European Health Care News

No.44 - December 2017


      

1

 Public health  [...]

European Commission: Communication on ‘Boosting growth and cohesion in EU border regions’
EU Compass Forum on mental health and well-being: report on the compass forum
European Commission: social factors and health inequalities faced by LGBTI people
European Commission: launch of the CHRODIS Plus joint action to alleviate the burden of chronic diseases
HSPA: reporting and communicating, practical guide for policy makers
European Commission: updated study on corruption in the healthcare sector
European Commission: cost-benefit analysis of a sustainable EU health information system
European Commission: European cross-border cooperation on health: theory and practice 
Euregio Meuse-Rhine: project on rare diseases (EMRaDi)

 

2

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

European Parliament: the new restrictiveness indicator for professional services: an assessment
German social security associations: press release on the standardisation of social and health services

 

3

 Medicines and medical devices  [...]

European Commission: public consultation on supplementary protection certificates and patent research exemptions
BeNeLuxA: launch of a website on international cooperation on medicines
EU-United States: mutual recognition of inspections of medicines manufacturers
European Commission: report on the state of children’s medicines in the EU
European Commission and EMA: new action plan on advanced therapy medicinal products
EMA: Exploring opportunities for collaboration between regulators and healthcare payers
European Commission: legislation on good manufacturing practice for medicinal products for human use
Greek government: severe tensions with the pharmaceutical industry
EXPH: opinion on innovative payment models for high-cost innovative medicines
EMA: action plan on the Commission recommendations on improving package leaflets
Council of Europe: final report of its pharmaceutical care quality indicators project

 

4

 e-Health  [...]

Estonian EU Presidency: Digital health society declaration
Estonian EU Presidency: conference on ‘Health in the Digital Society. Digital Society for Health’ 
EESC: opinion on the impact of the digital healthcare revolution on health insurance

 

5

 Social policy  [...]

Council of the EU: partial agreement on the proposal for a regulation on the coordination of social security systems
European Council: proclamation of the European Pillar of Social Rights
EPSCO Council: European Pillar of Social Rights
EPSCO Council: European Semester, the main messages from the Employment and Social Protection Committees endorsed by Council
Social Protection Committee: annual report 2017

 

6

 International agreements  [...]

EU–Canada: Entry into force of the Comprehensive Economic and Trade Agreement
France–Canada: French government’s action plan on the CETA

 

7

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

Judgment: a State may restrict the exercise of the profession of clinical dental technician for public health reasons
Opinion of the Advocate General: the dispute settlement mechanism contained in an investment treaty concluded between two Member States is compatible with EU legislation
Judgment: the VAT exemption for independent groups of persons is not limited to health

 

8

 Competition  [...]

European Commission: authorisation of the acquisition of Bard by BD, subject to conditions
European Commission: opening of an in-depth investigation into the proposed merger between Essilor and Luxottica
French competition authority: authorisation of the acquisition of MédiPôle-Partenaires by Elsan, subject to conditions
UK Competition and Markets Authority: publication of the full infringement decision on Pfizer and Flynn

 

9

 Publications  [...]

Article: Health policy in times of austerity
Article: Health technology assessment programme response to the challenges of dealing with orphan medicinal products
Article: Trade policy governance: what health policymakers and advocates need to know
Article: Recommendations from the European working group for value assessment and funding processes in rare diseases
Article: scenarios for Brexit and social security
EPHA: BENELUXA: First results of the multi-country cooperation on medicine price negotiations
OECD: Health at a Glance 2017
BMJ: most drugs entered the market without evidence of benefits on overall survival and quality of life
Eurohealth: special edition
Politico: the exodus of EU doctors and nurses

 

10

 Miscellaneous   [...]

WHO: ‘Towards a sustainable health workforce in the WHO European region: framework for action’ - Resolution
NHS Confederation: ‘Why reaching agreement on citizens’ rights post-Brexit is important for the NHS’
NHS Confederation: Brexit and the NHS, Election 2017
CBBA–Europe: new voice for the supporters of cross-border benefits in the EU
EIB: capital investment in health – for the first time
Conference: Regulating health professions in a European perspective

 

  

1

 Public health

European Commission: Communication on ‘Boosting growth and cohesion in EU border regions’
This Communication highlights ways in which the EU and its Member States can reduce the complexity, length and costs of cross-border interaction and promote the pooling of services along internal borders. The Commission also intends to carry out comprehensive mapping of cross-border healthcare cooperation. The Communication is accompanied by a working document from the Commission services.

