The Spanish Association of Orphan and Ultra-Orphan Drug Laboratories(AELMHU) has submitted its comments to the Collaborative Legislation Procedure of the Strategic Plan for Personalized Precision Medicine of Castilla y León 2024-2030.
The Association presents its annual report on Clinical Trials in Spain. Those of the 2023 fiscal year revealed that, during that year, Spain authorized 834 clinical trials, 190 of which were for rare diseases. Castilla y León participated in 30 of these trials for these diseases.
AELMHU is convinced that healthcare systems will be based on Personalized Precision Medicine (P.P.M.), Advanced Therapies and Artificial Intelligence , as these advances are driving an unprecedented therapeutic revolution, aimed at meeting the specific needs of each patient. That is why we welcome the participation and the cross-cutting and multidisciplinary approach that Castilla y León has integrated in the preparation of this plan. In particular, we welcome the objective set by the community to promote the development of an integrated and coordinated, equitable and sustainable model in order to improve the health outcomes of patients in Castilla y León.
During the last few years, the associates have been aware of the need to research and develop advanced therapies capable of improving the treatment of minority diseases, thus promoting personalized medicine; in this sense we join the impulse marked by the community in the identification of the elements of our Health System that allow its holistic and effective transformation towards the new model of personalized care, prioritizing a system that takes into account all the actors, levels and capacities involved.
RECOMMENDATIONS
After analyzing the publication of the Public Consultation of the Strategic Plan for Personalized Precision Medicine of Castilla y León 2024-2030, AELMHU would like to make the following contributions:
- Due to the level of knowledge and experience that the representatives of the pharmaceutical industry have in the field of P.P.M., AELMHU recommends including the industry and patient associations within the governance framework integrated in the Plan, so that they can provide a vision in this field. On the other hand, allowing the participation, within the technical committees, of experts from the pharmaceutical industry would improve synergies and public-private collaboration.
- Narrowing and reducing the timeframes for updating and integrating new personalized medicine services into the service portfolio in order to promote the identification of health risk factors and the development of diagnostic, preventive and therapeutic processes.
- Promote collaboration with regional and commercial actors in the research and development of analytical techniques and tools, since early detection is a fundamental and determining factor, both for the approach and progression of diseases and for the quality of life of patients and their family, social and work environment.
- Ensure rapid and equitable access to disease diagnosis. To this end, it is essential to reinforce coordination between health care levels (primary care - hospital) for the detection and follow-up of these patients as early as possible.
- In line with the previous recommendation, AELMHU considers it essential to reinforce the implementation of the services included in the service portfolio in order to ensure that there are no variations or inequalities in access to biomarker tests.