European Health Care News

No.49 - March 2019


      

1

 Public health  [...]

Council: recommendation on strengthened cooperation against vaccine-preventable diseases
Indicators for continuous monitoring of the European Reference Networks (ERN)
European Commission: network-specific criteria for the ERN
Fourth conference on the ERN
European Commission and OECD: Health at a glance Europe 2018
EXPH: report on assessing the impact of digital transformation of health services 
EXPH: mandate on 'task shifting' in healthcare systems
EXPH: mandate on 'value-based healthcare'
European Parliament: question on editing the human DNA structure
Eurostat: statistics on hospital discharges and length of stay
Health Equity Pilot Project (HEPP): final conference
European Commission: report on integrated care assessment
European Commission: report on measuring access to healthcare in the EU
European Commission: preparing the future of EU investments in health
European Commission: working group on proton therapy centres

 

2

 Medicines and medical devices  [...]

European Parliament: proposal for a regulation on health technology assessment 
Council: progress report on the proposal for a regulation on health technology assessment
European Commission: study on the use of antibiotics
New rules in force to tackle the falsification of medicines
Politico: EU fake drug rules could threaten supplies of generic medicines 
Council and Parliament: EU measures to support generic pharmaceuticals producers
EMA: the role of big data for evaluation and supervision of medicines in the EU
EMA: public consultation on the key principles for the electronic product information of EU medicines 
EMA: stakeholder workshop on support to quality development in early access approaches

 

3

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

HPCB: conference - 'Mobile professionals, safe patients'
European Parliament: resolution on implementation of the directive on cross-border healthcare
Belgium: amendments to legislation following the CJEU judgment on advertising of care services

 

4

 Social policy  [...]

European Parliament: proposal for a regulation amending the regulation on the coordination of social security systems
Agreement on measures to better protect workers against cancer-causing chemicals
Council: access to social protection for workers and the self-employed
Parliamentary question: stopping the medical brain drain from Eastern European Member States
Statbel: health suffers from poverty
European Commission: proposal on quality majority voting on employment and social protection initiatives
Missoc: updated information on social protection systems in the EU countries, Iceland, Liechtenstein, Norway and Switzerland

 

5

 e-Health  [...]

European Commission: recommendation on a European electronic health record exchange format
European Commission: consultation on a standard format for electronic health records
European Commission: smartphones will have to send the precise location of the person ringing the emergency services on 112
European Commission: market study on telemedicine
European Commission: coordinated plan on artificial intelligence (AI)
19 EU Member States sign a declaration to link genomic health data
Estonian pharmacists can dispense medicines which are prescribed electronically in Finland 
CEN: technical specifications for the international patient summary

 

6

 Economic policy  [...]

European Commission: reports assessing the economic and social situation in each Member State 
European Commission: EU's economic and social priorities for 2019
European Commission: joint employment report
European Commission: annual report on public finances in the EMU, 2018
Council: recommendation on the economic policy of the euro area
European Commission: post-programme surveillance report, Portugal, autumn 2018 
European Commission: post-programme surveillance report, Ireland, autumn 2018
European Commission: post-programme surveillance report, Cyprus, autumn 2018
European Commission: enhanced surveillance report, Greece
Council: position on an improved instrument to support investment, growth and jobs in the EU
European Commission: report on improving the cost-effectiveness of Slovakia's healthcare system

 

7

 Competition  [...]

European Commission: report on enforcement of competition law in the pharmaceutical sector
European Commission: merger between Amcor and Bemis approved, subject to conditions
European Commission: acquisition of Shire by Takeda Pharmaceutical Company approved, subject to conditions
Italy: bid-rigging practice in the medical sector wrongly identified
Netherlands: merger between the pharmaceutical companies Aurobindo and Apotex approved
Greece: GlaxoSmithKline fined for refusal to supply medicines 
Denmark: decision on excessive pricing confirmed
Netherlands: sector inquiry into anti-rheumatic drugs

 

8

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

Judgment: 'Off label' use of a medicinal product (Avastin)
Judgments: 'pay for delay' patent settlement agreements
Judgment: automatic recognition of academic qualifications following partially overlapping courses in another Member State
Judgment: a request to limit the scope of the marketing authorisation of a generic medicinal product

 

9

 Infringement proceedings   [...]

