LA DIRETTIVA EUROPEA 2011/24/UE: PRINCIPI FONDAMENTALI
La Direttiva fissa le regole in base alle quali i cittadini dell'Unione Europea potranno usufruire di prestazioni sanitarie in un Paese Europeo diverso da quello di residenza.
La libertà di ricevere assistenza sanitaria in tutta l'Unione Europea deve essere accompagnata da garanzie di qualità e di sicurezza.
Attraverso il principio della libera circolazione dei pazienti, la direttiva definisce i diritti dei pazienti europei che intendono sottoporsi a cure mediche in un altro paese membro a spese del paese di affiliazione, cercando di eliminare gli ostacoli che impediscono agli stessi di cercare cure in altri paesi dell'unione europea.
Tra gli obiettivi della direttiva è prevista la chiara definizione delle regole e delle procedure per ottenere il rimborso delle spese sostenute nel Paese che ha consentito al paziente di ricevere servizi di asssistenza sanitaria e l'istituzione in tutti gli stati dell'UE di punti di infornazione che offrano ai pazienti dati sui trattamenti, sui centri disponibili e sulle modalità per poterli raggiungere.
La normativa porevede che il Paese in cui avviene il trattamento deve assicurare ai pazienti l'accesso alla loro cartella clnica su supporto cartaceo o elettronico in modo da poter conoscere il tipo di trattamento che hanno ricevuto; il Paese d'origine deve garantire che il proseguimento delle cure avvenga con la stessa qualità indipendentemente dal paese dell'UE in cui sono state prestate le prime cure.
Questo permetterà di assicurare che l'assistenza sanitaria fornita in un altro Paese dell'Ue abbia un proseguimento adeguato quando il paziente rientra al suo paese d'origine.
Brussels, 22 October 2013
Q&A: Patients' Rights in Cross-Border Healthcare
An elderly German man with diabetes brings extra prescriptions with him on a trip to Italy but will the pharmacist accept the prescription? A Polish woman would like to receive hip surgery in the country where her grandchildren live and work but how can she organise this from Poland? A Portuguese man seeks cataract surgery from a specialist in Spain but will he be reimbursed? EU law now offers clarity on rights and rules for cross-border healthcare.
The law clarifies patients' rights to access safe and good quality treatment across EU borders, and be reimbursed for it. Patients travelling to another EU country for medical care will enjoy equal treatment with the citizens of the country in which they are treated. If they are entitled to that healthcare at home, then they will be reimbursed by their home country. Their reimbursement will be up to the cost of that treatment at home. In some cases, they may need to seek authorisation before travelling for treatment, in particular if the treatment requires an overnight stay at an hospital or highly specialised and cost-intensive healthcare.
This new law will benefit EU patients in several other ways. It will make it easier for patients to access information on healthcare in another EU country, and thus increase their treatment options. It will also make it easier for national health authorities to work closer together and exchange information on quality and safety standards of healthcare. It will support the development of "European Reference Networks" bringing together, on a voluntary basis, specialised centres of expertise already recognised in Europe. It will also promote co-operation between EU countries to help deliver the considerable potential benefits of Health Technology Assessments and eHealth.
What scale of cross-border healthcare are we talking about?
Patients prefer to receive healthcare in their own country.That is why the demand for cross-border healthcare represents only around 1% of public spending on healthcare, which is currently around €10 billion. This estimate includes cross-border healthcare which patients had not planned in advance (such as emergency care for tourists). This means that, at present, considerably less of that 1% of the expenditure and movement of patients is for planned cross-border healthcare, like hip and knee operations or cataract surgery.
What about the existing legislation in this area (Regulations on social security)?
Citizens needing care (including emergency care) when temporarily abroad will continue to benefit from the existing Regulations and the European Health Insurance Card, and be provided with the care they need.
For planned care, under the Regulation, a patient can apply for prior authorisation. This authorisation cannot be refused if he/she cannot be treated in the home country within a time limit which is medically justifiable.
It is important to note that the Regulations do not cover all healthcare providers. Some private providers are excluded, for example. In addition, under these Regulations, patients are usually obliged to apply for authorisation for all treatments, whereas under the Directive, authorisation should be the exception rather than the rule.
What is the added benefit of this legislation?
