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Europaudvalget 2012-13
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COUNCIL OF

THE EUROPEAN UNION

11081/13

(OR. en)

PRESSE 263

PR CO 33

PRESS RELEASE

3247th Council meeting

Employment, Social Policy, Health and Consumer Affairs

Luxembourg, 20 and 21 June 2013

Presidents

Richard BRUTON

Minister for Jobs, Enterprise and Innovation of Ireland

Joan BURTON

Minister for Social Protection of Ireland

James REILLY

Minister for Health of Ireland

PRESS

Rue de la Loi 175 B – 1048 BRUSSELS Tel.: +32 (0)2 281 6319 / 6319 Fax: +32 (0)2 281 8026

[email protected] http://www.consilium.europa.eu/press

11081/13

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20 and 21 June 2013

Main results of the Council

Employment and Social Policy

The Council held a policy debate on the

European Semester

2013 in the field of employment and

social policy.

It discussed

youth employment

in preparation for the forthcoming European Council's debate.

The Council agreed on a general approach on the

European globalisation adjustment fund

regulation, which allows for the start of negotiations with the European Parliament. It also reached

a general approach on the proposed

supplementary pension rights

directive.

It took note of progress reports on the

posting of workers

directive and on a regulation on a

fund

for European aid to the most deprived.

Ministers took stock of progress reports on a proposed directive improving the

gender balance

among non-executive directors of companies listed on stock exchange, and on a proposed directive

equal treatment.

The Council adopted conclusions on :"Towards social investment for growth and cohesion", and

"Women and the media: Advancing their roles as decision-makers".

It adopted without discussion:

- new rules

on capital requirements for banks and investment firms.

The proposals amend and

replace existing capital requirement directives by two new legislative instruments: a regulation

establishing prudential requirements that institutions need to respect, and a directive governing

access to deposit-taking activities, and

- a directive on the minimum health and safety requirements regarding the exposure of workers to

the risks arising from

electromagnetic fields

- new transparency rules for the extractive industry and simplification of accounting requirements

for companies.

Health and Consumer Affairs

The Council agreed a general approach on a revised draft

EU tobacco directive,

aimed at making

tobacco products less attractive by strengthening rules on how tobacco products can be

manufactured, presented and sold.

It also took note of presidency progress reports on a draft regulation concerning

clinical trials of

medicines

and on two draft regulations concerning

medical devices.

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20 and 21 June 2013

CONTENTS

PARTICIPANTS................................................................................................................................ 5

ITEMS DEBATED

EMPLOYMENT AND SOCIAL POLICY ......................................................................................... 8

European Semester 2013...................................................................................................................... 8

Youth employment............................................................................................................................... 9

Posting of workers ............................................................................................................................. 11

Supplementary pension rights ............................................................................................................ 12

Fund for European aid to the most deprived (FEAD) ........................................................................ 13

Social investment for growth and cohesion ....................................................................................... 14

European globalisation adjustment fund (2014-2020) ....................................................................... 15

Gender balance among non-executive directors of companies listed on stock exchanges ................ 16

Equal treatment .................................................................................................................................. 17

Women and the media........................................................................................................................ 18

Any Other Business ........................................................................................................................... 19

HEALTH AND CONSUMER AFFAIRS ......................................................................................... 20

Tobacco directive ............................................................................................................................... 20

Clinical trials on medicines ................................................................................................................ 22

Medical devices.................................................................................................................................. 24

Any Other Business ........................................................................................................................... 26



Where declarations, conclusions or resolutions have been formally adopted by the Council, this is indicated

in the heading for the item concerned and the text is placed between quotation marks.



Documents for which references are given in the text are available on the Council's Internet site

(http://www.consilium.europa.eu).



Acts adopted with statements for the Council minutes which may be released to the public are indicated by

an asterisk; these statements are available on the Council's Internet site or may be obtained from the Press

Office.

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OTHER ITEMS APPROVED

ECONOMIC AND FINANCIAL AFFAIRS

–

Bank capital requirements ..................................................................................................................................... 28

JUSTICE AND HOME AFFAIRS

–

Common European Asylum System - Eurodac ..................................................................................................... 28

Schengen Borders Code ........................................................................................................................................ 29

EMPLOYMENT

–

Directive on electromagnetic fields ....................................................................................................................... 29

Conventions on chemicals at work and on decent work for domestic workers ..................................................... 29

SOCIAL POLICY

–

European Court of Auditors' report ....................................................................................................................... 30

INTERNAL MARKET

–

Motor vehicles - International harmonised requirements ...................................................................................... 30

COMPANY LAW

–

New transparency rules for the extractive industry and simplification of accounting requirements for

companies .............................................................................................................................................................. 30

ENVIRONMENT

–

Interoperability of spatial data sets and services ................................................................................................... 31

EU Ecolabel........................................................................................................................................................... 32

