Austria’s EU Presidency will focus on “strong” investment in digital health as well as on regulatory issues when it comes to access to medicines, Dr Clemens Martin Auer told EURACTIV.com in an interview.
Dr Clemens Martin Auer is the president of the European Health Forum Gastein and director general at the Austrian federal ministry of health.
He spoke to EURACTIV’s Sarantis Michalopoulos.
- Austrian Presidency will try to fix the MFF, so we can really have a strong push in investment.
- Vienna will seek a better understanding and safeguard access to medicines.
- We have to do everything we can so that generics are available as quickly as possible.
- Key challenge is how to assess innovation – who assesses its true added value?
- HTA will improve the quality of assessments.
- Academia is the first place where innovation comes up.
What is the focus of Gastein this year?
We will focus predominantly on the need to have a bold political agenda on health on an EU level, meaning to push the agenda forward and not backward. There are talks, fears and rumours that health won’t be as important as it is right now. We think that health should be more important. You cannot talk about doing less but more efficiently and concentrate on the internal market. You cannot talk about safe borders and get a grip on migration without talking about health because an internal market without health doesn’t exist.
I’m not talking about public health issues, like vaccination or pandemic situations. I’m talking about health as it is mentioned in the sustainable development goals of the UN. We have to do more than less.
What should we expect from the Austrian presidency when it comes to health?
The informal ministers’ meeting will have two main topics. The first is the necessity to have a strong investment in health. In the Presidency, we want to focus on investment in digital health. We can dream of exchanging data and having data available for science and research, but as long as we don’t invest in health infrastructures for healthcare providers, we will never get there.
So this is what we try to fix/set in the MFF, so we can really have a strong push in investment, in digital infrastructures, to update the software products for patient, doctors and hospital. Otherwise, we can start dreaming again but we will not solve any problem if we don’t make data available for good purposes.
What are your intentions about healthcare data?
There are many good ideas and purposes concerning data. We need them to safeguard the continuity of care and to help healthcare providers. We also need them for research and health system analytics. It is not up to us as a Presidency and a government to come up with those ideas, but we have to guarantee that infrastructures are in place and that this data exchange can happen. We all agree on how important it is. But most of these infrastructures are not adapted to exchanging data easily and innovating.
And the second priority?
The ministers will hopefully have a good discussion with market authorisation agency, first of all with EMA, on regulatory issues when it comes to access to medicines.
Could you elaborate?
This is in line with the Dutch presidency. Do we gather enough data during the process of market authorisation to overcome the asymmetry of information between the industry and the reimbursement agencies of the public health sector? These are the issues we want to talk about. We want to do our homework on the regulatory side. It’s not about market, industry bashing, it’s about what we have to do to have a better understanding and safeguard access to medicines.
How did you see the Commission’s proposal for an SPC manufacturing waiver?
It isn’t a dossier which is negotiated much by the ministers of health because it has to do with IP regulations. This dossier will be mostly negotiated among the ministers of economic affairs or whoever is in charge of IP regulations in the member states.
What is your personal opinion?
We have to do everything we can so that generics are available as quickly as possible.
Do you see appetite/motivation from the member states to move things forward or from the European Commission to help them in this process?
There is a lot of progress in this discussion, though not much in concrete actions. The last 2-3 years showed a tremendous push in knowledge about what is at stake. The public sector probably didn’t understand many of the intrinsic mechanisms in the pharmaceutical sector.
We are leaning, analysing, and the fact that the ministers will talk for the first time to the responsible people in the EMA is one step of the learning process. You can change regulation without an in-depth knowledge about what you want to change. In that regard, I see progress. Our goal is to be more precise. We pick deliberately the regulatory side.
This is something governments, the Commission and member states can change because it is our obligation. We cannot change the way the pharmaceutical industry is manufacturing, taking up research programs, planning their pricing models, etc. That’s not easy to change. What we can do is change the regulatory framework.
Did the shift of the Austrian government have an impact on the previous health priorities? Because I remember Austria was more outspoken when it comes to pricing, as a general perception.
It is a wrong perception that it’s not outspoken anymore. We are guiding a discussion to the point. We really want to make sure that the existing regulation will change to improve the access to medicines.
There is not a single ministerial or political meeting which doesn’t discuss the non-availability of innovative drugs in certain member states, for instance. And we have to discuss that. One element is the price, but another is market authorisation and exclusivity for the molecule on the EU market and that’s especially true for orphan drugs, and then you find out that the product isn’t available in all member states.
It’s available in maybe one-third or 40%. If you grant market exclusivity for the whole EU market and products are not available on the market then something goes wrong. It’s not all black and white or to blame the license holders or the manufacturers. There are other reasons, like the unwillingness of some governments to pay a fair price. There is an ongoing discussion about fair pricing. That is not easy to solve but since medicines and drugs are not commodities like TV set, we have to look more carefully into that, because sick people are affected by that kind of things.
I’ve heard Germany has many objections to the change of the regulatory system and they don’t want to damage the pharmaceutical sector.
I won’t be talking about IP regulation because we are in a state of analysis, and it would be wrong to be judgmental considering the incoming Presidency. The IP regulation is a very complex issue. The Commission conducted a study on the incentives on behalf of the member states, we will discuss it and we will come up with conclusions after the process of carefully looking into that. This is not a thing we can change in one night and it would be naïve to think so.
Can you name a change you personally think will take place in the regulatory framework when it comes to market authorisation?
First of all, the Commission and the member states have to find a common understanding on what to change. We are not there yet. We still have very general discussions about pharma and now we have to be more concrete. It’s time to get to work. We have to dig in and find the right balance between the different interests at stake.
How about innovation assessment? Is HTA a move in the right direction?
This is one of the big challenges of the modern healthcare system on the side of reimbursers, managers of hospitals, doctors, patients: how to assess innovation. Those who produce it try to sell it as the best and the most innovative product, but who assesses the true added value of an innovation?
That’s a challenge, especially when it comes to very expensive innovation. I think it’s good that the Commission came up with a proposal for Health Technology Assessment. I think it will be tremendously helpful to join forces and improve the quality of assessments, so we welcome that. The proposal of the Commission has some shortfalls because they talk about the mandatory uptake of this kind of assessment, so I think these elements of the regulation text have to be deleted or reformulated. But the topic per se is important.
The biggest added value of this kind of regulation is that it really improves the methodology of assessment, because when I say that each and every innovation which comes on the market is a true innovation, there is a second sentence to add to it: each and everything which causes an assessment is already a good assessment of the added value of an innovation. We also have to improve this aspect of the healthcare sector. Since the public healthcare sector is interested in assessments, we have to support the improvement of assessments. That will be the biggest legal dossier during our Presidency and it will also be part of the Gastein conference.
Another discussion we will have, also related to the Presidency, is how to align public research in the medical sector with the priorities of public health’s needs. That’s also an issue. There are a lot of public expenditures for research…
And we don’t know exactly where it goes and why?
Exactly. And how can academia and public universities, which are a recipient of public grants for research, safeguard their interest when they come up with innovations? Because to be honest, the first place, where innovations come up, is academia. Then the industry buys it and brings it to the market. That’s the function of industry, it’s not a criticism, but we know that there are unmet medical needs or burdens, where public and private research is not enough.
That’s another topic for Gastein but also for the Presidency. It shows that we are not the big salespersons who make drama on the topic of pharma and want to step out of the “blame business” discussion and would like to focus on certain elements of the discussion, which have been identified in the meantime by studies, research, analysis, etc. Now we have to work with this. In two or three years, you can rightly raise the question of the output in terms of changed regulation and market accesses, but it’s too early to ask right now.