France is losing ground in Europe in terms of competitiveness and ability to innovate in the health industries. A cumbersome and highly regulated system explains investors’ caution.
- France has lost the latter of its competitiveness in the health industries in Europe
- The price regulation system and marketing procedures are barriers to investment
“To place the country in a dynamic of global growth”. This was the objective put forward by Edouard Philippe, Prime Minister, during the 8th Strategic Council of Health Industries on July 10, 2018. An ambition to respond to a worrying situation: “In many strategic areas (patient access to medicines, taxation of the sector, regulatory instability, France is losing ground against these European competitors”, notes the LEEM (the union of the pharmaceutical industry) in 2020. A finding based on figures which show that in this area our country has registered in 2019 almost zero growth (+ 0.5%) and especially between 2010 and 2015 a significant drop in productive investments (-4.5%) Performance much lower than that achieved by several of our European neighbors such as the United Kingdom , Spain, Italy and Germany.
France does not lack assets
And yet, France does not lack assets for its health industries to meet the new needs linked to the aging of the population and the development of chronic diseases: the health industries are more than 3,000 companies, large structures international to SMEs, ETIs and start-ups, 400 production sites which allow the pharmaceutical sector to be the 4th largest exporter behind aeronautics and the automobile by generating a surplus of 3.3 billion euros and , above all, more than 7 billion per year devoted to research and development in medicines and medical devices, which place the country in first place in Europe for public investments in health.
“We have tremendous know-how in France and our fundamental research in pharmacy is of a very high standard, confirms Jean-Jacques Zambrowski, doctor and health economist, but despite the quality of our research and our teams, this sector is the victim of a real poverty of incentives!”.
The weight of our social system
At a time when research is advancing rapidly towards innovative treatments based on genetics, stem cells, predictive biomarkers and in the field of medical robotics, what are the brakes that penalize France’s competitiveness? “Lack of prospects due to the lack of a forecasting system capable of detecting in advance innovative drugs likely to modify the supply of care and impact public finances, lack of visibility on a long-term drug policy with a framework appropriate funding and lack of consistency between industrial policy objectives and regulatory policies”, points out the LEEM.
But for Jean-Jacques Zambrowski, the problem is broader. “The weight of our social system crossed with the free movement of goods in Europe is obviously a deterrent in the eyes of industrialists who prefer to turn for their investments to countries like Ireland which put the health industry at the heart of their development. “, he analyzes.
Penalizing drug price regulation
“And then, above all, the state of mind that governs in France the fixing of drug prices is also very penalizing”, affirms for his part Jean-Jacques Zambrowski who denounces a regulatory system which “brings 50% of the savings to be made on the drug”. “When the CEPS (Economic Committee for Health Products) gives a price that is too low for a medicine, this does not encourage manufacturers to invest in France!”, He adds.
So many flaws that had to be filled by the “program” announced during the CSIS of July 10, 2018. With the red thread of better access to patient care, a revival of clinical research and new regulatory rules.
The decisions that were made that day concern first and foremost the strengthening of patient access to innovative treatments. While it is often necessary to wait more than 500 days -530 days on average, according to LEEM data- before these treatments, after their marketing authorization, see their price published in the official journal, which mark the real access of patients to the product, the government has set the objective of reducing this period to 180 days – which would bring France into compliance with the European directive on this subject – by 2022. The other commitment on access to innovation concerns the ATU system (temporary authorization for use). This makes it possible to deliver drugs before publication of the price in the OJ but currently only for their first indication. To better take into account clinical developments, particularly in oncology, the objective is to extend this system to extensions of therapeutic indications.
A return on research investment
What is the link between these measures and France’s competitiveness in medicines? Greater flexibility in bringing innovation to market and, in fact, an assurance for the industry of having a faster and less hypothetical return on its investments in research. It is the same objective that is pursued with the commitment to speed up the authorization procedures for clinical trials, the creation of the Health Data Club which should optimize the use of health data or the development of a excellence in the field of biotechnology and advanced therapy drugs.
For Jean-Jacques Zambrowski, “these promises were going in the right direction… but what happened? We are still a little hungry!”. And this connoisseur of the world of health has few illusions about the sequence of events: “Social security, which imposes savings based too heavily on medicine, is not going well… and it is not not the health crisis we are going through that will help!”.
According to him, the real solutions are to be sought, beyond the respect of the commitments made by the government during the CSIS of July 2018, in a new look at the finances of the “payer” that is Health Insurance. “Other sources of savings exist, let’s look at what is happening on the side of social fraud, let’s see what is the share of certain actors such as medical transport in the accounts of the Secu…!”, Suggests- he.
“A policy of deterrence”
This difficulty of France to regain its competitiveness in the health industries is however a quasi-emergency. The subject was very clearly mentioned by the President of the Republic, Emmanuel Macron, from the start of the coronavirus crisis: France must necessarily find its place in order to ensure its autonomy in its capacity to take charge of the health of all. . The shortages of certain products essential for healthcare during the acute phase of the Covid-19 epidemic have illustrated all too well the very concrete consequences of the decline in our country’s competitiveness. “We have real strengths in this area, but we must get out of what we can call a policy of deterrence!”, concludes Jean-Jacques Zambrowski.
This topic was created from the LEEM file “100 questions about medicine”
Find below the file on the theme “Competitiveness: is France still in the race of innovative nations?”
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