Pharmaceutical advertising regulation and medical device advertising in Spain

Applicable to both medicines and medical devices:

• General Advertising Act 34/1998 of 11 November (“Advertising Act”).
• General Health Act 14/1986 of 25 April.
• Re-casted Act on guarantees and rational use of medicines and medical devices passed by Royal Decree Legislative 1/2015 of 24 July.

1.1 Medicines

• Royal Decree 1416/1994 of 16 October on advertising of medicines for human use (“RD 1416/1994”).
• Circular 6/95 issued by the Spanish Agency of Medicines and Medical Devices (“AEMPS”), further developing RD 1416/1994.
• Guidance dated June 2019 issued by the Ministry of Health on advertising to the general public of medicines for human use, further developing RD 1416/1994 (“Guidance June 2019”).
• Guidance dated April 2016 issued by the Government of the Autonomous Region of Catalonia on the advertising of medicines for human use, further developing RD 1416/1994.

Additionally, it should be noted that the health competences in Spain are attributed to the Autonomous Communities. Therefore, advertising of medicines and medical devices will also be subject to obligations arising from the regulation said authorities. As an example, the Community of Madrid obliges the pharmaceutical laboratories with registered offices in the Community of Madrid to

1. communicate any advertising activity for their medicinal products at the time of dissemination of the promotional material and
2. submit to the Health Authority the annual index with detailed data on all advertising activities carried out after 31 December of each year and before 1 March of the following year.

Please find below the most relevant Spanish codes governing the promotion and advertising of medicines and medical devices, as well as the interaction with Healthcare Professional (“HCP”) and Healthcare Organisations:

1.2 Medicines

• Farmaindustria Code (reference medicines).
• ANEEP Code (OTC medicines and other self-care products).
• AESEG Code (generic medicines).

2.2 Medical devices

• FENIN Code.

3.1 The general public

• Medicines: no licenses/approvals/fees required.
• Medical devices: prior authorisation.

3.2 Healthcare professionals

• Medicines: prior communication.
• Medical devices: no licenses/approvals/fees required.

Yes, mainly that the advertising of prescription-only medicines addressed to the general public is prohibited.

5.1 Medicines

Advertising to the general public is prohibited in the following cases:

• Unauthorised medicines.
• Prescription-only medicines.
• Medicines under research.
• Medicines reimbursed by the Spanish National Health System (“SNS”).
• Medicines containing narcotics or psychotropic substances.

5.2 Medical devices

Advertising to the general public is prohibited in the following events:

• Medical devices reimbursed by the SNS.
• Medical devices applied by HCPs.

Under Spanish laws and regulations on medicines and medical devices, in order to guarantee the independence of the decisions relating to the prescription, dispensing, and administration of medicines and medical devices from commercial interests, the following is prohibited:

6.1 Medicines

• Offer any type of incentive, bonus, discount, pecuniary advantages or advantages in kind, premium or gift directly or indirectly to HCPs involved in the prescription, dispensing and administration of medicines or to their relatives and cohabitants, with the exception of those of negligible value and irrelevant to the practice of medicine or pharmacy.

6.2 Medical Devices

• Grant, offer or promise premiums, pecuniary advantages or advantages in kind to HCPs who prescribe the devices, as well as to their relatives or persons with whom they live.

In the context of “undue granting”, the relevant Codes applicable to both pharma and medical device companies provide for a number of rules governing interaction with HCPs, as well as other issues relating to promotional materials.

7.1 Medicines

In general terms, the information and promotion aimed at HCPs must be in accordance with the technical and scientific information authorised by the AEMPS and must be rigorous, well-founded and objective and not misleading, in accordance with current legislation, and comply with the technical specifications.

In particular, such information/promotion must, at least, include:

• The essential product information, as per the data contained in the technical specifications, including, at least: name of the medicine; qualitative and quantitative composition; complete clinical data; incompatibilities; instructions for use/handling, and name and address of the marketing authorisation holder;
• Prescription and dispensation regime;
• The different presentations of the medicine, if any, and the dosage and/or pharmaceutical form; and
• The retail price, reimbursement conditions, and, where appropriate, an estimate of the cost of treatment.

7.2 Medical devices

In general terms:

• Technical data necessary for an objective assessment to be made of the usefulness of the medical device; and
• Conformity of the product with the legislation in force, as well as the contraindications and possible secondary effects that could derive from the use of the products.