TELECOMMUNICATIONS

–

Re-use of public sector information ...................................................................................................................... 32

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20 and 21 June 2013

PARTICIPANTS

The governments of the member states and the European Commission were represented as follows:

Belgium:

Ms Laurette ONKELINX

Ms Monica DE CONINCK

Mr Philippe COURARD

Deputy Prime Minister and Minister for Social Affairs and

Public Health, with responsibility for Beliris and Federal

Cultural Institutions

Minister for Employment

State Secretary for Social Affairs, Families and the

Disabled, with responsibility for Occupational Hazards,

attached to the Minister for Social Affairs and Public

Health, and State Secretary for Science Policy, attached to

the Minister for Social Affairs and Public Health

Minister for Health

Minister for Labour and Social Policy

Deputy Minister for Labour and Social Affairs

Deputy Minister for Common Agriculture and Fisheries

Policies

Minister for Employment

Minister for Health and Prevention

Federal Minister for Labour and Social Affairs

State Secretary, Federal Ministry of Food, Agriculture and

Consumer Protection

Deputy Permanent Representative

Minister for Social Affairs

Minister for Jobs, Enterprise and Innovation

Minister for Social Protection

Minister for Health

Minister for Employment, Social Protection and Welfare

Minister for Health

Minister for Employment and Social Security

State Secretary for Health and Comnsumer Affairs

Conseiller à l’Economie et à la Compétitivité,

Communauté Autonome des Iles Baléares

Minister with responsibility for the Disability and Social

Exclusion Issues, attached to the Minister for Social

Affairs and Health

Deputy Permanent Representative

Minister for Labour and Social Policy

Minister for Health

Permanent Secretary, Ministry of Labour and Social

Insurance

Bulgaria:

Ms Tanya ANDREEVA-RAYNOVA

Mr Hasan ADEMOV

Czech Republic:

Mr Jan DOBEŠ

Ms Jaroslava BENEŠ ŠPALKOVÁ

Denmark:

Ms Mette FREDERIKSEN

Ms Astrid KRAG KRISTENSEN

Germany:

Ms Ursula VON DER LEYEN

Mr Robert KLOOS*

Mr Guido PERRUZO

Estonia:

Mr Taavi RÕIVAS

Ireland:

Mr Richard BRUTON

Ms Joan BURTON

Mr James REILLY

Greece:

Mr Ioannis VROUTSIS

Mr Andreas LYKOURENTZOS

Spain:

Ms María Fátima BÁÑEZ GARCÍA

Ms Pilar FARJAS

Mr Joaquin GARCIA MARTINEZ

France:

Ms Marie-Arlette CARLOTTI

Mr Alexis DUTERTRE

Italy:

Mr Enrico GIOVANNINI

Ms Beatrice LORENZIN

Cyprus:

Mr Petros PETRIDES

Mr George PAPAGEORGIOU

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Latvia:

Ms Ilze VIŅĶELE

Ms Ingrīda CIRCENE

Lithuania:

Ms Algimanta PABEDINSKIENĖ

Mr Vytenis Povilas ANDRIUKAITIS

Luxembourg:

Mr Nicolas SCHMIT

Mr Mars DI BARTOLOMEO

Hungary:

Mr András DONCSEV

Mr Miklós SZÓCSKA

Mr Olivér VÁRHELYI

Malta:

Mr Evarist BARTOLO

Mr Godfrey FARRUGIA

Netherlands:

Mr Lodewijk ASSCHER

Mr Wepke KINGMA

Austria:

Mr Harald GÜNTHER

Poland:

Mr Bartosz ARLUKOWICZ

Ms Malgorzata MARCINSKA

Portugal:

Mr Fernando LEAL da COSTA

Mr Pedro ROQUE OLIVEIRA

Romania:

Ms Mariana CÂMPEANU

Mr Eugen Gheorghe

NICOLĂESCU

Slovenia:

Ms Anja KOPAČ MRAK

Mr Tomaž GANTAR

Slovakia:

Ms Zuzana ZVOLENSKA

Mr Branislav ONDRUŠ

Finland:

Ms Lauri IHALAINEN

Ms Susanna HUOVINEN

Ms Marianne HUUSKO-LAMPONEN

Sweden:

Ms Hillevi ENGSTRÖM

Ms Maria LARSSON

United Kingdom:

Ms Anna SOUBRY

Mr Mark HOBAN

Minister for Welfare

Minister for Health

Minister for Social Security and Labour

Minister for Health

Minister for Labour, Employment and Immigration

Minister for Health, Minister for Social Security

State Secretary for Parliamentary Affairs

State Secretary for Healthcare, Ministry of Human

Resources

Deputy Permanent Representative

Minister for Education and Employment

Minister for Health

Vice Prime Minister, Minister of Social affairs and

Employment

Deputy Permanent Representative

Minister for Health

Undersecretary of State, Ministry of Labour and Social

Policy

State Secretary attached to the Minister for Health

State Secretary for Employment

Minister for Labour, the Family and Social Protection

Minister for Health

Minister for Labour, the Family, Social Affairs and Equal

Opportunities

Minister of Health

State Secretary at the Ministry of Labour, Social Affairs

and the Family

Minister for Labour

Minister for Health and Social Services

Deputy Permanent Representative

Minister for Employment

Minister for Children and the Elderly

Minister for Health

Minister of State for Employment

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Commission:

Ms Viviane REDING

Mr Joe BORG

Mr László ANDOR

Vice-President

Member

The Government of the Acceding State was represented as follows:

Croatia:

Ms Milanka OPAČIĆ

Mr Rajko OSTOJIĆ

Mr Mirando MRSIĆ

Deputy Prime Minister and Minister for Social Policy and

Youth

Minister for the Interior

Minister for Labour and Pension System

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ITEMS DEBATED

EMPLOYMENT AND SOCIAL POLICY

European Semester 2013

The EPSCO Council held a policy debate (based on document

10367/13)

approving its contribution

to the European Council regarding the employment/social policy aspects of the country-specific

recommendations (CSRs) and the results of the multilateral surveillance.

In general, ministers welcomed the progress in the 2013 Semester exercise. There was overall

greater satisfaction with the procedures, with member states pointing particularly to an amelioration

of the political dialogue with the Commission in their bilateral meetings. The contribution of the

EMCO and SPC committees in the process, as well as their coordination with the ECOFIN

committees on cross-cutting issues, were widely welcomed. Room for improvement was generally

recognised as well.

Most ministers underlined the importance of the involvement of social partners and the civil society

in the CSRs process in order to ensure broader social acceptance of the reforms. They called for

recognition of the efforts already undertaken at national level and for respecting the need to leaving

discretionary scope for member states to implement reforms that aim for agreed outcomes.

The process of reforms to restore competitiveness and get public finances under control takes place

in a context of protracted recession, high unemployment levels, most particularly for the young, and

rising poverty and inequalities.

The challenges the Union is facing in finding a more sustainable growth path are complex and

require a comprehensive and balanced policy mix. Conditions need to be put in place that will, at

the same time, favour investment by companies and create employment, improve the efficiency of

public expenditure and ensure the effectiveness of welfare systems.

The scale of the challenges, as well as the time needed for the positive effects of reforms to show

results, nonetheless makes it essential to tackle them effectively and urgently.

The Council endorsed the opinions of the Employment Committee (EMCO) (10397/13) and of the

Social Protection Committee (SPC) (10222/13) on the national reform programmes (2013) and the

implementation of the 2012 country-specific recommendations. It took note of reports of the EMCO

and SPC regarding the 2013 package of CSR's on cross-cutting issues. Additionally, it endorsed the

employment performance monitor and benchmarks (10373/13).

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Youth employment

The Council discussed youth employment to provide input for the discussion of the Heads of State

and government on 28-29 June (10375/13

COR 1

COR 2).

The Council discussed the extremely high unemployment rate of young people in a number of

member states that has to be addressed. The crisis has hit across all layers of society and young

people became one of the most affected groups. The situation is particularly acute in certain

member states and regional differences in the youth unemployment rate are significantly increasing.

Over the recent time, the EU and member states have launched a series of initiatives and proposals

to address the increasing unemployment rates for youth. However, youth unemployment continues

to present a major challenge for the EU and for most member states. In April 2013, the youth

unemployment rate reached 23.5% in the EU 27. Moreover, the disparities between regions within

member states are significant: the youth unemployment rate is over 50% in some member states and

over 70% in some regions, while in a few regions it is even below 5%. All in all, currently more

than 7.5 million of young people under 25 are neither in employment, education or training

(NEET).

Ministers pointed out that it is time now to move from words to action. They urged for accelerating

the implementation of initiatives adopted with the aim of increasing the youth employment rate, and

in particular of the recommendation on the Youth guarantee, in order to be able to use as quickly as

possible the 6 billion EUR which the European Council has set aside for the Youth Employment

Initiative for the next seven years. The ministers agreed that a firm commitment by the member

states is needed to adopt concrete plans for the implementation of the guarantee at national level by

the end of 2013 so that the funding can be available already from January 2014.

In order for the measures to be more effective, the ministers supported frontloading the funds of 6

billion EUR to achieve the maximum impact in the early years of the next Multiannual Financial

Framework period. For this to happen, quick finalisation of the programming of the European

Social Fund is crucial.

The ministers also highlighted the need of creating more jobs and the great potential of SMEs

across Europe in this respect. In this context, the involvement of the European Investment Bank

could be explored. The ministers also recognised the need to address the mismatches between

demand and supply in some sectors of economy and to tackle the labour market segmentation.