27 Member States: directive on the recognition of professional qualifications
Ireland: implementation of EU legislation on tissues and cells intended for human application
Austria: level of reimbursement of cross-border healthcare
Netherlands: level of reimbursement of cross-border healthcare

 

10

 Publications  [...]

OECD: stemming antimicrobial resistance
Article: The implementation of EU rules on cross-border care: moving towards convergence?
Article: The use of European instruments in the development of eHealth policies in France and the United Kingdom
Article: medical tourism of Polish immigrants in Belgium
Book: EU Health law and policy
OBS: ensuring access to medicines: how to stimulate innovation to meet patients' needs?
OBS: Eurohealth winter issue 
OECD: Pharmaceutical innovation and access to medicines
Book: Patent settlements in the pharmaceutical industry under US antitrust and EU competition law
WHO: Towards a roadmap of the digitalization of national health systems in Europe. Meeting report (2018)
BMJ: how lobbying blocked European safety checks for dangerous medical implants

 

11

 Brexit  [...]

Irish government: omnibus bill to prepare for a no-deal Brexit
Council: draft contingency measures to preserve social security entitlements in the event of a no-deal Brexit
European Parliament: protecting social security rights obtained before the UK's withdrawal from the EU in the event of a no-deal Brexit
European Commission: cross-border healthcare after Brexit
Germany: impact of Brexit on social security 

 

12

 Miscellaneous  [...]

Economic partnership agreement between the EU and Japan enters into force
Report on the implementation of the EU-Ukraine Association Agreement
Sectoral Social Dialogue Committee for the hospital sector: final report on follow-up to the directive 2010/32/EU on prevention from sharp injuries in the hospital and healthcare sector
EIB: loan to the City of Turku 
EIB: loan to the biotech company Apeiron Biologics

 

  

1

 Public health

Council: recommendation on strengthened cooperation against vaccine-preventable diseases
The Council adopted a recommendation on strengthened cooperation against vaccine-preventable diseases. Ministers also discussed the approach to vaccine hesitancy in the EU.

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Indicators for continuous monitoring of the European Reference Networks (ERN) 
A working group on the continuous monitoring of the European Reference Networks (ERN) proposed a set of performance, structural and outcome indicators. These indicators are to be used in the continuous monitoring and quality assessment system for the networks.

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European Commission: network-specific criteria for the ERN
The European Commission published network-specific criteria for the European Reference Networks.

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Fourth conference on the ERN
The fourth conference on the European Reference Networks was intended as an opportunity to present the most important clinical and organisational outcomes of the networks, and to identify the challenges and potential for future improvements. The conference report and presentations are available online.

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European Commission and OECD: Health at a glance Europe 2018 
This publication presents an analysis of the state of health of EU citizens, and of the performance of the EU health systems. In addition to chapters containing statistical indicators for 35 European countries, this year's report includes two cross-cutting chapters on the EU's political priorities: promoting mental health and reducing inefficient spending.

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EXPH: report on assessing the impact of digital transformation of health services 
The Expert Panel on effective ways of investing in health (EXPH) published a report on assessing the impact of digital transformation of health services.

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EXPH: mandate on 'task shifting' in healthcare systems
The EXPH was given a new mandate for an opinion on shifting the tasks of care providers in order to maintain a balance in terms of numbers, diversity and skills, by means of an interdisciplinary approach and innovative solutions.

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EXPH: mandate on 'value-based healthcare'
The Commission asked the EXPH to provide an analysis of 'value-based healthcare', starting from the various possible ways of defining 'value' in healthcare, and looking at how 'value-based healthcare' can inform decision-making and can contribute to transformation in health systems.

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European Parliament: question on editing the human DNA structure
Following the birth of twins whose DNA structure was artificially adjusted by a Chinese doctor to avoid them contracting HIV, Monika Beňová (S&D) asked whether the Commission will take steps to regulate gene editing. According to the Commission, allowing such techniques in in-vitro fertilisation would be a national decision. If a Member State were to allow such a technique, it needs to comply with EU requirements on safety and quality as set out in Directive 2004/23 / EC.