8.1 Medicines

Advertising of medicines to the general public must include the following information:

• To be carried out in such a way that the advertising nature of the message is obvious, and it is clearly specified that the product to be advertised is a medicine.
• Name of the medicine, as well as the common name when the medicine contains a single active ingredient.
• Essential information for the correct use of the medicine, as well an express and clearly visible invitation to read carefully the instructions on the package leaflet or on the outer packaging, and the recommendation to consult the pharmacist on its correct use.
• Identifying data and recommendations determined by the Ministry of Health to avoid their abuse and to prevent the risks derived from their normal use.
• Essential information to promote its rational use.
• Not include expressions that provide assurance of a cure, or testimonies about the virtues of the product, or from professionals or persons whose notoriety may induce consumption.
• Not use as an advertising claim the fact of having obtained a health/sanitary authorisation in any country or any other required authorisation, sanitary registration number or certification.

Please note that the Spanish laws and regulations on medicines provide for a number of restrictions when advertising medicines which must be observed.

8.2 Medical devices

• Advertising of medical devices to the general public must mention the conformity of the product with the legislation in force, as well as the contraindications and possible secondary effects that could derive from the use of the products.
• Advertising of products to the general public must not include any reference to a health authority or to recommendations made by scientists, HCPs or other persons who, by reason of their reputation, are likely to encourage their use.

As a general rule, the information and promotion aimed at HCPs must be in accordance with the technical and scientific information authorised by the AEMPS and must be rigorous, well-founded and objective, and not misleading, in accordance with current legislation, and comply with the technical specifications.

With regard to other provisions relating to scientific data when advertising medicines, please note the following:

• The advertising of a medicine addressed to the general public may not include any element referring to a recommendation made by scientists, HCPs or other persons who may, by reason of their reputation, encourage the consumption of medicines.
• With respect to documentary advertising, quotations, tables and other illustrations taken from medical journals or scientific works and used in advertising, material must be faithfully reproduced, the source being accurately stated.

According to the Advertising Act, comparative advertising is deemed to be unfair when is not based on essential and similar characteristics of the products or services, which cannot be objectively proven, or when the products or services subject to comparison are not similar or one of them is unknown or has a limited participation in the market.

Pursuant to the regulations applicable to the advertising of medicines:

• Comparative advertising is only allowed when it is intended for HCPs authorised to prescribe or dispense medicines.
• The advertising of a medicine addressed to the general public may not include any element which suggests that its effect is guaranteed, that it has no side effects, or that it’s effect is greater than or equal to that of another treatment or medicine.

In addition to the above, the Farmaindustria Code sates that comparative advertising cannot be degrading, and comparisons must be based on comparable and notable circumstances.

Advertising of medicines and medical devices on the internet/social media has not been addressed by the Spanish laws and regulations governing medicines and medical devices yet. Therefore, and in general terms, it is commonly accepted that advertising through “digital media” is subject to all the controls and requirements provided for in the Spanish laws and regulations applicable to (traditional) advertising of medicines and medical devices.

However, it is worth mentioning that the Guidance June 2019, which further develops the provisions of the RD 1416/1994 relating to medicines aimed at the general public, has included for the first time a section on “digital media” covering advertising on (i) websites; (ii) APPS; (iii) banners, post, social network ads, and other media ads digital; and (iv) digital media ads with limited space (microbanners, tweets, Search Engine Marketing, etc.).

In general terms, the failure to comply with the relevant rules applicable to the advertising of medicines and medical devices may entail administrative infringements punishable with the relevant fines, amounting from EUR 30,001 to EUR 90,000 if the infringement is considered serious (e.g. not complying with applicable regulation regarding medical devices advertisement) or from EUR 90,001 to EUR 1,000,000 (this amount might exceed by up to five times the value of the goods or services which are the object of the infringement) if the infringement is considered very serious (e.g. not complying with applicable regulation regarding medicines advertisement). 

Also, if an imminent and serious risk to health exists or is reasonably suspected, the Health Authorities may take the precautionary measure of suspending advertising.

Additionally, the regulation foresees a specific action (acción de cesación) aimed at obtaining a judgment ordering the defendant to cease the conduct of advertising medicines without complying with the relevant advertisement regulation.

The competent authorities for monitoring compliance with such rules are both the AEMPS and the health authorities of the different Autonomous Regions.

However, it is quite common that disputes among pharma and medical device companies, respectively, are settled by the relevant self-regulation system/bodies (Farmaindustria, Autocontrol, Fenin, etc.).

Likewise, the failure to comply with advertising/unfair competition rules may lead to civil and/or criminal liability.

The Regulation (EU) 2017/745 on Medical Devices, which entry into force was foreseen for 26 May 2020 has been postponed by one year and therefore it will fully apply from 26 May 2021. This postponement responds to the need to ensure the permanent availability of medical devices on the Union market, including those that are of vital importance in the context of the COVID-19 outbreak and the public health crisis resulting from this.

In the context of the Spanish market, a bill of royal decree on promotion of medicines and medical devices is still being processed within the Ministry of Health. One of its goals is to adapt the regulations to the current demands, in which there is a clear predominance of digital and audiovisual media.