“When we compare ourselves to countries across Europe, we are in a measly fifth place from the end, with more than 700 days” between the time the drug is authorized to enter the market by the European Medicines Agency (EMA) until it is made available to patients in Portugal, the president of the platform told Lusa.
According to Jaime Melancia, these innovative medicines, as well as having “slow access” for Portuguese patients when compared to other European countries, “can only be dispensed if they have been reimbursed because they are so expensive”.
This means that the National Medicines Authority (Infarmed) has to “negotiate the medicine in order for it to be financed by the state and this is the process that takes all these days,” explained the president of the platform that brings together around 70 associations that defend the chronically ill and health professionals.
“That’s too long, when the law in Portugal says six months,” lamented Jaime Melancia, pointing out that the issue is new drugs for oncological and chronic diseases, among others, which are more effective than those already on the market.
In practice, patients are being “treated with other medicines, they’re not waiting for this medicine to be treated, but they’re not being treated properly, because there are new medicines that are more effective,” explained the president of Saúde em Diálogo.
According to him, the platform’s expectation was that these price negotiation processes would “take a reasonable amount of time”, not least to prevent the pharmaceutical industry from giving up on placing a new drug on the Portuguese market because the amount sought by the regulator doesn’t pay off.
“The results for patients of these new drugs are better and they are being treated with drugs that are not tuned to treat their pathology in the best way,” said Jaime Melancia.
According to Infarmed, the aim of health technology assessment (HTA) is to support decisions on the use and financing of medicines and medical devices in the National Health Service (SNS).
This decision, according to the national regulator, is based not only on the quality, safety and efficacy criteria required of all medicines, but also on their comparative efficacy, efficiency and effectiveness “in order to optimize the use of available resources”.
According to Infarmed, these state funding processes require a “detailed pharmacotherapeutic and pharmacoeconomic assessment in order to guarantee rationality in the reimbursement and acquisition of health technologies”.
Therapeutic innovation in Portugal will be the subject of a debate organized by the Plataforma Saúde em Diálogo (Health in Dialogue Platform) on Thursday in Lisbon, with the participation of associations representing people with chronic illnesses, the regulator, representatives of the pharmaceutical industry and other stakeholders in the health sector, with the aim of reflecting on how patients can be more involved in these processes.
Infarmed created the INCLUIR Project to promote the involvement of people with diseases and their representatives at different stages of these evaluation processes, but Jaime Melancia argues that this participation should be broadened.
“We want our voice to be heard, not just in a mere questionnaire, but about the real needs of patients and what will bring us quality of life,” claimed the platform’s president, for whom the “fact that a particular medicine will improve patients’ quality of life has a return for the health system” and does not represent an “increase in cost for the state”.
