in addition, some specific matters are regulated by administrative regulations issued by the Regulatory Authority, the National Authority of Medicines and Health Products, I.P (“Infarmed”), and the Secretary of State of Health;
The Portuguese Pharmaceutical Industry Association (APIFARMA) approved the following self-regulatory codes:
The self-regulatory codes identified in 1.1 Laws and Self-Regulatory Codes Regulating Advertising on Medicines are ethical standards and they are binding for the APIFARMA’s associated members.
Advertising of medicines is defined in Article 150 (1) of Decree Law 176/2006 of August 30th, as amended, as any form of information, prospection or incentive which is within the scope of, or has the effect of, promoting the prescription, dispensation, sale, acquisition or consumption of medicines in any of the following circumstances:
Portuguese law and regulations do not make a clear distinction between advertising and information. Therefore, the definition of information, for this purpose, must be understood as included in the definition of advertising, once the disclosed information corresponds to the criteria established in Article 150 (1) of Decree Law 176/2006 of August 30th.
However, Article 151, No 1-d) of Decree Law 176/2006 of August 30th foresees that information relating to human health or human diseases, provided that they do not refer, even indirectly, to a medicine, are not subject to the advertising regulation, which deemed to mean that this information is not qualifiable as advertisement. Therefore, disease awareness campaigns and other patient-facing information as long as they comply with the quoted Article 151, No 1-d), are not qualifiable as advertisement.
In addition, APIFARMA’s Code of Ethics, specifically Article 4, No 3, foresees the exclusion from the prohibition of advertising medicines not yet authorised or off-label information the right of pharmaceutical companies to inform the scientific community about the advances in the field of medicinal products and therapeutics, permitting therefore the disclosure of the results of the scientific research they are carrying out for that purpose. Therefore, it deems that data on the advances of scientific research in the field of medicinal products and therapeutics should also be qualified as information, instead of advertising.
Case-by-case analysis is strongly recommended.
Press releases are not specifically addressed by the Portuguese law, regulations or self-regulatory codes. Therefore, the press releases issued by pharmaceutical companies should comply with the general rules applicable to the advertising activity, namely concerning the respective content and the audience.
Comparative advertising of medicines can only be addressed to HCPs and are therefore prohibited from being disclosed to the general public. In accordance with APIFARMA’s Code of Ethics, comparative advertising should be based on relevant and comparable aspects. It cannot be misleading, defamatory and the comparison of medicines should be based on the medicines’ characteristics specifications, instructions of use, technical documentation or credible clinical data.
The advertisement of unauthorised medicines or unauthorised indications (off-label advertising) is not permitted. However, as explained in 2.1 Definition of Advertising, the dissemination of information on advances of scientific research in the field of medicinal products and therapeutics is permitted, since the constraints mentioned are met. Such information may solely be disclosed to and accessible by the scientific community.
The information mentioned in 2.1 Definition of Advertising may be disclosed to HCPs, in any context, as they are, for this purpose, part of the scientific community.
See 3.2 Provision of Information During a Scientific Conference.
Taking into consideration the prohibition of advertising unauthorised medicines or indications, see 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, providing such information to healthcare institutions for thge purpose of preparing budgets, etc, is not permitted.
Taking into consideration the prohibition of advertising unauthorised medicines or indications and the limits mentioned in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, to publish such information is not permitted. Compassionate use is solely permitted in the scope of clinical trials.
Only non-prescription medicines not under State reimbursement may be advertised to the general public. Advertisement to the general public of prescription-on;y medicines and medicines containing substances defined as drugs or psychotropic substances in the international conventions for drugs and psychotropic substances is forbidden.
Advertising of medicines to the public must be unequivocally identified as such, expressly indicating the specific medicine.
Comparative advertising of medicines before the general public is prohibited.
On the mandatory and prohibited information disclosed in the advertising to the general public please consider the answer to 4.2 Information Contained in Pharmaceutical Advertising to the General Public.
Advertising of medicines before the general public must contain, as a minimum, the following information:
Additionally, it is not permitted to include any element that:
Pharmaceutical companies may, as a general principle, interact with patient organisations. However, such interactions must occur within the limits and constrains established by Decree Law 176/2006 of August 30th and of Apifarma's Code of Conduct, which established several rules on such interactions.
