(...PICT...)|COMMISSION OF THE EUROPEAN COMMUNITIES|

Brussels, 2.7.2008

SEC(2008) 2164

COMMISSION STAFF WORKING DOCUMENT Accompanying document to the

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the application of patients' rights in cross-border healthcare SUMMARY OF THE IMPACT ASSESSMENT

{COM(2008) 414 final} {SEC(2008) 2163}

1. Introduction

The aim of the impact assessment is to consider the need for and the potential impact of different options for Community action in the field of cross-border healthcare. After exclusion of healthcare services from the services directive, the Commission accommodates with this initiative the wish of both the European Parliament and Council to investigate the need to come up with a specific proposal in the field of cross-border healthcare.

Cross-border care can take different forms. This report will mainly focus on initiatives related to cross-border mobility of patients. Although patients prefer healthcare to be available as close to where they live and work as possible, there are situations when cross-border healthcare can be more appropriate. For the moment a limited amount of patients crosses borders to receive care. But the extent of cross-border healthcare is growing, and is likely to continue to grow in the future. For individual patients the possibility to receive healthcare abroad can be of enormous impact, but also for healthcare systems as a whole the consequences of cross-border care can be substantial. It can further stimulate innovation, it can contribute to more efficient planning and use of resources and to better overall quality of care. Some challenges have nevertheless been identified. Uncertainty exists about the general application of rights to reimbursement for healthcare provided in another Member State. A consultation with all relevant stakeholders showed that uncertainty also exists over how the necessary frameworks for safe and effective healthcare should be ensured for cross-border healthcare.

2. Consultation of stakeholders

The Commission invited with the publication of a Communication Commission Communication, Consultation regarding Community action on health services, SEC (2006) 1195/4, 26 September 2006. all relevant stakeholders to contribute to a consultation process regarding Community action on health services. The objective of the consultation was to clearly identify the problem(s) in the field of cross-border healthcare and to receive input concerning objectives and policy options. The 280 contributions to this consultation have been brought together in a summary report Commission document, Summary report of the responses to the consultation regarding "Community action on health services" (2007) The individual contributions have been published on the Commission website http://ec.europa.eu/health/ph_overview/co_operation/mobility/results_open_consultation_en.htm .[1][2][3]

Commission Communication, Consultation regarding Community action on health services, SEC (2006) 1195/4, 26 September 2006.

Commission document, Summary report of the responses to the consultation regarding "Community action on health services" (2007)

http://ec.europa.eu/health/ph_overview/co_operation/mobility/results_open_consultation_en.htm

Overall, contributors welcomed the initiative of the Commission regarding Community action on health services. The majority of national governments and many other stakeholders expressed the wish that any proposal of the Commission on health services should be based on the "Council Conclusions on Common values and principles in EU Health Systems" 2733 rd Employment, Social Policy, Health and Consumer Affairs Council meeting, Luxembourg, 1-2 June 2006 . Many contributions (in particular from national governments, unions and purchasers) emphasised that any Community action that affects the health systems should respect the subsidiarity principle, referring in particular to Article 152 of the Treaty establishing the European Community, although others argued that the principle of subsidiarity should not prevent the application of EU fundamental freedoms. [4]

2733 rd Employment, Social Policy, Health and Consumer Affairs Council meeting, Luxembourg, 1-2 June 2006

3. Additional research

The Commission asked the European Observatory on Health Systems and Policies to carry out a stocktaking exercise to give an overview of trends and the current situation concerning cross-border healthcare Wismar M, Palm W, Figueras J, Ernst K and Van Ginneken E, Cross-Border Healthcare: Mapping and Analysing Health Systems Diversity, European Observatory on Health Systems and Policies, 2007. . The study gives more insight in access to healthcare, experiences with cross-border collaboration, quality and safety of healthcare in the European Union, as well as developments concerning patient rights. Differences in benefit baskets and tariffs between member states are also presented. The study gives insight in the impact of cross-border care on the basic objectives and functions of healthcare systems and gives an overview of the existing cross-border healthcare data.[5]

Wismar M, Palm W, Figueras J, Ernst K and Van Ginneken E, Cross-Border Healthcare: Mapping and Analysing Health Systems Diversity, European Observatory on Health Systems and Policies, 2007.