This Directive will not affect the benefits already offered to citizens through the existing Regulations on social security, which have their basis in the EU Treaty article on free movement of people. However, it clarifies those patients' rights that have their basis in the free movement of services, and which have been set out in various European Court of Justice rulings. In the case of hospital care, one of the main achievements of this new Directive is that patients will be able to choose their healthcare provider.
Other advantages of the new legislation are:
More choice: the Directive covers all healthcare providers in the EU.
Less red-tape for patients: under the Directive, seeking prior authorisation should be the exception rather than the rule.
Information to patients: patients will receive all information they need to make an informed choice, for example on quality and safety of healthcare, through National Contact Points, which will be set up in all Member States. Moreover, the Directive introduces new measures to help all patients make the best use of their rights under both pieces of legislation.
Procedural guarantees: all patients are entitled to properly reasoned decisions, and to appeal if they feel their rights have not been respected. All patients have the right to complain and to seek redress (and all treatment must be covered by liability insurance or a similar guarantee). And patients have the right to a copy of their medical record.
When would I need prior authorisation from my national authority?
National authorities can introduce a system of "prior authorisation" for going to another Member State for treatment in 3 cases:
For healthcare which involves overnight hospital stay of at least one night
For highly specialised and cost-intensive healthcare
In serious and specific cases relating to the quality or safety of the care provided by the particular provider in question
In these three cases, patients may need to ask for permission in advance from their national health authority in charge of reimbursement. Member States are required to set out publicly which treatments are subject to such authorisation – you can find the list via your National Contact Point.
Can this authorisation be refused?
National health authorities can refuse authorisation if the treatment in question, or the healthcare provider in question, could present a risk for the patient. If the healthcare can be provided at home within a medically justifiable time limit, then authorisation can also be refused. However, Member States will need to explain why such a decision is necessary, and will need to base their assessment of what is "medically justifiable" on your individual case.
What if I am refused authorisation?
Patients have the right to request a review of any administrative decision on cross-border healthcare for their individual case.
How much will I be reimbursed after receiving a treatment abroad?
Patients will be reimbursed the same amount as they would receive in their own country for the same type of healthcare. Member States where care is free at the point of delivery will need to inform patients about their reimbursement tariffs. If the treatment abroad is cheaper than in the home country, the reimbursement will reflect the real price of the treatment.
Can I seek healthcare abroad if the treatment is not available in my country?
Yes, but you will only be entitled to reimbursement if it falls within the "basket of benefits" you are entitled to according to the legislation or rules of your home country.
Your National Contact Point will be able to advise you how to check whether a given treatment falls within your "basket of benefits".
Do I need to pay for cross-border treatment upfront?
Yes, generally the patient pays upfront and would then be reimbursed by their national authority as quickly as possible. The law also gives Member States the option of confirming the amount of reimbursement in writing in advance.
Member States also have the option of paying for the healthcare directly, rather than reimbursing patients.
Can I transfer my medical data to the Member State where I will be treated?
You have the right to a copy of your medical data from your home country prior to receiving treatment in another Member State, and from the provider in the country where you receive treatment before returning to your home country.
What should I do if something goes wrong whilst receiving treatment abroad?
The National Contact Point of that country will be able to explain your rights and give information on the regime applicable in the country of treatment.
Your home country is obliged to provide you with the same follow-up treatment it would have provided had the treatment taken place on its territory.
How can I be sure that the treatment I received abroad will be followed up properly on my return home?
Your home country has an obligation to ensure that the medical follow-up is of the same quality regardless of where in the EU the treatment took place.
Will my prescription be recognised in another EU Member State?
A prescription issued in another EU country should be recognised in a patient's country of residence and vice versa. This ensures that the healthcare provided in another EU country is properly followed-up on the patient's return home. The patient is entitled to obtain the prescribed medicine provided that the medicine in question is authorised for sale and available in the country where he or she wishes to have the product dispensed.
Although these principles are not new, in practice getting prescriptions recognised can be difficult. Although it will not solve the problem overnight, the provisions of the Directive should greatly increase the ability of pharmacists to understand and dispense prescriptions issues in another Member State.
What are the benefits of the networks on Health Technology Assessment (HTA) or eHealth?
Health Technology Assessments help decision-makers to make the right decisions on health investment and spending. There is clearly great potential benefit in greater collaboration between EU countries in this area, where currently each country makes such assessments on their own.
