A new regulation is helping Portugal’s market access conditions for pharmaceuticals catch up with those of other developed European markets, with a jump in the number of approvals for 2017. The situation is further enhanced by increasing inter-stakeholder communication and transparency, and a targeted focus on removing bureaucracy barriers, from authorities and industry members alike. However, the infrastructure needs more investment for rapid reviews of new drugs.
Although Portugal’s pharmaceutical market is similar in size to those of Sweden, Austria, and Denmark, it is one of the slowest countries for medicine reimbursement in Europe, with average waiting times for market access standing at two years rather than the 180 days legislated by INFARMED, Portugal’s regulatory agency. This puts Portugal’s reimbursement speed on a par with less developed European markets such as Slovakia and Romania, renowned for their market access difficulties. Between 2010 and 2012 only one out of the 139 medicines approved in Slovakia successfully gained reimbursement.
As is the case with many health systems across Europe, budgetary constraints create pressure on the resources available to medical authorities and give rise to delays. The time constraint is limiting both in terms of companies’ sales but also patients’ access to potentially life-saving innovations. Additionally, the fact that Portuguese hospitals have their own approval systems for medicines and a higher level of autonomy than comparable health systems—such as the UK’s National Health Service—exacerbates the issue.
From the regulator’s perspective, changes need to be made within companies themselves and in their relationships with stakeholders. Maria Machado, president of INFARMED, feels that there is a “lack of visibility from pharmaceutical companies” as to what products they have in the pipeline. For the industry, the consensus is that for a highly-developed and highly-skilled economy, value added to patients should be prioritized, and a long-term view of budgeting would improve outcomes.
However, change is in the air. Reforms within SiNATS, (the National System for the Analysis of Health Technologies) – Portugal’s HTA body – aims to drastically reduce drug approval times. Generic medications are slated to be approved in 30 days through a fast-track route, and innovative medicines in 90 days, with a 30-day leeway. Consequently, 60 innovative drugs were granted market access in Portugal in 2017 and more medications were reimbursed in the two years between 2015 to 2017 than in the five between 2010 to 2015. Furthermore, new PAPS (Patient Access Programs) are held in high regard by the vast majority of members of APIFARMA (the Portuguese Association of the Pharmaceutical Industry). This model, which is by and large considered to be an opportunity to improve patient outcomes, allows patients free access to medicines within 210 days but guarantees reimbursement at the end of the program. The program was introduced in 2017, and therefore, given the 210-day wait time, the results remain to be seen. Many are cautiously optimistic on the efficacy of the program but are spurred on by the open and collaborative government approach.
Overall, general managers of pharma companies in Portugal feel that these reforms act as a vehicle for increasing transparency, rendering processes more robust and easing the market access process. Indeed, Bayer’s Florian Ibe sees a benefit to being one of the last countries in Europe to launch a drug, as this paves the way for Portugal to “learn from the experience of other countries, providing better knowledge for patients and healthcare professionals alike,” concluding that Portugal can have an “excellent picture of a drug’s strengths and inefficiencies” when it finally enters the Portuguese market. Portugal, historically a first-mover, for example in drug decriminalization, and the second country after Canada to create a HTA in 1998, has a long way to go improving market access, but slowly but surely, it is turning the page.
Writer: Georgina Lott