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Eurostat: statistics on hospital discharges and length of stay
This article gives an overview of the European Union (EU) statistics on hospital discharges and the average length of stay for hospital patients.

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Health Equity Pilot Project (HEPP): final conference 
This project concentrated on health inequalities. It identified inequalities in nutrition, physical movement and alcohol consumption, as well as effective interventions for tackling health inequalities through policy-design. 

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European Commission: report on integrated care assessment
This report, drawn up by 'Optimity Advisors' as part of the EU health programme, assesses the extent to which EU Member States have developed integrated care systems. It also developed a framework of indicators to assess integrated care performance.

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European Commission: report on measuring access to healthcare in the EU
This report was produced by ICF for the European Commission. 
A conceptual framework was developed including the most important dimensions of access to healthcare: availability, affordability, adequacy, timeliness, accessibility and appropriateness. On this basis, 105 indicators were proposed, including suggestions for methodological improvements to some currently-used indicators. 

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European Commission: preparing the future of EU investments in health
The Commission brought together health workers to reflect on future EU investments in health. According to the Commission, the Member States must design investment strategies which include infrastructure, human capital, innovative technologies and new care models. The Commission is ready to help the Member States design such strategies, and to make cohesion policy funds and other EU instruments (such as InvestEU) available for this purpose.

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European Commission: working group on proton therapy centres
This working group was set up to investigate the availability and use of proton therapy centres across the EU, and to identify options for willing Member States to cooperate sustainably. Its work is intended to support the European Investment Bank (EIB) in assessing needs for proton therapy treatment and centres in Europe. 12 Member States are taking part in this exercise.

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2

 Medicines and medical devices

European Parliament: proposal for a regulation on health technology assessment 
On 14 February 2019, the European Parliament, in its first reading, adopted a legislative resolution on the proposal for a regulation on health technology assessment. The Commission proposal creates a framework for joint assessment by Member State bodies at EU level of the relative clinical effectiveness of particular medicines and medical devices. 

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Council: progress report on the proposal for a regulation on health technology assessment
The Romanian presidency presented a progress report to the Council on the proposed regulation on health technology assessment.

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European Commission: study on the use of antibiotics
A Eurobarometer study investigated public knowledge on antibiotics, and the general trends in their use.

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New rules in force to tackle the falsification of medicines
From 9 February, new rules apply concerning safety features for prescription medicines sold in the EU. Pharmaceutical companies now have to affix a 2D barcode and an anti-tampering device to the packaging of prescription medicines. Pharmacies, including online pharmacies, and hospitals have to check the authenticity of medicines before dispensing to patients. 

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Politico: EU fake drug rules could threaten supplies of generic medicines
The new EU rules on the falsification of medicines could threaten supplies of generic medicines, according to an article in Politico. Generic manufacturers, particularly those who produce older and lower-cost drugs, are warning about the impact on their margins.

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Council and Parliament: EU measures to support generic pharmaceuticals producers 
The Council and the European Parliament reached agreement on a draft regulation allowing an exemption to be made for the protection granted to an original medicine by a supplementary protection certificate (SPC), for export purposes or for stockpiling. Thanks to the exemption, EU generics producers will be entitled to manufacture and stockpile a generic medicine in the 6 months before the SPC expires, to be put on the EU market after the SPC expires.

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EMA: the role of big data for evaluation and supervision of medicines in the EU
A task force from the European Medicines Agency (EMA) published recommendations on exploring the preconditions for accepting evidence derived from big data in support of the evaluation and supervision of medicines by regulators.

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EMA: public consultation on the key principles for the electronic product information of EU medicines 
The product information of a medicine in the EU includes the package leaflet, for patients, and the summary of product characteristics, for healthcare professionals. The EMA is organising a public consultation on the key principles for electronic product information on medicines in the EU. 