DOC 1 FR  EN  NL  PDF  |  DOC 2 EN  PDF  

EU Compass Forum on mental health and well-being: report on the compass forum
This report provides an overview of the key messages from the presentations and round tables which took place at the second annual EU compass forum on mental health and well-being. The thematic areas for this year’s Forum were mental health at work, mental health in schools and prevention of suicide.

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European Commission: social factors and health inequalities faced by LGBTI people
These documents report back on tasks 1 and 2 of the Health4LGBTI project. This study looks at health inequalities faced by lesbian, gay, bisexual, transgender and intersex (LGBTI) people (particularly those in vulnerable situations), and at the potential obstacles confronting health professionals when providing care.

DOC 1 EN  PDF  |  DOC 2 EN  PDF  

European Commission: launch of the CHRODIS Plus joint action to alleviate the burden of chronic diseases
CHRODIS Plus (2017-2020) is a joint action which aims to support EU Member States in the implementation of initiatives identified in the first CHRODIS joint action (2013-2017) to alleviate the burden of chronic diseases.

DOC 1 EN  HTML  |  DOC 2 EN  HTML  

HSPA: reporting and communicating, practical guide for policy makers
This paper is addressed to policy makers who are assessing the performance of their health system. It provides them with practical tips and advice on how to effectively report and communicate the findings of their assessment. It was developed to respond to a request from the EU Expert Group on Health Systems Performance Assessment (HSPA), and benefited from discussion in the group.

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European Commission: updated study on corruption in the healthcare sector
The DG for Migration and Home Affairs commissioned Ecorys to conduct an initial study on corruption in the healthcare sector in 2012. The objectives were to develop a better understanding of the extent, nature and impact of corrupt practices in the healthcare sector across the EU, and to assess the capacity of the Member States to prevent and control corruption within the healthcare system and the effectiveness of such measures in practice. This study has just been updated.

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European Commission: cost-benefit analysis of a sustainable EU health information system
This study reviews the costs and benefits for Member State counterparts and beneficiaries of the EU health information system, and compares the current set-up with a possible future system built on a sustainable foundation.

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European Commission: European cross-border cooperation on health: theory and practice 
This publication from the European Commission’s Directorate-General for regional and urban policy provides an insight into the obstacles and success factors of cooperation in various geographical contexts. It contains several examples of cooperation supported by Interreg. 

DOC 1 EN/FR  HTML  |  DOC 2 FR  PDF  |  DOC 3 EN  PDF  

Euregio Meuse-Rhine: project on rare diseases (EMRaDi)
This project is part of the European INTERREG V-A Euregio Meuse-Rhine programme. It aims to increase the transparency of needs and availability of services in the field of rare diseases (RD) in the region, to develop models of RD patient pathways, to improve the network of healthcare providers, health insurance providers and patient organisations, and to raise public awareness of rare diseases.

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2

 Healthcare services in the internal market

European Parliament: the new restrictiveness indicator for professional services: an assessment
This study concerns the new Restrictiveness Indicator for national regulation of professional services in the EU, developed by the Commission. After setting out the background of recent EU initiatives in the realm of services, particularly professional services, the new indicator is presented and explained in considerable detail.

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German social security associations: press release on the standardisation of social and health services
The German social security associations (DSV), represented by the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the German Hospital Federation (DKG) and the German Medical Association (BÄK) have jointly declared that while European standardisation may be useful for health products such as medical devices or syringes, they add no value to health and long-term care services.

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3

 Medicines and medical devices

European Commission: public consultation on supplementary protection certificates and patent research exemptions
The European Commission published a study assessing the economic consequences of amending the provisions governing exemptions and supplementary protection certificates (SPOs) in Europe, particularly in the pharmaceutical sector. Following publication of this study, the Commission launched a public consultation on the subject, lasting until 4 January 2018.

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BeNeLuxA: launch of a website on international cooperation on medicines
Belgium, the Netherlands, Luxembourg and Austria (BeNeLuxA) are working together to make new medicines available to patients more quickly and at an acceptable price. These countries also wish to improve access to important innovative medicines and to affordable treatments. The joint website constitutes a new stage in this cooperation.

DOC 1  FR NL  HTML  |  DOC 2 EN  HTML 

EU-United States: mutual recognition of inspections of medicines manufacturers
The EU and the US have concluded a mutual recognition agreement on the inspections carried out of manufacturing sites for human medicines on their respective territories. This agreement entered its operational phase on 1 November 2017.

