European Health Care News

No.54 - June 2020


      

1

 Public health  [...]

European Commission: European public health responses to the pandemic
European Commission: guidelines on waste management in the coronavirus crisis
European Commission: Belgian virologist Peter Piot appointed to the post of special adviser to the Commission President
European Commission: launch of an online platform for researchers, to gather data on Covid-19
European Commission: launch of the 'COVID-19 Clinical Management Support System'
European Commission: European roadmap shows path towards common lifting of containment measures linked to the pandemic
ECDC: Surveillance of COVID-19 at long-term care facilities in the EU/EEA
ECDC: Guidance on discharge and ending isolation of hospitalised patients in the context of COVID-19
ECDC: increased risk that health and social care systems may be overwhelmed
ECDC: guidance document on the coronavirus disease and the supply of substances of human origin
ERN: creation of new capacity for the development of clinical practice guidelines and clinical decision support tools
ERN: Feasibility study on the opportunity of setting up a European Expert Network for rare communicable diseases and other rare pathologies
European Council: cooperation between the Member States in the fight against COVID-19
Chafea: tender to promote the mobility of health professionals working in the ERNs
European Commission: creation of a team of scientific experts to strengthen the European response to the pandemic
European Commission: recommendations on health systems' resilience in the context of the COVID-19 pandemic
Council of the EU: statement of the Member States on the EU actions in response to the COVID-19 epidemic
European Commission: communication on a European coordinated response to counter the economic impact of the coronavirus
CoR: launch of an exchange platform to support regions and local communities across Europe in the context of the health crisis
European Parliament: Resolution on EU coordinated action to combat the COVID-19 pandemic and its consequences
European Commission: EU recommendations for testing strategies in the context of the COVID-19 pandemic
European Parliament: the ENVI committee calls for a strengthening of the ECDC and for more solidarity between Member States
CESUE: appeal to make public health a shared competence of the EU and to abolish the compulsory balanced budget provision

 

2

 Health care services in the internal market  [...]

European Commission: guidelines on EU emergency assistance on cross-border cooperation in healthcare related to the COVID-19 crisis
Euractiv: Austria imports workers from Bulgaria and Romania to plug gaps in COVID-19 care
European Commission: guidance on speeding up the recognition of the professional qualifications of health workers
Politico: Germany will cover the cost of treating European coronavirus patients hospitalised in the country
European Commission: new guidance to encourage and facilitate cross-border treatment of patients and deployment of medical staff
European Commission: guidelines for border measures to protect health and keep essential goods and services available
European Commission: guidance on customs issues related to the COVID-19 emergency
European Commission: temporary restriction on non-essential travel to the EU, due to the pandemic
European Commission: Coronavirus - European solidarity in action
European Commission: substances of human origin are considered to be essential goods and services

 

3

 Medicines, protection equipment and medical devices  [...]

European Commission: a new industrial strategy for greater European autonomy
Council of the EU: debate on the EU's strategic autonomy in critical industrial sectors
European Parliament: the INTA committee calls for a reduction in the EU's dependence on trade for the supply of medical products and equipment
European Commission: 7.4 billion euros in pledges to tackle COVID-19
EMA: global regulators work towards alignment of policy approaches and regulatory flexibility during the COVID-19 pandemic
EMA: supporting availability of medicines during COVID-19
EMA: fast-tracking development support and approval of medicines and vaccines against COVID-19
EMA: the International Coalition of Medicines Regulatory Authorities calls for regulatory flexibility during the pandemic
ICMRA: joint statement pledges collective support to combat the COVID-19 pandemic
EMA: Update to guidance on regulatory expectations in the context of the COVID-19 pandemic
EMA: launch of enhanced monitoring system for availability of medicines used to treat COVID-19
European Commission: delivery of millions of FFP2 masks suspended
Council of the EU: debate on a platform for dialogue aimed at preventing shortages of medicines
European Commission: draft negotiating directives for Brexit
European Commission: Single Market Enforcement Task force in relation to the pandemic
European Parliament: discussions with the Commissioner for the Internal Market on the pandemic 
European Commission: Germany and Romania hosting the European reserves of medical equipment
European Parliament: MEPs in the ENVI Committee warn the European Commission and the ECDC of the risk of a shortage of medicines
European Commission: guidance on clinical trials during the pandemic
EPHA: position paper on medicine shortages during the pandemic
European Commission: the EU mobilises help for Italy, Croatia and neighbouring countries via the EU Civil Protection Mechanism
European Commission: greater flexibility for the export authorisation scheme for exports of personal protective equipment outside the EU
European Commission: exports of medical equipment to countries outside the EU subject to an authorisation during the pandemic
Council of the EU: implementation of the 'medical devices' regulation postponed
European Commission: temporary waiver of VAT and customs duties on the import of medical equipment
NATO: agreement on coordinated military support to tackle COVID-19
EMA: new system to prevent shortages of medicines during the COVID-19 pandemic
Council of the EU: research and innovation are one of the priorities in the fight against COVID-19
European Commission: guidelines to avoid shortages of medicines during the COVID-19 outbreak
Eurojust: support for cross-border investigations into fraud linked to COVID-19
EMA: global regulators publish a report on treatments for COVID-19
European Commission: European programme on the collection and transfusion of plasma from convalescent COVID-19 patients
European Commission: guidelines on COVID-19 in vitro diagnostic tests and their performance
EMA: Addressing the potential impact of COVID-19on medicines supply in the EU
European Parliament: MEPs call for solidarity among Member States to tackle the pandemic
European Commission: harmonised standards for medical devices to respond to urgent needs related to COVID-19
European Commission: 'questions and answers' to help increase production of essential medical equipment and supplies
Euractiv: Commission's new pharmaceutical strategy wants to touch core issues
EMA and European Commission: notice concerning the withdrawal of the United Kingdom and EU rules on medicinal products for human use
EMA: call to pool research resources into large multi-centre, multi-arm clinical trials on COVID-19 treatments
ECDC: cloth masks and respirator sterilisation as options in health establishments in response to shortages
EPSU: health professionals call on the authorities to ensure that front-line staff are protected against COVID-19
European Commission: joint procurement of personal protective equipment during the coronavirus crisis
OLAF: enquiry into fake COVID-19 related products
European Commission: action against the spread of fake COVID-19 products online
IMI: EUR 45 million call for proposals on research into COVID-19

 

4

 e-Health  [...]

Eurofound: Now is the time for the digital transformation of social services
eHealth Network: presentation of interoperability guidelines for contact tracing apps in the EU
European Data Protection Board: guidelines on the processing of health data, geolocation and other tracing tools
European Commission: launch of a consultation on the GDPR
European Commission: recommendation on the use of digital tracing technologies in relation to the pandemic
European Commission: communication on apps supporting the fight against the pandemic in relation to data protection
eHealth Network: common EU toolbox for Member States for mobile applications to support the fight against COVID-19

 

5

 Social policy  [...]

European social partners: appeal to the Member States to adopt all the Commission proposals on COVID-19

 

6

 EU funding  [...]

Council of the EU: adoption of essential support measures relating to the pandemic
Eurogroup: opening of a credit line to combat COVID- 19 as part of the European Solidarity Mechanism
European Parliament: the Commission President outlines the EU recovery plan
Council of the EU: reallocation of structural funds to tackle the pandemic and its impact on health systems
European Commission: funding of projects in vaccine development, treatment and diagnostics
European Commission: Commission offers 80 million euros financing to the CureVac laboratory to help tackle the pandemic
European Parliament: the budget committee deplores 're-use' of existing funds in the fight against COVID-19
European Commission: allocation of funds to tackle COVID-19 from the Horizon 2020 programme
European Commission: vast mobilisation of European financing instruments to respond to the coronavirus pandemic
Council of the EU: the Member States approve the freeing up of more than 3 billion euro to support the European health sector
EIB: 24 million euros to support the company AM-Pharma to develop a treatment for acute kidney injury
EIB: collaboration with the Israeli Innovation Authority and financing agreement with the German pharmaceutical company Pluristem 

 

7

 Economic policy  [...]

