Contributed By Morais Leitão, Galvão Teles, Soares da Silva & Associados
Legislative Acts
Administrative Regulations
In addition, some specific matters are regulated by administrative regulations issued by the regulatory authority, the National Authority of Medicines and Health Products, IP (Autoridade Nacional do Medicamento e Produtos de Saúde or “Infarmed”), and the Secretary of State of Health.
Self-Regulatory Codes
The Portuguese Pharmaceutical Industry Association (Associação Portuguesa da Indústria Farmacêutica or “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 30 August, 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 laws 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 30 August.
However, Article 151, No 1-d) of Decree Law 176/2006 of 30 August foresees that information relating to human health or human diseases, provided it does not refer to or mention, even indirectly, a medicine, is not subject to advertising regulations, which is deemed to mean that this information does not qualify as advertising. Therefore, disease awareness campaigns and other patient-facing information, as long as they comply with the quoted Article 151, No 1-d), do not qualify as advertising.
In addition, APIFARMA’s Code of Ethics, specifically Article 5, No 4, 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 advances in the field of medicinal products and therapeutics, therefore permitting the disclosure of the results of 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 Portuguese law, regulations or self-regulatory codes. Therefore, press releases issued by pharmaceutical companies should comply with the general rules applicable to advertising activity, namely, concerning the respective content and the audience.
Comparative advertising of medicines can only be addressed to HCPs and is 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 deceitful or defamatory, and the comparison of medicines should be based on the medicines’ characteristics and specifications, instructions for use, technical documentation or credible clinical data, or objective features, such as the price of the medicinal products.
The advertising 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 in 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 on 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 the purpose of preparing budgets, etc, is not permitted.
Taking into consideration the prohibition on advertising unauthorised medicines or indications and the limits mentioned in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, the publishing of such information is not permitted. Compassionate use is solely permitted in the scope of clinical trials.
It is forbidden to advertise the following to the general public: prescription-only medicines; medicines containing substances defined as drugs or psychotropic substances (at international conventions for drugs and psychotropic substances); and medicines under reimbursement by the state.
Advertising of other medicines to the public must be unequivocally identified as such, expressly indicating the specific medicine.
Comparative advertising of medicines to the general public is prohibited.
Regarding what information is mandatory and what is prohibited – in advertising to the general public – see 4.2 Information Contained in Pharmaceutical Advertising to the General Public.
Advertisements for medicines directed at the general public must contain, as a minimum, the following information:
Advertising to the public in general cannot contain any element that:
Pharmaceutical companies may, as a general principle, interact with patient organisations. However, such interactions must occur within the limits and constraints established by Decree Law 176/2006 of 30 August and APIFARMA’s Code of Conduct, which establish several rules on such interactions.
The limits and constraints are generally established to prevent interactions with patient associations that qualify 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 ruled by Article 150 (1) of Decree Law 176/2006 of 30 August.
In this regard, it should be highlighted that APIFARMA’s Code of Conduct prohibits the promotion of prescription-only medicines before a patient association, but foresees that such medicines may be promoted to HCPs who assist or co-operate with patient associations. In the same sense, the events promoted by the industry in which patient association representatives participate, cannot be of a promotional nature. Furthermore, the partnerships, services supply and financial support granted by the industry must be under a written contract. Companies in the industry cannot be the sole financing entity of any of the activities and events promoted by a patient association.
Advertising to HCPs must 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 advertising support must be correctly reproduced and should mention the respective source.
Advertising material 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 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 advertising 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.
See 5.3 Advertising of Combination Products.
In Portuguese law and regulations there are no specific rules regarding the reprinting of journal articles. However, 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.
In accordance with APIFARMA’s Code of Ethics, promotional materials published in any printed or digital means of communication should not resemble independent editorial articles and should be clearly identified as being of an advertising nature (Article 5 (11)).
The activity of medical science liaisons (MSLs) is not specifically regulated by Portuguese law or regulations. However, regarding 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 relating to each medicine within ten days of respective distribution starting dates.
In the context of the sponsorship of congresses, symposiums or any actions or events of a scientific nature or aimed to directly or indirectly promote medicines, the sponsor company must communicate the sponsorship to Infarmedten business days before the event.
Vaccination campaigns or promotional campaigns of generic medicines aimed at 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 to 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 the 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 co-operate with this authority and other competent authorities, in all that is deemed necessary within the scope of the authorities’ respective legal powers. The scientific service should be supervised by a qualified person (a physician or a pharmacist, as established by Article 4 (2) of APIFARMA’s Code of Ethics).
Decree Law 176/2006 of 30 August expressly addresses advertising on the internet. However, this should obviously follow the general rules applicable to advertising activities described previously.
