Pharmaceutical Advertising 2026 Comparisons

Advertising of medicinal products in Spain is regulated by a combination of laws, regulatory authority guidelines, and industry self‑regulation.

Laws

General rules on advertising are set out in Law 34/1988 on General Advertising and Law 3/1991 on Unfair Competition. EU provisions on the advertising of medicinal products have been implemented in Spain through Royal Decree 1416/1994. The Ministry of Health has supplemented this framework with interpretative guidance on that Royal Decree, specifically Circular 6/1995 (as amended by Circular 7/1999), as well as guidance on advertising over‑the‑counter (OTC) medicinal products.

Enforcement of medicinal product advertising rules is carried out by the health authorities of Spain’s autonomous regions. As a result, some regions have issued their own guidelines, most notably Madrid (Circular 1/2000) and Catalonia (latest version from February 2024).

Royal Legislative Decree 1/2015 sets out the sanctions applicable to breaches of pharmaceutical advertising rules.

Self‑Regulatory Codes

Spanish pharmaceutical industry associations have also adopted self‑regulatory codes governing interactions with healthcare professionals (HCPs), healthcare organisations (HCOs), and patient organisations (POs).

Farmaindustria, the association that represents innovative pharmaceutical companies, has adopted a Code of Practice (the “Code of Farmaindustria”) that regulates the advertising of prescription‑only medicinal products, as well as interactions with HCPs, HCOs, and POs.

In addition, the AESEG (generics) and ANEFP (OTC medicinal products) associations have also issued their own self‑regulatory codes.

Self‑regulatory codes are binding on companies that are members of the issuing trade association or that have voluntarily adhered to them. In addition, such companies may also be held liable for breaches of the Code committed by their affiliates or by third parties acting on their behalf in Spain (eg, external sales forces, advertising agencies, etc).

Beyond their formal scope of application, self‑regulatory codes – especially the Code of Farmaindustria – also reflect the prevailing social and ethical standards governing the promotion of medicinal products. Although not binding on non‑member companies, their provisions may nevertheless be taken into account by regional authorities and courts when interpreting Spanish pharmaceutical legislation.

In this context, the Catalonia and Madrid regional authorities entered into collaboration agreements with Farmaindustria in December 2023 and November 2025, respectively. These agreements recognise its self‑regulatory system and the role of its control bodies, and they establish mechanisms for collaboration in the oversight of scientific and promotional meetings.

In Spain, legislative changes to the regulation of pharmaceutical advertising and promotion are expected in the near future as part of the forthcoming reform of Royal Legislative Decree 1/2015. A draft bill was published in the first quarter of 2025, with final adoption anticipated in 2026. The reform is expected to focus primarily on the content of promotional materials and the applicable sanctions regime. For more information, refer to the Spain Trends and Developments chapter in this guide.

In parallel, an important recent development has arisen from case law. The Spanish Supreme Court’s judgment of 4 March 2025 has resolved a longstanding debate regarding the promotion of medicinal products prior to pricing and reimbursement approval. Based on this ruling, promotion is now permitted once Marketing Authorisation (MA) has been granted, even if price and reimbursement have not yet been approved, provided that a price is included in the promotional materials (as described in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals). The Code of Farmaindustria has been updated accordingly, along with amendments to its Q&A guidance.

Under Royal Decree 1416/1994, the advertising of medicinal products is defined as any form of informational activity, canvassing, or inducement intended to promote the prescription, dispensing, sale, or consumption of medicinal products.

In particular, the advertising of medicinal products includes:

• advertising directed at the general public;
• advertising directed at persons qualified to prescribe or dispense medicinal products;
• visits by medical sales representatives or other company agents to persons qualified to prescribe or dispense medicinal products;
• the supply of free samples;
• the sponsorship of promotional meetings attended by persons qualified to prescribe or dispense medicinal products;
• the sponsorship of scientific meetings attended by persons qualified to prescribe or dispense medicinal products, including the payment of their travel and accommodation expenses in connection therewith; and
• any inducement to prescribe or dispense medicinal products through the gift, offer, or promise of any benefit or bonus, whether in cash or in kind, except when the intrinsic value of such items is minimal.

