Criteria are established for the promotion and advertising of pharmaceutical products, medical devices and sanitary products
On July 9, 2020, through Ministerial Resolution No. 474-2020-MINSA, the Ministry of Health adopted the Sanitary Technical Standard No. 162-MINSA/2020/DIGEMID (hereinafter referred to as the Technical Standard) establishing ethical criteria for the promotion and advertising of pharmaceutical products, medical devices and sanitary products (hereinafter referred to as the Products).
As can be seen from the aforementioned Technical Standard, its purpose is to contribute to the protection of the health of the Peruvian population, through the ethical and responsible promotion and advertising of the Products, as well as to optimize their rational use.
Preliminarily, it is important to mention that the Act on Pharmaceutical Products, Medical Devices and Sanitary Products – Law No. 29459 – and its Regulations, provide that the promotion and advertising of pharmaceutical products and medical devices authorized for sale under medical prescription must be directed exclusively to health professionals.
Likewise, it must be noted that the only competent authority in advertising matters is INDECOPI, through the Commission for the Audit of Unfair Competition.
Now, in relation to the general aspects established for the promotion and advertising of the Products, among others, the following stand out:
– Expressions that suggest that health may be affected by not using the Products must not be included.
– If there is no technical or scientific evidence, it is forbidden to claim that any of the Products is (i) completely innocuous or safe; and/or, (ii) suggest or claim that one Product is safer or more effective than others.
– The health registration (RS) and/or mandatory health notification (NSO) of the Products must be included in the promotion and advertising.
– Exaggerations or inaccuracies about the therapeutic, nutritional, cosmetic, diagnostic, preventive or any other properties that are not consistent with their RS or NSO must not be included.
– Advertising of over-the-counter products aimed at children or using mechanisms that attract their attention and induce their consumption is prohibited.
– Advertising and promotion on the Internet of prescription pharmaceutical products is prohibited.
– If the advertising and promotion of any Product does not comply with the Technical Standard, the DIGEMID may suggest improvements to the advertisements, without prejudice to the complaint that may be filed with the National Institute for the Defense of Competition and the Protection of the Intellectual Property (“INDECOPI”)
In addition, the Technical Standard establishes specific criteria and provisions for the promotion and advertising of:
(i) Pharmaceutical products sold with and without a prescription.
(ii) Herbal medicines, dietary products and natural therapeutic resources (natural resources and products for use in health, sold with or without a prescription).
(iii) Medical devices.
(iv) Sanitary products (cosmetics, household hygiene and personal hygiene).
(v) In health establishments (public and private), events and activities.
(vi) Free medical samples.
It is appropriate to mention that INDECOPI is the competent authority for advertising; any advertisement shall be analyzed based on the criteria and obligations established in Law No. 1044 – Act on Repression of Unfair Competition – as well as in the applicable case law.
The Technical Standard is mandatory and shall enter into force 90 calendar days after its publication, that is, on October 7, 2020. For more information, please contact Maritza Reátegui (mreategui@estudiorodrigo.com), María del Carmen Alvarado (mcalvarado@estudiorodrigo.com) and/or Daniela Supo (dsupo@estudiorodrigo.com).
