Portugal boasts a well-developed universal healthcare system and saw healthcare spending increase by 6.2 percent annually between 2016 and 2021, according to the OECD. However, the representatives of innovative medicines manufacturers embedded in the country are keen to point out that access to the latest drugs remains a big issue in Portugal, compounded by lengthy pricing and reimbursement procedures. Here, four local affiliate leaders weigh in on Portugal’s access challenges, strategies for confronting them, and signs of progress.
Lengthy Turnaround Times for Pricing and Reimbursement
Frédéric Bengold, general manager at Servier Portugal, laments the complexity and lengthiness of the country’s pricing and reimbursement negotiations.
On average, it takes 700 days to achieve price and reimbursement approval for a pharmaceutical product in Portugal
Frédéric Bengold, Servier
“On average, it takes 700 days to achieve price and reimbursement approval for a pharmaceutical product in Portugal,” he says. “The government tends to scrutinize every aspect of pricing and budget impact before making a decision. This process is often opaque, lengthy, and a generator of inequities.”
These delays are compounded by the difficulty in reaching product approval, says Bengold, adding up to significant access challenges. “This protracted process, combined with a low success rate for product approvals (only 31 percent of products succeed), creates a significant barrier to market access.”
“The delay in bringing crucial drugs to the Portuguese market is indeed a pressing concern,” Pedro Moura, managing director at Merck Portugal confirms. “This extended period [for pricing and reimbursement negotiations] creates inequalities … impacting patient care.”
As a result, Portugal is one of Europe’s slowest countries for access to innovation according to the EFPIA/IQVIA ‘WAIT’ Indicator. “The issue of delayed access to innovation in Portugal is a high priority issue for us,” says Johnson & Johnson Innovative Medicine’s managing director Filipa Mota e Costa. “The indicator reflects the amount of time patients have to wait for new therapies after EMA approval. This delay is identified as among the highest in Europe, and it is seen as a significant problem that needs urgent attention.”
Strategies for Improvement
For Portugal country heads simplifying the current system to accelerate the process would benefit companies and patients alike. “Streamlining the pricing and reimbursement process could benefit patients, pharmaceutical companies and the healthcare system,” Bengold asserts.
Prioritising drugs based on their compelling data and real unmet needs should be a central consideration
Pedro Moura, Merck
Moura argues for a re-evaluation of the decision-making processes involved using a more data-centred approach and taking into account unmet patient needs. “Prioritising drugs based on their compelling data and real unmet needs should be a central consideration,” he claims.
“This delay [in the time taken by authorities to evaluate and grant access to new drugs] is attributed to the need for a more data-driven approach in decision-making,” Johnson & Johnson’s Mota e Costa agrees. “Authorities are urged to understand and make decisions based on the data available rather than going through prolonged cycles of information requests.”
Portugal affiliate leaders understand that they need to adapt their own approach to the market based on these delays. “In Portugal, navigating the complex landscape of reimbursement and patient access programmes requires a nuanced strategy,” Moura contends, advocating for ongoing dialogue with the Portuguese government. “In Portugal, we have made significant progress in fostering genuine discussions with policymakers and establishing agreements that provide market predictability. The agreement between Merck, represented by APM Pharma, and the Portuguese government, renewed annually, serves as a framework, offering predictability amid the dynamic market landscape.”
One specific strategy Merck’s managing director indicates is the simultaneous request for reimbursement and the initiation of a patient access programme. “This dynamic approach ensures earlier access in most cases and underscores the importance of demonstrating competitive data and the absence of viable alternatives,” says Moura. “It is a strategy tailored to the unique regulatory environment in Portugal, ensuring timely access while addressing the challenges inherent in this market.”
Other Challenges
In addition to complex pricing processes, there are other issues that complicate access in Portugal as local affiliate leaders point out. “Out-of-pocket costs in Portugal are relatively high, at around 30 percent of the total healthcare expenditure, compared to the European average of 15 percent,” asserts Servier’s Bengold. “
Some regions, particularly rural areas, face challenges with insufficient adult psychiatrists
Sara Barros, Lundbeck
This extra financial burden on patients is a challenge, especially considering the average salary in Portugal.” Economic pressures end up influencing patient choices. “Patients are increasingly constrained by their financial capacity, which influences their healthcare decisions.”
Moreover, in the view of Sara Barros, country manager at Lundbeck, a company specialised in mental health, certain regions in the country suffer from a shortage of doctors, particularly psychiatric doctors. “Some regions, particularly rural areas, face challenges with insufficient adult psychiatrists,” she claims. Nonetheless, Barros remains hopeful about the Portuguese government’s acknowledgement of the need to invest in mental health, as seen with its comprehensive plan to reform mental health services, the National Mental Health Programme, which is supported by an investment of EUR 88 million from the Recovery and Resilience Plan.
Signs of Progress
Beyond the EU funds earmarked for healthcare, leaders of Portuguese affiliates have seen progress within the country and foresee that recent directives coming from Europe could also have a positive impact.
Discussions around HTA processes have become more standardised and widely accepted
Filipa Mota e Costa, J&J Innovative Medicines
Commenting on the progress the country has made with respect to its market access challenges Mota e Costa pinpoints improvements in the Health Technology Assessment (HTA) system over the past five years. “While the system was already in place, it has consolidated further during this period,” she contends. “One notable development is the establishment of a consolidated system where discussions around HTA processes have become more standardised and widely accepted.” However, she again emphasises the need for data-based decisions.
In Barros’s opinion, the recent proposed changes in European Medicines Regulation present a unique opportunity for Portugal. “We believe that this reform could pave the way for more timely and equitable access,” she says. “The reduction of the administrative burden, a key goal of the proposed reform, is deemed crucial for expediting processes and significantly reducing authorisation times for medicines. This streamlined approach is vital for ensuring faster access to medications.”
Meanwhile, political uncertainties such as the caretaker government and the country’s upcoming elections have added another layer of difficulty for Portugal’s affiliates. “The political uncertainties in Portugal … present challenges and opportunities for Merck in 2024,” asserts Moura. “Amidst this backdrop, the ongoing reforms in the national health system, particularly the SNSD law 61/2022, signal a significant shift in governance models, accountability, and service accessibility. The reform aims to enhance patient access to specialised services and improve the overall efficiency of the healthcare system. While the political landscape introduces uncertainties, we trust that policymakers will act responsibly, ensuring the continuity of essential reforms.”