Similarly, eHealth has the potential to deliver great benefit to health systems. Formal and permanent cooperation between Member States will help decision-makes within countries, and improve interoperability between them.
These networks benefit national health systems directly, and patients indirectly.
Where can I find more information about my rights to healthcare abroad?
You can check with your National Contact Point, or on the Your Europe website, via a link which will be activated on October 25th, the day of entry into force of the Directive.
Where can I find more information about my rights to healthcare abroad?
Check with your National Contact Point, or on the Your Europe website:
For further information:
Brussels, 12 May 2014
European Patients' Rights Day: 10 benefits the EU brings to patients
A high level of health protection; the right to benefit from medical treatment; access to healthcare - preventive, diagnostic and curative treatment regardless of financial means, gender or nationality. These principles are enshrined in the European Union's Treaty1 and its Charter of Fundamental Rights2 and the EU institutions are bound to them in their actions. On European Patients' Rights Day, let's take a look at some of the benefits of being a patient in the European Union. As an EU citizen, you can expect:
1) To receive healthcare when visiting another EU country
If you fall ill unexpectedly during a trip to another EU country and need to visit a doctor, there's no need to cut short your visit to return home for treatment. Take your European Health Insurance Card with you to a local doctor.
2) To be reimbursed for healthcare sought in another EU country
Should you decide to receive medical treatment in other EU country you can be reimbursed for it at home, under certain circumstances, and normally up to the amount you would be reimbursed in your home country for the same treatment. In some cases, your home country may require you to seek prior authorisation before travelling for treatment.
3) To receive information on safety and quality standards in EU countries
A national contact point in each Member State shall provide information to patients on their rights to healthcare across Europe. Access to information on the quality and safety of care will allow you to make informed decisions.
These contact points can also provide information on the European Reference Networks where you can receive highly specialised healthcare in the case of complex, low prevalence or rare conditions.
4) To be treated by qualified healthcare professionals
Patients have the guarantee that whether receiving medical care in their home country or another EU country, they will be treated by healthcare professionals – be they doctors, dentists, nurses, midwives or pharmacists, who have met EU-wide minimum requirements.
Patients will, upon request, receive information from their national contact point about a healthcare provider's right to practice.
5) To get a copy of your medical records
When you are treated, your healthcare provider must make a medical record of the treatment provided. As a patient you have the right to a copy of this medical record in order to secure continuity of care and be treated by a doctor of your choice, also if you continue treatment in another Member State.
6) To have your prescription recognised in all EU Countries
The Commission has set rules on mutual recognition of prescriptions between Member States and on a minimum list of elements to be included in a cross border medical prescription.
As a patient, when travelling to another EU country it is reassuring to know that your prescription can be recognised at your destination. To avoid delays, interruptions in treatment and extra costs, ask your health professional for a cross border prescription before you leave.
7) To be treated with safe and effective medicines
Medicines must be authorised by the Member States or the European Commission before they can be placed on the EU market. This ensures patients are treated with medicines that are in compliance with strict standards on quality, safety and efficacy.
Once a medicinal product has been authorised in the Union and placed on the market, its safety is monitored during its entire lifespan to ensure that, in case of adverse reactions, appropriate action is taken swiftly, including additional warnings, restrictions of use or even withdrawal of the product.
8) To be able to report suspected side effects of medicines
As a patient, you have the right to report any adverse reactions to medicines you are taking directly to your national authorities. You can also do so through your doctor, pharmacist, nurse or other healthcare professional.
Medicines for which additional monitoring is considered necessary have a black inverted triangle in the package leaflet, along with information on how to report suspected adverse events through the national reporting system.
9) To be treated with safe medical devices
EU rules on medical devices, varying from simple bandages to the most sophisticated life-support machines, aim to ensure a high level of patient safety and rapid access to innovative technologies.
10) To benefit from common high standards of quality for blood, organs, tissues and cells
To guarantee quality and patient safety, the EU has developed common rules that apply across the EU to ensure that all donated human material is safe and carefully screened to prevent transmission of disease, for example HIV or hepatitis.
In addition, the EU funds projects and actions that support national authorities in training their inspectors, improving their vigilance systems as well as the organisation of and access to national transfusion and transplantation services.
For more information:
Website of Commissioner Borg:
1The scope for EU action in health policy is set in Article 168 of the Treaty on the Functioning of the European Union.
2 Article 35 of the Charter of Fundamental Rights of the European Union.