Joint Oireachtas Committee on Health and Children
Meeting of the 20th November 2012
Brief for Committee Members
Employment Social Policy Health and Consumer Affairs (EPSCO)
Contents
1.
Pre-council briefing
2.
Outcome of previous Council meeting
3.
Irish Presidency – overview
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Joint Oireachtas Committee on Health
Meeting of the 20th November 2012
Brief for Committee Members
Employment Social Policy Health and Consumer Affairs (EPSCO)
1.
EPSCO meeting of 6th/7th December 2012 – under Cypriot Presidency
The December Council will take place in Brussels on 6th and 7th December
2012.(Health issues are discussed on Day 2). Minister Reilly will attend.
The Council will provide an opportunity for the Minister to meet with the new
Commissioner (Mr Tonio Borg from Malta) if his appointment is confirmed. (Note:
Mr Borg attended a hearing on his appointment at the European Parliament on 13
November 2012. A vote on Mr Borg’s appointment will take place at the November
Plenary session).
The Minister will also have the opportunity to meet the Health Ministers from the
other Trio-partners (Lithuania and Greece) and to meet Ministers from other Member
States.
The Agenda for the Council will be presented to the Committee of Permanent
Representatives (COREPER) on the 21st of November 2012. Therefore it is not
possible to be absolutely sure what will be included on the agenda. It is expected that
the Cypriot Presidency will outline its achievements in the health area including
progress made on; dossiers on the Health For Growth Programme; Serious CrossBorder Threats to Health, Medical Devices, Clinical Trials; the Transparency
Directive and Food for intended for infants and young children and food intended for
special medical purposes (PARNUTS). The brief below is based on our understanding
to date.
Legislative Items:
Health For Growth Programme
The Presidency is currently in negotiation with the European Parliament. It is
hoped that agreement will be reached on the text but the dossier cannot be
completed until such time as wider agreement on the Multiannual Financial
Framework MFF1 is achieved. This means that final agreement will more than
likely be reached under the Irish Presidency.
Significance/Irish Position
1
The Multiannual Financial Framework (MFF)The financial framework sets the maximum amount of
commitment appropriations in the EU budget each year for broad policy areas ("headings") and fixes an overall
annual ceiling on payment and commitment appropriations.
2
This is the EU Public Health programme for 2014-2020. The proposed budget
over 7 years is €446m (this may change during the Multiannual Financial
Framework MFF negotiations). The objectives of the programme are:
 Encourage innovation in healthcare
 Increase the sustainability of health systems
 Improve the health of EU citizens
 Protect citizens from cross-border health threats
Ireland is fully supportive of the proposed programme.

Serious Cross-Border Threats to Health
It is not expected that the Cypriot Presidency will finalise this dossier. The
Presidency is expected to present a progress report to EPSCO. It is expected that
Ireland will enter into negotiations with the European Parliament, commencing
Trilogues early in 2013.
Significance/Irish Position
This dossier includes proposals to strengthen existing rules on preparing for, and
managing, health emergencies. The proposal will also provide a legal mechanism
for the joint procurement by Member States of vaccines to fight pandemics.
Ireland supports the proposal and hopes that agreement on it will be reached
during the Irish Presidency.

Medical Devices
This is a complex dossier, consisting of two proposed Regulations (one on
medical devices and one on in-vitro diagnostic medical devices) was presented
later than expected by Commission (due to the necessity for the Commission to
take account of the implications of the PIP Implant scandal). The Presidency is
expected to present information to the Council.
Significance/Irish Position
The role of medical devices in healthcare is essential to save lives and improve
the quality of life for citizens. Improvements in medical technology can also
boost the EU’s global competitiveness and create jobs, while reducing healthcare
costs and enhancing the quality and efficiency of healthcare. The Medical Devices
industry is particularly important to the Irish economy.
These Medical Device proposals will be a priority for negotiations during the Irish
Presidency.

Clinical Trials
Progress on this dossier, which was presented by the Commission in July 2012,
has been slower than expected with only 14 out of 95 Articles examined so far.
The Presidency may present information to the Council on progress to date.
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Ireland will hope to progress negotiations on this dossier under our Presidency.
Significance/Irish Position
This proposal is designed to address the fall in clinical trial applications in Europe,
which are essential to providing new innovative medicines for patients and
maintain a strong pharmaceutical industry in Europe, by reducing the
administrative burden and costs on sponsors while at the same time ensuring that
subjects are fully protected.
Ireland aims to make significant progress on the proposal.

