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.
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.
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 Infarmed ten 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 Infarmed ten 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 holders or 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.
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While the previous few years were focused on how to deal with the COVID-19 pandemic, 2022 finally brought some sense of normality.
Gone, hopefully, are the days of prohibition or of severely restricted visits of sales representatives to healthcare professionals (HCPs) imposed by governmental measures. Events are steadily shifting from digital platforms to classic venues – although digital platforms have certainly come to stay, with hybrid events now making up part of day-to-day life, enabling an increasing proximity and availability which until very recently was not even realisable.
The industry is once more focused on new initiatives and projects, with more innovative ways of promoting products, creating value-added initiatives where healthcare is crucial, and engaging with both HCPs and patients with one key goal: delivering for patients.
Patients have assumed a new and more pronounced role and, now more than ever, are the purpose and the driver for change, in a push for access and affordable medicines. While traditional means of advertising are still present, the truth is that communication has gone digital. This was already the case before the pandemic, and is even more so following it. In the aftermath of COVID-19, pharmaceutical and medical device companies have understood that embracing the digital transformation is not optional – it is the only way forward.
As always, the world changes faster than legislation, and with it come new challenges. In the pharmaceutical sector, the key challenge is navigating a legal framework construed for a non-digital world. In the medical devices sector, in addition to this challenge, companies are faced with a non-harmonised regime at the European Union (EU) level where promotion is concerned.
The Portuguese legal regime applicable to the advertising of medicinal products stems from Directive 2001/83/EC (the “Directive”). Considering the extremely narrow margin of freedom given to member states in the transposition of the Directive, particularly concerning promotion rules, this might be expected to lead to a common legal framework; unfortunately, this is not the case for Portugal.
The Portuguese legislature has gone beyond what the Directive provides in specific matters, including with the notion of advertising and the prohibition on granting any kind of benefit to patients (similarly with the EU prohibition for HCPs). These aspects of the Portuguese legal framework significantly impact the activities of pharmaceutical companies in Portugal.
As an example, the disclosure of scientific information, a sensitive topic throughout the EU, faces additional hurdles in Portugal. Similarly, certain initiatives freely carried out by pharmaceutical companies throughout the EU are often barred from being implemented in Portugal, as is the case with patient support programmes.
Contrary to the Directive, the Portuguese regime does not require that the information, canvassing or inducing activity be “designed” to promote medicinal products, it being sufficient that it has such an effect. This constitutes a significant departure from the wording of the Directive, and a considerable challenge for pharmaceutical companies operating in Portugal, rendering the distinction between “informing” and “promoting” almost artificial, with very little room for the former.
Under Portuguese law, the underlying purpose of a given initiative developed by a pharmaceutical company is completely immaterial to its qualification as advertising. In other words, if an initiative promotes a given medicine, it will fall within the notion of advertising, even if this is not its intention. Should it be designed to promote a medicine, it is undoubtedly advertising. However, initiatives which are not intended as such, but which directly or indirectly have as an effect an increase in the purchase, dispensation or consumption of a medicinal product will also fall under the notion of advertising. The law provides for very few exceptions.
In line with the Directive, only the labelling and information leaflet, correspondence required to reply to a specific query, information related to packaging, warnings or adverse reactions, price lists and information related to human health or diseases – if these do not make any direct or indirect reference to a medicine – are excluded from the scope of promotion rules.
As a result of this extremely broad definition of advertising, 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.
This extremely thin line between information and advertising poses several challenges to pharmaceutical companies and is a relevant setback in the dissemination of information and knowledge.
One of the clearest examples of said challenges is the disclosure of information regarding ongoing clinical research or regarding medicines which are still undergoing regulatory approval, even if at early stages.
While the prohibition of off-label advertising is a common standard within the EU, in Portugal 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 severely limited.
In fact, any communication of this nature can be considered off-label advertising, and therefore prohibited. Consequently, the debate regarding new medicines and ongoing clinical research is very often made behind closed doors and no incentive is given for a more public, comprehensive and transparent discussion on future available treatments within the scientific/medical community. Disclosure of scientific advances is therefore often severely compromised.
A further example of these challenges is related to the disclosure of information by pharmaceutical companies to the public. Another standard within the EU is the prohibition on advertising of prescription drugs to the public. Disclosing purely objective and educational information on a given prescription drug, such as educational material with precautions and/or instructions for the administration of the medicine, if not within the scope of a risk management plan, entails a very significant risk of being condemned by the Portuguese regulatory agency.
Given patients’ potential vulnerability and absence of knowledge that could enable them to “filter” information, the Portuguese regulatory agency has always been particularly cautious with patient protection, and described as somewhat conservative in its approach to promotion before the public, be it direct or indirect (as could be the case in disease awareness campaigns not strictly raising disease awareness).