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EMA: stakeholder workshop on support to quality development in early access approaches
This workshop is a joint initiative of the EMA and the US Food and Drug Administration (FDA). These agencies launched PRIME and breakthrough therapy schemes in order to provide early access to the market for medicines addressing unmet medical needs. The aim of this workshop was to discuss scientific and regulatory approaches to support quality development in cases of early access. Documents from the workshop are now available.

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3

 Health care services in the internal market

HPCB: conference - 'Mobile professionals, safe patients'
On 4 February 2019, Health Professionals Crossing Borders (HPCB) organised its yearly meeting of healthcare regulators, entitled 'Mobile professionals, safe patients'. The presentations are available online.

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European Parliament: resolution on implementation of the directive on cross-border healthcare
The European Parliament adopted a resolution on implementation of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare. The resolution was based on a report which examines the current shortcomings in the implementation of the directive.

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Belgium: amendments to legislation following the CJEU judgment on advertising of care services
The Belgian legislation on advertising by care providers was amended in line with a judgment of the Court of Justice of the European Union, relating to Belgian legislation prohibiting the advertising of dental care services (judgment in case C-339/15). From now on, a distinction will be made, for healthcare providers, between information on the practice and advertising as such (Articles 64 - 66 of the law containing various health provisions).

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4

 Social policy

European Parliament: proposal for a regulation amending the regulation on the coordination of social security systems
The MEPs in the Committee on employment and social affairs voted on the proposal for a regulation amending the regulation on the coordination of social security systems. The rapporteur was given a mandate by Parliament to negotiate with the Council.

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Agreement on measures to better protect workers against cancer-causing chemicals
The European Parliament, the Council and the Commission reached a provisional agreement on the Commission's proposal to broaden the list of recognised cancer-causing chemicals, adding five new substances. These will be included in the carcinogens and mutagens directive. This measure should ensure better protection of workers in laboratories and in a number of sectors, including healthcare.

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Council: access to social protection for workers and the self-employed
Ministers agreed unanimously on a proposal for a Council recommendation on access to social protection for workers and the self-employed. This proposal applies to various branches of social protection: unemployment, sickness and healthcare, maternity and paternity, invalidity, old age and survivors' benefits and accidents at work and occupational diseases.

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Parliamentary question: stopping the medical brain drain from Eastern European Member States
According to the Romanian MEP Maria Grapini (S&D), the medical brain drain from Eastern Europe is leading to difficulties accessing basic health services in these Member States. The countries are also incurring financial losses by training doctors who then leave to work in Western Europe. European Commissioner M. Thyssen has responded to questions on how the Commission intends to stop this process, and how it supports Member States who have incurred these financial losses. 

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Statbel: health suffers from poverty
According to the figures from the 2017 survey on income and living conditions (EU-SILC), which is harmonised at European level, 5.1% of the Belgian population is living in serious material deprivation. Of these people, 25% have had to postpone medical care, and 32% dental care, although they needed it. These figures compare to figures of 1% and 4% respectively for members of the population not living in poverty.

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European Commission: proposal on quality majority voting on employment and social protection initiatives
The Commission published a roadmap for presentation of a proposal to amend the EU's decision-making process in the area of social policy. The plan is to see whether there is support for greater use of qualified majority voting on initiatives relating to employment and social protection. Stakeholders' reactions to a consultation on this initiative are available online.

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Missoc: updated information on social protection systems in the EU countries, Iceland, Liechtenstein, Norway and Switzerland
Updated information (up to July 2018) on social protection systems in all EU countries, Iceland, Liechtenstein, Norway and Switzerland - including brief descriptions of how these systems are organised and information on social protection of the self-employed - is now available on the MISSOC (Mutual Information System on Social Protection) website.

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5

 e-Health

European Commission: recommendation on a European electronic health record exchange format
The Commission presented a set of recommendations to give citizens and health workers secure access to electronic health records, whichever country they are currently in. The proposal concerns the making available of laboratory tests, medical discharge reports and medical imaging. The Commission and the Member States will be establishing a joint coordination process in order to further develop this exchange of information.

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European Commission: consultation on a standard format for electronic health records
To prepare the recommendation for a European exchange format for electronic health records, the Commission published a roadmap with requests for feedback. 60 comments were received. 

