For a health e-sovereignty!

When we take stock, Europe notes that the vice has tightened further with China to the east and the United States to the west. The new era is initiated by this Chinese-American duopoly led by their famous GAFAM and BATX. This geopolitical situation raises the question of strengthening the impact and sovereignty of Europe

 

If the epidemic has precipitated this transformation, it has also accelerated European decisions in favor of the EU's digital and health sovereignty. In order to tackle this subject seriously, we wanted to call on someone who is as knowledgeable about economic and geopolitical issues related to health, with a strong affinity for digital technology. That's why we spoke to Clotilde Jolivet, Director of Public and Government Affairs at Sanofi.

 

Digital technology at the heart of Europe's transformation

 

The crisis has made most people aware of the importance of having a good level of autonomy on essential and innovative products, whether they are drugs or technologies, an issue that the healthcare industry sector has been addressing for years. In both cases, digital technology plays a central role, as it is transforming our entire industry. This quest is that of e-health sovereignty. E-health is going to play an increasingly core role in the provision of healthcare, as well as in the organization of the healthcare system. The supply, organization and development of treatments must be thought out on a European scale, otherwise we will not be able to establish our own sovereignty.

 

This objective is vital, not only for the production of goods, but also for the creation of value in the short, medium and long term. It is a question of reconquest, since we have too quickly left this subject in the hands of other geographical spaces. Digital technology is only in its infancy and could well be our best ally in this reconquest.

We need to move quickly from aspiration to operation, and organize ourselves on a European scale with a clear and easily deployable roadmap.

 

Health data as a driver of e-sovereignty

 

In the West as in the East sides of the world, the ideology is relatively different from the one in Europe. The European Union, the world's third largest economy, is still struggling to position itself as the instigator and federator of European e-health. In particular, because there are still major disparities between member states.

Digital technology is a creator of value and an opportunity for economic growth, job creation and attracting investors and talent. So, how can we develop Europe in this field?

Faced with the temptation to turn to solutions emanating from North America or China, Europe must provide itself with the means to create real conditions for the deployment and massive use of health data by research teams, startups and industrialists, and resolve the challenges of the ecosystem with regard to the use of these data: Facilitating the identification of sources and pooling them, providing for European data storage, establishing interoperability, avoiding the multiplicity of national legislations, guaranteeing the valuation of these data by regulatory and evaluation authorities, ...

 

Data protection is another interesting example. Europe was a pioneer with the GDRP, and showed citizens that the protection of their data was important. So we have a secure framework to develop innovation on health data and health solutions. China is in the process of strengthening its legislation which allows the State to access all data generated on its territory, under the guise of national security, and this without any guarantee of protection of personal data or intellectual property. Europe can therefore assert itself as an attractive and competitive region compared to the USA.

 

To achieve this, the European institutions must harmonize and pool their approaches. This means fighting against a heterogeneous vision of its 27 members and not reproducing the same mistakes as those of the past decades for medicines. Until now, it has been difficult to produce and distribute at scale, as Europe has multiple approaches specific to each country.

 

In 2022, if we want to be attractive and successful, we need to help our European startups avoid an obstacle course for evaluation and market access, to develop rapidly on our market, then expand and leave for the United States or elsewhere. Because the reality today is that some of our most ambitious entrepreneurs are thinking first of the market across the Atlantic, even before they make their business in Europe. Fundraising is easier and faster in the US because the market is unified, and the launch of a healthcare solution is in a vast and harmonized market. We have to guarantee them a secure, interoperable and harmonized space.

 

In the short term, the European Union must make three steps forward:

 

• Propose harmonized regulations throughout Europe to ensure simplified and secure deployment of health data, which is the key area of innovation for startups
• Guarantee European markets to encourage the emergence and industrialization of our future champions on our territory first, before exporting them.
• Interconnecting the dozens of European initiatives around data, such as the Health Data Hub in France. These initiatives, however brilliant they may be, will only be of limited interest in the medium term without interoperability. At least if we want to guarantee a sufficiently large and solid market to compete with the East and West.

