1 General – Medicinal Products
1.1 What laws and codes of practice govern the advertising of medicinal products in your jurisdiction?
The primary legislation for the advertising of medicinal products is the General Health Law (Ley General de Salud) (HL), and its Regulations (Reglamento de la LGS en materia de Publicidad) (HLR). These norms are supplemented by guidelines published by the Regulatory Agency, the Federal Commission for Protection against Sanitary Risks (COFEPRIS). This agency is part of the Ministry of Health and controls the advertising of medicinal products. Industry Codes of Practices complement this regulation. The Council of Ethics and Transparency of the Pharmaceutical Industry (CETIFARMA) has issued the following self-regulatory instruments (the Codes):
- The Code of Ethics and Transparency of the Pharmaceutical Industry (Code of Ethics & Transparency).
- The Code of Good Practices of Promotion (Code of GPP).
- The Code of Good Practices of Interaction of the Pharmaceutical Industry with Patient Organisations (Code of GPI).
The latest versions of these Codes have been in force since April 1, 2013. Affiliate members of the National Chamber of the Pharmaceutical Industry (CANIFARMA) are required to follow these Codes. CETIFARMA supervises members' and adherents' compliance. There are also opinions issued by the Advertising Council, which include representatives from the Ministry of Health, the academic and scientific communities, the business sector, the media and consumer groups.
Additionally, other general legislation may be relevant for the advertising of medicinal products, particularly, the Federal Law for the Protection of Consumers and the Industrial Property Law.
1.2 How is "advertising" defined?
Article 2 of the HLR defines advertising as, "the activity comprehending any process of creation, planning, execution, and circulation of ads in media channels which aims to promote the sales or consumption of products and services".
An advert is, according to this Article, "the message directed to the public or a section of the same, with the purpose of informing about the existence or characteristics of a product, service or activity for its commercialisation and sale or to motivate a conduct ".
For the Code of GPP, promotion means any activity undertaken, organised or sponsored by a pharmaceutical company or under its authority (subsidiaries, foundations, associations, institutes, agencies, etc.) which supports the prescription, dispensing, sale and acquisition or administration of its medicines, complying with applicable rules, regulations and standards.
1.3 What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as "sign off" of promotional copy requirements?
The Code of Ethics & Transparency requires members to strictly comply with the applicable legal provisions, and their personnel to have at least a broad knowledge of all of the applicable provisions. Concerning advertising and promotional activities, the above Code requires them to give accurate and objective explanations on the characteristics, functions, advantages or disadvantages of their products or services.
The Code of GPP requires that the information provided to healthcare professionals is accurate, balanced, fair and objective, and sufficiently complete to enable them to form their own opinion of the therapeutic value of the medicine.
Under no circumstances can promotional material be distributed in a final version, to which no further amendments will be made, if it has not been certified and authorised by the medical authorities of the laboratory and the person in charge of confirming its compliance with the Codes. These authorities must certify that the material's final form has been examined: that it abides by the provisions of the Code of GPP and by the applicable standards on advertising practices; and that it complies with commercial authorisations and, in particular, with the information of the marketing authorisation in effect. Presentations must be true and faithful to the medicine's stated characteristics.
1.4 Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities or to employ personnel with a specific role? If so, what aspects should those SOPs cover and what are the requirements regarding specific personnel?
The Code of Ethics & Transparency requires members to act in accordance with sound trading practices and in strict compliance with the prevailing legislation. In this regard, members are required to establish the proper measures and monitoring procedures to verify that their associated members abide by the regulations applied to the different activities they perform.
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