Healthcare across EU borders: a safe framework - European Union Committee Contents


Supplementary memorandum by the NHS Confederation

  1.  Jo Webber, the NHS Confederation's Deputy Director of Policy, gave oral evidence on 4 December as part of the Committee's inquiry into the European Commission's proposals on cross-border healthcare.

  2.  The Committee requested a supplementary written note on the challenge of understanding the different systems in place across the EU and obtaining practical information on cross-border healthcare options, whilst ensuring that systems to support cross-border healthcare remain proportionate to the level of cross-border activity.

  3.  The NHS Confederation recognises that this is a considerable challenge. The draft directive includes proposals for a network of national contact points on cross-border healthcare, which, it is envisaged, would be responsible for collating and exchanging information about cross-border healthcare in each EU member state.

  4.  As we said in our evidence, we think these national contact points may be helpful in terms of providing general information about rights to cross-border healthcare and how other member states' systems function, but we do not think they will be able to provide personal advice on the best care or act as advocates for individual patients.

  5.  Most patients will look to their local NHS, often their own clinician, to help them make decisions about their healthcare. However, responses to the NHS European Office's[15] recent consultation on the proposals suggested that, with a few exceptions, awareness of rights to cross-border healthcare is very limited at local levels of the NHS. In view of this, we think there will be a need for capacity building and support in this area as part of implementation of any future directive.

  6.  We also think it is important to be realistic about the level of information on cross-border healthcare that health professionals and staff in local NHS organisations will be able to give. It may be that in many cases, they would discuss a patient's individual needs and entitlements with them, and then signpost them to other sources for more general information, eg on standards of quality and safety that would apply in the country where they were interested in receiving treatment.

  7.  In our evidence, we explained that we strongly support the use of prior authorisation systems as a mechanism to provide information to patients interested in cross-border healthcare to help them make an informed choice. It is unlikely that the NHS would ever be able to provide the same level of information about cross-border healthcare options as it could about options within the NHS. However, prior authorisation systems do offer an opportunity to make patients aware of important factors to be considered in a decision to seek cross-border healthcare, for example, the fact that standards of quality and safety and clinical practices may be different in other member states.

  8.  There may be merit in developing materials to support patients considering cross-border healthcare options, such as sets of questions they could ask a prospective healthcare provider. Involving public and patients in the development of guidance and information on cross-border healthcare would be helpful in trying to dispel misconceptions and misunderstandings about what exactly patients are entitled to.

  9.  We also think that, in the interests of equity, consideration will need to be given to the provision of information in accessible formats and potential extra help or support for vulnerable patients or those with complex needs. This may be an area where approaches that share resources or pool expertise could be useful.

  10.  We think the NHS has a responsibility to ensure that patients can access information about their healthcare options, including cross-border healthcare, easily and in a format that is clear and understandable to them. Where patients are interested in cross-border healthcare, the NHS should provide clear information on eligibility requirements, level of reimbursements and processes for obtaining prior authorisation, where this is required.

  11.  However, it would be neither proportionate nor equitable for the NHS to devote unlimited resources trying to provide the same level of information about cross-border healthcare options as about options within the NHS. We do not, for example, think it would be the role of the NHS, in the majority of cases, to try to obtain information about whether a particular specialist or centre in another EU country has capacity to treat an individual patient who is interested in travelling there for treatment.

  12.  We consider that, where the NHS can provide treatment in a timely manner in the UK and patients are deciding for personal reasons to seek treatment in another EU country, in choosing to obtain care outside the NHS, patients take on an additional degree of personal responsibility for their choices. We think, for example, that patients should be responsible for finding and choosing their own healthcare provider.

  13.  Nevertheless, we think that a number of actions, such as the development of materials as mentioned above, could be taken to support patients in making informed choices about cross-border healthcare. We think that these actions, though requiring some additional resource, may well prove cost effective in reducing the risk of complications arising from poor quality or inappropriate healthcare received in another country.

