Spain is set to implement a comprehensive reform to its law of guarantees and rational use of medicines, designed to modernise its pharmaceutical policy. These reforms, as shared by Javier Padilla, secretary of state for health, will introduce significant changes aimed at ensuring sustainability, enhancing access to innovative treatments, and improving the overall management of medicines within the public healthcare system (SNS).
Key areas of reform:
- Reference pricing overhaul
The reforms will allow more flexibility in the pricing of off-patent drugs. By enabling generic medicines to undercut reference prices without forcing the originator brands to lower theirs, the policy aims to create a more competitive and dynamic market. - Clawback payments extended to hospitals
Currently limited to sales through retail pharmacies, the clawback payments will now also apply to certain hospital drug sales. This extension is intended to provide additional funding to support policies related to the rational use of medicines and better management within the SNS. - Patient participation in HTA
In an effort to make health technology assessments (HTA) more comprehensive, the new policy will ensure that patient voices are included in the evaluation process, alongside health economists and clinical experts. - Transparency in drug pricing
Companies will be required to provide detailed information on public and private funding sources for drug development, as well as production costs. This transparency is intended to offer clearer insights into the cost structure of new drugs, without necessarily tying prices directly to production costs. - CIPM decision records
For the first time, detailed records of decisions made by the interministerial price commission (CIPM) will be kept. These records will document the factors considered during decision-making, including indications for reimbursement and evaluation criteria.
These reforms highlight Spain’s commitment to fostering a sustainable and efficient pharmaceutical policy, where innovation and patient access can be balanced with economic realities. With these changes, Spain aims to solidify its role as a leader in European healthcare innovation, ensuring that the needs of patients, payers, and pharmaceutical companies are addressed.
Source:
Diariofarma. Padilla plantea excepciones a las nuevas aportaciones de la industria por la DA sexta. Diariofarma. Published October 14, 2024. Accessed October 17, 2024. https://diariofarma.com/2024/10/14/padilla-plantea-excepciones-a-las-nuevas-aportaciones-de-la-industria-por-la-da-sexta