The limits and constrains are generally established to prevent interactions with Patient Associations qualifying as a form of information, prospection or incentive which is within the scope of, or has the effect of, promoting the prescription, dispensation, sale, acquisition or consumption of medicines, in the terms established by Article 150 (1) of Decree Law 176/2006 of August 30th.
Advertisements before HCPs shall include, in a legible way in the respective advertising material, the following:
The information contained in the advertising material must be accurate, updated, verifiable and sufficiently complete to allow the recipient to correctly assess the therapeutic value of the medicine. The references and the illustrative material of medical publications or scientific works used in the advertising support shall be correctly reproduced and should mention the respective source.
Advertisements may refer to data or studies not mentioned in the summary of product characteristics, provided that the information complies with that mentioned in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals, and, therefore, once no contradiction is found between the summary of product characteristics and the information provided on the data on file and on the clinical studies.
Since combined aadvertising would be qualified as off-label advertising, which is prohibited as explained in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, any reference to a combination of products or companion diagnostics not included in the summary of product characteristics is not admissible.
In Portuguese law or regulations there are no specific rules regarding the reprinting of journal articles. However, and assuming that the reprints are of scientific journal articles, it is believed that such reprints may be provided if referring to human health and diseases or to scientific information relevant to the practice of medicine.
The activity of Medical Science Liaisons (MSLs( is not specifically regulated by Portuguese law or regulations. However, regardign MSLs, pharmaceutical companies should comply with the general rules applicable to the advertising activities already described.
The market holders, or holders of medicine registers, are required to submit one sample of each advertising material concerning each medicine within ten days of respective distribution starting dates.
In the context of the sponsorship of congresses, symposia or any actions or events with scientific nature or aimed to directly or indirectly promote medicines, the sponsor company must communicate the sponsorship to Infarmed ten business days before the event.
Vaccination campaigns or promotional campaigns of generic medicines before the general public are to be approved beforehand by Infarmed. If not, such campaigns could be classified as prohibited advertising activity.
Pharmaceutical companies are not legally required to establish standard operating procedures (SOPs) governing advertising activities. However, they are required have a scientific service responsible for the information related to medicines and for maintaining complete and detailed records of all the advertising of medicines with indications of the target audience, channel and date of first dissemination. The same scientific service must ensure that the advertising activities comply with all the obligations imposed by law and codes and that the medical sales representatives have appropriate professional qualifications.
The scientific service should keep advertising records for a five-year period and should make such records available for consultation or inspection by the local regulatory authority. The scientific service is also required to cooperate with such authority and other competent authorities in all that is deemed necessary within the scope of the authorities’ respective legal powers. The scientific service should preferably be supervised by a qualified person (a physician or a pharmacist, as established by Article 3 of APIFARMA’s Code of Ethics).
Decree Law 176/2006 of August 30th expressly addresses advertising on the internet. However, it should obviously follow the general rules applicable to the advertising activities better described perviously.
In addition, local a regulatory authority issued two Informative Circulars establishing specific rules on advertising through the internet and other digital channels. Accordingly, pharmaceutical companies may publish information, accessible by the general public, in the following ways:
Advertising, on websites and social media, of medicines containing substances defined as drugs or psychotropic substances in the international conventions for drugs and psychotropic substances is forbidden.
Pharmaceutical companies cannot use social media to advertise medicines (see 7.1Regulation of Advertising of Medicinal Products on the Internet).
Access restrictions are not specified by law or regulations, however, companies should take all actions needed to ensure access to the information occurs in compliance with the general rules applicable to advertising medicines (before the healthcare professionals and before the general public) described in the previous sections.
Since disease awareness information is out of the scope of the advertising activities regulation (see 2.1 Definition of Advertising), companies may provide disease awareness information to patients online as long as the general rules are met (namely in what concerns to the absence of any direct or indirect reference to a medicine).
Online scientific meetings are not specifically regulated in the Portuguese law or regulations, therefore, they are subject to the general rules applicable to the conventional scientific meetings and to the rules applicable to the advertising activities in general.
