Measures for the Revision of Medicinal Products’ Prices in 2025

On November 15, 2024, Ordinance No. 293/2024/1 was published, which, as happens annually, redefines the reference countries for the annual price review (“RAP”) of medicines for 2025.

In this context, the reference countries defined are: Spain, France, Italy, and Belgium. We note that this Ordinance thus marks a change to be considered, as Slovenia (which had been a reference country since 2020) is replaced by Belgium.

Additionally, considering the medicinal products’ shortages that have been experienced (both nationally and internationally) and to avoid a significant decrease in the prices of medicinal products, the Ordinance also established exceptional criteria for the RAP 2025, similar to those already established for 2024. Below, we include a summary of these criteria:

• Outpatient Market

In the case of the outpatient market, the prices of all medicinal products with a maximum retail price (MRP) of up to €16 (inclusive) can be increased by 2.6% and will be exempt from RAP in 2025.

The remaining medicinal products, i.e. medicinal products with a maximum MRP of more than €16 will continue to be subject to RAP, as was the case in 2024. In addition, the revision of these prices continues to benefit from a cap mechanism, which limits a possible price reduction resulting from the RAP of 2025:

1. For medicinal products with an MRP above 16 euros and up to 30 euros (inclusive), the price cannot be reduced by more than 5%.
2. For medicinal products with an MRP above 30 euros, the price cannot be reduced by more than 10%.

• Hospital Market

In the case of the hospital market, all medicinal products with a maximum acquisition price of up to 75 euros (inclusive) are exempt from RAP.

In 2024, the exempted hospital medicinal products only concerned those with an acquisition price equal to or below 15 euros, which means this measure significantly expands the hospital market medicinal products exempt from RAP in 2025.

The remaining medicinal products, i.e., those with an acquisition price above 75 euros, will continue to be subject to RAP and will also continue to benefit from a cap mechanism, which prevents the price reduction resulting from the RAP 2025 from exceeding 5%.

• Generic and Biosimilar Medicines

Finally, regarding generic and biosimilar medicines, they continue to benefit from exceptional measures similar to those already applicable in 2024, namely:

1. On the one hand, medicinal products with an MRP of up to 16 euros (inclusive) can be increased by 2.6%.
2. On the other hand, all generic and biosimilar medicinal products remain exempt from RAP in 2025, except when (i) they have an MRP of up to 16 euros (inclusive) and (ii) their price is higher than the MRP of the reference medicinal products (as resulting from the increase or RAP of 2025)

Once again, in accordance with the general regime, these measures seek to safeguard the sustainability of the system and, likewise, ensure that generic and biosimilar medicinal products do not have an MRP higher than the respective reference medicinal product.

Regarding the impact of these criteria on the industry and without prejudice to the considerations mentioned above, we highlight that this regime took effect on November 16, 2024.

Indeed, marketing authorization holders must ensure that they establish and communicate the new prices of their respective medicinal products to Infarmed, taking into account the exceptional criteria mentioned above, within the following deadlines:

1. Non-generic and non-biosimilar medicines: by December 15, 2025, with the new prices taking effect on January 1, 2025;
2. Generic and biosimilar medicines: by January 15, 2025, with the new prices taking effect on February 1, 2025.

As a final note and in summary, we emphasize that these measures highlight a governmental trend in Portugal to annually approve “exceptional” measures to mitigate the effects of the price reduction of medicinal products resulting from the general price review regime applicable to medicinal products.

Thus, this trend and the periodicity of these measures, which are recognized as useful for the pharmaceutical industry, raise a question: is it time to rethink the medicinal products’ pricing regime in Portugal?