The document proposes, without the need for a regulatory change, a procedure that would allow the equitable arrival of drugs that meet certain criteria that make their funding more urgent.
“We need to ensure that all patients receive the best possible treatment on an equitable basis, and sometimes this is not possible through the usual funding channels. We propose establishing criteria and a clear and predictable system to improve the availability of new treatments when they are most needed,” says Farmaindustria CEO Juan Yermo.
Sometimes, the arrival of a new medicine is the only alternative for a patient to cope with their disease. Other times, the drug represents a substantial increase in their quality of life or a new hope for a serious or life-threatening disease. On these occasions, as well as in rare diseases, the time from approval of an innovation in Europe to its funding in Spain may be too long.
For such medicines, a special procedure is needed to allow patients to benefit from innovations as a matter of urgency. This is the objective of the Proposal for Early Access to Innovative Medicines, drafted by Farmaindustria. “We need to ensure that all patients receive the best possible treatment under equitable conditions, and sometimes this is not possible through the usual funding channels. We propose establishing criteria and a clear and predictable procedure to improve the availability of innovative medicines when they are most needed,” says Farmaindustria CEO Juan Yermo.
Currently, there is a procedure – governed by the Royal Decree on medicines in special situations – that provides individualised solutions in exceptional situations, but which in practice generates situations of inequality between autonomous communities or even between hospitals in the same territory. Farmaindustria’s proposal therefore puts forward a solution that allows these indications to be harmonised, in conditions of fairness and immediately.
This early access route, which does not require a legislative change, starts with the establishment of clear criteria by the Spanish Agency for Medicines and Health Products (AEMPS) to determine which medicines are subject to this procedure. Farmaindustria proposes that they should be those that target a rare, serious or disabling disease, that there is no alternative treatment or, if there is, that the new drug provides relevant improvements in efficacy or safety.
When a drug is selected as a candidate for this early access, Farmaindustria proposes a maximum period of 15 days after authorisation in Europe for the company to apply for the national code, which is essential for marketing in Spain. While in this first stage the price of the drug is set by the company, the proposal aims to reach a financing agreement as soon as possible between the government and the marketing laboratory. The period would be 90 days, half that established by current regulations.
Once this period is over, if the decision is not to fund the drug, the government and the pharmaceutical company will have to agree on how to continue treatment for patients who have received the drug in the first stage.
“Improving access to new drugs in Spain is a pending issue, and this proposal provides solutions in cases where the delay is even more detrimental to the patient,” says Yermo. In our country, the average time from when a new drug is authorised in Europe until it reaches the public health system is 619 days, which means 21 months of waiting and places Spanish patients far behind neighbouring countries such as France (508), Italy (436) and Germany (128). These are data from the latest report on Indicators of Access to Innovative Therapies in Europe in 2022, drawn up by the consultancy firm Iqvia.
This document of proposals is part of the innovative pharmaceutical industry’s commitment to improve patient access to new drugs and follows the document Proposals for improving patient access to orphan drugs and the report Access to medicines in Spain: diagnosis and recommendations. All proposals have been submitted to the Ministry of Health, to which Farmaindustria continues to extend its hand in order to reach solutions for the benefit of patients as soon as possible.