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Saving Lives Through Participatory Democracy - All the materials of the 5th Council on Participatory Democr

EU CAN DO IT was a comprehensive package of proposals to manage the COVID emergency and social, economic and climate crisis with a coordinated European effort presented through an official Petition to the European Parliament. Whilst it started very well with the public hearing, it got bounced to different committees and then got stuck. The Petition was supported by 8,000 people and over 50 organisations across Europe. Now, we feel it is important to reach out to all those who signed it, and involve others, to invest in following-up to the Eu Can Do It petition by updating its demands and objectives
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VirginiaFiume
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Saving Lives Through Participatory Democracy - All the materials of the 5th Council on Participatory Democr

Post by VirginiaFiume »

On the 15th of December during the Citizens Take Over Europe Event "Launching a citizens led Conference on the Future Of Europe" EUMANS coordinated the 5th Meeting of the Council on Participatory Democracy.

At this link, you can find the full recording:

List of speakers:
Virginia Fiume, Coordinator of EUMANS
Professor Ramona Coman, Associate Professor in Political Science at the ULB and President of the Institute for European Studies
Marco Cappato, President of EUMANS
Vytenis Andriukaitis, former EU Commissioner for Health and Promoter of the European Union Health Manifesto {document}
Violeta Bulc, former EU Commissioner for Transport and Promoter of the European Union Health Manifesto
Roger Casale, Executive Director of New Europeans and promoter of the Health Union Manifesto {document}
Julie Steendam, promoter of the European Citizens Initiative Right to Cure https://noprofitonpandemic.eu/
Marco Perduca, co-founder of Science for Democracy {document}

The Council on Participatory Democracy agreed on three next steps:
  • - Identify the need to launch a formal participatory phase for the European Health Union within the Conference on the Future of Europe AND before the Conference on the Future of Europe. Starting with a Petition and an Open Letter to address the European for Health Commissioner and UVDL

    - Connect the matter of European Citizenships with the right to health and holistic approach to health reforms competencies / it is a matter that needs to be discussed among citizens and experts, transparently, with a feedback loop.

    - Relaunch the petition on the design of the Conference on the Future of Europe and the transparency around it submitted by Citizens Take Over Europe to the European Parliament https://citizenstakeover.eu/news/ep_petition/2020/
Follow this thread to take part in this process, that is connected to the work that EUMANS did with the petition EU CAN DO IT.

Below you find all the documents presented during the event


EUMANS PROPOSALS FOR THE COUNCIL ON PARTICIPATORY DEMOCRACY

The 5th Meeting of the Council on Participatory Democracy will be held on December 15th 2020 as part of the Citizens Take Over Europe initiative, the civil society coalition for the immediate launch of a citizens-centered Conference on the Future of Europe.

This is a format developed in collaboration with a lot of the organisations that kicked off Citizens Take Over Europe after it started to be evident that the Conference on the Future of Europe would have been postponed.

We heard in the Plenary some of the contextual elements which led to the organisation of today’s appointment. And the appointments that are organised in January.

In this session we will focus - with our discussants and with all of you on three main questions:

1) how different citizens proposals that came out “from” the Pandemic revealing the urgency of coordination for the Health Union overlap?

2)  which instruments of civic participation can be activated for a shared bottom-up push for these proposals?


3) How the pressure created by Citizens Take Over Europe for a citizens-led Conference on the Future of Europe and the existing EU CAN DO IT Petition to the European Parliament can be integrated and leveraged on matters related to change in the EU Competencies on Health and Civil Protection?

[Overview of the discussants]

Additional foundational elements that can give us perspective and hope - also on the basis of previous meetings of the Council On Participatory :
1) Democracy Action Plan now includes “Participatory Democracy” - this was part of the output of previous sessions “Equal Dignity for Participatory Democracy”: 

- The Commission will continue to promote participatory and deliberative democracy,
- as well as citizen participation in the shaping of EU policies and existing laws 27 . The Commission’s annual Rule of Law report 28 also assesses the inclusiveness of the legislative process and civil society involvement.
- The Conference will be a catalyst for new forms of public participation at the European, national, regional and local levels. I

- The Commission encourages Member States to make best use of relevant EU structural and investment funds to support and reinforce civil society capacities at both national and local level and involve civil society organisations in the partnership with the different levels of public administration, including by building a deliberative democracy infrastructure. This will allow for better civic participation and public engagement in the shaping of priorities, including for the Next Generation EU initiative in each Member State.