Young people have a high propensity to be mobile and the potential of targeted mobility schemes,

such as "Your first EURES Job" should be therefore explored.

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Finally, the ministers highlighted the importance of interconnecting the worlds of education and

work and in particular the need for improving the traineeship and apprenticeship offers for young

people and providing information on their carrier prospects based on the labour market situation.

The social partners and public employment services have an important role to play in this process.

The Commission presented its communication on Youth Employment. This new communication

should cover the following topics:

–

the implementation of the Youth Guarantee;

investment in young people through the European Social Fund;

the front-loading of the Youth Employment Initiative;

support for intra-EU labour mobility with EURES;

steps to ease the transition from education to work by boosting the supply of high-

quality apprenticeships and traineeships and addressing skills shortages;

acceleration of reforms to deliver a genuine EU labour market in the longer run; and

measures to support job creation in the immediate term, especially by SMEs, and to

incentivise the hiring of young people.

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Posting of workers

The Council took note of a progress report regarding enforcement of the directive on posting of

workers in the framework of the provision of services (10430/13).

The presidency’s progress report notes that a possible way forward could be found by ensuring that

Article 9 (national administrative requirements and control measures) contains some degree of

flexibility. Such flexibility would involve incorporating existing national administrative

requirements and control measures in the exhaustive list, while subjecting them to transparency

requirements. In addition, a notification procedure would apply to new administrative and control

measures with a view to ensure that they are compatible with Union law.

The proposed enforcement directive aims to provide posted workers with the minimum protection

provided for in the posting of workers directive. It contains a long list of measures, including

awareness raising (better information), state enforcement mechanisms (inspections and sanctions)

and private law enforcement mechanisms (joint and several liability).

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Supplementary pension rights

The Council reached a general approach on a proposed directive improving the acquisition and

preservation of supplementary pension rights (10890/13

ADD1+ ADD 2).

The Commission proposal dating back to 2005 has grown in importance: supplementary pensions

are becoming more significant and there is a need to facilitate worker mobility. Following the

European Parliament's opinion in 2007, the Commission adopted an amended proposal which

excludes the issue of transferability of pension rights.

In 2012, the European Council called for the sustainability of pension systems to be improved and

for the acquisition and preservation of supplementary pension rights of mobile workers to be

strengthened.

The Irish presidency tabled a compromise suggestion, restricting the scope of the directive to cases

of mobility between member states only.

The compromise suggestion would leave the member states free to decide on the rules they apply to

internally mobile workers. However, the Council and the Commission made a statement

encouraging the member states to ensure the equal treatment of internally and externally mobile

workers.

Statutory social security pensions (so-called 'pillar I' pensions) earned in different member states are

co-ordinated under regulation 883/2004/EC, which ensures that if a person works in more than one

member state they do not lose out when it comes to their statutory social security pension

entitlements. Occupational pensions (so-called 'pillar II' pensions) enjoy limited protection under

Council directive 98/49/EC, with respect to the preservation of pension rights.

The proposal under discussion aims to strengthen the protection of occupational pensions.

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Fund for European aid to the most deprived (FEAD)

The Council took stock of the progress made on the proposal on the Fund for the most deprived

regulation (10896/13), submitted by the Commission in October 2012.

In February 2013, the European Council confirmed that the support for aid for most deprived people

will be EUR 2.5 billion for the period 2014-2020 and will be taken from the ESF allocation.

Substantial progress has been achieved under the Irish presidency on many parts of the text. More

particularly, the discussions have shown broad support to the objectives of the Fund, with a

majority of delegations also supporting the instrument itself while, at the same time, some

delegations maintain reservations on the new Fund (whether a new EU-level Fund, covering all

member states, would be the most appropriate way of assisting the most deprived persons, and what

form such a fund should take).

Delegations have also discussed in detail how the Fund's management should be organised, so that

it would not create unnecessary duplication and administrative burden to the member states and to

the partner organisations working with the most deprived persons.

The EP Plenary has only voted its mandate on 12 June. The Council will further examine the text,

including the EP's opinion.

The general objective of the proposed instrument, which is expected to be operational on 1 January

2014, is to promote social cohesion by contributing to achieving the EU2020 poverty reduction

headline target. More specifically, the instrument will aim to alleviate the worst forms of poverty by

providing non-financial assistance to the most deprived people.

The proposed budget is 2.5 billion euros over the period 2014 to 2020 under the heading of the

cohesion policy budget. The Fund would support schemes in member states providing food to the

most deprived people as well as basic goods such as clothing and other essential goods to homeless

people and materially-deprived children.

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Social investment for growth and cohesion

The Council adopted conclusions (11487/13) following Commission's communication "Towards

social investment for growth and cohesion" presented in February this year.