Annex

NHS EUROPEAN OFFICE CONSULTATION ON THE EUROPEAN COMMISSION'S PROPOSALS FOR A DIRECTIVE ON THE APPLICATION OF PATIENTS' RIGHTS IN CROSS-BORDER HEALTHCARE: SUMMARY OF RESPONSES

KEY POINTS EMERGING FROM THE CONSULTATION

  Responses to the consultation came from a diverse range of NHS organisations and many different opinions and points of view were represented. However, some common themes emerged strongly from the consultation. These can be summarised as follows:

    —  We do not expect a large increase in the volume of cross-border healthcare as a result of the framework set out in the draft directive. Systems established to provide for and facilitate cross-border healthcare should be proportionate to the level of cross-border activity and should respect the organisation and structure of health systems.

    —  Where a patient makes an informed choice that they wish to receive planned healthcare in another EU country, they should be supported to do so. As well as looking to remove unjustified barriers to accessing cross-border healthcare, the legislative framework put in place should consider mechanisms to support informed decision-making.

    —  It is crucial to recognise that, within many systems, decisions about what treatment an individual can receive are made at regional and/or local levels. Such decision-making processes must be allowed to continue.

    —  Prior authorisation systems should not be seen as a barrier to accessing cross-border healthcare. They offer a valuable opportunity to ensure patients have the information they need to make informed choices about cross-border healthcare. They are also an important aid to help healthcare systems plan services and manage financial resources to the benefit of all patients.

    —  The provision of information is absolutely fundamental to supporting patients who are interested in accessing cross-border healthcare. It is important to recognise that patients will need a range of information from different sources to make an informed choice about the best healthcare options for them.

    —  Information on quality and safety systems as well as differences in clinical practices and the way healthcare is organised and delivered in other EU countries will be a key element of patient information. However, these matters are the responsibility of the appropriate national authorities and the legal framework should not interfere in how they are managed within member states.

    —  There is significant and widespread confusion and misconceptions throughout the NHS about the current rules on cross-border healthcare, existing arrangements under social security provisions and what changes EU proposals in this area may lead to. There were strong calls for clear guidance on the different routes to accessing healthcare abroad and their application in the context of the NHS.

    —  Some NHS organisations expressed an interest in developing opportunities to offer more cross-border healthcare. There were calls for guidance clarifying what scope NHS organisations have to pursue such opportunities.

    —  There were concerns that requirements in relation to data collection on cross-border healthcare should not be too complex or burdensome and should not result in resources being diverted from patient care.

    —  There was interest and support for cooperation with healthcare systems and providers in other EU countries, particularly from providers of highly specialised services. It is important that current initiatives are taken into account and that flexibility is maintained in the scope and direction of future developments.

Introduction

  In the past, the NHS did not provide reimbursements for healthcare received in other EU countries. As the vast majority of NHS healthcare is provided free at the point of use, the NHS had no systems for calculating levels of reimbursements due if healthcare were paid for upfront. In addition, the NHS has no defined list of healthcare for which all patients are eligible. The treatment that a patient can receive is determined at a local level, based on an assessment of their individual circumstances balanced against the healthcare needs and priorities of the wider local population. As a result of these and other factors, implementing rights to cross-border healthcare raises some significant challenges for the NHS.

  In July 2008, the European Commission published proposals for a directive on the application of patients' rights in cross-border healthcare. The aim of the proposals is two-fold: to clarify the rules associated with the right to access cross-border healthcare; and to put in place measures to support the provision of cross-border healthcare.

  The right to access cross-border healthcare in certain circumstances has been established by the European Court of Justice, and cannot be removed. However, the detailed framework set out in the draft directive could make a big difference in terms of how complex and potentially burdensome implementation is, in practice, for the NHS and how clear and easy the system is for patients to use.

  In view of this, NHS European Office undertook a major consultation process focussing on the potential implications for the NHS of the proposals set out in the draft directive. In particular, the consultation aimed to explore aspects of the current proposals which might be particularly problematic for the NHS, or where changes to the proposals could potentially make the framework clearer, easier to implement, or less burdensome to the NHS.