France and Germany: French-German initiative for a European recovery from the coronavirus crisis
European Commission: publication of the 'European Semester Spring Package'
European Commission: adoption of reports on the excessive deficit procedures
European Commission: Post-programme surveillance report - Spain, spring 2020
European Commission: Post-programme surveillance report - Cyprus, spring 2020
European Commission: Enhanced surveillance report - Greece, May 2020
European Commission: Post-programme surveillance report - Portugal, autumn 2019
European Commission: protection of critical European assets and technology during the pandemic

 

8

 Competition  [...]

European Commission: approval of a Belgian aid scheme to finance research and development activities concerning COVID-19
European Commission: temporary framework for State aid measures to tackle COVID-19
European Commission: temporary framework on cooperation between businesses to supply critical goods
European Competition Network: joint statement on application of competition law during the COVID-19 crisis
European Commission: streamlining of procedures and shortening of time periods for procurements of medical supplies
United Kingdom: open letter from the competition authority to the pharmaceutical and food and drink industries
European Commission: approval of State aid for COVID-19 research and development
European Commission: approval of the merger of Mylan and Pfizer's Upjohn division, subject to conditions
European Commission: approval of a Dutch public scheme to support the social and healthcare services during the pandemic
Portugal: Hospital Particular do Algrave (HPA) fined for circumventing the competition rules
United Kingdom: guidance on business cooperation in response to COVID-19
European Commission: opening of an in-depth investigation into the proposed acquisition of Tachosil by Johnson & Johnson

 

9

 Court of Justice of the European Union  [...]

Judgment: the CJEU finds implementing regulation 2016/1140, concerning the classification of certain goods in the Combined Nomenclature, invalid
Judgment: health telephone services can be exempted from VAT
Judgment: a private hospital can be eligible for VAT exemption
Judgment: A product developed after the filing date of an application for a basic patent is not protected by that patent
Judgment: the package leaflet referred to in directive 2004/27/EC must only contain the information listed therein
Judgment: rehabilitation allowances are subject to the regulation on coordination of social security systems

 

10

 Publications  [...]

OSE: Another European rescue of the Member States? EU public health policy for COVID-19
Concurrences: Mergers & COVID-19 - the impact on EU and national merger control
Concurrences: Collaboration among competitors and COVID-19: the impact on EU and national case laws
Eurofound: COVID-19 intensifies emotional demands on health workers
Jacques Delors Institute: The race to develop a vaccine against COVID-19 – A major challenge for Europe
European Parliament Think tank: Exceptional coronavirus support measures of benefit to EU regions
OECD: Trade interdependencies in COVID-19 goods
Concurrences: analysis of the Commission decision to impose a fine on Canon in relation to its acquisition of Toshiba Medical Systems Corporation
WHO/Europe: Strengthening the health financing response to COVID-19 in Europe
OECD: The face mask global value chain in the COVID-19 outbreak: evidence and policy lessons
OECD: Trade facilitation and the COVID-19 pandemic
EURODIS: 9 in 10 people living with a rare disease are experiencing interruption of care because of COVID-19
The Progressive Post: Highway to Health?
International Journal of Health Policy and Management (IJHPM): COVID-19: a window of opportunity for positive healthcare reforms (article)
European Association of Hospital Pharmacists: Medicines shortages report
ETUI: COVID-19 contact tracing apps: how to prevent privacy from becoming the next victim
ETUI: Sickness benefits in the EU: making sense of diversity
Cedefop: Why our heroes will never be automated: investing in healthcare workers
Bruegel: EU trade in medical goods - why self-sufficiency is the wrong approach (blog post)
European Parliament: EU imports and exports of medical equipment (briefing)
Council of Europe: MEDICRIME vs Volcano
Europol: How criminals profit from the COVID-19 pandemic
VoxEU: EU solidarity in fighting COVID-19: State of play, obstacles, citizens' attitudes and ways forward
Health Policy: hospital reforms in 11 Central and Eastern European countries between 2008 and 2019 - a comparative analysis
BMJ: Coronavirus shows how the UK must act quickly before being shut out of Europe's health protection systems
COVID-19 Health system response monitor: cross-country analysis
Jacques Delors Institute: Health: a highly perfectible added value for the EU
Politico: How Europe failed the coronavirus test
LTCovid: LTC responses to COVID-19
Politico: Health ministers squabble over face masks at coronavirus talks
Politico: Blood supplies disrupted by coronavirus crisis
Eurofound: Impact of digitalisation on social services
FPS Health: International mobility of doctors (2020)
ESPN: Belgium - automatic identification of potential beneficiaries of social benefits, to reduce non-take-up
ESPN: The Italian health system on the eve of the pandemic
ESPN: Cyprus - First results of the new healthcare system
The Lancet: The resilience of the Spanish health system against the COVID-19 pandemic
CEPS: How is EU cooperation on the COVID-19 crisis perceived in Member States?
BMJ blog: Saving lives by European solidarity and cooperation in response to COVID-19
BMJ: Covid-19 exposes weaknesses in European response to outbreaks

 

11

 Miscellaneous  [...]

European Parliament: a timeline of EU action in response to the pandemic
Robert Schuman Foundation: Fighting the virus around Europe
Council of Europe: statement on respecting human rights in the management of the health crisis
FRA: Coronavirus pandemic in the EU: fundamental rights implications
Joint statement of the Alliance for Multilateralism
G20: the COVID-19 pandemic has highlighted systemic weaknesses in health systems
European health associations welcome the European Commission's response to the health crisis
WHO Europe: preventing COVID outbreak in prisons: a challenging but essential task for authorities
Council of Europe: Draft recommendation of the Committee of Ministers on the human rights impacts of algorithmic systems
Council of Europe: call for the implementation of social measures to improve access to healthcare
UNI Europa: Belgian care workers call out dangerous levels of understaffing in Orpea nursing homes
WTO/WHO recall the importance of open trade in ensuring flow of vital medical supplies 
WTO/IMF call for lifting trade restrictions on medical supplies
OECD: COVID-19 and international trade: issues and actions
CEB issues social inclusion bond in response to the COVID-19 pandemic 
WHO Europe: Strengthening the health system response to COVID-19: recommendations for the WHO European region
WHO Europe: Guidelines to help European countries maintain essential health services during the COVID-19 pandemic
WHO Europe: new WHO tools launched to help hospitals manage surge in COVID-19 patients
WHO Europe: sustaining population immunity to vaccine-preventable diseases during the COVID-19 pandemic
Council of Europe and UNHCR call on Member States to bring refugee health workers into the COVID-19 response

  

 

1

 Public health

European Commission: European public health responses to the pandemic
This is the a general web page gathering and describing the main European public health measures taken to tackle COVID-19.

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European Commission: guidelines on waste management in the coronavirus crisis
This document, published on 14 April 2020, provides guidelines, particularly directed at healthcare establishments, about waste management and treatment.

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European Commission: Belgian virologist Peter Piot appointed to the post of special adviser to the Commission President
Appointed to his post on 7 May 2020, he will advise the Commission in supporting and steering research and innovation in the global fight against the COVID-19 pandemic.

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European Commission: launch of an online platform for researchers, to gather data on Covid-19
The online platform, created on 20 April 2020, enables researchers to download, access and analyse reference and specialised data on COVID-19.

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European Commission: launch of the 'COVID-19 Clinical Management Support System'
Based on the experience with the European Reference Networks, this initiative, launched on 24 March 2020, will help to create rapid connections between the hospitals indicated by the Member States as reference centres for COVID-19, particularly by means of online conferences and meetings. This system is a means of communication which enables users to exchange information on clinical cases, share their skills and information on case diagnosis and treatment. 

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European Commission: European roadmap shows path towards common lifting of containment measures linked to the pandemic
On 15 April 2020, the Commission, in cooperation with the European Council, presented a roadmap showing a path towards the gradual lifting of the containment measures. This roadmap recommends, in particular, harmonised data gathering, increasing the resilience of healthcare systems and an increase in testing capacity.

