In October, the draft law on the financing of social security PLFSS 2023 achieved a feat: to unite all pharmaceutical companies in France against it. With the France 2030 Health Innovation plan announced in June 2021 by Emmanuel Macron, the country’s politics seemed to take a 180 degree turn. The desire to attract investment by claiming that France was returning to being fertile ground for inventing and producing innovative medicines lasted a year before the health administration returned to impose budget cuts. After this cold shower, the government corrected the situation by retouching or abandoning the most controversial articles. But also this year, like the others, drug prices must fall by 800 million euros despite inflation that is melting margins. Especially with the safeguard clause that laboratories consider a tax of 2.4 billion euros in 2023 on the pharmaceutical industry. And while some large labs are still doing very well with record profits, others are wondering if they will continue to produce capsules at French prices. Will France finally be able to break away from its lack of pharmaceutical appeal?
Chronic lack of attractiveness
For twenty years, our drug policy has discouraged Big Pharma from investing. From the discovery of a new treatment to its commercialization, our country lags far behind the performance of our European neighbors. With more authority and complex procedures, a new treatment takes three times longer than in Germany to reach the market! And when it does, it’s cheaper than most of our northern European neighbors. Suddenly, labs exfiltrate manufacturing to low-cost countries to maintain their margins.
If France was a pioneer in the drug market, today it aligns five handicaps: delayed research, little growth for laboratories, bargain price negotiations, complex regulations and delays in accessing the extended market. The two years of health crisis have shown it well, all these defects lead to the absence of a single anti-covid vaccine formulated in our country and of antibodies against the coronavirus that are not French.
Awareness and innovation plan
Faced with this rampant deindustrialization and our difficulty in accessing health innovations, we had to act as quickly as possible. This is why in June 2021 the Strategic Council for Health Industries (CSIS) listed a series of measures adopted by Emmanuel Macron in the Health Innovation 2030 plan. The program: restore the attractiveness and competitiveness of our country to make France the first innovative and sovereign European nation in health, by 2030. An ambition that requires a serious revision of the research and development ecosystem. But an ambition that may still seem realistic as the country, despite its handicaps, remains in fourth place in Europe behind Switzerland, Germany and Italy. With its announced investments of € 7.5 billion, the June 2021 plan has boosted momentum. Among the planned investments: clusters, R&D credits and a health innovation agency capable of seriously improving our attractiveness.
Read the interview hereOlivier Laureau, President of Servier
A return of inspiration
The general manager of the union of pharmaceutical companies, Leem, Philippe Lamoureux, was delighted at the time. ” The government shares the observation of the CSIS, drug policy has come to the end of a system. Our regulatory mechanisms as well as our lack of funds prevent France from achieving its goals. “As soon as it was announced, the plan strengthened the confidence of the laboratories. Pierre Fabre relocated part of its production to the southwest, Servier opened a new production unit in Normandy, IPSEN relocated the production of a medicine and the French biotechnology group LFB is building a new plant in Pas-de-Calais, not forgetting the new generation vaccine production site announced by Sanofi in the Lyon region, nor the investments of foreign laboratories such as Merck or Lilly. wave of “drug” dynamism that we haven’t seen in France for some time.
But application times too slow
But even with these good intentions, France seems to have difficulty in realizing the announcements to exit the display policy. It is true that the first measures have been taken, as justified by numerous decrees implementing the Innovation Plan, which are still pending. ” Furthermore, the reform of direct access to the market for innovative medicines is not yet effective: it is expected by the end of the year. “, Explains Didier Véron, president of the G5 Santé, which brings together the leaders of the eight main French healthcare companies. Another long overdue benefit is the “made in France” bonus. ” The price of drugs should take into account the location of manufacturing sites in order to promote locally manufactured treatmentssays Didier Veron. But we are still awaiting the implementation of the measure, the committee (CEPS) that sets the price of health products should finalize its doctrine on the subject by the end of the year.. “
At the end of October, the Ministerial Steering Committee “Health” France 2030 presented the progress of the health innovation plan. As indicated, direct market access for innovative medicines is expected by the end of the year. The first wave of the biocluster call has been closed and the winners are expected to be announced shortly before a second wave. In this review, € 230 million is announced for various research programs, especially around biotherapies. Finally, the Health Innovation Agency was formally launched. It will lead the implementation of the France 2030 health component in collaboration with the ministries and stakeholders involved. It will coordinate work on health forecasting and “propose simplifications of existing processes to accelerate them by identifying priority use cases”. Dr. Lise Alter has just been appointed to lead her.
Another promising measure but included in PLFSS 2023: a new funding model for innovative therapeutic drugs that require administration only. These treatments, often derived from gene therapy, have staggering prices that are hard for health insurance to bear. The latest record to date: $ 3 million injection for American biotechnology Bluebird’s Skysona against a rare genetic disease. For these treatments that should completely cure the patient, the management will distribute the payments to the laboratory and a performance contract will result in the suspension of the discipline in case of lack of efficacy.
Towards a new drug policy
For Cédric Moreau, partner of Sofinova Partners, the recipes of Health Innovation are well known: ” Unique procedures and prices 3 to 4 times higher than those at home, as practiced in the United States. In Europe we are not yet centralized enough, the European Medicines Agency has not harmonized all processes. In this fertile ground, the best ideas of our young biotechnological talents struggle to grow and then turn into unicorns, only some e-health champions manage to emerge internationally, the most recent authorization rules seem to be more suitable. According to the co-founder and CEO of Truffle Capital, the ground is slowly improving. “Investments are more numerous but the surface area of Euronext is 10 to 15 times less than that of Nasdaq. What is the point of being a “start-up nation” if we are not able to retain and develop our young innovative shots ? Furthermore, Philippe Pouletty points out the delay of our academic research. ” If we want to stimulate it, we make the National Research Agency the main vehicle for financing projects. This will multiply its budget by four to reach € 5 billion. And it will be able to focus these credits on labs that prepare real innovations, like in the United States. As long as our academic research remains governed by the administration, it will remain diluted and ineffective.. “
A delay in research that seems also linked to the lack of scientific culture among the new generations. It’s hard to dream of a career in biotech mode. ” Innovation starts with young talents who develop in middle and high schools before our system supports their revolutionary inventionsbelieves Fabrice André, research director at Gustave Roussy. There is a cultural issue in our time and in our country, with a real lack of appetite for science. Germany, the Netherlands and Great Britain have returned to a culture of innovation in their education system, but not in France. Fortunately, our workshops bring together young talents from South America, Eastern Europe and Italy “. Funding and risk appetite, a culture of science and engineering, simplification of lengthy administrative procedures and an end to systematic dispersion, the France 2030 Health Innovation program has many challenges to address.
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to know more
Follow this Tuesday 8 November 2022 on latribune.fr our Health Innovation Forum organized in Lyon.
The program here.
https://forum-sante-innovation.fr/
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