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European Commission: report on the state of children’s medicines in the EU
The Commission presented a report to the European Parliament and the Council on progress made in children’s medicines since the Paediatric Regulation came into force 10 years ago. It concludes that positive advances in the development of medicines for children could not have been achieved without specific EU legislation.

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European Commission and EMA: new action plan on advanced therapy medicinal products
The Commission services and the European Medical Agency (EMA) have launched a joint action plan to foster the development of advanced therapy medicinal products (ATMPs) with the aim of streamlining the procedures and better addressing the specific requirements of ATMPs developers.

DOC 1 EN  HTML  |  DOC 2 EN  HTML  |  DOC 3 EN  PDF 

EMA: Exploring opportunities for collaboration between regulators and healthcare payers
The European Medicines Agency (EMA) and the healthcare payer organisations met in London to explore synergies and foster mutual understanding and cooperation to help improve timely and affordable access of patients to new medicinal products.

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European Commission: legislation on good manufacturing practice for medicinal products for human use
The European Commission adopted a directive and a delegated regulation to enhance patient safety in the EU thanks to good manufacturing practice for medicinal products for human use.

DOC 1 FR/EN/NL HTML  |  DOC 2 FR/NL/EN  HTML 

Greek government: severe tensions with the pharmaceutical industry
Several pharmaceutical companies in Greece have threatened to stop supplying the market with innovative drugs and said they could even withdraw existing drugs as the result of a mandatory 25% ‘rebate’ on the prices of new innovative products, imposed by the Greek government and applied retroactively.

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EXPH: opinion on innovative payment models for high-cost innovative medicines
The expert panel on effective ways of investing in health drafted an opinion on innovative payment models for high-cost innovative medicines. Health systems are under pressure from the very high prices required by companies for inclusion of newly developed products in health insurance coverage: these models are therefore being discussed with a view to ensuring the financial sustainability of these systems.

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EMA: action plan on the Commission recommendations on improving package leaflets
The Commission recommendations on improving the information contained on product leaflets for EU medicines are the basis of the European Medicines Agency (EMA)’s newly published action plan on improving production information for EU medicines.

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Council of Europe: final report of its pharmaceutical care quality indicators project
The report from the Council of Europe’s European Directorate for the Quality of Medicines and Healthcare (EDQM) presents the results of the multinational validation study aimed at validating four basic sets of indicators to assess the quality of pharmaceutical care in Europe.

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4

 e-Health

Estonian EU Presidency: Digital health society declaration
The Ministry of Social Affairs of Estonia, supported by the European Connected Health Alliance (ECHAlliance) launched a Digital Health Society Declaration, as a call for actions on ‘Health in the digital society and the Digital society for health’.

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Estonian EU Presidency: conference on ‘Health in the Digital Society. Digital Society for Health’ 
This conference, organised jointly by the Ministry of Social Affairs of Estonia, ECHAlliance and HIMSS Europe focused on three topics: strengthening demand from citizens for digital health; the contribution made by digital health to social and health services; and digital health as a driver for innovation and economic development. The speakers’ presentations are available on the conference website.

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EESC: opinion on the impact of the digital healthcare revolution on health insurance
In the view of the European Economic and Social Committee (EESC), given the digital revolution in the field of health, it is vital to maintain and promote health insurance systems which serve the needs of everyone and are solidarity-based, inclusive and non-discriminatory.

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5

 Social policy

Council of the EU: partial agreement on the proposal for a regulation on the coordination of social security systems
The Council reached a partial general approach on the proposal for a regulation amending Regulation 883/2004 on the coordination of social security systems. The partial agreement covers the chapters on access by economically inactive mobile citizens to certain social benefits and on applicable legislation. This agreement determines the country in which an individual in cross-border employment must pay social security contributions.

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European Council: proclamation of the European Pillar of Social Rights
The European Pillar of Social Rights was proclaimed and signed by the Council of the EU, the European Parliament and the Commission during the Gothenburg Social Summit for fair jobs and growth.

DOC EN  PDF 

EPSCO Council: European Pillar of Social Rights
The European Ministers for employment and social affairs unanimously endorsed the European Pillar of Social Rights. In 2018, the Commission will also propose initiatives in favour of fair mobility, including a European Social Security Number, to make social security rights more visible and (digitally) accessible.