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ECDC: Surveillance of COVID-19 at long-term care facilities in the EU/EEA
In this document, published on 19 May 2020, the European Centre for Disease Prevention and Control (ECDC) finds that it is of paramount importance to be able to rapidly identify, assess and control COVID-19 outbreaks in LTCFs. This document provides guidance for Member States planning to implement surveillance systems.

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ECDC: Guidance on discharge and ending isolation of hospitalised patients in the context of COVID-19
On 8 April 2020, the ECDC published a report containing guidance on the discharge of hospital patients at an early stage of improvement, particularly in order to maintain healthcare capacity for seriously ill patients.

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ECDC: increased risk that health and social care systems may be overwhelmed
In a report dated 8 April 2020, the ECDC estimates that there is a high risk of exceeding the capacity of health and social care systems in the EU/EEA and the United Kingdom, and calls for a stepping-up of measures to help cope with the flow of COVID-19 patients.

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ECDC: guidance document on the coronavirus disease and the supply of substances of human origin 
On 20 March 2020, the ECDC published a document evaluating the risks and management options for the safe and sustainable supply of substances of human origin in the context of the pandemic.

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ERN: creation of new capacity for the development of clinical practice guidelines and clinical decision support tools
The aim of this project is to provide technical assistance to the ERNs. Given the different approaches within the ERNs to clinical guidelines, it was deemed necessary to develop a common methodology, particularly in order to better define the specificity of the ERNs in this area.

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ERN: Feasibility study on the opportunity of setting up a European Expert Network for rare communicable diseases and other rare pathologies
This study, published on 28 February 2020, concludes that, since all identified rare non-communicable diseases linked to mobility and globalisation are already covered by various existing ERNs, there is no need to create a new specific network for them. The study therefore focused on rare communicable diseases linked to mobility and globalisation and considered three scenarios.

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European Council: cooperation between the Member States in the fight against COVID-19
On 10 March 2020, the EU Heads of State agreed to step up coordination in order, notably, to limit the spread of the virus, to provide medical equipment and to promote research.

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Chafea: tender to promote the mobility of health professionals working in the ERNs
The aim of this tender, launched on 11 March 2020 by the Consumers, Health, Agriculture and Food Executive Agency (Chafea) is to strengthen clinical and organisation expertise and thus to enhance cooperation within the networks.

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European Commission: creation of a team of scientific experts to strengthen the European response to the pandemic
The aim of this team, set up on 17 March 2020 and made up of epidemiologists and virologists from various Member States, is to draw up EU guidelines on the management of COVID-19-related risks.

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European Commission: recommendations on health systems' resilience in the context of the COVID-19 pandemic
This document, published on 30 March 2020, recommends that all Member States carefully review their national strategies in the light of these recommendations in order to take measures to reduce the pressure on their respective health systems.

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Council of the EU: statement of the Member States on the EU actions in response to the COVID-19 epidemic
On 26 March 2020, the Member States called on the Commission to pursue and accelerate its efforts to help ensure urgent and adequate provision of medical equipment throughout the EU. The Member States highlight the importance of close cooperation in this regard and of providing the Commission with reliable data in a timely manner. 

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European Commission: communication on a European coordinated response to counter the economic impact of the coronavirus
On 13 March 2020, the Commission published the overall list of the available tools and mechanisms to tackle the pandemic, and in particular to ensure the necessary provision of national health systems

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CoR: launch of an exchange platform to support regions and local communities across Europe in the context of the health crisis
The platform falls under the action plan set up in reaction to the health crisis by the Committee of the Regions (CoR) on 24 March 2020. It will make it easier to target the health needs of local communities.

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European Parliament: Resolution on EU coordinated action to combat the COVID-19 pandemic and its consequences
The resolution, adopted on 17 April 2020, calls particularly for the Union to be given extended competences to act in the case of cross-border health threats, to ensure a coordinated response, and to propose a health autonomy action to strengthen European autonomy in strategic areas such as active pharmaceutical ingredients.

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European Commission: EU recommendations for testing strategies in the context of the COVID-19 pandemic
In this document published on 18 March 2020, the Commission emphasises that testing strategies must adapt to ensure an optimal use of resources and to reduce the pressure on laboratories.

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European Parliament: the ENVI committee calls for a strengthening of the ECDC and for more solidarity between Member States
In early April 2020, the ENVI committee wrote to the Council and to the Member States, calling for a strengthening of the ECDC and the use of the EU coordination mechanisms to ensure that the countries which still have material and human capacities put them at the service of those at risk of being overwhelmed by the pandemic. 

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CESUE: appeal to make public health a shared competence of the EU and to abolish the compulsory balanced budget provision
This appeal, published by the International Centre for European and Global Governance (CESUE) and signed by more than 1,500 public figures, calls, in particular, for public health and the fight against epidemics to become a shared competence of the EU, and for the Commission to be given extraordinary powers to coordinate responses to epidemics. 

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2

 Health care services in the internal market

European Commission: guidelines on EU emergency assistance on cross-border cooperation in healthcare related to the COVID-19 crisis
In a communication, published on 3 April 2020, the Commission invites the national, regional and local health authorities to fully operate the existing structures and mechanisms to step up cooperation between the Member States, and to maximise the human and material capacity of EU health systems.

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Euractiv: Austria imports workers from Bulgaria and Romania to plug gaps in COVID-19 care
An article published in Euractiv on 31 March 2020 reports that the Austrian health system is heavily dependent on staff from Eastern Europe, many of whom shuttle back and forth, staying in Austria for several weeks.

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European Commission: guidance on speeding up the recognition of the professional qualifications of health workers
The aim of this communication to the Member States, published on 8 May 2020, is to ensure, as far as possible, the free movement of health workers during the pandemic.

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Politico: Germany will cover the cost of treating European coronavirus patients hospitalised in the country
On 19 April 2020, the German government announced that Germany will cover the treatment costs of COVID-19 patients transferred to Germany from other Member States. 

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European Commission: new guidance to encourage and facilitate cross-border treatment of patients and deployment of medical staff
The purpose of this decision, issued on 3 April 2020, is to help ease overburdening in hospitals by transferring patients, and to provide support to the cross-border deployment of medical teams.

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European Commission: guidelines for border measures to protect health and keep essential goods and services available 
The purpose of these guidelines, published on 16 March 2020, is to ensure the right treatment of people who have to travel, and to make sure that essential goods and services remain available, particularly healthcare related goods in the context of the COVID-19 pandemic.

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European Commission: guidance on customs issues related to the COVID-19 emergency
One of the aims of this specialist guidance, dated 29 April 2020, is to reduce to a minimum the custom formalities for the import of human organs and bone marrow for transplant.

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European Commission: temporary restriction on non-essential travel to the EU, due to the pandemic
On 30 March 2020, the Commission published practical guidance exempting health professionals from these restrictions. In addition, on 8 April 2020, the Commission recommended the creation of special priority lanes for the transport of goods or health products.

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European Commission: Coronavirus - European solidarity in action
On 15 May 2020, the European Commission set up an online platform listing all the cross-border cooperation initiatives in the EU aimed at tackling the COVID-19 pandemic and helping the most affected countries.

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European Commission: substances of human origin are considered to be essential goods and services 
This document, published on 29 April 2020, confirms that substances of human origin should be considered as essential goods and services, for which free circulation within the EU is crucial.

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3

 Medicines, protection equipment and medical devices

European Commission: a new industrial strategy for greater European autonomy
On 10 March 2020, the Commission presented the new European industrial strategy. In addition to the new European pharmaceutical strategy, the EU will develop a new action plan to secure the supply of critical goods, particularly pharmaceutical products. 

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Council of the EU: debate on the EU's strategic autonomy in critical industrial sectors
On 15 May 2020, the EU ministers responsible for industry highlighted the need to guarantee the EU's strategic autonomy by reducing its dependency on third countries for critical supplies such as pharmaceutical ingredients and raw materials. However, the Member States still do not agree on the political instruments to be used to this end.

