Pharmaceutical Advertising 2024

Last Updated March 07, 2024

Portugal

Law and Practice

Authors



Morais Leitão, Galvão Teles, Soares da Silva & Associados is a leading, full-service law firm in Portugal with a solid background of decades of experience. Its reputation among both peers and clients stems from the excellence of the legal services provided. The firm’s work is characterised by unique technical expertise, combined with a distinctive approach and cutting-edge solutions that often challenge some of the more conventional practices. Morais Leitão’s team consists of over 250 lawyers spread between its headquarters in Lisbon and additional offices in Porto and Funchal. Due to its network of associations and alliances with local firms and the creation of the Morais Leitão Legal Circle in 2010, the firm can also offer support through offices in Angola (ALC Advogados), Cabo Verde (VPQ Advogados) and Mozambique (MDR Advogados).

Legislative Acts

  • Decree Law 176/2006 of 30 August, as amended, which establishes the legal regime applicable to medicines;
  • Decree Law 5/2017 of 6 January, which establishes the advertising principles and a prohibition on National Health Service (NHS) hospitals from requesting and receiving benefits from the pharmaceutical industry and from other health technologies companies, except if suchreceipt is previously authorised by the competent authority (local regulatory authority) and does not harm their impartiality and neutrality; and
  • Decree Law 330/90 of 23 October, as amended, which approves the Advertising Code.

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 Code of Ethics for Promotion Practices of the Pharmaceutical Industry and Interaction with Healthcare Professionals and Health Organisations;
  • the Code of Conduct for the Relations between the Pharmaceutical Industry and Patient Associations, Patients’ Advocates, Patients’ Experts, Patients and Caregivers; and 
  • the Code of Good Practice for Communication.

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: 

  • before the public in general; 
  • before wholesale distributors and healthcare professionals (HCPs); 
  • through the visit of medical sales representatives to HCPs;
  • through the provision of samples or commercial bonuses to wholesale distributors and HCPs;
  • through the granting, offer or promise of pecuniary or in-kind benefits, except when their value is insignificant; 
  • through the sponsorship of promotional meetings attended by HCPs;
  • through the sponsorship of congresses or meetings of a scientific nature attended/participated in by HCPs, namely, through the direct or indirect payment of the respective hosting costs; and 
  • through reference to the commercial name of a medicine.

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: 

  • the name of the medicine, as well as its common name, if the medicine contains only one active substance, or the brand; 
  • essential information on the rational use of the medicine, including therapeutic indications and special precautions; and
  • advice to the user to carefully read the information on the packaging and in the leaflet, and a warning about the need to consult a physician or pharmacist in case of doubt or persistence of symptoms.

Advertising to the public in general cannot contain any element that:

  • leads to the conclusion that a medical consultation or surgery is unnecessary, in particular, by offering a diagnosis or by suggesting treatment by mail;
  • suggests that the effect of the medicine is guaranteed without adverse reactions or secondary effects,with superior or equivalent results in comparison to another treatment or medicine;
  • suggests that the average health condition of a person may be harmed if the medicine is not used, except in the case of vaccination campaigns approved by the local regulatory authority;
  • is exclusively or mainly targeted at children;
  • refers to recommendations of scientists, HCPs or other individuals who could, because of their celebrity status, encourage the consumption of the medicinal products;
  • treats the medicinal product as a food, cosmetic or body hygiene product or as any other product;
  • suggests that the safety or efficacy of the medicine derives from it being a natural product;
  • induces an incorrect self-diagnosis, by a description or detailed representation of a person’s medical history;
  • refers, in an abusive, daunting or misleading way, to statements or guarantees of recovery; and
  • uses, in an abusive, daunting or misleading way, visual representations of human body changes caused by diseases or lesions, or by the effect of a medicine on a human body or parts of it.

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 name of the medicine; 
  • the essential information compatible with the summary of product characteristics (“SmPC”); 
  • the classification of the medicine concerning the dispensation regime of the same, namely, if it is a prescribed medicine, when applicable; 
  • the respective reimbursement regime; and
  • the date of the issuance of the advertising.

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: 

  • exclusively on the respective institutional website and not on social media or on any other disclosure support; and
  • the information to be disclosed, jointly and simultaneously, must solely contain the faithful reproduction of the packaging of the medicine and the literal and full reproduction of the medicine leaflet and/or of the summary of the medicine characteristics, as authorised. 

