The Spanish Association of Orphan and Ultra Orphan Drug Laboratories(AELMHU) has presented its contributions to the Draft Bill of the Public Health Law of the Principality of Asturias.
Asturias maintains a growing commitment to rare diseases, as demonstrated by the Health Plan of the Principality of Asturias 2019-2030, approved on May 8, 2019, which establishes as a goal (action 2.16) to ensure the implementation in Asturias of the actions included in the Rare Diseases Strategy of the National Health System and, therefore, expressly recognizes rare diseases as part of the priority areas of action in public health. This strategic framework has been reinforced in 2025 with the announcement of an Autonomic Plan for Rare Diseases, presented in the institutional act of the World Rare Diseases Day.
From AELMHU we value these commitments very positively and we trust that their effective implementation will contribute to improve the care and quality of life of people with rare diseases in the region. In this context, we welcome the fact that the Government of the Principality of Asturias and the Ministry of Health are responding by updating the regional regulations in the framework of Law 33/2011, of October 4, General Public Health, with the aim of adapting the national standard to the regional singularities.
For our association, it would be very convenient that this regulation explicitly contemplates the orientation of activities for the early detection, diagnosis and early treatment of rare and ultra-rare diseases, as well as the socio-sanitary coordination, the financing of therapies, research and the improvement of registries. This normative articulation would be a clear demonstration of the institutional commitment with the promotion of health and welfare of all citizens, and especially of those who suffer from these pathologies.
Likewise, although the Principality of Asturias has its own Rare Diseases Information System (SIERA), created to collect epidemiological information and improve knowledge, diagnosis and patient care, and contributes to the State Rare Diseases Registry (ReeR), there are still limitations in the interoperability between the regional and state registries. For this reason, we consider it necessary to continue to make progress in the harmonization of data structures, the updating of diagnostic lists and the incorporation of new clinical and care sources that improve the quality and completeness of the information collected.
RECOMMENDATIONS
The following are some proposals for recommendations in the development of future lines of regulatory action:
- Include rare diseases in the autonomous Public Health Law, with specific measures for prevention, diagnosis, care and follow-up.
- Request the inclusion of as many rare diseases as possible in the neonatal screening program as a common tool for early and accessible detection.
- Recognize the social value of orphan drugs in the evaluation processes, incorporating social, economic and family impact indicators.
- Streamline access procedures, reducing waiting times and guaranteeing territorial equity.
- Promote and encourage innovation to ensure the health and well-being of citizens throughout their lives.
- Strengthen information systems, expanding automatic data collection, incorporating data from the private sector and improving interoperability with the ReeR.
- Encourage and promote public-private collaboration in research, development and the improvement of accessibility to medicines, as it has proven to be a very useful tool for improving people's quality of life.
- Promote the active participation of patients and associations in the planning, monitoring and evaluation of public policies.
