Cross-border healthcare for rare disease patients in Europe
Are you interested in accessing a treatment for your rare disease in another EU Member State?
Introduction
Do you live in Europe? Have you or a family member been diagnosed with a rare disease? Are you interested in accessing a medical treatment for your rare disease in another EU Member State? If so, then please consider the following tips and advice.
The treatment
The rare disease treatment you seek should be well supported by evidence, which demonstrates that the treatment is safe, and effective. An example of evidence would be scientific studies published in peer-reviewed medical journals about the treatment in question. Safety and efficacy are super important, and should be the starting point for all cross-border healthcare.
The patient
Two patients with the same rare disease may suffer from very different symptoms and problems. Is the rare disease treatment which you seek appropriate for you? Does it address your symptoms, at the current stage of your rare disease or condition? Is this the right treatment, for the right patient, at the right time?
These questions will probably seem very basic to you. If that is the case, do not worry; please just continue reading. We just want you to ensure that this treatment is safe and effective, and that it makes sense for you, before you put your time and energy into traveling abroad.
Your local doctors
If you want to access cross-border healthcare in another EU Member State, you are going to need the support of doctors from your home country. One of the challenges you may face as a rare disease patient is that your local doctor may not be an expert on your particular rare disease or condition. This is not the fault of your local doctor; there are thousands of rare diseases, and there is no way your doctor can be an expert on every single one. If indeed your local doctor has limited familiarity with your rare disease, then you may be able to find a doctor with more knowledge and experience somewhere else in your country. One way to locate experts on your rare disease in your home country is to use Orphanet, which will be discussed below.
Orphanet
To find experts on your rare disease in your home country, you can use Orphanet. This is a very simple thing to do; it is totally free, and you don’t even have to register as a user. Visit:
https://www.orpha.net/en/expert-centres
First, type in the name of your rare disease. Second, select your country. Third, click the blue button which says “Search”. You should now be able to see whether there is a center of expertise in your home country, which has experience treating patients with your rare disease.
Finding experts on your rare disease in your home country, using Orphanet.
If there is a center of expertise in your home country, which has experience treating patients with your rare disease, then we suggest you do the following. Send them an email using the email address you see on the screen. In your email, tell them that you have been diagnosed with a rare disease. Explain that you have learned about a safe and effective treatment. Provide them with the evidence – for example, the medical studies that were carried out on the treatment. Ask this center of expertise if they can please help you to access this treatment through cross-border healthcare.
To review: in order to access cross-border healthcare, it is very important that you identify a doctor, whether in your own local hospital, or at a center of expertise located somewhere else in your country, who is willing to support you in your effort.
Paying for cross-border healthcare
If you are wealthy, and if you can afford to pay for all of your medical care using your own money, then cross-border healthcare is very straightforward. You simply travel to the foreign country, check into the hospital, and pay for the treatment yourself. This scenario only applies to a tiny proportion of EU citizens.
The overwhelming majority of European citizens are not in such a position. Different countries have different standards of living, but almost all of us, wherever we are in Europe, depend on the financial support of our national healthcare system for our medical care. We rely on our national healthcare system to pay for the medical care we receive in our local hospital, and in the same way, we rely on our national healthcare system to pay for the medical care we receive abroad.
If you want your national healthcare system to cover the cost of your cross-border healthcare, then you must follow certain rules. These rules will be discussed below.
The 2011 Cross-border Healthcare Directive
When it comes to EU cross-border healthcare, there are two main laws to focus on: the 2011 Cross-border Healthcare Directive, and Regulation 883 (Regulation 883 is sometimes referred to as the social security coordination rules).
Many people are familiar with the 2011 Cross-border Healthcare Directive. It is a relatively newer law, and in the context of cross-border healthcare, it is often cited as the default rule. The 2011 Cross-border Healthcare Directive does provide a way to access cross-border healthcare in the EU. However, under the 2011 Directive, a patient who wishes to access cross-border healthcare must first pay for the entire cost of the medical treatment out of his or her pocket. Then, after the treatment is done, and the patient is back home in their own country, recovering, the patient must seek reimbursement, or partial reimbursement, from their national healthcare system.
If the treatment is simple, and relatively inexpensive – for example, routine dental work – then the 2011 Directive can be a good option for accessing cross-border healthcare. However you, as a rare disease patient, are likely to need more significant and more time-consuming medical care. You may be required to stay one or more nights in a foreign hospital. And you as a rare disease patient will probably undergo a treatment which costs more than a routine dental cleaning, or a pair of eyeglasses. For these and other reasons, we advise rare disease patients to focus on the second option for accessing cross-border healthcare. That is, we advise rare disease patients seeking access to cross-border healthcare to focus on Regulation 883 (which is sometimes referred to as the social security coordination rules).
Regulation 883
Under Regulation 883, if you want to access cross-border healthcare in another EU Member State, you must first apply for something called “prior authorisation”. What prior authorisation means is the following. BEFORE you travel abroad and receive healthcare treatment, you must first submit an application to your national healthcare system. You must ask your national healthcare system to grant you permission to access cross-border care. If your application is successful, and if they do indeed grant you prior authorisation, then your national healthcare system will give you a document called an “S2”.
