EN Official Journal of the European Union C 71/30

Opinion of the Committee of the Regions on the Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions eHealth — making healthcare better for European citizens: An action plan for a European eHealth Area

(2005/C 71/08)

THE COMMITTEE OF THE REGIONS,

Having regard to the Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on eHealth – making healthcare better for European citizens: An action plan for a European e-Health Area (COM(2004) 356 final),

Having regard to the decision of the European Commission of 30 April 2004 to consult it on this subject, under the first paragraph of Article 265 of the Treaty establishing the European Community,

Having regard to the decision of its President of 8 September 2004 to instruct its Commission for Culture and Education to draw up an Opinion on this subject,

Having regard to its Draft Opinion 256/2004 rev. 1 adopted on 22 September 2004 by its Commission for Culture and Education, (Rapporteur: Mr Olivier Bertrand, Maire de Saint-Silvain-Bellegarde (FR/EPP),

unanimously adopted the following opinion at its 57th plenary session, held on 17-18 November 2004 (meeting of 17 November).

1. The Committee of the Regions' views

Introduction

1.1 e-Health, widely interpreted as in the Introduction to the Commission's Communication, has the potential to deliver improved healthcare, effectively and economically. However, the key to success will be securing the confidence of citizens that all aspects of e-Health that have implications for them, are designed giving first priority to their interests. The involvement of representatives of organisations representing patients and citizens, in the design of e-Health products, systems and services, will thus be very important. For systems designed for specific groups of patients representatives of the relevant patient support groups should be involved. The issue of confidentiality of personal medical records will be a major concern for citizens.

1.2 The designation ‘citizen centred health service’ must be seen to apply in the practical implementation of policies and not merely as a description of intent in policy documents.

1.3 Experience of the introduction of e-Health systems has also clearly demonstrated the need to involve health professionals from the very outset of discussions on any e-Health project designed for their use.

1.4 The issue of quality assurance of (Webseal) validated e-Health information systems will also be of vital importance in establishing and maintaining public confidence. Establishment of confidence should be recognised as a key issue in encouraging citizens to use sources that provide sound, balanced and impartial information and advice, instead of those that offer poor, or even dangerous, information, often for commercial purposes (1).

2. Challenges and Expectations facing Europe's Health Sectors and the Role of e-Health

2.1 Accessibility of services: The Communication states that by 2051, nearly 40 % of the Union's population will be over 65. The younger segments of this age-group will be people who have lived and worked in an electronic environment, and are likely to be familiar and to be comfortable with e-Health provided the necessary quality controls have been in place throughout their experience. However in early years of the 21st century many of those in older age groups may have little experience of e-Health and some may lack IT skills necessary to gain maximum benefit from e-Health developments. These are the very people who are most likely to require increasing access to healthcare services. Systems must be in place to ensure that their interests are not prejudiced. For some years there will be a need to provide other channels of communications for citizens to access services, for example by telephone. Printed information should also be available.

2.2 It is understood that a Committee convened under the auspices of DG Employment and Social Affairs is examining e-Health including the ‘digital divide’, urban and rural differences and questions about education and training for health professionals and citizens. Resolution of these issues is essential for successful implementation of e-Health.

2.3 Technology infrastructure: Reference is made in the Communication of the need for action on the ‘roll out of broadband networks in telecommunications’. Some current broadband connections to the Internet in some geographical areas, are currently not sufficiently robust. This has important implications for hospitals and primary care professionals in such areas. Some facets of telemedicine such as the transmission of x-ray results, would be extremely uncertain, if not impossible. In the rural or sparsely populated areas where current broadband connections are relatively fragile, the distances between healthcare facilities are likely to be greater than in other areas, and thus the potential benefits of e-Health applications greater. In addition, if local healthcare providers wish to make information available on-line for local residents, it is essential that these residents have a reliable technological infrastructure to provide ready access.

2.4 There is therefore a need for investment in the necessary equipment to ensure that the appropriate technological infrastructure is in place for all concerned to have ready access to e-Health services. The investment could come from EU cohesion and/or structural funds and possibly through the European Investment Bank.

2.5 Empowering health consumers - patients and healthy citizens: Reference is made to the support people now need in managing their own diseases, risks and lifestyles and to the fact that people are looking proactively for information on their medical conditions. In brief, people nowadays wish to be partners with health professionals in decisions on treatment.

2.6 The use of medication is by far the most common intervention in the treatment of illness and to safeguard citizens against suffering serious medical incidents such as coronary heart disease or stroke. The published proposals for the ‘road map’ of the European Medicines Agency (EMA) indicates the wish to have an EMA database covering all the medicines for which marketing authorisations have been granted in any EU Member State and under the centralised procedure. This proposal should be implemented as soon as practicable. People who wish to seek information on medicines via the Internet should be strongly encouraged to use the EMA database as their priority source because the information provided will be objective, reliable and scientifically proven.

