Clinical Trial Volunteers in Portugal Keep Getting Their Medicine Free After the Study Ends, Until the SNS Can Supply It, Under an Ordinance in Force From Saturday

People who take part in a clinical trial in Portugal and still need the medicine when their part of the study ends must go on receiving it free of charge from the company running the trial, under rules that take effect on Saturday 24 October. Portaria n.º 465/2026/1 (ministerial ordinance), signed by the Secretary of State for Health, Ana Povo, was published in today's Diário da República (official gazette).

The ordinance fills in Article 14 of Lei n.º 9/2026 (Law 9/2026, of 6 March), which applies the EU Clinical Trials Regulation 536/2014 in Portugal. That law already promised continued treatment after a trial but left the detail to an ordinance, which it said should follow within 30 days of the law taking effect. It has taken several months longer.

Who qualifies

The obligation falls on the promotor (the trial sponsor, usually a pharmaceutical company). It covers the medicine being tested and any medical devices needed to give it. It applies when two conditions are met: the trial investigator considers it indispensable that the participant keeps taking the medicine, and there is no other treatment of comparable efficacy and safety.

The decision rests with the investigator, based on an individual, reasoned clinical assessment. Under the 2026 law, the investigator must obtain the participant's informed consent, write a clinical report justifying the continued treatment, and tell Infarmed (the national medicines authority), the CEIC (Comissão de Ética para a Investigação Clínica, the clinical research ethics committee) and the head of the health unit within one month. Adverse reactions during continued treatment are reported to Infarmed.

How long it lasts

The free supply continues until the medicine is actually on the market and available in SNS (national health service) establishments. In practice, the sponsor's duty ends once it has applied for public availability of the medicine and either that application is approved, or the legal deadline for a decision passes and supply to that participant is authorised under the exceptional availability scheme in Decreto-Lei n.º 118/2026 (Decree-Law 118/2026). If the sponsor never applies, or the application is refused, the free supply continues.

The sponsor pays. The ordinance says these costs cannot be charged to any public funding contract. The trial protocol must set out the continuity arrangements in advance, including clinical follow-up, safety monitoring and the move to whatever access route comes next. Any exceptional change that could put continuity at risk must be justified and submitted to the CEIC and Infarmed. Older trials follow older rules: under the law, trials authorised before it took effect in April keep the post-trial terms approved at the time.

What it means for you

Portugal is an active trial country. Infarmed's figures for the first half of 2026 show 110 trial applications submitted and 86 trials authorised, with cancer the largest single therapeutic area. Trials that are recruiting can be found on the EU's Clinical Trials Information System map, which works in Portuguese and English, and on the national RNEC register (National Register of Clinical Trials), as Infarmed explains.

If you are offered a place in a trial, ask before you sign:

• What does the protocol say about continuing treatment after my participation ends?
• Who decides whether I qualify, and when will that assessment be made?
• Is there an existing treatment that could count as an equivalent alternative?
• Was the trial authorised before or after the 2026 law, and which post-trial terms apply?

Under the same law, medicines, extra tests and consultations required by the trial are free for participants during the study, and the sponsor must carry insurance for any harm the trial causes.