Concerning the international or national nature of online scientific meetings, despite a lack of legislation, they are held in accordance with local practice and local regulatory authority understanding. If the promoter/organiser of such meetings is a national entity, the same should comply with the applicable local law and regulation on advertisement and on conventional scientific meetings principles.
The anti-bribery rules applicable to the interactions between pharmaceutical companies, healthcare professionals and healthcare organisations are, in general, the rules defined in the Portuguese Criminal Code and specific legislation on anti-bribery, which are applicable to both sectors: public and private.
According to the Portuguese law, as a general rule (Article 158 (1) of Decree Law 176/2006 of August 30), the marketing authorisation holder, the company responsible for the information or promotion of a medicine, or the wholesale distributor are prohibited from giving or promising, directly or indirectly, to health professionals, or their patients, prizes, offers, bonuses or pecuniary or in-kind benefits, except if the same are cumulatively of insignificant economic value (under EUR60) and relevant for the medical or pharmaceutical practice (exceptions are pointed out in 9 Gifts, Hospitality, Congress and Related Payments). The same prohibition falls upon HCPs, which are prevented from receiving such benefits under the quoted Article 158 (2).
In accordance with Article 9 of Decree Law 5/2017 of January 6th, Public Hospitals and Services and Bodies of the Ministry of Health cannot request nor receive directly or indirectly, any pecuniary or in-kind benefit from pharmaceutical companies or health technology companies that impair or may impair its impartiality, except if previously granted with a specific authorisation of local Regulatory Authority.
Any form of inducement to prescribe medicines is forbidden.
Following on from 8.2 Legislative or Self-Regulatory Provisions, pharmaceutical companies may sponsor the participation of healthcare professionals in scientific or educational events, promoted by pharmaceutical companies or by third parties. Such sponsorship is limited to the registration and hosting costs: travel, lodging and meals.
According to the APIFARMA’s Code of Ethics, the support for such costs can only be granted to the HCP(s) who will attend the concerned event and the costs are to be restricted to the main purpose of the event and cannot include entertainment events.
The stay costs cannot surpass the period one day either side of the event, and cannot be locations and/or touristic resorts that are best known for their leisure, entertainment or sports facilities.
The cost of the meals within the national territory cannot exceed EUR60 per meal (EUR90 at international events, except when in this last case, the legislation or the Code of Ethics in effect in a specific foreign country establishes a higher amount for the meal cost, which will therefore be applicable).
In addition to this, pharmaceutical companies only may give pecuniary or in-kind grants or donations to HCPs if the same are cumulatively of insignificant economic value (under EUR60) and relevant for the medical or pharmaceutical practice.
The provision of samples is, under the Portuguese law, subject to the following conditions:
Pharmaceutical companies may sponsor scientific meetings or congresses organised by third parties, even if the same take place abroad. The local Regulatory Authority must be informed of all granted sponsorships in the 10 days before the event.
According to the APIFARMA’s Code of Ethics,a sponsorship must be preceded by a written request from the organising entity, dated and signed, addressed to the pharmaceutical company, specifying the scope and the purpose of the same. A sponsorship of any event must be clearly announced prior to and during the event and must be disclosed in all event documentation, as well as in any information material that may result from the event.
According to the same Code of Ethics, the sponsored events should take place in premises suitable for the main purpose of the event or action, and places and/or developments that are known for their facilities for leisure, entertainment or sport should not be chosen.
Pharmaceutical companies may also support HCPs attendance costs to such events, limited to the registration and hosting costs, see 9.1 Gifts to Healthcare Professionals.
The sponsorship or organisation of cultural, sports or other non-scientific events (even if in relation to scientific conferences) are expressly prohibited.
Besides those referred in 9.1 Gifts to Healthcare Professionals, no other grants or donations are permitted.
Regarding healthcare institutions, it is possible to provide support, both monetary or non-monetary, with the aim of supporting healthcare services, research activities or continuing medical education.
However, in accordance with Article 9 of Decree Law 5/2007 of January 6th, NHS hospitals cannot request nor receive, directly or indirectly, pecuniary or in-kind benefits from pharmaceutical companies, health technology companies or from related companies when such actions may harm the impartiality and neutrality of the hospitals. When impartiality and neutrality are not at risk, a previous authorisation to receive the benefit should be previously requested by the NHS hospital’s management bodies to Infarmed.