 DOC 1  EN/FR/NL  HTML   DOC 2  EN/FR/NL  HTML  DOC 3  EN  - FR  - NL PDF 

EPSCO Council: European Semester, the main messages from the Employment and Social Protection Committees endorsed by Council
The Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council endorsed the main messages from the Employment Committee (EC) and the Social Protection Committee (SPC) as part of the European Semester. According to these committees, there are still significant differences between the Member States in access to quality healthcare. Further efforts are needed to ensure universal access to quality health services, while guaranteeing adequate and sustainable financing for these services.

 DOC 1  EN  - FR  PDF  |  DOC 2  EN  - FR  - NL PDF 

Social Protection Committee: annual report 2017
The report shows that the efficiency of curative and preventive healthcare is still a challenge for 9 Member States, and that 10 Member States are faced with serious challenges with regard to access to healthcare, due to cost, waiting times or distance. The financial sustainability of healthcare systems is a serious issue for 16 Member States.

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6

 International agreements

EU–Canada: Entry into force of the Comprehensive Economic and Trade Agreement
The comprehensive economic and trade agreement (CETA) between the EU and Canada has entered into force provisionally. However, it will only enter into force fully and definitively once all the EU Member States have ratified it.

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France–Canada: French government’s action plan on the CETA
The French government has approved an action plan concerning the comprehensive economic and trade agreement with Canada (CETA). This action plan is in response to the report from the independent expert commission chaired by K. Schubert. In line with the commitment made by E. Macron, the commission analysed the expected impact of the CETA on the environment, climate and health.

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7

 Court of Justice of the European Union

Judgment: a State may restrict the exercise of the profession of clinical dental technician for public health reasons
In case C-125/16, the Court of Justice of the EU found that a Member State may, for public health reasons, adopt provisions stating that clinical dental technicians may only exercise their profession if patients are sent to them directly by a dental practitioner.

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Opinion of the Advocate General: the dispute settlement mechanism contained in an investment treaty concluded between two Member States is compatible with EU legislation
In the opinion of the Advocate General (case C-284-16, Slowakische Republik/Achmea BV), the dispute settlement clause of the bilateral agreement between the Netherlands and Slovakia on the protection of investments (1993) is compatible with European Union law. In 2006, Slovakia partially revoked the liberalisation of its health insurance market when it prohibited, in particular, the sale of insurance portfolios.

 DOC 1 EN/FR/NL  PDF  |   DOC 2  EN  - FR  - NL PDF 

Judgment: the VAT exemption for independent groups of persons is not limited to health
Ruling on an action for failure to fulfil obligations brought by the European Commission, the Court of Justice of the European Union found that Germany failed to meet its obligations under directive 2006/112/EC on the common system of value added tax (C‑616/15) by restricting the value added tax exemption to independent groups of persons whose members exercise activities of general interest in the field of healthcare.

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8

 Competition

European Commission: authorisation of the acquisition of Bard by BD, subject to conditions
The European Commission has approved, under the EU Merger Regulation, the acquisition of Bard by BD. Both these companies are suppliers of medical devices. The decision is conditional on the divestment of BD’s core needle biopsy devices business, as well as its tissue marker product which is currently under development.

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European Commission: opening of an in-depth investigation into the proposed merger between Essilor and Luxottica
The European Commission has opened an in-depth investigation to assess the proposed merger between Essilor and Luxottica under the EU Merger Regulation. The Commission has concerns that the merger may reduce competition for ophthalmic lenses, and will further investigate its effects on eyewear.

DOC  FR/EN  HTML 

French competition authority: authorisation of the acquisition of MédiPôle-Partenaires by Elsan, subject to conditions
This case led the French competition authority to examine the effects of mergers in the private clinic sector. It considered whether this acquisition could have adverse effects on the price of ancillary non-medical services or result in a reduction in the quality of medical care offered to patients.

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9

 Publications

Article: Health policy in times of austerity
This article provides a framework for the evaluation of changes in health policy against overarching health system goals. The authors propose a categorisation of policies into seven distinct health system domains, and develop existing analytical concepts of insurance coverage and cost-effectiveness further to examine the effects of policies, in each domain, on equity and efficiency.

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Article: Health technology assessment programme response to the challenges of dealing with orphan medicinal products
This study aimed to understand why these new health technology assessment (HTA) initiatives in England, Scotland and at European-level were established and whether they resolve the challenges of orphan medicinal products.

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Article: Trade policy governance: what health policymakers and advocates need to know
The author uses the TAPIC (transparency, accountability, participation, integrity, capacity) governance framework to analyse how trade policy is commonly governed. He concludes that the health sector is likely to benefit when transparency in trade policymaking is increased, since trade negotiations to date have often left out health advocates and policymakers.

