Regulatory Decree on Cystic Fibrosis Law.
CIRCULAR
Healthcare and Life Sciences Department Report | Regulatory Decree on Cystic Fibrosis Law
Dear Sir or Madam,
Executive Branch’s Decree No. 884/2020 (the “Decree”), published in the Official Gazette yesterday, regulates the Cystic Fibrosis of the Pancreas Law No. 27.552. By means of the Decree the Cystic Fibrosis is incorporated as a “priority disease” within the National Program for Rare Diseases created by Decree No. 794/2015.
The Decree appoints the Ministry of Health, through its Secretariat of Medicines and Strategic Information (dependent on the Secretariat of Access to Health) as the Enforcement Authority of the law.
In addition to the regulation provided for by the Decree, the Ministry of Health is expressly authorized by the Decree to issue any and all complementary and clarifying regulations that may be necessary for the application of the law and this decree.
Taking into account that the regulation made by the Decree is in general and broad terms (even repeating issues that were already in the law), for certain aspects of the law to be operational, it will be necessary, beyond the indicated regulation, additional procedural or clarifying standards that the Ministry of Health will be expected to issue.
In addition, in its capacity of Enforcement Authority, the Ministry of Health shall, among other things:
(i) coordinate its work with public and private effectors and with social security entities responsible for the application of patient coverage, as well as with the National Ministerial Portfolios, in order to define joint strategies;
(ii) adopt the protocols and treatment guides necessary for the definition of the benefit baskets for the comprehensive care of patients with Cystic Fibrosis, which must be reviewed and updated every two years
(iii) establish the necessary measures to ensure and simplify the provision of the treatments provided for in the guidelines and protocols, as well as the conditions and procedures for access by people with Cystic Fibrosis.
(iv) prepare a complementary list of medicines and supplies to deal with the emergencies of this pathology, intended for patients with exclusive public coverage that will be available in the care centers that each jurisdiction determines.
(v) create an Advisory Council with federal representation which will include referents in the approach and treatment of the pathology, in order to make recommendations for the adoption and elaboration of treatment guides and protocols.
(vi) establish the minimum data necessary to keep the National Cystic Fibrosis Registry updated, which article 15 of the law provides that all public and private health care institutions must prepare, in order to identify patients and track their treatment.
The inclusion of the patient in the aforementioned Registry will be required for their inclusion in the public coverage defined for the pathology in the National Program for Rare Diseases.
(vii) Incorporate into the list of drugs that are acquired and distributed by the Special Drugs Bank to be created by virtue of art. 16 of the law to those who are included for the comprehensive approach to this pathology as established in the treatment guides and protocols.
Should you require any further information on this matter, please do not hesitate to contact us.
Sincerely,
Ana Andrés