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European Commission: smartphones will have to send the precise location of the person ringing the emergency services on 112
The European Commission has adopted measures to more precisely locate people in emergency situations, and to increase the effectiveness of relief operations. Under the new EU rules, all smartphones sold in the EU have to send the precise location of the person ringing 112 to the emergency services.

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European Commission: market study on telemedicine
This study, carried out by PricewaterhouseCoopers (pwc) for the European Commission, analyses the factors which most strongly influence the development of the telemedicine market. The analysis maps telemedicine solutions and standards, and describes the potential obstacles preventing greater use of telemedicine. Finally, the study assesses the cost-effectiveness of large-scale deployment of telemedicine.

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European Commission: coordinated plan on artificial intelligence (AI)
In this plan, the Commission proposes a number of joint actions to increase investment, make more data available, encourage talent and ensure trust in AI. The plan includes AI applications in healthcare, such as support for the development of a joint database of health images, to improve diagnosis and treatment.

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19 EU Member States sign a declaration to link genomic health data
19 EU Member States have signed a declaration to link genomic health data throughout the EU. These countries are committed to collaborate on the secure and authorised access to national and regional banks of genetic and other health data. This should ensure Europe's leading place in health research.

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Estonian pharmacists can dispense medicines which are prescribed electronically in Finland 
Finnish patients can now go into a pharmacy in Estonia, as long as this pharmacy has joined the system, and retrieve medicines which were prescribed electronically by their doctor in Finland.

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CEN: technical specifications for the international patient summary
The European Committee for Standardisation (CEN) established a technical specification (TS) with guidance for the use of the International Patient Summary dataset in a European context. The TS sets out principles to support the safe and legitimate use of patient summary data and affords protection for efficient cross-border data exchange in scenarios involving unscheduled care.

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6

 Economic policy

European Commission: reports assessing the economic and social situation in each Member State 
In the country reports assessing the economic and social situation in the Member States as part of the European Semester winter package, the European Commission emphasises the need to promote investment, pursue a responsible budgetary policy and to implement well thought-through reforms. The country reports also discuss the financial sustainability of healthcare systems and access to healthcare.

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European Commission: EU's economic and social priorities for 2019
In its Annual Growth Survey for 2019, part of the European Semester's autumn package, the Commission calls for continued emphasis on financial sustainability and universal access to high-quality healthcare. To ensure this, Member States should increase cost-effectiveness by investing in innovation, improving the integration of healthcare at the primary, specialised out-patient and hospital care levels, and strengthening links with social care.

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European Commission: Joint Employment Report
The draft Joint Employment Report is part of the European Semester's autumn package. It also discusses the access to and the effectiveness of high-quality healthcare in the Member States. Self-reported unmet need for medical care is one of the key indicators used in the social scoreboard, a central tool for monitoring the Member States' performance in social policy and employment.

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European Commission: annual report on public finances in the EMU, 2018
This annual report presents a review of key policy developments and analytical findings in the area of public finances. Healthcare is also addressed. 

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Council: recommendation on the economic policy of the euro area
The Council issued a recommendation on the economic policy of the euro area. It calls, among other things, for measures to be taken to combat tax fraud, which will release resources for investment in areas such as healthcare.

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European Commission: post-programme surveillance report, Portugal, autumn 2018 
This European Commission report presents the findings of the ninth post-programme surveillance mission to Portugal, and identifies the challenges still facing the Portuguese economy. Emphasis is placed on more efficient monitoring of spending, including in the health sector.

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European Commission: post-programme surveillance report, Ireland, autumn 2018
This report presents the findings of the tenth post-programme surveillance mission to Ireland, and identifies the remaining challenges for the Irish economy. The cost-effectiveness in the health sector and the serious overshoot of the budget in this sector are two of the issues discussed.

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European Commission: post-programme surveillance report, Cyprus, autumn 2018
This report presents the findings of the fifth post-programme surveillance mission to Cyprus and identifies the remaining challenges for the economy. The reform of the health system and the financial impact of this reform are among the issues discussed.

