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AMERICAS: ARGENTINA

StrictER Rules on Advertising of Prescription Drugs in Argentina
Author: Dámaso A. Pardo, Pérez Alati, Grondona, Benites, Arntsen & Martínez de Hoz (h)

Argentina has strict criteria in respect to the advertising of prescription drugs. In such respect, advertising of prescription-only medications directed to the general public is prohibited by Article 19 of Law Nº 16.463. It is worth mentioning that Disposition Nº 4980/2005 (Annex IX “GLOSARY”) defined “Advertising” as: “a technique which, when applied in an organised way through mass media, is generally aimed at informing of or promoting the characteristics, benefits or qualities of goods and services to achieve its purchase by consumers and users”.

A recent Resolution issued by the Ministry of Health and Environment on June 2007 provides for new restrictions.  In effect, Article 3 of Resolution 627/2007 issued by the Ministry of Health and Environment bans the advertisement of prescription-only medicines which have not been approved of by the Argentine health authorities.

The new Resolution 627/2007 also governs the distribution of scientific papers and/or proceedings of congresses to doctors. Article 4 of Resolution 627/2007 provides that advertising directed to health professionals allowed to prescribe medications should include technical-scientific information in order to enable them to learn the therapeutic properties of the medication, and shall include: (i) essential information of the drug, such as: generic name and commercial brand,; quantitative and qualitative composition,; therapeutic form;, indication;, contraindications;, adverse effects;, warnings;, precautions;, doses;, and name and address of the company; and. (ii) its prescription regime and the selling conditions.

Article 6 of Resolution 627/2007 provides that promotional material directed to health professional shall not be accessible to the general public. Moreover, Article 12 of said resolution states that all announcements, ads and promotional messages shall be made exclusively in publications or events of scientific divulgation directed only to health professionals who are able to prescribe or sell medications, excluding all other means of communication accessed by or directed to the general public.

Although Argentine legislation admits providing free samples only when they are delivered directly to health professionals qualified to prescribe medications,   Resolution 624/2007 (ANMAT) set forth the following restrictions:

a. Promotional presentations, such as free samples, must only be provided to persons qualified to prescribe medicinal products.
b. The promotional presentations (including free samples) must be identified both by the generic drug and the commercial name (trademark). Those presentations must contain brief information content in label and inside leaflet concerning: indications, dosages, adverse effects, contraindications and avoid including promotional expressions.
c. Suppliers must maintain an adequate system of control and accountability of the free samples given.
d.It is forbidden to provide samples of medications containing psychoactive or narcotic substances and medications that may cause addiction.

Pharmaceutical companies may sponsor continuing medical education programmes for health professionals.  

According to Resolution 627/2007 (Section 16), pharmaceutical companies are allowed to finance or offer training courses and scholarships to health professionals, under the following conditions:

• That they previously inform professionals of the conditions for accessing grants and the procedures for applicants’ selections with fair and transparent mechanisms for their granting. 
• That selection of professionals is carried out by Academic Committees or the Head of Departments or Services as appropriate.
• No scholarship shall depend on prescribing a certain product