The so called Social Investment Package (SIP) is a new policy framework that should give a fresh

impetus to achieving the overall Europe 2020 target of reducing the number of people at risk of

poverty by 20 million and fighting social exclusion, progress having stalled in the last two years.

According to the Commission, the package should demonstrate that, despite the current budgetary

constraints, better social outcomes can be achieved, without necessarily spending more.

The conclusions stress that finding a longer-term exit from the crisis in terms of poverty and social

exclusion would be difficult without well-designed and effective reforms at national level. These

reforms should aim at strengthening human capital, health, education and skills, fostering social

inclusion and participation. Improving the effectiveness and efficiency of social protection systems

is a central goal.

The conclusions also highlight the usefulness of the European Semester and the open method of

coordination in this respect, and in particular mutual learning and sharing experiences and good

practices in the future.

Finally, the conclusions welcome in particular the recommendation on child poverty which is a part

of the package and which calls for preventative and child-friendly approach to social investment.

Providing access to adequate resources and good quality and affordable services is crucial for

breaking the vicious circle of transmission of disadvantage across generations.

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European globalisation adjustment fund (2014-2020)

The Council agreed on a general approach on the European globalisation adjustment fund

regulation, which allows for the start of negotiations with the European Parliament. Ministers

discussed the presidency compromise proposal amended by a (joint Franco-German) proposal

strengthening the support to unemployed people between the age of 15-24 years in regions of high

youth unemployment rates.

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Gender balance among non-executive directors of companies listed on stock exchanges

The Council took note of a progress report (10422/1/13) on a directive which would improve the

gender balance on company boards.

Aiming to address the problem of women's under-representation in economic decision-making at

the highest level, the directive would set a quantitative objective for the proportion of the under-

represented sex on the boards of listed companies of 40% by 2020 (by 2018 in the case of public

undertakings). The companies would be obliged to work towards that objective, inter alia, by

introducing procedural rules on the selection and appointment of non-executive board members.

Should companies fail to reach the 40% target by the deadline set, they would be required to

continue to apply the procedural rules, as well as to explain what measures they had taken and

intended to take in order to reach it. Companies would face sanctions only for failing to implement

those procedural obligations. For member states that choose to apply the objective to both executive

and non-executive directors, a lower target (33%) would apply.

Some parliaments have submitted reasoned opinions within eight weeks from the submission of the

Commission's proposal, alleging that it did not comply with the principle of subsidiarity.

During the examination of the directive under the Irish presidency significant progress has been

made. It appeared that while all delegations were in principle in favour of improving gender balance

on company boards, some prefer national measures while others support EU-wide legislation.

Accordingly, more work will be needed to clarify and amend aspects of the Commission proposals

before a compromise can be reached.

Women account for around 60 % of new university graduates in the EU, yet are under-represented

in economic decision-making positions, especially at the top. The situation is improving, albeit

slowly, thanks to measures being taken nationally as well as to the intensifying public debate on this

issue.

According to the Commission, in October 2012, only around 15.8% of board members and just 3%

of board chairs of the largest companies listed on the stock exchanges of the EU member states

were women.

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Equal treatment

The Council took note of a progress report (10039/13) on the proposed equal treatment directive

that would prohibit discrimination on the grounds of religion or belief, disability, age or sexual

orientation in the following areas: social protection, including social security and healthcare; social

advantages; education; and access to goods and services, including housing. The Irish presidency

focussed in particular on the scope of the directive and on the issue of disability.

A large majority of delegations welcomed the proposal submitted to the Council in 2008,

considering that it completes the existing legal framework by addressing the before-mentioned four

grounds of discrimination through a horizontal approach.

As the proposal falls under article 19 of the Treaty on the functioning of the EU, unanimity in the

Council is required, following the consent of the European Parliament.

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Women and the media

The Council adopted conclusions (10665/13) concerning women and the media, with a specific

focus on the role that women play in decision-making.

These conclusions are based on a report prepared by the European Institute for gender equality

(10366/13

ADD 1).

The report shows that persistent gender inequalities in the media can be

challenged by advancing women in decision-making.

Therefore, the present conclusions make an appeal for active and specific measures to foster gender

equality at all levels in this important sector. They also include a set of three indicators for

measuring progress on this issue. The first two indicators track the proportion of women and men in

decision-making positions in media organisations and in boardrooms. The third indicator monitors

the policies that media organisations have put in place to promote gender equality.

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Any Other Business

–

Proposal for a decision of the European Parliament and of the Council on public

employment services and the functioning of the European labour market

The Council took note of the information given by the Commission.

–

Legislative files and other issues

The presidency informed the Council on the state of play of various legislative dossiers.

–

G20 labour and employment ministers' meeting and joint meeting with finance ministers

(Moscow, Russia, 18-19 July 2013)

The Council took note of the information given by the presidency and the Commission on

the upcoming G20 ministerial meetings.