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European Commission: enhanced surveillance report, Greece
This is the first enhanced surveillance report for Greece since the completion of the European Stability Mechanism (ESM) support programme in August 2018. It also discusses the reforms in the healthcare sector.

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Council: position on an improved instrument to support investment, growth and jobs in the EU
The Member States reached a political agreement on the InvestEU fund, which is intended to bring together under one programme all the different financial instruments currently available to support investment in the EU. The fund, with a budget of 38 billion euros, will attract public and private resources to stimulate investment, including social investments such as those in healthcare.

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European Commission: report on improving the cost-effectiveness of Slovakia's healthcare system
This paper reviews current and future challenges facing the Slovakian healthcare system and its cost-effectiveness.

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7

 Competition

European Commission: report on enforcement of competition law in the pharmaceutical sector
The European Commission has published a report which shows that active enforcement of competition law, at EU and national level, in the pharmaceutical sector helps to deliver more affordable medicines and more choice to patients and healthcare systems, and to promote further innovation.

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European Commission: merger between Amcor and Bemis approved, subject to conditions
The European Commission has approved the merger between Amcor and Bemis. Both companies manufacture packaging products worldwide, for many different sectors, including the food, consumer, medical and pharmaceutical industries. The approval is conditional on the divestment of Bemis' medical packaging business in Europe.

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European Commission: acquisition of Shire by Takeda Pharmaceutical Company approved, subject to conditions
The European Commission has approved the takeover of Shire by Takeda Pharmaceutical Company. The approval is conditional on the divestment of a product being developed by Shire to treat inflammatory bowel disease.

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Italy: bid-rigging practice in the medical sector wrongly identified
The Italian Council of State has confirmed that the Italian competition authority was wrong to identify a bid-rigging practice in the medical sector (Alliance / Siemens / Philips / Toshiba / AGCM).

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Netherlands: merger between the pharmaceutical companies Aurobindo and Apotex approved
The takeover by Aurobindo Pharma Limited of Apotex Europe B.V. and Apotex Nederland B.V. has been approved subject to conditions. The decision was taken by the Autoriteit Consument & Markt (ACM) on 21 December 2018.

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Greece: GlaxoSmithKline fined for refusal to supply medicines
The Greek Competition Commission (HCC) has fined GlaxoSmithKline ('GSK') 4.1 million EUR for refusing to supply medicines.

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Denmark: decision on excessive pricing confirmed
The Danish competition appeals tribunal upheld the Danish CD Pharma case concerning the drug Syntocinon given to pregnant women during childbirth. In an article, the Danish Competition Council (DCC) explains the substance of the case and the reasons why it was given high priority.

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Netherlands: sector inquiry into anti-rheumatic drugs
The Dutch competition authority (ACM) has launched a sector inquiry into TNF inhibitors, a type of drug mainly used to treat rheumatism. TNF inhibitors are among the drugs with the highest costs, because of their relatively high price and the large number of patients using them. Besides TNF inhibitors, the ACM will also look into possible alternatives.

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8

 Court of Justice of the European Union

Judgment: 'Off label' use of a medicinal product (Avastin)
The reimbursement by a national health insurance system of a medicinal product for a use not covered by its marketing authorisation ('off label' use) is not contrary to EU law. The medicinal product, however, must still adhere to EU pharmaceutical rules. This was decided by the Court in its judgment concerning case C-29/17 Novartis Farma SpA v Agenzia Italiana del Farmaco (AIFA) and Others.

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Judgments: 'pay for delay' patent settlement agreements
In its judgments in the cases T-677/14, T-679/14, T-680/14, T-682/14, T-684/14, T-701/14, T-705/14 and T-691/14, the General Court partially overturns a European Commission decision and therefore reduces the fine imposed on a pharmaceutical company (Servier). The decision found the existence of restrictive agreements and abuse of a dominant position on the market for perindopril, a medicine used to treat hypertension and heart failure. The Court nevertheless confirms that certain patent settlement agreements may be restrictive of competition by object.

