from the pandemic, and prepare for future health crisis.
Slowly but steadily EU institutions and bodies have begun to play a critical role in addressing the pandemic. Incidents of the provision of cross-border health care between countries has been witnessed and the European Commission has taken a leading role, notwithstanding some reluctance on the part of Member States. The Commission coordinated the purchase of critically needed PPE, medical supplies and medicines. The European Centre for Disease Prevention and Control (ECDC) created and continues to publish scientific guidance based on the epidemiological spread of the virus. The European Medicines Agency (EMA) continues to play a vital role in establishing in-depth assessments of Covid-19 treatments and potential future vaccines.
The search for closer collaboration among the Member States and for a more significant role of the EU in health matters, has led to the launch of a plan for the creation of a European Health Union. The European Commission, in November 2020, published a plan to support the creation of a European Health Union. The proposed European Health Union would enhance and strengthen communications and coordination between Member States and EU institutions. The proposed European Health Union would focus on preparing for and responding to cross-border health threats. One of the key recommendations is the inclusion of a pharmaceutical strategy, which aims to ensure affordable medicines for all. A more harmonised approach to fighting cancer is proposed, and a ‘European Beating Cancer Plan’ will be adopted to promote a coordinated approach to the prevention and treatment of cancer. In particular, the proposal focuses on developing a European Health Union, which will actively respond to cross-border health threats and strengthen the role of EU agencies.
A new EU Regulation on serious cross-border threats to health has been proposed to strengthen the EU’s ability to prepare for future health crisis and pandemics. The proposed regulation would strengthen the EU’s health security framework by mandating the European Commission and other agencies to coordinate health responses with European countries. At a European level, the Commission will draft pandemic and health crisis preparedness plans. Other agencies, such as the ECDC will then play an important role in supporting European countries in adopting the preparedness plans at national levels.
At a national level, Member States will be required to inform the Commission of health systems indicators. The Commission is mindful that increasing data reporting requirements will undoubtedly increase costs and administrative burden for European countries, and aims to mitigate against these increased burdens by relying on artificial intelligence and investing in new technologies. A highly technological approach to health surveillance has been suggested, relying on linking electronic health records, environmental data and data analytics. Improving and developing new technologies will assist the ECDC in monitoring the systems at the EU level and providing accurate risk assessments and informed decision-making. It is envisioned that during a health crisis, Member States will be mandated to report on a variety of health systems indicators, including hospital beds availability and ICU capacity. The ECDC will respond accordingly and where appropriate will deploy an EU Health Task Force to assist the local response in Member States.
Specifically, the proposals call for extending the mandates of the ECDC and the EMA. In particular, the ECDC’s role would be expanded to include the provision of non-binding recommendations and options for risk management, reporting and auditing of preparation plans, and real-time surveillance of epidemiological statistics. The EMA’s mandate will be reinforced so that it can rigorously monitor supplies of critical medicines and devices, publish guidance on the use of new medicines which have the potential to treat or prevent diseases at the centre of a health crisis, and the coordination of clinical medical trials.
The question must be asked: do we actually need a European Health Union? As the core elements of the recent Commission proposal is to support the fight and recovery against Covid-19, is it necessary to establish a European Health Union centred on this sole purpose? Indeed, it will be costly to implement, with costs to be imposed at both EU and national levels. Numerous pharmaceutical companies are claiming that possible Covid-19 vaccines will be ready for public use shortly, which if successful, will undoubtedly ease the health, social and economic burden currently caused by the pandemic. Hopefully, the pandemic will be an exceptional occurrence, as was the Spanish Flu, and society might not have to endure another pandemic in the foreseeable future. Is it wasteful in times of economic uncertainty to require Member States to invest in a specialised version of a European Health Union? The answer is most definitely no. A European Health Union is needed, and has probably always been needed, and never more so than now. The coordinated actions of the European Commission, other EU agencies, and Member States have saved lives over the last nine months by securing access to scarce medical equipment, supplies and treatments. This coordinated approach should be maintained beyond this pandemic, as this approach has the potential to support Member States in fighting cancer, securing access to vital medications for rare illnesses, and improving fair access to innovative health technologies. Member States will continue to retain autonomy to manage their health and care systems independently, while enjoying the benefit of better coordination and the support of a Pan-European system, not only to navigate through a health crisis, but also to increase their efficiency.
The SHAPES project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 857159.