Portugal: A Life Sciences Overview
Challenges in the Portuguese Life Sciences Sector
Portugal’s life sciences sector, especially pharmaceuticals, has faced a persistent challenge in recent years: balancing the sustainability of the National Health Service with continued patient access to cutting-edge health technologies.
The government formed after the May 2025 elections reinforced its position in the Parliament in relation to the last election. However, it still lacks an absolute majority. Its political latitude is inhibited by the need to secure opposition support for the state budget. With public health policy carrying significant financial weight, the government’s capacity and willingness to pursue reform is limited. Geopolitical pressures also contribute, as more spending is being directed towards defence and economic stimulus. Although there are notable regulatory developments, these largely stem from market demands and EU legislation. The current government is expected to take a moderate approach, focusing on strengthening the existing system rather than introducing major structural changes.
Public expenditure
Public expenditure and improvement of the national health system are at odds in just about every nation. However, the national health system has somehow become even more scrutinised and decisive since the COVID-19 pandemic. As in other European countries, resources during the pandemic were diverted to managing the public health crisis. Routine care was postponed, and budgets and resources were allocated to COVID-19 prevention and treatment. The healthcare system now faces intense strain, not only because of the need to provide ongoing, complex care for an aging population but also to address injury and disease buildup from the pandemic. Public hospitals and state-funded healthcare, once a given, have been brought to the centre of public debate.
Although public spending has risen, the increase was used to finance equally rising costs of human resources and materials. Health technologies, notably medicines and medical devices, are still perceived as saving opportunities, resulting in delayed adoption of innovation.
Medicines sector
Portugal’s regulatory framework for clinical trials can be burdensome and overbearing. While previous governments sought to enhance Portugal’s allure for research, no significant reforms were enacted. The EU Clinical Trials Regulation holds promise for harmonisation, but specific national requirements may still stifle progress. Nonetheless, there is a growing movement towards streamlining and simplifying clinical trial processes, which may ease some of these difficulties.
Market access
The most significant barriers are found in market access. Portuguese patients experience some of the longest delays for innovative products in Europe. Market entry for medicines into the National Health System almost always requires an agreement with the Regulatory Agency, acting on behalf of the Ministry of Health. These agreements strictly limit flexibility for pharmaceutical companies, often imposing rigorous and inflexible procedures.
After launch, innovative companies face a system that strongly encourages generics, including annual price revisions and regular renegotiations of agreements, which discourages innovation. Over the past few decades, generic promotion policies have succeeded: their market share peaked in 2022 and is expected to remain high.
This regime aims to protect the public interest, ensuring patient needs are met cost-effectively. However, it has created a significant power imbalance between innovative pharmaceutical companies and the state, frequently jeopardising or significantly delaying access to the latest treatments.
This imbalance is now being called out not only by pharmaceutical companies, but also by patients, advocacy groups and associations. These stakeholders have become more insistent, demanding better access – especially to orphan drugs.
Medicine promotion
Portugal’s regulations on medicine promotion are particularly restrictive, limiting communication between the pharmaceutical industry and patients. The definition of promotion is extremely broad, encompassing almost any information directed at the public that could directly or indirectly promote a medicine. This means that communication can be promotional irrespective of intent. Therefore, nearly all communication about prescription-only medicines is prohibited.
Unlike the EU norm, which merely prohibits companies from granting benefits to healthcare professionals, Portuguese law explicitly bans pharmaceutical companies from offering benefits to patients, clogging patient support programmes that are permitted elsewhere in Europe. These restrictions curtail informed discussions between companies and patients.
Medical devices
Before the recent EU regulations, Portugal already had comprehensive rules for the marketing, distribution and promotion of medical devices. The adoption of these stricter European standards has raised the bar further.
Many market participants are SMEs often lacking the capacity to adapt to higher regulatory standards. This problem has intensified with the influx of non-traditional players and the introduction of new regulations.
As in the pharmaceutical sector, companies supplying medical devices are now pressing for reform in pricing and reimbursement. Unlike medicines, reimbursement for medical devices in Portugal is limited and typically restricted to specific conditions. Increasingly, patients and advocates are demanding reimbursed access to these technologies. As the importance of medical devices for quality care is recognised, access to these technologies remains a key issue.
Emerging trends
Expansion of home-based and portable health services
There is increasing adoption of home-based health services and portable devices, driven by efforts to reduce hospital admissions and improve patient convenience. Telemedicine and portable medical technologies are enabling care to be delivered directly to patients’ homes.
Clinical data analysis
The use of big data and advanced analytics is becoming central to healthcare, offering insights into outcomes, treatment effectiveness and disease patterns. This data-driven direction is expected to drive more personalised care solutions.
The 2025 Protocol between Apifarma (the Pharmaceutical Industry Association) and the government
In its previous iteration, enacted between 2014 and 2024, the Protocol mostly corresponded to an expenditure control mechanism, which provided companies with an alternative, simpler and ultimately more favourable way to pay sector-specific tax contributions.
The most recent Protocol is more ambitious. Besides managing expenses with innovative medicines, it was designed as a public policy tool, which sought to promote pharmaceutical innovation in Portugal.
Key players in the sector are expectant regarding the Protocol’s execution and whether it meets its purpose over the next few years.
The future
Material changes seem unlikely in the near term. Innovative pharmaceutical and medical device companies will continue to call for improved access to innovation, while regulators remain focused on affordability. As clinical care becomes more invested in prevention (ultimately funded by patients), and as groundbreaking medicines of the past drift into patent expiry, sustainability seems likely to slowly take precedence over innovation. It is no longer enough to be new. To be approved, or successfully priced or reimbursed, health technologies must also be great.