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...