The consultation process

  The NHS European Office prepared a consultation document which was circulated to NHS organisations, and published on the internet. A number of specific consultation meetings were organised and the issue also raised and discussed at a range of other meetings, conferences and events. Discussions were also held with a range of other stakeholders from the UK healthcare community. The consultation ran for a period of three months. The consultation document can be viewed via the NHS European Office website at:

    www.nhsconfed.org/europe

SUMMARY OF RESPONSES TO THE CONSULTATION

Cross-border healthcare: potential impact on the NHS

  From a UK perspective, travelling to another EU country for healthcare is likely to be associated with additional costs and inconvenience as well as possible language barriers, when compared to obtaining treatment at home. Bearing this in mind, contributors did not anticipate a large expansion in the volume of cross-border healthcare, either to or from the UK, within the framework of the draft directive, provided that patients understood that they did not gain any rights to receive reimbursements for treatments that would not have been funded at home.

  In view of this, contributors felt that systems established to provide for and facilitate cross-border healthcare should not be disproportionate in scale and cost to the level of cross-border activity and should not have wider, unintended, consequences for health systems as a whole. Contributors did not believe that the promotion of cross-border healthcare should be an objective in itself. Rather, the objective should be to provide clarity about the rules relating to cross-border healthcare so that interested patients are able to make informed decisions within a framework that respects the organisation and structures of different health systems.

  Some NHS organisations, for example, centres of very highly specialised care, have long experience of providing healthcare to patients from other countries. Other NHS organisations have had to respond to a changing local population as a result of recent migration patterns. Compared to these wider phenomena, contributors did not think that incoming patient flows as a result of cross-border healthcare provisions would, in general, have a significant impact on NHS provider organisations.

  Nevertheless, there could be an impact on a small number of highly specialised services, where expertise and/or capacity are limited, and some contributors felt that, in some circumstances, there could be a need to give UK-resident patients higher priority than incoming patients from other countries. Examples cited included when dealing with organs for transplantation that are in short supply and when supplying a very highly specialised service, of which there may be no other or a very small number of EU providers, and the number of incoming patients risked jeopardising the NHS' ability to meet relevant standards for domestic patients, such as the 18 week waiting standard. However, these were very much exceptional examples, and for the vast majority of services, contributors felt that incoming patients would be accommodated and treated on an equal basis to local patients.

  Some NHS providers said they would be interested in exploring opportunities to provide more services to EU patients, in particular in areas of specialist expertise. In such cases, extra capacity would be planned so that additional patients could be treated to the benefit of, and not the detriment of, NHS patients. In order to facilitate this, NHS providers would welcome clarification on the rules which apply to patients coming from other countries and what scope NHS organisations have to pursue such opportunities.

  Turning to outgoing patient flows, whilst, overall, contributors thought that relatively few NHS patients would seek treatment abroad, it was noted that there may be some circumstances in which greater numbers of patients could choose to obtain cross-border healthcare. Some examples might include:

    —  Individuals with personal links in other EU member states who prefer to receive healthcare in the system they know best.

    —  Individuals who regularly spend extended periods of time in another EU country (eg retirees who spend three to six months of each year in the Mediterranean region) for whom it is convenient to receive healthcare in that other country.

    —  If capacity limitations or the lack of a nearby provider for a type of healthcare means that it is easier for patients to travel abroad to access healthcare.

    —  If a patient wished to receive treatment from a specific specialist or facility because they perceived they could benefit from their particular expertise.

  Contributors recognised that patients in circumstances such as those illustrated in these examples may benefit from receiving treatment in another EU member state. There was a strong view that where patients had made an informed choice to seek treatment abroad they should be supported to do so. In order to facilitate this, there was overwhelming support in favour of a system providing for patients and their commissioner/insurer to discuss arrangements before treatment is obtained abroad as the best way of doing this.

