Preamble

In 2020, an invisible virus swept through Europe, leaving hundreds of thousands dead and many others with severe disability. Economic activity has crashed, forcing governments to intervene in ways that would have been unimaginable.

This will not be the last pandemic. There will also be many other threats to health, including the effects of climate change, antimicrobial resistance, and much else. We cannot continue with life as before. We have to safeguard our societies but in ways that are proportionate to the dangers which threaten them. We must welcome the clear statement by the European Commission President Dr Ursula von der Leyen in her “State of the Union” address, setting out the necessity to create  a stronger European Health Union ( EHU ), building on recent efforts by the European Commission to take action on cross border health threats.

The governments of the European Union’s Member States, in successive Treaties, have committed to a high level of human health protection.[1] In the Charter of Fundamental Rights, they have committed to humanity, dignity, and solidarity.[2] In the Sustainable Development Goals, they have committed to a sustainable future for all. They are also all committed, as members, to the Constitution of the World Health Organization. However, these safeguards for health are not, on their own, sufficient.

We, the undersigned, as European citizens, call on our political leaders, meeting together in the European Council and the Conference on the Future of Europe, to take the next step, to commit to creating a European Health Union.

Goals

A European Health Union will:

1. Strive for health and wellbeing of all Europeans, with no one left behind;
2. Strengthen solidarity within and among Member States, based on the principle of progressive universalism, providing support, including universal health coverage, for all, but with particular attention to the needs of those who are disadvantaged;
3. Ensure environmental sustainability, by adopting the European Green Deal[3] and prioritising measures to promote One Health, the concept that links our health with that of the animals with which we share this planet;
4. Provide security for all Europeans, protecting them from the major threats to health and from the vulnerability that is created by living a precarious existence;
5. Enable everyone’s voice to be heard, so that policies that affect their health are created with them and not for them.

Policies and other measures

These goals can be achieved in a number of ways:

1. The status of health policy in the European Treaties will be strengthened, with provisions for a European Health Union incorporated into Articles 2 and 3 of a revised Treaty on European Union, giving the European Union explicit competence to take action on health policy;
2. The voice of the citizens of Europe, expressed through their representatives in the European Parliament, will be heard more strongly;
3. Recognising the cross-border nature of many threats to health, the Health Threats regulatory framework will be revised, including the proposed creation of a Health Emergency preparedness and Response Authority (HERA), enhanced mechanisms provisions to procure adequate supplies in emergencies, to enable the rapid publication of consistently defined health data (including strengthened roles for EUROSTAT and ECDC, working closely with Member States), to strengthen the mechanisms for rapid generation of accurate and trusted evidence from research and practice, and to counter the threat from “fake news”.
4. The European Union’s activities in health research will be expanded, with an enhanced health programme within Horizon Europe, the creation of a European equivalent of the US Biomedical Advanced Research and Development Authority (BARDA), a strengthened EMA, other measures to promote research collaboration across Europe;
5. Recognising the importance of the health workforce, the European Union and the Member States will work together to address the unequal distribution of health workforce capacities in Europe, providing support to regions that have difficulties in attracting health workers as well as promoting training and education of health professionals according to common standards, coupled with measures to safeguard the rights of health workers, including those from other parts of the world.
6. Recognising the benefits of European collaboration on rare diseases, measures to support those who are affected by them will be strengthened by a health security mechanism.
7. Recognising the global nature of many threats to health, the EU will develop a Global Health Policy, working with the UN and its specialised agencies, and especially a strengthened World Health Organization, and other multinational organisations contributing to health, to achieve the health-related Sustainable Development Goals.

Principles

All health policies will be based on a series of principles:

1. Priority to measures that deliver wellbeing and longer and healthier lives for all Europeans;
2. Precaution, proportionality, and dignity, while also respecting fundamental rights, including equality on any grounds, including sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation of gender, ethnicity, or sexuality[4];
3. Respect for regional and national differences, both in the design and prioritisation of policies, taking account of differing contexts, and in their implementation, taking account of the principle of subsidiarity;
4. Solidarity within and among Member States and with the rest of the world, with measures to safeguard their ability to deliver safe and effective health services. No one is safe until all are safe.

On 9 May 2020, Europe commemorated the 70^th anniversary of the Schuman Declaration that paved way for the EU. The history of Europe over seven decades demonstrates that major transformations are rarely fast or easy. Let us be inspired by the words of Robert Schuman: World health “…cannot be safeguarded without the making of creative efforts proportionate to the dangers which threaten it”.