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European Parliament: the INTA committee calls for a reduction in the EU's dependence on trade for the supply of medical products and equipment
On 21 April 2020, the MEPs in the European Parliament's Committee on international trade called on the Commission to adjust its industrial policy to this effect.

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European Commission: 7.4 billion euros in pledges to tackle COVID-19
These pledges were made on 4 May 2020, during the 'Coronavirus Global Response' pledging event, gathering funding to ensure the development and universal distribution of diagnostics, treatments and vaccines against COVID-19.

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EMA: global regulators work towards alignment of policy approaches and regulatory flexibility during the COVID-19 pandemic
An EMA press release dated 18 May 2020 reports that global regulators spoke in favour of greater cooperation and closer alignment of their approaches to clinical trial management, medicine supply issues and pharmacovigilance.

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EMA: supporting availability of medicines during COVID-19
On 13 May 2020, the EU Executive Steering Group on Shortages of Medicines caused by Major Events discussed with the heads of the national competent authorities on the measures taken to ensure the future availability of essential medicines. They also discussed ways to improve their forecasting capacities and looked at best practices regarding data modelling.

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EMA: fast-tracking development support and approval of medicines and vaccines against COVID-19
On 4 May 2020, the EMA published a note on how it will accelerate its regulatory procedures so that market authorisations for COVID-19 medicines can be granted as quickly as possible.

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EMA: the International Coalition of Medicines Regulatory Authorities calls for regulatory flexibility during the pandemic
A press release of 5 May 2020 states that the global regulators are calling for an alignment of pre- and post-authorisation regulatory requirements to facilitate the rapid development and availability of COVID-19 medicines.

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ICMRA: joint statement pledges collective support to combat the COVID-19 pandemic
On 28 April 2020, the international regulators called for priority to be given to large, controlled clinical trials. These are most likely to generate the robust evidence needed for decision-making by regulators on COVID-19 treatments.

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EMA: Update to guidance on regulatory expectations in the context of the COVID-19 pandemic
A note dated 20 April 2020 recalls the measures taken in cooperation with the Commission and the national competent authorities concerning inspections of manufacturing facilities or other sites relevant for medicinal products, in order to avoid the 'disruptions'.

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EMA: launch of enhanced monitoring system for availability of medicines used to treat COVID-19
On 21 April 2020, the EMA, together with the pharmaceutical industry and the EU Member States, launched its enhanced fast-track monitoring system to help prevent and mitigate supply issues with crucial medicines used to treat COVID-19 patients.

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European Commission: delivery of millions of FFP2 masks suspended
On 14 May 2020, the Commission suspended the delivery of several million FFP2 masks coming from China and intended for healthcare workers. A first delivery of one and a half million masks had been sent to 16 Member States and to the United Kingdom. On receipt, some countries noted that the masks did not meet European standards. 

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Council of the EU: debate on a platform for dialogue aimed at preventing shortages of medicines
On 12 May 2020, the Ministers of Health discussed political ideas to tackle shortages of medicines, and emphasised, in particular, the need of setting of up a platform for dialogue with the pharmaceutical industry.

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European Commission: draft negotiating directives for Brexit
These draft directives, published on 18 March 2020, refer, among other things, to the arrangements for trade in medical products and equipment between the United Kingdom and the EU.

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European Commission: Single Market Enforcement Task force in relation to the pandemic
The first meeting of the Single Market Enforcement Task force, 'SMET', was held on 8 April 2020, for a discussion of the need to allow free movement within the EU of goods such as masks, medical supplies and foodstuffs.

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European Parliament: discussions with the Commissioner for the Internal Market on the pandemic
On 2 April 2020, in the European Parliament committee on the internal market and consumer protection, the Commissioner expressed his willingness to increase the production of medical equipment. Some aspects of globalisation, he said, particularly in the pharmaceutical sector, should be re-evaluated.

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European Commission: Germany and Romania hosting the European reserves of medical equipment
Germany and Romania are hosting the EU strategic distribution centres, RescEU. These centres are fully funded from the EU budget.

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European Parliament: MEPs in the ENVI Committee warn the European Commission and the ECDC of the risk of a shortage of medicines
On 5 March 2020, the MEPs in the Committee on the Environment, Public Health and Food Safety asked the Commission and the ECDC about a possible 'Plan B' to ensure availability of essential medicines during the pandemic.

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European Commission: guidance on clinical trials during the pandemic
On 28 April 2020, the Commission published guidance on harmonised actions, as well as national guidance to ensure flexibility and simplification of clinical trial procedures during the pandemic.

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EPHA: position paper on medicine shortages during the pandemic
The pandemic has tended to exacerbate a situation which is already critical. On 27 April 2020, the European Public Health Alliance (EPHA) made nine recommendations to address medicine shortages.

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European Commission: the EU mobilises help for Italy, Croatia and neighbouring countries via the EU Civil Protection Mechanism
In late April 2020, following requests for assistance via the EU Civil Protection Mechanism, Slovakia sent masks and disinfectant to Italy, while Austria sent gloves and disinfectant to Croatia and to the Balkans.

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European Commission: greater flexibility for the export authorisation scheme for exports of personal protective equipment outside the EU
From 23 April, this regime, established in agreement with the Member States, eases the export restrictions decided at the peak of the health crisis.

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European Commission: exports of medical equipment to countries outside the EU subject to an authorisation during the pandemic
A communication published by the Commission on 20 March 2020 states that Member States are authorised to grant export authorisations for medical equipment outside the EU, particularly when this will not jeopardise the fulfilment of needs within the Union, and as a response to a genuine medical need elsewhere.

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Council of the EU: implementation of the 'medical devices' regulation postponed
On 22 April 2020, the Council of the EU adopted a Commission proposal postponing implementation of the regulation, so that Member States, health establishments and economic actors can prioritise the fight against COVID-19.

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European Commission: temporary waiver of VAT and customs duties on the import of medical equipment
On 3 April 2020, at the request of the Member States, the Commission decided to temporarily waive VAT and customs duties on medical devices and protective equipment imported into the Union from third countries. 

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NATO: agreement on coordinated military support to tackle COVID-19
On 2 April 2020, NATO Foreign Ministers advocated military support to combat the coronavirus crisis and the use of fast-track paths through Europe's airspace for military flights transporting medical supplies.

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EMA: new system to prevent shortages of medicines during the COVID-19 pandemic
In a press release dated 6 April 2020, the EMA announced that the i-SPOC system created by the EU Executive Steering Group on Shortages of Medicines caused by Major Events and the pharmaceutical industry, will enable pharmaceutical companies to report any possible shortages directly to the EMA.

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Council of the EU: research and innovation are one of the priorities in the fight against COVID-19
On 7 April 2020, the European ministers responsible for research supported the priority action plan for research (ERAvsCorona Action Plan) developed together with the Commission. They also highlighted the need to step up exchange of information and data and to increase cooperation with a view to developing a vaccine.

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European Commission: guidelines to avoid shortages of medicines during the COVID-19 outbreak
On 8 April 2020, the Commission published a series of guidelines to Member States, to help them bridge the gap between supply and demand, and to reduce the risks of shortages of essential COVID-19 medicines.

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Eurojust: support for cross-border investigations into fraud linked to COVID-19
On 8 April 2020, the EU's judicial cooperation unit, Eurojust, said that it was supporting several cross-border investigations, particularly involving the sale of fraudulent face masks, as well as a case of criminals who hacked into the computer system of a Czech hospital.

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EMA: global regulators publish a report on treatments for COVID-19
This report, published on 9 April 2020, stresses the need for robust evidence on the development of potential therapeutics, clinical trials and compassionate use programmes.

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European Commission: European programme on the collection and transfusion of plasma from convalescent COVID-19 patients
This programme, launched in early April, aims to develop a common EU approach to the donation, collection, monitoring, treatment, storage, distribution and follow-up of plasma to treat Covid-19.

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European Commission: guidelines on COVID-19 in vitro diagnostic tests and their performance
This document, published on 15 April 2020, describes the EU regulatory context of COVID-19 in vitro diagnostic tests and gives an overview of the various types of test and their objectives. It sets out considerations to be borne in mind by Member States when defining their national strategies, and by economic operators when placing tests on the market, with a view to ensuring that COVID-19 tests are safe and effective.

