Weekly Update for Intellectual Property in Health

On July 28th, 2025, the Official Gazette of the Union (DOU) published Ministerial Ordinance GM/MS No. 7,687, dated July 24, 2025, issued by the Ministry of Health, which amends Chapters III and V-A of Annex XXVII of Consolidation Ordinance GM/MS No. 2/2017, which governs the National Medicines Policy (PNM). The Ordinance became effective on the date of its publication in the DOU (07/28/2025).

Key changes brought by the Ministerial Ordinance GM/MS No. 7,687/2025:

• Patent applications of interest to the Ministry of Health: The ordinance amends Article 12 of Chapter III of Annex XXVII to include, among the patent applications for which a public Consultative Opinion must be issued by ANVISA regarding the patentability of the application—provided it is requested by the Ministry of Health—any patent application related to pharmaceutical products and processes, as well as medical devices, that involve technology subject to legal action seeking access to the respective medication or medical device.

• Composition and Functioning of GAPIS: Amendments were made to Articles 14-B, 14-C, 14-D, 14-E, and 14-F to establish that the Intellectual Property and Health Coordination Group (GAPIS)—responsible for identifying and evaluating, for the purpose of issuing public consultative opinions, patent applications for pharmaceutical products and processes that are relevant to the Medicine Policies or Pharmaceutical Assistance under the SUS, including those deemed strategic to public health policies—must also comply with regulations governing medical devices (in addition to the National Medicines Policy already included in the regulation). The group will be composed of four representatives from the Health Economic-Industrial Complex of the Ministry of Health, which will coordinate it. Furthermore, clarifications were made regarding the format of GAPIS meetings.

• Composition and Functioning of COMPIS: Changes were made to Article 26, item I, to include in the composition of the Commission on Intellectual Property in Health (COMPIS)—which aims to propose actions and support the Ministry’s efforts regarding Intellectual Property—two representatives from the Health Economic-Industrial Complex, which will coordinate COMPIS. Additionally, item XV was added to Article 26 to include a representative from the Secretariat of Information and Digital Health of the Ministry of Health as a member of COMPIS. The amendments also addressed the format of COMPIS meetings and the designation of its members. Article 30 was updated to establish that the General Coordination of Promotion and Regulation of the Industrial Complex within the Department of the Health Economic-Industrial Complex and Innovation for SUS will provide technical, logistical, and administrative support to COMPIS.

The changes introduced by Ordinance GM/MS No. 7,687/2025 have been in effect since July 28, 2025, the date of its publication in the Official Gazette of the Union.

Our team is closely monitoring developments in the field of Intellectual Property in Health and is available to assist with further clarifications and to follow up on the outcomes resulting from the aforementioned changes. Please contact us at mail@kasznarleonardos.com.