Key contacts

Jean-Christophe Top

Lawyer

DLA Piper Brussels

T: +32473191519[email protected]
Geoff Mowatt

Partner

DLA Piper Toronto

T: +14 168 623 375[email protected]
Marco de Morpurgo

Marco de Morpurgo

Partner, Global Co-Chair, Life Sciences sector (International)

DLA Piper Rome

T: +39 066 888 0520[email protected]
Marco de Morpurgo

Marco de Morpurgo

Partner, Global Co-Chair, Life Sciences sector (International)

DLA Piper Rome

T: +39 066 888 0520[email protected]
Line Voldstad

Line Voldstad

Partner, Head of Regulatory and FPR

DLA Piper

T: +47 24 15 13 00[email protected]
Michaela Stessl

Michaela Stessl

Country Managing Partner

DLA Piper Bratislava

T: +42 125 920 2142[email protected]
Argentina

Argentina

Topic Details
Relevant statutory law(s)

Law 16,463
Prohibits any form of public advertising of products whose sale has only been authorized "under prescription." Such advertising should only be directed to HCPs.

Resolution of the Ministry of Health 627/2007
Based on the prohibition set by Law 16,643, Resolution 627/2007 establishes Good Practices for the Promotion of Prescription Drugs among HCPs.

Disposition of the National Administration of Drugs, Food and Medical Technology (ANMAT) N°6516/2015 
It establishes that the companies holding prescription-only medicines must notify ANMAT of the promotion of medicines directed at HCPs, along with the corresponding promotional material, such material to be presented in a specific format.

Industry code(s) of conduct

Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME)

This Code outlines the principles and general guidelines governing interactions between CAEME members and healthcare professionals (HCPs). CAEME is a private chamber comprised of multinational laboratories, and the provisions of this Code are mandatory solely for its members.

The Code covers various topics concerning the interactions between HCPs and laboratories, including:

  • Promotion of Medicinal Products.
  • Promotional Material.
  • Use of Reference Quotations.
  • Promotional and other Medical Utility Items.
  • Visits to Physicians and Pharmacies.
  • Scientific, Educational or Continuing Medical Education Activities.
  • Services provided by Healthcare Professionals.
  • Clinical Research.
  • Market Research.

Local laboratories are primarily organized under a different chamber, CILFA, which does not impose these principles.

Other Not applicable.

Last modified 17 Oct 2024

Argentina

Argentina

Topic Details
Competent authority/authorities enforcing the above statutory law(s)

Argentinian Ministry of Health (AMH)
Among its objectives, the AMH is responsible of supervising everything related to the production, distribution and marketing of medicinal products, biological products, drugs, dietary products, foods, insecticides, toiletries, mineral waters, medicinal herbs and medical application materials and instruments.

National Administration of Drugs, Food and Medical Technology (ANMAT)
Through its Institutional Relations and Advertising Regulation Division, ANMAT is in charge of ensuring compliance with advertising regulations by monitoring and supervising all advertising communications for products subject to health surveillance.

Competent authority/authorities enforcing the above code(s) of conduct

Argentine Chamber of Medical Specialties (CAEME)
CAEME is a private Chamber whose members are multinational laboratories, and the provisions of its Code of Good Practices are mandatory exclusively to them. Local laboratories are principally gathered in another chamber, CILFA, which does not have such principles.

Competent authorities enforcing any other provisions indicated above Not applicable.

 

Last modified 17 Oct 2024

Argentina

Argentina

Topic Detail
Restrictions on event locations (e.g., events abroad, touristic locations, mountain or beach locations during winter/summer season, etc)

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to Event Location:

Companies that are members of CAEME cannot organize or sponsor events outside Argentina (international events) unless this makes more sense from a logistics and/or security viewpoint, such as that the majority of invited participants are foreigners and/or multiple countries participate or that a relevant resource or expertise that is the main purpose of the event is located abroad. If international events are organized or sponsored, in addition to the CAEME Code, member companies must also observe the specific provisions of the Codes of Practice of the country in which the event is held.

Last modified 17 Oct 2024

Argentina

Argentina

Topic Details
Restrictions or requirements regarding event venues (e.g., resorts, castles, SPAs, proximity to transport connections or centers with relevant medical expertise, etc)  

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to Event Venue:

All events should be held in an appropriate venue that is conducive to the scientific or educational objectives and the purpose of the event or meeting. Companies that are members of CAEME should avoid using luxurious venues. Hospitality must not include the sponsorship or organization of entertainment or leisure activities (such as sports events, music events or other).

When companies that are members of CAEME organize or participate in events, this fact must be disclosed in all documents regarding the invitation as well as in any published paper, speech or document related to such event. Companies that are members of CAEME must duly document, pursuant to their internal procedures, any transfer of value, they directly or indirectly make to the healthcare system stakeholders. This includes, among other, fees paid for services provided, collaboration given for the organization of scientific and professional events, expenses for hospitality offered due to an event, comprising travel, registration, accommodation and meals expenses, and the provision of scientific or medical publications.

Last modified 17 Oct 2024

Argentina

Argentina

Topic Details
Restrictions or requirements regarding accommodation provided to HCPs (e.g. five star hotels, maximum number of nights, minimum duration of events, etc.)

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to Accomodation:

Accomodation expenses must be reasonable and limited to the days on which the scientific or professional event is planned to be held. Accomodation cannot be extended beyond a reasonable period after the Event.