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EMA: Addressing the potential impact of COVID-19on medicines supply in the EU
A press release published on 10 March 2020 states that the EMA and its partners in the European medicines regulatory network are closely monitoring the potential impact of the outbreak of COVID-19 on pharmaceutical supply chains into the EU. 

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European Parliament: MEPs call for solidarity among Member States to tackle the pandemic
During the plenary session of 10 March 2020, MEPs called for medical supplies to be produced in the EU and made available to all Member States to purchase.

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European Commission: harmonised standards for medical devices to respond to urgent needs related to COVID-19
Publication and adoption of these harmonised standards by the Commission on 25 March 2020 enables manufacturers to place high-performing devices on the market, more quickly and cheaply.

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European Commission: 'questions and answers' to help increase production of essential medical equipment and supplies
These questions and answers, published by the Commission on 30 March 2020, are intended to assist manufacturers of masks and other personal protective equipment, leave-on-hand cleaners and other hand disinfectants, or working in the field of 3D printing.

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Euractiv: Commission's new pharmaceutical strategy wants to touch core issues
An article published by Euractiv on 12 March 2020 reports that the Commission is planning to examine the affordability of medicines for patients and national health systems, as well as reviewing the EU's dependence on third countries for supplies of essential pharmaceutical products.

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EMA and European Commission: notice concerning the withdrawal of the United Kingdom and EU rules on medicinal products for human use
This notice, published on 13 March 2020, emphasises that Brexit will create new conditions with regard to market access, the customs union, and VAT and excise duties, including for medicines for human use.

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EMA: call to pool research resources into large multi-centre, multi-arm clinical trials on COVID-19 treatments
On 16 March 2020, the EMA's Committee on medicinal products for human use published a statement calling on EU researchers to prioritise large randomised controlled studies, as they are most likely to enable rapid development and approval of potential COVID-19 treatments.

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ECDC: cloth masks and respirator sterilisation as options in health establishments in response to shortages
This document, published on 26 March 2020, gives advice on the use of cloth face masks and on the sterilisation of respirators and surgical masks as an option in health establishments with suspected or confirmed cases of COVID-19, in situations where there is a shortage of surgical masks and specialised respirators. 

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EPSU: health professionals call on the authorities to ensure that front-line staff are protected against COVID-19
On 26 March 2020, twelve European organisations representing all health professionals listed the key needs which must be met in response to the health crisis. They denounced the lack of medical supplies and personal protection equipment in almost all Member States.

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European Commission: joint procurement of personal protective equipment during the coronavirus crisis
This procurement should make it possible to equip hospitals, health professionals, care homes and individuals in greatest need. For most equipment, the procurement was launched on 17 March 2020, and a call for masks was launched on 28 February 2020.

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OLAF: enquiry into fake COVID-19 related products
On 19 March 2020, the European Anti-fraud Office (OLAF) launched an enquiry into the import of fraudulement medical products and devices.

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European Commission: action against the spread of fake COVID-19 products online 
A press release issued on 19 March 2020 reports that the European Commission and the network of national consumer protection authorities at EU level have now launched joint actions, to increase the sharing of information and to develop a consist approach to tackling the sale of fake goods.

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IMI: EUR 45 million call for proposals on research into COVID-19
On 3 March 2020, the Innovative Medicines Initiative (IMI) launched a fast-track call for proposals on the development of therapeutics and diagnostics to tackle the coronavirus.

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4

 e-Health

Eurofound: Now is the time for the digital transformation of social services
In a report published on 23 April 2020, Eurofound underlines that some barriers need to be addressed before the full potential of digital technologies can be realised. The nature of social care and social welfare, including healthcare systems, makes the use of big data and artificial intelligence particularly difficult. The data dealt with are sensitive, and there is a lack of clarity about how and with whom these data should be shared.

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eHealth Network: presentation of interoperability guidelines for contact tracing apps in the EU
This document, drawn up together with the Commission and published on 13 May 2020, concerns the tracing of cross-border infection chains. In the long term, this work will support the gradual lifting of border checks within the EU and the restoral of freedom of movement.

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European Data Protection Board: guidelines on the processing of health data, geolocation and other tracing tools
In these guidelines, published on 21 April 2020, the Board recalls the general principles of effectiveness, necessity and proportionality, as well as the importance of anonymisation, and warns against a 'ratchet effect'.

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European Commission: launch of a consultation on the GDPR
This public consultation was open throughout the month of April, and related to a monitoring of the General Data Protection Regulation (GDPR), two years after its entry into force. The scope of the regulation includes the management of medical data.

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European Commission: recommendation on the use of digital tracing technologies in relation to the pandemic
In this recommendation, adopted on 8 April 2020, the Commission indicates that the use of digital data can be very important in fighting COVID-19, while fully respecting European rules, particularly those related to privacy.

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European Commission: communication on apps supporting the fight against the pandemic in relation to data protection
The aim of this communication, published on 16 April 2020, is to promote the least intrusive solutions which respect European legislation on the protection of personal data and privacy.

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eHealth Network: common EU toolbox for Member States for mobile applications to support the fight against COVID-19
This toolbox, published on 15 April 2020, sets out a common approach aiming to harness the latest privacy-enhancing technologies that enable at-risk individuals to be contacted and, if necessary, to be tested as quickly as possible, regardless of where they are and the app they are using.

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5

 Social policy

European social partners: appeal to the Member States to adopt all the Commission proposals on COVID-19
In a joint statement published on 24 March 2020, the European Trade Union Confederation and the employers' organisation BusinessEurope called for an end to export restrictions on medical supplies, strengthening of national health services and the use of European funds to this end. 

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6

 EU funding

Council of the EU: adoption of essential support measures relating to the pandemic
The Coronavirus Response Investment Initiative and the extension of the EU Solidarity Fund were adopted on 30 March 2020 by the Parliament and the Council. The aim of these texts is to use European funds to tackle the pandemic, particularly by supporting the national healthcare systems of the Member States.

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Eurogroup: opening of a credit line to combat COVID- 19 as part of the European Solidarity Mechanism
On 8 May 2020, the Member States agreed to open this new credit line, on one condition: that the amounts be disbursed to finance the direct and indirect costs of healthcare, treatment and prevention of COVID-19.

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European Parliament: the Commission President outlines the EU recovery plan
On 13 May 2020, Ursula von der Leyen told MEPs that the Commission will propose a new investment facility in strategic sectors, particularly the pharmaceutical sector, to relocate the production of certain key products. The resources of the European Civil Protection Mechanism will be increased, as will those of the future Horizon Europe research programme. A new public health programme will also be launched.

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Council of the EU: reallocation of structural funds to tackle the pandemic and its impact on health systems
On 22 April 2020, the Council of the EU adopted a legislative act to redirect some of the structural funds and European investments towards health systems.

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European Commission: funding of projects in vaccine development, treatment and diagnostics
Following the publication of a EUR 10 million call in January, the Commission has secured an additional EUR 37.5 million for research into COVID-19 vaccine development, treatment and diagnostics.

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European Commission: Commission offers 80 million euros financing to the CureVac laboratory to help tackle the pandemic
On 16 March 2020, the Commission offered financial support of up to 80 million euros to CureVac, for the development and production of a COVID-19 vaccine.

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European Parliament: the budget committee deplores 're-use' of existing funds in the fight against COVID-19
On 16 March 2020, the chair and coordinators of the budget committee claimed that the resources allocated are insufficient to counter the negative impact of the crisis on European health systems. They deplore that most of these funds are existing funds which are being reallocated.

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European Commission: allocation of funds to tackle COVID-19 from the Horizon 2020 programme
On 25 March 2020, the Commission adopted an update of the 2020 work programme of Horizon 2020, to redirect its priorities notably towards research and innovation projects related to COVID-19.

