Statement by Dutch Minister of Health, Welfare and Sport, at the meeting of the committee on the Environment, Public Health and Food Safety, in Brussels 14 January 2016.

In the light of international tensions, European policies on healthcare may seem business as usual. ‘But’, Minister Schippers emphasized, ‘the contrary is true. Fighting antibiotic resistance, ensuring peoples access to innovative, yet affordable medicines and working on healthy products are on the top of the list during the Dutch presidency. That is how we hope to serve all European patients’.

Dear Chair, dear members of the ENVI Committee,

We live in a time where international tensions and terrorism demand our full attention. The attacks in Jakarta this morning shocked us all. I feel sorry for the victims and their loved ones.

Also refugees and unemployment need our focus. There are also topics that we could frame as “business as usual”.

Topics that may seem less important.

The contrary is true.

Just a glimpse at the field of cross border health issues in Europe today:

27.000 Europeans die each year due to antibiotic resistance. European citizens like you and me. European citizens that suffered from – sometimes simple – infections. Infections that we are not always able to treat anymore. Because our drugs are losing their effectiveness. By squandering antibiotics, we risk undoing nearly a century of medical progress.

No business as usual, at all.

At the same time, prices of new, innovative, monopolistic personalized medicines are extremely high. There are a lot of highly important medicines in the making that can make a huge difference for severely ill patients. Enabling them to live much longer, with less side effects.
But these extremely high prices endanger the sustainability of healthcare. They endanger access of patients to these medicines. They endanger lives. Already today, in some member states, people are denied access to these innovative medicines.

No business as usual, at all.

These are just two examples of the big cross-border challenges that Europe faces in the field of healthcare. Issues that can only be solved by cooperation and political courage.

So, I am grateful for this opportunity to meet you today in the heart of our European Democracy. And proud to present the Health Program of the Council of the European Union, during the Dutch presidency.

I will start with the legislative agenda that you already have devoted so much attention to. Then I will go into our priorities for the coming six months.

First Medical Devices and in-vitro diagnostics

Members of the European Parliament, the safety of patients is crucial in healthcare.
We have seen several incidents with medical devices that prove the importance - for patients AND the industry - of new legislation for medical devices and in-vitro diagnostics.
We share the same objective: a solid regulatory framework. Access for patients to products that are safe and of high quality. Promoting an innovative European market.
You have paved the way for the negotiations, together with the Luxemburg Presidency and the Commission. Still, a lot of work has to be done. I sincerely hope that a final agreement can be reached under the Dutch presidency.

The same is true for the proposed amendment on the regulation for medicinal products for human use. It entails the authorization procedures, certain administrative aspects and the fees. The Dutch Presidency would like to start the Council’s first reading on that amendment.

The EU also wants to ensure a high level of human, animal and plant health. Therefore it is necessary to have a harmonized legislative framework for official controls. The aims are: to improve the efficiency of official controls along the food chain. To minimize the burden for operators. And to ensure a level-playing field. The Dutch Presidency will strive for a political agreement on this proposal.
Finally, the minister of Agriculture would like to make progress on the proposal concerning veterinary medicinal products and medicated feed. This proposal addresses also the issue of antimicrobial resistance, one of the priorities of our Presidency. We want to ensure that the Union sets high standards of protection of human and animal health in this field.

So what are the priorities of the Council of the European Union under Dutch Presidency?

I already mentioned Antibiotic resistance.
•    It is clear that we have no time to lose in the battle against antibiotic resistance. So, it is time for action. And the only effective approach is the One Health approach. Because without the commitment of the veterinary world we cannot win this battle.
•    To facilitate this, we propose to set up a One Health Network. A network that will enable intensive cooperation between the human and veterinary sector. A network that will be the platform for Member States to update and assist each other.
•    Now changing policies into a national action plan is the easy part. Executing your plans - that is the hard part. We all come across obstacles. It is crucial not to let them slow us down.
It is crucial to become transparent about these obstacles. It is crucial to use the knowledge available. To help each other, we suggest to set up a peer-review mechanism in the EU for action plans on antimicrobial resistance. Not to check or to ‘control’ each other, but to support each other.
•    To broaden the possibilities, we should facilitate a more focused European research agenda to enable the development of new antibiotics and alternatives for antibiotics. This also requires new business models.
•    On all these topics, my colleague from agriculture and I will host a ministerial conference on the 10th of February in Amsterdam. All EU Ministers of Health AND all ministers of Agriculture are invited. During the conference we will have a scenario based policy discussion. That means we will use a film especially made for the Conference, confronting us with realistic dilemma’s on this topic. This is an important part of the conference.
•    Especially for you, we could have a similar session here in Brussels. We will be more than happy to invite you to such a session. It’s a very insightful and interactive way to look at Antimicrobial Resistance.
•    Following up on the conference, we strive to achieve joint Council Conclusions on Antimicrobial Resistance in the Health- and Agriculture Council.
•    Furthermore, we will ask the Commission to come up with a new EU Action plan with strong targets.

