The Portuguese pharmaceutical market has seen permanent and intense government intervention over the last decade and particularly since the country’s financial crisis in 2011. The Economic Adjustment Programme for Portugal and associated Memorandum of Understanding with the European Commission, European Central Bank and International Monetary Fund, required cuts in government spending on health care. The result is tougher pricing rules, promotion of a framework more conducive to competition from generics, reduction of distribution margins, and more rational prescription patterns by doctors. Most of the measures set in the MoU have been adopted.
Portugal first recognised the “right to health” in its 1974 Constitution. The National Health Service (Serviço Nacional de Saude – SNS) was established in 1979 and over the years has enjoyed the support of all government leaders, regardless of their political orientation.
Portugal’s Payer Stakeholders
- The SNS covers all Portuguese residents; it is universal, comprehensive and nearly free at the point of use (in accordance with the Portuguese Constitution, Article 64). SNS is financed primarily by general taxes, and tax revenue also funds the employer contributions for state and public sector employees. User charges exist for consultations (primary care and hospital outpatient visits), emergency visits, home visits, diagnostic tests and therapeutic procedures.
- The health subsystems, which provide healthcare coverage to between 20 and 25 percent of the Portuguese population, are funded mainly through employee and employer contributions (including contributions from the state as the employer of public servants).
- In Portugal, the national prescription drug authorisation procedure is supervised and evaluated by the National Authority for Medicines and Health Products (INFARMED), which evaluates drugs only after EMA approval. After a company files a national Marketing Authorisation Application, INFARMED has 10 days to verify it is within the required parameters, and to respond to the sponsor with questions.
- Prescribed drugs are subject to variable patient co-insurance based on effectiveness criteria, and require the patient to pay all of the cost of pharmaceuticals deemed to have little or no clinical value or deemed not cost-effective. All reimbursement decisions are guided by principles of necessity and social justice, and as such, the government seeks to reimburse at the lowest price possible. Because of this it can take up to a year of negotiations for pharmaceutical companies to reach agreement on a price with INFARMED and the Ministry of Health.
Important Points to Keep in Mind
A new drug is classified into one of five reimbursement categories or levels using criteria based on its therapeutic characteristics:
1. Innovative medicinal products expected to fill a therapeutic gap (i.e., drugs that demonstrate higher efficacy or tolerance when compared with existing products).
2. New form, dosage or package of an already reimbursable product (i.e., drugs for which therapeutic advantage, need, and economic benefit must be demonstrated).
3. Products that are neither therapeutically innovative nor identical to those already reimbursed (i.e., drugs demonstrating an economic advantage over those already reimbursed for the same indications).
4. A combination product in which its components are already marketed separately (i.e., a combined drug in which the therapeutic benefit is greater than that of the same drugs administered separately).
5. A combination product in which its components are not marketed separately (i.e., a combined drug offering a therapeutic benefit over that of other drugs within the same therapeutic group).
- If the cost-benefit ratio, economic outcomes data, or other issues surrounding reimbursement presented by the pharmaceutical company does not meet the requirements of Article 15 of the Estatuto do Medicamento, the sponsor is notified that the application cannot move forward. If the request is deemed valid, INFARMED’S Direção de Avaliação de Medicamentos (DAM, or Drug Evaluation Department) has 210 days to evaluate and give an opinion on the Market Authorisation Application. Here, the drug product is evaluated under parameters of quality, safety and efficacy.
- During these 210 days, INFARMED may request further information from the sponsor, as well as request documents that it deems necessary, under a rejection penalty. Once INFARMED completes its evaluation, the decision is sent to the applicant and is published on INFARMED’s website.
- A national market authorisation is valid for five years. INFARMED also plays a role in the renewal of the authorisation, through a risk-benefit evaluation of the data collected over the years. The sponsor must submit a renewal request to INFARMED 180 days before the marketing authorisation is due to expire. Following the first renewal, the authorisation is valid indefinitely, unless INFARMED, for pharmacovilgilance reasons, demands a renewal request for an additional period of five years.
Implications for Industry
In Portugal, pharmaceutical companies agree to issue refunds to the National Health Service if its spending on medicines exceeds €2 billion each year. Pharmaceutical companies operating in Portugal paid back €160 million to the SNS at the end of 2014.
However, as part of this deal, the Ministry of Health must pay back old debts that it had not been able to pay in recent years due to the economic crisis. Debts on previous contracts are a lingering problem.
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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