The S2 document is very important. First of all, it proves that you have officially obtained prior authorisation, which is formal permission to access cross-border healthcare. Second of all, the S2 document serves a financial purpose. Instead of you paying the foreign hospital for the treatment you need, and then requesting reimbursement when you get back home, you simply send the foreign hospital the S2 document, BEFORE you undergo the treatment in question. Once you have given the foreign hospital the S2 document, that foreign hospital won’t ask you to give them cash, checks, or bank cards to pay for your treatment. Instead, the foreign hospital will simply provide you with the treatment you need. Then, the foreign hospital will send the medical bills for your treatment directly to your national healthcare system, in your home country.
This represents a dramatic difference between the 2011 Directive, and Regulation 883. Under Regulation 883, if you obtain the S2 document from your national healthcare system before you travel abroad, then the foreign hospital will send the hospital bills directly to your national healthcare system. You, the rare disease patient, can simply focus on your medical care.
To sum up: for relatively low cost, routine medical procedures, the 2011 Directive is a viable option for accessing cross-border healthcare. But for a rare disease patient like you, who may require more substantial healthcare, Regulation 883 is likely the better option.
Your S2 application under Regulation 883
We know that there are many challenges involved in being a rare disease patient; our goal, therefore, is to make things as simple as possible. If we could provide you with a checklist of the exact information and documents you will need to include in your S2 application, we would do so. Unfortunately, every EU Member State has slightly different rules when it comes to the S2 application procedure.
However, no matter where you live in Europe, there is help – and that help is available to you in your own country, in your own language. It comes in the form of “National Contact Points”.
National Contact Points
A National Contact Point is an official public office which is there to provide you with information and advice on cross-border healthcare. Wherever you are in Europe, we recommend that you reach out to your country’s National Contact Point. We suggest that you ask them for detailed instructions on the S2 application procedure. Exactly what information and documents should your S2 application include? Who should you send it to? How long will it take to get an answer on whether or not your S2 application has been approved? The National Contact Point should provide you with detailed information on all of these questions, specifically tailored to your country’s healthcare system.
Here is an official EU list of every National Contact Point in the European Union. Scroll down to your country. When you find it, write down their email address and other contact information.
Now, send the National Contact Point an email. We advise you to explain that you are a rare disease patient, and that you would like to use Regulation 883 to access cross-border healthcare. You may have many questions for your National Contact Point, but as mentioned above, your questions should definitely include the following: (1) exactly what information and documents should your S2 application include? (2) Who should you send it to? (3) How long will it take to get an answer on whether or not your S2 application has been approved?
Scientific evidence, and support from local doctors
As mentioned above, every EU Member State has slightly different rules when it comes to the S2 application procedure. However, whatever country you might be in, you should always keep in mind that two parts of your S2 application will be especially important. The first part is the scientific evidence which demonstrates the safety and efficacy of the treatment you seek – for instance, the peer reviewed medical studies which have been published on the treatment in question. The second part is support for your S2 application from a doctor or doctors in your home country.
Earlier on we said that it is very important for you to gain the support of a doctor in your home country, if you want to access cross-border healthcare. Here is where that doctor’s support will come into play. When you are preparing your S2 application, you should include a letter from that doctor. In that letter, the doctor should talk about you, your rare disease, and your symptoms. If a treatment is available for your rare disease in your home country, your doctor should identify this treatment, and discuss its safety and its efficacy. Then the doctor should discuss the treatment you wish to access abroad. What are the advantages of this foreign treatment, when compared with the treatment which is offered locally? By “advantages”, we mean not only the clinical benefits of the foreign treatment, but also any improvements it offers in terms of your quality of life as a rare disease patient.
Acceptance and refusal
When exploring the opportunity to access cross-border healthcare in Europe, you may have heard here or there or read on a website that you as an EU citizen have the “right” to access cross-border healthcare in another EU Member State. For patients suffering from a rare disease, healthcare is a very weighty issue; the stakes are extremely high. Rare diseases disproportionately strike young, vulnerable children. The symptoms are often grave. At times it can be difficult to keep our spirits up, and maintain a sense of optimism and hope. This is very serious business. Out of respect for you, the rare disease patient, we want to be as open and as honest as possible. Even if you prepare a very strong S2 application, there are no guarantees that your national healthcare system will grant you the S2. Even an outstanding, scientifically supported, technically perfect S2 application may be refused.
If your S2 application is refused, your national healthcare system is legally required to provide you with a reason for the refusal. If you disagree with their reasoning, you can appeal the refusal. Your National Contact Point can tell you exactly how to file your appeal.
The better your S2 application is, the more likely it is that your S2 application will be approved. We strongly advise you to dedicate as much time and energy as possible into creating an outstanding S2 application.
Contact us
We hope that the above tips and advice are helpful. We would welcome any feedback you might have on these materials, and any stories you would like to share on your own experience as a rare disease patient accessing cross-border healthcare in Europe. Thank you.
Philippe Pakter
Université de Genève, PhD candidate, law (“The effectiveness of EU legislation in the context of rare disease patients”)