Transparency Directive
Progress on this dossier has been extremely slow. Many Member States have
expressed strong reservations on this proposal. The Presidency may present a
“state of play” report.
At this time it is not possible to say how the Irish Presidency will handle this file
as much will depend on the outcome of discussions under the Cypriot Presidency.
Significance/Irish Position
This proposal is intended to update EU legislation on transparency of pricing and
reimbursement of medicines which are included in health insurance systems. It is
also proposed to reduce the time limit for the adoption of national decisions on
pricing and reimbursement of medicines. Many Member States have concerns
about the original Commission proposal which could have imposed financial
penalties on Member States who failed to adhere to the new tighter timelines and
would have imposed additional administrative burdens on MS.
Ireland is conscious of its role as a future Presidency when our role will be that of
a neutral chair trying to build consensus within the European Council on this
contentious proposal and representing the Council in negotiations with other
Institutions. While we share many of the concerns of other Member States we are
prepared to continue negotiations to ensure the best possible outcome for Member
States and their citizens.

Food for intended for infants and young children and food intended for
special medical purposes (PARNUTS)
The Cypriot Presidency is finalising negotiations with European Parliament.
There a number of outstanding issues, in particular the demand from the EP for
the use of Delegated Acts to update the Union List of substances, which remain to
be resolved.
If these issues cannot be resolved under the Cypriot Presidency then it is likely
that it will fall to Ireland to instigate a Second Reading negotiation with the EP.
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NOTE: The Cypriot Presidency held a Trilogue with the EP on Wednesday 14
November. We are awaiting the outcome of this Trilogue and may be able to
update this brief shortly.
Significance/Irish Position
The proposed Regulation is intended to update, harmonise and simplify EU rules on
specialised food products. Ireland supports adoption of this proposal.
Non-legislative items

Council Conclusions on Organ Donation and Transplantation
The Presidency will present these Council Conclusions for adoption at EPSCO.
The draft Council Conclusions propose key political messages on organ donation and
transplantation and are intended to compliment the Commission's Action Plan on
Organ Donation and Transplantation (2009-2015). A mid-term review of the Action
Plan is due to be completed this year.
The draft Conclusions address the areas of:- increasing organ availability
- enhancing efficiency and accessibility of transplant systems
- improving quality and safety.
Significance/Irish Position
Council Conclusions are not legally binding but are a statement of political intent.
Ireland fully supports these Conclusions.

Council Conclusions on Healthy Ageing across the Lifecycle.
The Presidency will present these Council Conclusions for adoption at EPSCO.
The draft Council Conclusions are aimed at making the issue of healthy ageing across
the lifecycle, one of the priorities for the coming years. The Conclusions call on MSs
to adopt an approach that shifts the focus towards health promotion, disease
prevention and early diagnosis from the early years of life and throughout the
lifecycle, as a strategy to improve quality of life and reduce the burden of chronic
diseases, frailty and disability.
Significance/Irish Position
Council Conclusions are not legally binding but are a statement of political intent.
Ireland fully supports these Conclusions.
AOB
Minister Reilly will present his plans and priorities for Ireland’s Presidency under
AOB at EPSCO on 7th December.
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2.
Outcome of previous council meeting 22 June 2012 Luxembourg
The Health Council had a reasonably light agenda. Ireland was represented by
Minister for Health James Reilly. Partial general agreement was reached on the
Health for Growth Regulation (MFF). There was orientation debate on the Serious
Cross Border Threats to Health (legislative Decision). Council Conclusions on the
Impact of antimicrobial resistance in the human health sector and in the
veterinary sector were adopted. AOB points included the results in field of health
during the Danish Presidency, information from the Commission on the European
Innovation Partnership on Active and Healthy Ageing, information from France and
Luxembourg on the supply of raw materials for pharmaceutical use and information
from France on the Medicrime convention. The Incoming Cypriot Presidency gave
a presentation on its work programme. The lunchtime discussion was on the joint
procurement of vaccines.
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3. Ireland’s Presidency of the European Council of the European Union
January – June 2013
Two themes, namely, “health and well being” and “innovation and research” will
inform the Presidency Programme in the area of Health.
In addition to progressing legislative priorities in public health, pharmaceuticals, and
medical devices (some of which are outlined below), the Presidency will hold two
high-level conferences in Dublin; the first on ehealth which will run in parallel with
the World of Health IT Conference & Exhibition, and the second on the future of
brain research2
Key legislative proposals in the public health and pharmaceutical & medical device
sectors will include:

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


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Clinical Trials
Medical Devices
Serious Cross Border Threats to Health
Tobacco Products (likely to published by the Commission in late January 2012 –
this proposal has been delayed due to the resignation of Commissioner John Dalli
but his replacement Dr Tonio Borg could be place by 1 December which allow
this proposal to move forward again).
Transparency of Measures for Pricing & Reimbursement of Pharmaceuticals
Health for Growth Programme
The Minister will host an Informal Meeting of EU Health Ministers in Dublin on 4th
and 5th March 2013.
In addition Ireland will be responsible for coordinating the EU Council position at the
WHO.
2
Co-hosted with DG Research & Innovation
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