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 Practice complement this regulation. The
Council of Ethics and Transparency of the Pharmaceutical Industry
(CETIFARMA) has issued the following self-regulatory instruments
(the Codes):
- TheCodeofEthics andTransparencyofthePharmaceutical 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.) that 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.
1.5 Must advertising be approved in advance by a regulatory
or industry authority before use? If so, what is the procedure for
approval? Even if there is no requirement for prior approval in all
cases, can the authorities require this in some
circumstances?
Article 79 of the HLR sets forth that the advertisement of
medicinal products must be approved. Approval applications should
be filed before COFEPRIS. These applications must include all of
the characteristics of the intended advertising.
There is also the possibility of submitting only a notice rather
than an approval application when the advertising is only directed
to healthcare professionals.
The regulations allow companies to have a previous opinion by an
authorised expert. This opinion may be filed along with the
approval application to speed up the process.
1.6 If the authorities consider that an advertisement which
has been issued is in breach of the law and/or code of practice, do
they have powers to stop the further publication of that
advertisement? Can they insist on the issue of a corrective
statement? Are there any rights of appeal?
COFEPRIS has specific authority to order the suspension of an
advertising activity in breach of legal framework. This order has
to be followed by both the responsible party and the media channel
within a term of 24 hours.
COFEPRIS may warn companies with approved products to modify ads
that are presumably in breach of the legal framework. If not
modified, or the modification is considered to not comply with the
legal provisions, COFEPRIS may suspend the advertising activities
and impose a fine.
The decision and orders issued by COFEPRIS may be appealed
before itself or the Federal Courts.
1.7 What are the penalties for failing to comply with the
rules governing the advertising of medicines? Who has
responsibility for enforcement and how strictly are the rules
enforced? Are there any important examples where action has been
taken against pharmaceutical companies? If there have not been such
cases, please confirm. To what extent may competitors take direct
action through the courts in relation to advertising
infringements?
The penalties for failing to comply with the rules related to
advertising are the suspension of advertising activities ordered
either to the responsible party or directly to the media, and the
imposition of a fine to each one, which can range from 2,000 to
16,000 times the minimum wage (around 9,000.00 USD to 73,000.00
USD). The responsibility for imposing these penalties falls
directly on the Ministry of Health, through COFEPRIS.
Regarding the strictness on the imposition of these fines, in
our experience it has been steadily increasing. COFEPRIS constantly
monitors advertising activities throughout the country,
particularly regarding drug-like products. COFEPRIS has been
directing the efforts of coordination agreements related to
publicity, and the enforcement of the same.
There has also been a strong coordinated effort between COFEPRIS
and pharmaceutical companies tending to the self-regulation of
advertising, which is still monitored.
As for any important examples where action has been taken
against over-the-counter pharmaceutical companies, it is worth
mentioning that COFEPRIS has imposed large fines against specific
over-the-counter medication manufacturers for using misleading
advertising related to its products, inciting the public to
self-medicate and taking their products at the first symptom
without consulting a doctor.
Regarding the possibilities for competitors to take direct
actions related to advertising infringements, the HL and the HLR,
regarding advertising, both contemplate the possibility of a
so-called “people’s action”, which is a complaint
filed before COFEPRIS regarding a breach of the provisions of the
law. Issues related to unfair competition will be directly
addressed in question 1.9 below.
The Industry Codes of Practice empower CETIFARMA to supervise
and impose monetary sanctions on members in breach of these
Codes.
1.8 What is the relationship between any selfregulatory
process and the supervisory and enforcement function of the
competent authorities? Can and, in practice, do, the competent
authorities investigate matters drawn to their attention that may
constitute a breach of both the law and any relevant code and are
already being assessed by any self-regulatory body? Do the
authorities take up matters based on an adverse finding of any
self-regulatory body?
COFEPRIS’s supervisory and enforcement functions are
supplemented by the Codes enforced by CETIFARMA. This
self-regulatory process, therefore, does not preclude the statutory
powers of COFEPRIS, which, at its discretion, may or may not take
into account findings from the self-regulatory body
1.9 In addition to any action based specifically upon the
rules relating to advertising, what actions, if any, can be taken
on the basis of unfair competition? Who may bring such an
action?
Actions based on unfair competition derived from advertising
activities can be taken based on the provisions set forth by the
Industrial Property Law before the Mexican Institute of Industrial
Property (IMPI) either by the directly affected party or by the
authority itself.
If there is a firm unfair competition decision, the affected
party can claim damages and lost profits before a Civil Court.
Additionally, Article 32 of the Federal Law for the Protection
of Consumers establishes the possibility of filing a complaint
before the Bureau of Consumer Protection (PROFECO) regarding false
or tendentious advertising, which can impose a fine on the
responsible party and an order to stop the specific advertising
activities.
There is also the possibility of filing a civil action under
article 6 bis of the Commercial Law, which establishes the
possibility of initiating civil actions derived from unfair
competition acts. This action for unfair competition under the
Commercial Law may be applicable for cases that cannot be claimed
before an administrative authority and are not contemplated in the
Industrial Property Law.
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Originally published by ICLG
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
