Drug-Access Pipeline in Portugal Stalls at 650 Days Between EU Authorisation and SNS Funding Decision — Pharma Takes 272 Days to Submit, Infarmed Takes 332 to Decide, Negotiation Adds 319 More

The average new medicine that wins European Medicines Agency authorisation then waits almost two years before patients in Portugal can access it through the Serviço Nacional de Saúde, according to a study summarised by Lusa on Monday 18 May. The headline number — 650 days from the EMA green-light to a final SNS-funding decision — is the cumulative effect of three slow handovers between the pharmaceutical industry and the Portuguese regulator.

Where the 650 Days Go

Across the 102 dossiers that ran fully through the system between 2020 and 2025, the average breaks down as follows:

• 272 days — the time a pharmaceutical company takes to submit a public-funding application to Infarmed after the EMA authorisation lands. The clock starts at the European level but the dossier has to be re-prepared for the Portuguese assessment, which weighs cost-effectiveness against the SNS budget impact.
• 332 days — Infarmed's own evaluation-and-decision window. This is the National Authority of Medicines and Health Products' time to run the therapeutic and economic appraisal, score the dossier and put a recommendation on the minister's desk.
• 319 days — the price-and-volume negotiation that follows. This is where the company and Infarmed agree the actual unit price the SNS will pay, the cap on annual exposure, and any risk-sharing on outcomes.

The three add up to 923 days on average for the complete chain; the 650-day headline figure that Lusa reported represents the most commonly cited end-to-end measure (EMA authorisation to funding decision), with overlap in the negotiation phase. Either way, the conclusion is the same: a Portuguese patient waits the better part of two calendar years longer than a German or Dutch patient for access on public funding.

The 188-to-77 Funnel

The volume picture is even tighter than the timing. Between 2020 and 2025, the EMA authorised 282 new medicines. Of those, pharmaceutical companies submitted 188 for public-funding evaluation in Portugal — already a 33% drop-off, reflecting either small-market commercial calls or low expected SNS uptake. By the end of 2025, Infarmed had finished evaluating 102 of those dossiers. The final tally: 77 medicines approved for SNS funding, with 26 in oncology and 23 classified as orphan drugs for rare diseases.

A separate early-access mechanism — the autorização de utilização excecional and related cohort-access routes — delivered another 93 medicines to specific patient groups while the full funding evaluation was still running. That number is the safety valve that keeps oncology and rare-disease patients from waiting the full 650 days, but it does not cover most chronic-disease treatments.

What Infarmed Has Said

The regulator has indicated it expects the timelines to compress under the new EU pharmaceutical regulation currently moving through the European Parliament, which is intended to standardise health-technology assessment across member states. The HTA Regulation already requires joint clinical assessments for oncology and advanced-therapy medicines, which should in theory shave months off Infarmed's evaluation step from 2026 onwards.

This study sits alongside Infarmed's recent push for transparency, including the public online tracker for SNS-funded medications that launched in late April, and a more contentious file — the disputed glucose-sensor prescription circular that the Sociedade Portuguesa de Diabetologia and Ordem dos Médicos have demanded the regulator revoke.

What This Means for Expats

• Plan around the gap: If you take a recently authorised specialty medicine in your home country, do not assume the SNS will fund it on arrival. The Infomed public tracker is the right first stop to check whether it is on the funded list — anything authorised in the EU in the last 24 months has a real chance of still being in the pipeline.
• Private and complementary coverage: The 650-day gap is one of the main drivers behind why private insurance and ADSE-style coverage remain economically useful even for residents fully entitled to the SNS. The EY-Parthenon study lands the private sector channelling 9 million procedures and a €1.945 billion saving for the SNS in 2023; that capacity is part of how patients bridge the SNS funding lag.
• Oncology and orphan drugs: The 26 oncology and 23 orphan-drug approvals between 2020 and 2025, plus the 93 early-access medicines, mean that serious-disease patients usually have an in-system route faster than the headline 650 days suggests. Ask your hospital oncologist about the autorização de utilização excecional pathway specifically.
• Cross-border purchase: EU rules let you fill a Portuguese prescription in another member state and seek partial reimbursement under the cross-border healthcare directive. For a medicine that is authorised in the EU but not yet funded by Infarmed, this is a narrow, paperwork-heavy, but legally available route.

The Lusa-reported figures will land on the desk of health minister Ana Paula Martins in the same week the Direção-Geral da Saúde is fielding the parallel debate on private-sector contribution to SNS waiting lists. The political response will hinge on whether the new EU HTA framework actually delivers the compression Infarmed is counting on, and on whether the pharmaceutical industry's own 272-day submission lag can be pushed down at the same time. On the food-supplements, consumer-health regulation and DGAV-side of the file, our 7 June read on Saturday's Público multi-part investigation framing Portugal's suplementos alimentares pipeline as a 47% adult-use wave, a +80%-in-ten-years notification surge tracked in 'tens of thousands of avulso emails' in Outlook folders at DGAV, an IGAMAOT inspection report homologated by Minister José Manuel Fernandes on 20 October 2025, a €600 million market estimate and an end-of-2026 DGAV commitment to deliver a proper database sets the latest reference. On the Bial Phase 2 BIA 28-6156 discontinuation, Opicapone (Ongentys), Portuguese pharma R&D, SIFIDE II and CNS development pipeline side of the file, our 11 June read on Bial shelving the BIA 28-6156 Parkinson Phase 2 trial after the Trofa pharma read no efficacy signal at the primary endpoint, folding the five-year GBA1-targeted disease-modification programme while leaving the Opicapone (Ongentys) symptom-control franchise unaffected sets the latest reference.