The European Parliament and the Council of Ministers formally adopted the Directive on patients' rights in cross-border healthcare in March 2011. This is an important issue for the NHS and one on which the NHS European Office has been actively involved in over the past three years.
***Understanding the implications of cross-border healthcare - register for the session now***
The NHS European Office will be hosting a session at the NHS Confederation 2012 Annual Conference which will start a series of discussions on the national implementation of the EU Directive into UK law, now just over a year away. Discover what the emerging implications are for the NHS and consider the likely effect on the strategic focus of our national and local NHS organisations. Be part of an open discussion with commissioners, providers and policy-makers about where the challenges will arise and where opportunities, financial and otherwise, might emerge. Register for the session on 20 June here.
Recognition of medical prescriptions - NHS European Office responds to an EU consultation
The NHS European Office has responded on behalf of NHS pharmacists and other healthcare professionals to an EU consultation on the recognition of medical prescriptions from other EU countries. The consultation will feed into the European Commission's understanding of how pharmacists identify medicines, patients and prescribers across borders, an important issue in implementing the EU Cross-border Directive.
Article 11 of the Directive states that the European Commission shall adopt:
- Measures enabling a health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by a member of a regulated health profession who is legally entitled to do so through developing a non-exhaustive list of elements to be included in the prescriptions and which must be clearly identifiable in all prescription formats, including elements to facilitate, if needed, contact between the prescribing party and the dispensing party in order to contribute to a complete understanding of the treatment, in due respect of data protection.
- Measures to facilitate the correct identification of medicinal products or medical devices prescribed in one Member State and dispensed in another, including measures to address patient safety concerns in relation to their substitution in cross border healthcare where the legislation of the dispensing Member State permits such substitution. The Commission shall consider, inter alia, using the International Non-proprietary Name and the dosage of medicinal products.
- Measures to facilitate the comprehensibility of the information to patients concerning the prescription and the instructions included on the use of the product, including an indication of active substance and dosage.
The response highlighted in particular the difficulties dispensers face in identifying medicines, patients and prescribers across borders and suggested ways of improving identification in future.
Read the full response here.
Background to the Directive
A proposal for a Directive to clarify the rights of patients to receive healthcare in another Member State was released by the European Commission in summer 2008. The proposal was based on a succession of European Court decisions during the last ten years (including the ‘Watts case’ which concerned the NHS directly) and is widely regarded as the first genuine example of EU legislation specifically in the area of healthcare services, which are traditionally the sole preserve of national governments.
There were a number of uncertainties around the case law which made it difficult to implement them in practice. This Directive sought to clarify the present situation and put in place measures to support the provision of cross-border healthcare, for the benefit of both patients and those managing health services.
The European Parliament voted on 19 January 2011 to adopt an agreed legal text for the Directive. The text agreed by the Parliament was then formally approved by the EU Council of European Ministers on 28 February. It is now EU law.
What will this mean for patients and the NHS?
The NHS European Office is pleased with the final text of the Directive. This Directive will clarify the present situation and put in place measures to support patients to make informed decisions about the provision of cross-border healthcare. For healthcare managers, it will end the uncertainty commissioners currently face over decisions about what care patients can receive abroad, while allowing the NHS to maintain control on patients’ entitlements. On the provider side, the agreement offers opportunities to increase income by providing services to EU patients when capacity allows.
The European Office has published a new briefing giving a detailed overview for both NHS commissioners and providers of the anticipated implications of this new Directive. Download the document here. Separate summaries of the key points for both commissioners and providers are also available.
The Office has also published two separate articles on the implications of the cross-border Directive, one in the Health Service Journal which you can read here and another in Eurohealth magazine, which can be accessed here.
Key points of the Directive
The text which has been agreed addresses the following key points:
Patients’ entitlements – Patients can only receive healthcare abroad that they would be entitled to receive under the NHS.
Patients with rare disease – The text recognises the importance of cooperation between Member States in the diagnosis and treatment of rare diseases notably through the establishment of European Reference Networks (voluntary networks of healthcare providers and centres of expertise for cooperation in areas where concentration of expertise is required).
Gatekeeping – The Directive now includes the possibility to require patients to be assessed by a health professional – such as a GP – or an NHS commissioner to determine the patient’s entitlement to healthcare. In essence, patients wishing to receive cross-border healthcare may be subject to the same ‘formalities’ as patients seeking healthcare in the NHS. This point takes into account the way in which the NHS operates, and in particular the fact that, unlike many other EU countries, we do not have a list of the healthcare our patients are entitled to receive.
Prior authorisation – The NHS will have the option of introducing a system of prior authorisation for patients seeking cross-border healthcare. Prior authorisation is only possible for healthcare which is subject to planning requirements and which involves at least one night in hospital or requires the use of highly specialised and cost-intensive medical equipment. Authorisation can be refused in specific circumstances, including when that healthcare can be provided by the NHS ”within a time-limit which is medically justifiable taking into account the current state of health and the probable course of the illness of the patient”. For other types of healthcare, a voluntary system of prior notification can be introduced.
System of payment – The NHS will be free to decide on the system of payment to be used to cover the costs of cross-border healthcare. This means that commissioners can decide to reimburse patients who have paid the cost of their cross-border healthcare upfront or, alternatively, they can transfer funds directly to the providers abroad. It was thought that a compulsory system of direct payments could have had the effect of diverting limited national resources from the provision of healthcare to patients in greater need because of the significant resources required to administer such a complex system and the possible risk of fraud.
Cost of cross-border healthcare – Patients will be reimbursed for the cost of cross-border healthcare up the level of cost of that treatment under the NHS. Proposals to oblige healthcare systems to assume additional costs for certain patients have been defeated. Nevertheless, healthcare systems may decide to pay additional related costs such as accommodation and travel costs if they so wish.
Information to patients – National Contact Points will have to be established to provide patients with information related to cross-border healthcare on request. This includes information about the quality and safety standards that apply and which providers will be subject to them.
Incoming patients – Providers will have the right to refuse for planned treatment patients from other EU countries or to prioritise them to the detriment of NHS patients, for example by increasing the waiting time for treatment. This amendment to the text is particularly relevant for NHS organisations providing highly specialised services, for which a possible surge of incoming patients could lead to negative implications in terms of increased waiting times for NHS patients.
Quality and safety – Quality and safety standards of the country of treatment will apply. Member States will remain fully responsible for regulating the quality and safety of healthcare provided in their territory.
E-health – The European Commission shall support and facilitate cooperation across the EU on e-health. This cooperation will take place through the establishment of a network which will consider issues related to the transferability of electronic patients’ records in cases of cross-border healthcare.
NHS Confederation members can read more about the new Directive on the related documents section of this page.
Next Steps
Now that the Directive is EU law, the UK and other European Member States have 30 months to enact it nationally.
The NHS European Office will be working closely with decision-makers, policy analysts and the NHS Confederation and its members as the law is enacted into EU legislation.
Understanding the implications of medical tourism
The NHS European Office is on the advisory group for an NIHR-funded project focusing on the economic implications of medical tourism for the NHS, the decision-making process for individuals contemplating accessing care abroad, and the development of the medical tourism industry.
The findings from the Medical Tourism Project, organised by the University of York, will be of direct benefit to NHS organisations and will cover many issues, including: cost, quality, administrative and legal dimensions, decision-making and unintended consequences for the NHS.
The project team has been speaking with the medical tourism industry and those who have experienced treatment overseas, and is now seeking to speak directly with NHS managers.
If you are willing to be interviewed by a member of the research team please contact: Dr Neil Lunt (neil.lunt@york.ac.uk) for further information.
Current guidance for the NHS
Until the new Directive becomes national law, the existing rules on cross-border healthcare, established in a number of European Court cases, remain in force and it is important that NHS organisations are aware of these.
Alongside engaging in the negotiations at EU level, the Department of Health (DH) has been reviewing how the existing UK framework fits with the rules that have emerged from EU case law, as well as preparing for implementation of the new rules of the agreed Directive.
As part of this work, DH has published regulations (which entered into force on 1 June 2010), directions and guidance on the establishment of prior authorisation and reimbursement arrangements for NHS patients seeking treatment under the cross-border rules. This guidance sets out important additional advice which will help local commissioners deal with requests for treatment in another European country.
NHS organisations should be aware of their obligations relating to patient's rights in cross-border healthcare and be prepared for managing such requests, otherwise they leave themselves open to the threat of legal action.
Our healthcare for EU travellers page gives more information for NHS organisations about the EHIC system, which gives travellers access to emergency and urgent treatment whilst in another EEA country.
Cross-Border Healthcare Network
This is a new online community which aims to link colleagues working in the patient mobility and cross-border healthcare fields, to help interpret policy, facilitate discussion, share materials and facilitate the implementation of the European Directive on patients' rights in cross border healthcare.
This is about harnessing the power of the web in a positive and helpful way. Virtual networks can often respond to the challenges that real organisations struggle to meet. The ambition for this network is to enable people to connect in interesting new ways and to provide a common space in which leaders, clinicians, managers and support staff and their partners beyond the NHS can work collaboratively, share intelligence and freely exchange ideas.
The network will be the central platform on cross-border healthcare policy and practice and will support all future activity relating to implementation of the Cross-border Healthcare Directive into NHS systems.
The network can be reached here.