The Portuguese pharmaceutical market has seen permanent and intense government intervention since the country’s financial crisis in 2011. Portugal’s Economic Adjustment Program (EAP) and the international loan agreement were enacted and subsequently prompted health sector reforms. Some of the key EAP measures included reducing pharmaceutical expenditures, cutting healthcare professionals’ salaries and increasing co-payments. The EAP also gave new impetus to reforms that had stagnated during the economic downturn. These included a primary care reform to expand enrollment in general practitioner’s patient lists and to create Family Health Units, although in practice few opened because of budgetary constraints.
To strengthen preventive care measures, the Government is taking action to bring more general practitioners into the National Health Service (Serviço Nacional de Saúde- SNS), boost patient registrations with GPs, and give municipalities a greater role in primary care planning and management as a step toward further decentralization. Other recent reforms have focused on strengthening public health interventions, on improving access to care and tackling shortages in the healthcare workforce.
Portugal’s Payer Stakeholders
The SNS, which is financed by the state budget, covers all Portuguese residents; it is universal, comprehensive and nearly free at the point of use (in accordance with the Portuguese Constitution). New legislation introduced in 2019 has abolished user charges for primary care visits, healthcare procedures and consultations covered by the SNS. Nevertheless, fees can be charged for certain outpatient services; however, they only represent a small part of the cost of the service. Health subsystems are funded mainly through employee and employer contributions (including contributions from the state as the employer of public servants) and can either be public or private. Citizens also have the option to enroll in Private Voluntary Health Insurance (VHI), which is supplementary and may speed up their access to outpatient procedures.
Important Points to Keep in Mind
Regulation, Pricing and Reimbursement
Pricing and reimbursement are exclusively dealt with at the national level, as they are outside the scope of EU legislation, with the exception of transparency measures and procedural requirements set out by the Council Directive (relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems). Public expenditure cuts have significantly impacted the cost of medicinal products that were being reimbursed by the SNS, which led the government to impose a tax (designated as “a special charge on the pharmaceutical industry”), which was incorporated into the state budget in 2015, and most recently, in 2020.
In Portugal, jurisdiction over medicines and medical devices is centralized in the National Authority for Medicines and Health Products (INFARMED). A national market authorization is valid for five years. INFARMED also plays a role in the renewal of the authorization, through a risk-benefit evaluation of the data collected over the years. The sponsor must submit a renewal request to INFARMED nine months before the marketing authorization is due to expire. Following the first renewal, the authorization is valid indefinitely, unless INFARMED, for pharmacovilgilance reasons, demands a renewal request for an additional period of five years.
Prices of drugs are regulated by the System of Assessment of Health Technologies (SiNATS), which was created by Decree-Law 97/2015. A maximum sale price for a prescription drug is determined and subsequently approved by reference to the price applied in reference countries. This price is subject to an annual revision. Spain, France, Italy, and Slovenia are the reference countries to be considered in 2020.
Decree-Law 97/2015 also allows for discounts at all stages of medical distribution, from the manufacturer to the retailer. Discounts applied by pharmacies to the price of medicines partially reimbursed by the SNS are applicable only to the part of the price not subject to reimbursement.
In 2000, the Ministry of Health strongly pushed for the expansion of generics in the Portuguese market, with several multinational companies bringing them to market. The uptake of generics increased rapidly between 2005 and 2012 but has since levelled off over the past few years. New trade margins for retailers and pharmacies were set in 2011, as well as new prices for generics, with the highest sale price set at least 50 percent lower than that of the reference product (or 25 percent, if the retail price is below €10). Therefore, special provisions to encourage the sale of generics exist in a variety of areas. For example, generics benefit from a simplified pricing and reimbursement structure. Also, by law prescriptions are mandatorily written by a physician in the name of the active substance, rather than the brand name, once a generic is launched in the market. This rule of generic substitution has very few exceptions, which are expressly written into the law. Similar incentives also exist for biosimilars. Moreover, recent measures, such as a €0,35 incentive to pharmacies for each pack of generics sold has also played a role in increasing generic sales.
Implications for Industry
Portugal’s Government is committed to improving patient access to medicines and treatments that demonstrate innovation, including orphan drugs and those for specific populations.
The coming years will prove challenging for the pharma and life sciences sector in Portugal, as new cost-effective measures are adopted by public and private healthcare providers, coupled with complex regulations and reform.
GLOBALHealthPR can help you map and carry out your strategy for engaging and communicating to key players at all levels in Portugal.
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