2) The essential and urgent need for the activation of the European Citizens Assemblies - which is somehow it is the underlying element of the entirety of today’s event.
 

The centrality of the Rule of Law

The Council on Participatory Democracy analyzed the latest decisions on the Rule of Law conditionality, which was holding the Recovery Plan hostage.

The respect of the rule of law within the European Union has been a controversial issue on the agenda of EU institutions for almost a decade now. Major democratic backsliding in Hungary and Poland, and to a lesser extent in other Member States, has prompted heated debates around the very definition of the Rule of Law and an institutional mechanism to safeguard European values. The EU toolbox to protect the Rule of Law has proved to be ineffective and useless, mainly due to a lack of political will and to the unanimity voting rule within the European Council. In this context, the European Commission has recently presented its first Rule of Law Report, a new tool supposed to evaluate all Member States on an equal foot in order to prevent potential breaches of the rule of law. Moreover, the Covid19 pandemic, and the unprecedented Recovery Plan put forward by the European Commission, have accelerated negotiations on a mechanism to link the disbursement of EU funds to the respect of the rule of law, the so-called Rule of Law conditionality - which is the main reason why the whole Recovery Plan has been held hostage by Hungary and Poland’s veto. Once again - and probably more than ever - the issue of the rule of law became the terrain of evolution of the functioning of the European Union and we witnessed last week an important “unlock”.

A general regime of conditionality linking the disbursement of EU funds to the respect of the Rule of Law and EU values has been agreed by EU leaders in December 2020. However, such a mechanism will not apply to “generalized deficiencies” concerning the Rule of Law, but only to those measures directly affecting the sound financial management of EU funds and EU financial interests. Furthermore, the activation of the mechanism will be pending a challenge to its legality by Hungary and Poland before the European Court of Justice, delaying its implementation by months, if not years.

In light of these developments and of the weak nature of the conditionality itself, the issue of the Rule of Law should be included in the Conference on the Future of Europe, as also suggested in the “S&D Strategy on the Conference on the Future of Europe”.

But how did we get here? What is the rule of law conditionality and how will it work?


Health coordination and reforms of the EU health competencies

Health emergency has restricted the democratic public space, starting from the marginalization of Parliaments. It has been even worse for participatory democracy. The indeterminate suspension of the Conference on the future of Europe is an example at the european level. In Italy, the constitutional right to propose civic legislative proposals or referendums has been suspended de facto since last march.

But democracy and participation are needed to foster the collective mobilization for the right to health and well-being, especially at european level to promote sharing of resources, experiences, data.

Even though as an immediate response to the Covid-19 outbreak the EU has activated and broadened the EU Civil Protection Mechanism and the RescEU reserve, in the long term the European Union has been failing to address the Covid-19 health crisis in a coordinated way. In fact, the majority of basic decisions concerning wearing masks, quarantine rules, limits on social gatherings, or the closure of schools and businesses, remain a prerogative of national and local health authorities. It is now fundamental that EU leaders manage to coordinate at least their gradual lifting of restrictions, vaccination plans, vaccination certificates as well as the mutual recognition of test results. 

In this context, we should welcome European Commission’s proposal for an European Health Union to better equip the European Union to prevent and manage future health emergencies. We regret that such a proposal would not entail a radical paradigm shift in the health competences of the EU, but it is anyhow the moment to ask for concrete actions.

Both Chancellor Merkel and EU leaders acknowledged that greater formal EU cooperation on health care matters and health data sharing are needed.

It is of utmost importance to foster sharing of scientific research data, to ensure open access to scientific knowledge as well as to provide scientific research with adequate funding and investments. In particular, Member States should foster their coordination efforts to make truly effective the interoperability platform connecting national contact tracing apps, as well as they should commit to sharing epidemiologic and research data on the European COVID-19 Data Platform in order to foster the free circulation of scientific knowledge. Furthermore, the EU should establish an online platform for clinical trials in Europe, as well as a network for rapid evaluation of the vaccine effectiveness in order to improve vaccination campaigns in different countries, as suggested by Dr. Rasi, former Executive Director of the European Medicines Agency. 

The EU and its Member States should take stock of the lessons learnt from the Covid19 pandemic and of citizens’ demands in order to make healthcare and civil protection concurrent competences of the EU subject to the ordinary legislative procedure, as well as to establish a European Civil Protection Corps, with its own resources and assets. We thus encourage the EU and its Member States to frame a harmonic legislation in these strategic fields as soon as possible.