 

Evaluating to ensure reliable industrialization over time

 

Obviously, moving fast and offering a clear and predictable framework is only a short-term asset.

In e-health, more than anywhere else, we are not in a sprint, but a marathon. A key challenge for creating value in e-health is evaluation. It is essential to guarantee safety and efficiency, whether it be with CE marking for medical devices, and of course clinical trials for drugs. We still need to find the right evaluation model for digital health products and services.

 

This logic must obviously remain demanding for the good of patients, without becoming counterproductive, and it must be thought out on a European scale. Once an e-health startup has validated its technology, it must be able to deploy it quickly, not knock on 27 evaluation agencies' doors. Research and development work is already risky, so we need to facilitate the evaluation stages as much as possible, and support our entrepreneurs before their launch on the market.

 

This does not mean reimbursing all devices and solutions, but rather formalizing and harmonizing approaches and methodologies, for example, to measure the impact of solutions that generates efficiency gains in healthcare. In short, we need to move towards more co-construction and put real resources in front of the entrepreneurs.

 

Co-investing in risk, with entrepreneurs

 

The digital reconquest in health in Europe is also a question of multidisciplinarity. The relationship between the private and public sectors, at the local level and even more so at the European level, is perceived as a power struggle due to structural and cultural differences. Yet they are interdependent. The role of the public authorities is to ensure that the framework in which we evolve is adapted. At the same time, private actors, whether they are industrialists, investors or entrepreneurs, play an initiating role. The former need solutions that respond to the problems encountered by citizens, the latter need favorable regulations and capital to think and deploy them.

 

However, today it is difficult to obtain financing when there is risk (regulatory, but not only). This is what is holding back the rise of our startup ecosystem. They take risks, it's in their nature and we need them to innovate. The same is true for manufacturers. 

 

There is a whole acculturation to think around this notion.

 

Today, we have a logic centered around subsidies (research tax credits, etc.), but no logic of co-investment in national and European risk. In the USA, the crisis has highlighted the role of the BARDA agency, which has invested massively in vaccine research, but which existed long before the crisis and whose role is to co-finance risk with private companies, whether in R&D or industrial deployment. The co-financing of risk is one of the strong points that will enable Europe to find its identity and achieve health sovereignty. We have been able to do this in the field of defense, in a regalian logic, since the public authorities do not question the vitality of defense. The creation of the future HERA agency, and its industrial arm Eu-FAB, is a step in the right direction, and we must accelerate its creation and operation so that startups projects and larger companies can be boosted and anchored in Europe.

 

Everything is linked to risk. The greater the risk, the more important the resulting companies will be.

 

A clear framework for risk-taking is what will set us apart from other geographies and attract more talent capable of thinking up solutions. They need to have confidence that risk-taking is embedded in our culture.

 

Focus on multidisciplinarity 

 

Beyond risk-taking, consolidating a unified vision of health data will undoubtedly be key to becoming a key player again. Obviously, not all European Union countries are committed in the same way and at the same pace. Moving forward together means accepting to deal with the differences of others. With the Presidency of the EU in the first half of 2022, France can make progress in the area of health data.

 

• Define the rules of the game and interoperability. That is to say, provide a secure, easily accessible and value-creating structuring.
• Include the citizen. Help them understand that the challenge is not to trace, but to create value for them, to care for them, to serve progress, etc. Also to make him a contributor to this new system. 
• Helping patient associations. These key players have understood, especially for rare diseases, that registries and monitoring are needed to gain time and win the race against time in the face of these diseases. 
• Reducing inequalities. Sharing data will allow us to rationalize our healthcare system and thus help each citizen benefit from a personalized and therefore fairer system.
• Prevent future crises. Data will ensure the resilience of the healthcare system, thanks in part to its predictive promise.

 

What is certain is that these objectives will not be achieved without multidisciplinarity and risk-taking. We need open institutions, ambitious entrepreneurs, agile industrialists and, more broadly, an ecosystem that is resolutely positive and in the service of European-style sovereignty.

 

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