Pharmaceutical advertising regulation and medical device advertising in Peru

  1. 1. Which laws are applicable regarding advertising of medicines and medical devices?
  2. 2. Are there any other legal regimes such as self-regulatory codes of conduct that govern the advertising of medicines and medical devices?
  3. 3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?
  4. 4. Does the law in Peru regulate the advertising of prescription-only and over-the-counter medicines differently?
  5. 5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?
  6. 6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?
  7. 7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?
  8. 8. What information must appear in advertisements directed to the general public for medicines and medical devices?
  9. 9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?
  10. 10. Are there specific rules for comparative advertisement of medicines and medical devices?
  11. 11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?
  12. 12. Please describe the enforcement mechanism. Which bodies monitor compliance with the advertisement provisions and what are the legal consequences (e.g. penalties) for non-compliance?
  13. 13. Any future developments in Peru?

1. Which laws are applicable regarding advertising of medicines and medical devices?

In Peru, the advertising regulations of medicines and medical devices are included in:

  • Law on Pharmaceuticals, Medical Devices and Sanitary Products – Law N° 29459;
  • Regulation for the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products – Legislative Decree N° 016-2011-SA;
  • The National Politics of Medicines – Ministerial Resolution N° 1240-2004/MINSA- and
  • The Administrative Directive regulating the activities of medical visitors or other agents of pharmaceutical companies in health establishments – Ministerial Resolution N° 413-2015 / MINSA;
  • Law of Repression of Unfair Competition – Legislative Decree No. 1044;
  • The Code of Protection and Defence of the Consumer – Law No. 29571.

In Peru, the following ethical criteria must be taken into consideration:

  • The Ethical Criteria for the promotion of medicines of World Health Organization – WHO;
  • The Ethical Criteria for the Promotion, Propaganda and Advertising of Medicines of the Pan-American Network for the Harmonization of Pharmaceutical Regulations of WHO – RED PARF;
  • The Andean Ethical Criteria for the Promotion and Publicity of Medicines of the Andean Health Agency of the Andean Community – CAN.

Currently in Peru, there is a proposal for a Technical Health Standard that establishes the Ethical Criteria for the Promotion and Advertising of Pharmaceutical Products, Medical Devices and Health Products. This proposal has been published for comments and it is still in evaluation.

3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?

The advertising of over-the-counter medicines and medical devices does not require prior approval or a licence. The advertising of prescription-only medicines and medical devices is prohibited.

Pharmaceutical companies that wish to advertise their products to health care professionals should request an admission authorisation from their medical visitors or other agents annually before the General Directorate of Health – (“DIGEMID”) or the Headquarters of each public or private health facility.

4. Does the law in Peru regulate the advertising of prescription-only and over-the-counter medicines differently?

Yes, it does.

5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?

For prescription-only medicines and medical devices, the Peruvian Law prohibits advertising directed to the general public. In that sense, the Peruvian Law stipulates that the advertising of these medicines and medical devices must be directed to healthcare professionals and must be carried out through medical visitors or other agents of pharmaceutical companies, who must be duly accredited.

6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

For the advertising of medicines and medical devices to healthcare professionals, medical visitors or other agents of pharmaceutical companies should not interfere with the activities of healthcare professionals with patients in health facilities.

7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?

  • In the case of medicines, the advertising must contain the information on the data sheet filed to obtain the sanitary registry.
  • In the case of medical devices, the advertising must contain its technical report filed to obtain the sanitary registry.

In both cases, such information must be given in a legible, visible, truthful, accurate, complete and updated manner according to the information filed to obtain the sanitary registry.

Also, advertising that disseminates scientific, clinical or pharmacological information must be supported and updated in the medicines and medical devices sanitary registry.