The Commission also conducted a EuroBarometer about cross-border healthcare in the EU, in order to provide further insight into the actual scope of patient cross-border mobility, the willingness of patients to go abroad for medical treatment and the advantages and challenges they foresee when going abroad to receive healthcare Flash Eurobarometer Series #210, Cross-border health services in the EU, Analytical report, conducted by The Gallup Organization, Hungary upon the request of the European Commission, the Health and Consumer Protection Directorate-General (DG SANCO), 2007. . [6]

Flash Eurobarometer Series #210, Cross-border health services in the EU, Analytical report, conducted by The Gallup Organization, Hungary upon the request of the European Commission, the Health and Consumer Protection Directorate-General (DG SANCO), 2007.

4. Subsidiarity

It is primarily the responsibility of the individual Member States to organize their healthcare systems in the way that best suits their country and citizens. Nevertheless, sometimes the healthcare that citizens need can best be provided in another Member State, due to its proximity, its specialised nature, or the lack of capacity to provide that care in their own country. In accordance with the principle of subsidiarity, the Community should only act in this area if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the proposed action, be better achieved by the Community.

Community law already provides rights in principle for cross-border movement of goods, services and people in general and health products, services and patients in particular. But there are questions and uncertainties over what this means in practice; for citizens and for all other stakeholders involved. The European Court of Justice has interpreted Community rules in a different way compared to interpretation by national governments. But, as emphasised by several Member States during the consultation, also after the Court came with its interpretation, Member States still lack certainty about how these individual cases should be interpreted in general. Due to these uncertainties it is difficult for Member States to manage their healthcare systems properly. Cooperation on Community level, for example by the development of secondary legislation, would bring the requested clarity, which would not be realised with measures on national level alone.

In the second place there are concerns about how to ensure that cross-border healthcare is as safe and efficient as possible. Cross-border healthcare has, as the name already predicts, many Community-wide transnational aspects. For both patients and professionals, there is a crucial difference between having some confidence in the applicable rules for cross-border care, and being certain. The potentially very serious consequences of any legal uncertainty concerning responsibilities in cross-border healthcare settings are an important reason to act on this issue. When citizens cross borders to receive healthcare, it is important that it is clear which country is responsible for what. Currently that clarity is lacking. It is not possible for individual Member States to define their own responsibility without agreeing on these responsibilities with other involved countries. Therefore also to solve this issue, agreement concerning responsibilities is needed on Community level.

5. Policy options

In the impact assessment report five options for Community action are described to improve cross-border care, varying from no further action (the baseline scenario) to a detailed legal framework to improve legal certainty, clarity and cross-border cooperation. These options have been assessed on the basis of existing data and by using basic modelling tools. The work of the European Observatory on Health Systems and Policies and the result of the Eurobarometer survey were used as valuable input.

The first option would be to do nothing on Community level. This baseline scenario would leave all responsibilities to create clarity to the individual Member States. Under the second option, the Commission would provide guidance on cross-border healthcare issues, but would not propose additional binding legal measures. The Commission would come up with a Communication with a detailed interpretation of the implication of the Court of Justice's rulings. It would include recommendations on information to enable informed choices, plus principles or recommendations on ensuring quality and safety of cross-border care. The Commission would under this option establish a mechanism to bring Member States together to share ideas and best practice in the field of cross-border care, and it would support activities to develop common data and indicators as an evidence base for policymaking on health services.

The third option would mean, possibly in combination with the soft actions described under option 2, the establishment of a general legal framework for health services, through a directive on health services. It would provide clarity about rights to be reimbursed for healthcare provided abroad. It would put a general requirement in place that Member States must provide information to their own citizens about their rights to healthcare abroad.

Under option three two sub-options (3A and 3B) have been described for dealing with the issue of legal uncertainty regarding financial entitlements and prior authorisation for cross-border healthcare. Under sub-option 3A, the existing framework for coordination of social security schemes would remain in place in its current form. In addition to this existing structure, the new directive would put in place a mechanism based on the principles of free movement and building on the interpretation of the treaty by the Court of Justice. This would allow patients to seek any healthcare abroad (both hospital and non-hospital) that they would have been provided and reimbursed at home and be reimbursed up tot the amount that would have been paid had they obtained that treatment at home. The patient would bear the financial risk of any additional costs arising. Prior authorization of hospital care would remain possible. Under mechanism 3A Member State would need to provide evidence that the outflow of patients without an authorization procedure would undermine the financial balance of their social security system, the maintenance of treatment capacity or medical competence on their national territory..

Sub-option 3B takes the same approach as for sub-option 3A in all areas except for the financial entitlements and prior authorisation for cross-border hospital care. As with sub-option 3A, the new directive on health services would put in place an alternative mechanism based on the principles of free movement and building on the principles underlining decisions of the Court of Justice, but whereas for sub-option 3A this directive would apply to the financial aspects of all cross-border healthcare, under sub-option 3B for financial aspects this directive would only apply to non-hospital cross-border care.

