The average time that elapses from the time a new medicine receives authorization in Europe until it is available for use in Spain is 517 days, more than 17 months late. In addition, between 2017-2020 Only 85 of the 160 drugs approved in the National Health System (SNS) were available. European Union, that is, 53%. The data is the annual WAIT Indicator report, prepared by the consulting firm Iqvia.
The delay in approval and availability in Spain is also reflected in areas of particular gravity for patients such as Oncology and rare diseases. In recent months, the demands for a solution by health professionals and patient organizations have focused on them.
For this reason, Farmaindustria, the National Business Association of the Pharmaceutical Industry established in Spain that brings together the vast majority of innovative pharmaceutical companies, has made a series of specific proposals to the Ministry of Health.
The new Farmaindustria document includes the proposals presented to the Administration to reverse the deterioration in the indicators of access to innovation. This report, under the title Access to medicines in Spain: diagnosis and recommendationsdescribes the Current situation, presents an analysis of the causes and brings together a series of measures to tackle the main problems identified.
«The worsening of access to innovative medicines in Spain in recent years is seriously damaging the quality, effectiveness, cohesion and equity in the SNS. The main damage is for patients, who cannot access the most effective treatments or do so with a long delay or under restricted conditions -explains John Yermo, General Director of Farmaindustria-. But there is a second impact, also important, for biomedical research in our country, since pharmaceutical companies may lose their interest in investing in the country if they do not see an outlet for their innovative medicines.
The arrival of an innovative medicine is a new hope for sick people
This second consequence can mainly affect in the clinical trials, an area in which Spain is a world leader. “The worsening of access in the country therefore affects the sector’s contribution to economic growth,” the document underlines.
The arrival of an innovative medicine is a new hope for people who suffer from a disease and do not yet have a treatment, and also for those who, despite having some therapeutic option, can see improvement your healing expectations the of increased quality of life.
Spain has a pressing problem of access to innovative medicines, which requires an urgent solution, because the health and well-being of patients are being put at risk and health and non-health costs are being incurred that could be saved thanks to the new medicines .
In this context, in order to try to shorten these times and equalize the opportunities of Spanish patients with those of their European neighbours, “Farmaindustria has been proposing a series of improvements in the procedure for evaluating and setting prices and public financing of medicines in our country . The goal is to establish an agile, predictable and efficientin a way that helps to solve the current problem”, says Yermo.
The goal is attainable, but requires an in-depth reform of the price and financing system, a review of the function, terms and structure of the therapeutic positioning reports (IPT) that accompany new drugs, and early access mechanisms for drugs that provide greater clinical benefit to patients.
Specifically, pharmaceutical companies propose to provide greater predictability, clarity and objectivity to the procedures and decisions regarding the price and financing of innovative medicines. The necessary reforms in these procedures should allow compliance with the term established in the legislation for the decision on financing (180 days, compared to the current average of 517 days) and achieve financing rates for new authorized medicines that are closer to those of the European countries of reference.
There is also a need – says the document – reforms in the Reference Price System (SPR) to recognize incremental innovation, which has proven adherence and therapeutic benefits.
A clear separation between therapeutic and economic evaluation of drugs is necessary
Likewise, a clear separation between the therapeutic and the economic evaluation of innovative medicines is necessary and to take into account the valor social total that the medicine contributes, that is, including health and non-health savings and impact on productivity and employment.
It would also be advisable to establish a drug early access system that provide greater clinical benefit, with the participation of physicians and patients and with a provisional price that is later adjusted based on results, as well as the identification of uncovered medical needs and specific price and financing mechanisms to treat rare diseases.
A nivel regionala follow-up and greater coordination between the autonomous communities to ensure equitable access throughout the SNS to the medicines included in the service, with access indicators that objectify the situation and allow deviations to be corrected.
Finally, the document recalls that prescription by brand reinforces adherence to treatment (a major challenge in Spain, since half of chronic patients do not comply well with their treatment), avoid mistakes in taking medication, especially in older patients, and facilitates the necessary pharmacovigilance work.
And what is key: the prescription by brand is not more expensive neither for the SNS nor for the patient, since in Spain originals and generics are at the same price. “These rights must be protected, and the prescription by active ingredientconsequently, it lacks a foundation in terms of efficiency, so its generalization is questionable”, he stresses.