Pharmaceutical Industry Strategy in Spain (2024-2028)

The pharmaceutical industry strategy, promoted by the Government of Spain, addresses key challenges of the sector in the coming years. This document, aligned with the recovery, transformation and resilience plan, establishes a framework to strengthen Access to medications, Promote innovation and ensure the Sustainability of the National Health System (SNS).

Main objectives

Access and sustainability

One of the main objectives is the Equitable access to medications and health technologies through evaluation systems efficient and Proper financing. However, several challenges are presented: there are difficulties in equanimous access to new medications and is tending to an unsustainable increase in pharmaceutical expense.

The proposals indicating the plan to mitigate the challenges detected are:

• EVALUATION AND FINANCING SYSTEM: Creation of a specialized organism to evaluate health technologies and set drug prices with clear and transparent criteria.
• Timely access: Modification of the regulatory framework to facilitate the use of medicines during phases prior to its full authorization.
• Promotion of generic and biosimilar: Implementation of policies that encourage their use, improving financial viability.
• Incorporation of biomarkers and genetic tests: Equal access to advanced diagnostic tools as a basis for precision medicine.

Promotion of research, innovation and development

One of the key objectives of the plan is to increase investment in Biomedical Research, promoting an innovative ecosystem that accelerates the development of new treatments. To achieve this, a closest collaboration between the public and private sector, encouraging strategic alliances between universities, hospitals and pharmaceutical companies. This approach will allow Optimize resources, improve the knowledge transfer and strengthen the Competitiveness of Spain in the field of biomedicine, promoting significant advances in the health and quality of life of the population. The specific areas of action are:

• INCREASE OF INVESTMENT IN R&D: Gradual increase in public and private financing, with the aim of achieving a total expenditure of 3% of GDP by 2030.
• Public-private collaboration: Promotion of joint projects between hospitals, universities and companies.
• Decentralized clinical research: Expansion of essays in primary care and diverse populations, reinforcing capacities throughout the national territory.
• Advanced and Personalized Therapies: Potentiation of areas such as gene therapy and personalized medicine, allowing more effective and accessible treatments.
• European initiatives: Spain will actively participate in European partaries as ERA4HEALTH and the initiative 1 Million Genomes to strengthen international cooperation in biomedical research.

Strategic axes

SNS access and sustainability

The strategy seeks to guarantee the coverage of Not met medical needs, ensuring that patients access innovative treatments in an equitable and timely manner. For this, improvements will be implemented in the Acquisition and financing processes of medications, optimizing the evaluation mechanisms, negotiation of prices and reimbursement. In addition, the use of generic and biosimilar medicines as a key measure to balance health spending and strengthen long -term maintenance of the health system.

Innovation and development

Spain seeks to consolidate as a referent in biomedical research, promoting both clinical and preclinical research to accelerate the development of new treatments. To do this, collaboration between hospitals, universities and the pharmaceutical industry will be encouraged, facilitating the Access to clinical trials and promoting him Use of advanced technologies. In addition, personalized medicine and advanced therapies will be reinforced, allowing more effective treatments and adapted to the individual characteristics of patients, thus improving health results.

Competitiveness, resilience and strategic autonomy

To strengthen its pharmaceutical industry, Spain is committed to a more competitive, resilient and self -sufficient model. This implies the implementation of tax incentives that favor investment in the sector, as well as the impulse to biomedicine and Advanced technologies. In addition, strategies will be developed to guarantee a stable supply of essential medicines, reducing the dependence of external markets and reinforcing the national production capacity, with the objective of consolidate an innovative and sustainable industry in the European and global context.

Governance

To ensure one effective and coordinated implementation of the strategy, a governance model is established based on cooperation between public institutions, sector private and Social agents. This approach guarantees that policies are applied structured, avoiding duplicities and ensuring compliance with the objectives. In addition, a Transparent management and based on the evidence, allowing the actors involved to actively contribute to decision making, the supervision of progress and adaptation of measures according to the evolution of the pharmaceutical sector.

Interministerial Committee

A supervision organ is established with Representatives of different ministries (Health, Industry, Science, Finance), with the objective of:

• Coordinate pharmaceutical policies and guarantee alignment with European pharmaceutical strategy.
• Monitor compliance with objectives and propose adjustments in sectoral policies.
• Ensure effective integration between scientific advances, access to medicines and economic sustainability.

Alliance for Pharmaceutical Strategy

In order to promote continuous dialogue, trigger consensus and facilitate the implementation of measures in the health and industry system, the alliance is encouraged through a Collaboration Forum, which groups: the pharmaceutical industry (companies and associations), autonomous communities and general state administration, universities, research centers and hospitals and representatives of patients and health professionals.

Expected impact

The plan seeks not only benefit public health, but also enhance development economic from the country, promoting the Competitiveness and the sustainability of the pharmaceutical sector.

The implementation of this will have a significant impact on three key areas:

1. Improvement in public health and medicines availability:

• • Reduction of access times to innovative medicines.
  • Greater territorial equity in the availability of advanced treatments.
  • Impulse of personalized medicine, improving the effectiveness of treatments.

2. Sustainability and efficiency of the National Health System (SNS):

• • Optimization of pharmaceutical expenditure through the use of generic and biosimilar.
  • Reduction of pressure on the health system thanks to the most effective prevention and treatments.
  • Greater capacity to respond to health crises, guaranteeing the supply of critical medicines.

3. Economic growth and impulse to industrial competitiveness:

• • Creation of qualified employment in R&D, manufacturing and distribution.
  • Reinforcement of the export capacity of the Spanish pharmaceutical sector.
  • Attraction of national and international investments in biomedical research and technological development.

In conclusion, the pharmaceutical industry strategy 2024-2028 draws a clear path to strengthen the sector In Spain, combining innovation, equitable access to medicines and sustainability of the National Health System. Through public-private collaboration and efficient governance, it seeks to consolidate Spain as a Referent in Biomedical Research and Pharmaceutical Production. With an approach to competitiveness and strategic autonomy, it will not only promote economic development, but also guarantee a more resilient and prepared health system for the future.