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:

  • the number of samples provided each year to each HCP cannot be more than four, if the lowest number is not defined by the marketing authorisation;
  • the samples are to be requested by the HCP in a written document, duly dated and signed;
  • the samples cannot be larger than the smallest presentation of the medicine under commercialisation;
  • the samples’ packaging must contain the references “Free Sample” and “Prohibited Sale” or other similar words;
  • the samples must be accompanied by a summary of product characteristics; 
  • the samples can only be provided within the two years following the start of the commercialisation of the medicine; and
  • the provision of samples of medicines containing drugs or psychotropic substances is prohibited.

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:

  • Infarmed is the authority responsible for punishing infringements of the law and public regulations; 
  • APIFARMA’s Ethics Council may impose penalties on respective members for infringements of respective codes; and
  • competitors may take action in relation to advertising infringements through civil liability lawsuits.

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):

  • loss in favour of the state of illicit objects, equipment and devices;
  • interdiction, for a maximum period of two years, of activity of the infringing company;
  • deprivation of the right to participate in public tenders for a maximum period of two years; and 
  • suspension of authorisations, licences and other titles attributing rights for a maximum period of two years. 

Accompanying sanctions specific to the case of infringement of advertising legal provisions may also apply:

  • the decision on the imposing of fines may also determine the publication on social media of the essential elements of the condemnation; 
  • advertising of the relevant medicine may be suspended for a maximum period of two years; 
  • a procedure to exclude the relevant medicine from the reimbursement regime by the state may also be initiated; and
  • the infringer’s medical sales representative may be prevented from visiting public hospitals and services, in the case of violation of the legal regime of such visits.

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:

  • only veterinary medicinal products that are authorised or registered may be advertised, unless otherwise decided by the competent national authority;
  • the advertising of a veterinary medicinal product will aim at promoting the supply, sale, prescription, distribution or use of the veterinary medicinal product;
  • the advertising may not be formulated in such a way as to suggest that the veterinary medicinal product could be a feed or a biocide;
  • the advertising must comply with the summary of the product characteristics of the advertised veterinary medicinal product;
  • the advertising must not include information in any form which could be misleading or lead to incorrect use of the veterinary medicinal product;
  • the advertising must encourage the responsible use of the veterinary medicinal product, by presenting it objectively and without exaggerating its properties;
  • the suspension of a marketing authorisation will preclude any advertising during the suspension period of the veterinary medicinal product;
  • veterinary medicinal products may not be distributed for promotional purposes, except for small quantities of samples;
  • the samples must be appropriately labelled as “samples” and are to be provided directly to veterinarians or other persons allowed to supply such veterinary medicinal products during sponsored events, or by sales representatives during their visits; and
  • antimicrobial veterinary medicinal products may not be distributed for promotional purposes as samples or in any other presentation.

The advertising of veterinary medicinal products that are subject to veterinary prescription will only be allowed when addressed exclusively to the following persons:

  • veterinarians; and
  • persons permitted to supply veterinary medicinal products in accordance with national law.

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.

Morais Leitão, Galvão Teles, Soares da Silva & Associados

Rua Castilho, 165
1070-050
Lisboa
Portugal

+351 21 381 74 00

+351 21 381 74 99

fmatoso@mlgts.pt www.mlgts.pt
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Trends and Developments


Authors



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Portuguese Pharmaceutical Advertising Rules Are Stricter Than the Common EU Standard

The legal regime applicable to the advertising of medicinal products in Portugal stems from EU Directive 2001/83/EC (the “Directive”). Considering the extremely narrow margin of freedom given to EU member states in the transposition of the Directive, particularly where promotion rules are concerned, one would expect this to lead to a common legal framework throughout the EU.

Although such a common legal framework does exist, the truth is that Portuguese lawmakers went beyond what the Directive provides in matters which significantly impact the activity of pharmaceutical companies operating in Portugal. This is so in relation to, at least, two key aspects: the notion of advertising itself and a general prohibition on granting any kind of benefit to patients.

Broad Portuguese definition of advertising

Firstly, contrary to the Directive, Portuguese law does not require that an informative, canvassing or inducing activity be aimed at promoting a medicinal product for it to qualify as advertising for that product; it is sufficient that it has such an effect.