Under Royal Decree 1416/1994, the following activities do not qualify as advertising and are therefore not subject to advertising rules:

• the labelling and the leaflet of the medicinal product;
• correspondence, together with any non‑promotional document (for example, scientific articles or the SmPC) required to respond to a specific question about a particular medicinal product, provided that such information is limited to the query raised and is truthful and non‑misleading;
• information and reference documents relating, for example, to changes in packaging, pharmacovigilance warnings, sales catalogues and price lists, provided that no other information on the medicinal product is included; and
• information relating to human health or diseases, provided there is no direct or indirect reference to the medicinal product.

In addition, the Code of Farmaindustria provides that the following activities are not considered advertising:

• the summary of product characteristics (SmPC);
• information provided by HCPs to patients on certain medicinal products which, due to their complexity of dosage, route of administration, or other characteristics, require additional information, and only if such information is intended to improve adherence to treatment;
• corporate advertising, meaning information that relates to the company itself;
• journalistic content produced in the normal course of professional activity, which may refer to specific medicinal products, new lines of research, or product launches, provided that there is no contractual relationship between the company and the publisher or author of the content;
• originals, reprints, or literal translations of scientific articles or abstracts published in recognised scientific sources or presented at scientific congresses, provided that they do not include any additional element such as trade marks (including links or accompanying materials), highlighted texts, or promotional claims;
• information on new lines of research with mention of the active substance and its properties; and
• educational materials for HCPs or patients where their distribution is a condition of the MA or has been approved by the competent health authorities.

The following practical considerations are relevant in assessing the above:

Corporate advertising (eg, a company’s mission, therapeutic areas, ESG policies or social initiatives) should avoid references to trade marks or active substances. Such references may, however, be acceptable in certain publicly available materials, such as pipeline information, annual reports or corporate brochures, provided that they are proportionate, consistent with market practice, and not accompanied by promotional claims.

Disease awareness campaigns are not considered advertising provided that they: (i) are genuinely aimed at public health education, including awareness of specific diseases, disease burden, prevention or early detection; (ii) do not make any direct or indirect reference to a medicinal product (including trade marks, active substances, brand elements or imagery); and (iii) do not suggest or encourage the use of a particular treatment.

Particular caution is required where the company is the sole MAH for the product used to treat such disease. In such cases, the authorities and courts may consider indirect references to exist – for example, through references to therapeutic classes, generic terms such as “treatment”, or emphasis on the company’s role in developing solutions for patients with that disease, which may imply promotional intent (see, eg, the judgment of the High Court of Justice of Madrid of 12 March 2024).

Patient educational materials or patient support programmes, where the purpose is limited to treatment support (eg, follow‑up facilitation, patient information or adherence support), should be provided through HCPs or nurses. References to a trade mark or active substance may be included solely where necessary to correctly identify the medicinal product.

Patient‑facing information issued by a company should avoid product comparisons, as these may be considered indicative of promotional intent.

Pharmaceutical companies may issue press releases concerning medicinal products addressed to laypersons in Spain. However, such communications must not amount to the promotion of prescription‑only medicinal products, as this would constitute prohibited direct‑to‑consumer advertising.

Determining Whether or Not a Press Release Is Advertising

The Code of Farmaindustria (Annex III), together with the case law of Autocontrol’s Jury of Advertising – the control body responsible for ruling on breaches of self‑regulatory codes, including the Code of Farmaindustria – provides guidance on when press releases qualify as information rather than advertising. In particular:

• The press release must relate to a genuine newsworthy event, such as a research milestone, a regulatory development, or another occurrence with an impact on the company’s business or financial performance.
• Information must be based on objective and verifiable data, not opinions, and should include the original source where relevant, enabling journalists to assess its accuracy.
• The identity of the entity issuing the press release must be clear, whether issued directly or through third parties. Contact details for the corporate communications department should be provided.
• References to specific medicinal products may be included. Trade marks may be used only after a positive CHMP opinion; otherwise, references should be limited to the active substance. Where a product is approved outside the EU, the local trade mark may be mentioned together with the relevant country.
• Trade marks or active substances should be used sparingly (a maximum of twice), should not appear in headlines, and should preferably be replaced with generic terminology wherever possible.

The choice of distribution channel is also relevant. Press releases should be disseminated through appropriate channels (eg, investor relations communications, specialised trade press, or mainstream media), and content should be in lay language. Targeting press releases specifically at HCPs, or tailoring their content exclusively for HCPs, may be regarded as promotion of prescription‑only medicinal products and would therefore be subject to advertising rules.

