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    John Lamont

    Chief Executive - Medical Council

    15th May 2009

    CEOM - Paris

    Proposed Directive on application of patients'

    rights in cross-border healthcareand other recent patient related documents

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    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% ofbudget allocated to salaries and other charges)

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    Can the EU Regulate?

    y The European Aviation Safety Agencyy a Commission Regulation establishing the implementing rules

    for the licensing and medical certification of pilots

    y Executive Director of the European Aviation Safety Agency

    y on acceptable means of compliance and guidance material

    on the licensing and medical certification of pilots

    y The European Commission

    y 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 moderntechnologies and new working methods. It will ensure more

    efficient flight safety management, while minimising the

    environmental impact of aviation.

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    European Regulation

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    AIRCRAFT

    PILOTS

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    The Purpose of Regulation

    y Q: Why is regulation of professional and

    occupational groups needed in the health arena?

    y A: The primary purpose of professional regulation

    is to ensure patient safety. In order to assure asafe 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)

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    The EU and Health

    y 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.y DG SANCO - Future Challenges Paper: 2009-2014

    y Three different policy areas

    y food safety

    y consumer policy

    y public health.

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    DG SANCO and Public Health

    y 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 tocontribute to common publichealth goals and

    towards sharing of information and good

    practices.

    - Future Challenges Paper: 2009-2014

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    The various documents

    y Proposal for a Directive of the European Parliament andthe Council on the application ofpatients' rights in cross-

    border healthcare (PRCB) (2008/0142 (COD) 2nd July 2008)

    y Communication from the Commission to the European

    Parliament, the Council, the European Economic and SocialCommittee and the Committee of the regions on

    telemedicine for the benefit of patients, healthcare

    systems and society (TMBP) (COM(2008)689 final 4th November 2008)

    y 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 15th December 2008)

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    And finally

    y Green Paper On the European Workforce for Health

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

    y DIRECTIVE 2005/36/EC on the recognition of

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

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    Where does that leave us?

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    RPQ

    PRCB

    GPEWH

    PSPCI

    TMBP

    Patient Rights

    Cross-Border

    (PRCB)

    Telemedicine

    Benefits to Patients

    (TMBP)

    Patient Safety

    (PSPCI)

    HC Workforce(GPEWH)

    RPQ (2005/36)

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    Proposed Directive PRCB key dates

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

    strengthen co-operation on patient mobility

    y Autumn 2006: The Commission decided to establish an EU

    framework on healthcare services

    y The basic strategy is to provide two things: legal certaintyand support for cooperation between national health

    systems. (Europa Sept 2006)

    y 2 July 2008: The Commission published a proposal for a

    directive on patients' rights in cross-border healthcare

    y Sept. 2008: In-depth analysis of the draft Directive by theCouncil

    y Debate in EU Parliament Spring 2009 - but may have to start

    from scratch after the elections (EurActiv.com)

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    Proposal for a Directive of the European

    Parliament and the Council - PRCB

    y 2nd July 2008 - proposal published by the Commissioner

    Androulla Vassiliou

    y The stated aims of the proposal are three-fold:

    y To help patients exercise their rights to access cross-

    border care;

    y To give people assurances about safety and quality of

    cross border care, and;

    y To help national health systems cooperate to achieve

    economies of scale.

    y Let us concentrate on the second of these

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    Patient Safety and Quality

    y 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 apatient.

    y Interestingly, patient safety did not feature on

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

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    Proposed Directive (PRCB)

    y Article 18

    y Data collection for statistical and monitoring purposes

    y 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 costand the outcomes in accordance with national and Community

    law for the production of statistics and on the protection of

    personal data.

    y 2. Member States shall transmit the data referred to in paragraph 1

    to the Commission at least annually, except for data that are alreadycollected pursuant to Directive 2005/36/EC. (MS report containingstatistical data to determine the impact of the system for the recognition of

    professional qualifications.)

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    and Patient Safety?

    y Patient Safety is mentioned in a footnote in the

    proposed Directive only in a footnote

    y

    The proposed Directive PRCB does state that:y it is vital for patients to ensure... mechanisms for

    ensuring the quality and safety of the healthcare that is

    provided

    y Caveat emptor applies?

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    PRCB - Set of operating principles that

    are shared by health systems

    y These operating principles include

    y quality, safety, care that is based on evidence and ethics

    y patient involvement

    y redress

    y the fundamental right to privacy with respect to the

    processing of personal data, and

    y confidentiality.

    y 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

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    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

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    PSPCI - Member States are

    recommended to:

    y (1) Support the establishment and development of national policies and

    programmes on patient safety in general terms.

    y (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.y (3) Set up or improve comprehensive blame-free reporting and learning

    systems so that the extent and type and causes ofadverse 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 thatthey can report without fear of negative consequences.

    y (4) Ensure that patient safety is embedded into the education and training of

    healthcare workers, as the providers of care.

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    PSPCI - Operational action at EU Level

    yAt the EU level, the Commission should, in close collaboration with MemberStates:

    y (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.

    y (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.

    y

    (3) Continue promoting European research programmes on patient safetyparticularly focusing on filling the current research gaps and on complementing

    existing research on national level.

    y (4) Consider how best to achieve and sustain effective collaboration on patient

    safety between Member States in the longer term.

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    And what of 2005/36 (RPQ)?

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    DIRECTIVE 2005/36/EC - RPQ

    yArticle 56

    Competent auth

    oritiesy 1. The competent authorities of the host Member State and of the home

    Member State shallwork 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.

    y 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).

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    Where does that leave us?

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    RPQ

    PRCB

    GPEWH

    PSPCI

    TMBP

    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 isnot centred on

    patients and..

    ourownRPQ

    (2005/36)

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    However..on the one hand

    y While the proposed Directive (PRCB) does

    not refer explicitly to patient safety issues in

    the text, there are references to RPQ in

    respect ofy Professional qualifications

    y Established Rights

    y Free Movement

    y Free Provision of services on a temporary or

    occasional basis

    y But not Article 56

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    On the other handy In the Green Paper (GPEWH) there is only one reference to 2005/36 and that

    is explicitly to Article 56:

    y Managing mobility of health workers within the EU

    y 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 Stateother 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 theHealth 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.

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    Documents

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    RPQ

    PRCB

    GPEWH

    PSPCI

    TMBP

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    Whats my point?

    y Patient safety is a stated priority for the EUy Professional regulation is primarily about patient safety

    y However, there is an inconsistency of approach, in a range

    of recent documents, over what patient safety entails

    y The only reference to Article 56 a key patient safetyfeature of RPQ is in GPEWH where there is a reference to

    competent authorities sharing disciplinary and related

    information.

    y

    GPEWH also refers to patient safety: Focusing on healthprofessionals' continuous professional development (CPD).

    Updating professional skills improves the quality of health

    outcomes and ensures patient safety.

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    Conclusions

    y EU wide initiatives involving patient care

    should tie into the Directive 2005/36 that

    mandates competent (regulatory)

    authorities to share information that couldprotect patients

    y The proposed Directive on the application

    of patients rights in cross-borderhealthcare should exploit that link to

    better ensure patient safety

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    A final point an inconsistency

    y 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!

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    Thank you..

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    ... questions?

    [email protected]