New price revision rules for 2026 aim to strengthen the protection of essential medicinal products and prevent price erosion
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SubscribeOn November 14, 2025, Ordinance 394/2025/1 of November 14 (the “Ordinance”) was published, defining reference countries and exceptional criteria for the annual review of medicinal product prices. which will apply to 2026.
As in previous years, these measures are designed to prevent price erosion of essential and low-cost medicinal products in a context marked by persistent challenges related to medicinal product shortages.
Reference countries
For the purposes of price authorizations and annual price reviews applicable in 2026, the reference countries defined for 2025 remain unchanged: Spain, France, Italy, and Belgium.
Exceptional rules of the 2026 annual price review
The Ordinance introduces significant adjustments for the sector. These adjustments follow methodologies from prior years and distinguish between medicinal products: (i) excluded from the annual review; and (ii) subject to review but with reduced limits on price reductions.
Thus, we highlight the following:
In 2026, the following Medicinal products are excluded from the annual price review in 2026:
- Non-generic and non-biosimilar medicinal products dispensed in the outpatient market, with a maximum retail price of €30 or less.
- Non-generic and non-biosimilar medicinal products dispensed in the hospital market, with a maximum price for National Health Service (“NHS”) procurement of €75 or less.
- Essential medicinal products of critical importance (as listed in Ordinance 235/2023) and dispensed in the outpatient market.
- Generic and biosimilar medicinal products in both the outpatient and hospital markets.
Exception: If the maximum price of a generic medicinal product exceeds that of its corresponding reference medicinal product after the 2026 annual review, its price must be adjusted so as not to exceed that value. Whether this rule also applies to biosimilar medicinal products is yet to be confirmed.
In other cases, the medicinal products remain subject to annual review However, specific limits are introduced for the ambulatory market:
- Non-generic, and non-biosimilar medicinal products dispensed in the outpatient market with a maximum retail price exceeding €30 cannot experience a price reduction of more than 20%.
Compared to 2025, exemptions from annual review, alongside limits on price decreases (with slight variations), have been maintained for outpatient market products that are non-generic and non-biosimilar. However, it is notable that permission to raise prices has been eliminated.
For hospital medicinal products that are non-generic and non-biosimilar, exemptions from annual review persist where the maximum NHS procurement price does not exceed €75. However, in 2026, reductions beyond this threshold will no longer be exempt, which may lead to more substantial downward price revisions.
Deadlines for submitting revised prices
- Non-generic and non-biosimilar medicinal products: Maximum prices must be communicated to Infarmed by December 15, 2025. These prices will take effect on January 1, 2026.
- Generic and biosimilar medicinal products: Maximum prices must be communicated to Infarmed by January 15, 2025. These prices will also take effect on January 1, 2026.
Impact and protection for the industry
The government asserts that these measures offer significant protection for the industry, particularly for low-priced, essential or critical medicinal products, preventing automatic reductions that could compromise profitability or supply continuity.
For hospital-exclusive innovative medicinal products, which may face substantial price reductions, this safeguard appears to be aimed more at promoting NHS sustainability; however, further developments in this area remain to be seen.
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