However, the latest case law of the Court of Justice of the European Union (CJEU), rendered on 22 December 2022 in Case C-530/20 “Euroaptieka”, may bring this into question and potentially suggest that such a position is to be followed across Europe.
Following a request for a preliminary ruling from the Latvian Constitutional Court, the CJEU was called to decide on a set of questions focusing on a national provision which forbade the inclusion of any information encouraging the purchase of a medicinal product on the basis of its price, special sale or bundle in the advertising of a given medicinal product before the general public. The questions put forward to the CJEU entailed, in essence, addressing two topics:
In its judgment, the CJEU clarified that activities that do not relate merely to dissemination to the public solely of information about medicinal products, but are activities which encourage the purchase of medicinal products, should be considered advertising even if not referring to a specific medicinal product but to unspecified medicinal products.
It is true that the court was called to analyse a very specific measure which arguably, by its very nature, is promotional. The question remains on how far the agencies of member states will apply the principles arising from such judgment, particularly as regards the following:
While this discussion is not new, it has again gained relevance given the shift in patient behaviour. Patients are taking their place at the table and are eager to receive more and more information, and are now able to find such information very quickly through digital channels, social media and the internet. Patients are not only interested in knowing their treatment options but are also increasingly interested in knowing and publicly discussing topics such as the safety profile of medicinal products, their reimbursement statuses and even their approval processes.
Although this trend appeared prior to the COVID-19 pandemic, the health crisis undeniably emphasised it. Information on medicinal products and health technology was available everywhere, with no filters, and was directly provided to patients.
Understanding that the market has changed, pharmaceutical companies are trying to keep up the pace: even when engaging with HCPs, the focus is on patients and on reinforcing their presence on the internet and digital channels.
Naturally, as patients’ interest in these topics grows, so does the need to protect patients. As the latest judgment by the CJEU has shown, the tendency is to increase control over the information shared with patients. While the Portuguese regulatory agency has not been very active in the past year concerning pharmaceutical advertising, there is no doubt it will continue to closely watch companies’ activities and behaviour. The question is whether supervising the activities of the pharmaceutical industry will be sufficient for ensuring the protection of patients, especially considering that today patients can easily access information from all kinds of sources.
For now, pharmaceutical companies are left with a dilemma regarding how to comply with the rules while still engaging with patients and answering their demands for more transparent information, including from the pharmaceutical industry, without putting at risk the need to safeguard public health.
Contrary to with medicinal products, the rules on advertising of medical devices were not addressed at the EU level, either under the former regimes scattered through different directives, or under the Medical Device Regulation and the In Vitro Medical Device Regulation (hereinafter the MDR and IVMDR, respectively).
The MDR and the IVMDR very timidly address this issue, stating solely that advertising cannot contain elements that may mislead the user or patient concerning the device’s intended purpose, safety and performance. Such a principle would always arise from the general rules applicable within the EU both for consumers and for HCPs.
In the absence of harmonisation at the EU level, there are naturally different regimes throughout member states affecting cross-border activities.
While some member states have left the rules on advertising of medical devices subject to the general rules on advertising, others such as Portugal have approved a specific legal regime. This regime closely follows that provided for medicinal products:
Such a regime was approved prior to the entry into force of the MDR and IVMDR, yet continues to apply.
Although a major departure from the existing rules is not expected, local legislation to be enacted to complement the regime provided for in the MDR and IVMDR would be a good opportunity to introduce tailor-made rules on the advertising of medical devices – as different from pharmaceuticals and covering an enormous range of realities – and to clarify exactly what can or cannot be advertised before the public.
In the absence of EU harmonisation, self-regulation arising from Medtech Europe and “transposed” by local industry associations plays a significant role and helps to create common standards.
While the rules provided for in self-regulation are quite detailed regarding the interaction between medical device companies, HCPs and healthcare organisations, there is still a significant gap concerning the interaction with patients and patients’ associations. Aside from some specific guidance provided by Medtech Europe and the general principle that all advertising activity should prioritise patients, most rules do not address such types of interactions.
This is increasingly more relevant given that the market for medical devices has grown exponentially in the past few years. Medical technology is adding to this pace and new medical devices are available each day. These devices are not only intended for professional use, but also for laypersons. Medical devices made available through app stores or through online platforms are now common – proof that medical device software for patients is at its peak.
The industry has changed, and will continue to do so in a digital era where patients change with it and are at the centre of what is to come. As the medical devices legal framework is significantly altered, it will certainly be important to seize the opportunity to provide for a more adequate legal regime, which should be sufficiently flexible for catering to all types of devices, while still ensuring a high level of protection for patients.
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