Pharmaceutical advertising regulation and medical device advertising in Portugal

For all matters not foreseen in the Legal Regime of Human Medicinal Products or the Regulation on Medical Devices and Related Accessories, the rules of the Portuguese Advertising Code shall apply.

1.1 Medicines

The primary legal source is the Legal Regime of Human Medicinal Products (Decree-Law 176/2006, of 30 August). 

1.2 Medical devices

The most important legal source regarding medical devices is the Regulation on Medical Devices and Related Accessories (Decree-Law 145/2009, of 17 June), likewise in accordance with the Advertising Code. 

Yes, the most relevant codes of conduct are:

• Code of Conduct for Promotional Practices in the Pharmaceutical Industry and for Interactions with Health Professionals and Institutions, Organisations or Associations Formed by Health Professionals of Apifarma, which regulates advertising in the context of medicines and medical devices.
• Additionally, the INFARMED – National Authority for Medicament and Health Products, has issued a series of circulars and informative communications in order to clarify providers about specific rules and norms regarding advertisement All made available at: 
  • https://www.infarmed.pt/web/infarmed/circulares 

3.1 Medicines

Holders of marketing authorisations must submit to INFARMED a description of all and any advertisement of medicines, using the specific form made available by INFARMED. Said information must be sent within 10 days after the releasing date of the advertisement campaign. Alternatively, the holder can send a copy of the support of each advertising piece within 10 days after the first publication. 

3.2 Medical devices

As regards to the advertising directed to health professionals, holders of marketing authorisation or registration of medicines, must submit a description of all and any advertisement of medicines before the INFARMED, through the form specifically made available. Said information must be sent within 10 days after the releasing date of the advertisement campaign.

The form requires that interested parties must provide the following information:

1. Name of the medicine;
2. Qualitative and quantitative composition;
3. Pharmaceutical form;
4. Presentation of the medicine;
5. Pharmaco-therapeutic group;
6. Name of the marketing authorisation holder;
7. Means of dissemination;
8. Advertising medium(s)
9. Place and dates of dissemination;
10. Target publics (general public or identification of the category or categories of health professionals);
11. Identification of the entity responsible for the promotion of the medicine.

Additionally, there is an ex post control, as further complains on this matter can be presented before the ERS

Yes.

• Article 153, of the Decree-Law 176/2006, expressly prohibits advertising of medicines that: (i) are prescription-only; (ii) contain substances defined as narcotics or psychotropics, under international conventions binding upon the Portuguese State; (iii) covered by the National Health Service.
• Additionally, prescription-only medicines may only be advertised or promoted through technical/scientific publications or information media intended for and accessible exclusively by doctors and other health professionals.

5.1 Medicines

Advertising of medicines  to the general public shall not contain any of the following elements which may:

1. Lead to the conclusion that medical consultation or surgical intervention is unnecessary, in particular by suggesting a diagnosis or advocating treatment by correspondence;
2. Suggest that the effect of the medicine is guaranteed, with no adverse reactions or side effects, with results superior or equivalent to those of another treatment or medicine;
3. Suggests that the person's normal state of health can be improved through the use of the medicine;
4. Suggest that the person's normal state of health may be impaired if the medicine is not used, except for the vaccination campaigns;
5. It is exclusively or mainly addressed to children;
6. Refer to a recommendation issued by scientists, health professionals or any other person that, due to its celebrity, may incite to the consumption of medicines;
7. Treat the medicine as a food product, cosmetic or body hygiene product or any other consumer product;
8. Suggest that the safety or efficacy of the medicine is due to the fact that it is considered a natural product;
9.  Induce, through a description or detailed representation of the medical history, a false self-diagnosis;
10. Refer in an abusive, frightening or misleading way to demonstrations or guarantees of cure;
11. Use in an abusive, frightening or misleading way visual representations of changes in the human body caused by diseases or injuries, or of the action of a medicine in the human body or in parts of the human body.

Furthermore, it is not permitted to give consumers free samples or promotional offers on drugs.

Medicines’ advertisement will not be admissible if referring to:

• Prescribed-only medication;
• Medicines which are subsidised by the National Health System;
• Medicines containing narcotic or psychotropic substances psychotropic substances. 

