GENERIC MEDICINES
Emergency Decree No. 005-2024 was published, which dictates extraordinary measures to guarantee access to generic medicines to the population.
The purpose of this regulation is to guarantee the availability and affordability of generic essential drugs in International Nonproprietary Names in pharmacies and pharmacies of the private sector.
The decree establishes the following obligations for private pharmacies and drugstores:
To offer generic essential drugs in International Nonproprietary Names (INN) contained in the List of Essential Drugs approved by the Ministry of Health. This obligation is limited to those drugs that are part of the supply of brand-name drugs, and does not imply the obligation to expand such supply.
Maintain a minimum stock of 30% of the total supply of each of the generic essential drugs in INN contained in the List of Essential Drugs.
Failure to comply with such obligations constitutes an administrative infraction, punishable by a fine of up to two (2) UIT.
BPM CERTIFICATION – FOREIGN LABORATORIES
Ministerial Resolutions No. 201, 200, 197, 189 and 188 -2024/MINSA authorized the travel of Digemid officials to carry out inspections to laboratories in China, India, Mexico, Brazil and Uruguay, respectively, with the purpose of granting GMP certification.
MINSA
NATIONAL HEALTH PRIORITIES 2024-2030
The “National Health Priorities 2024-2030” prepared by the National Health Council, a consultative body of the Ministry of Health, were published. These priorities have been delineated after an analysis of the health situation and living conditions of the population.
There were 53 proposals for national priorities organized in three dimensions: diseases and damages (ED) with 22 proposals, health services (SS) with 21, and living and working conditions (CVT) with 10.
The proposals indicated in health services:
Deficient supply of the portfolio of services, medicines and supplies for comprehensive care with emphasis on people with diabetes, cancer, rare and orphan diseases, disability, as well as for emergency and disaster response.
Deficient monitoring of pharmaceutical products, medical devices and biomedical equipment necessary for emergency care.
Deficient regulation and oversight of medicines by the corresponding authorities.
Delays in granting sanitary registration for products that have an impact on health.
Poor implementation of the digital government policy with emphasis on data exchange between the platforms of the Minsa-EsSalud healthcare information system and the Integrated Health Networks.
Limited regulatory framework to promote bioethics and high quality ethical clinical research in the country, with emphasis on the production of vaccines and rapid diagnostic methods in the event of a pandemic.
CARE OF PATIENTS WITH DENGUE FEVER
Ministerial Resolution No. 175-2024-MINSA approved NTS No. 211-MINSA/DGIESP-2024, Technical Health Standard for the comprehensive care of patients with dengue in Peru.
The standard is mandatory for private health facilities and establishes provisions for:
The control of sanitary activities in health facilities.
Clinical and laboratory diagnosis and treatment, according to the clinical form of dengue.
Health promotion actions through intergovernmental and intersectoral coordination and citizen participation.
BLOOD BANKS
Ministerial Resolution No. 190-2024/MINSA approved Sanitary Directive No. 156-MINSA/DIGDOT-2024 “Sanitary Directive that regulates the normative framework for the subscription of agreements between health facilities or medical support services that have blood banks”. The previous Directive regulating this matter (Sanitary Directive No. 040-MINSA/DGSP.V.02, approved by Ministerial Resolution No. 468-2015/MINSA) was also repealed.
SENASA
PROHIBITION OF THE ACTIVE INGREDIENT CHLORPYRIFOS
Directorial Resolution No. D0000015-2024-MIDAGRI-SENASA-DIA modified Article 4 of Directorial Resolution No. 0032-2023-MIDAGRI-SENASA-DIA which prohibits the export, manufacture, formulation, marketing, distribution, storage and/or packaging of chemical pesticides for agricultural use containing the active ingredient Chlorpyrifos.
Directorial Resolution No. 0032-2023-MIDAGRI-SENASA-DIAIA prohibited since August 1, 2024, among other things, the marketing, distribution, storage and/or packaging of chemical pesticides for agricultural use or products containing the active ingredient Chlorpyrifos. By means of the present Directorial Resolution No. D0000015-2024-MIDAGRI-SENASA-DIA, this list of prohibited activities was extended, adding export, manufacturing and formulation activities.
DRAFTS
DRAFT REGULATION ON PREVENTIVE MEASURES AGAINST THE EFFECTS OF SOLAR RADIATION
Ministerial Resolution No. 178-2024/MINSA published the draft regulation of Law No. 30102, a law that provides for preventive measures against the harmful effects on health of prolonged exposure to solar radiation.
This regulation would apply to central, regional and local government, and to public and private educational institutions, and to public and private employing entities.
