Six major patient advocacy groups in Portugal have delivered a formal petition to Adalberto Campos Fernandes, coordinator of the Strategic Health Pact, demanding immediate reform of the country's pharmaceutical approval process—a system currently ranked second-to-last in Europe for speed of access to innovative medicines.
Why This Matters
• Portugal takes an average of 700–864 days to make new drugs available after European authorization, compared to Germany's 56 days.
• Six patient associations representing cancer, neuromuscular diseases, psoriasis, and Alzheimer's are pushing for concrete policy changes before the new health strategy is finalized.
• A new European regulation on Health Technology Assessment, now being implemented domestically, offers a rare chance to modernize the Infarmed evaluation process—but only if backed by political will.
• Rare disease patients face the longest waits, with no cost-effectiveness threshold adjusted to their unique treatment realities.
The Numbers Behind the Delay
Portugal's drug approval bottleneck is not abstract bureaucracy—it is a measurable health equity problem. According to the Patients W.A.I.T. Indicators 2024, Portugal occupies the penultimate position in Europe for time-to-availability of innovative therapies. While the European Medicines Agency (EMA) grants marketing authorization relatively quickly, the subsequent evaluation and pricing negotiation by Infarmed—Portugal's medicines authority—adds substantial delays, with reports suggesting review cycles can take over 600 days in total from submission to conclusion, though some cases exceed 2 years from European approval to Portuguese pharmacy shelves.
By comparison, Spain reduced its approval window from 519 days in 2020 to 344 days in 2023. Germany, which has a near-immediate reimbursement pathway, averages just 56 days. The European Union average hovers around 532–597 days. For patients with progressive diseases—leukemia, motor neuron disorders, metastatic cancer—every month of delay translates directly into lost treatment windows and, in some cases, survival odds.
The coalition behind the petition includes the Portuguese Association Against Leukemia, Portuguese Neuromuscular Association, Europacolon Portugal, Alzheimer Portugal, Gynecological Oncology Movement, and the Portuguese Psoriasis Association. Their letter frames the issue not as a technical shortcoming but as "a measure of avoidable suffering, lost opportunities, and lives suspended while awaiting decisions that arrive months earlier in other countries."
Four Concrete Proposals on the Table
Rather than simply highlighting the problem, the patient groups are offering a detailed roadmap for reform as the Strategic Health Pact is still being drafted. Their proposals include:
1. Overhaul Infarmed's evaluation and decision-making processes. The current review cycle involves multiple stages—technical assessment, company response and negotiation, and submission coordination—that collectively consume months. The groups argue for streamlined timelines, particularly for drugs addressing unmet medical needs.
2. Introduce risk-sharing and outcomes-based payment models. These arrangements would allow provisional access to innovative therapies while real-world effectiveness data is collected, with pricing adjustments tied to actual patient outcomes. Such "managed entry agreements" are already standard practice in countries like the Netherlands and the Czech Republic.
3. Integrate patient experience directly into health technology assessments (HTA). The petition emphasizes that "equity in health decision-making is not achieved through technical criteria alone—it requires the effective integration of patient perspectives, recognizing them as partners in the process, not merely recipients of decisions." This would formalize patient input in the cost-effectiveness and therapeutic value deliberations conducted by Infarmed and the National Commission for Pharmacy and Therapeutics (CNFT).
4. Create a rare-disease-specific cost-effectiveness threshold. Portugal currently uses informal cost-effectiveness benchmarks, but applies them uniformly across all drug categories. The patient groups propose a modified cost-effectiveness standard for rare diseases, similar to England's Highly Specialised Technology program, which permits higher thresholds for ultra-rare conditions. Without this adjustment, orphan drugs—often expensive due to tiny patient populations—are systematically disadvantaged.
European Regulation Offers a Window, But No Guarantee
The timing of the petition is strategic. Portugal is currently transposing the EU Regulation 2021/2282 on Health Technology Assessment, which came into force across the bloc in January 2025. Recent implementing legislation rewrites the National System for Health Technology Assessment (SiNATS) to align with the new European framework.
Under this system, Joint Clinical Assessments (JCA) conducted at the EU level will feed into national decisions, reducing duplication of effort and theoretically accelerating approvals. However, Portugal retains full autonomy over pricing, reimbursement, and the final determination of therapeutic added value. The European report must be considered, but it does not bind national authorities.
The patient groups see this regulatory shift as a "unique opportunity to harmonize criteria, accelerate processes, and bring Portugal closer to the European pace," but they caution that success depends on "political will, reinforced technical capacity, and a clear commitment to transparency and predictability." Without those elements, the new regulation risks becoming another layer of process rather than a catalyst for reform.
The updated SiNATS also extends systematic evaluation to medical devices, in vitro diagnostics, digital health tools, and AI-based applications, and formalizes "horizon scanning" to identify emerging technologies earlier. Importantly, it mandates real-world data monitoring, allowing for dynamic re-evaluation of drugs based on actual effectiveness in the Portuguese population.
What This Means for Residents
For patients living with cancer, Alzheimer's, rare genetic disorders, or chronic inflammatory diseases, the petition represents a rare moment of organized advocacy at a critical juncture in health policy design. Adalberto Campos Fernandes—a former Minister of Health (2015–2018)—was appointed in April 2026 by the Presidency of the Republic to lead the Strategic Health Pact, a long-term initiative aimed at achieving political consensus and stability in health governance.
If the patient groups' proposals are adopted, the practical impact would be:
• Faster access to new cancer therapies, gene therapies, and targeted treatments for conditions like psoriasis, multiple sclerosis, and rare metabolic disorders.
• Transparent timelines and predictable decision-making, reducing the current uncertainty that leaves patients and clinicians in limbo.
• Fairer evaluation of orphan drugs, which currently struggle to meet cost-effectiveness standards designed for mass-market medications.
• Greater accountability through real-world data collection, ensuring that high-cost drugs deliver on their promises—or are re-priced if they do not.
The associations emphasize that "a medication can only be effective if it reaches the person who needs it in time." For Portugal's healthcare system, this is not just a question of efficiency—it is a question of equity. As the country prepares to implement both the European regulation and its own domestic reforms, the voices of those who live daily with the consequences of delay are demanding a seat at the table.
The Political Test Ahead
The Strategic Health Pact is designed to transcend electoral cycles and establish a durable framework for healthcare governance. But its strength, the patient groups argue, will be measured by "the capacity to listen to those who live daily with the consequences of decisions—or their absence."
Campos Fernandes has expressed openness to collaboration, and the government has pursued initiatives aimed at increasing efficiency and speed in access to treatments while reinforcing the financial sustainability of the National Health Service (SNS). That package includes measures to facilitate generic and biosimilar substitution and to modernize the SiNATS for greater agility.
Yet the patient associations are clear: modernization of process is not enough. Without a commitment to strategic prioritization of therapeutic innovation and explicit recognition of patient experience as a core input, the reforms risk addressing symptoms rather than causes. The petition closes with a direct appeal to the coordinator: "We are ready to contribute, collaborate, and build solutions—but access to innovation must stop being a postponed issue and become an assumed commitment."
Whether that commitment materializes will become clear in the coming months as the Strategic Health Pact moves from consultation to concrete policy. For thousands of patients across Portugal, the difference between reform and rhetoric could be measured in months of life.
