The Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (AELMHU) has participated in the Public Hearing process on the draft Royal Decree amending Royal Decree 1093/2010, of September 3, which approves the minimum set of data for clinical reports in the National Health System (SNS).
From AELMHU we consider that there is ample room for improvement in the field of interoperability of the information produced within the SNS. Specifically, within the process of approval and financing of high-impact drugs, such as orphan drugs, since October 2019 the VALTERMED tool has been in force, an information system of the SNS to determine the therapeutic value in real clinical practice of these products, and that, after two years of its validity, has shown an increase in the administrative burden for physicians in terms of data collection.
Among the main areas for improvement are the elimination and prevention of duplication in the process; the reduction of manual information and the development of future scenarios that will make it possible to capture the information available in the patient's clinical history. Therefore, AELMHU considers that this Public Hearing represents an excellent opportunity to "unify" the language of the different clinical information systems (from VALTERMED to the Clinical History or the health card) and we have participated in it, formulating some recommendations:
- Avoid collecting additional data to that already collected in patient records and hospital or Autonomous Community registries.
- Promote system interoperability.
- Enable industry to participate in the data download functionality.
- Incorporate participation in clinical trials as relevant information in the medical record.
- Reinforce the opportunity that real life data (RWE) could offer to improve knowledge in the diagnosis, treatment and follow-up of patients and take advantage of the data obtained to be able to generate new hypotheses or anticipate possible diagnoses.
- To reach a consensus on adequate, rigorous and transparent criteria for pharmacoclinical protocols.
- Establish a communication channel to the Autonomous Communities, establishing a basic information model.
- Homogenize territorial disparity.
- Collect patient feedback.
If you would like to know the details of all these proposals, please consult the complete Recommendations document.