Which action can we take toward this end? I think that putting pressure for the convening of the conference on the future of Europe, having health policies on the top of the agenda, is crucial. We need to gather even more support to the petition launched by Citizens take over Europe on this regard, being ready to convene a citizen-led self-organized conference if EU institutions will fail to do so.

EU global role in preventing future pandemics

 The recently proposed "International pandemic treaty" is a signal that the principles of a coordinate cooperation, at the center of the EU CAN DO IT petition, are the way forward, yet another reason to open this brainstorming phase to prevent future sanitary emergencies to the expertise and vision of non-state actors.

In this context, we also encourage the EU and its Member States to develop a Global Health Policy in close collaboration with the WHO, the UN and its specialized agencies. The EU should also promote the creation of a Health Emergency preparedness and Response Authority (HERA), of 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”.

We welcome EU leaders’ commitment to guaranteeing affordable and fair access to vaccines and medicines, and we encourage them to take all the necessary steps to guarantee citizens’ Right to Science, in particular by upholding the provisions contained in the UN General Comment on Science and by ratifying the additional protocol to the ICESCR. In this context, transparency should be guaranteed on deliberative and decision-making processes within EU institutions. 


Manifesto for a European Citizens' Assembly

Through the submission of a Petition to the European Parliament, the Citizens Take Over Europe coalition called on EU institutions to make sure the Conference on the Future of Europe will be a sortition based citizens-centered democratic process. 


In a further effort to push for the institutionalization of sortition based citizens’ assemblies, political scientists and representatives of different national/local citizens' assembly experiences came together in the context of Citizens Take Over Europe to launch a collective draft blueprint on deliberative democracy, starting from the "Manifesto for a European Citizens' Assembly". Should the Conference on the Future of Europe continue to be delayed and vague, NGOs, activists, experts and European citizens are ready to discuss a new pioneering self-organised European Citizens' Assembly.

We encourage European institutions to take stock of citizens’ demands by launching the Conference on the Future of Europe as soon as possible, introducing sortition based citizens’ assemblies and institutionalizing them afterwards.



The right to know and democratic participation

The Conference on the Future of Europe, and all forms of participatory democracy, starting from European Citizens Initiatives, need a boost in terms of popular awareness and knowledge in order to allow citizens to truly take part in the democratization of the European Union, especially in those matters where either the quest for electoral consensus, the heavy role of nation states or the lack of transparency of the Council of the EU have undermined progress towards a more democratic and sustainable European Union.

 For these reasons, it is of utmost importance to guarantee citizens’ Right to Know, as well as “Equal dignity for participatory democracy” by making sure that the same amount of economic resources used to inform citizens on their electoral voting rights is also used to inform them on their participation rights, especially in relation to the European Citizens’ Initiative.

Evaluation of the Proposals of The ECI CAMPAIGN Moreover, the European Commission should provide a second deadline extension for all ongoing ECIs as soon as possible; reduce data requirements, especially ID numbers; extend the possibility to use Individual Online Collection Systems instead of banning it by 2023; lower the minimum age required to sign an ECI to 16;.; perform public hearings also for ECIs with at least 100.000 but less than a million signatures.

 

EU CAN DO IT 

EU Can Do It was a comprehensive package of proposals in the form of an official Petition to the European Parliament to manage in a European coordinated way the COVID19 health, social, economic and climate crisis. It was supported by 8,000 people and over 50 organizations across Europe, including the Good Lobby, European Alternatives and many others.

 Whilst it started in a successful way with its public hearing in the PETI committee of the European Parliament, it got bounced to different committees and then got stuck. Now, it is important to reach out to all those who signed it, and involve others, to invest in following-up to the Eu Can Do It petition by updating its demands and objectives, starting from what the EU has done and what is yet to be done, as well as new ideas/proposals. It is important to follow-up using participatory democracy tools to prove that they are not useless even during an emergency and that they allow us to gather consensus on ideas which are not even circulating among political elites.


