Early this year, the Portuguese Minister of Health stated the public expense with medicines in 2022 showed an increase of more than EUR 300 million compared to 2021. Commenting on the constant rise in the National Health System’s (NHS) expenditure with medicines, the Minister was adamant that Portugal cannot increase its expenditure on medicines by 10% a year.

Whilst 2022 data is still not fully ascertainable, it is safe to conclude that NHS’ expenditure with medicines has been growing since 2014, the biggest rise having occurred in 2019 (compared to 2018) and 2021 (compared to 2020). Available numbers are overwhelming, especially when the total expenditure in 1990 (EUR 305.9 million) is compared with 2021 (EUR 1.430.3 million).

Collected data from 2021 shows the total NHS expenditure with medicines that year concerned 167.8 million dispensed packages, reflected an increase of 0.7% in the average price per package of medicines, a total increase of EUR 70.9M in the NHS expenditure and an additional 6.7 million packages of medicines sold, all in comparison with 2020.

Given this context and following several public statements on the affordability of medicines and the financial sustainability of the NHS that go back to the second semester of 2022, the Minister of Health established, in Ordinance no. 35/2023, of 26 January, a mechanism for identifying overpriced medicines, which can lead to a downward revision of their price.

Pursuant to Article 7 of Ordinance no. 35/2023, the prices of medicines may be extraordinarily revised, by decision of the member of the Government responsible for the area of health, on the grounds of their excessive cost to the NHS, namely when resulting from a high and unexpected growth rate and share in NHS expenditure.

Criteria for determining the excessive cost for the NHS shall be defined in the future and shall consider, notably:

• the average daily treatment cost calculated on the basis of the defined daily dose approved annually by the World Health Organization, or the average daily dose when a defined daily dose has not been approved, of medicines that are already reimbursed within the NHS, which are not generic medicines and have the same therapeutic indications and belong to the same therapeutic group and subgroup, as contained in the summary of the characteristics of the approved medicine; and
• the maximum price of medicines with the same active substance or identical combination of medicines, in the same pharmaceutical form, dosage and presentation, and with at least 10% market share in the NHS, referring to the previous year.

Ordinance no. 35/2023, of 26 January