New drugs take 517 days to reach patients with the current government

To the serious structural problem that Spanish public health suffers with the surgical and diagnostic waiting lists –at record levels in the country as a whole–, we must add another one with disastrous consequences for patients: the excessive delay in arrival at health centers of the new drugs. Although it has been going on for a long time, this problem has also worsened since Pedro Sánchez took office after winning the motion of no confidence against Mariano Rajoy, in mid-2018.

The data held by LA RAZÓN reveal that when the PP left the Executive as a result of said motion, the incorporation of innovative drugs against many types of diseases accumulated an average delay of 385 days from the time they were authorized by the European Medicines Agency (EMA, for its acronym in English) or its counterpart in Spain. After the arrival of Pedro Sánchez at Moncloa, the term has been extended to 517 days on average or, what is the same, almost 1.5 years. They are, therefore, 132 days more than those registered at the end of the previous period.

The annual report «Indicators of access to innovative therapies in Europe (WAIT Indicator)», prepared by the consulting firm Iqvia for the European Federation of Associations of the Pharmaceutical Industry (Epfia), attests to this delay and ignores that «the level of access to new treatments in Spain is lower than in the countries of our immediate environment", a problem that, he points out, "gets worse every year".

The data from this specialized consultancy specifically reveal that in the 2017-2020 period, the average time that elapsed from the time a new drug was approved by the regulatory authorities until it was available for use in Germany was barely 133 days; in France, 240 days; in England, 340 days, and in Italy, 429 days. All of them far from the mark reached in Spain in 2020, which was 453 days, producing another great jump to 517 days just one year later.

Said delay basically coincides with the time in which Patricia Lacruz remained in the position of General Director of Pharmacy of the Ministry of Health, highly questioned by the entire pharmaceutical sector in Spain. Lacruz was replaced in the position by César Hernández, a renowned expert in the field of drugs.

The Iqvia study also focuses on what is called the availability of new drugs, which is the number of those that are finally included in public funding and are made available to patients.

According to the conclusions, the percentage in Spain is the lowest of the large European markets. Specifically, 85 of the 160 drugs approved in the European Union (EU) in the 2017-2020 period are available in Spain, a period that basically coincides with the establishment of Pedro Sánchez in power.

In Germany, the availability is 92% of the drugs authorized in the EU –147 drugs–; In Italy, 79% -127 drugs-; in England, 68% –108 drugs–; and in France, 66% –105 medicines–.

As if that were not enough, Spain also has the highest percentage of restricted availability, with 41%. This is equivalent to saying that of the 53% of the medicines available in our country out of the total authorized in Europe, four out of ten are in Spain with some type of access restriction. The restricted availability is much lower in other countries in Europe. In Germany, it barely reaches 1%; in Italy, 13%; in France, 15%, and in England, 39%.

Although the delay in the incorporation of new medicines to the Spanish market is widespread, the case of some of them is especially dramatic. Especially for patients who could benefit from treatments. Examples in this regard are abundant.

Nerlynx, from the Pierre Fabre laboratory, for the extended adjuvant treatment of hormone receptor-positive early-stage breast cancer, has had to wait 906 days for its incorporation since it was authorized by the Spanish Agency for Medicines and Health Products. Zeposia, a Bristol drug for hormone receptor-positive relapsing-remitting multiple sclerosis, had to wait 736 days.

Angelini's drug Ontozry, for the concomitant treatment of seizures of focal onset with or without secondary generalization in adults with epilepsy, which have not been adequately controlled, had to do so for 456 days. Roche's Evryski product for spinal muscular atrophy took 620 days, and Novartis' Adakveo, aimed at preventing recurrent strokes in patients 16 years and older with sickle cell disease, had to wait 668 days. days.

These and other delays have led numerous patient associations and scientific societies to demand more diligent action by the health authorities. Pharmaceutical companies, grouped in the employers' association Farmaindustria, have also denounced the situation in recent years. There is also the circumstance that once they are authorized, the new products run into obstacles in some autonomies and even in some community hospitals.