The EU Can Do It petition was based on 5 main pillars, which have all been relatively addressed by the EU: … EU CAN DO IT reviewed
Last edited by VirginiaFiume on 21 Dec 2020 17:04, edited 1 time in total.
Coordinator of EUMANS
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Re: Saving Lives Through Participatory Democracy - All the materials of the 5th Council on Participatory Democr

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MANIFESTO FOR THE EUROPEAN HEALTH UNION

FULL TEXT OF MANIFESTO
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. In the Charter of Fundamental Rights, they have committed to humanity, dignity, and solidarity. 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:
Strive for health and wellbeing of all Europeans, with no one left behind;
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;
Ensure environmental sustainability, by adopting the European Green Deal and prioritising measures to promote One Health, the concept that links our health with that of the animals with which we share this planet;
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;
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:
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;
The voice of the citizens of Europe, expressed through their representatives in the European Parliament, will be heard more strongly;
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”.
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;
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.
Recognising the benefits of European collaboration on rare diseases, measures to support those who are affected by them will be strengthened, mechanism.
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:
Priority to measures that deliver wellbeing and longer and healthier lives for all Europeans;
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;
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;
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 70th 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”.


EXPLANATORY MEMORANDUM ON THE MANIFESTO
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:
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.
Establish an EU equivalent of the US Biomedical Advanced Research and Development Authority (EU BARDA), explore the potential to create afully integrated European Health Agency, and strengthen further European health research.
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.
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.
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.
Support innovations in health system reform in Member States.
Consider stress testing of Member States’ healthcare systems and an EU Directive for Minimum Standards for Quality Healthcare.
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.
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.
Establish a EU Global Health Policy and incorporate an enhanced health dimension in the EU Neighbourhood Policy.
Strengthen the EU representation, with the status of a legal entity, in the WHO, and promote multilateralism at global level.
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.
Mandate the European Commission to monitor the European health workforce and support pan-European solutions related to healthcare workforce shortages.
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.
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.
Harmonise vaccination schedules across the EU and work with the WHO on this process across the whole European region.
Create Pan-European e-vaccination passport for EU residents, placing a priority on children.
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.
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.
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.
Explore the feasibility of an European Observatory on Health and Well-Being and Charter on Health and Well-Being.
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 11th 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 policy in 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 subsidiarityas 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 centre 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
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Re: Saving Lives Through Participatory Democracy - All the materials of the 5th Council on Participatory Democr

Post by VirginiaFiume »

Time for a European Health Union - proposal for an international conference on lessons learned by New Europeans

The Covid-19 pandemic has changed everything. In Europe as well. Before this nightmare ends (and, unfortunately, we are not there yet!) we have to build on the lessons learnt and create something new and positive out of this this dramatic experience. This was the message of the call for a European Health Union that we launched on May 9th – 70th anniversary of the Schuman Declaration - with the "New Europeans" group of the former Labour MEP Roger Casale.

We are pleased that the idea has been brought up by the President of the European Commission, Ursula von der Leyen in her Speech on the State of the Union on September 16th, also in light of the World Health Summit which will be organized in 2021 by the Italian Presidency of the G20.

Also, while Member States are struggling to cope with the second wave of infection, it is reassuring to see that at least the European Commission is developing a coordinated strategy to ensure the best effectiveness of future vaccines. Only united and determined we will overcome this tragedy.

After all, it was Columbus’ egg: during the forced lockdown that radically transformed our lives, it was quite straightforward to think how the European Union would have resisted only through a bottom-up model of renewal, instead of focusing on the illusory closures of walls, quotas and duties against the invasions of viruses, migrants and underpriced products. Such model should have been based on the needs that unite us, the values in which we recognize ourselves and the synergies that emerge while working together.

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A model for Europe
Doctors suggested the "One Health" model proposed by WHO as the approach that would have allowed to organically link the prospects of a health reform on a continental basis to the more general transformation of our society required by climate change and the search for sustainable, green, fair and digital development. We should not choose between health or climate, solidarity or innovation, sectoral reforms or overall paradigm shift: "Win-win? Yes, we can!".

It is an overall package, built on a precise vision and synergies. Yet, it must be explained and assimilated. Primum vivere, deinde philosophari. The bet then becomes reconstructing through our survival instinct, stimulated once more by the pandemic. It becomes trying to shake off the existential discomfort of an atomizing complexity which dismays us and often makes us slaves of charlatans, who speak directly to our emotionality with hypocritical messages that are too easy to grasp.

Let us start instead from the rediscovery of health as a "global public good", which can constitute the basis for a renewed social contract where the European demos can rediscover its common identity, made – from the Beveridge Plan onwards – of a universal health care. When confronted with a disease, “no one must be left behind". Here is a fundamental step on which we need to make maximum clarity: the hypothetically future European Health Union would be based on the reform of the Treaties signed by sovereign nation states but it should most importantly focus on the rights and duties of individual European citizens, regardless of their passports and identity cards.

