Sustaining Europe’s position as a powerhouse of healthcare innovation

Last week I was invited to speak at the FT Global Pharma and Biotech Summit in London. I decided I would use the opportunity to talk about Europe, or more specifically what it will take to re-establish a leadership position in health innovation.

I am happy to share the speech with you now.

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Europe has a long history as a leader in innovation. For a long time we have prided ourselves on:

• the strength of our medical research
• the quality of care we provide to our people
• and the advances we have made in life expectancy and outcomes.??

But in recent years, just as the pace of innovation is accelerating, our leadership position has come under threat - with serious potential consequences for patients, health system sustainability and our economy.?

If we want to change this trajectory, if we want to re-establish Europe’s position as a leader, we need to start by recognising that both the public and the private sector have a role to play. Then? we must work together to foster better outcomes for patients, stronger health care systems, and sustainable industry footprint with economic factors associated.?

Unfortunately, over the past few decades, Europe has fallen behind. And it's fallen behind in a way that means many of us probably didn't even notice what was happening.?

20 years ago, the US attracted 2 billion euros more investment in research and development than Europe. Today the difference is 25 billion.?

At the same time, the share of emerging biopharma companies headquartered in the EU is declining. Most new companies are now based in the US, though China based companies are also on the rise.?

What is behind this shift?

One of the things that's important is that in other parts of the world there seems to be more of a recognition of the mutually supporting, but different roles, the varying interests play within the system.?

There's an understanding that patients need better outcomes, that health systems need more sustainable solutions, and that the research and development industry can and must play an important role in addressing those needs.?

But importantly, there is also a recognition of what the industry needs to be able to do that: access and an appropriate level of reward.

Do we have that same level of recognition here in Europe??

If you are a start-up today, with money to invest and innovations to get into patients’ hands, is Europe the best place for you??

For sure Europe historically had a strong industrial base, and that could be very attractive. And we do have strong healthcare systems. But does Europe see health innovation as a truly strategic, valuable and important sector??

Will it work with you to make your investment work???

Importantly, will it give you the best prospect of getting your innovations to patients??

Unfortunately, as it stands today there's a real possibility that the answer to those questions is no.

I believe that one of the key reasons why Europe’s status as a health innovation leader is under threat - is that it’s not ready to deliver the future of healthcare.?

New types of highly-effective healthcare solutions are being developed for which there are no clear regulatory or reimbursement pathways in Europe

We lack the data infrastructure needed to accurately assess the value of treatments that offer curative, long term or system wide benefits.?

Even for those solutions with pathways that do exist, they're often quite slow.?

• We know it takes an average of 426 days for the European Medicines Agency to review a medicine compared to 244 days at the FDA.?In the UK, we are also seeing some advances with faster regulatory pathways becoming available.?
• The average time for reimbursement for innovative treatments across the EU and European Economic Area countries can be as long as 504 days? - ranging from 127 days in the fastest to over 823 days in the slowest countries

Crucially, these differences between Europe and other parts of the world are emerging, not in a benign environment, but in the face of an industrial revolution the likes of which none of us have seen before. Gene therapies, bi-specific antibodies, next generation mRNA vaccines - the potential is absolutely breathtaking.?

For Europe to lose our leadership position now would be of monumental consequence. Quite literally lives are at stake. And we're already beginning to see the implications.?

Whilst overall life expectancy in Europe continues to be higher than in the US or China, in those areas that have seen some of the greatest scientific and medical breakthroughs like cancer, Europe is already falling behind.

Our policies, our systems, our ways of thinking and working together, have been undermining our leadership over time - acting like a slow puncture slowing us down.?

And as the pace of health innovation continues to accelerate, the gap between Europe and other centres for health innovation will only grow wider.?

This isn't the future I want to see and I am sure?nobody else here does either.?

The advances that are happening in healthcare have way too much promise for that. This is the dawn of something which will impact the rest of the 21st century in healthcare. We need to be ready for it. We need to own it. And we need to shape it.?

But as with previous industrial revolutions, geography matters. Investment matters, infrastructure matters.?

We've all got to step back now and see our situation for what it is.

I don't think it's too late to make course corrections. But we do need to act soon.?

We have many of the tools that we could use to fix the problem? - the EU Pharma Strategy, the European Health Data Space, the varying proposals made by the Industry Association EFPIA.

The tools are there and if we know how to use them we can make a difference.?

But if we don't make course corrections, let's be clear. We are heading for a blowout on the motorway.?

So, what needs to change?

