Proposed Directive on application of patients'

rights in cross-border healthcare

and other recent patient related documents

John Lamont
Chief Executive - Medical Council

15th May 2009

CEOM - Paris
 European Union today

27 countries

493 million citizens

Health sector:
• Total expenditure on health: 8.2% of GDP (OECD 2006)
• Employer for 10% of the EU workforce (with 70% of
budget allocated to salaries and other charges)
15 May 2009
Can the EU Regulate?
 The European Aviation Safety Agency
a Commission Regulation establishing the implementing rules
for the licensing and medical certification of pilots
 Executive Director of the European Aviation Safety Agency
on acceptable means of compliance and guidance material
on the licensing and medical certification of pilots
 The European Commission
SESAR, the project for the modernisation of the air traffic
control infrastructure adding a new dimension to the Single
European Sky initiative by providing it with modern
technologies and new working methods. It will ensure more
efficient flight safety management, while minimising the
environmental impact of aviation.

15 May 2009
European Regulation
PILOTS

AIRCRAFT

15 May 2009
The Purpose of Regulation
Q: Why is regulation of professional and
occupational groups needed in the health arena?
A: The primary purpose of professional regulation
is to ensure patient safety. In order to assure a
safe and high-quality experience for patients
when encountering health professionals there is a
need for proportionate arrangements to be in
place to ensure patient safety.
(DH conference on ‘Extending Professional Regulation’ November 2008)

15 May 2009
The EU and Health
The European White Paper "Together for Health:
A Strategic Approach for the EU 2008-2013" of 23
October 2007 identifies patient safety as an area
for action.
DG SANCO - Future Challenges Paper: 2009-2014
Three different policy areas
 food safety
 consumer policy
 public health.

15 May 2009
DG SANCO and Public Health
As regards public health, there are only a limited
number of EU legislative rules. Attention has been
focused on increasing co-operation with Member
States and with relevant stakeholders to
contribute to common public health goals and
towards sharing of information and good
practices.
- Future Challenges Paper: 2009-2014

15 May 2009
 The various documents
 Proposal for a Directive of the European Parliament and
the Council on the application of patients' rights in cross-
border healthcare (PRCB) (2008/0142 (COD) 2 July 2008)
nd

 Communication from the Commission to the European

Parliament, the Council, the European Economic and Social
Committee and the Committee of the regions on
telemedicine for the benefit of patients, healthcare
systems and society (TMBP) (COM(2008)689 final 4 November 2008)
th

 Communication from the Commission to the European

Parliament and the Council on patient safety, including
the prevention and control of healthcare-associated
infections (PSPCI) (COM(2008) 837 final 15 December 2008)
th

15 May 2009
And finally…

Green Paper On the European Workforce for Health

(GPEWH) (COM(2008) 725 final Brussels, 10 th December 2008)

DIRECTIVE 2005/36/EC on the recognition of

professional qualifications (RPQ) (L255/22 30 th September 2005)

15 May 2009
 Where does that leave us?

Patient Rights
Cross-Border
(PRCB)

Telemedicine
Benefits to Patients
(TMBP)

Patient Safety
(PSPCI)

HC Workforce
(GPEWH)

RPQ (2005/36)

15 May 2009
Proposed Directive PRCB – key dates

June 2002: The Council agreed that there was a need to

strengthen co-operation on patient mobility
Autumn 2006: The Commission decided to establish an EU
framework on healthcare services
“The basic strategy is to provide two things: legal certainty and
support for cooperation between national health systems.”
(Europa Sept 2006)
2 July 2008: The Commission published a proposal for a directive
on patients' rights in cross-border healthcare
Sept. 2008: In-depth analysis of the draft Directive by the Council
Debate in EU Parliament Spring 2009 - but may have to start from
scratch after the elections (EurActiv.com)
 
15 May 2009
Proposal for a Directive of the European
Parliament and the Council - PRCB

2nd July 2008 - proposal published by the Commissioner

Androulla Vassiliou
“The stated aims of the proposal are three-fold:
To help patients exercise their rights to access cross-
border care;
To give people assurances about safety and quality
of cross border care, and;
To help national health systems cooperate to achieve
economies of scale.“
Let us concentrate on the second of these…

15 May 2009
Patient Safety and Quality
Patient safety is defined by the WHO as ‘freedom
for a patient from unnecessary harm or potential
harm associated with healthcare’. An adverse
event is ‘an incident which results in harm to a
patient’.

Interestingly, “patient safety did not feature on

the EU agenda until the recent past.”
Robert Madelin - Director General DG SANCO 2009

15 May 2009
Proposed Directive (PRCB)
Article 18
Data collection for statistical and monitoring purposes
 1. Member States shall collect statistical and other additional data
needed for monitoring purposes on the provision of cross-border
healthcare, the care provided, its providers and patients, the cost
and the outcomes …… in accordance with national and Community
law for the production of statistics and on the protection of
personal data.
 2. Member States shall transmit the data referred to in paragraph 1
to the Commission at least annually, except for data that are
already collected pursuant to Directive 2005/36/EC. (MS report
containing statistical data to determine the impact of the system for the recognition
of professional qualifications.)

15 May 2009
and Patient Safety?
Patient Safety is mentioned in a footnote in the
proposed Directive – only in a footnote

The proposed Directive PRCB does state that:

it is vital for patients to ensure... mechanisms for
ensuring the quality and safety of the healthcare that is
provided
‘Caveat emptor’ applies?