  Patients would, in any case, need to contact their commissioner/insurer to obtain personalised information regarding eligibility requirements, level of reimbursements and processes for obtaining prior authorisation, where this is required. Therefore such an approach would not constitute an undue barrier to cross-border healthcare and should reduce risks for both parties at later stages, eg disputes over reimbursements or whether a treatment was necessary.

  In the UK, where most local commissioners have relatively little experience of cross-border healthcare, capacity-building and clear guidance on the legal framework and its application in the NHS will be needed to support implementation.

  Although not directly affected by provisions on cross-border healthcare, discussions in this area also highlight questions about eligibility to NHS funded healthcare. Under current arrangements, it can be extremely difficult, in practice, to determine whether an individual is entitled to NHS-funded treatment, for example, in the case of individuals dividing their time between the UK and another EU country. A number of contributors have said that they would welcome clearer guidance on these issues.

Conditions for accessing healthcare: local eligibility criteria and procedures

  We understand the current EU framework, and the proposals in the draft directive, to be based on the principle that patients should be eligible for reimbursements towards the costs of healthcare received in another EU country only to the extent that they would have received the same healthcare at home. So, for example, if a patient's commissioner/insurer had decided not to fund a particular treatment for them, the patient could access that treatment in another EU country, but would have to pay for it themselves and would not be eligible for a reimbursement towards the cost. Contributors were clear and unanimous in the view that this principle is correct and it is crucial that it is preserved.

  In relation to this, many contributors highlighted the fact that the NHS does not have national level eligibility criteria for determining access to particular treatments or a defined "basket of care" which NHS patients are automatically entitled to receive. The treatment which an individual can receive is determined at a local level, based on their particular health needs balanced against the health needs and priorities of the wider local population.

  Access to specialist care in the NHS is by referral from primary care, and decisions about an individual's care are usually taken by their NHS clinician, where relevant taking into account, or with reference to, local commissioners' guidance on low priority treatments. Contributors were again unanimous in the view that the legal framework must recognise the legitimacy of local priority-setting and allow for the "gatekeeper function" and local decision-making processes to continue.

  Contributors noted that if NHS patients have sought treatment abroad without a needs assessment from an NHS clinician, it may be extremely difficult to determine retrospectively whether treatment would have been available under the NHS, and therefore, whether the patient is eligible for a reimbursement.

  For example, the NHS will not normally fund the removal of moles for cosmetic reasons but mole removal for biopsy where cancer is suspected is funded. However, after the procedure has taken place there may be no way of proving whether the procedure was for medical or cosmetic reasons.

Supporting patients opting for cross-border healthcare: prior authorisation

  In England, patients referred for specialist care can choose to be seen by any provider contracted with the NHS to provide the appropriate treatment. This is referred to as "patient choice" and is a relatively new development (introduced in April 2008, after a gradual phase-in). It is in this context that many NHS organisations considered the proposals on patients' rights in cross-border healthcare, and many felt that cross-border healthcare could be viewed as an extension of patient choice.

  Contributors therefore considered that, where it has been established that a patient is eligible to receive a particular treatment, the fact that healthcare could be provided locally should not, alone, be a reason to prevent the patient from seeking treatment abroad. It was, however, felt that patients should be advised of local options where they existed, as well as being given information about their rights to access healthcare in other EU countries.

  One key difference between patient choice in England and cross-border healthcare is that patient choice is limited to providers contracted to the NHS. This includes a range of independent and third sector providers, but crucially, all are required to provide healthcare according to NHS standards and conditions. By contrast, in a cross-border situation, a patient can access treatment from any healthcare provider, private or state/public sector, and without reference to issues such as compliance with quality and safety standards. This difference lay at the heart of a large proportion of contributions to the consultation.