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Judgment: automatic recognition of academic qualifications following partially overlapping courses in another Member State
In its judgment in case C-675/17, the Court holds that academic qualifications obtained as a result of taking partially overlapping courses must automatically be recognised in all Member States as long as the minimum conditions set out in EU law are met. It is up to the Member State in which the qualification is issued to ensure that the conditions are complied with.

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Judgment: a request to limit the scope of the marketing authorisation of a generic medicinal product
Case C-423/17 concerns an application for a marketing authorisation for a generic medicine. The Court finds that, if, in the communication to the national competent authority of the package leaflet or a summary of the product characteristics of that generic medicine, no reference is made to indications or dosage forms which were still covered by patent law at the time when the medicine was placed on the market, this constitutes a request to limit the scope of the marketing authorisation of the generic medicinal product in question.

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9

 Infringement proceedings 

27 Member States: directive on the recognition of professional qualifications
The Commission sent letters of formal notice to 27 Member States (all the Member States apart from Denmark) for the non-compliance of their legislation and legal practice with the EU rules on the recognition of professional qualifications and the corresponding access to activities. Most healthcare professions fall under this legislation.

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Ireland: implementation of EU legislation on tissues and cells intended for human application
The Commission is urging Ireland to notify transposition of the EU legislation on tissues and cells intended for human application.

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Austria: level of reimbursement of cross-border healthcare
The Commission is asking the Austrian authorities to ensure that the costs of healthcare received in another EU country under the EU cross-border healthcare directive (Directive 2011/24/EU) are reimbursed up to the level applicable when healthcare is received in Austria.

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Netherlands: level of reimbursement of cross-border healthcare
The Commission is asking the Dutch authorities to ensure that the costs of healthcare received in another EU country under the EU cross-border healthcare directive (Directive 2011/24/EU) are reimbursed up to the level applicable when healthcare is received in the Netherlands.

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10

 Publications

OECD: stemming antimicrobial resistance
Superbug infections could cost the lives of around 2.4 million people in Europe, North America and Australia in the coming 30 years unless more is done to stem antibiotic resistance. This OECD report emphasises that three out of four deaths could be averted by simple measures such as handwashing and more caution in the prescription of antibiotics.

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Article: The implementation of EU rules on cross-border care: moving towards convergence?
The article 'The implementation of European Union (EU) rules on cross-border care: moving towards convergence?' studies the implementation of the EU Patients' Rights directive in Germany and Norway.

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Article: The use of European instruments in the development of eHealth policies in France and the United Kingdom
The article 'La soft law européenne dans la mise sur agenda nationale. L'usage des instruments européens dans la construction des politiques d'e-santé en France et au Royaume-Uni' investigates the power of EU soft law mechanisms to influence the national policy agenda in areas not subject to EU law. It compares the use of eHealth technologies in France and the United Kingdom. 

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Article: medical tourism of Polish immigrants in Belgium
This article explores motivations for medical tourism of migrants. It studies, in particular, the case of the Polish diaspora in Belgium, who make return trips to their country of origin to obtain healthcare services.

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Book: EU Health law and policy
The book 'EU Health Law & Policy. The Expansion of EU Power in Public Health and Health Care' describes the scope of EU health law and policy. Two specific case studies are analysed: measures against swine flu and access to medical care.

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OBS: ensuring access to medicines: how to stimulate innovation to meet patients' needs?
The European Observatory on Healthcare Systems and policies (OBS) published a report, 'Ensuring access to medicines: How to stimulate innovation to meet patients’ needs?', for the Austrian presidency of the EU. According to the report, the high price tags placed on new medicines do not always reflect the added value for patients. The report expresses concerns that innovation and early access to medicines may be prioritised over patient safety.

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OBS: Eurohealth winter issue 
The latest issue of Eurohealth contains a series of articles, including one on challenges in long-term care in Europe, as well as a number of articles on specific reforms in health systems in European countries. An article on advertising of dental services discusses the consequences of a 2017 judgment of the Court of Justice of the EU concerning the free movement of commercial communication of dental services in the internal market.

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OECD: Pharmaceutical innovation and access to medicines
This report reviews the role of medicines in health systems, describes recent trends in pharmaceutical expenditure and financing and summarises the approaches used by OECD countries to determine coverage and pricing. It then highlights current issues for policymakers.