2.7 All ‘validated’ websites on medicinal products and medical treatments should contain explicit advice to people to discuss the information, or any medication difficulties with their doctor or pharmacist. The 2003 WHO Report ‘Adherence to long term therapies – evidence for action’, emphasised the major problems that arise through non-adherence to courses of long term medication for chronic medical conditions. This represents not only a waste of resources, but also a threat to the future health of the individual.

2.8 Recent research (2) has indicated that people often take positive decisions to cease taking their medicines, rather than just forgetting. The WHO report indicated that the reasons for non-adherence vary but often encountering an unpleasant side effect can be a trigger. This should be taken into account in all e-Health initiatives providing information about medicines and medical treatments, with a positive approach to encouraging adherence.

2.9 A conclusion in the WHO report was that ‘increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvements in specific medical treatments.’ In time of pressure on resources for healthcare appropriate e-Health initiatives should focus on improving adherence.

2.10 The Communication emphasises the improvements in quality of care and patient safety that can result from access to ‘comprehensive and secure electronic health records’. The dilemma is how to maintain patient confidence in the security and confidentiality of medical records, while at the same time ensuring that all necessary information is available to all health professionals providing health care to an individual, enabling them to provide the best possible quality of care. The problem of maintaining public confidence on confidentiality of data is likely to be made more difficult with increasing cross border provision of health care. The Communication opens up the possibility of a study specific to data protection in the context of e-Health. This should be a priority.

2.11 Supporting health authorities and health managers: The Communication suggests that e-Health opens up new opportunities for people who live in remote areas with only limited healthcare services, as well as ‘marginalised groups’ such as people with varying degrees of disability. This will only be true if the necessary investment is made in the technology infrastructure in remote areas, where needed. Training for citizens will also be vital.

3. State of Play

3.1 Major challenges for wider implementation: As the Communication makes clear, interoperability is a key issue that, if it is to be achieved, will require a much more positive approach than has been demonstrated up to now. User-friendliness should be less difficult to achieve, given the necessary investment. Confidentiality and security issues have already been covered in this Opinion.

3.1.1 The provision within the general data protection directive to create a code of conduct for special domains such as health should be taken forward as a matter of urgency especially to address issues of confidentiality and security.

3.1.2 Apart from assurance about confidentiality, citizens will be concerned to be confident that, if problems arise subsequent to cross-border provision of services, their rights to compensation will be protected. The discussions on the proposal for a Directive on Services in the Internal Market (COM(2004) 2 final) show that professional indemnity cover differs widely between Member States. Insurers have suggested that a requirement for compulsory professional indemnity cover for health professionals could make it impossible for some health professions to obtain affordable cover. They would then be faced with withdrawing services or acting illegally. This problem must be resolved if citizens are to have confidence in using cross border e-Health services.

3.2 The question of the qualifications of those offering health services cross border is also an issue for citizens, as the debates on the proposed Directive on the mutual recognition of professional qualifications (COM(2002) 119 final), have clearly demonstrated. It is essential that e-health services are not used to bypass national regulations, which means that the regulatory authority in the host Member State must know that a service is being offered by a health professional from another Member State and be satisfied that the professional concerned is properly qualified, licensed to practise their profession, and not subject to disciplinary sanctions. Citizens want to be certain that health professionals from other Member States providing services to them meet the same standards required in their Member State. A solution must be found in the text of the Directive concerned, if citizens are to be confident using e-Health services.

3.3 An example, which would help enhance security and legal certainty, would be the standardisation of e-prescription forms. There is currently no standardisation of format of paper prescriptions throughout the EU, which is an additional element leading to difficulties for patients seeking to have a prescription dispensed in a Member State other than the one in which it was issued. It seems appropriate therefore to investigate the standardisation of e-prescription formats while e-prescription services are in their infancy, rather than wait until systems are in place in individual Member States. EU representatives of the medical, dental and pharmaceutical professions should be invited to cooperate with such an initiative.

3.4 As the Communication states, citizens prefer services tailored to their needs and requirements, while knowing that their right to privacy is protected. It is agreed that the take-up of e-Health systems and services would take place more rapidly were the needs and interests of the user communities (health professionals, patients and citizens) to be taken on board. Representatives of user groups should therefore be integrated into the development of e-Health projects. These communities will then be much more likely to be users and promoters of e-Health. The fact that each stakeholder group has the ability to veto implementation of any project if not considered beneficial should be uppermost in the mind of those planning these projects.

3.5 The risk that the sections of the community mentioned under the subheading Access for all to e-Health might be excluded from the possibilities offered by e-Health, must be tackled as a priority issue if people in these already disadvantaged groups are not to feel further excluded. e-Health, appropriately provided, could be a major element in the delivery of improved health care to them;

4. Towards a European e-Health Area: Issues and Actions

4.1 The objectives listed on issues raised earlier in the Communication will only be achieved if there is full commitment on the part of Member States, if all stakeholders, including representatives of patients, citizens and the professions are closely involved from the outset at both national and Community level, if there is careful and consistent monitoring of achievement of the targets set out and if there is the necessary investment in technology infrastructure. This will assist greatly in encouraging citizens to be confident in using e-Health services and in supporting their further development. Without their support little will be achieved. The Committee of the Regions has not commented on every subheading in this section of the Communication.