5.2 Medical devices

Similarly, advertising of medical devices to the public shall not contain any element that:

1. Leads to the conclusion that medical consultation or surgical intervention is unnecessary, in particular by suggesting a diagnosis or advocating treatment by correspondence;
2. Suggests that the effect of the medical device is guaranteed, with no adverse reactions or side effects, with results superior or equivalent to those of other treatment with a medical device or medicine;
3. Suggest that the person's normal state of health can be improved through the use of the medical device;
4. Suggest that the person's normal state of health may be impaired if the medical device is not used;
5. Addresses children exclusively or mainly;
6. Refer to a recommendation issued by scientists, health professionals or other person that, by its celebrity, may incite consumption of medical devices;
7. Treat the medical device like a food product, cosmetic or body care product or any other consumer product;
8. Suggest that the safety or efficacy of the medical device is due to the fact that it is considered a natural product;
9. May induce, by a detailed description or representation of the anamnesis, a false self-diagnosis;
10. Refers in an abusive, frightening or misleading manner to demonstrations or assurances of healing;
11. Use abusive, frightening or misleading visual representations of changes in the human body caused by disease or injury, or of the action of a medical device on the human body or parts of the human body;
12. Take the form of comparative advertising.

It is expressly prohibited to advertise medical devices to the general public, if its use requires the intervention and decision of a health professional, such as implantable devices, long-term invasive devices, devices that incorporate as an integral part a medicinal product or a stable derivative of human blood or plasma and devices manufactured utilising cells or tissues of animal origin.

Shall only be permissible if regarding medical devices that are subject to a prior conformity assessment and notification to the competent authority. 

6.1 Medicines

Advertising of medicines through electronic medical prescription computer applications or in other applications or computer programmes connected therewith is expressly prohibited. 

Free samples of medicines shall be exclusively given to persons authorized for prescribing or dispense medicines in in-house pharmacies but only at their request (and only for some products and in limited quantities).
 

6.2 Medical devices

Medical devices that necessarily require healthcare professionals' advise, such as implantable devices, long-term invasive devices, devices that incorporate as an integral part a medicinal product or a stable derivative of human blood or plasma and devices manufactured utilising tissues and cells of animal origin, must  be advertised or promoted only in technical publications or by means of information media which are intended for use and accessible only by doctors and other healthcare professionals.

All documentation transmitted to health-care professionals, must indicate the date on which it was drawn up or last reviewed. The information contained in the documentation must be accurate, updated, verifiable and sufficiently complete to allow the recipient to form a correct impression of the performance and safety of the medical device.

Moreover, any quotations and illustrative material taken from medical publications or scientific papers to be used in the documentation must be correctly reproduced and the source indicated.

7.1 Medicines

As regards to the information that must be mandatorily be included in advertisements directed to healthcare professionals only, it shall include: 

1. Name of the medicine;
2. Essential information in accordance with the summary of the product's characteristics, such as:
   1. The qualitative and quantitative composition;
   2. Pharmaceutical formula;
   3. Therapeutic indications;
   4. Recommended dose and method of administration;
   5. Counter-indications;
   6. Adverse effects.
3. Classification of the medicine for dispensing purposes, namely the indication that the medicine is a prescription-only medicine, where appropriate;
4. The system of reimbursement.

7.2 Medical devices

Medical devices that require the mediation and decision of a health professional, may only be advertised in technical publications or information media intended for and accessible exclusively by doctors and other health care professionals.

Medical devices advertisement directed to healthcare Professionals, must provide all promotional materials directed to the healthcare professionals, containing:

• Date it was last reviewed;
• Accurate, updated, verifiable and sufficiently complete to give an accurate understanding of the expected performance and the safety of the medical device;
• Any quotes and illustrative material from scientific and medical publications should be correctly reproduced and the source indicated.

8.1 Medicines

Advertising medicines must expressly mention that the considered product is a medicine, and shall mandatorily include the following information:

1. Name of the medicine, as well as the common name if containing only one active substance, or the brand name;
2. The essential information for assuring a correct use, including therapeutic indications and any special precautions;
3. Advise the patient to carefully read the instructions on the accompanying secondary packaging and the package leaflet and, in case of any questions or if the symptoms persist, to consult the doctor or the pharmacist.