Well above all we need a commitment from all the stakeholders involved in this sector, to? work together with the imagination and political will needed to reestablish Europe as a leader in healthcare. This starts with an appreciation of the value that this leadership position delivers for patients, for health systems and to the economy across Europe.?

Then we need a change in mindset.?

I spoke earlier about the different approaches adopted in other countries, the understanding that they have that the public sector alone can't deliver the best health care - partnerships with the private sector are essential.

I spend lots of my time talking to people outside of Europe about how health care is provided, and what it will take for them to be ready for the latest innovations coming out of the labs.?

What's striking to me is how different these conversations are to the ones that we often have in Europe.?

Elsewhere, we get a recognition that the private sector has an important role to play. Elsewhere, we get an interest in attracting investment. And elsewhere, we get a commitment to work together to deliver better results for patients and society.?

I'd say that at times it does feel like Europe is taking the private sector a little bit for granted.?

In the future, we need to work together in lockstep - private and public sectors together. That's the key.?

Importantly, I am not a specialist in healthcare policy, and I would never pretend to be. I don't know what it takes to run a well functioning and sustainable healthcare system. I don't pretend that I understand the day to day pressures that those who are running healthcare systems face.?

But I would like to hear what they are.

I would like to have a genuine conversation about what they are, and to share the concerns and the needs that we have, as an industrial healthcare partner to help serve on that basis, with a shared commitment, and hopefully, a better mutual understanding.?

My invitation is for us to work together to fully leverage the many, many opportunities that lie before us.

We do need some regulatory reform. But with the review of the Pharma Strategy, there is regulatory reform on the table and it can make a difference. We just need to talk about how we can make it so that it works effectively for everyone.?

We do need a way of evaluating medicines and accelerating access in the EU. And we already have the EU HTA legislation, a number of proposals from the industry through EFPIA, and the ongoing initiative from WHO Europe to create a multi stakeholder platform on access to innovative medicines. I think those things can make a real difference.?

We need systems that enable us to truly evaluate the impact of healthcare interventions on patient outcomes. And we already have good proposals on the European Health Data Space, which if we work together to make it happen could be made to everyone's needs.? This is a potential game changer because health data is undoubtedly one of the most powerful tools to enable more targeted, more efficient provision of healthcare for patients, more sustainably. It could be transformational. And by the way, it could be a significant competitive advantage.?

None of these things are answers on their own. But if we work together with a deep understanding of each other's needs, and how we can meet those needs, then I'm sure they could make a real, real positive impact.?

Because let's be clear about this.? The solutions we put in place need to be beneficial to everyone. Because the very fact that they are beneficial to all stakeholders that allow them to be sustainable.?

Roche is not a bystander in this, we’re far too invested in the future of healthcare and in Europe for that.

We've been transforming and have already reengineered our entire business - we've turned it inside out? - all the way? from how we research and develop medicines through how we engage with the world in Europe and beyond, in order to help shape and deliver this revolution for patients.?

One of the consequences of being the world's biggest investor in research and development is that we spend an awful lot of time looking over the horizon. And I see others in the room do the same.?

We spend a lot of time looking at both the needs of patients today. But also what's likely to be true in 10 years or 15 years from now.?

And again, I cannot claim to have perfect vision. but I do want to make an offer to share what we can see with anyone else who would like to talk. We’re open to sharing what we see on the horizon so that we can have a conversation about what is needed from us in order to make the most of it.?

I know we are not alone in wanting this shift to happen. New conversations, new platforms are already starting to emerge and I welcome this. What I hope to see though is more, and for us to accelerate.?

We have these incredible opportunities ahead of us -? once in a generation opportunities - and it's on all of us to determine whether or not we make the most of them.?

Now certainly isn't the time for complacency or division. It is time to work together to find an approach that brings value for all

• Earlier access to innovation,?
• Better outcomes for patients
• More efficient investment of resources enabling the strengthening of healthcare systems - making them more sustainable?
• Appropriate rewards for the private sector innovation -? establishing protection for a strong industrial base, recognising the benefit that this can bring in terms of high value jobs, exports, access to innovation.?

It can be done but we need to work together and we need to be ready to have open conversations.

Let's not let a lack of ambition, or narrowness of vision hold us back.

We?stand ready to join with others. Ready to learn,? to listen - all to help us advance in lockstep.?

It's time to be bold and ambitious, to acknowledge that incremental improvements are no longer enough.?

We mustn't miss this opportunity to make Europe stronger, more competitive, and most importantly healthier.