In addition, a local 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 at international conventions for drugs and psychotropic substances, is forbidden.
Access restrictions are not specified by the law or regulations, however, companies should take all the necessary measures to ensure that the general public has no access to advertising intended for HCPs and must ensure that the information disclosed complies with the general rules applicable to advertising medicines (to HCPs and to the general public) described in the previous sections.
Since disease awareness information is beyond 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, the absence of any direct or indirect reference to a medicine).
Online scientific meetings are not specifically regulated under Portuguese law or regulations, but are subject to the general rules applicable to conventional scientific meetings and to the rules applicable to advertising activities in general.
Concerning the international or national nature of online scientific meetings, despite the 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 regulations on advertising and with the principles of conventional scientific meetings.
Pharmaceutical companies cannot use social media to advertise medicines (see 7.1 Regulation of Advertising of Medicinal Products on the Internet).
The anti-bribery rules applicable to the interactions between pharmaceutical companies, HCPs and healthcare organisations are, in general, the rules defined in the Portuguese Criminal Code and specific legislation on anti-bribery, applicable to both sectors: public and private.
According to Portuguese law, as a general rule (Article 158 (1) of Decree Law 176/2006 of 30 August), the marketing authorisation holder, the company responsible for the information or promotion of a medicine, and the wholesale distributor are prohibited from – directly or indirectly – giving or promising HCPs 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 defined in 9. Gifts, Hospitality, Congresses and Related Payments). The same prohibition falls on HCPs, who are prevented from receiving such benefits under the quoted Article 158 (2).
In accordance with Article 9 of Decree Law 5/2017 of 6 January, public hospitals and services and bodies of the Ministry of Health cannot request, or directly or indirectly receive, any pecuniary or in-kind benefit from pharmaceutical companies or health technology companies that either impair or might impair their impartiality, except if previously granted with the specific authorisation of the 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 HCPs in scientific or educational events, promoted by pharmaceutical companies or by third parties. Such sponsorship is limited to the registration and hosting costs, ie, travel, lodging and meals.
According to APIFARMA’s Code of Ethics, the support for such costs can only be granted to the HCP(s) who will attend the event concerned, and the costs are to be restricted to the main purpose of the event and cannot include entertainment events.
The length of stay covered cannot surpass a period of one day either side of the event and the event cannot be held in a location or tourist resort that is best known for its 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 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 may only give pecuniary or in-kind grants or donations to HCPs if the same are cumulatively of insignificant economic value (under EUR60) and relevant to the medical or pharmaceutical practice.
In accordance with APIFARMA’s Code of Ethics, within the scope of the promotion of over-the-counter medicinal products, promotional gifts can be given to healthcare professionals provided they consist of benefits in kind, the value of which does not exceed EUR25, which are cumulatively relevant to their professional activity and/or involve a benefit for the patient (Articles 15 (2)).
The provision of samples is, under Portuguese law, subject to the following conditions:
Pharmaceutical companies may sponsor scientific meetings or congresses organised by third parties. However, even if the same take place abroad, the local regulatory authority must be informed of all granted sponsorships in the ten days before the event.
As established by Decree Law 176/2006, the sponsorship of congresses, symposiums or any actions or events of a scientific nature that directly or indirectly promote medicines, must be mentioned in the promotional documentation of such events, in the documentation to be provided to the attendees and in the documents and reports that might be published after the events. APIFARMA’s Code of Ethics contains similar provisions in this regard.
The Code of Ethics establishes that the sponsored events should take place in premises suitable for the main purpose of the event or action, and that places and/or complexes which are known for their leisure, entertainment, sport, or luxury and extravagant facilities should not be chosen.
Pharmaceutical companies may also support HCPs’ attendance of 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) is expressly prohibited.
Besides those referred to 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 and 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 6 January, NHS hospitals cannot request or receive, directly or indirectly, pecuniary or in-kind benefits from pharmaceutical companies, health technology companies or from related companies where 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 requested by the NHS hospital’s management bodies to the local regulatory authority (Infarmed).
Price discounts or rebates are expressly considered as beyond the scope of the rules on advertising of medicines. However, Article 153 (6) of Decree Law 176/2006 expressly prohibits pharmaceutical companies from advertising discounts to the general public on medicines subject to medical prescription, medicines containing substances defined as drugs or psychotropic substances, and medicines under reimbursement by the state. Pharmaceutical companies can offer discounts to healthcare institutions in the context of an established commercial relationship, but not to HCPs, as the companies are prevented from executing sales to the same.
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. However, the payments cannot constitute financial compensation for the prescription of medicines.