  Contributors were generally concerned about standards of quality and safety in providers overseen by systems they were not familiar with. Furthermore, a particular concern was raised around the issue of different clinical practices in other countries, which may have implications for patient outcomes and potential complications. In England and Wales evidence-based guidance on the appropriate treatment and care of people with specific conditions is produced by an independent body, the National Institute for Health and Clinical Excellence (NICE). Whilst NICE guidance is not binding, NHS providers would be expected to take it fully into account in deciding what treatment is appropriate for patients.

  A specific example raised was In-Vitro Fertilisation (IVF) treatment for fertility problems. NICE guidance recommends that a maximum of two fertilised embryos are put back into the womb in a cycle of treatment. This is because multiple pregnancies are associated with increased risks of problems during pregnancy and labour, including an increased risk of premature birth. Respondents were aware of cases of UK patients travelling to other countries where similar guidelines did not apply. The motivation was that clinics could indicate a higher success rate in terms of clinical pregnancy. However, this was achieved by putting more embryos back into the womb, with a consequent increased risk of multiple pregnancies and increased risk of complications for both mothers and babies at a later stage.

  This example illustrates why a number of contributors were concerned about whether patients would, in reality, be able to make informed decisions about suitable providers in other countries if they wished to seek cross-border healthcare. From the NHS perspective, a patient can be assured that an NHS provider will take into account relevant clinical guidance, but this is not the case for cross-border healthcare, and therefore additional information will be needed to support informed choice where cross-border healthcare is considered.

  In view of this, contributors very strongly supported the use of prior authorisation systems as a mechanism for providing patients with clarity on matters such as what specific treatment their clinician recommends for them, what reimbursements they will be eligible for and what costs they will have to meet themselves, arrangements for any after-care needed and what will happen if anything goes wrong.

  Provided that prior authorisation systems met criteria such as transparency and proportionality, were simple and straightforward for patients to use, and gave timely responses to requests, contributors did not feel they would constitute an undue barrier to accessing cross-border healthcare. On the contrary, many contributors viewed such systems as being essential to protecting patients' interests by ensuring that they understand the conditions that apply to cross-border healthcare, in terms of quality and safety, potential differences between services and financial arrangements.

  Contributors felt that the provisions in the draft directive, which envisage that prior authorisation systems could only be compulsory in exceptional circumstances, were inadequate. In particular, the distinction between hospital and non-hospital is a false one, as the degree of risk and resource-intensiveness of healthcare can depend as much on the individual circumstances of the patient as the degree of complexity of the treatment itself. In addition, the need to plan services and manage financial resources applies equally to healthcare provided in hospitals and in other settings.

  In view of this, it is likely that NHS commissioners would encourage systems of prior authorisation on a voluntary basis if the legal framework does not allow such systems to be mandatory on a routine basis.

  Alongside this, some contributors suggested that EU healthcare providers who wished to provide services to NHS patients could sign up to NHS terms and conditions and be placed on the NHS "choice menu". It was suggested that in such circumstances, as packages of treatment would be matched to UK practice and prices, different arrangements could apply such that prior authorisation might not be required. However, it was recognised that different systems of regulatory oversight might make such arrangements legally complex to realise in practice. Guidance on the feasibility of such approaches would be welcome as part of the implementation process.

Limiting the right to travel for treatment

  In most cases, where it has been established that a patient is eligible to receive a particular treatment, contributors felt that if patients had made an informed choice to seek treatment abroad that they should be free do to so. However, contributors did suggest that in certain exceptional circumstances, it might be appropriate to restrict a patient's right to travel to obtain healthcare. Examples given included: patients with a highly contagious and dangerous infectious disease, patients requiring care in a secure psychiatric facility, and prisoners.

  Some contributors also presented the view that limiting the right to travel for treatment may be necessary in certain low volume, highly specialised services where a small reduction in caseload could threaten service viability. For example, clinicians may need a minimum caseload in order to maintain their levels of expertise in treating rare or highly complex conditions. The strong view was that any patient refused access to treatment abroad should be able to obtain a clear explanation of how and why the decision had been reached.