–

Conferences organised by the Irish presidency.

The presidency informed the delegations on the conferences organised during its term.

–

Work programme of the incoming presidency

The Lithuanian delegation informed the Council about its work programme.

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HEALTH AND CONSUMER AFFAIRS

Tobacco directive

The Council agreed a general approach

on a revised draft EU tobacco directive aimed at making

tobacco products less attractive by strengthening the rules on how tobacco products can be

manufactured, presented and sold (11483/13).

The deal, which was reached on the basis of a compromise proposal from the Irish presidency,

includes the following key elements:

–

ban

on the use of cigarettes and roll-your-own tobacco with

characterising flavours

such as fruit flavours, chocolate or menthol or which contain additives that increase

addictiveness and toxicity. This is to make sure that tobacco products taste and smell like

tobacco products.

An obligation for

combined picture and text health warnings to cover 65 %

of the front

and the back of packages of tobacco products for smoking.

ban

of any

misleading labelling

(such as "natural" or "organic").

The

extension of the scope

of the directive to

•

novel tobacco products

(products that are placed on the market after the entry into

force of the directive) which would require a prior notification before being placed on

the market;

•

nicotine containing products

(such as electronic cigarettes); these products would be

allowed on the market below a certain nicotine threshold provided they feature health

warnings; above this threshold such products would only be allowed if authorised as

medicinal products (e.g. nicotine replacement therapies);

•

herbal products for smoking

which would have to carry health warnings.

–

A general approach is a political agreement of the Council pending the first-reading position

of the European Parliament.

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–

Introduction of a

tracking and tracing system,

together with safety features in order to

strengthen the fight against illicit trade and falsified products;

Member states may decide to ban

cross-border distance sales

of tobacco products;

Member states may introduce more stringent rules on additives or on packaging of tobacco

products (such as

plain-packaging),

subject to certain conditions (such as notification of

the Commission).

The general approach agreed today enables the incoming Lithuanian presidency to engage

discussions with the European Parliament on this file. The committee for environment, public

health and food safety of the European Parliament is expected to vote its draft amendments in July.

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Clinical trials on medicines

The Council took note of a presidency progress report on a draft regulation concerning clinical trials

on medicines for human use (10452/13).

The Commission proposal published on 17 July 2012 (12751/12) is aimed at speeding up the

authorisation of investigations of medicines in humans where patients are recruited in more than

one member state while maintaining the high standards of patient safety.

Medicines are clinically tested in human volunteers to

•

test the safety and effectiveness of new products,

•

test new applications for existing medicines or to

•

compare two treatments.

Clinical trials are hence essential to develop new medicines and to improve medicinal treatment.

The data generated in clinical trials are published in medical journals and can be used by companies

applying for marketing authorisations.

The Commission proposed to:

•

set up a

simplified authorisation procedure

with a swift assessment by all member

states in which the clinical trials are intended to be conducted;

•

make a distinction between aspects where member states must cooperate in the

assessment and those where member states conduct their assessment individually (such

for instance on ethical aspects);

•

to ensure that the principle of

risk-proportionality

is applied, for instance on the

compensation for damages;

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•

replace the current directive by a regulation in order to

ensure a uniform application

of common rules.

During its first read-through of the proposal the Council's working party on pharmaceuticals and

medical devices identified a number of elements on which further discussion is needed, notably:

•

the shortening of time-limits for the authorisation and validation of clinical trials;

•

the ethical evaluation of clinical trials;

•

the protection of volunteers;

•

the damage compensation and indemnification mechanism.

Due among others to a divergent transposition of the current clinical trials directive the clinical trial

activity has considerably decreased in the EU in the last years. The number of applications for clinical trials

fell by 25% from 2007 to 2011 (from 5000 to 3800).

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Medical devices

The Council took note of a presidency progress report on two draft regulations concerning medical

devices and in vitro diagnostic medical devices (11051/13).

Medical devices cover a huge spectrum of products and include for instance sticking plasters,

corrective glasses, dental filling material, X-ray machines, bone screws, heart valves and breast

implants. Likewise, there is a wide range of in vitro diagnostic medical devices which include for

instance blood tests and other products used for disease prevention, diagnosis, monitoring of

prescribed treatments and assessment of medical interventions.

The Commission proposals, presented on 26 September 2012 (14493/12

14499/12),

are aimed at

strengthening transparency on the available medical devices and in vitro diagnostic medical

devices, increasing their traceability, beefing up market surveillance and reinforcing the powers of

so-called notified bodies.

Unlike medicinal products medical devices and in vitro diagnostic medical devices are not subject

to any pre-market authorisation but to a conformity assessment which, depending of the risk

potential of the product, involves an independent third party, the notified body. Notified bodies are

designated and monitored by the member states and act under the control of the national authorities.