These institutions will have the duty to disseminate the Ultraviolet Radiation Indexes issued by SENAMHI (and the respective prevention measures) and will use the legend “Prolonged exposure (in time) to the sun increases the risk of suffering from diseases such as skin cancer, premature aging, cataracts and other eye diseases, in addition to the weakening of the immune system”.
Articles 9, 10, 11, 12 and 13 establish the various measures to be implemented by public and private educational institutions and public and private employers to prevent the harmful effects of prolonged exposure to the sun on students and workers.
DRAFT TO MODIFY REGULATIONS OF THE NATIONAL CANCER LAW
Ministerial Resolution No. 179-2024/MINSA published the draft Supreme Decree that modifies the Regulation of Law No. 31336, National Cancer Law, approved by Supreme Decree No. 004-2022-SA.
This draft, among others, proposes the following amendments to the Regulation of the National Cancer Law:
It empowers the National Institute of Neoplastic Diseases (INEN), in its capacity as Executing Public Body (OPE), to implement differentiated procurement mechanisms when determined by the General Directorate of Strategic Interventions in Public Health (DGIESP).
It is provided that the National Institute of Health (INS), in coordination with the National Institute of Neoplastic Diseases (INEN), will implement the Tumor Banks that make up the National Network of Tumor Banks (RNBT).
It is provided that the National Institute of Neoplastic Diseases (INEN) will update the Budgetary Program 0024 “Prevention and Control of Cancer”.
The National Institute of Neoplastic Diseases (INEN) is granted the competencies to propose to MINSA norms and guidelines on oncological care.
DRAFT REGULATION OF THE LAW ON RARE OR ORPHAN DISEASES
Ministerial Resolution No. 170-2024/MINSA published the draft regulation of Law No. 29698, Law that declares the treatment of persons suffering from rare or orphan diseases to be of national interest and preferential attention, in order to adapt to the amendments of Law No. 31738.
It should be noted that, in the fifth final complementary provision of the draft regulation, it is stated that the provisions related to the sanitary registration of pharmaceutical products for the diagnosis and/or treatment of rare or orphan diseases (ERH) and oncology, mentioned in article 9 of Law 29698, will be approved by Supreme Decree following the guidelines of the Andean Community and the World Trade Organization.
The draft regulation in question regulates the following topics:
National plan for prevention, diagnosis, comprehensive health care, treatment, rehabilitation, research and monitoring of rare or orphan diseases- PLANDERH.
Prevention of HRE.
Diagnosis and timely treatment of HRE.
Differentiated procurement mechanisms for pharmaceuticals, medical devices and health services.
Research and knowledge management of HRE.
National registry of patients suffering from HRE.
Financing for HRD
Strengthening of the infrastructure and equipment for comprehensive care of HRD.
DRAFT REGULATION OF THE LAW ON ORGAN DONATION
Ministerial Resolution No. 202-2024-MINSA published the draft Regulation of Law No. 31756, Law that promotes the donation of human organs and tissues for transplantation for therapeutic purposes. When said Regulation enters into force, the Regulation of Law No. 2947, approved by Supreme Decree 011-2010-SA, will cease to be in force.
This rule seeks to clarify the definition of presumed donation. It provides that every person is presumed to be a donor, unless otherwise declared. It details the procedure to declare the will not to donate organs and its revocation before the RENIEC, as well as the procedure regarding the declaration to donate formulated by the relatives, and the last will of the donor.
It also details the procedure that health establishments must follow before the General Directorate of Donations, Transplants and Blood Bank (DIGDOT) to obtain an accreditation as a donor and/or transplanting establishment.
Finally, it establishes the creation of “procurement units” (their functions and the requirements for their operation are detailed) in all the establishments that have the UPSSS Intensive Care and UPSSS Emergency. These will be registered in the National Information System on Donation and Transplantation (SINDOT).
DRAFT REGULATION ON THE USE OF MODELING SUBSTANCES IN BODY TREATMENTS FOR AESTHETIC PURPOSES
Ministerial Resolution No. 209-2024-MINSA published the draft Regulation of Law No. 31014, Law that regulates the use of modeling substances in body treatments for aesthetic purposes and defines such procedure as a medical act.
This Draft Regulation establishes the following:
The DIGEMID is the competent authority in the granting of sanitary registrations for modeling substances.
Body treatments will only be performed with modeling substances that have a sanitary registration.
The modification of the anatomy for aesthetic or plastic purposes through the use of modeling substances is considered a medical act; this medical act may only be performed by a registered surgeon specialized in plastic surgery or dermatology.
Only duly registered and categorized establishments are required to provide this service.
Prohibitions on the use and application of modeling substances are specified.