  The draft directive appears to give little scope to providers to refuse to accept incoming patients, and contributors felt it was important to be clear that nothing in the draft directive interferes with the right of a provider to refuse to accept a patient for a specific treatment if the provider deems it clinically inappropriate to treat that patient, or the provider is unable, eg for reasons of limited capacity or expertise, to provide adequate or appropriate treatment to that patient.

Costs, mechanisms and levels of reimbursement

  Contributors felt it was very important that all parties were clear about costs and levels of reimbursement in cross-border healthcare. Where it has been established that a patient is eligible to receive a particular treatment and they elect to receive that treatment abroad, most contributors agreed that reimbursement should be limited to the amount that the same treatment would have cost the home system.

  Contributors noted that in practice, however, this is likely to present particular challenges, relating to both incoming and outgoing patients, in calculating the "NHS cost of care". Although the NHS in England operates a system of tariffs for healthcare, not all treatments are subject to tariff, and for those that are, prices are factored to take account of local costs, so there is not, in reality, a standard price for any treatment. Furthermore, a tariff may cover a package of care, rather than a single procedure, and therefore costs may need to be "unbundled" if a patient receives a different package of care in another EU country.

  Whilst the majority of contributors did not think these problems were insurmountable, several felt that national guidance on the calculation of costs and reimbursements would be needed to provide greater clarity to patients and local NHS organisations.

  Under the provisions of the draft directive, the patient must meet costs up front, and must cover costs that would not be incurred if they were treated at home, such as travel costs. If treatment is more expensive abroad, the patient must cover the difference. If, however, treatment is cheaper abroad, the patient cannot be reimbursed more than they have paid—ie they cannot make a profit. Contributors supported this approach, as it was felt that a patient's choice to be treated outside the UK should not lead to higher costs for the NHS, thereby reducing the resources available for the wider population.

  Concerns were raised that patients might seek treatment abroad without being aware that the reimbursement they are eligible for may not cover their full costs of treatment. Contributors considered that this was another argument to support the use of prior authorisation systems.

  Whilst some contributors suggested that treatment costs might be paid directly from the patient's commissioner/insurer to providers in some cases, removing the need for patients to pay upfront, there was no support for this to be a universal requirement. Indeed, because patients are able to "top-up" their cross-border healthcare with additional treatments or services that would not be funded at home, and because some systems require patients to make a co-payment, it emerged that paying the provider directly could, in practice, be extremely complicated and less transparent for patients.

  Furthermore contributors felt that payments from patients to providers would avoid potential difficulties with large scale and potentially bureaucratic systems for processing and securing payments between healthcare systems, and reduce difficulties associated with following up debtors from other countries where monies are outstanding at the conclusion of treatment.

Health inequalities and cross-border healthcare

  The issue of equity is challenging and there was no clear consensus amongst contributors as to what impact the proposals would have on inequalities. A range of issues such as the state of an individual's health, geographical factors, family and work commitments, how articulate and well-informed a patient is, the ability to speak another language, as well as their financial position, will all affect an individual's ability to seek treatment abroad.

  In general, contributors felt that rights' to access cross-border healthcare should be well publicised, so that patients were aware of the options. However, where treatment could be provided in a timely manner in the UK and patients are deciding for personal reasons to seek treatment in another EU country, contributors felt that they should not confer a special advantage over patients who are unable or unwilling to do so. They should, therefore, as a general rule, be responsible for costs which would not be incurred if they received NHS-funded treatment in the UK.

  The NHS has a "Healthcare Travel Costs Scheme" to support patients who have financial difficulties with travel costs associated with accessing healthcare. Contributors were not clear to what extent this scheme could apply to cross-border healthcare, but many felt it provided a framework that could usefully be extended.

  Many contributors felt that, where there was a particular need, NHS commissioners should have flexibility to make special arrangements on an individual basis to cover costs of treatment abroad upfront and/or pay additional costs if care was more expensive. However, it was not clear whether contributors were always aware of existing options under social security arrangements (the "E112 referral"), or whether they felt a different mechanism was needed within the framework of the cross-border healthcare provisions. In view of this, guidance on the various options available to NHS commissioners would be helpful.