1. Klaus Hänsch – The 18th President of the European Parliament, the Member of the Presidium of the European Convention
2. Jean-Claude Juncker – President of the European Commission from 2014 to 2019, the 23rd Prime Minister of Luxembourg from 1995 to 2013.
3. Ilona Kickbusch – Professor at the Graduate Institute of International and Development Studies, Geneva, for many years worked on  senior position for the World Health Organization
4. Vytenis Povilas Andriukaitis – former European Commissioner for Health and Food Safety (2014-2019), former member of the European Convention
5. Violeta Bulc, former European Commissioner for Transport (2014-2019), former Deputy Prime Minister of Slovenia
6. Dorli Kahr-Gottlieb – Secretary General of the European Health Forum Gastein (EHFG)
7. Josep Figueras – PhD, Director and cofounder of the European Observatory on Health Systems and Policies
8. Mark Flear – PhD, Reader in Law at Queen’s University Belfast, Northern Ireland
9. Tamara Hervey, Professor of European Union Law at the University of Sheffield, UK
10. Martin McKee -Professor of European Public Health and Medical Director at the London School of Hygiene & Tropical Medicine, Research Director at the European Observatory
11. Anniek de Ruijter – Associate Professor in health law. Research fellow at the University of Amsterdam School of Law, Amsterdam Centre for European Law and Governance and on the board of the Amsterdam Institute for Global Health and Development
12. Markus Schneider – PhD, Director of BASYS, Augsburg, Germany
13. Birutė Tumenienė – PhD, Lithuanian representative on the Board of Member States for European Reference Networks. Chair of Working group on ERN integration into national systems

[1] Art 168 TFEU https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A12008E168

[2] https://ec.europa.eu/info/aid-development-cooperation-fundamental-rights/your-rights-eu/eu-charter-fundamental-rights_en

[3] https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal_en

[4] Art 21 Charter of Fundamental Rights

If You agree to support the Manifesto, please sign it in our joint website europeanhealthunion.eu

Explanatory Memorandum to the MANIFESTO FOR A EUROPEAN HEALTH UNION

What is the Explanatory Memorandum about?

• The Explanatory Memorandum has been prepared in order to assist the reader of the Manifesto and contribute to informed debate on it. It does not form a part of the Manifesto.
• It explains what the Manifesto is calling for and provides background information on the its development.
• The paper is best be read alongside the Manifesto. It is not, and is not intended to be, a comprehensive description of the Manifesto.

Overview of the Manifesto

The Manifesto addresses three issues:

It calls on the political leaders of Europe in the frame of the Conference on the Future of Europe to commit to creating a European Health Union.

It invites the people of Europe to engage in building a health policy that contributes to the long-term sustainable development of the European Union. Commitment to progress should not be framed just by the necessity to fight COVID -19 within the framework created by existing European Treaties. Rather it should be framed by the necessity to show the people of Europe that our Union is there to protect us all. The pandemic has created a window of opportunity to take strong public action to build a Union where lives and health of everyone matters.

The Manifesto sets out a vision of a European Health Union (with goals, policies, measures, principles) developed by the signatories of the Manifesto. We need to build a European Health Union where all people are as healthy as they can be throughout their lives.

 Health in the European Policy

I. EU Member States are committed to health via the Constitution of the World Health Organisation, European Treaties, the European Charter of Fundamental Rights, and the Sustainable Development Goals. The list of main Legal provisions is as follows:

a)      Art. 168 of the TFEU states that “A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.”

b) Art. 191 of the TFEU states that “Union policy on the environment shall contribute to pursuit of the following objectives: preserving, protecting and improving the quality of the environment; protecting human health; prudent and rational utilisation of natural resources; promoting measures at international level to deal with regional or worldwide environmental problems, and, in particular, combating climate change.”

c) The preamble to the European Charter of Fundamental Rights states that “the Union is founded on the indivisible, universal values of human dignity, freedom, equality and solidarity “. Art. 35 states that “Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices.”

d) Art. 34 of the European Charter of Fundamental Rights states that “The Union recognises and respects the entitlement to social security benefits and social services”.

e) Art. 41 of the European Charter of Fundamental Rights confers “the right of every person to be heard, before any individual measure, which would affect him or her adversely is taken.”

f). The WHO Constitution recognises:” Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being…”

g). Under the UN Convention on the Rights of the Child, Art.12 states that the Parties “shall assure to the child… the right to express those views “and in Art. 24 “shall take appropriate measures to ensure the provision of necessary medical assistance and health care to all children.”

h). the EU and all Member States are obliged to implement UNDP Sustainable Development Goals (SDGs). SDG 3 commits signatories to “ensure healthy lives and promote well-being for all at all ages”. SDG 3.8 commits signatories to “achieve universal health coverage, including financial risk protection, access to quality essential healthcare services and access to safe, effective, quality and affordable essential medicines and vaccines for all”. Various SDGs commit the signatories to environmental goals including SDG6, SDG11, SDG12, SDG13, SDG14 and SDG 15. All those environmental goals are closely related to health and interlinked with Paris Climate Agreement and the EU Green Deal agenda.

i). Under the International Convention on Economic, Social and Cultural Rights all Member States are obliged to progressively realise the goal “to support the right to health through allocation of “maximum available resources “.

II.     The SARS-CoV-2 pandemic has shaken Europe. The experience of the pandemic has shone light on the weaknesses of existing mechanisms for collaboration among Member States and with the European institutions. Collectively, Europe was slow to act and the response was severely fragmented, with Member States often pursuing their own national objectives to the detriment of Europe as a whole. An obvious example was the scramble to procure scarce equipment. In response, the Commission President, Dr Ursula von der Leyen, has called for a European Health Union. “For me, it is crystal clear- we need to build a stronger European Health Union,” she said. The Manifesto supports this initiative and invites the people of Europe to take an active role in creating a European Health Union.

The people of Europe must respond to the call for new EU competences in the field of health, supported by a strengthened of how many other areas of the EU policy impact on health. The challenge is not to make the EU responsible for all matters in health; that would be a great mistake. Rather it is to find the best was to enable cooperation among the EU and its Member States, enabling them to act more strongly and more effectively in both “normal“ and “pandemic” times. Progress in achieving this will go hand in hand with actions mapped out in other policy initiatives such as the social market economy, the Green Deal, and the digitalisation agenda. This progress must first and foremost build on the EU Pillar of Social Rights and the commitment of the EU and its Member States to the SDGs.

A European Health Union (EHU) would promote healthy living and working standards and well-being for all people of all ages. The EHU would achieve a high degree of synergy with measures implementing Social Europe, the Green Deal, Universal Health Coverage, and policies to protect and promote health and prevent disease. The EHU will help Europe prepare for future threats to health with stronger crisis preparedness mechanisms.

III.  What are the specific actions, mechanisms & instruments of the European Health Union?

The scope of EHU actions is potentially vast. Some proposals as identified by various stakeholders include:

1. Strengthen European health agencies, their competences, budget and staff (ECDC, EMA, EU HTA) and ensure better cooperation among them and with other EU agencies (EFSA, EU-OSHA, EEA, ECHA, EMCDDA, JRC) in health related issues.
2. Establish an EU equivalent of the US Biomedical Advanced Research and Development Authority (EU BARDA), explore the potential to create a fully integrated European Health Agency, and strengthen further European health research.
3. European policies on key areas of public health (such as the AMR Action Plan, vaccination strategy, cancer screening programme) could be developed further, including harmonization measures.
4. Strengthen legislation on cross border threats (e.g. AMR), embedding a ”One Health “approach in European policies. The EC should strengthen networks of European experts on infectious diseases and zoonoses, including EU centres of excellence.
5. Establish the proposed Health Emergency Preparedness and Response Authority (HERA), drawing on lessons from the Union Civil Protection Mechanism. The response could be strengthened by a health solidarity clause that works in a similar way as the EU civil protection clause.
6. Support innovations in health system reform in Member States.
7. Consider stress testing of Member States’ healthcare systems and an EU Directive for Minimum Standards for Quality Healthcare.
8. Share responsibility in “care and cure” in the areas of rare cancers and rare diseases. Explore the feasibility of a European Health Insurance Fund for Rare Diseases.
9. Increase the mandate and scope of the European Reference Networks, developing them as legal entities and assisting them to take advantage of developments in digitalisation and Artificial Intelligence. Full implementation of the Cross-Border Healthcare Directive and the Clinical Trials Regulation is essential.
10. Establish a EU Global Health Policy and incorporate an enhanced health dimension in the EU Neighbourhood Policy.
11. Strengthen the EU representation, with the status of a legal entity, in the WHO, and promote multilateralism at global level.
12. Set out a legal basis to strengthen health considerations in areas of EU competence such as the internal market and fiscal governance. The responsibility for health cannot be secondary to economic and industrial policy. The role of public health experts and health lawyers must be strengthened.
13. Mandate the European Commission to monitor the European health workforce and support pan-European solutions related to healthcare workforce shortages.
14. The EU mandate on joint procurement should be expanded and strengthened, with greater enforcement of provisions on transparency. Measures that recognise the particular features of the pharmaceutical sector are needed in the Public Procurement Directive.
15. Revision of the Transparency Directive on pricing of medicines. Health sovereignty must be restored, taking back control of medicine and vaccine production in Europe, robust Pharmaceutical Strategy and a European Resilience Strategy should be developed.
16. Harmonise vaccination schedules across the EU and work with the WHO on this process across the whole European region.
17. Create Pan-European e-vaccination passport for EU residents, placing a priority on children.
18. Work for common digital and eHealth standards across Member States. Procedures for standardisation and data sharing in a European Health Data Space should be considered.
19. New legislation on health and safety in the workplace should be considered, including a new Directive on work related musculoskeletal disorders and on mental well-being in the workplace.
20. Develop a new and stronger EU health strategy that implements Health in All Policies Approach, pushing EU health policies out of silos created by economic and political considerations, fostering implementation of the 2019 Council Conclusions on the Economy of Well-Being. Paradigm shift from ‘illness system’ to ‘well-being system’ should be strengthened.
21. Explore the feasibility of an European Observatory on Health and Well-Being and Charter on Health and Well-Being.
22. Develop broad public health guidelines that address the main risk factors and strengthen measures to prevent NCDs.