The Commission proposal contains the following key elements:

•

Patients

who are implanted with a device should be

given essential information

on the

implanted product, including any necessary warnings or precautions to be taken, for

example on whether or not it is compatible with certain diagnostic devices or with

scanners.

•

Manufacturers of medical devices and in vitro diagnostic medical devices must fit their

products with a unique device identification to

ensure traceability.

•

Manufacturers and importers of both categories of products must register themselves

and the devices they place on the EU market in a

central European database.

•

Manufacturers of high-risk devices and diagnostic devices must make publicly available

summary of their safety and performance,

with key elements of the clinical data.

•

Introduction of an

EU portal where manufacturers must report serious incidents

and corrective actions they have taken to reduce the risk of recurrence.

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20 and 21 June 2013

•

Notified bodies have the right and duty to carry out

unannounced factory inspections

and to conduct physical or laboratory tests on devices and diagnostic devices.

•

The

scope

of the current EU rules on medical devices is

extended,

for instance

implants for aesthetic purposes,

and, as far as in vitro diagnostic medical devices are

concerned, for example to tests providing information about the predisposition to a

disease.

•

The two existing directives are replaced by two regulations in order to ensure that the

EU rules are applied in the same manner in all member states

In its examination of the proposals the Council's working party on pharmaceuticals and medical

devices has so far identified the following main difficulties:

•

the procedures for clinical evaluation;

•

the method for strengthened control by notified bodies.

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Any Other Business

Serious cross-border health threats

The presidency informed the Council on the agreement on the draft decision on serious cross-border

threats to health reached at the trilogue discussions with representatives of the European Parliament

and the Commission on 6 May 2013. The agreement is expected to be formally voted by the

European Parliament in September, after which it will be formally approved by the Council. This

would allow the decision to enter into force before the end of the year (10332/13).

For details on the content of the agreement see

9610/13.

Coronavirus

The Council took note of the information provided by the Commission on the middle East

respiratory syndrome coronavirus several cases of which were also identified within the EU (United

Kingdom, Germany, France and Italy) (11000/13).

Drugs action plan

The presidency informed the Council about the EU action plan on drugs for 2013-2016 adopted by

the Justice and Home Affairs Council at its meeting on 6-7 June 2013 (10448/13). The EU action

plan on drugs focuses on the two policy areas of drug demand reduction and drug supply reduction,

and three cross cutting themes - coordination, international cooperation and information, research,

monitoring and evaluation.

Patient's rights in cross-border healthcare

The Council took note of information provided by the Commission on the state of play in the

transposition of the directive into national law (10363/13). Directive 2011/24 on the application of

patients' rights in cross-border healthcare is due to be transposed by the member states by 25

October 2013. The Commission services have carried out a programme of visits to member states to

assist in transposition of the directive.

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Transparency of prices of medicinal products

The presidency informed the Council on the progress achieved on the amended Commission

proposal (10365/13). The Commission proposed inter alia new time lines for decisions in order to

guarantee a transparent and equal treatment of manufacturers of medicinal products applying for the

inclusion of a product in national health insurance system of member states.

Imports of active pharmaceutical ingredients

The Council took note of a Commission report concerning the import of active pharmaceutical

ingredients within the context of the entry into application of new provisions on this issue as part of

directive 2011/62 on falsified medicines (10364/13).

Work programme of the forthcoming presidency

The Lithuanian delegation informed ministers on its work programme in the field of health and

consumer affairs as the incoming Presidency of the Council of the EU.

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20 and 21 June 2013

OTHER ITEMS APPROVED

ECONOMIC AND FINANCIAL AFFAIRS

Bank capital requirements

The Council adopted new rules on capital requirements for banks and investment firms (14/13 and

15/13).

The decision was taken by a qualified majority of delegations, with the United Kingdom

voting against (10851/13

10853/13).

Adoption of the "CRD4" legislation follows agreement reached with the European Parliament at

first reading on 28 February, and subsequent approval by the Permanent Representatives

Committee, on behalf of the Council, on 27 March.

The proposals amend and replace existing capital requirement directives

by two new legislative

instruments: a

regulation

establishing prudential requirements that institutions need to respect, and

directive

governing access to deposit-taking activities.

For details see

11290/13.

JUSTICE AND HOME AFFAIRS

Common European Asylum System - Eurodac

The Council adopted the last piece of legislation needed to complete the Common European

Asylum System (CEAS), namely the amended Eurodac regulation (PE-CONS

17/13).

For more information see

11160/13.

Directives 2006/48/EC and 2006/49/EC

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Schengen Borders Code

The Council adopted a number of amendments to regulation (EC) No 562/2006 establishing a

Community Code on the rules governing the movement of persons across borders (Schengen

Borders Code)

and a number of consequential amendments to related provisions in other

instruments such as the Schengen Convention (PE-CONS

3/13).

