Early Access Programmes in Portugal: INFARMED Data 2017-2026

How many early access programmes (PAP) does INFARMED approve in Portugal, for which diseases, and why are requests refused? We analysed every decision in INFARMED’s official PAP list, from December 2017 to February 2026.

Key figures

• 170 decisions on PAP requests between December 2017 and February 2026.
• 122 approved (72%), 40 refused (24%) and 8 classified as not applicable.
• 2025 was a record year: 48 decisions, more than double the 23 of 2024.
• 1,190 patients in the 112 approved programmes that report a number, with a median of 6 patients per programme.
• 108 of the approved programmes are listed as active with costs, and 12 as active without costs.
• About 4 in 10 decisions concern oncology and haemato-oncology (our classification of the indications).

Decisions per year

2026 includes only one decision, up to the last update of the list on 19 March 2026.

Why requests are refused

In 35 of the 40 refusals, INFARMED considered that the clinical situation did not fall within the legal exception of article 25 of Decree-Law no. 97/2015, which requires, among other conditions, the absence of a satisfactory therapeutic alternative. The share of refusals rose in 2025, to 15 of 48 decisions.

Who pays

Under INFARMED Deliberation no. 80/CD/2017, medicines in a PAP are, as a rule, supplied free of charge to the National Health Service, with a limit on the free period for authorised medicines awaiting the prior assessment. After that period, supply conditions are agreed with INFARMED. This is why most active programmes in the list are marked “with costs”. For companies, early access is a real launch cost that should be planned. See our guide to budget impact analysis in Portugal.

What this means for companies

• Early access is used a lot, but it is not automatic: one in four requests is refused, mostly because the case does not meet the legal exception.
• Oncology dominates, which reflects both the pipeline and the unmet need in advanced disease.
• Programmes are small, usually a few patients each, so they complement rather than replace a funding decision.

Method and source

Source: INFARMED, list of early access programmes (Lista dos PAP), file last updated on 19 March 2026 and downloaded on 29 September 2026. Figures are counted directly from the list. “Other” groups the decisions recorded as not applicable. The grouping by therapeutic area is our own, based on keywords in the approved indication, and is approximate.

You may reuse these figures, citing Clevidence with a link to this page.

Read more in our practical guide to market access in Portugal, our article on the new SiNATS, or learn about our HTA and market access services.