A European Health Union (EHU) is emerging. We are looking to a multi sectorial and multi-dimensional cooperative model of a EHU that combines local, regional, national and European shared rules in Health. The European Commission’s competences on Health are currently restricted. While the Article 168 of the Treaty on the Functioning of the EU provides a basis for the EU’s policies, it also leaves health policy as the responsibility of the Member States. The EC may only complement, coordinate, and encourage cooperation or sometimes supplement it. Many argue for a Treaty change. For example, Margaritis Schinas, the vice-president of the EC told reporters (on 28 of May):” If the moment is right, it will happen. “

There are many initiatives related to the idea of a European Health Union within the European Parliament. The European Commission is working hard on the EHU. Their efforts are greatly welcomed. On 11^th November 2020,  the Commission Communication “Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats” proposed the “first building blocks for a European Health Union”, based on existing Treaty competences. Legal services of the Council, European Parliament and EC strictly follow the Treaty obligations and limits.

How a European Health Union will actually evolve and what it will look like will depend on the political process. This is in the hands of the people of Europe. The road forward can be seen in three different scenarios.

IV. Different scenarios can be envisaged to achieve health and well-being of all Europeans:

a)       Measures to make progress in health concentrate on what can be done with existing legal, financial and managerial instruments, upgrading already functioning institutions, and improved implementation of already agreed policies.

b)      Fine tuning of existing instruments of health policy in parallel to the development of secondary legislation and establishment of new institutions that can create added value for European health. The scenario does not foresee amendments to the European Treaties.

c)      Europeans decide that in addition to “a” and “b”, a “c” is needed, where the status of health policyin the European Treaties is strengthened, with provisions for a European Health Union incorporated into the Treaty on European Union, giving the European Union explicit competence in health policy in very concrete areas, while preserving the principle of subsidiarity as a core.

All three scenarios have their own advantages and disadvantages. None is perfect and none can be implemented immediately. According to the vision of Robert Schuman expressed in 1950, “Europe will not be made all at once, or according to a single plan. It will be built through concrete achievements which first create a de facto solidarity”.

The former European Commission President Jacques Delors lamented that the lack of solidarity in response to an earlier pandemic was a mortal danger to the EU. The solidarity he sought is what a European Health Union would deliver.

Health is a political choice and it requires a strong political will, passion, and ambition. From this point of view a scenario “c” is, of course, the most ambitious. The best choice would be to adopt this scenario. By opting for scenario “a” or “b” Europeans would restrict the benefits they would obtain from deeper cooperation on health. The existing Treaty constrains what can be achieved. Let us be bold and inspired by another, paraphrased, call by Robert Shuman: people’s health “cannot be safeguarded without the making of creative efforts proportionate to the dangers which threaten it”. We cannot miss a once in a generation opportunity to place health at the center of our European Union.

Actions that will follow publishing of the Manifesto

• The Manifesto in English will be available on #EuropeanHealthUnion #EUHealth4All #EUHealthManifesto and Websites of the European Health Forum Gastein (EHFG) and the European Institute of Health and Sustainable Development (EIHSD).
• All comments on the document are welcomed and will be collated and presented to institutions working on the design of a European Health Union.
• The text of the Manifesto will be translated into all official EU languages and presented to national parliaments of Member States for consideration.
• European NGOs, if they see it reasonable, will be invited to support calls for a European Health Union to be placed on the agenda of the Conference on the Future of Europe.

On behalf of signatories of the Manifesto for a European Health Union

Vytenis Povilas Andriukaitis – former European Commissioner for Health and Food Safety (2014-2019), former member of the European Convention

Gediminas Cerniauskas –  PhD, Partner of European Institute of Health and Sustainable Development, former Minister of Health of Lithuania

If You agree to support the Manifesto, please sign it in our joint website europeanhealthunion.eu