Toespraak van minister Schippers tijdens de EU expert meeting innovatieve geneesmiddelen

Toespraak | 01-03-2016

I would like to start with the story of Henke. Henke is an 11-year-old Dutch boy struggling with the severe and rare muscular disease of Duchenne. A few years ago, he participated in a clinical trial for a new drug. And… it seemed to work wonders for him. You can imagine the joy of his parents as they saw their boy running up the stairs for the first time!

But the trial failed. And in 2014, he was taken off the medicine. All the progress he made, was gradually lost. His parents started to renovate the house, moving his bedroom downstairs.

And then, another pharmaceutical company decided to give the same drug another try. Since January, Henke is back on medication. His parents are desperately hoping to see the same progress as before. Have 2 years without medication caused too much damage? Or will they see their son running up the stairs again?

And if it works again, will the drug finally be registered? Or will it - as Henkes father called it - get stuck again? 'These procedures are meant to protect patients,' he said. 'But they do not protect our son!'

Ladies and gentlemen. This meeting is a first-timer. Never before in Europe have experts and policymakers from the whole chain of Market Authorization, Health Technology Assessment, Pricing and Reimbursement got together in one room. You come from different worlds, it may seem.

However, you all have one major thing in common. Which is the interest of our patients. How can we provide severely ill people with the medicines they really need? And how can we speed up access for patients that have no time left to wait? That is our common challenge.

But there is more…

Imagine that the drug for Duchenne had come on to the market for Henke, and for patients like him… Would we be able to afford it? A crucial question as well. Too often, new, innovative drugs come on to the market for skyrocketing prices. This poses a threat to the sustainability of our healthcare systems.

And it poses a threat to patients as well. Because if we cannot afford innovative medicines, how will they ever be able to benefit? That is why we cannot discuss access to medicines without discussing affordability as well. Both are amongst the top priorities of the Dutch EU-presidency. They are interconnected!

Ladies and gentlemen,

Of course, we have a lot to be proud of. Pharmaceuticals are of major importance to millions and millions of European citizens. Curing people. Giving the chronically ill a chance to lead active and productive lives. Patients with severe illnesses like cancer have gradually obtained a better quality of life and an increasing perspective on survival.

Yet, we have entered a new era. An era in which we witness major changes in the field of pharmaceuticals.Remarkable progress in the field of anti-cancer drugs. Remarkable progress in the field of orphan diseases. Remarkable progress in the field of personalized medicines. This provides hope to many severely ill patients! It is therefore only logical that patients call for faster access. And for availability of the right products.

Their call will get louder, considering the amount of unmet medical needs. It will get louder, considering the fact that we will be dealing ever more with smaller patient groups. It will get louder, challenging the traditional way of doing clinical research.

Therefore it is of the utmost importance to see how we can make best use of early access schemes, without compromising safety.

And I feel that we ought to keep an eye on the concerns of marketing authorization holders as well.

Concerns about the administrative burdens on both the registration process as well as on reimbursement. This often hampers timely access for patients. Shouldn’t we work on better alignment of these two worlds?

My question for you today is: how can we kill two birds with one stone?

Improve flexibility in the system, on the one hand, to provide better access. And counter the ever increasing prices on the other? The Italian Medicines Agency has very promising and interesting experiences in this field. And I am very glad that they will be sharing these experiences with us here in Amsterdam.

Of course, we invited you together for a reason. We feel that early interaction between EU market authorization and national reimbursement requirements is needed in order to facilitate early access for patients.

I see 3 important steps in this regard.

Today we are making the first step, which is getting to know each other. The 2th step is to improve the coordination and cooperation between market authorization, Health Technology Assessment and Pricing & Reimbursement.

And the 3th step is to share each other’s knowledge and documentations. The Norwegians lead the way on better coordination between market authorization and Health Technology Assessment and also on a better alignment between the various documentations.

I am grateful that the Norwegian Medicines Agency will give us insight into their working model here in Amsterdam. Ladies and gentleman, I hope your discussions today will be fruitful and lay the foundation for a future agenda on this important subject.

And I definitely hope that this first time won’t be the last! Let us stay in touch, work together and move forward. For the sake of patients like Henke. For the sake of all patients that are waiting.