Spanish public health makes a notable effort to incorporate innovative medicines into its pharmacological arsenal, those that improve or complement current therapies or those that even represent a ray of hope for pathologies without any treatment, but the waiting time … of patients who need them is too long.
This is the main conclusion of the comparative study carried out in 36 European countries by the consulting firm Iqvia for the European Federation of the Pharmaceutical Industry. The investigation takes an x-ray of the capacity and diligence of continental states to incorporate the 167 innovative drugs reviewed and authorized for health distribution by the European Medicines Agency (EMA) between 2019 and 2022.
The positive thing is that Spain is one of the European countries that makes the most effort to increase and update its portfolio of medicines. At the beginning of this year, health officials had authorized public financing for the administration of 103 of the new drugs approved by the EMA to patients who need them, which means that they incorporated 62% of these novelties into the Spanish therapeutic arsenal. almost two out of every three.
The percentage means two things. That it is in the head of the European countries that incorporate the most innovative medicines into their hospitals and health centers and that the effort is going further. The 62% represents four points more effort than twelve months before and nine points improvement over two years ago, an increase that occurs while the main partners suffer setbacks. Spain has 20 points more incorporation of new drugs than the European average (43% of those authorized). It is still far from the capacity of Germany (88% of incorporations) and Italy (77%), but it has already equaled France and has clearly surpassed the United Kingdom (56%), which only two years ago was 15 points ahead of it. of advantage.
Great delays
The negative, the slowness of the authorization process for new drugs. Spain, on average, takes four months longer to incorporate innovative medicines than the rest of the continent. While the European average wait time since the EMA authorization is 531 days (almost a year and a half), our country is 661 (one year and ten months). The problem is that these delays, which translate into desperate waits for some patients, not only do not reduce but even worsen. The average time for incorporating this type of therapies was one month slower in 2023 than a year before and almost five months longer than two years ago.
The second negative element is that just over half of these novel drugs for which their inclusion in the public financing portfolio is authorized are dispensed with very specific restrictions and indications on the patients for whom they can be prescribed by doctors. New drugs with restricted availability in Spain have increased by eleven points, up to 52%, in just two years.
The general director of Farmaindustria is, however, optimistic about the Spanish ability to straighten out the negative part of this process. According to Juan Yermo, “increasing the number of medications available and reducing delays in their incorporation into the National Health System is one of the great pillars of the Strategic Plan for the Pharmaceutical Industry that we are finalizing together with the Government.” He assures that this plan, which he described as a “country project”, is “an ambitious and realistic project for Spain to become in a few years one of the few global logistics centers for biomedical innovation, cutting-edge clinical and preclinical research, production of medicines (including biologicals and advanced therapies) and whose ultimate objective is to improve and accelerate the arrival of new medicines to all patients who need them and when they need them.
Exceptional procedure
However, the association that includes pharmaceutical companies based in Spain has made another specific proposal to the Government to minimize the most urgent waits while the authorities decide whether or not to incorporate a new medicine into public financing. It is about creating an exception for early access to the drug, limited to the patients who most need this therapy, either because of their particularly serious condition or because they lack a therapeutic alternative. A formula to accelerate arrival when the benefit is very relevant.
Farmaindustria proposes, without the need to address regulatory changes, a procedure that allows for accelerated financing authorization, within a maximum period of 90 days, for all patients who (selected by the Administration) meet certain criteria that make receiving the medication more urgent. .
