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[HEALTH] · France, Germany · 4 sources

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Pharmaceutical industry faces regulatory shifts in France and Germany

In France, the drug regulatory agency ANSM is investigating whether the shelf life of 73 frequently used medications can be extended. Fourteen pharmaceutical companies are participating in this five-year program. For 47 of these preparations, the approved shelf life could potentially increase to at least four years, up from the current maximum of three years. The initiative follows the PERIMED study, which found that 7,675 tons of unused medications were collected in French pharmacies in 2024, many of which had not yet expired. The goal is to reduce waste caused by factors such as large pack sizes and short expiration dates.

In Germany, the pharmaceutical industry is facing regulatory challenges due to the Contribution Rate Stabilization Act (BStabG). Starting January 1, 2027, manufacturer rebates are set to increase from 7 percent to 15.5 percent. In response, the Federal Association of the Pharmaceutical Industry (BPI) has proposed a “location clause” to a newly formed commission. The BPI suggests that companies making verifiable investments to secure, modernize, or diversify production and supply chains in Germany should be eligible for exemptions from the increased rebate to protect the country's pharmaceutical manufacturing base.

Entities

ANSM · Assurance Maladie · BPI · Cyclamed