4.2 Issue 1: Addressing common challenges: (Communication point 4.2.1) It is important that Member States and the Commission study the matter of the reimbursement of services provided cross border. It is possible to imagine a situation where a patient living close to a border might find that the nearest and apparently most suitable specialist for providing a second opinion, by teleconsultation - as set out in point 4.3.2 - is in a hospital in a Member State other than that of residence of the patient. For such people an absence of regulation on this matter would be difficult to understand, and any regulation introduced should be adapted to the regulations applying in each Member State.

4.2.1 (Communication point 4.2.3) In relation to mobility of patients, the achievement of a common approach to patient identifiers as envisaged in section 4.2.2.1 and confidence that strict controls are in place for assurance of the competence of health professionals, offering services in Member States, will be very important.

4.2.2 (Communication point 4.2.4) Here the Committee of the Regions reiterates its earlier statement that financial support from the Community will be essential in accelerating the roll out of broadband communications in some underserved localities.

4.2.3 (Communication point 4.2.7) The Commission's Communication states that certainty of e-Health product and service liability ‘would be beneficial’. The Committee of the Regions considers that these words should be replaced by ‘is essential’ if patient confidence in using e-Health services is to be stimulated and maintained. An earlier date than 2009 should be set for the Commission, in collaboration with Member States, to provide the necessary framework for greater legal certainty in this regard.

4.3 Issue 2: Pilot actions: accelerating beneficial implementation

4.3.1 (Communication point 4.3.1) The Committee of the Regions welcomes the co-funding by the Commission for the development of a set of quality criteria for health related websites. There should be long-term campaigns by governments and health professionals to encourage citizens to use sites with a ‘webseal’, in preference to others. Formal, constant monitoring of such sites to ensure continuing compliance with the quality criteria will be essential.

4.3.2 (Communication point 4.3.3) The Committee of the Regions welcomes the introduction of the European health insurance card. The proposed European health card should, on its introduction, incorporate the information on the health insurance card together with the essential health data should the patient so wish. The patient should then be able to permit individual health professionals to access relevant data to ensure that they can provide the best possible quality of healthcare. This again points to the importance of ensuring interoperability of electronic technology. Care should be taken that certain medical data that could be used for ‘cherry picking’ is not made available to health insurance organisations.

4.3.3 (Communication point 4.4.1) The establishment of the high level e-Health forum, to support the Commission will provide the ideal opportunity to establish confidence by confirming that all necessary stakeholders will be involved from the outset. It is understood that the forum will be able to set up working groups on specific topics, one of which should obviously be interoperability. There should be close liaison between the e-Health forum and the high level reflection group on healthcare and medical services to be established under the Commission's Communication on patient mobility.

5. The Committee of the Regions' recommendations

THE COMMITTEE OF THE REGIONS,

5.1 recommends that financial support be provided via EU structural/cohesion funds or from the European Investment Bank to ensure the required effectiveness of broadband communications in localities that would otherwise be underserved;

5.2 recommends that the problem of maintaining public confidence on confidentiality of personal medical data, while explaining the benefits of the sharing of relevant information by health professionals involved in their treatment, be tackled as a priority by the Commission in cooperation with Member States;

5.3 recommends that representatives of patients, citizens and the health professions be involved from the outset in all proposals relating to e-Health projects;

5.4 recommends that positive steps be taken to ensure that the interests of those in older age groups and other vulnerable groups, are specifically addressed in relation to all e-Health projects and that for some years, alternative means for seeking information and advice are provided;

5.5 recommends that a much earlier date than 2009 be set for the Commission, in cooperation with Member States, to provide the necessary framework for greater legal certainty on e-Health product and service liability;

5.6 recommends that the issue of reimbursement for services provided cross border be given priority;

5.7 recommends that the benefits of using ‘webseal’ sites rather than others be promoted to citizens, on a long term basis, by governments of Member States and health professionals;

5.8 recommends that a system be established to ensure that ‘webseal’ sites consistently adhere to the established quality criteria;

5.9 recommends that e-Health services associated with treatments by medication, positively address the serious problem of non-adherence to medication regimens;

5.10 recommends that there be close liaison between the e-Health forum and the high level refection group on healthcare and medical services to be established under the Commission's communication on patient mobility.

Brussels, 17 November 2004 The President of the Committee of the Regions Peter STRAUB

(1) A recent survey of 32 of the most popular alternative and complementary therapy websites, said to attract tens of thousands of ‘visitors’ each day, offered 118 different ‘cures’ for cancer, and 59 so-called preventative treatments, none of which could be demonstrated to have the effect claimed. And one fifth of the websites either actively or indirectly discouraged patients from using conventional treatments for cancer (study published in the Journal ‘Annals of Oncology’, cited on BBC News 15 April 2004)

(2) Barber N, Parsons J, Clifford S, Darracott R, Horne R, ‘Patients' problems with new medication for chronic diseases’Quality and Safety in Healthcare, No 13, June 2004