Hence, the call to Ursula von der Leyen: we cannot speak of a "European Health Union" only among Governments and Parliaments. The matter must in fact become one of the main pillars of the announced Conference on the Future of Europe, as a widespread procedure of consultation and planning for a common future.

Regarding health, the European Union theoretically possessed – already at the beginning of the pandemic – the tools for a propulsive role. Instead, we have written dark and demeaning pages of selfishness, hypocrisy and disorganisation, which certainly did not honor the bonds solemnly enshrined in the European Treaties.

The call precisely aims at addressing the challenges emerging from the pandemic and the lessons learnt in different areas: health, of course, but also economics, subsidiarity, education, citizenship and external relations. Only the combination of such reflections with the consequent action plans will manage to relaunch the "European project" Coronavirus seemed to hit, thanks to incredible unintended consequences (naked and in scattered order in the face of the evil, now instead more cohesive and determined not to repeat similar experiences).

Regarding health, the European Union theoretically possessed – already at the beginning of the pandemic – the tools for a propulsive role. Instead, we have written dark and demeaning pages of selfishness, hypocrisy and disorganisation, which certainly did not honor the bonds solemnly enshrined in the European Treaties. It is enough to read Article 168 of the Treaty on the Functioning of the European Union (TFEU), which expressly prescribes that "action by the Union, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health. Such action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission and their prevention, as well as health information and education, and monitoring, early warning of and combating serious cross-border threats to health." One could possibly not be clearer! If Covid-19 is not a "major scourge", what would be?

The Solidarity clause in Article 222, point 1(b) of the TFEU should be recalled as well: "The Union shall mobilize all the instruments at its disposal, including the military means put at its disposal by the Member States, to ... to provide assistance to a Member State on its territory, at the request of its political authorities, in case of natural or man-made disaster". Such clause appears to have been used to activate a European coordination of emergency supplies to China. However, when the Italian Permanent Representative to the European Union invoked the same clause to receive emergency masks and ventilators, the same mechanism immediately stopped functioning. It is therefore clear how Europe turned deaf ears and brought up all the possible red tape to Italy, while generously distributing almost the same goods to the other end of the world.

The necessary means
Luckily, winds have now changed. German President Frank-Walter Steinmeier's Easter speech was beautiful: "Germany cannot come out of this crisis strong and healthy if our neighbors are not strong and healthy too. This blue flag is not here by chance. Thirty years after the Unification of Germany, seventy-five years after the end of the war, we Germans are not only called upon, we are obliged to solidarity! [...]. After this crisis we will be another society. We don't want to become a fearful, distrustful society. We can, instead, be a society with more trust, more respect, and more optimism". To put it simply, coronavirus is nobody's fault, and we cannot continue to fight against one another: we are all in the same boat and we must not let it be overturned.

As Mario Draghi clearly stated in 2012 to defend the euro, we must do “whatever it takes”. But four years have passed between the Lehman Brothers crisis and the declaration of the Governor of the European Central Bank. Luckily, it took only few months for Angela Merkel to recall the saying "you have to move quickly when the ice is melting". Haste is obviously a very temporally dilatable concept for Brussels, which, however, seems to have set now the right pace. Perhaps, it will even permanently establish instruments such as the Recovery Fund, to allow an explicit European economic policy without the current impositions to the European Central Bank.

However, a European response to global health challenges is not just a matter of money. It also requires adequate governance. Subsidiarity then comes into play, not only to guarantee space for local authorities in the optimal management of territories, but also to call for supranational direction/coordination of tasks that would otherwise get out of hand. Complexity can be governed if there is the will.

It is also impossible not to shed a light on the topic of education, especially in an inter-generational perspective. Scientific and technological education are crucial means against our evils and denials, to eventually overcome the "digital divide". Civic education is essential too, because without a clear awareness of the interrelation between rights and duties, it will be impossible for our societies to overcome the challenges of contagion and its deadly pitfalls. Citizenship therefore emerges as a key element in the bottom-up construction of the European Union we want, made of rights and duties, guarantees of fundamental freedoms and the rule of law, an indispensable condition for our physical and mental health.

While remaining certain and thorough in demanding respect for these priorities of ours, we must not turn a blind eye on the rest of the world. It seems lost in a worrying scenario of turmoil, among authoritarian, populist and sovereignist drives, all sharing the desire to pass on their problems to others. Can Europe, instead, aspire to stand as a beacon for those who, everywhere, think differently and find in the terrible pandemic a further reason for solidarity, vision, willingness to work together, in mutual respect?