8.2 Medical devices

It must clearly identify that the product is a medical device and that it is being advertised.

As regards to the mandatory information to include within advertising of medical devices displayed to the general public, that advertising must be unequivocally identified as such, expressly stating that it is a medical device and including the following information:

1. Name of the medical device or the trademark;
2. Information essential to safe use of the medical device, including the purpose and special precautions;
3. Advising the user to read carefully 

In general, advertising of medicines and medical devices must provide true and scientifically proven information about medicines and medical devices in compliance with ethical criteria, and in order to ensure their adequate and rational use, without misleading the users. Medicine advertises must also be in accordance with the summary of main medicine characteristics and the approved medicine manual.

Advertisements directed at the general public cannot contain any comparative reference to other medical devices, medications or treatments that represent the advertised product. Whereby comparative advertising is expressly prohibited.

Nonetheless, as regards to advertising directed to health professionals (under Article 6 of the Code of Ethics), comparative advertising will be admissible if based on relevant and comparable aspects of those products, and are not, in anyway, misleading or defamatory. Hence, comparisons between different medicinal products must grounded on details that appear in the summary of the products’ characteristics or on the basis of credible clinical data.

National law does not provide for any additional requirements depending on the medium used for dissemination, and the above requirements are the same for any medium used. Therefore, the rule is that conditions that apply “offline” also apply “online”. 

As regards to testimonial advertising which in the context of social media is of particular relevance, i.e., when intending to use digital influencers to spread the message. The Advertising Code provides that testimonial advertising must:

• integrate personalized testimonies,
• genuine and verifiable, 
• linked to the experience of the deponent or whom he represents,
• being admitted the depersonalized testimony, provided it is not attributed to a specially qualified witness, namely due to the use of uniforms, uniforms or garments characteristic of a certain profession.

With regard to the advertising of medical devices, in particular that are carried out through recommendations, there are some reservations to be taken into consideration, the regime is rather limited. Accordingly, the Advertising Self-Regulation Code of Conduct provides that:

• advertising must not reproduce or quote any testimony, qualified recommendation or supporting documentation that is not genuine, responsible, verifiable and relevant. 
• the truthfulness of the claims made by the individual providing the testimony must be verified.
• adding that testimonials or qualified recommendations should be related to the experience of the person.

As regards medicines or in vitro diagnostic medical devices advertising, the Code of Ethics establishes that internet advertisement or through other digital channels must be based on technical-scientific and professional principles and respect the national legislation in force. Furthermost, adequate measures must be implemented to ensure that only health professionals have access to any advertisement concerning prescription-only medicines or in vitro diagnostic medical device that require mediation and decision by a Healthcare Professionals.  

Advertising of prescription-only medicines and directed to health care professionals requires the implementation of access restrictions to the general public.

Compliance with the obligations and requirements   in the context Medical Devices and Medicines Advertisement is monitored by the INFARMED, authority which is competent for the examination of the advertising of the devices and to initiate the respective administrative offence proceedings.

Breach of the here considered obligations may determine the application of penalty between 2,000 EUR, up to 15 percent of the annual turnover, or 180,000 euros, whichever is lower. 

The decision imposing a fine may determine the mandatory publication of the essential elements of the conviction in the national media, at the expense of the defendant. As well as the suspension of the advertising of the medicine for a period that may not exceed two years.

As regards to the allocation of liability, can be held liable the perpetrators or co-infringers of the administrative offences for the violation either:

1. the advertiser,
2. the advertising agency or any other entity that exercises the activity of advertising, or for the dissemination of advertising,
3. the holder of the advertising medium or
4. the respective concessionaire.

If justified by the gravity of the infraction and the level of guilt of the agent, INFARMED may determine the application of additional accessory sanctions, namely:

• Forfeiture in favour of the State of illicit objects, equipment and devices;
• Prohibition to exercise the respective activity for up to a maximum of two years;
• Loss of the right to participate in public tenders, up to a maximum of two years;
• Suspension of authorisations, licences or other titles conferring rights, up to a maximum of two years.

Yes, given that the Decree-Law 145/2009 is under revision and following the recent updates in European regulation on this matter, future advances in national regulation are expected.