As a result of this extremely broad definition of advertising, the common EU standard on prohibition of off-label advertising goes a step further in Portugal: any disclosure of information directly or indirectly related to a product made by pharmaceutical companies both to the scientific/medical community and to patients may result in the application of advertising rules. The possibility of pharmaceutical companies informing the scientific/medical community of research that is being carried out or of potential new therapies which could have a significant impact on the treatment of patients – even if made in an objective and balanced manner – is therefore severely limited.

Prohibition on the granting of benefits extend to patients as well as HCPs

Secondly, and whereas throughout the EU the rule is that pharmaceutical companies are prevented from providing any kind of benefit to healthcare professionals (HCPs), as set-forth in the Directive, in Portugal, this prohibition has been extended to patients: pharmaceutical companies are also forbidden from granting any kind of benefit to patients, regardless of its nature. And this entails that patient support programmes, often implemented in other member states, are set aside when it comes to Portugal – often negatively impacting patients.

These aspects of the Portuguese legal framework significantly affect the activities of pharmaceutical companies operating in Portugal.

As the setting evolves to digital and patients seek an active role in their treatment options, the existing legal framework is proving insufficient to address these new challenges.

Key Trends in Portuguese Pharmaceutical Advertising

Navigating the digital world

In recent years, the digital world has emerged as the primary platform for dialogue and interaction between pharma companies and the healthcare community.

Initially, online initiatives were modest and primarily focused on institutional advertising, introducing companies, their core values, and product portfolios. Websites and platforms primarily served as information deposits, without facilitating further engagement or allowing for further interaction.

Regarding prescription-only medicinal products, caution was partly due to the interpretation of Infarmed (the Portuguese agency responsible for supervising pharmaceutical advertising activities) of the applicable law, which forbade any reference to products on companies’ websites. This stance has since been revisited following the Court of Justice of the European Union case law on this matter, but the conditions under which references to prescription-only medicines on websites are allowed remain stringent.

As the online ecosystem has evolved and become more sophisticated, so have the initiatives carried out by pharma companies. Turning to IT and consultancy firms, pharma companies started to develop highly specialised and targeted online resources, such as e-learning platforms, websites for hosting webinars and online events, podcasts, e-commerce platforms and apps designed to aid disease management or to assist HCPs in their medical practice. These tools have proven to be crucial for educating both HCPs and patients.

Beyond the general complexities of advertising medicinal products within a detailed and strict legal framework, the set-up of these online resources has brought its own set of challenges.

The legal regime was utterly unprepared for the digital revolution. While regulation is abundant in what concerns printed materials (eg even determining the font and size of the text to be included) and physical events (eg, even determining limits to hospitality costs and regulating the dates of travel) such rules were enacted when advertising was limited to face-to-face interaction and visits of sales representatives – far from to digital ads, platforms and webinars.

In this regard, Infarmed has not yet provided for any additional guidance on how to adapt the existing rules to the new landscape. The general position is that the regime applies equally to the online and physical worlds, without exceptions, and should be interpreted accordingly.

Unfortunately, no changes are expected on this front. In the absence of guidance from the authorities, self-regulatory guidelines from the Portuguese Pharmaceutical Industry Association, Apifarma, have been filling the gaps for digital advertising. In 2021, Apifarma published its Guide for the Use of Digital Channels, which includes general rules and principles applicable to all online communications and guidelines for specific digital channels. It further identifies permitted activities for each. These sets of rules should be followed by Apifarma member companies, which constitute the majority of the pharma companies operating in Portugal, whenever engaging in digital activities.

Patient engagement

More importantly and consistent with the trend of the last few years, pharma companies are eager to maintain discussions with the general public, including patients and patients’ organisations.

Medicinal products, together with other health technologies, have taken over the spotlight and have been extensively debated in public forums. The general public is awakening to topics such as market access, the pricing of medicinal products, reimbursement policies, and the availability of innovative treatments. As a result, the media has also shown a greater interest over the last few years in several different medicinal products, from medicines used for treating diabetes and obesity to new treatment options for cancer, as well as new uses for psychotropics. This interest has been accompanied by increased concerns related to the unavailability of medicinal products, which has also been subject to heavy public scrutiny. Patients’ organisations have also turned more active, carrying out several initiatives aiming at increasing public awareness and demanding swifter access to innovative products.

Unfortunately, more information being available does not always equate to more informed patients. The absence of reliable sources is one critical aspect of this trend. Patients are, by default, more vulnerable and exposed. Without the knowledge needed to assess the profile of medicinal products and treatments from a clinical standpoint, they rely on the sources they have access to.

