The Council of Ministers has approved the roadmap that will mark where pharmaceutical policy will go in the coming years in Spain. The Government, through the Pharmaceutical Industry Strategy 2024-2028 prepared by the Ministries of Health, Finance, Industry and Science, intends to establish new rules of the game based on “public-private collaboration” but more favorable to the State. The plan is based on the same paradigm as the new Industry law, also approved this Tuesday.
“Legislative and non-legislative measures will be implemented that favor greater public leadership throughout the medicine chain, a greater priority of patient health in research and greater strategic autonomy of the sector,” explained the Minister of Health, Mónica García. , in statements sent by the Ministry to the media.
The strategy seeks to end a model focused “on the industry’s supply capacity” to transform it into a “system where the health needs of the population are the main driving force,” so that public institutions are the ones that “guide the priorities of the next decade” in chronic diseases, advanced therapies or precision medicine.
“The demands of the patients – García added – are above the supply of the companies.” This means, in practice, that the State will have more capacity to promote lines of research that are of interest to Spain through collaboration contracts with large pharmaceutical companies, according to the Chain Being has advanced.
A committee to avoid bilateralism
The document creates two inter-ministerial committees. One for monitoring to supervise that the strategy is fulfilled at the government level and another mixed, where Health, Treasury, Industry and Science can discuss with the industry in a framework of “cooperation and dialogue between the public and private sectors.” This last committee lands as a way to neutralize the bilateral pressures of some brands with the ministries. An Alliance for Strategy is also founded: “a space that brings together the Interministerial Committee with public and private agents to promote participation and joint work.”
The strategy includes these six fundamental measures: “Create a system for the evaluation of the efficiency of health technologies and the financing and pricing of medicines”, “encourage the use of generic and biosimilar medicines”, “increase research funding clinical and preclinical”, “reinforce critical support structures in clinical and preclinical research” and “promote regulation and strategic autonomy”.
Spain is the fourth largest pharmaceutical market in the European Union in terms of turnover and the ninth worldwide. The pharmaceutical industry invested 1.4 billion euros in research and development in 2022, especially in clinical research (834 million euros). Furthermore, the Spanish territory is also the third in the world – only behind the United States and China – where the most clinical trials are carried out.
The Ministry of Health has expressed on several occasions its intention to improve transparency in relations between the State and the industry, so that the former has a greater margin of control and decision in the negotiations. In the coming months, once the new royal decree on the evaluation of health technologies is approved, companies will have to account for how much it costs them to produce, research and develop a product as part of the ordinary evaluation process to include it in the National Health Technology System. Health. Negotiations between health institutions and pharmaceutical companies still involve opaque processes.
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