Requirements relating to information on cross-border healthcare

  The point that emerged most consistently from contributors was the need for patients to be able to obtain good quality information about their options, including treatment abroad, in a way that enables them to make informed decisions about their healthcare. Consideration will need to be given to the provision of information in accessible formats and potential extra help or support for vulnerable patients or those with complex needs.

  Many contributors were concerned that local NHS organisations and clinicians lack the knowledge to advise patients on their rights in cross-border healthcare or to direct them to where they can find out more about these. As a result, there were strong calls to be realistic about the level of information that local clinicians and services will be able to provide, and for national guidance and support in this area. Involving public and patients in the development of guidance and information on cross-border healthcare would be helpful in trying to dispel misconceptions and misunderstandings about what exactly patients are entitled to.

  A number of contributors were interested in exploring options for shared resources or expertise. Whilst the idea of a national contact point was thought to be potentially useful as a source of information about other healthcare systems, it was noted that information would also be needed at a local level to reflect the level at which decisions are made in the NHS.

  Contributors were also clear that provisions relating to the availability of information and data collection on cross-border healthcare should not place new costly, bureaucratic burdens on NHS organisations. It was suggested that a useful approach might be to collect data on a sample basis.

What happens when things go wrong: issues of liability and redress

  Based on experiences of patients seeking treatments not available under the NHS, such as cosmetic procedures, in other countries, many contributors raised concerns that some patients may have unsuccessful or incompetently undertaken treatment abroad. Whilst the number of patients affected is, overall, likely to be small, contributors felt that this further supported the need for a system of prior authorisation, which could help equip patients with the information they need in order to be able to choose the best treatment for them and a safe and high quality healthcare provider.

  In this context, contributors noted that is important that local NHS organisations and clinicians are able to help patients make a decision about where to receive healthcare without liability being conferred upon them if something goes wrong.

  Contributors supported the position set out in the draft directive that it is the systems of the country where healthcare is provided that apply in terms of liability and redress when things go wrong. However, concerns were raised about the draft directive's focus on compensation rather than wider redress (which can include a range of steps such as regulatory action, changes in practices, action to rectify a problem). Furthermore, the definition of "harm" proposed in the draft directive was identified as very problematic and contributors suggested that a reference to "adverse events" or a definition based on avoidable incidents arising from negligence which resulted in serious harm, should replace this.

  There was no support from contributors for the development of international out-of-court settlement schemes as proposed in the draft directive. This was because contributors thought the situation was simply too legally complex.

Provisions relating to cooperation in the field of healthcare

  The Commission's proposals also include a number of provisions designed to promote cooperation between EU member states, in areas such as the establishment of European reference networks (ERNs) of healthcare providers, e-health and the management of new health technologies. Some contributors expressed an interest in the development of ERNs particularly with regards the development of specialist services in other EU countries, however no specific views were expressed on whether the inclusion of this provision in legislation would be helpful or not.

  Contributors did raise concerns about proposed provisions on mutual recognition of prescriptions, e-health and health technology assessment. These all related to concerns that the proposed provisions were too far-reaching and risked cutting across existing national or local decisions or ongoing work in these areas.

  In particular, contributors were concerned that the draft provision on recognition of prescriptions was unclear and open to misinterpretation. For example, some contributors thought this provision could be read as conferring rights to reimbursement for medicines not funded by a patient's health system, or placing an obligation on clinicians to administer a drug not licensed in the member state they work in. Contributors were strongly opposed to either of these propositions and felt it was important to clarify that this was not the effect of the proposed provision.

January 2009




*Different arrangements apply in Scotland, Wales and Northern Ireland.



15   The NHS European Office is part of the NHS Confederation and is funded by the Strategic Health Authorities. It was set up in September 2007 to inform NHS organisations of key EU developments and to promote the priorities and interests of the NHS to the European Institutions. Back


 
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