Companies that are members of CAEME should avoid providing luxurious accomodations. Hospitality must not include the sponsorship or organization of entertainment or leisure activities (such as sports events, music events or other).

Last modified 17 Oct 2024

Argentina

Argentina

Topic Detail
Restrictions on air travel (e.g. economy class only; minimum flight duration for business class)

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to travel expenses:

Payment of reasonable fees and reimbursement of out-of-pocket expenses related to the Events, including travel for speakers and moderators at meetings, conferences, symposia and similar scientific or professional events, is acceptable. Travel expenses must be reasonable and limited to the days on which the scientific or professional event is planned to be held. There are no specific rules or restrictions on air travel.

Restriction on train transportation (class; duration; etc.)

The principles related to air travel also apply to train transportation. There are no specific rules or restrictions on train transportation.

Other restrictions regarding travel Not applicable.

Last modified 17 Oct 2024

Argentina

Argentina

Topic Details
Limitation on providing meals (e.g. only refreshment for events lasting for half a day or more)

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to meal expenses:

Payment of reasonable fees and reimbursement of out-of-pocket expenses related to the Events, including meals for speakers and moderators at meetings, conferences, symposia and similar scientific or professional events, is acceptable. Meal expenses must be reasonable and limited to the days on which the scientific or professional event is planned to be held.

Maximum value for meals (e.g., EUR 60) – please specify by meal (breakfast, lunch, dinner) where applicable The principles related to meal expenses described in the first box, also apply to this point.
Restrictions on where meals can be provided? (e.g. no Michelin-starred restaurant) The principles related to meal expenses described in the first box, also apply to this point.
Other restriction (e.g. no alcohol may be offered) The principles related to meal expenses described in the first box, also apply to this point.

Last modified 17 Oct 2024

Argentina

Argentina

Topic Details
Rules applicable to family members travelling together with HCPs to the event location.

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to family members:

Hospitality offered by companies that are members of CAEME should not be extended to persons other than HCPs.

Last modified 17 Oct 2024

Argentina

Argentina

Topic Details
Rules originally designed for traditional events (described in previous points) but applicable also to online conferences

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines related to traditional Events, which are also applicable to online conferences:

When member companies organize or participate in events (including online Events), this fact must be disclosed in all documents regarding the invitation as well as in any published paper, speech or document related to such event. This includes any documents, papers or speeches published in the website platform running the Event.

Additional rules applicable specifically to online conferences (incl. communication / advertising rules in relation to events attended by multinational audience) No specific rules.

Last modified 17 Oct 2024

Argentina

Argentina

Topic Details
Specific rules applicable to promotional events organized by/on behalf of MAH in comparison to independent scientific events described in previous points (incl. event location, venue, accommodation, transport, meals, family members, online conferences

Events are neither legislated nor regulated by local authorities. The Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) described in previous points (incl. event location, venue, accommodation, transport, meals, family members, online conferences), apply also to Promotional Events.

No medicinal product or therapeutic indication may be promoted prior to approval by the competent regulatory authority, ANMAT.

At Promotional Events, any material and/or information related to medicinal products and their uses, sponsored by a company, should clearly indicate that it has been sponsored by such company.

Whenever a member company finances, ensures, or directly or indirectly organizes the publication of promotional material related to Promotional Events, it should be expressly stated that such material and/or information is not presented as an independent editorial topic, and the sponsoring company should be included in a visible place.

Information on medicinal products should be accurate and not misleading, precise, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. Information should be based on an adequate evaluation of scientific evidence and clearly reflect that evidence; and it should not mislead by distortion, undue emphasis, omission or in any other way.

Promotion should be supported by scientific studies and the qualities of the medicinal product and not by the weaknesses of competitors. Comparison will be acceptable provided it is objective, true and does not contain statements affecting the reputation of third parties. Comparisons must be drawn on analogous or comparable products and should have scientific backing in a publication.

No gifts, bonuses, benefits in cash or in kind, or incentives may be given, offered or promised to healthcare professionals to induce prescription, recommendation, dispensation, supply, sale, administration or consumption of medicinal products.

Gifts for the personal benefit of HCPs (including, but not limited to, entertainment CDs and/or DVDs, sports or entertainment tickets, electronic items, cultural items, among other) should not be offered to HCPs.

Promotional items offered at events must be related to scientific and/or educational activities attended by HCPs such as items serving as containers of scientific information and/or that may be used by the HCP at the event. Moreover, promotional aids that can be delivered in the course of medical visits may also be offered at events.

Last modified 17 Oct 2024

Argentina

Argentina

Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to medical devices that can be offered or delivered to HCPs at Events:

Companies that are members of CAEME may offer or deliver medical utility items or devices provided they have a modest value, they are not items that the HCP should provide for itself or should be provided by the institution in which it exercises its regular professional activity and are beneficial to the improvement of the provision of medical services or patient care. These items may not be offered more than two times per year per HCP. Medical utility items may include the name or logo of the member company but not the name of the product, unless the name of the product is essential for the correct use of the item by the patient.

Companies that are members of CAEME may provide information or educational items to healthcare professionals for their education or for the education of patients on diseases and their treatments, provided such items are mainly intended for educational purposes. Information or educational items may include the name or logo of the member company but not of a product, unless the name of the product is essential for the correct use of the item by the patient.

Last modified 17 Oct 2024