Given their position in the market, pharma companies are expected to contribute to the debate, directly receiving information requests from patients and requests for collaboration from patients’ organisations. Patients and patients’ organisations are also interested in working together with pharma companies to understand their treatment options and wish to join efforts to demand faster access to new health technologies. There is an increased demand for comprehensive and understandable information on medicinal products, and pharma companies are also eager to a play a role in educating the several involved stakeholders.

Regrettably, once again, the regulatory regime has not kept up with this evolution. With the exception of disease awareness campaigns, in the broad sense, interaction between pharma companies and the public faced significant risk of being considered advertising, allowing no room for dialogue between these stakeholders outside of promotion rules. The regime does not recognise pharma companies as a potential vehicle for accurate and valuable information for the general public, and therefore discourages interaction.

While Pharma Companies have been calling for a distinction between informative and promotional information for the past few years, Infarmed has remained silent on the matter. Promotional rules apply if there is a reference, even an indirect one, to a medicinal product.

Apifarma tends to have a more lenient approach on this matter, having approved a specific Code of Conduct for the relations between the pharmaceutical industry and patients’ associations, patients’ advocates, patient experts, patients and caregivers, in line with the principles approved by European Federation of Pharmaceutical Industries and Associations (EPFIA), self-regulatory rules cannot supersede the legal regime.

Pharma companies are severely limited in their ability to engage with patients. Maintaining a close link with these stakeholders, providing objective, accurate and balanced information, without crossing into promotional territory, is key. It is a difficult balance to achieve, but there should be room for it.

What Lies Ahead: No Expected Changes for 2024?

While pharma companies operating in Portugal have been vocal about the unsuitability of the legislative framework for pharmaceutical advertising given the changes in the sector and the shift to the digital environment, such concerns have not yet been addressed by the regulator and are not expected to be addressed soon.

The most significant development on this front is the much-anticipated review of the pharmaceutical framework in Europe, published by the European Commission on 26 April 2023 and currently under discussion in the European Parliament.

However, as far as advertising is concerned, the proposal does not represent a major departure from the rules provided for under the Directive. While the true impact can only be assessed following approval of the legislative package, as it stands, the proposal maintains the core rules of the current regime.

It is true that a number of changes are introduced, such as the reference to professionals licensed to administer medicinal products under the definition of HCPs and the prohibition on using any form of advertising that aims to negatively highlight another medicinal product. However, this is already covered by the Portuguese rules and will therefore have only limited impact.

Bearing the above in mind, the regime for pharmaceutical advertising will most likely remain unchanged in 2024, requiring pharma companies to continue to seek a balance between ensuring full compliance with the high standards of the regime while still striving to contribute to debates within the community and to conduct innovative projects and initiatives.

VdA

Rua Dom Luís I, 28
Lisbon
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Portugal

+351 21 311 3400

+351 21 311 3406

vda@vda.pt www.vda.pt
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Law and Practice

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Morais Leitão, Galvão Teles, Soares da Silva & Associados is a leading, full-service law firm in Portugal with a solid background of decades of experience. Its reputation among both peers and clients stems from the excellence of the legal services provided. The firm’s work is characterised by unique technical expertise, combined with a distinctive approach and cutting-edge solutions that often challenge some of the more conventional practices. Morais Leitão’s team consists of over 250 lawyers spread between its headquarters in Lisbon and additional offices in Porto and Funchal. Due to its network of associations and alliances with local firms and the creation of the Morais Leitão Legal Circle in 2010, the firm can also offer support through offices in Angola (ALC Advogados), Cabo Verde (VPQ Advogados) and Mozambique (MDR Advogados).

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VdA is a leading international law firm with more than 40 years of history, recognised for its impressive track record and innovative approach in legal services. The excellence of its highly specialised legal services covering several industries and practice areas enables VdA to overcome the increasingly complex challenges faced by its clients. VdA offers robust solutions grounded in consistent standards of excellence, ethics and professionalism. Recognition of the excellence of our work is shared by the team, as well as with clients and stakeholders, and is acknowledged by professional associations, legal publications and academic entities. VdA has been consistently recognised for its outstanding and innovative services, having received the most prestigious international accolades and awards of the industry. Through the VdA Legal Partners network, clients have access to seven (Angola, Cabo Verde, Equatorial Guinea, Mozambique, Portugal, São Tomé and Príncipe) jurisdictions, with a broad sectoral coverage in all Portuguese-speaking African countries, as well as Timor-Leste.

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