For several decades, our health policy has faced a major difficulty: containing the growth in drug spending while guaranteeing rapid access to innovative treatments, which are the most expensive.
French regulation has long made it possible to curb price increases, unlike in the United States. Indeed, American price negotiations are not conditional on an evaluation of their efficiency. In France, the systematic evaluation of drugs, the level of proof required to demonstrate their benefits, and the harshness of negotiations between the authorities and manufacturers lead to prices much lower than American prices. For example, the price of treatments for cholesterol and asthma are four to five times cheaper in France than in the United States.
But if low prices allow Health Insurance to finance universal access to care, they reduce the attractiveness of the French market. Thus, innovative drugs are marketed primarily in the United States, and often for a minimum period of one year, before being launched on other world markets.
Regulation of drug prices
Two reasons lead us to believe that the situation could deteriorate following the American presidential elections. On the one hand, one of the main arguments of candidate Biden’s campaign is based on the implementation of the Inflation Reduction Act, one of the objectives of which is to reduce the price of the most expensive drugs. This new regulation introduces for the first time the principle of price negotiations at the federal level for drugs reimbursed by Medicare.
On the other hand, the election of Donald Trump could also impact American price regulation. We remember that in 2018 his administration considered that European patients were the “free riders” in financing global innovation, because they paid much less for innovative medicines than American patients.
Therefore, whatever the outcome of the American election, the trend is towards falling prices on the American market. A drop in American prices will make negotiations on the European market more difficult, and could lead manufacturers to consider launching their products as a priority on more buoyant markets, such as the Chinese market. We are therefore facing an important economic question, but also a major public health issue, which must be anticipated.
Data and joint assessment
Two avenues deserve to be explored, at the national and European levels. Firstly, increased use of real-life data, that is to say collected outside of clinical trials, must provide us with new solutions. This data could feed into the initial price setting and allow for more rapid reassessments. The implementation of these developments requires an effort to collect and use data which has not yet been carried out on a sufficient scale. This development will allow us to reopen reflection on the link between the use of real-life data and the valorization of the product during its marketing.
Secondly, harmonization of the conditions of access to the European market could make it more attractive because it is more transparent. The European Union introduced the principle of joint evaluation of medicines in 2022, relying on cooperation between health technology assessment agencies from different countries. This measure should make it possible to standardize future market access conditions in all European countries.
In the future, the sustainability of our health system will depend on our ability to facilitate market access for innovations, while conditioning their prices on a value demonstrated by both clinical trial and life-use data. real.
Thomas Rapp is professor of economics and holder of the AgingUP! at Paris Cité University.
Maurice Pierre Planel is an associate professor at the Fontainebleau Institute of Political Studies and former president of the Economic Committee for Health Products.