The Ministry of Health has initiated the procedures for the drafting of the Royal Decree regulating the procedures for the financing and pricing of medicines
On 12 December, the Ministry of Health launched a public consultation on the long-awaited draft Royal Decree regulating the procedures for the financing and pricing of medicines.
Some of the objectives of the new regulation are as follows:
• To regulate and define the procedures and methodology applicable to funding and pricing decisions for medicines and the criteria to be used, as well as those for the application of unique reservations and exclusions from the benefit.
• Establish procedures and conditions for accelerated, conditional and interim funding authorisations and to complement the generation of knowledge on how the medicine works in real life in areas where uncertainty prevails.
• Establishment of criteria for the development of guidelines, guidance and assessment procedures.
• Establish the framework within which the economic evaluation analysis and the budgetary impact of the medicinal product is developed to meet the efficiency criterion.
• Modify the reference price system by introducing elements that increase competition.
• Reform the procedures for inclusion and pricing of generic and biosimilar medicines.
• Establish and define the framework for the relationship of persons and groups directly or indirectly involved in decision-making related to the financing and pricing of medicines.
• Systematise the application situations and existing channels for early interaction between companies and the health administration.
• Establish mechanisms for monitoring and basic rules for the revision of prices for those products that already have a positive financing decision.
• Define procedures to ensure transparency in accountability, as well as the confidentiality of those aspects that need to be accountable.
• Establish the procedures and systems for communicating to the Ministry of Health the information necessary to monitor price and financing decisions.
This amendment is in line with the Pharmaceutical Industry Strategy also approved last week and the Recovery, Transformation and Resilience Plan.
The government submits the Strategy for the Pharmaceutical Industry
On 10 December, the Government presented the Pharmaceutical Industry Strategy 2024-2028 to the Council of Ministers. The aim of the plan is to strengthen the sector's industry in order to guarantee access to quality medicines, promoting innovation and ensuring the sustainability of the system.
In this regard, the measures contemplated in the strategy include the following:
• Creation of a system for the evaluation of the efficiency of health technologies and the financing and pricing of medicines.
• Improving health technology assessment and timely access to medicines.
• Promoting the use of generic and biosimilar medicines.
• Increasing funding for clinical and pre-clinical research.
• Strengthening critical support structures in clinical and pre-clinical research.
• Boosting regulation and strategic autonomy.
The Government approved the Law on Industry and Strategic Autonomy
Last week, the preliminary draft of the Industry Law, which went out to public hearing last July, was approved.
The scope of application of this new law includes industrial activities related to medicines and health, so it will have an impact on the pharmaceutical and health sector.
Draft Medicines Law has been leaked
Last week a digital media leaked the content of the text of the draft Medicines Law. Although the draft proposes relevant changes such as the modification of the current reference price system, the text cannot yet be considered definitive, so it will be necessary to keep an eye out for further updates from the Ministry.