It takes the State 344 days to finance a new drug.
The Ministry of Health has reduced the evaluation period to less than a year, but admits there is still "room for improvement."
BarcelonaThe average time it takes to decide whether a drug is incorporated into the national health system's portfolio of services and, therefore, funded by the state, is 344 days. Once the European Union approves a new drug, Member States begin a specific evaluation and negotiation process with the pharmaceutical company to agree on whether it will ultimately be made available to the public with public funding. In Spain, this period is already less than a year. The Ministry of Health boasted about this figure on Monday, as it represents a substantial improvement compared to recent years: in 2020, the average time could have exceeded 519 days, that is, 170 days more than currently.
This is one of the report's conclusions. Financing of innovative medicines in Spain, presented at a press conference by the Secretary of State for Health, Javier Padilla, and the Director General of the Common Portfolio of Services and Pharmacy, César Hernández, and which analyzes the period between 2020 and 2023. Despite the reduced deadlines, the ministry believes there is still "room for improvement" and work on all new drugs. However, Padilla has assured that they are on "the right path" and have made "significant progress," with three out of four drugs registered in Spain now receiving public funding.
When the European Medicines Agency (EMA) authorizes a drug and the European Union ratifies this decision, each member state, through its drug regulatory agency, initiates a process to determine whether to fund it and at what price, for which it must negotiate with the pharmaceutical company that developed the drug. Furthermore, the EMA's decision does not oblige companies to market their medicines in all EU countries; they are free to choose whether or not to register them in each Member State. According to the report's findings, of the 232 medicines authorized in Europe between 2020 and 2023, 84% were registered in Spain.
Improving access
Although the average delivery time is 344 days, more than half of the new drugs and therapies registered between 2020 and 2023 reached patients before official funding through the Medicines in Special Situations (MSE) route, which allows for their administration even if they are not approved. This early access is one of the "keys" to the improvement in the delivery times outlined in the report, according to the Ministry of Health. Hernández believes it is "unfair" to say that there are "access problems" in Spain, but he did admit that it is necessary to improve decision-making to be more agile in delivering medicines.
In fact, the ministry notes that there are other projects underway to improve accessibility to medicines, such as the draft law on medicines and medical devices. A month ago, the Council of Ministers approved this draft law, which seeks to reform a system that has remained virtually unchanged since the 1990s. The objective of the future regulation is to "modernize" the drug pricing system, promote generic treatments, and streamline the prescription of medications. Among other measures, they emphasize that nurses and physical therapists will be empowered toThey can also prescribeDrugs. However, the drugs that will be able to be prescribed have not yet been defined and will have to comply with the new "powers," which are still pending definition.
With this law, the Spanish government also aims to improve access to medicines and reduce public spending. In fact, Pedro Sánchez's administration estimates that more than €1.3 billion could be saved annually, as it will make drug prices more flexible. In 2023, for example, the Spanish government exceeded €27.7 billion in pharmaceutical spending.
