This country-specific Q&A provides an overview of the legal framework and key issues surrounding pharmaceutical advertising law in Venezuela.
This Q&A is part of the global guide to Pharmaceutical Advertising.
For a full list of jurisdictional Q&As visit http://www.inhouselawyer.co.uk/index.php/practice-areas/pharmaceutical-advertising
What laws are used to regulate advertising on medicines in your jurisdiction?
The regulation of advertising of medicinal products in Venezuela is spread in various domestic legislations as well in international laws.
The main sources for domestic regulation of advertising of pharmaceutical goods are the follow:
- Norms of the Board for Review of Pharmaceutical Products (Junta Revisora de Productos Farmacéuticos - NJRPF) of 1998; and
- The Administrative Resolution of the Health Ministry (Ministerio de Salud y Desarrollo Social – MSDS) for the Promotion and Advertising of Pharmaceutical Products (Normas para la Promoción y Publicidad de los Medicamentos - NPPM) from June 23, 2004.
Both regulations broadly develop the fundamental principles from the Medicines Law (Ley de Medicamentos), limited to pharmaceutical products approved and registered in Venezuela. Additionally, this law contemplates among its objectives, the establishment of an ethical frame for regulating the information, promotion and advertising of medicinal products.
All domestic provisions establish that the promotion and advertising of medicinal products must be conducted in compliance to the rules issued by the Board for Review of Pharmaceutical Products, who is the national authority for granting sanitary permission). Moreover, all advertising must comply the following ethical principles:
- Offering truthful information, without deceiving or exaggerating;
- There must be an ethical-sanitary criteria; and
- Induce to the rational consumption of medicinal products.
All domestic provisions must be in compliance to the “Ethical Criteria for the Medicine Promotion of the World Health Organization” (ECMP – WHO).
Even though the Consumer Protection Act was withdrawn back in 2014, a new Government Agency called National Superintendence for the Defense of Socio-Economic Rights would be entitled to prosecute and sanction any infringement related to the advertising and promotion of pharmaceutical products.
Finally, all advertising on television, radio and digital media is governed by the Law on Social Responsibility in Radio, Television and Electronic Media (Ley Resorte).
Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?
There is a self-regulation body and an arbitration procedure, but it is only applicable to members of the National Advertisers Association (ANDA).
It´d apply only to those companies and their employees engaged into the business of pharmaceutical related products and services member of ANDA
Like an arbitration clause, mandatory only to those who have committed themselves to resolve all disputes through a self-regulatory code.
Is there a statutory or generally accepted definition of “advertising”? a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?
The NPPM defines ADVERTISING as “every way of impersonal communication paid by a sponsor about a product, service and organization, transmitted to the public by means of a social mass media”; and PROMOTION as “every informative, for divulgation, persuasion and recordation activity, developed by manufacturers, distributors and representatives, with the aim of leading to the prescription, dispensation, supply, acquisition or utilization of such products”.
Yes, it´d be under the scope of the definition of promotion.
Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?
Yes, but only related to OTC products. The promotion and advertising of the prescription-only products can be directed exclusively to health professionals, advertising or promotion in non-scientific journals, would be considered as a breach of the Law.
Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?
In Venezuela all advertising must be approved in advance by the Health Ministry along with conjunction with the Board for Review of Pharmaceutical Products.
The approval application must be carried out by the sponsor pharmaceutical submitting all the requirements. The Board will evaluate such application between the fifteen days following the filing of the application.
Do companies have to have material approved by regulatory bodies prior to release?
The regulation only allows the possibility of promoting or advertising medical products without previous authorization, when following form is strictly used:
Pharmaceutical Company device
(Pharmaceutical company’s slogan)
It informs to the health professionals that it is already available in drug stores and pharmacies its product:
XXX mg tablets
Health Registration (EF, PB, PN), No. XXX
For more information contact to:
Pharmaceutical Company XXXX
(Authorized address by MSDS)
Telf.: XXX – Fax: XXX – Web page: XXX
Acquire medicinal products exclusively in the establishments authorized by the MSDS.
Is comparative advertising for medicines allowed and if so, what restrictions apply?
The regulation only allows the comparison between medicines, when the nature of the scientific information therefore allows it, and always it must be endorsed. The comparison will have to become between generic terms and the registered trademarks will never be able to be used, including the medicinal product which is promoted or advertised.
The regulations expressly establish the possibility of basing the promotion and advertising of medicines in price comparisons, as long as such comparison is reliable. Also, it is establish that when the scientific information contained in the advertising or promotion allows the comparison between different medicines, such comparison only can be made using the generic denomination and never the registered trademark, including the one of the product being advertised or promoted.
Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?
Venezuelan regulations expressly prohibit to promote or to advertise non-authorized medicinal products.
Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, an indication of the information that must or must not be included.
OTC products may be promoted and advertised by any social mass media with the previous authorization of the Health Ministry, as long as complying with the conditions or restrictions stated when approved.
The general conditions are: (i) Medicinal product indications; (ii) Dosage and the group which the administration of the medicinal product is directed; and, (iii) Via of administration and way of use. Regarding the restrictions they would be: (i) Unfair competition; (ii) To allege properties to the medicine based on ones it does not contain; (iii) To use the word “innocuous” in relation to the use of the medicine; and, (iv) The use of the word “quality” in relation to the characteristics and the properties of the medicine.
