The EU’s new health agenda: Challenge or Opportunity for startups?

September 17, 2019

With the new European Commission and Parliament settling in, we made a list of the EU’s health agenda for the next 5 years, looking at what the new priorities will bring for startups in the European healthcare ecosystem. All in all, it looks like the interest in health this mandate will place startups under the spotlight. 

Increasing prominence of health policy in the EU. In the European Commission, the Directorate-General of Health and Food Safety (DG SANTE) now has increased responsibility and authority: medical devices will now fall under DG SANTE, while the Biotechnology and Food Supply Chain as well as the Health Technology and Cosmetics units, both previously part of DG GROW, will now be part of DG SANTE. 

In the European Parliament, the Committee on Environment, Public Health and Food Safety (ENVI) is now the biggest committee in size, with 76 Members of Parliament. This interest, coupled with the emphasis on more digital and affordable health, is likely to get more attention from policymakers on startups dealing with digital health solutions. The committee size will also allow for the formation of a stable coalition of MEPs. 

Vaccination. A Eurobarometer survey shows that more than 12.000 measles cases were reported in the European Economic Area and 35 people died from them last year, but less than 40% of people surveyed were aware that measles is still a cause of death in the EU. At the moment, ensuring people are vaccinated is a major challenge in Europe. In an effort to tackle this problem, the first Global Vaccination Summit was held in Brussels on 12 September by the European Commission and the WHO followed with a 10-point plan. The fight against vaccine-scepticism looks like it will be one of the topics driving EU health priorities in the coming years.

In her Mission Letter to the incoming European Health Commissioner Kyriakides, Commission President-elect Ursula von der Leyen states that she wants “to prioritise communication on vaccination, explaining the benefits and combating the myths, misconceptions and scepticism that surround the issue”. Startups bridge the gap between traditional health systems and patients through cutting-edge technology. They merge scientific research with a patient-centric approach, hence effectively communicating the benefits of healthcare solutions, including vaccines. You can find out more about European startups working on vaccine solutions in this blogpost.  

Fight against cancer and antimicrobial resistance. In her Mission Letter, von der Leyen asked Kyriakides to put forward a plan to beat cancer as well as to implement an EU-wide plan against antimicrobial resistance (AMR), which would support EU countries to improve prevention and care.

French Therapixel, Dutch SkinVision and UK-based Nanovery developing cancer treatment solutions or UK-based Procarta Biosystems developing therapies to combat AMR are notable startup examples that have been aiming to revolutionise healthcare in these two fields. There is plenty of room for manoeuvre for startups in terms of innovating in both areas. 

Medical devices. The European Commission claims it is on track to deliver on the new Medical Device Regulation (MDR) by the May 2020 deadline, but national governments, industry and patients have expressed reservations that without alterations, the new MDR could see products pulled from the market.

Von der Leyen seems to be aware of the widespread worry around this issue: she has not only shifted the medical device file to DG SANTE, but also mentions the topic among the top three priorities in her Mission Letter to Kyriakides, stating that she wants a “focus on the effective implementation of the new regulatory framework on medical devices”.

From developers of wearables or apps to medical software -e.g. Belgian Byteflies, Danish Brain+ or Finnish Disior-, most European startups will be affected by the new MDR. Preventing a backlog of medical devices pending for approval or any other problem that might arise will not only benefit startups that produce medical devices, but all health stakeholders, especially care providers and patients. 

More digital and affordable health. Finland, holding the Presidency of the Council of the European Union until the end of 2019, had already set forth the digitalisation of healthcare in its Presidency Programme earlier this year. So it is no surprise that von der Leyen’s Mission Letter to Kyriakides states the “need to make the most of the potential of e-health to provide high-quality healthcare and reduce inequalities” and “to work on the creation of a European Health Data Space to promote health data exchange and support research on new preventive strategies”. 

It goes without saying that startups drive digitalisation in health. Data is a vital resource for startups, particularly in creating innovative e-health solutions. Through a European health data space, startups can fully use their potential to add to a more affordable and patient-centered healthcare.   

All the issues mentioned above indicate an increasing relevance of startups in European health policy in the upcoming 5 year-term. Regulation, especially in healthcare, is necessary for ensuring patient safety. Difficulties in regulatory regimes need to be adapted to advances in technology and science in order to develop approaches better suited to today’s world. This is essential to increasing the potential of startups as the drivers of innovative digital solutions for better quality, more equal and accessible healthcare.