PIERRE ROBIN EUROPE – INTRODUCTION

On 29 March 2017 my partner gave birth to a baby girl, Lysiane, who was diagnosed with a rare disease called Pierre Robin Syndrome. Pierre Robin Syndrome, which is also called Pierre Robin Sequence, is a rare disease which strikes only approximately 1 out of 10,000 babies. Pierre Robin Syndrome is associated with potentially life threatening breathing problems and eating difficulties; babies with this rare disease face many risks, including oxygen deprivation, brain damage, failure to thrive, and death.

Our daughter Lysiane suffered a dangerous, difficult birth. She never came home from the French hospital. She was attached to a ventilator machine in the intensive care unit, and she remained in that intensive care unit, in the same French hospital where she was born, for five straight weeks – with no scheduled date of release.

A BREAKTHROUGH TREATMENT FOR PIERRE ROBIN SYNDROME, DEVELOPED IN THE EU

Doctors in Germany have spent over 10 years developing a highly specialised, medically proven and cost-effective treatment for Pierre Robin Syndrome. The treatment is called the Tübingen Palatal Plate – the “TPP” treatment. The TPP is a safe, non-surgical, oral medical device which resolves the baby’s torturous breathing difficulties, liberates the baby from the ventilator machine, and eliminates the need for invasive surgical procedures. The TPP represents a dramatic breakthrough in the treatment of Pierre Robin Syndrome.

As you can imagine, we as parents felt incredibly lucky to learn that this breakthrough Pierre Robin Syndrome treatment was developed here in the EU, and in fact that it was available just next door, in Germany. This, we thought, was one of the special advantages of living in the European Union: collaboration and pooling of knowledge between EU Member States, allowing all European citizens, especially babies suffering from a rare disease, to benefit from Europe’s great medical innovations.

In accordance with EU law, we, Lysiane’s parents, both EU citizens, submitted an application to France’s national health insurance fund, “L’Assurance Maladie”. In our application we requested official authorisation – what is called an “S2” form – to permit our daughter Lysiane, herself a French citizen, to receive the highly specialised, medically proven and cost-effective TPP treatment in Germany…

THE FRENCH GOVERNMENT REJECTS OUR REQUEST FOR THE TPP TREATMENT IN GERMANY

The French government rejected our daughter Lysiane’s S2 application to receive the TPP treatment in Germany.

We believe that the French government’s rejection of our S2 request for this highly specialised and medically proven German healthcare treatment was a shameful violation of European law. Why? Because based on the EU’s 2011 Cross-border Healthcare Directive, Article 13, “Rare diseases”, EU Member States are legally required to respect an EU citizen’s right to choose the best medical treatment available in the EU, especially in the context of a rare disease, “even for diagnosis and treatments which are not available in the Member State of affiliation”. It is a confirmed fact that the TPP treatment in Germany is not yet available in France. Furthermore, there is no treatment which is available in France which is equally effective as the TPP treatment.

OUR ALLIES

We are not alone in considering the French government’s rejection of our request for the highly specialised TPP rare disease treatment in Germany to be a violation of EU law; our growing list of allies includes:

  1. The European Commission’s SOLVIT network; after carefully analysing our case, SOLVIT formally concluded that France, in rejecting our daughter Lysiane’s S2 application, violated EU law, as documented in SOLVIT Case Number 2569/17/DE.
  2. EURORDIS, the largest rare disease patient organization in the EU. EURORDIS sent a highly detailed letter of support to L’Assurance Maladie, explaining why they too believe the rejection violated EU law. EURORDIS has pledged to accompany us, Lysiane’s parents, in court, all the way up to the European Court of Justice.
  3. A senior Member of European Parliament, Ms. Françoise Grossetête. Ms. Grossetête has extensive experience working with the EU’s 2011 Directive on Cross-border Healthcare; in fact she was the European Parliament’s special rapporteur for this Cross-border Healthcare legislation. Ms. Grossetête knows this law, and she too knows it was broken; she has sent a formal letter of support directly to France’s Minister of Health, Madame Agnès Buzyn, making it clear that this situation is “unacceptable”, and that the rejection was legally unfounded.
  4. The European Patients’ Forum, the largest patient advocacy umbrella organization in the entire EU. The European Patients’ Forum was a key stakeholder in the drafting of the 2011 Cross-border Healthcare Directive; they too know this law. The European Patients’ Forum has sent a formal letter of support directly to the President of France, President Macron. In their letter they state that this situation is “shocking”, and that France’s rejection was legally unfounded.
  5. Pro Rare Austria, an Austrian umbrella organization for rare disease patient advocacy groups. In their letter to France’s L’Assurance Maladie, they ask the Director, Nicolas Revel, to revise the unfounded rejection of Lysiane’s right to a safe and medically proven treatment in Germany.
  6. Rare Diseases Denmark, a leading rare disease advocacy group from Scandinavia, and a highly respected voice in the international rare disease movement. In their letter of support, they point out that the case of Lysiane “is a devastating example of the struggle that many rare disease patients and families have faced, and continue to face, right here in Europe.”
  7. The Member of Parliament representing our district in France, Mr. Bruno Bonnell, of the Assemblée Nationale (France’s Parliament). MP Bonnell, who is supporting us in our appeal, is an active defender of patients’ rights and people with disabilities.
  8. An international network of law professors who specialise in EU cross-border healthcare and social security law. They too agree that L’Assurance Maladie’s rejection of our daughter Lysiane’s S2 application was legally unfounded.

Every single one of these people and organisations agree that whatever the French government’s real reason was for rejecting Lysiane’s S2 application to obtain the highly specialised, medically proven and cost-effective TPP treatment in Germany, the rejection violated European law.

We, Lysiane’s parents, are formally appealing the rejection. We are continuing our fight to obtain the S2 cross-border healthcare authorisation form which our daughter Lysiane was wrongfully denied.

WHY OUR APPEAL IS IMPORTANT

Our struggle to exercise our legally guaranteed right to access cross-border healthcare in the EU is not just about our baby Lysiane. And it is not just about us. And it is not just about other babies who are suffering from this particular rare disease, Pierre Robin Syndrome. It is broader than that.

This case raises an issue of wider principle which matters to all EU citizens, and which affects their daily lives: if a newborn baby suffering from a rare disease, immobilized in an intensive care unit and connected to a ventilator machine, doesn’t have the right to obtain a highly specialised, medically proven and cost-effective treatment for her rare disease in another EU Member State – then who does have the right to obtain cross-border medical care?

We, Lysiane’s parents, both EU citizens, appeal to France’s President, President Macron, and to the leadership of the European Union in Brussels, to correct this glaring injustice.

Read our letter of appeal to French President Emmanuel Macron

Please read our letter of appeal to French President Emmanuel Macron.

© Copyright 2019 - Stichting Pierre Robin Europe; dedicated to David, Lysiane's hero; and to Fernand and Rachel, two kind and decent people - RIP.