We would like to talk about this issues at the G20 Summit in 2021 on world health and, even before that, at the Conference on the Future of Europe, which should start before the end of the year under the German Presidency.

In preparation for such events, "New Europeans" has started discussing about it again in an online conversation on November 5th.

Contact New Europeans (bureau@neweuropeans.net) if you would like to learn more about the call for an international conference on the lessons learned from Coronavirus and the European Union for Health (#EuropeanHealthUnion).
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Re: Saving Lives Through Participatory Democracy - All the materials of the 5th Council on Participatory Democr

Post by VirginiaFiume »

The General Comment on Science - Presentation by Marco Perduca, co-founder of Science for Democracy


People, citizens have the right to take part in the decision making process. This is not a request that comes from civil society, it is one of the elements of the international rule of law.

Now if we all know what the most known international human rights instruments say about this right, the UN has recently adopted a general comment on science that further clarifies what it is intended with it.

Science is crucial as is the supplier of data and evidence that should inform the public decision-making process. So, on top of reaffirming the right to be actively involved in laws and policy design, also the ground on which those decisions are taken should be open to citizens participation.

Let’s have a look at what the General Comment on Science says on the subject


Para 53 states that “The principles of transparency and participation are essential to make science objective and reliable, and to ensure that it is not subject to interests that are not scientific or are inconsistent with fundamental human rights principles and the welfare of society.

Secrecy and collusion are in principle contrary to the integrity of science, States should take measures to avoid the risks associated with the existence of conflicts of interest by creating an environment in which actual or perceived conflicts of interest are adequately disclosed and regulated, especially those involving scientific researchers who give policy advice to policymakers and other public officials.

Para 56 - Participation also includes the right to information and participation in controlling the risks involved in particular scientific processes and its applications. In this context, the precautionary principle plays an important role. This principle demands that, in the absence of full scientific certainty, when an action or policy may lead to unacceptable harm to the public or the environment, actions will be taken to avoid or diminish that harm.

Unacceptable harm includes harm to humans or to the environment that is: (a) threatening to human life or health; (b) serious and effectively irreversible; (c) inequitable to present or future generations; or (d) imposed without adequate consideration of the human rights of those affected. Technological and human rights impact assessments are tools that help to identify potential risks early in the process and the use of scientific applications.

Para 57 The application of the precautionary principle is sometimes controversial, particularly in relation to scientific research itself, as limitations on the freedom of scientific research are compatible with the Covenant only in the circumstances set out in article 4. On the contrary, this principle is more broadly applied for the use and application of scientific outcomes. The precautionary principle should not hinder and prevent scientific progress, which is beneficial for humanity. Nonetheless, it should be able to address available risks for human health and the environment, inter alia. Thus, in controversial cases, participation and transparency become crucial because the risks and potential of some technical advances or some scientific research should be made public in order to enable society, through informed, transparent and participatory public deliberation, to decide whether or not the risks are acceptable.

So transparency, participation but also evaluation, assessment are all elements of the right to participate that we should insist become central in the debate on the future of Europe also because they are all ingredients that can help us contribute to the necessary update and or upgrade of rules and regulations to govern new phenomena that science has discovered or invented.
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Re: Saving Lives Through Participatory Democracy - All the materials of the 5th Council on Participatory Democr

Post by VirginiaFiume »

Press release by President Charles Michel on an international Treaty on Pandemics


COVID-19 has disrupted the world as we know it with the declaration of national disaster, imposition of strict quarantines, and economic disruptions. In order to provide some context for the role of international law in public health emergencies, this Insight provides brief history of how the international community has created institutional governance to respond to global health pandemics.

Introduction

COVID-19 is not the first pandemic to face the world and managing pandemics has not been an easy matter for sovereign States. Cholera appeared on the Southeastern edge of the Russian Empire after having traveled across India from the Asian steppes. Europe was unprepared and it quickly became apparent that different quarantine requirements by different countries were contributing to continued transmission of the disease. In 1834, a French health administrator called for an international meeting to be organized to create harmonized standards. Of particular concern to countries were the "disastrous hindrances to international commerce" that the outbreaks were having.[1] In 1851, France helped to convene the first International Sanitary Conferences designed to address the standardization of quarantine regulations aimed at preventing the importation of cholera, plague, and yellow fever.[2]