If the announcements about the introduction of prescription-only medicines and medical devices are disseminated in mass written media, they must contain the following information:

  • Name of the medicine or medical devices
  • International Common Name of the Active Pharmaceutical Ingredient – IFA, even if it contains up to 3 Active Pharmaceutical Ingredient(s) – IFA(s), under the name clearly and legibly.
    • In the case of a homeopathic product, the phrase “Homeopathic Product” must be entered, followed by the scientific name of the natural resource used in its formula;
  • Pharmaceutical form;
  • The amount of Active Pharmaceutical Ingredient – IFA (expressed in unit dose or concentration) of each. In the case of a homeopathic medicinal product, the degree of dilution must be recorded;
  • Form of presentation;
  • Sanitary Registry Number;
  • Name, address and / or telephone number of the holder of the sanitary registry, specifically indicating that there is more information available about the product. If the product is imported, it also bears the name, address and / or telephone number of the importer.

8. What information must appear in advertisements directed to the general public for medicines and medical devices?

For advertising over-the-counter medicines and medical devices, it must contain the main precautions and warnings according to its sanitary registries. Also, the advertising of over-the-counter medicines and medical devices that refer to therapeutical prescriptions or the pharmacological action of the product must contain or refer to the main precautions and warnings that must be observed in its uses.

9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?

The scientific data indicated in advertisements must be the same approved in its medical registry and must accord to ethical parameters that will be established by DIGEMID.

10. Are there specific rules for comparative advertisement of medicines and medical devices?

There are no specific rules for the comparative advertisement of medicines and medical devices. However, the Law of Repression of Unfair Competition – Legislative Decree No. 1044 – establishes that comparisons made between competitors and a company’s own products in an advertisement must be objective and pertinent.

11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?

For prescription-only medicines and medical devices, advertising on the internet or social media is not allowed.

For over-the-counter medicines and medical devices, the rules for internet advertising are the same as those for audiovisual and print media, which are the following:

  • Advertising in print media must record the corresponding technical information of the sanitary registry in a visible and legible way, proportionally adjusting to the size of the advertisement. The minimums font size is eight points.
  • The advertising in audiovisual media must record the information of the main precautions and warnings about the pharmaceutical product or medical device, in a clear, legible manner, and with a font size that is perceptible by the viewer. Written legends require a duration proportional to the duration of the advertising.

Finally, email advertising should not encourage self-medication or be misleading.

In Peru, the Bureau of Competition and Consumer Protection – INDECOPI is the authority tasked with enforcing the advertising legislation through the application of penalties, precautionary and corrective measures.

Penalty proceedings for advertising infractions can be initiated ex officio at the initiative of INDECOPI or at the request of a party through a claim that may be filed by consumers, competitors or an authority such as DIGEMID.

In the case of fair competition infractions, the Commission of Repression of Unfair Competition of the INDECOPI is the supervisory body for advertising infractions. In these cases, the penalties for advertising infractions range from a maximum of USD $ 62 000.00 (approx.) for minor infractions, USD $ 309 000.00 (approx.) for serious infractions and USD $ 865 000.00 (approx.) for very serious infractions.

On the other hand, while commercial advertising is understood as a supplier’s commitment to the consumer, the Commission for the Protection of the Consumer is the supervisory body that deals with how consumers are affected by misleading advertising.

Penalties for advertising infractions range from a maximum of USD $ 62 000.00 (approx.) for minor infractions, USD $ 186 000.00 (approx.) for serious infractions and USD $ 556 000.00 (approx.) for very serious infractions.

Also, the bureau of medicines and medical devices, DIGEMID, is tasked with monitoring the compliance of the medicines and medical devices legislation.

13. Any future developments in Peru?

The Commission for the Suppression of Unfair Competition of INDECOPI has published the proposal for an Informative Guide on Digital Advertising, especially focused on advertising by influencers. Currently, the Commission is collecting opinions in order to prepare a final draft of the Guide.

Picture of Marite Aragaki
Marite Aragaki
Partner
Lima
Picture of Maria Delia Oxley
Maria Delia Oxley
Partner
Lima