From different fields, including the academic one, it has long been pointed out the incongruity that Spain is the fifth European pharmaceutical market in sales and the seventh worldwide, and lacks an organization and methods for public evaluation in this area comparable to those of European countries such as United Kingdom, Germany, France or Sweden, among others. The evaluation of efficiency is included in the Spanish regulations on financing and price setting for medicines. However, the evaluative activity and the procedures through which this information is incorporated into decision-making have not been developed, nor do we know how they are applied.
The Spanish situation reflects a manifest anachronistic delay of several decades, which translates into financing and pricing decisions for new medicines with a high potential opportunity cost, which, in the healthcare field, is not only transferred to budgetary terms but to lost health. Costs that are not very visible to citizens, that do not make headlines in the media, and with little wear and tear for our representatives and high decision-makers.
The need to adapt Regulation (EU) 2021/2282 on health technology assessment has led to Royal Decree 415/2026, approved by Parliament on May 29, after a long incubation period. The new RD and the European impetus to improve the assessment of new health technologies, including medicines, are welcome. However, a new mold needs a new and comparable oven.
The existing one has shown its shortcomings. The RD represents advances in comparative clinical evaluation and improvements in several dimensions of governance (technical separation between evaluation and decision-making, greater participation of stakeholders in the evaluative process, greater transparency in it). Nevertheless, it still leaves uncertainties about its real effect, which will have to be clarified in the coming months.
Four basic criteria for landing the new mold in an appropriate oven: (i) simplify the composition of the Governance Council, establish the entry of its members based on scientific-technical merits and guarantee independence and transparency in its performance; (ii) unify procedures and methodology in the evaluation of the efficiency of medicines and any other health intervention or program with those already applied in other European countries; (iii) provide the process with adequate human and material resources; (iv) consider the evaluation dynamically, that is, not only at the time of arrival in the healthcare system but re-evaluating when circumstances advise it.
The decision-making regarding the financing and price of medicines and other health technologies must be informed by evaluations of the best scientific-technical quality, which must be developed within a framework of sufficient resources and supported by solid principles of good governance in their processes. Starting from this situation, the principles of comparative evaluation, transparency, and accountability can also be extended to other areas of our National Health System. Let us trust in this, but let us also demand the application of these principles. We already know the alternative: high opportunity costs that result in losses of health and well-being for the population.
about the author:
Jaume Puig-Junoya is Distinguished Professor at the UPF-Barcelona School of Management. Juan Oliva is a professor at the University of Castilla la Mancha.