The Ministry of Health wants to regulate the participation of healthcare workers who are paid by the pharmaceutical industry.

The Ministry of Health is finalizing the Royal Decree (RD) on Health Technology Assessment to achieve "more transparent and bias-free" drug financing. The regulations will govern, among other aspects, the participation of professionals paid by the pharmaceutical industry in evaluation decision-making.

This was confirmed by the Minister of Health, Mónica García , in a post on the social network 'X' on Tuesday. Her department published the draft of this Royal Decree in August of last year and is currently finalizing the details to submit it to the Council of State, according to sources from the Ministry who spoke to Europa Press .

Among other aspects, this project formalizes the participation of patients and healthcare professionals in health technology assessment processes. In this regard, it states that all participants in the "System for the Evaluation of the Efficiency of Health Technologies" will carry out their activities in an "independent, impartial, and transparent" manner.

In this regard, it specifies that participants " will not have any financial or other interest in the healthcare technology development industry that could affect their independence or impartiality." It specifies that participation in scientific, strategic, or any other type of advisory services provided to the pharmaceutical industry through consulting will be considered a conflict of interest.

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Likewise, all participants must submit a declaration of their financial and other interests , which they must update annually and as necessary. They must also disclose any facts that may pose a conflict of interest .

For his part, the Director General of Portfolio and Pharmacy of the National Health System (SNS), César Hernández , reported last week during a Summer Course at the Complutense University of Madrid organized by Roche that the Ministry of Health is confident that the Official State Gazette (BOE) will publish the RD "after the summer."

This standard aims to adapt the European Regulation on Health Technology Assessment to the Spanish context.

The Royal Decree regulates the evaluation of health technologies, including medications, medical procedures, medical devices, in vitro diagnostic tests, and other health-related technologies . In this regard, the Ministry of Health emphasizes that evaluation is a scientific process that allows authorities to decide on the incorporation, financing, pricing, reimbursement, or divestment of these technologies, with the goal of ensuring an "equitable and efficient" health system .

This regulation aims to adapt the European Health Technology Assessment (HTA) Regulation to the Spanish context . It came into effect on January 12th, with the goal of introducing improvements to ensure that all patients in the European Union can access health technologies.

Among other new features, the Royal Decree will incorporate a 180-day period from the authorization of a drug to a decision on its funding. The Director General of Portfolio and Pharmacy of the SNS had already warned pharmaceutical companies a few weeks ago that this period will apply "to everyone" and that, during this period, a decision must be made, which could be positive or negative.