Our second priority: timely access to affordable medicines for our patients.
Mister Chairman, members of the Envi-committee – medicines play a crucial role in the lives of millions of patients in the European Union. Curing people. Giving the chronically ill a chance to lead active and productive lives. Supporting the independence of our elderly. Patients with severe illnesses like cancer have gradually obtained a better quality of life and an increasing perspective on survival.
Recently, we have been seeing remarkable advances in this field. Disruptive medical innovations, advanced new products that provide hope to severely ill people. This is great news!

But these developments come at a cost: prices of new innovative monopolistic pharmaceutical products have dramatically increased, while more and more drugs come to market for very small groups of patients. It is not always very clear what their added value is.

Our overall goal must be to keep our healthcare systems sustainable and make innovative medicine available to very ill people at the same time.

In my view, three urgent matters need to be addressed:
First of all : patients call for faster access and the industry complains about unnecessary regulation that adds nothing to safety, that makes the process slower and much more expensive.

The question is: how do we make better use of flexible market authorization mechanisms? In addition, early interaction between EU market authorization and national reimbursement requirements can help to shorten the time to patiënt. It is also  necessary to set the right conditions for flexible market authorization.
Safety, of course, can never be compromised, so we need clear conditions for using these more flexible ways of market access.

Second: how do we counter ever increasing prices of medicines. Many of these innovative products encounter very little or no competition at all. And no or few alternatives.
The current prices have no clear relationship anymore with Research & Development costs, or even with added value. This puts a lot of pressure on our health care systems.

I see it like this: very ill patients want access to these products. Doctors want to prescribe them. The industry wants to sell them. And politicians want to have an up-to-date health care system which provides patients with what they really need.

These are shared goals, ladies and gentlemen.

So there is common ground for good discussion. A solution could be to cooperate. In sharing information on prices between countries. Or even in shared price negotiations. Of course on a voluntary basis.

Third: it is time we discuss whether the current incentives in the EU market access legislation – meant to promote innovation - are still in balance.
In addition to the basic patent of 20 years, aimed at safeguarding innovation, several top ups have been introduced to promote the development and marketing authorization of medicines. Top ups like supplementary Protection Certificates, data protection and market exclusivity.

Are they still necessary, given the rapid changes in the production of medicines? Isn’t it time to redefine the balance of safeguarding innovation on the one hand and quick access and affordability on the other?
Our proposal is to analyze the existing regulations and top-ups, and their added value, in the coming months.

Our third priority is Food product improvement .
The health of our citizens is interconnected with eating habits. But even if people try to eat healthy, they risk consuming way too much salt, sugar and saturated fats. Because our processed foods contain too much of it. A lot of Member States already are taking action on a national level. And food business operators have started with food product improvement. This is encouraging. But with 28 countries and ONE internal market… isn’t it time for a next step? A joint, European step.
The food business is, in essence, a cross border business. The lack of a harmonized approach undermines the level playing field. And hampers product innovation. Shouldn’t we aim at making healthy choices easier with healthier product offerings?

Together with trade and industry and NGO’s, the member states, the Commission and the WHO, we will organize a conference to identify the actions necessary. At this conference in February, our aim is to translate these actions into a joint roadmap. So we can discuss this at the informal Council in April.
Changing product composition to make the healthy choice the easy choice, requires stamina. Therefore, we will join forces with incoming presidencies in the trio and anchor important European actions in Council Conclusions.
Closely related is the topic of Trans Fatty Acids. Another threat to the health of the European population. And unnecessary, since they can be replaced by healthier fats. So there is no excuse not to act.
The European Commission has published a long awaited report on Trans Fatty Acids last December.
Right after this, Commissioner Andriukaitis announced that he will start a public consultation and impact assessment on limiting the intake of industrially produced trans fatty acids through legislative norms.
We are looking forward to the conclusions.

Next to these three main priorities, we will work on other important topics.
Such as dementia. 7 million patients in Europe today. 15 million in 2050. We all know someone with dementia. We all have seen or experienced the loss and suffering this disease brings. To patients. To their relatives and friends. Since the French presidency in 2008, successive presidencies, including Luxembourg, have made dementia a priority. We believe the time is right to combine the numerous activities in every member state into an overarching view: how to tackle all aspects of the challenges dementia poses to us. Not as a binding agreement, but as a guideline combining years of experience on policies, innovation in care, social innovation and research. Hopefully a step forward in enhancing the quality of life of so many people in our ageing societies.
Last but not least; The Netherlands will host a conference on the quality of healthcare professionals. It is titled ‘Professional Qualifications safe in motion’. Which may sound a bit abstract. But the subject concerns our patients directly. How do we prevent that health care personnel functions below par?

Overall, we hope to serve all European patients during our presidency. By finalizing the work on medical devices and in vitro-diagnostics. By fighting antibiotic resistance. By ensuring peoples access to innovative, yet affordable medicines. By working on healthy products. By enhancing the quality and safety of care.

No business as usual, at all.

I look forward to working with you!