Under option 4 detailed legal rules would be established at European level. The Commission would propose a detailed framework of harmonising legal measures for issues as data collection, information provision to patients, criteria for authorization and the authorization procedure, standards of quality and safety, patient rights and compensation for harm. This option might be difficult to justify in the light of the subsidiarity principle.

6. Impact of community action

In the impact assessment five different types of impact have been analysed. First of all the impact on treatment costs and on treatment benefits due to patient mobility has been mapped. From table 1 it becomes clear that an increase of possibilities to receive healthcare abroad will create an increase in treatment costs. These costs remain nevertheless marginal compared to the increased treatment benefits, which also increase with the increase of possibilities to receive healthcare abroad. The compliance costs were also analysed. The impact assessment makes clear that with the creation of more legal certainty these compliance costs decrease.

Nevertheless, the creation of a detailed legal framework (option 4) creates initially a significant increase in costs, due to the fact that each health care system needs to be adapted to the new detailed rules. In the impact assessment report are also changes of administrative costs in each of the options analyzed. The more legal certainty is created, the more those administrative costs can be reduced. By creating more clarity about possibilities for cross-border care, more people will be able to receive the treatment they need quicker. Therefore the social benefits increase with more patients being involved.

7. Comparing the options

Table 1 Impacts of each option presented in financial terms

Under option one, the current problems continue to exist. The rights to reimbursement for cross-border healthcare through direct application of free movement principles have been established in theory. Nevertheless, without Community action these rights will be difficult to use in practice. Without a clear framework for ensuring minimum requirements for safe and efficient cross-border healthcare, uncertainty remains, also in this field. Moreover, no further action does not mean avoiding costs of cross-border healthcare. Rather, it means continuation of current trends, but accompanied by costs of managing these uncertainties. Social inequity will remain. The less well-off will be unwilling to advance the cost of healthcare without solid legal guarantees that they will be reimbursed.

With option two, there is some improvement. The key issue here is certainty; given the potentially catastrophic consequences for patients of problems with cross-border care, merely having guidance rather than legal certainty about cross-border care is not enough, either for patients or professionals. Option three provides a balance between action on Community and national level. It achieves the core aim of providing sufficient certainty about the key issues in cross-border healthcare. It maximises the benefit of cross-border care overall, and does most to ensure social equity. This option provides certainty in relation to reimbursement. In contrast, although option four provides a still greater degree of certainty, it involves wholly disproportionate costs and implies a degree of change and harmonisation which is not appropriate and not consistent with the principle of subsidiarity.

Within option three, the key choice is about the handling of cross-border hospital care. By maximising the potential access to cross-border care, option 3A is the only option where the likely value of the benefits to patients outweighs the overall costs of the system. For the long run, there is no reason to assume that planning and overall sustainability will be disturbed by the implementation of option 3A. Both sending and receiving countries will on the contrary benefit from increased efficiency and quality both for cross-border and for domestic healthcare. Sub-option 3B has lower costs of treatment, but also provides lower benefits, and thus does not provide a clear net benefit over the cost of the option. The preferred option is therefore option 3, sub-option 3A.

Option four has potentially a positive outcome. Nevertheless the additional administrative burden during the implementation phase, due to the harmonisation, is substantial. This option would undermine the subsidiarity principle. Member States have different backgrounds and different healthcare systems. This diversity makes a detailed 'top down' approach to Community action as the case in this option potentially unfeasible and ineffective in several instances.

[1] Commission Communication, Consultation regarding Community action on health services, SEC (2006) 1195/4, 26 September 2006.

[2] Commission document, Summary report of the responses to the consultation regarding "Community action on health services" (2007)

[3] http://ec.europa.eu/health/ph_overview/co_operation/mobility/results_open_consultation_en.htm

[4] 2733 rd Employment, Social Policy, Health and Consumer Affairs Council meeting, Luxembourg, 1-2 June 2006

[5] Wismar M, Palm W, Figueras J, Ernst K and Van Ginneken E, Cross-Border Healthcare: Mapping and Analysing Health Systems Diversity, European Observatory on Health Systems and Policies, 2007.

[6] Flash Eurobarometer Series #210, Cross-border health services in the EU, Analytical report, conducted by The Gallup Organization, Hungary upon the request of the European Commission, the Health and Consumer Protection Directorate-General (DG SANCO), 2007.

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