Price discounts or rebates are expressly considered as out of scope of the rules on advertising of medicines. However, pharmaceutical companies can offer discounts to healthcare institutions in the context of the established commercial relationship, but not to healthcare professionals, as the companies are prevented to execute sales to the same.
The pharmaceutical companies can enter into professional services agreements with HCPs in order to acquire expert services. HCPs can also be paid for acting as an active participant (speaker, moderator, etc) in a scientific or training event.
In accordance with APIFARMA’s Code of Ethics, the payment to HCPs must be reasonable and reflect the market value of the services to be provided by the same.
Sponsorships of congresses, symposia or any actions or events with scientific nature or aimed to, direct or indirectly promote medicines must be communicated by the sponsor company to Infarmed ten business days before the event.
The market holders or respective local representative must report to local Regulatory Authority all benefits of EUR60 or above, granted to healthcare professionals, healthcare organisations, patient organisations, workers of the National Health Service and bodies or services of the Ministry of Health or of the National Health Service.
Such report is to occur in a specific transparency platform in the following 30 working days counted from the effectiveness of the benefit (payment of the benefit or granting of the benefit in case of granting of goods or rights assessable in cash). The information to be reported is the following: name and data of the beneficiary, nature of the benefit and amount granted.
Beneficiaries shall be notified via email by the local regulatory authority to validate – or not – the receipt of the benefit, case in which the reasoning for the non-validation is to be informed to the Authority. If the recipient remains silent on the reported information, the benefit is considered tacitly accepted.
Benefits are defined in Article 159 of Decree Law 176/2006 of August 30th, as any advantage, value, good or right assessable in cash, regardless of the respective form, as a prize, sponsorship, subsidy, fee, subvention or any other form.
No additional regulations were issued by local regulatory Authorities regarding COVID-19. As such, reports are to be executed within the established legal deadline.
Transparency requirements apply to all market holders or to respective local representatives granting benefits to the individual and entities identified in 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value. Hence, if the market holder is a foreign entity, the report on the granting of benefits to Portuguese HCPs or to entities mentioned in 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value is to be executed.
Companies that do not have any products placed on the market and are not operating under a wholesale distribution licence or register do not fall under the legal provisions on transparency.
The public competent authority for enforcing the rules on advertising is Infarmed – Autoridade Nacional do Medicamento e Produtos de Saúde (National Authority of Medicines and Health Products) I.P.
The self-regulatory body is the Portuguese Pharmaceutical Industry Association (Associação Portuguesa da Indústria Farmacêutica or APIFARMA).
The competent court to decide on any issued related to the rules on advertising depends on the specific claim under decision: as a general rule, the acts issued by Infarmed should be challenged before the administrative courts; however, if it is at stake a sanction decision, it should be challenged before the Competition, Regulation and Supervision Court (according to the available jurisprudence). For the civil liability lawsuits, if applicable, civil courts are competent (see 11.2 Initiating Proceedings for Pharmaceutical Advertising Infringements).
The companies may initiate procedures against competitors before any of the bodies identified in 11.1 Pharmaceutical Advertising: Enforcement Bodies, depending on the specific violation at stake:
The same conduct my be qualifiable as an infringement of the codes and to the law and public regulations. In those cases, procedures before APIFARMA and procedures before Infarmed may be conducted in parallel. The procedures, decisions and penalties are completely separate.
The fines range from EUR2,000, at the minimum, to 15% of the business volume of the infringer or EUR180,000, whichever is lower, at the maximum.
General accompanying sanctions may also be imposed (depending on the seriousness of the infraction and the level of fault):
Accompanying sanctions specifics for the case of infringement of advertising legal provisions may also applied:
There is no relationship between the procedures before or measures taken by the self-regulatory entity and the measures taken by the courts.
APIFARMA is the association of the pharmaceutical industry and supervises and enforces its codes upon its members. The procedures, decisions and penalties have deontological nature and are completely independent of the ones taken by public entities (such as Infarmed or courts).
Infarmed and APIFARMA do not disclose the decisions on advertising or on any other topic concerning infringements of the applicable law and established rules. Therefore, there are no identifiable trends in relation to pharmaceutical advertising.