Guide for Interacting With the Media

Journalistic content or press releases prepared by journalists where a contractual relationship exists between the company and the journalist or media outlet may be regarded as advertising and therefore subject to advertising rules, in accordance with Circular 1/2000.

However, Farmaindustria’s control bodies have clarified that the mere existence of a contractual relationship does not automatically mean that a journalistic text should be classified as advertising. This assessment must be made on a case‑by‑case basis, taking into account additional factors, including:

• whether the content seeks to promote the consumption of a product;
• whether the statements are made by experts engaged by the company;
• whether the tone is laudatory; and
• in cases of multiple publications, whether the similarity of the content suggests limited journalistic input, which may indicate the company’s control over the content and therefore a promotional purpose (Ruling of Autocontrol in Gilead v VIIV 2DR‑JULUCA‑DOVATO, dated 25 June 2020).

Under Law 3/1991 and the Code of Farmaindustria, comparative advertising directed at HCPs is permitted provided that:

• the products or characteristics being compared are comparable, essential, and relevant;
• the comparison is objective, scientifically proven, and verifiable from sources that are immediately accessible to the competitor; and
• the overall tone of the advertisement is balanced and fair.

The competitor’s brand name or trade mark may be used in a comparison, provided that such use is proportionate and does not seek to unfairly capitalise on the competitor’s brand reputation. According to the Code of Farmaindustria, if a competitor’s brand names are used, the owner of the brand must be clearly and visibly identified. There is no legal or ethical requirement to expressly reference the registered trade mark of the medicinal product, as comparative advertising allows both explicit and implicit references to a competitor (Ruling of Autocontrol in Sanofi‑Aventis v Italfarmaco – Hepaxane, dated 8 January 2020).

Advertising medicinal products that have not been granted a Marketing Authorisation (MA) is not permitted. However, companies may provide scientific information to HCPs and HCOs regarding unauthorised medicines or indications. This must follow a highly restrictive approach, given the risk that such communications could otherwise be perceived as promotional.

In particular, such communications are only permissible in the situations described in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient‑Facing Information, as well as in the situations described below.

Additionally, according to Royal Decree 1015/2009, MA holders must not distribute any type of information that may directly or indirectly stimulate the use of a medicinal product outside the conditions approved in its SmPC.

Objective and non‑promotional scientific information on unauthorised medicinal products or unauthorised indications may be provided during congresses or meetings organised by a prestigious scientific society.

In addition, regional authorities and the Code of Farmaindustria accept that information – and also promotion – on medicinal products or indications authorised in countries other than Spain may be distributed at international congresses or meetings held in Spain, provided that:

• the meeting is attended by numerous HCPs from other countries;
• the materials are written in the language of the country where the product is approved or in English (this requires the product being approved somewhere other than Spain); and
• the materials include a clear warning indicating (at least in Spanish) that the medicinal product is not marketed or authorised in Spain.

Although the Code of Farmaindustria does not specify a minimum font size for this warning, it must be clearly visible and proportionate to the rest of the content. Including this warning as a footnote using a small font size is not sufficient (Ruling of Jury of Autocontrol in Glaxosmithkline v Astrazeneca CD‑PS 1/20 Symbicort, dated 7 July 2020).

Companies may respond to specific requests for information from HCPs as set out in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient‑Facing Information. Such information must be provided reactively and should be handled by the medical affairs department, rather than by sales or marketing teams.

Spanish law and the Code of Farmaindustria do not contain specific provisions on providing information to HCOs regarding unauthorised medicinal products or indications. In practice, regulatory authorities accept that objective information on a medicinal product may be supplied to HCOs before its approval to help them prepare their budgets, provided that the information does not include any promotional statements.

Under Spanish law, advertising of compassionate use programmes or other forms of early access is prohibited, as these relate to unauthorised medicinal products and would constitute advertising prior to the granting of a MA. Furthermore, even where a medicinal product is authorised in another country outside the EU, Royal Decree 1015/2009 expressly prohibits the MA holder in the country of origin from advertising the use of such product in Spain.

Advertising to the general public is prohibited for prescription‑only medicinal products and for publicly financed medicinal products under Spanish law and the Farmaindustria Code.

Advertising to the general public is permitted only for non‑prescription medicinal products that are not publicly financed, except when such products are indicated for any of the following conditions:

• tuberculosis;
• sexually transmitted diseases;
• other serious infectious diseases;
• cancer;
• chronic insomnia; and
• diabetes and other metabolic illnesses.