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Book: Patent settlements in the pharmaceutical industry under US antitrust and EU competition law
The book 'Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law' examines patent settlements between originators and generic pharmaceutical manufacturers under US antitrust and EU competition law. The major focus is on patent settlements involving reverse payments, commonly known as 'pay-for-delay' settlements, to delay the sale of generic medicines.

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WHO: Towards a roadmap of the digitalization of national health systems in Europe. Meeting report (2018)
This report provides a summary of the proceedings and discussions which took place at an event to address the future of the digitalization of health systems in Europe.

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BMJ: how lobbying blocked European safety checks for dangerous medical implants
An article in the British Medical Journal (BMJ) shows how industry lobbyists have wrecked plans to overhaul safety regulations for medical devices in Europe. An investigation by the International Consortium of Investigative Journalists and its partner news organisations, including the BMJ, has discovered how top  EU politicians and officials were won over by misleading claims from implant industry lobby groups.

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11

 Brexit

Irish government: omnibus bill to prepare for a no-deal Brexit
On 22 February, the Irish government published a 15 part 'omnibus bill' to protect citizens and businesses in the event of a no-deal Brexit. The law states, for example, that Irish patients can still be reimbursed for healthcare received in Belfast or London.

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Council: draft contingency measures to preserve social security entitlements in the event of a no-deal Brexit
On 22 February, the Council's Permanent Representatives Committee approved the text of a draft regulation establishing contingency measures in the field of social security coordination. The aim is to safeguard the social security rights of citizens of the EU Member States in the UK, and UK nationals in the EU 27, who benefited from the right of free movement before the UK's withdrawal from the Union.

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European Parliament: protecting social security rights obtained before the UK's withdrawal from the EU in the event of a no-deal Brexit
The European Parliament's Employment and Social Affairs Committee approved the text to safeguard social security entitlements of EU citizens in the UK, and UK citizens in the EU 27, acquired before the UK's withdrawal from the EU in the event of a no-deal Brexit. 

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European Commission: cross-border healthcare after Brexit
The Commission published a notice on travelling between the EU and the United Kingdom (UK) following withdrawal of the United Kingdom from the EU. One chapter is on medical treatment.

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Germany: impact of Brexit on social security 
Germany's social security system is preparing for various Brexit scenarios and has published information for insured persons, employers, workers and service providers.

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12

 Miscellaneous

Economic partnership agreement between the EU and Japan enters into force
The economic partnership agreement between the EU and Japan entered into force on 1 February 2019. Both tariff and a number of non-tariff barriers between the EU and Japan will be removed, for example in the field of medical devices. The markets for services and public procurement will also be opened up, while public services will in principle be safeguarded. Personal data will also be able to flow freely, as the two sides have agreed to recognise each other's data protection system as 'equivalent'.

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Report on the implementation of the EU-Ukraine Association Agreement
This report sets out the state of play of Ukraine's commitments under the EU-Ukraine Association Agreement. It also reports on the implementation of healthcare reforms.

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Sectoral Social Dialogue Committee for the hospital sector: final report on follow-up to the directive 2010/32/EU on prevention from sharp injuries in the hospital and healthcare sector
On 13 February 2019, the meeting of the Sectoral Social Dialogue Committee for the hospital sector, HOSPEEM and EPSU approved the final report on follow-up to directive 2010/32 / EU on prevention from sharp injuries in the hospital and healthcare sector.

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EIB: loan to the City of Turku 
The City of Turku has signed a loan agreement with the European Investment Bank (EIB) for EUR 150 million. The loan is intended, among other things, to finance day care centres and schools in the city, infrastructure investments, cultural attractions, traffic and social housing construction.

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EIB: loan to the biotech company Apeiron Biologics
The Austrian biotech firm Apeiron Biologics develops pharmaceutical products to treat cancer, with a particular focus on rare forms that mainly affect children. An EU loan of EUR 25 million will help the company to expand its research and develop new ways of fighting the disease.

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Information for this Newsletter was gathered up to the date of 29 February 2019.