Negotiating international agreement around disease was difficult with parties disagreeing about the nature of various diseases. After 41 years of meeting and seven International Sanitary Conferences, states finally agreed in 1892 to a narrow treaty providing for maritime quarantine regulations for cholera on westbound shipping routes from the East.[3] Subsequent agreements were signed and eventually in 1909, States opened an "Office International d'Hygiene Publique" in Paris.[4] At the 13th International Sanitary Conferences, countries that had weathered the extremely deadly 1918 Influenza Pandemic agreed in an updated International Sanitary Convention to provide immediate notification to every other government and to the Office International d'Hygiene Publique of first confirmed cases of cholera, plague, and yellow fever, as well as epidemics of small pox and typhus.[5] The term "epidemics" was never defined. Curiously, states refused to include influenza, arguing that it was impractical to quarantine for this disease.[6]

In 1943 during World War II, the United Nations Relief and Rehabilitation Administration focused on the "giving of aid in the prevention of pestilence and in the recovery of the health of the people" with a focus on displaced individuals.[7] Decisionmakers in this new body took over the work that had been done by the Office International d'Hygiene Publique and focused on additional infectious diseases, including influenza. The 1926 International Sanitary Convention was revised in 1944 to better reflect the new realities of global disease so that countries were expected to exchange epidemiological information about more diseases that would constitute "a menace to other countries."[8]

World Health Organization and Governance of Pandemics

On March 11, 2020, the Director General of the World Health Organization (WHO) announced that COVID-19 was a global pandemic. This announcement, while specific to COVID-19, emerged from multiple decades of experience of institutional efforts to cooperate and coordinate around managing the spread of infectious disease.

The World Health Organization began operation in 1948 and introduced better practices in international coordination around pandemics that are still being developed today as we react to novel health threats. In 1952, the WHO created the Global Influenza Surveillance and Response System (GISRS) to monitor the evolution of influenza viruses. The hope was to be able to identify, in a timely fashion, strains of influenza that might become pandemic and develop vaccines.

In 1969, building on the International Sanitary Regulations, countries adopted the "International Health Regulations" (IHR) requiring that WHO be notified whenever cases of cholera, plague, yellow fever, smallpox, relapsing fever, and typhus occurred within their territory.[9] The IHR was criticized for being too narrow because no attention was given to highly infectious diseases, such as influenza, in these early regulations.

In 1999, the WHO published an influenza pandemic planning framework that emphasized the need to enhance influenza surveillance, speed vaccine production and antiviral drugs (particularly to developed countries that may not have their own drug production means), and improve influenza research and emergency preparedness.[10]

In 2002, WHO had a chance to put new theories about effective global pandemic containment into practice with a coronavirus. In 2003, the Global Outbreak Alert and Response Network formed in 2000 provided a tip about an unusual clustered outbreak of respiratory illness in Guangdong China. This Global Network was a new WHO-facilitated multi-stakeholder response to controlling pandemics that collected and disseminated information not just from national governments but from a broad array of additional public health surveillance networks. On February 14, 2003, the Chinese government reported 305 unusual cases, but indicated that the outbreak was "coming under control." The World Health organization called upon its network of influenza laboratories to identify any novel influenza viruses that might have pandemic potential. On February 19, 2003, the WHO Global Influenza Surveillance Network reported that a 33-year-old Hong Kong man and his nine-year-old son had contracted the H5N1 virus after travelling through Guangdong Province to Fujian Province—where the family's 8-year-old daughter had developed a severe respiratory illness, died, and was buried. After an outbreak report in Hong Kong, the WHO called for heightened global surveillance as cases began emerging in Canada, Vietnam, and Singapore. By March 15, the number of cases had exploded and WHO declared a worldwide health threat of "sudden acute respiratory disease" and declared need to control air travel. On March 27, scientists in the WHO network identified the novel coronavirus causing SARS. Through a combination of vigorous and relatively aggressive national containment activities put into place through national emergency regulations (including case identification, case isolation, contract tracing, surveillance, closing of international borders, and quarantine of contacts) as well as well-publicized international travel recommendations, human-to-human transmission of SARS was remarkably contained within four months by July 5, 2003. The rapid sharing of information across networks of experts and decisionmakers was key; the good faith participation of states in containment efforts was essential.

