Client Alert

Ministry of Health creates IP advisory bodies and changes criteria for ANVISA's prior approval process

The Ministry of Health has (i) created a new organizational structure to provide technical support for its work on IP in health; and (ii) changed the patent application criteria for pharmaceutical products and processes considered to be of interest under the Public Healthcare System's (SUS) assistance policy and subject to Brazil's FDA (ANVISA) prior approval process, as established in Article 229-C of the Brazilian IP Statute (Law #9,279/1996).

Two advisory bodies were also created: The Commission on Intellectual Property in Health (COMPIS) and the Health and Intellectual Property Development Group (GAPIS).  Both entities are free from the control of any secretariat and are tasked with providing direct technical support to the Ministry of Health.  As such, they are administratively equivalent to the National Council of Health, the National Council of Supplementary Health, and the National Commission of SUS Technology Incorporation.

These changes were enacted through Ordinance #2,466/2020, published on October 15, 2020.

The Science, Technology, Innovation and Strategic Health Supplies Secretariat (SCTIE) is responsible for coordinating the organizational and operational logistics of COMPIS and GAPIS.  The SCTIE is responsible for scientific development and health innovation policies, acting in support of research and pharmaceutical assistance .

Although the Ordinance is already in force, COMPIS and GAPIS are not yet active as representatives must still be appointed and rules of operation approved. The Ordinance did not specify a date for the beginning of the bodies' activities, but it is expected that the administration will move in the coming weeks.

Commission on Intellectual Property in Healthcare (COMPIS)

Responsibilities

COMPIS' responsabilities are extensive, and include: (i) implementing IP health policies ; (ii) proposing priority areas for mappings, assessments, and management actions; (iii) providing technical observations to assist the Ministry of Health's participation in joint ministerial committees related to the theme, in particular, the Joint Ministerial Group on Intellectual Property (GIPI); and (iv) promoting social engagement.

One of the roles of COMPIS is to provide support to the Ministry of Health in decisions regarding requests for priority examinations in the Brazilian Patent and Trademark Office (BRPTO). This responsibility is related to the amendments made by Ordinance #2,466/2020 in the criteria for pharmaceutical products and processes patents applications considered to be of interest under the SUS' assistance policy and, therefore, subject to ANVISA's prior approval analysis, currently regulated by article 12, Chapter III, Annex XXVII of Ordinance #2/GM/MS.

Under the previous system, the designation of a patent application being of interest to SUS was made according to the application's therapeutic usage (vaccines, antivirals, and antiretrovirals, neglected diseases, degenerative diseases, etc.). With the amendment of Ordinance #2,466/2020, the requirement related to therapeutic usage was maintained, with some inclusions (diseases of the respiratory, digestive, circulatory systems and rare diseases) and exclusions (neglected diseases), with the possibility that the Ministry may include other therapeutic usages (article 12, sole paragraph). Patent applications related to products obtained through biological means were also excluded. However, the most substantial change was the inclusion of three new criteria, expanding the scope for a designation of interest.

Thus, the new wording of Article 12 establishes a list of four alternative and independent requirements. To be characterized as of interest, the patent application for a product and pharmaceutical processes must now meet one of the following criteria:

a) Being the subject of a request for priority examination by the Ministry of Health to BRPTO;

b) The technology related to the patent application being the subject matter of a lawsuit to obtain access to the drug, upon request from the Ministry of Health to ANVISA;

c) Being related, based on technological prospects, to an area relevant to the actions of the Ministry of Health;

d) Being selected by ANVISA, according to therapeutic use, from among the following groups: (a) infectious and parasitic diseases; (b) diseases of the respiratory system; (c) diseases of the nervous system; (d) rare diseases; (e) diseases of the digestive system; (f) diseases of the blood or blood-producing organs; (g) diseases of the immune system; (h) diseases of the circulatory system; (i) neoplasms; and (j) vaccines and serums.

COMPIS will play a significant role in shaping the first requirement by assisting the Ministry of Health to set priorities for examination. Although the commission's decision is not binding, the body's technical nature guarantees the significance of any technical opinion issued. Any contrary decision taken by the Ministry will require adequate justification to overrule the technical position adopted by COMPIS.

Composition and Function

COMPIS will be composed of 13 representatives from a range of relevant federal public administrative bodies and entities. The formal nomination of representatives has not yet taken place, and there is no indication when the process will be completed.

Each representative will be appointed by the Director of the contributing body or entity and titled by an act of the Secretary of Science, Technology, Innovation, and Strategic Health Supplies.

Members from civil society with proven knowledge in IP related matters will be allowed to participate in COMPIS' meetings, through special invitation, to assist in debates, but without the right to vote. The Ordinance did not define the rules for inviting external participants, but the commission's rules should regulate the matter.

Composition of COMPIS
Agency or Entity Nº of representatives
Secretariat of Science, Technology, Innovation and Strategic Health Supplies (SCTIE/MS) 2
Health Surveillance Secretariat (SVS/MS) 1
Specialized Health Care Secretariat (SAES/MS) 1
Primary Health Care Secretariat (SAPS/MS) 1
Indigenous Health Special Secretariat (SESAI/MS) 1
International Health Affairs Advisory (AISA/MS) 1
Oswaldo Cruz Foundation (FIOCRUZ) 1
National Cancer Institute (INCA) 1
National Institute of Cardiology (INC) 1
National Institute of Traumatology and Orthopedics (INTO) 1
National FDA (ANVISA) 1
National Commission of Research Ethics (CONEP) 1

The representatives will ordinarily meet twice a year or, on an extraordinary basis, whenever called by the coordinating body. They will also send an annual report of their activities to the Ministry of Health.

Health and Intellectual Property Development Group (GAPIS)

Responsibilities

The responsibilities assigned to GAPIS fall into two groups .

The first group includes responsibilities directly related to the Ministry of Health, which involve screening and formulating technical subsidies. According to the Ordinance, these include: (i) prospecting and identifying pharmaceutical products and processes patents applications; and (ii) assisting the Ministry of Health in decisions regarding requests for priority exams in the BRPTO.

The second group is comprised of residual and general responsibilities directly related to the role of COMPIS. Item III of Article 14-B only provides that GAPIS will "assist the Commission on Intellectual Property in Health (COMPIS)." There are no defined parameters for these responsibilities.  However, this legal provision indicates a degree of connection between both bodies and potential interaction between them in determining subsidies to the Ministry of Health. GAPIS' rules may yet define the exercise of this responsibility in more detail.

Composition and Function

GAPIS will be composed of 6 representatives, equally divided between the Secretariat of Science, Technology, Innovation and Strategic Health Supplies (SCTIE), and ANVISA – specifically from the agency's Second Board of Directors responsible for Coordinating the Intellectual Property and General Management of Medicines and Biological Products.

Composition of GAPIS
Agency or Entity Nº of representatives
Secretariat of Science, Technology, Innovation and Strategic Health Supplies (SCTIE/MS) 3
Coordinator of Intellectual Property and General Management of Medicines and Biological Products (ANVISA's Second Board of Directors) 3

GAPIS will not operate in the same model as COMPIS with a pre-defined schedule of ordinary and extraordinary meetings. Instead, their meetings will be convened at their coordinator's discretion, without a fixed timetable defined by the Ordinance.

In addition, we provide a table comparing the responsibilities of the two new bodies, available here; and an organizational chart for the Brazilian Ministry of Health, available here.

For more information, please contact us at info@lickslegal.com.

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