When it comes to shortages or tight supplies of medicines, this almost always only concerns specialties prescribed and dispensed on a daily basis. Mature drugs, which have fallen into the public domain and whose price is very low. “Over the last decade, an average of 950 million euros in price reduction savings per year has been imposed on mature drugs, which is considerable, recalls Éric Baseilhac, president of the Association for the Good Use of Medicines (ABUM), director of economic and international affairs at Leem (Medicine Companies) and member of the Academy of Pharmacy. This price has a regulatory function and it is the second lever by which we are today seeking to make savings in terms of spending on medicines, after discounts and before the safeguard clause comes into play. Acting on volumes, although an extremely important issue, is today the poor relation of this regulation,” he summarizes during the bi-academic session (Medicine, Pharmacy)*, organized on November 20. During the same session, Jean-Patrick Sales, vice-president of the Economic Committee for Health Products (CEPS), warned: “If price reductions on mature drugs are to gain momentum with regard to sustainability, they will have to be extended to less mature products. »
However, this French obsession with price reductions, regularly denounced by manufacturers as well as by representatives of health professionals, seems to have reached its limits today. “This price regulation mechanism is now outdated, Judge Éric Baseilhac. For years, innovation was financed by regulating the prices of mature products and losing patents. This worked very well for years but not anymore. It has no longer been effective since 2014, the year of the arrival of new treatments against hepatitis C, an event which inaugurates a historic dynamic of return to pharmaceutical innovation, with the production of new molecules. analyzes the president of ABUM. As Éric Baseilhac observes, this policy today has deleterious effects, both in terms of supply and in terms of sovereignty. It is time to use other methods to sustainably regulate the price of medicines: “increases and no longer decreases in prices, a reflection on the establishment of floor prices, but also alternative savings methods, in particular good use and prevention”, he suggests.
On the industrial side, several other factors, in addition to regulatory policies on drug prices, explain why French and European pharmaceutical production is in difficulty. Causes that Philippe Truelle, vice-president of the Association of Laboratories and Health Industries (AMLIS), is trying to identify. “The Covid-19 pandemic has forced manufacturers to quickly produce vaccines to the detriment of other products, even if the situation tends to return to normal. We have a workforce problem with a pharmaceutical industry that is struggling to attract. We must face the surge in energy costs, multiplied by 3 between 2021 and 2023, security and environmental constraints which are not the same here in Europe as elsewhere, the increase in the safeguard clause… We are facing a significant challenge and we will only be able to achieve this if we coordinate at European level,” he judges.
Protectionism, competitiveness or both?
Proof of the decline of the Old Contain in terms of pharmaceutical production: “Manufacturers of active ingredients in Europe are disappearing. The fall is dizzying, there is massive disinvestment, alerts Vincent Touraille, president of the fine chemicals and biotech industries union (SICOS). A short circuit of active ingredients is the best way to avoid shortages. In 2014, Europe produced 48% of active ingredients globally, this rate increased to 30% in 2023 and it is decreasing every day. he laments.
If this picture is not encouraging, we will have to look for solutions to encourage the relocation of the production of medicines in Europe, insists Éric Baseilhac. “We have to find an economic model. Either we assume a model, in Europe, with more expensive production and therefore higher prices, which would then require a protectionist model. Either we try to play the role of competitiveness, through technological innovation in production, to try to compete with countries like China or India. » Protectionism or competitiveness, if it wants to get things back on track, Europe may not have to be content with choosing one of these two options. “We absolutely have to have both sides, we have no other solution,” says Bruno Bonnemain, honorary president of the Academy of Pharmacy.
The price of innovation or hope?
There is also the question of the price of innovative medicines, which increasingly weighs on health spending. “The share of innovative medicines, that is to say medicines which have a high improvement in actual benefit (ASMR between I and III), increased from 20% of expenditure in 2017 to 26% in 2022”, observed Thomas Fatôme, general director of the national health insurance fund during the presentation of the figures for reimbursement of medicines on November 14. A dynamic of innovation to put into perspective with the drop in expenses linked to old medicines (MA before 2004) or generics: from 53% in 2017, they represent 41% of the amounts of medicines reimbursed in 2022. This is explained by a price effect (innovative drugs are more expensive), a volume effect (aging of the population and chronicization of treatments) and above all a structural effect with the increasing deviation of medical prescriptions to the newest and most expensive drugs. Innovative and expensive medicines that pharmacies are seeing increasingly arrive at pharmacies, but which are eating into their margins.
Behind the price of the innovative medicine, “the industrialist has three ideas in mind, explains Éric Baseilhac: amortize the cost of research and development, finance production costs, invest in innovation so that therapeutic progress can continue. » However, the cost of each item is much higher for biotherapies than for traditional chemical drugs. “When you have an overall development success rate of 11%, you can imagine the amount of money that must be invested initially to produce a drug that will be marketed,” sums up the industrialist.
But what do we pay for in the end? “A health supplement, crudely evaluated through ASMR, replies the vice-president of CEPS. Perhaps we need to refine it with medico-economic data? It’s in development. » For Professor Gilles Bouvenot of the National Academy of Medicine: “We pay far too much for hope, more than for concrete results. Many marketing authorizations granted both across the Atlantic and in Europe mean that X years later, and in almost 50% of cases, it has not been possible to really demonstrate the effectiveness of the product. »
Thinking of new models
“The nation also wants a return on investment,” underlines Francis Megerlin, professor of pharmaceutical sciences and other health products at the University of Strasbourg and member of the National Academy of Pharmacy. The new post-MA contract approaches aim to share economic risks between the paying organization and the industry, and are based on real-life data: “Satisfied or refunded”; “Payment if successful”, Italian doctrine which consists of advancing the products in kind and if they are effective, the buyer pays the manufacturer; “Payment while success”, supported by the Social Security Financing Law (LFSS) for 2023, lists the academician. For the latter, “the unit of account is 1 million euros, he continues. The price is justified by the expected forms of savings that would result from the accumulation of costs necessary to care for the patient until the end of his life. But how are we going to do it? Payments will be spread out, and we pay as long as it works. »
Plus simple, “since 2022, the law has made it possible to promote local roots by revaluing the price set by social security, but this revaluation is still not practiced”, recalled Isabelle Van Rycke, president and CEO of UPSA, in the press. His laboratory, however, concluded with the government a price freeze for two years on its paracetamol-based specialties, Dafalgan and EfferalganMed, while it launches into the production in France of two essential drugs, not yet defined. A deal to say the least unprecedented.
*“Too expensive or not expensive enough: the price of the drugs in question”
