AELMHU has sent the Ministry of Health its contributions to the Public Consultation prior to the draft Royal Decree regulating the Evaluation of Health Technologies.
We recognize the important role that Health Technology Assessment (HTA) processes play in ensuring that the best possible therapies are available to patients. However, we see an opportunity to strengthen the current system to ensure that it is fairer, flexible, robust and involves all relevant parties to capture the real value of innovation and treatments, including for rare diseases.
In that sense, we show our willingness to collaborate and support initiatives to build a modern and adequate STD process that reflects the needs of patients with serious diseases, their families and society.
In general terms, AELMHU would like to thank the DGGCCyF for taking this initiative. As clearly stated, it is necessary to implement legislation in this regard. Therefore, we agree that now is the time to strengthen Health Technology Assessment in Spain. On a general level, we would have three comments. Firstly, it is important to reach the greatest possible consensus among all the agents involved, including the industry. In this regard, and as agreed at the La Moncloa summit held on December 21 between the Government and the highest representatives of our sector, we believe it is important to create a National Council in which all the agents of the healthcare ecosystem are represented and in which the challenges facing the sector can be addressed jointly. In addition, it would allow innovation to be oriented in accordance with the priorities of both the National Health System and the Pharmaceutical Industry. On behalf of AELMHU, we continue to offer our full willingness to collaborate with the DGGCCyF during the next steps in the development of this draft Royal Decree. 4 1 Secondly, AELMHU believes that it is necessary to provide the system with sufficient resources, both economic and human, to be able to implement an ETS system in Spain on the basis of the Draft Royal Decree. Although we agree with the problems identified, no mention is made of the lack of existing resources, as well as the lack of professionalization of the activities (especially for drugs). In addition, multidisciplinarity needs to be encouraged if we want a robust, effective and efficient system. Thirdly, in a context of implementation of the European HTA Regulation (focused on Joint Clinical Assessment), clear governance should be ensured to avoid subsequent duplication of processes at the national and regional levels, clearly delimit the competencies of the agents involved in decision-making, and establish specific evaluation deadlines.