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LEGISLATION | Draft Royal Decree regulating the rules establishing the criteria defining irreversible and highly complex care processes that fall within the scope of Law 3/2024 of 30 October to improve the quality of life of people with amyotrophic lateral sclerosis and other highly complex and irreversible diseases or processes
During the month of August and until 5 September, the deadline is open for submitting allegations in the hearing and public information process for the Draft Royal Decree regulating the rules establishing the criteria that define the irreversible and highly complex care processes that fall within the scope of Law 3/2024 of 30 October to improve the quality of life of people with amyotrophic lateral sclerosis and other highly complex and irreversible diseases or processes, published by the Ministry of Health on 31 July.
The text of this draft Royal Decree aims to define the general and operational criteria that highly complex and irreversible diseases and processes must meet in order to be included within the scope of Law 3/2024, of 30 October, to improve the quality of life of people with amyotrophic lateral sclerosis and other highly complex and irreversible diseases or processes. To this end, the text establishes criteria that enable public administrations to identify situations of vulnerability that require rapid assessment in order to avoid leaving people unprotected in emergency situations.
The text can be consulted at this link
The publication schedule for the Royal Decree on Health Technologies remains unchanged
Although the Royal Decree on Health Technologies has not yet been published, it seems that the wait may be coming to an end. Since the message posted on social media in mid-July in which the Minister of Health reported that the Ministry was working to finalise the long-awaited Royal Decree, and following the latest statements made by the Director General of Portfolio and Pharmacy before August, it seems that the Ministry's objective is to maintain the publication of the regulation before the end of the year.
It should be noted that this Royal Decree aims to regulate the evaluation of health technologies (medicines, medical devices, in vitro diagnostic tests and other medical procedures) insofar as they are specifically intended to inform administrative decisions regarding the incorporation, financing, pricing, reimbursement or divestment of health technologies.
The text can be consulted at this link