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Article: Recommendations from the European working group for value assessment and funding processes in rare diseases
This article proposes nine principles to help improve the consistency of orphan medicinal product assessment in Europe, and to ensure that the value assessment, pricing and financing processes for orphan medicinal products reflect the specificities of rare diseases and contribute to both the sustainability of healthcare systems and the sustainability of innovation in this field. 

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Article: Scenarios for Brexit and social security
H. Verschueren examines the questions raised by the United Kingdom’s withdrawal from the European Union (EU), and the impact on the social security rights of people who find themselves in a cross-border situation between the UK and the EU27.

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EPHA: BENELUXA: First results of the multi-country cooperation on medicine price negotiations
The European Public Health Alliance (EPHA) has published a reflection document on the first results of the cooperation within the BeneluxA (Belgium, the Netherlands, Luxembourg and Austria) in negotiations on the prices of medicines. This document tells the story of this innovative cooperation and summarises the initial results announced by the participating governments.

DOC  EN  PDF 

OECD: Health at a Glance 2017
This new edition of Health at a Glance presents the most recent comparable data on the main indicators of the health status of populations and health system performance in the OECD countries.

DOC  EN  - FR  HTML 

BMJ: most drugs entered the market without evidence of benefits on overall survival and quality of life
A systematic evaluation of oncology approvals by the EMA in 2009-13 shows that most drugs entered the market without evidence of benefits on overall survival or quality of life.

DOC  EN  HTML 

Eurohealth: special edition
This special edition of Eurohealth looks, inter alia, at the future of health systems, pathways to better and affordable medicines and at policy failures in the pharmaceutical sector.

DOC  EN  PDF 

Politico: the exodus of EU doctors and nurses
An analysis by POLITICO of European Commission data found that the exodus of healthcare professionals is particularly pronounced from Eastern and Southern Europe. In effect, these countries are training doctors for their richer neighbours.

DOC  EN  HTML 

 

10

 Miscellaneous

WHO: ‘Towards a sustainable health workforce in the WHO European region: framework for action’ - Resolution
At the 67th session of the WHO Regional Committee for Europe, Member States adopted a resolution on the sustainability of the health workforce in the WHO European region, and the related framework for action. This resolution seeks to accelerate progress towards the values and objectives of Health 2020, the European policy framework for health and well-being, and of the 2030 Agenda, by sustaining a transformed and effective health workforce within strengthened health systems.

DOC  FR  - EN  PDF 

NHS Confederation: ‘Why reaching agreement on citizens’ rights post-Brexit is important for the NHS’
According to Elisabetta Zanon, director of the NHS European Office, fundamental decisions on workforce planning and NHS funding hinge on the right deal being struck on citizens’ rights.

DOC  EN  HTML 

NHS Confederation: Brexit and the NHS, Election 2017
The NHS Confederation has published a leaflet on Brexit and its consequences for the UK National Health Service.

DOC  EN  PDF 

CBBA–Europe: new voice for the supporters of cross-border benefits in the EU
A new European association, Cross Border Benefits Alliance Europe (CBBA–Europe), lobbying for the removal of barriers to cross-border worker protection benefits in Europe, has been set up in Brussels. CBBA-Europe will have a wide variety of members, such as employers’ and workers’ representatives from a whole range of sectors, insurance providers, lawyers and consultants, academics and consumer organisations.

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EIB: capital investment in health – for the first time
The European Investment Bank (EIB) will be financing innovative medical research, with a EUR 75 million loan to Evotec. This is the first large equity type investment under the European Fund for Strategic Investments (EFSI) in industry in Europe. It follows the granting of EUR 25 million in funding to the Austrian biotechnology company Apeiron Biologics AG, and of EUR 35 million to the German company MagForce, as well as a EUR 29 million loan to the Ca 'Foncello hospital in Treviso.

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Conference: Regulating health professions in a European perspective
On the occasion of a major reform of the regulatory framework for health professions in Belgium, this conference looked at the experience of other EU Member States and explored in more detail how EU integration affects the organisation and regulation of health professions. We more specifically discussed the impact of professional mobility on national workforce planning policies and how Member States can ensure quality and patient safety in a European and international context. Event organised by the Belgian National Institute of Health and Disability Insurance (NIHDI), the Federal Public Service Health, Food Chain Safety and Environment, the European Observatory on Health systems and Policies and the European Social Observatory (OSE).

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Information for this Newsletter was gathered up to the date of 20 November 2017.