Access to innovative drugs and therapies has become one of the main examples of health inequity among European countries. This inequality is evident in the WAIT survey, published by the consulting firm Iqvia, which collects information on 152 drugs of this type authorized by the agencies between 2016 and 2019.
Spain is below the main members of the European Union in terms of access level. In addition, the report points out that the area where our country shows its worst records is the time interval between authorization, obtaining public funding and making it available to patients.
According to data updated on December 31, 2020, only 82 drugs were available in Spain of the 152 that were authorized between 2016 and 2019. This translates into a little more than half, 54%, of the new compounds approved in Europe . Plus, on average, they take 453 days to be available. For this reason, access to therapeutic compounds presents great challenges that require solutions to mitigate the impacts of delayed innovation.
In the words of Humberto Arnés, CEO of Farmaindustria, “it is useless to develop the best medicine if it does not reach the patient who needs it . After the long R&D processes of the new drugs, which represent an improvement in the treatment of diseases, it is everyone’s responsibility to make them available to patients in the shortest possible time, ”says Arnés.
The Federation of Spanish Medical Scientific Associations (Facme) delves into the delay in decision-making, which causes delays. Cristina Avendaño, member of the entity and head of the Covid-19 Vaccination Group, points out that the main challenge would be to reform the current system in the face of the coexistence of therapeutic and economic evaluations “that are the subject of differentiated and public reports.”
The reflex and the consequence of the delay are suffered by specific diseases such as cancer. “We must ensure that all patients have access to innovation in competitive times. In oncology, individualized treatment is a key element that enhances research, and it is essential to continue advancing ”, says Enriqueta Felip, vice president of the Spanish Society of Medical Oncology (SEOM). In fact, the delay in the availability of treatments means, according to Felip, “that some patients do not get to receive them, with the consequent damage to survival and / or quality of life.”
“In recent years, the mortality of metastatic disease has decreased globally by between 1% and 3% as a consequence of the incorporation of new systemic treatments. The longer the delay, the less mortality we will have ”, supports Rafael López, president of the ECO Foundation. And it is that this situation generates for the patients “a loss of opportunity and a totally unnecessary burden of anguish,” adds López.
In order to tackle the problem, one of the possible solutions is to emulate the speed of action with which the immunization against the covid-19 pandemic has been carried out. Pilar Martínez, president of the General Patient Alliance (AGP) has an impact on this: “ The vaccines have shown that the approval processes can be shortened . Without taking the exception of the pandemic as an example, it is clear that there is room for improvement in all the approval processes ”.
Sources from the Ministry of Health assure MUY that a protocol is being worked on: “It is about establishing an accelerated evaluation mechanism to reduce the processing times in the financing procedure and price of new drugs; in particular, from the moment the documentation of the offer is presented by the laboratory that owns the medicine until the file is included on the agenda of the Interministerial Commission for the Prices of Medicines (CIPM) ”.
This is in addition to measures already taken by Health, which has been working for some time to speed up the arrival of drugs to hospitals. To this end, the REvalMed platform was created, which seeks to evaluate the compounds, or to establish specific mechanisms for a faster evaluation.
The political sphere also proposes various solutions, such as “acting in the trial period and at the level of human and economic resources”, according to Guillermo Díaz, spokesman for Citizen Health in Congress. For its part, Podemos advocates “a public drug industry” as a solution to shortages. “The military pharmacy could be a good starting point,” adds Rosa Medel, purple representative in the Lower House.
Elvira Velasco, PP Health spokesperson in Congress, considers that it is important that the administrative processes “adhere as closely as possible to the legally established times.” In this context, it proposes reviewing visas for direct-acting oral anticoagulants and minimizing administrative barriers. Of course, “always from the criteria of quality, safety and sustainability.”