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European Commission: vast mobilisation of European financing instruments to respond to the coronavirus pandemic
A press release issued on 2 April 2020 reports that the funds made available include 3 billion euros allocated to the European emergency support instrument, of which 300 million will go to RescEU to support the common stockpile of medical equipment.

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Council of the EU: the Member States approve the freeing up of more than 3 billion euro to support the European health sector
On 14 April 2020, the Council adopted two proposals amending the European budget for 2020. These amendments will free up funds to be used to finance the needs of European health care systems, particularly by stockpiling and distributing medical supplies. These funds will be made available via the European Civil Protection Mechanism/ rescEU.

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EIB: 24 million euros to support the company AM-Pharma to develop a treatment for acute kidney injury
On 31 March 2020, the European Investment Bank (EIB) and AM-Pharma B.V. signed a financing agreement to accelerate the development of the recombinant alkaline phosphatase enzyme (recAP).

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EIB: collaboration with the Israeli Innovation Authority and financing agreement with the German pharmaceutical company Pluristem
The EIB is providing 50 million euros of financial support to the company Pluristem, for the clinical development of cell therapies and treatment of serious medical conditions. In parallel, on 30 April 2020, the EIB and the Israeli Innovation Authority signed a cooperation agreement in the field of innovation, and will work together on investment possibilities in the area of bio-convergence in health.

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7

 Economic policy

France and Germany: French-German initiative for a European recovery from the coronavirus crisis
On 18 May 2020, Germany and France presented a proposal for a recovery plan. This plan will make 500 billion euros available, and will be built around four main pillars: health protection, economic recovery, the green transition and economic sovereignty. Under the proposed initiative, the EU would be given specific competences to stockpile masks and tests, to coordinate procurements and the production of treatments and vaccines, in epidemic prevention and to develop common methods for recording cases.

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European Commission: publication of the 'European Semester Spring Package'
On 20 May 2020, the Commission published its Country-specific Recommendations, calling on all Member States to take measures to enhance the resilience of their national health systems. This is the first time, in the wake of the COVID-19 crisis, that the Commission has proposed health-related recommendations to every Member States.

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European Commission: adoption of reports on the excessive deficit procedures
On 20 May 2020, the Commission adopted reports on the European budgetary rules for all the EU countries (except for Romania). The reports include an analysis of the effect of the COVID-19 pandemic, which has led Member States to adopt budgetary measures strengthening their health systems capacity.

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European Commission: Post-programme surveillance report - Spain, spring 2020
This report, published on 20 May 2020, presents the findings of the thirteenth post-programme surveillance mission to Spain and identifies the remaining challenges for the Spanish economy. The Spanish deficit is set to reach around 10% of GDP, partly due to increased health expenditure to tackle the pandemic.

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European Commission: Post-programme surveillance report - Cyprus, spring 2020
According to this report, the recession triggered by COVID-19 is expected to take a heavy toll on public finances in Cyprus in 2020. The fiscal measures adopted to fight the pandemic, including additional expenditure on health, are equivalent to around 4.5% of GDP. 

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European Commission: Enhanced surveillance report - Greece, May 2020
In this report, the Commission addresses, among other topics, the reforms in the healthcare sector. According to the Commission, the structural reforms already put in place, as well as 200 million euros in additional funding, should enable the system to cope with the pandemic. Nevertheless, additional financial resources may be necessary in the short term.

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European Commission: Post-programme surveillance report - Portugal, autumn 2019
This report, published on 8 April, emphasises that the national plan to improve the sustainability of the health system is 'promising', particularly if it is swiftly and 'forcibly' implemented.

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European Commission: protection of critical European assets and technology during the pandemic
On 25 March 2020, the Commission published guidelines setting out an approach to foreign investment screening, to preserve EU companies and critical assets, notably in areas such as health.

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8

 Competition

European Commission: approval of a Belgian aid scheme to finance research and development activities concerning COVID-19
The aid scheme, approved by the Commission on 12 May 2020, makes 25 million euros available to all companies in Wallonia that have the capacity to carry out R&D projects linked to COVID-19, including diagnostic solutions and the development and validation of treatment and vaccines.

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European Commission: temporary framework for State aid measures to tackle COVID-19
The purpose of this framework, adopted by the Commission on 19 March, is to use the full flexibility foreseen under state aid rules to support the economy in the context of the COVID-19 outbreak. The framework will allow Member States to grant national funds to health or other public services to fight the pandemic. A later extension to the framework, adopted on 3 April, is aimed at encouraging Member States to pursue and step up the research, testing and manufacturing of products useful in fighting the virus.

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European Commission: temporary framework on cooperation between businesses to supply critical goods
This temporary framework, published by the Commission on 8 April 2020, aiming at preventing shortages, particularly of medical supplies, authorises businesses, under certain conditions, to cooperate and coordinate the production, stock-management and distribution of goods.

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European Competition Network: joint statement on application of competition law during the COVID-19 crisis
On 25 March 2020, the European competition authorities recalled, in a joint statement, that action will be taken against companies cartelising or abusing their dominant position in sectors producing essential goods to protect health.

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European Commission: streamlining of procedures and shortening of time periods for procurements of medical supplies
The guidance published by the Commission on 1 April 2020 concern an extension of the negotiated procedure without publication, which allows public buyers to acquire medical supplies in a few days, even a few hours.

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United Kingdom: open letter from the competition authority to the pharmaceutical and food and drink industries
On 20 March 2020, the UK Competition Authority warned the pharmaceutical and food and drink industries not to capitalise on the COVID-19 epidemic to charge unjustifiably high prices. It has received more than 20,000 complaints in relation to the COVID-19 pandemic.

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European Commission: approval of State aid for COVID-19 research and development
During March and April 2020, the Commission authorised several Member States to provide State aid for the research, development and manufacture of products such as medicines, vaccines, hospital as well as medical supplies and equipment related to COVID-19.

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European Commission: approval of the merger of Mylan and Pfizer's Upjohn division, subject to conditions
This merger, authorised by the Commission on 22 April 2020, will lead to the combination of Mylan, one of the top five generic suppliers in the EEA, and the medicines manufacturer Upjohn.

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European Commission: approval of a Dutch public scheme to support the social and healthcare services during the pandemic
This 23 million euro State aid scheme, approved on 3 April 2020, will enable service providers to purchase, lease, licence and implement e-health applications.

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Portugal: Hospital Particular do Algrave (HPA) fined for circumventing the competition rules
The Portuguese competition authority published a press release on 19 March 2020 reporting that the hospital had been fined 155,000 euros for acquiring sole control of Hospital de S. Gonçalo de Lagos S.A. (HSGL) without obtaining approval from the antitrust entity.

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United Kingdom: guidance on business cooperation in response to COVID-19
The UK competition authority, in a press release dated 25 March 2020, states that, if cooperation takes place purely to ensure the supply of essential goods, it will take no action against it. 

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European Commission: opening of an in-depth investigation into the proposed acquisition of Tachosil by Johnson & Johnson
On 25 March 2020, the Commission opened an investigation, to determine whether this acquisition restricts competition and innovation for the supply of dual haemostatic patches.

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9

 Court of Justice of the European Union

Judgment: the CJEU finds implementing regulation 2016/1140, concerning the classification of certain goods in the Combined Nomenclature, invalid
This case is the result of a dispute between Pfizer Consumer Healthcare Ltd and the British tax authorities. The Court of Justice of the European Union (CJEU) found, in case C-182/19, that the Commission's implementing regulation (EU) 2016/1140, on the classification of certain goods in the Combined Nomenclature, is invalid.

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Judgment: health telephone services can be exempted from VAT
In case C-48/19, the CJEU found that medical services provided by telephone may be exempt from VAT, as long as they pursue a therapeutic objective. Moreover, the nurses and medical assistants providing this service do not require additional professional qualifications to be VAT-exempt.

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Judgment: a private hospital can be eligible for VAT exemption
The judgment in case C-211/18 concerns VAT exemption for care provided by a private hospital. According to the judgment, the competent authorities of a Member State may take into account the fact that care provided by the hospital is supplied under contracts concluded with the public authorities, at prices fixed by those contracts, and that the costs are partially borne by the social security institutions.

