Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals.
In January 2023, Prime Minister Elisabeth Borne launched a mission on the regulation of healthcare products. The report, crucial for the overall pharmaceutical industry, has finally been published. However, the conclusions leave all those involved at a loss.
Safeguard Clause: A Lack of Concrete Measures
Eagerly awaited, in particular by pharmaceutical companies marketing low-cost pharmaceutical products, the recommendations on the safeguard clause have proven to be a disappointment. Not only has there been no concrete proposal for an adjustment of the contribution rate for these companies, but innovators are no better off. The only step forward, a recommendation for a reduction of the safeguard clause to 500 million euros, is being made alongside price decreases and measures to control medical costs.
Biosimilars: No Major Breakthroughs
With regard to biosimilars, the mission suggests extending the list of substitutable groups, but does not recommend introducing direct billing (“tiers-payant”). An increase of the price reduction for biosimilars has been proposed, but no measures are in place to simplify the registration process.
Rebates on Generics: Overstated estimates
One of the report’s most controversial recommendations is the reduction of the maximum generic rebates rate from 40% to 20%. The impact of this measure on the French Health Insurance seems to be overestimated by the mission. This proposal has already met with strong opposition from pharmacists and is unlikely to be included in the Social Security Financing Law Project for 2024.
Towards Volume-based Regulation
In conclusion, the Borne mission favors regulation by volumes rather than by prices, without making any concrete proposals to reach the objectives set by the Prime Minister.
All in all, one is left with the impression of half-hearted and piecemeal measures which fail to meet the expectations and challenges of the pharmaceutical industry. Opportunities for dynamic regulation seem to have been missed.
Next steps
We are currently waiting to see whether these measures will be reflected in the 2024 Social Security Financing Law Project, which the entire industry is eagerly awaiting, given the importance of financing therapeutic innovation in France.
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