For more information see

11300/13.

EMPLOYMENT

Directive on electromagnetic fields

The Council adopted a directive on the minimum health and safety requirements regarding the

exposure of workers to the risks arising from electromagnetic fields (10700/13).

This directive is to replace a 2004 directive which has never entered into force because of problems

with its implementation. It reviews exposure limitations on the basis of new scientific evidence and

provides for derogations, in particular for medical applications using magnetic resonance imaging.

Conventions on chemicals at work and on decent work for domestic workers

The Council reached a general approach for Council decisions authorising member states to ratify,

in the interests of the EU:

–

the 1990 Convention concerning safety in the use of chemicals at work, of the International

Labour Organization (Convention No 170), and

the 2011 Convention concerning decent work for domestic workers, of the International

Labour Organisation (Convention No 189).

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SOCIAL POLICY

European Court of Auditors' report

The Council adopted conclusions on following European Court of Auditors' report: "Are tools in

place to monitor the effectiveness of European Social Fund spending on older workers?"

(10095/13).

INTERNAL MARKET

Motor vehicles - International harmonised requirements

The Council adopted a decision on the EU's position, to be taken within the United Nations

Economic Commission for Europe (UNECE), with a view to adapting to technical progress

regulations Nos 13, 13H, 16, 29, 44, 53, 79, 94, 95, 96, 117 and 130, as well as adopting a proposal

for a UNECE global technical regulation on hydrogen and fuel cell vehicles and the adaptation of

regulations Nos 2 and 12

(10157/13).

The UNECE develops international harmonised requirements intended to remove technical barriers

to the trade in motor vehicles.

COMPANY LAW

New transparency rules for the extractive industry and simplification of accounting

requirements for companies

The Council adopted a directive for the review of the accounting rules applicable to EU companies

(PE-CONS

20/13).

The Estonian and Hungarian delegations voted against and the Portuguese, Spanish and Bulgarian

delegations abstained

(10703/13

ADD1).

The key objectives of the review are:

–

to reduce administrative burdens and to simplify accounting rules, particularly for small

and medium-sized enterprises;

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20 and 21 June 2013

–

to increase the clarity and comparability of financial statements; and

to enhance transparency on payments made to governments by the extractive industry and

loggers of primary forest.

The new rules will impose an obligation to report on payments made by the extractive industry and

loggers of primary forest to goverments in third countries (also referred to as country-by-country

reporting).

Large undertakings and public-interest entities which are active in the extractive industry or logging

of primary forests shall disclose payments made to governments in the countries in which they

operate if the total amount of payments exceeds EUR 100 000 per year. Such undertakings normally

operate in countries rich in natural resources, in particular minerals, oil, natural gas as well as

primary forests.

For more information see press release

8530/13.

ENVIRONMENT

Interoperability of spatial data sets and services

The Council decided not to oppose the adoption of a Commission's regulation amending regulation

(EU) No 1089/2010 implementing directive 2007/2/EC as regards interoperability of spatial data

sets and services (8982/13,

8982/13 ADD1).

The Commission regulation is subject to the so called regulatory procedure with scrutiny. This

means that now that the Council has given its consent, the Commission may adopt the regulation,

unless the European Parliament objects.

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EU Ecolabel

The Council decided not to oppose the adoption of a Commission's regulation amending annex III

to regulation (EC) No 66/2010 of the European Parliament and of the Council on the EU Ecolabel

(9400/13).

The Commission regulation is subject to the so called regulatory procedure with scrutiny. This

means that now that the Council has given its consent, the Commission may adopt the regulation,

unless the European Parliament objects.

TELECOMMUNICATIONS

Re-use of public sector information

The Council adopted a revision of the 2003 directive on re-use of data produced and collected by

public bodies, also called public sector information (PSI) (PE-CONS

18/13),

following the approval

given by the European Parliament on 13 June.

The objective of the new directive, which forms part of the

Digital Agenda for Europe

and the

Europe 2020 strategy for smart, sustainable and inclusive growth, is to eliminate differences

between member states in the exploitation of public sector information which hamper attainment of

the full economic potential of this resource. In doing so, the revision aims to facilitate the creation

of Union-wide products and services based on PSI and to ensure the effective cross-border use of

PSI.

The revision extends the directive's scope to cover certain cultural institutions, namely museums,

libraries and archives. Moreover, member states will have the obligation to allow the re-use of

existing generally accessible documents held by public sector bodies. Finally, the new directive

establishes rules on charging for re-use of public service information.

Public sector information is the single largest source of information in Europe. It includes digital

maps, meteorological, legal, traffic, financial, economic and other data. Most of this raw data could

be re-used, that is, used for other purposes than the initial purpose, or integrated into new

products

and services

which we use on a daily basis, such as car navigation systems, weather forecasts,

financial and insurance services.

11081/13