The distribution of free samples of non-prescription and prescription-only medicines to the general public, as a way of promotion is expressly forbidden.
The promotion and advertising of the prescription-only products can be directed exclusively to health professionals, advertising or promoting themselves in non-scientific journals, would be considered as a breach of the Law
Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.
The Venezuelan law does not have a provision regulating interactions between patients or patient organisations and pharma industry. However, if meetings and funding of patients support groups are not with promotional or advertising content and without making express mention of a certain medicine, and it is in benefit of the population, there would not be reason for which it cannot be conducted.
Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example can information about clinical trials, or copies of journal be sent?
There is no express provision that regulates the distribution of papers and/or proceedings of congresses to doctors. However, the information will always have to comply with all the regulations related to clinical and scientific studies necessary to commercialize the medicinal products, in order to guarantee the veracity of the information.
Additionally, it is mandatory that when a pharmaceutical company sponsors educative or scientific activities, it cannot jeopardize the scientific truth, nor the freedom of opinion of the participants.
May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?
The promotion and advertising of medicines can never occur in form of financial or material benefit in favor of the health professionals, or of any other physician or legal person in charge of prescribing and administrating medicines. Consequently, any support to health professionals from the pharmaceutical industry for participating in scientific, educational or international events can never be conditioned to the obligation of promoting or announcing any kind of medicines.
The entertainments or any other gesture of hospitality of the health professionals by a pharmaceutical company in educative scientific events must occupy a secondary place in respect to the primary target of the meeting and have to stay in a modest level.
Are pharmaceutical companies allowed to provide samples to healthcare professionals?
The distribution of free samples of prescription medicines to health professionals, only can be made as consequence of the visit of the representatives of the producer, distributor or representative company of the medicinal product, with the objective of familiarize the professional with such medicine being promoted.
Is sponsorship of scientific meetings or congresses and/or attendance by healthcare professionals to these events? If so, which restrictions apply? Do additional restrictions apply to events taking place abroad?
When a pharmaceutical company sponsors educative or scientific activities, it cannot jeopardize the scientific truth, nor the freedom of opinion of the attendees and speakers.
The sponsor of the attendance of a healthcare professional to an educational or international events may never be conditioned to the obligation of promoting or advertising any kind of medicines.
Any interaction between a physician and a company may be disclosed either at a patient or the Ministry request. However, in any case such interaction should never compromised the physician objectivity.
What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?
No restrictions whatsoever other than the regular limitations for advertising and promotions of either OTC or prescription products.
Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?
It is possible to pay physicians to provide expert services (e.g. participating in focus groups), as long as such payment is not made as a consequence of the promotion or advertising of a medicinal product, and does not compromise the scientific truth or the opinion of the health professional.
Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?
Yes, it is possible. However, the grants or donations cannot be understood by the competent authorities as a form of promotion or advertising of medicinal products, since if that is the case, it would be against the general prohibition of the health professionals to receive financial or material benefits.
Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and/or companies that do not yet have products on the market?
There are no special provisions on this regard, however, any interaction between a physician and a company may have to be disclosed either at a patient or the Ministry request. In any case such interaction should never compromised the physician objectivity
When if at all with a competent authority have to get involved in authorising advertising? Is advertising on the internet (including social media) for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?
All advertising must be authorized unless it complies with the form stated in 6. above. There are no special provisions related to Internet and social media, and hence, same regulation will apply. If special information is intended only to physicians, then access must be restricted.
Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?
No other than common law actions against bribery. Moreover, a physician might be subject to either ethical or criminal sanctions whether it can be supported he failed to provide the best care to a patient due to payments, grants, favours or bribery.
What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?
The promotion or advertising of medicinal products will be only allowed free or below their real value, if related to the health professional or hospitals and offer a benefit for the patient. Otherwise, the discount could be considered as a financial benefit against the provisions of the Board.
Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.
Ministry of Health and criminal courts, only when it can be supported that health of a patient was compromised.
On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?
Administrative actions would have to be lodged and prosecuted before the Ministry of Health (Board for Review of Pharmaceutical Products). The criminal actions must be lodged by the Office of the Attorney General after an investigation conducted by prosecutor after a notitia criminis.
What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?
The Ministry of Health can enforce the following penalties against infringers:
- Verbal reprimand;
- Written reprimand;
- A publication in a mass media of a clarifying/rectification notice;
- Either definitive or temporary suspension (no longer than 1 year) of all products’ advertising or promotion;
- Payment of fines.
What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts/government competent authorities?
There´s no relationship between procedures. In fact, self-regulatory boards are usually a measure of private companies to avoid the intervention of a governmental board into matters that companies would like to resolve in a quiet and private fashion.
Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.
Recently, there has been an alarming increase of lookalike pharmaceutical and personal care products entering the Venezuelan market without any registration whatsoever.
Such infringements have been enforced through the Ministry of Health, who after review the scientific and legal grounds may issue a health alert to the entire Venezuelan population recommending to refrain the use and purchase of a lookalike product.