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Judgment: A product developed after the filing date of an application for a basic patent is not protected by that patent
This judgment follows proceedings between Royalty Pharma and the German Patent and Trade Mark Office concerning the Office's refusal to issue a supplementary protection certificate for sitagliptin, a treatment for diabetes mellitus. In case C-650/17, the CJEU found that a product is not protected by a basic patent in force if it was developed after the filing date of the application for the basic patent, following an independent inventive step.

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Judgment: the package leaflet referred to in directive 2004/27/EC must only contain the information listed therein
This judgment refers to two disputes between the German Homeopathy Union (DHU) and the Republic of Germany, concerning a refusal to register homeopathic medicinal products the package leaflet of which included information related to posology. In joined cases C-101/19 and C-102/19, the CJEU found that, under European law, the package leaflet should not contain any information other than that listed in directive 2004/27/EC.

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Judgment: rehabilitation allowances are subject to the regulation on coordination of social security systems
In case C-135/19, the CJEU found that rehabilitation allowances are sickness benefits, and are therefore covered by regulation 465/2012 on coordination of social security systems. A person who moves his/her place of residence to another Member State may therefore be refused such a benefit by the competent institution of his/her Member State of origin, since that person is now subject to the legislation of the Member State in which his/her place of residence is situated.

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10

 Publications

OSE: Another European rescue of the Member States? EU public health policy for COVID-19
According to the author of this article, the EU is 'trapped in a fork'. On one side, there is a strong norm of subsidiarity which keeps it from doing visible and popular things to help its citizens. On the other is the urge to show European citizens what it can do for them. 

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Concurrences: Mergers & COVID-19 - the impact on EU and national merger control
This article highlights that, during the COVID-19 pandemic, increasing attention has been paid to foreign investment, as countries do their best to protect their assets and health infrastructure.

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Concurrences: Collaboration among competitors and COVID-19: the impact on EU and national case laws
This article emphasises that cooperation between companies to ensure the supply of essential goods, particularly medical supplies, has an impact on competition law and impacts the usual applicable rules.

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Eurofound: COVID-19 intensifies emotional demands on health workers
This article, published on 31 March 2020 on the Eurofound website, emphasises the impact of the COVID-19 pandemic on the mental health of healthcare professionals, throughout the world.

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Jacques Delors Institute: The race to develop a vaccine against COVID-19 – A major challenge for Europe
In this race to find a vaccine against Covid-19, says the article, Europe should develop a new type of governance and should achieve a high level of cooperation between businesses, laboratories and governments in order to create a vaccine.

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European Parliament Think tank: Exceptional coronavirus support measures of benefit to EU regions
Actions under various EU funds and policy instruments, including the cohesion funds, are now geared towards health-related purposes and the economic recovery.

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OECD: Trade interdependencies in COVID-19 goods
No country can efficiently produce all the goods it needs to combat COVID-19. This document explores the trade interdependencies in the goods linked to COVID-19, and finds that trade can help to increase access to essential supplies.

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Concurrences: analysis of the Commission decision to impose a fine on Canon in relation to its acquisition of Toshiba Medical Systems Corporation
The Commission's decision which led to a 28 million euro fine on Canon for non-compliance with the competition rules is now being called into question by the legal analysis of a CJEU Advocate General in another case.

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WHO/Europe: Strengthening the health financing response to COVID-19 in Europe
This document refers to three objectives: improving access to healthcare, mobilising additional public funding and giving service providers the required flexibility.

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OECD: The face mask global value chain in the COVID-19 outbreak: evidence and policy lessons
According to the OECD, policies should support the efforts of multinational companies to create robust supply chains. Export bans are disastrous for countries with no production capacity, but can also backfire on countries which impose them when they, in turn, need to import inputs, additional masks or other essential goods.

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OECD: Trade facilitation and the COVID-19 pandemic 
Expediting the standard formalities needed for the movement of goods frees up more time for additional checks, particularly sanitary measures, during the pandemic, particularly for essential medical supplies.

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EURODIS: 9 in 10 people living with a rare disease are experiencing interruption of care because of COVID-19
The European federation of associations of patients living with a rare disease (EURODIS Rare Diseases Europe) has found that the pandemic is seriously hampering access to care for people living with a rare disease.

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The Progressive Post: Highway to Health?
Freedom of movement enables European citizens to travel abroad, but also aggravates staffing shortages in the health sector in some Member States, thus exacerbating social inequalities.

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International Journal of Health Policy and Management (IJHPM): COVID-19: a window of opportunity for positive healthcare reforms (article)
This article describes the possibilities opened up by the COVID-19 crisis to address problems in health systems, such as overtreatment, administrative complexity, fraud and abuse.

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European Association of Hospital Pharmacists: Medicines shortages report
This report explores issues such as the communication of medicines shortages, current management strategies, reasons for shortages, and their impact on patients.

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ETUI: COVID-19 contact tracing apps: how to prevent privacy from becoming the next victim
According to a Policy Brief published by the European Trade Union Institute (ETUI), contact tracing apps to combat the COVID-19 pandemic have been mentioned as useful tools to tackle the spread of the virus despite the many ethical and legal questions they raise.

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ETUI: Sickness benefits in the EU: making sense of diversity
The ETUI has published an information note comparing the different sickness benefit systems throughout the EU. The authors suggest, in particular, that in the context of the COVID-19 pandemic, public authorities should remove waiting periods and eligibility conditions for the self-employed, and provide them with a replacement rate comparable to that of employees.

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Cedefop: Why our heroes will never be automated: investing in healthcare workers
The European Centre for the development of vocational training (Cedefop) estimates that over the period 2018-30, the EU-27 will need almost 4 million health professionals, in all sectors.

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Bruegel: EU trade in medical goods - why self-sufficiency is the wrong approach (blog post)
The authors of this article claim that while localisation of production may be necessary for some specific goods, there are substantial advantages to keeping Europe's markets for medical goods open. 

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European Parliament: EU imports and exports of medical equipment (briefing)
The Parliament's research service shows that the production chain for medical goods is far more scattered that direct import figures would suggest.

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Council of Europe: MEDICRIME vs Volcano
This study shows how proper implementation of the MEDICRIME convention could improve the fight against pharmaceutical crime and the current regulations.

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Europol: How criminals profit from the COVID-19 pandemic
Europol has published several analytical reports on crime linked to the health crisis, and in particular on the sale of fraudulent medical supplies.

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VoxEU: EU solidarity in fighting COVID-19: State of play, obstacles, citizens' attitudes and ways forward
This article uses a survey conducted before the COVID-19 pandemic to understand EU citizens' attitudes towards a joint solidarity programme.

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Health Policy: hospital reforms in 11 Central and Eastern European countries between 2008 and 2019 - a comparative analysis
According to this article, there is 'considerable' potential for shared learning on hospital reforms for the 11 countries, since they are facing similar challenges: lack of a comprehensive approach, unclear outcomes of their reforms, and political influence.

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BMJ: Coronavirus shows how the UK must act quickly before being shut out of Europe's health protection systems.
The UK government is entitled to choose how closely it aligns with the EU rules on health and access to the single market. This choice will have consequences for the health of its citizens and that of its European neighbours.

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COVID-19 Health system response monitor: cross-country analysis
The health system response monitor is a joint undertaking of the WHO Regional office for Europe, the European Commission and the European Observatory on Health Systems and Policies. It performs a series of analyses comparing countries, looking at the responses and strategies put in place to combat the pandemic.

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Jacques Delors Institute: Health: a highly perfectible added value for the EU
According to this report, the health crisis should be an opportunity to review the existing coordination mechanisms in the field of health, and to consider establishing a common European health policy, particularly in terms of industrial policy.

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Politico: How Europe failed the coronavirus test
This article claims that the Member States did not take the measures needed to properly protect their populations and to manage the COVID-19 pandemic effectively. In particular, it criticises the lack of coordination and solidarity between the Member States. 