Any advertising material directed to the general public must clearly indicate that it is an advertisement and that the product being promoted is a medicinal product.

Messages must contain, at a minimum, the complete name of the product, the MA holder’s name and/or logo, the therapeutic indication, the product composition, an invitation to read the instructions in the leaflet and to consult a pharmacist, and any additional recommendations issued by the Ministry of Health to prevent risks and promote the rational use of the product.

Additionally, according to Royal Decree 1416/1994, such advertising must not include statements that:

• imply that medical consultation or a surgical procedure is unnecessary;
• guarantee efficacy, suggest an absence of adverse effects, or claim superiority/equivalence to another treatment – adjectives such as “perfect”, “maximum”, “unique”, “safe” or “total” are expressly prohibited;
• suggest that health will be improved by taking the medicinal product or worsened by not taking it;
• suggest enhanced sporting performance;
• are directed exclusively or mainly to children;
• present the product as a foodstuff, cosmetic or other consumer product, or imply safety/efficacy because it is “natural”;
• could, through description or detailed representation of a case history, lead to erroneous self‑diagnosis;
• use, in improper, alarming or misleading terms, imagery of changes in the human body caused by disease or by the action of the medicinal product;
• include promises of cure, exaggerated testimonials on the virtues of the product, or recommendations from scientists, HCPs or public figures (including influencers); and
• refer to the fact that the product has obtained an MA (or other authorisation).

Reminder advertisements, whose purpose is solely to remind the target audience of the medicinal product’s name, are only acceptable for products that are well‑known and have been promoted for at least two years. These advertisements may only include the name of the medicinal product. According to the Ministry of Health’s guidelines on the advertising of OTC medicinal products, a blurred image of the packaging is also acceptable in such advertising, provided that the only clearly visible information is the name of the product, the company logo, and the product’s identifying colours. Any additional references – such as to the therapeutic area or the product’s indication – fall outside the scope of the reminder‑advertising regime and therefore render it inapplicable.

Spanish law does not contain specific provisions regulating interactions between patients or patient organisations (POs) and the pharmaceutical industry. Nevertheless, under the Code of Farmaindustria, such interactions must comply with the principle of non‑promotion of prescription‑only medicines and must respect the independence of POs.

Collaboration With Patient Organisations

Collaborations between a company and POs must be formalised in a written agreement specifying:

• the purpose of the collaboration;
• the activities to be performed by each party;
• the financial amount of the collaboration; and
• any relevant indirect support provided, including its sources and purposes.

Additionally, companies must have an internal process for approving these collaborations and must refrain from:

• (i) requesting to be the exclusive collaborator or sponsor of a PO or its main activities; and
• (ii) influencing the content of publications issued by a PO.

Any interactions with, or engagements of, patients must be channelled through POs.

Meetings and Hospitality

Meetings with PO representatives, patients, or caregivers – and any associated hospitality – must comply with the same requirements described in 9.1 Gifts to Healthcare Professionals except that hospitality may also be extended to caregivers where justified. All hospitality must be arranged through the PO and must exclude entertainment or leisure activities, other than modest working meals or similar ancillary hospitality such as gala dinners.

Scientific Meetings and Expert Services

POs may be remunerated for the provision of expert services (eg, participating in advisory boards, acting as speakers or moderators at scientific meetings, educational activities, etc), provided that:

• a written agreement is in place clearly describing the nature of the services and the basis for remuneration;
• the purpose of the services is to co-operate with health assistance and/or research;
• the legitimate need for such services has been clearly identified;
• the selection of experts aligns with identified needs and is reviewed by the company’s scientific service;
• the number of experts engaged is limited to what is reasonably necessary to achieve the identified objectives;
• the company keeps documentary records of the services and the use given to those services;
• hiring a PO is not linked to its participation in a promotional event for a medicinal product;
• payment does not entail any inducement to recommend the company’s medicinal products;
• fees reflect fair market value, considering actual hours or services provided and the expert’s responsibilities (in‑kind payments are exceptional and require prior authorisation from Farmaindustria’s Surveillance Unit); and
• it is recommended that the agreement require the expert to disclose their relationship with the company whenever they write or publicly assert any matter related to the company.