15 May 2009
PRCB - Set of operating principles that
are shared by health systems
These operating principles include
quality, safety, care that is based on evidence and ethics
patient involvement
redress
the fundamental right to privacy with respect to the
processing of personal data, and
confidentiality.
Patients, professionals and authorities responsible for
health systems must be able to rely on these shared
principles being respected and structures provided for
their implementation
15 May 2009
Patient safety, including the prevention
and control of healthcare-associated
infections
Communication from the Commission to the European Parliament
and the Council 15th December 2008

15 May 2009
PSPCI - Member States are
recommended to:
 (1) Support the establishment and development of national policies and
programmes on patient safety in general terms.
 (2) Inform and empower patients by involving them in the patient safety
policy process, by informing them of levels of safety and, if things go wrong,
how they can find accessible and comprehensible information on complaints
and redress systems.
 (3) Set up or improve comprehensive blame-free reporting and learning
systems so that the extent and type and causes of adverse events are
captured to enable resources to be efficiently channelled into developing
solutions and interventions which can then be shared at the EU level. Such
reporting on adverse events should be done in a constructive, rather than a
punitive or repressive, manner so that healthcare providers feel confident that
they can report without fear of negative consequences.
 (4) Ensure that patient safety is embedded into the education and training of
healthcare workers, as the providers of care.

15 May 2009
 PSPCI - Operational action at EU Level
 At the EU level, the Commission should, in close collaboration with Member
States:
 (1) Take the necessary initiatives to develop common definitions, terminology
and indicators on patient safety. This action should build on the work undertaken
by international bodies such as the WHO, the OECD and the Council of Europe
and exploit, where appropriate, the results of relevant research projects at the EU
level.
Agreed indicators should also be developed for public reporting of safety levels.
 (2) Facilitate sharing information and best practice on patient safety, including on
the prevention and control of HCAIs. Sharing major patient safety alerts should
also be possible at the EU level.
 (3) Continue promoting European research programmes on patient safety
particularly focusing on filling the current research gaps and on complementing
existing research on national level. 
 (4) Consider how best to achieve and sustain effective collaboration on patient
safety between Member States in the longer term.

15 May 2009
And what of 2005/36 (RPQ)?

15 May 2009
DIRECTIVE 2005/36/EC - RPQ
Article 56 Competent authorities
 “1. The competent authorities of the host Member State and of the home
Member State shall work in close collaboration and shall provide mutual
assistance in order to facilitate application of this Directive. They shall
ensure the confidentiality of the information which they exchange.
 2. The competent authorities of the host and home Member States shall
exchange information regarding disciplinary action or criminal sanctions
taken or any other serious, specific circumstances which are likely to have
consequences for the pursuit of activities under this Directive, respecting
personal data protection legislation provided for in Directives 95/46/EC of
the European Parliament and of the Council of 24 October 1995 on the
protection of individuals with regard to the processing of personal data and
on the free movement of such data (1) and 2002/58/EC of the European
Parliament and of the Council of 12 July 2002 concerning the processing of
personal data and the protection of privacy in the electronic
communications sector (Directive on privacy and electronic
communications).
15 May 2009
 Where does that leave us?
Three ‘patient
centred’ documents:
- One dealing with
Patient Rights
(PRCB)
- One with Benefits
to Patients (TMBP)
and
- One with Patient
Safety (PSPCI)
at the centre.
A fourth on HC
Workforce
(GPEWH) which is
not centred on
patients and..
our own RPQ
(2005/36)

15 May 2009
However…..on the one hand
While the proposed Directive (PRCB) does
not refer explicitly to patient safety issues in
the text, there are references to RPQ in
respect of
Professional qualifications
Established Rights
Free Movement
Free Provision of services on a temporary or
occasional basis
But not Article 56
15 May 2009
On the other hand…
 In the ‘Green Paper (GPEWH) there is only one reference to 2005/36 and that
is explicitly to Article 56:
 “Managing mobility of health workers within the EU
 Directive 2005/36/EC provides for the recognition of professional
qualifications in view of establishment in another Member State and in view
of facilitating the provision of crossborder services in a Member State other
than the one of establishment. The Directive has also introduced a
requirement for the competent authorities of the host and home Member
States to exchange information regarding disciplinary action or criminal
sanctions taken or any other serious, specific circumstances. Outside the
regulatory framework, some initiatives linked to the mobility of health
professionals have been taken by professional organisations such as the
Health Professionals Crossing Borders initiative and the professional card
pilot initiative which both aim at improving access to information where
conduct has been brought into question. The progress of these initiatives will
need to be kept under review.”

15 May 2009
Documents

15 May 2009
What’s my point?
 Patient safety is a stated priority for the EU
 Professional regulation is primarily about patient safety
 However, there is an inconsistency of approach, in a range
of recent documents, over what patient safety entails
 The only reference to Article 56 – a key patient safety
feature of RPQ – is in GPEWH where there is a reference to
competent authorities sharing disciplinary and related
information.
 GPEWH also refers to patient safety: “Focusing on health
professionals' continuous professional development (CPD).
Updating professional skills improves the quality of health
outcomes and ensures patient safety.”

15 May 2009
Conclusions
EU wide initiatives involving patient care
should tie into the Directive 2005/36 that
mandates competent (regulatory)
authorities to share information that could
protect patients
The proposed Directive on “the application
of patients’ rights in cross-border
healthcare” should exploit that link to
better ensure patient safety
15 May 2009
A final point – an inconsistency
Example:
If an EU surgeon is erased by the Irish Medical
Council (the competence authority responsible for
regulating the medical profession in Ireland)
BUT
is not sanctioned in his/her ‘home’ State, his / her
patients can continue to receive treatment in their
‘home’ State paid for by the Irish Government!

15 May 2009
 Thank you..

jlamont@ireland.com

... questions?
15 May 2009