It’s More Than Just the End of the Year
Throughout 2024, we’ve highlighted in several publications how technology is transforming the business model of the healthcare industry: personalized treatments, telemedicine, artificial intelligence, blockchain, on-demand production with 3D printing, a focus on preventive health, cross-industry collaborations between tech companies and healthcare to develop product-service apps, challenges in ethics and sustainability, and more.
These innovations are not only reshaping how pharmaceutical, biotech, and medical device companies are operating but also how they interact with patients and other stakeholders within the healthcare ecosystem. Undoubtedly, it’s an exciting time for the healthcare sector.
However, regulations set the framework in Europe. In recent years, significant regulatory changes have emerged in the region, including Spain, concerning pharmaceutical policy and health technology assessment (HTA).
The new European Regulation on HTA came into force in January 2022 and will be gradually applied starting in January 2025. This regulation aims to ensure a uniform and scientifically robust evaluation of the added clinical benefit of new medicines, eliminate repetitive and inefficient assessments at the national, regional, or local levels, and ultimately improve patient access to new treatments.
Additionally, in April 2023, the European Commission adopted a proposal for a new directive and regulation to revise and replace the current EU pharmaceutical legislation. The main objectives are:
- Establish a forward-looking regulatory framework.
- Reduce the period of regulatory data protection.
- Introduce new incentives for antimicrobial development, including a “transferable exclusivity voucher.”
- Implement measures to improve access to and availability of medicines across the EU.
- Promote research in areas of unmet medical needs.
- Support the industry in advancing research and technologies that benefit patients.
- Address market and systemic deficiencies exposed by COVID-19.
In Spain, the Ministry of Health is working on a draft Royal Decree for health technology assessment. This aims to regulate HTA in the country, determine which health technologies are included or excluded from the National Health System (SNS in Spanish), and establish a system for evaluating the efficiency of these health technologies.
Planned changes in Spain include evaluating the added clinical benefit and integrating the European procedure for assessing added clinical benefit into the Spanish system. This will allow a robust evaluation of a drug’s clinical benefits, improve the availability of innovative medicines in terms of product variety and approval timelines, and prioritize HTA based on unmet needs, first-in-class innovations, potential patient impact, AI-powered information systems, and significant value-added contributions at European level.
Monitoring studies will continue to assess technologies already introduced in the National Health System where uncertainty exists regarding their effectiveness, safety, or economic impact.
In summary, these regulatory changes aim to improve the efficiency and quality of HTAs, promote innovation, and ensure better patient access to innovative drugs and treatments in Europe and Spain.
Amid these regulatory changes — and keeping in mind the challenging economic conditions of EU member states, declining birth rates and an aging population — it’s crystal clear that only companies with lateral and cross-functional thinking will successfully connect the dots between payer needs and the integration of all available technologies. This spans from designing and implementing clinical trials for developing new molecules to deploying new product-service solutions for patients.
Achieving this is only possible through the intersection of industries and public-private collaboration. This is especially vital as the European Health Data Space is simultaneously under development. Companies adopting open innovation models and critical, lateral, and cross-disciplinary thinking will lead healthcare innovation in Europe in the coming years.
If you’ve read this far, thank you for taking the time to explore this humble publication. My aim is simply to read, study, and understand the constant advancements in this exciting sector to connect better the dots in the scenarios I manage.
Let’s not forget that we will all be patients someday. Our only one mission is to improve and extend the quality of life for those patients. That will be our legacy.
Wishing you a happy 2025, filled with health and joy for you and your loved ones.
EDUCATIONAL PILLS:
International Master in Medical Affairs. Program part of the educational offerings of the BioTech and Pharma School. In Memoriam César Nombela. Certified by the Catholic University of Ávila. Information
Advanced Management Program. IE Business School. Executive Development Programs. Information
READING PILLS:
Longevity biotech aims to unleash the power of NAD+ against age-related diseases. Longevity Technology.
Choices, costs, and challenges in US healthcare: insurance intricacies, drug pricing, economic impacts, and potential reforms. Petter Attia.
EU’s baby bust: New data reveals the terrifying population plunges across the continent that are set to condemn future generations to life in a crippled economy. Daily Mail.
The gift, by Rafael Nadal. The Player Tribune.
The Biological of Politics. Wrong Speak Publishing.
How Did Digital Health Investors View This Year’s Funding Environment — and What Do They Predict for 2025? Med City News.
Cancer death rates rise steeply with age. Our World in Data.
How do antibiotics work, and how does antibiotic resistance evolve? Our World in Data.
Cancer vaccines will have a pivotal moment in 2025. The Economist.
Dear Brussels: regulation is supposed to help innovation, not hinder it. Enrique Dans.
STARTUP PILLS:
Investment oportunitties: Capital Cell
R2G’s Global Digital Health Business Outlook Survey — 2025. Research2Guidance
PODCAST PILLS:
Health Tech Trends: AI, Private Markets, and 2025 Predictions from Bessemer Venture Partners. Startup Health.
EVENT PILLS:
Spanish Association of Health Economics. Health Strategies for a Global Future: Effectiveness, Efficiency, and Sustainability. Madrid, June 18–20, 2025. Faculty of Economic and Business Sciences, Complutense University of Madrid.
Key Deadlines:
