DRAFT DIRECTIVE ON PATIENTS' RIGHTS IN CROSS-BORDER HEALTHCARE
STATEMENT BY NICOLA STURGEON MSP, DEPUTY FIRST MINISTER AND CABINET SECRETARY FOR HEALTH AND WELLBEING, ON THE RESPONSES TO THE SCOTTISH CONSULTATION EXERCISE
Background
1. The draft Directive on patients' rights in cross-border healthcare was proposed to codify and clarify the application of European Court of Justice case law on patients' rights in cross-border healthcare. This case law has established that as part of the EU freedom to obtain services, patients have the right to access healthcare in another EEA Member State and be reimbursed for this up to the cost of the treatment in their home state if entitled to this healthcare in their home country. The draft Directive also proposes additional provisions around EU level co-operation in healthcare. For further details, see the original Scottish consultation document, which includes a copy of the draft Directive, and which can be accessed at:
http://www.scotland.gov.uk/Publications/2008/10/15082114/0
Consultation
2. Between 15 October and 3 December 2008, the Scottish Government Healthcare Policy and Strategy Directorate carried out a public consultation on the Commission's draft Directive on cross-border healthcare. By the launch date of the consultation negotiations within the Council of the European Union had already begun. The Scottish Government, therefore, decided to consult for seven weeks rather than twelve weeks, which is the normal duration of Scottish consultation periods. In addition, this shorter response time for the consultation allowed a review of the consultation responses prior to the meeting of EU Health Ministers on 15 and 16 December where the draft Directive was discussed.
3. The Scottish consultation was carried out to inform the UK's Government's initial and subsequent negotiating position as Member State, acting on behalf of Scotland and the other devolved administrations, and to begin to gather data to help assess the impacts that the proposed Directive could have on Scotland. Fifteen responses were received, mostly from NHS organisations, regulatory bodies, and professional bodies in Scotland. Six organisations also responded to the UK Government's consultation. The responders are listed at Annex A. Their responses can be accessed at:
http://www.scotland.gov.uk/Publications/2009/01/09095940/0
Summary of Responses
4. The majority of responders to the Scottish consultation broadly welcomed the draft Directive as it will codify the case law and allow healthcare systems to develop frameworks to support the arrangements. Most of the responses concerned the specific implications for Scotland and the UK in implementing the Directive, rather than the content of the Directive.
5. A notable exception was the consultation response from the International Public Health Policy Unit at the University of Edinburgh, who are opposed to the proposals and have called for the Scottish Government to withdraw its engagement on the draft Directive. While noting the Unit's concerns, if we refused to engage with the UK Government on the proposals our concerns could not be incorporated into the UK negotiating position. Our stance, therefore, is to influence the negotiations as far as possible through engagement.
6. The Medical Defence Union did not respond to the specific questions asked in the consultation, but gave its views on Article 5 - responsibilities of the Member State of treatment and the implications in respect of arrangements for indemnity for clinical negligence claims. This is an area that may require further consideration as the Directive develops.
7. The key issues for stakeholders in the consultation responses were largely themes that had been identified already in discussions between the four UK administrations and, in the vast majority, were also brought out during the UK Government's consultation exercise. They included:
8. Ensuring this Directive did not infringe on Scotland's competence in healthcare in areas such as setting standards or defining hospital care.
We agree that the final Directive should not expand Commission competence. Different countries will have different ways of running their healthcare systems and such differences are legitimate. The Directive should respect the rights and ability of Member States, and devolved administrations within them, to do so.
9. Ensuring patients travelling abroad have the necessary information to make the right decision for them (including aftercare), often linked to prior authorisation.
We agree the final Directive should focus on providing sufficient information to patients so that they can make informed decisions to move from one system to another if they so wish.
10. Requiring Member States' regulatory bodies share fitness to practice data so that healthcare professionals removed from practice in one country cannot market their services to other EEA country nationals.
We agree there should be a duty on EU regulators to share fitness for practice information on healthcare professionals, and that the UK Government should raise the possibility of including this in this Directive in future negotiations.
11. Concerns over equity for those who cannot afford to pay upfront to access treatment in another Member State and suggestions that this might be remedied by the UK/Scotland paying upfront for all patients in cross-border healthcare.
We agree that equity is an important issue and that socio-economic factors require further consideration, but do not believe that upfront payments would satisfactorily resolve issues around equity, both for those who wish to access cross-border healthcare and those who do not. By paying upfront for those who wish to travel to other European countries, the ability of the Scottish healthcare system to provide NHS healthcare for the vast majority of patients who wish to stay within Scotland to receive their treatment might be compromised.
12. Concerns over the potential adverse impact on the NHS in key areas such as prior authorisation, allowing Scottish 'gate-keeping' functions, and making sure that Scotland, as part of the UK, and other Member States determine entitlements for its patients.
We agree there is a potential danger the Directive could have a negative impact on NHS systems if the final Directive does not get right the areas of prior authorisation, gate keeping, and determining entitlements. These are key issues for both Scotland and the UK Governments.
13. Concerns over the potential costs, complexities, and legal issues arising from some of the proposals from the Commission, particularly in what the Commission proposes in the area of co-operation. This includes prescription recognition; European Reference Networks; e-health, health technology assessment and data collection. A number of stakeholders did, however, recognise the value of less prescriptive EU co-operation in health.
We agree that the Commission's proposed measures and mechanisms in cross-border healthcare give cause for concern. Scotland is already co-operating in a range of areas on a voluntary basis and the UK Government, acting on our behalf, should continue to seek clarity from the Commission on what is proposed in this area and why it is necessary.
14. Although we recognise that majority of issues are UK-wide, we are also alert to issues that may have a particular Scottish dimension. For example, it is crucial that the Directive recognises that there are different entitlements to treatment at Member State, devolved administration and local level within the UK. It is very important that it is made clear in the Directive that it does contemplate different entitlements at different levels i.e. regional, local etc. While this has been touched upon in a recital to the Directive, we do not believe that this in itself is enough and wish to see this matter covered in the body of the Directive if this can be achieved.
Next Steps
15. The draft Directive is currently the subject of negotiation within and between the European Parliament and Council of the European Union to agree on a revised final text. The UK is playing a key role in these negotiations and Scotland is playing its part in informing the negotiations to safeguard the rights of our citizens whilst safeguarding NHS Scotland's ability to provide quality care for the people of Scotland.
16. My officials are in the process of setting up a group, led by the Director of Healthcare Policy and Strategy Directorate, to inform the next stages of negotiations and to begin to plan for implementation. This will include representation from all Health & Wellbeing Directorates and Chief Professional Officers (there are potentially particular issues in relation to pharmacy and dentistry) as well as the Scottish Government Legal Directorate. NHS Scotland will also be represented on the group as necessary. The Scottish consultation responses will inform this work.
NICOLA STURGEON
March 2009