In 2005, WHO updated the International Health Regulations focused on establishing and improving the global capacity to prevent, detect, and respond to infectious disease threats such as pandemic influenza. Under the revised IHR, countries were required to improve international surveillance and reporting mechanisms for disease outbreaks and to strengthen their national surveillance and response capacities.[11] Where historic international agreements limited what types of events were to be shared, the revised IHR called upon states upon to report any event that: (1) has a serious public health impact; (2) is unusual or unexpected; (3) might be internationally virulent; and (4) is likely to trigger a significant risk of international travel or trade restrictions.[12] National IHR Focal Points report to regional WHO IHR Contact Points, and someone must be available as a contact point around the clock. Under the revised regulations, WHO can make a combination of temporary emergency recommendations combined with standing recommendations for ongoing health risks.[13] Under the regulations, an Emergency Committee advises the Director-General of WHO on temporary recommendations during a public health emergency of international concern."[14]

In 2011, WHO introduced a Pandemic Influenza Preparedness (PIP) Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. The pandemic framework operates through the sharing of influenza viruses, genetic sequence data from these viruses, reagents, and risk assessments, all though the GISRS.

WHO International Health Regulations and COVID-19

Will the COVID-19 situation be more like SARS where technical cooperation and aggressive national public health actions eventually achieved containment, or will the situation generate conflict between states? As COVID-19 continues to spread to far more countries than SARS spread to,[15] cooperative prevention and preparation in the context of international public health law becomes essential to prevent the pandemic from becoming a borderless disaster.

For the COVID-19 outbreak, key states have been responding in compliance with the International Health Regulations. The WHO China office reported the initial cluster in December 2019, isolated the virus on January 7, 2020, and then shared the genetic sequence of COVID 19 on January 12, 2020, to ensure proper diagnostic kit developments.[16] Appealing to the object and purpose of the International Health Regulations, the WHO has continued to remind countries of the need for proportionality in applying measures that are "restricted to public health risks, and which avoid unnecessary interference with international traffic and trade."[17] Meanwhile, travel bans have been, and continue to be, imposed that are questioned by public health law experts.[18]

As this Insight is written, there is a great deal of uncertainty regarding the direction of the pandemic, but the WHO has played a key role as a facilitator in managing transmission of epidemiological information and sharing of effective national strategies across global networks. There are many difficult decisions ahead for individual governments but there is strength in affirming international solidarity to contain the disease equitably without damaging long-term State reputations or creating conditions for future unwarranted discrimination.

Anastasia Telesetsky is Professor of Law at the University of Idaho College of Law and is a member of the Insights Editorial Board.

[1] Norman Howard Jones, Scientific Background of the International Sanitary Conferences 1851-1938, History International Public Health 1 (1975) p. 11, https://apps.who.int/iris/bitstream/han ... 49_eng.pdf

[2] Id. p. 12.

[3] Id. p. 65.

[4] Id. p. 89

[5] Id. p. 98

[6] Id. p. 97.

[7] Agreement for United Nations Relief and Rehabilitation Administration, November 9, 1943, https://www.ibiblio.org/pha/policy/1943/431109a.html

[8] Convention Modifying The International Sanitary Convention of June 21, 1926: "Every Contracting Party shall, in addition to the diseases specifically mentioned in [Article 1], to wit, plague, cholera, yellow fever, typhus, and smallpox, notify to UNRRA outbreaks of such other communicable diseases as, in the opinion of that Party or in the opinion of UNRRA, constitute a menace to other countries by their spread or potential spread across frontiers, and shall keep UNRRA regularly informed of the course of the disease and the measures taken to prevent its spread."

[9] World Health Assembly. 1983. International health regulations (1969). Geneva: World Health Organization.

[10] World Health Organization. WHO/CDS/CSR/EDC/99.1 Influenza Pandemic Plan. The Role of WHO and Guidelines for National and Regional Planning (Apr. 1999).

[11] International Health Regulations (2005), 2nd edition. Geneva: World Health Organization, art. 6.

[12] Id. Annex 2.

[13] Id. arts. 15-16.

[14] Id. arts. 48-49.

[15] As of March 12, 2020, 110 countries had reported confirmed COVID-19 cases.

[16] World Health Organization, Novel Coronavirus-China, https://www.who.int/csr/don/12-january- ... -china/en/.

[17] Updated WHO recommendations for international traffic in relation to COVID-19 outbreak (Feb. 29, 2020), https://www.who.int/news-room/articles- ... 9-outbreak.

[18] R. Habibi et al., Comment, 'Do not violate the International Health Regulations during the COVID-19 outbreak', The Lancet, Volume 395, Issue 10225 (Feb. 29, 2020): 664-666. ("Responses that are anchored in fear, misinformation, racism, and xenophobia will not save us from outbreaks like COVID-19.")
Coordinator of EUMANS