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LTCovid: LTC responses to COVID-19
LTCovid, supported by the International Long-Term Care Policy Network and the Care Policy and Evaluation Centre, publishes cross-cutting reports on the impact of COVID-19 on users and providers of long-term care, and on the measures adopted globally to contain and mitigate the impact of the virus on this sector.

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Politico: Health ministers squabble over face masks at coronavirus talks
On 6 March, at the Council of EU Health ministers, Maggie de Block criticised the ban imposed by Germany and the Czech Republic on exports of medical supplies.

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Politico: Blood supplies disrupted by coronavirus crisis
Blood donations are dropping, even though travelling to give blood counts as 'essential'.

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Eurofound: Impact of digitalisation on social services
This report explores the main issues surrounding digitalisation of social services, and addresses the challenges and needs in this area, particularly in the healthcare sector. According to the study, digital technologies can lead to savings by reducing the need for more costly and intensive care, detecting fraud more effectively and ensuring that scarce resources are allocated more efficiently.

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FPS Health: International mobility of doctors (2020)
This report analyses flows of doctors to and from abroad, with regard to the number of Belgian doctors and students trained in Belgium over the period 2004-2018.

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ESPN: Belgium - automatic identification of potential beneficiaries of social benefits, to reduce non-take-up
On 26 March 2020, Belgium decided to put in place a system allowing the automatic identification of potential beneficiaries of increased reimbursement of healthcare costs.

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ESPN: The Italian health system on the eve of the pandemic
The Italian healthcare system provides a good quality of care. Nevertheless, it has three sizeable weak points: its limited financial resources, the excessive workload of health professionals and inequalities in access to services.

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ESPN: Cyprus - First results of the new healthcare system
This long-awaited healthcare system will be an integrated system, financed by State revenues and contributions levied on wages, incomes and pensions.

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The Lancet: The resilience of the Spanish health system against the COVID-19 pandemic 
The Spanish health system is being severely tested by the pandemic. This is partially due to a decade of under-investment in the sector.

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CEPS: How is EU cooperation on the COVID-19 crisis perceived in Member States?
19 institutes from15 different countries analyse European solidarity during the pandemic, particularly with regard to the provision of medical equipment and supplies.

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BMJ blog: Saving lives by European solidarity and cooperation in response to COVID-19
The COVID-19 pandemic has demonstrated the importance of cooperation in healthcare between Member States and the need to develop cooperation mechanisms between countries. 

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BMJ: Covid-19 exposes weaknesses in European response to outbreaks
This editorial in the British Medical Journal (BMJ) emphasises that despite high level political commitment from the EU, the European response has exposed serious obstacles.

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11

 Miscellaneous

European Parliament: a timeline of EU action in response to the pandemic
This timeline lists the main measures taken by the EU to combat the pandemic, and classifies them into various topics.

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Robert Schuman Foundation: Fighting the virus around Europe
The Foundation provides a selection of reports on the fight against COVID-19 and the consequences of the epidemic, particularly on healthcare systems, in various Member States.

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Council of Europe: statement on respecting human rights in the management of the health crisis
On 14 April 2020, the Council of Europe's Committee on Bioethics recalled that the Oviedo Convention is the only legally binding instrument at international level in this field, to guide decisions and practices both in clinical work and research, including in a context of emergency health crisis management.

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FRA: Coronavirus pandemic in the EU: fundamental rights implications
In April 2020, the EU's Agency for Fundamental Rights (FRA) published a report on the implications of the COVID-19 pandemic, and the legislative measures adopted to contain it, for fundamental rights, particularly with regard to access to healthcare.

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Joint statement of the Alliance for Multilateralism
On 17 April 2020, the Alliance, of which several Member States are members, published a joint statement, emphasising that a continued efficient flow of medical supplies is critical to effective crisis response. Signatories to the statement include the Belgian Foreign Minister.

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G20: the COVID-19 pandemic has highlighted systemic weaknesses in health systems 
On 19 April 2020, the Health ministers highlighted the need to improve the effectiveness of global health systems by sharing knowledge and closing the gap in response capabilities and readiness.

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European health associations welcome the European Commission's response to the health crisis
In a joint letter published on 18 March 2020, the International Association of Healthcare Mutuals and Healthcare Funds (AIM), the European Hospital and Healthcare Federation (HOPE), the Standing Committee of European Doctors (CPME) and the European Social Insurance Platform (ESIP) welcomed the financing and coordination initiatives taken by the European Commission in response to the crisis. However, they would welcome a review of investments in research and development, and call for discussion on the growing shortages of essential medicines in Europe.

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WHO Europe: preventing COVID outbreak in prisons: a challenging but essential task for authorities
On 15 March 2020, the WHO's regional European office published interim guidance on dealing with COVID-19 in prisons and other detention centres.

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Council of Europe: Draft recommendation of the Committee of Ministers on the human rights impacts of algorithmic systems
On 8 April 2020, recognising the unprecedented scale of the use of digital applications, particularly in the field of health, the Committee of Ministers called for a precautionary approach.

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Council of Europe: call for the implementation of social measures to improve access to healthcare
In a statement published on 23 April 2020, the Council of Europe's Commissioner for Human Rights declared that healthcare costs in Europe are a major barrier to universal health coverage, and called for measures to address this situation and make healthcare more affordable.

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UNI Europa: Belgian care workers call out dangerous levels of understaffing in Orpea nursing homes 
Belgian workers from the Socialist and Christian trade unions went on strike in a nursing home on 10 March 2020. This is part of broader action by a European network set up by the unions representing staff working for the company Orpea, to coordinate their protests and voice their demands.

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WTO/WHO recall the importance of open trade in ensuring flow of vital medical supplies 
In a joint statement published on 20 April 2020, the WHO and the World Trade Organization (WTO) stress that keeping trade in health technologies as open and predictable as possible is therefore 'of vital interest'. 

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WTO/IMF call for lifting trade restrictions on medical supplies
On 24 April 2020, the International Monetary Fund (IMF) and the World Trade Organization (WTO) called on governments to refrain from imposing trade restrictions on medical and pharmaceutical goods. 

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OECD: COVID-19 and international trade: issues and actions
The Organisation for Economic Cooperation and Development (OECD), in an article published on 10 April 2020, calls for an international agreement to improve the availability of essential goods, notably pharmaceutical and medical supplies, in any future pandemics.

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CEB issues social inclusion bond in response to the COVID-19 pandemic
A press release issued on 8 April 2020 states that this 1 billion euro bond, issued by the Council of Europe Development Bank (CEB), aims at financing social inclusion projects and can be extended to the health sector in the countries that have been most affected by the pandemic.

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WHO Europe: Strengthening the health system response to COVID-19: recommendations for the WHO European region
This policy brief, published on 1 April 2020, makes 16 policy recommendations to break the chains of transmission, diagnose and treat COVID-19 cases while maintaining essential services.

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WHO Europe: Guidelines to help European countries maintain essential health services during the COVID-19 pandemic
In this document published on 25 March 2020, the WHO calls for transparent decision-making concerning the definition of 'essential the health services' and the training, reorientation, and mobilisation of health workers to meet the increasing demand while ensuring psychosocial follow-up.

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WHO Europe: new WHO tools launched to help hospitals manage surge in COVID-19 patients
At the beginning of April 2020, the WHO launched permanent tools to help estimate staffing, supplies and logistical needs in hospitals, accompanied by guidance to increasing hospital capacity.

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WHO Europe: sustaining population immunity to vaccine-preventable diseases during the COVID-19 pandemic
On 20 March 2020, WHO/Europe published guidance on systematic vaccination services during the COVID-19 pandemic in the European region. The organisation calls on countries to ensure that immunisation is maintained wherever possible and that surveillance for such diseases remains in place during the pandemic.

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Council of Europe and UNHCR call on Member States to bring refugee health workers into the COVID-19 response
A press release issued on 14 April 2020 reports that the Council of Europe and the UN High Commissioner for Refugees (UNHCR) are working together to identify and assess the qualifications of refugee health workers, and are inviting Member States to include them into the COVID-19 response.

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Information for this Newsletter was gathered up to the date of 20 May 2020.