In accordance with APIFARMA’s Code of Ethics, the payment of HCPs must be reasonable and must reflect the market value of the services to be provided by the same.
Sponsorships of congresses, symposiums or any actions or events of a scientific nature or aimed to, direct or indirectly, promote medicines must be communicated by the sponsor company to Infarmedten business days before the event.
The entities under the scope of Decree Law 176/2006, among them pharmaceutical companies, must report to the local regulatory authority all benefits of EUR60 or above, granted to HCPs, 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 be filed via a specific transparency platform within 30 working days following the effectiveness of the benefit (payment of the benefit or granting of the benefit in the 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 will be asked via email by the local regulatory authority to validate – or not – receipt of the benefit. In the case of non-validation, the authority is to be informed of the reason. If the recipient remains silent, the benefit is considered tacitly accepted.
Benefits are defined in Article 159 of Decree Law 176/2006 of 30 August, as any advantage, value, good or right assessable in cash, regardless of whether in the form of a prize, sponsorship, subsidy, fee, subvention or any other form.
Transparency requirements apply to all market holdersor to respective local representatives granting benefits to individuals 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 the entities identified in the previous point, is still required.
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. Such companies are prevented from promoting medicines within the Portuguese market and therefore cannot grant benefits to the individuals or entities mentioned in the previous point.
The public competent authority for enforcing the rules on advertising is Infarmed.
The self-regulatory body is APIFARMA.
The competent court to decide on any issued related to the rules on advertising will depend on the specific claim under decision: as a general rule, the acts issued by Infarmed should be challenged before the administrative courts; however, if a sanction decision on the scope of an administrative offence procedure is at stake, it should be challenged before the Competition, Regulation and Supervision Court (according to the available jurisprudence). For civil liability lawsuits, if applicable, the civil courts are competent (see 11.2 Initiating Proceedings for Pharmaceutical Advertising Infringements).
Proceedings may be initiated before any of the bodies identified in 11.1 Pharmaceutical Advertising: Enforcement Bodies, depending on the specific violation and whether the respective requisites are met in each case:
The same conduct may qualify as an infringement of the law and public regulations, and of APIFARMA's Code of Ethics provisions, in which case, proceedings may be conducted in parallel, making the respective decisions autonomous.
The fines range from a minimum of EUR2,000 to a maximum of 15% of the business volume of the infringer or EUR180,000, whichever is the lower maximum.
General accompanying sanctions may also be imposed (depending on the seriousness of the infraction and the level of fault):
Accompanying sanctions specific to the case of infringement of advertising legal provisions may also apply:
There is no relationship between the procedures before, or measures taken by, the self-regulatory entity and the measures taken by the courts.
As the association of the pharmaceutical industry, APIFARMA has a supervisory function and enforces its codes upon its members. The procedures, decisions and penalties have a deontological nature and are completely independent of the ones taken by public entities (such as Infarmed or the courts).
Infarmed and APIFARMA do not disclose their 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.
Advertising of veterinary medicines is regulated by Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 (the “Regulation”), on veterinary medicinal products.
Advertising of veterinary medicinal products is defined in Article 4 (40) of the Regulation as the making of a representation in any form in connection with veterinary medicinal products to promote the supply, distribution, sale, prescription or use of veterinary medicinal products, and comprising also the supply of samples and sponsorships.
The following rules apply:
The advertising of veterinary medicinal products that are subject to veterinary prescription will only be allowed when addressed exclusively to the following persons:
The advertising of inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals in an epidemiological unit and used for the treatment of that animal or those animals in the same epidemiological unit or for the treatment of an animal or animals in a unit having a confirmed epidemiological link is prohibited.
Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefit in kind may be provided, offered or promised to such persons unless they are cumulatively inexpensive and relevant to the practice of the prescription or supply of medicinal products. On the other hand, persons qualified to prescribe or supply medicinal products may not solicit or accept any prohibited inducement.
This prohibition does not prevent the possibility of offering hospitality, directly or indirectly, in events with exclusively professional and scientific purposes, as long as this hospitality is strictly limited to the main objectives of the event.
Although the advertising rules pointed out above address similar topics to those established for human medicinal products, for instance, in establishing prohibitions and constraints on the advertising of veterinary medicines (promotional actions, provision of samples, granting of benefits, and advertising of veterinary products), the legal framework on human medicinal products is much stricter and more detailed.
The General Directorate for Food and Veterinary Medicine is the enforcement authority for the advertising of veterinary medicines.
Rua Castilho, 165
1070-050
Lisboa
Portugal
+351 21 381 74 00
+351 21 381 74 99
fmatoso@mlgts.pt www.mlgts.pt