France is one of the leading countries in Europe for Biotech and MedTech innovation, with a strong ecosystem of research institutions, startups, and investors. However, bringing new healthcare technologies to the market is not an easy task, as it requires clinical validation, regulatory approval, and reimbursement schemes. To overcome these challenges, France has established a unique mechanism to support the development and adoption of innovative healthcare technologies: the innovation funding.
What is Innovation Funding?
Innovation funding is a special funding scheme that allows innovative healthcare technologies to be financed by the national health insurance system before they are covered by the mainstream reimbursement schemes. This way, innovation funding acts as a bridge between research and market, enabling the technologies to be tested and evaluated in real-world settings, while providing access and benefit to patients and healthcare professionals.
Innovation funding is granted by the Ministry of Health, based on the opinion of the French National Authority for Health (HAS), which assesses the eligibility of the technologies according to the criteria of innovation and potential benefit. Innovation funding is exceptional, temporary, and conditional, meaning that it is only available for technologies that are not yet reimbursed, for a limited period of time, and under the obligation to conduct a study to demonstrate their added value.
How Does Innovation Funding Work in France?
The innovation funding procedure involves two main sequences: the assessment of the innovation funding request by HAS, and the decision on the implementation of innovation funding by the Ministry of Health.
- The first sequence is the assessment of the innovation funding request by HAS. This sequence involves two steps: determining the admissibility of the application and analysing the eligibility of the innovation funding request. HAS has a maximum of 75 days to issue an opinion on the request, based on the criteria defined in the Social Security Code (CSS). The opinion is reasoned and published on the HAS website. It is also addressed to the applicant and to the Ministers of Health and Social Security.
- The second sequence is the decision on the implementation of innovation funding by the Ministry of Health. This sequence also involves two steps: conducting the budget analysis and deciding whether to grant exceptional funding or not. The Ministry of Health has another 75 days to make a decision on the innovation funding, taking into account the opinion of HAS, the budget estimate, and the overall cost of the study. The decision is notified to the applicant and to HAS.
If the innovation funding is granted, the technology developer must sign a contract with the Ministry of Health, specifying the terms and conditions of the funding, such as the amount, the duration, the protocol, and the objectives of the study. The technology developer must also report regularly on the progress and results of the study and submit a final report at the end of the funding period. The study must provide evidence of the clinical or medico-economic benefit of the technology, as well as its safety, quality, and performance. Based on the study results, the technology developer can apply for the inclusion of the technology in the mainstream reimbursement schemes, such as the LPPR, CCAM, NABM, or NGAP nomenclatures.
What are the Benefits of Innovation Funding?
Innovation funding is a win-win situation for all the stakeholders involved: the technology developers, the health authorities, the healthcare professionals, and the patients.
- For the technology developers, innovation funding is a valuable opportunity to accelerate the development and adoption of their technologies, while reducing the financial risk and uncertainty associated with the market access process. Innovation funding also provides them with feedback and data from the real-world use of their technologies, which can help them improve their products and services, as well as prepare for the subsequent reimbursement applications.
- For the health authorities, innovation funding is a way to foster innovation and competitiveness in the healthcare sector, while ensuring the quality, safety, and efficiency of the technologies funded. Innovation funding also allows them to anticipate the impact of the technologies on the health system and the public budget, and to adjust the reimbursement policies accordingly.
- For the healthcare professionals, innovation funding is a source of professional development and satisfaction, as it enables them to access and use the latest technologies in their practice, and to participate in the evaluation and improvement of the technologies. Innovation funding also enhances the quality of care and the patient outcomes, as well as the collaboration and communication among the healthcare professionals involved in the innovation funding projects.
- For the patients, innovation funding is a benefit for their health and well-being, as it gives them access to new and better technologies that can improve their diagnosis, treatment, and follow-up. Innovation funding also empowers them to be more involved in their care and to contribute to the innovation process, by providing their feedback and preferences on the technologies.
Some Examples of Innovation Funding in France
In December 2021, there were 120 innovation funding projects in France, covering various fields of healthcare, such as cardiology, neurology, oncology, orthopaedics, and telemedicine. Here are some examples of innovation funding projects that illustrate the diversity and potential of this scheme:
- CardioMEMS HF System: This is a wireless sensor that is implanted in the pulmonary artery of patients with heart failure, and that transmits real-time data on the pulmonary artery pressure to a remote monitoring system. The innovation funding project aims to evaluate the impact of this technology on the hospitalization rate, the quality of life, and the mortality of the patients, as well as on the cost-effectiveness of the care pathway.
- NeuroAD: This is a non-invasive device that combines transcranial magnetic stimulation and cognitive training to treat patients with mild to moderate Alzheimer’s disease. The innovation funding project aims to assess the efficacy and safety of this technology on the cognitive functions, the functional autonomy, and the quality of life of the patients, as well as on the burden and satisfaction of the caregivers.
- ExactVu: This is a high-resolution micro-ultrasound system that allows the detection and characterization of prostate lesions, and the guidance of prostate biopsies. The innovation funding project aims to compare this technology with the standard of care, which is the multiparametric magnetic resonance imaging (mpMRI), in terms of diagnostic accuracy, patient comfort, and cost-effectiveness.
- [SpineJack]: This is a titanium implant that is inserted into the vertebral body of patients with vertebral compression fractures, and that restores the height and shape of the vertebra. The innovation funding project aims to measure the clinical and medico-economic benefits of this technology, compared to the conventional treatment, which is the balloon kyphoplasty.
- [Diabeo]: This is a smartphone application that provides personalized recommendations on insulin doses for patients with type 1 or type 2 diabetes, based on their blood glucose levels, their carbohydrate intake, and their physical activity. The innovation funding project aims to evaluate the impact of this technology on the glycemic control, the quality of life, and the complications of the patients, as well as on the health expenditure.
Conclusion
France is a pioneer and a leader in supporting innovation in healthcare technologies, thanks to its innovation funding scheme, which bridges the gap between research and market, and benefits all the stakeholders involved. Innovation funding is a key driver of the French Biotech and MedTech ecosystem, and a model for other countries to follow.