With the publication of Oerdinance No. 433-B/2026/1, of 21 September, the first special public-availability scheme is established under the new SiNATS framework, applicable to the treatment of ichthyosis and epidermolysis bullosa.
The Life Sciences and IP Litigation team at MFA Legal & Tech has reviewed the new scheme and its key implications, and remains available to clarify any questions relating to this new framework.
Key takeaways:
- First scheme under the new SiNATS: the Ordinance gives effect to the possibility set out in Article 41 of Decree-Law No. 118/2026, allowing special public-availability schemes to be established for specific conditions or patient groups.
- Specific access and funding conditions: the scheme sets out the technologies covered, the dispensing channels and the corresponding conditions for reimbursement or availability within the NHS.
- Regulation still pending: the new scheme emerges while other matters provided for under Decree-Law No. 118/2026 — namely the administrative procedures for public availability and price setting and revision — have yet to be regulated.
Find out more about the key aspects of the new scheme and its impact on the Life Sciences sector.