Gifts and Informative Materials

According to the Code of Farmaindustria, offering money or any kind of gift or services for personal benefit to patients or PO representatives is prohibited.

Any material or publication directed to patients must:

• aim to help patients better understand the development of their disease and improve their quality of life – its content must therefore relate to patient health, specific illnesses, hygienic/sanitary measures, or healthy habits;
• expressly state whether it is sponsored by a company;
• be clearly non‑promotional in nature; and
• include messages clarifying that the material is for guidance and information only and cannot be interpreted as a substitute for diagnosis or advice from a healthcare professional.

Additionally, under the Code of Farmaindustria, member companies must publish a list of the POs they support and the POs with which they have entered into service agreements. This publication must include a sufficiently detailed description of the support provided to each PO and the amounts paid annually for their services.

According to Royal Decree 1416/1994, advertising directed to HCPs entitled to prescribe or dispense medicinal products must include:

• the name of the product and the name and address of the MA holder;
• the qualitative and quantitative composition of the product;
• essential data according to the SmPC, including complete clinical data, indications for use, cautions, and relevant contraindications;
• the different dosages and pharmaceutical forms in which the product is available;
• the prescription and dispensation regime applicable to the product;
• the retail price and the conditions under which the product is publicly financed; and
• the estimated cost of treatment, if possible to determine.

According to guidance issued by the Ministry of Health in 2023, essential SmPC data may be included through a QR code linking to the authorised SmPC published on the Spanish Medicines Agency (AEMPS) website (CIMA). However, information relating to the prescription and dispensing status, available presentations, and price and reimbursement conditions must be provided directly in writing within the promotional material.

Messages must be precise, balanced, honest, objective, based on adequate scientific evaluation, and sufficiently complete with respect to the therapeutic value of the product.

Reminder advertisements – permitted only for well‑known products that have been promoted for at least two years in Spain – may include only the name of the medicinal product and the International Non‑proprietary Name (INN) if the product contains a single active substance, as well as the product and company logos. No other statements may be added (eg, a generic reference to the therapeutic area). Regulatory authorities and the Farmaindustria Code’s control bodies also accept the inclusion of packaging images.

Advertising may refer to studies not included in the SmPC, provided that such studies are compatible with the information contained in the SmPC. This means that any claims must confirm or clarify the information in the SmPC without being misleading, exaggerating the properties of the medicine, or encouraging inappropriate or excessive use. This may include references to real‑world evidence, as recently confirmed by the confirmed Ruling of Autocontrol in Lilly v Novo Nordisk, dated 20 November 2025.

In all cases, any reference to clinical studies must be accurate and appropriately contextualised, and the promotional material must include sufficient information to allow the recipient to verify the reliability and accuracy of the data. Therefore, advertising cannot refer to the so‑called “data on file”.

Advertising the use of one medicinal product in combination with another is legally permitted as long as the advertising materials or message are consistent with the SmPC of both products. It is not required for the SmPC to include a specific reference to studies on the combined use of the products, provided that such use is compatible with the SmPC (Ruling of Autocontrol in Gilead v ViiV Healthcare New 2DR Era, dated 14 February 2019).

Furthermore, medicinal products incorporating a medical device may be advertised, provided that the advertising is consistent with the SmPC of the medicinal product and with the intended purpose and instructions for use of the medical device.

Spanish regulations establish a specific legal framework for “companion diagnostics”. Their advertising is subject to the general rules governing medicinal products and medical devices, depending on how the product is legally classified.

Companies may provide reprints of journal articles to HCPs. However, under the Farmaindustria Code, these reprints must not contain printed, stamped, or electronically linked trade marks or trade names of medicinal products, advertising slogans, or any other advertising materials, whether or not they relate to the information.

Medical Science Liaisons (MSLs) must not proactively discuss scientific information on unauthorised medicines or indications with healthcare professionals (HCPs), as this may be considered promotion of unauthorised medicinal products.

MSLs may provide information to HCPs – provided the conditions outlined in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient‑Facing Information are met – in order to respond to specific questions asked by the HCPs.

All information must be provided reactively, not proactively.

Advertising directed to HCPs who are qualified to prescribe or dispense medicinal products does not require prior approval. However, it must be notified to the health authority of the autonomous region in which the company is based. In exceptional cases, the Ministry of Health may require prior approval for the advertising of a specific product. Any such decision must be duly justified and must apply to all products with the same composition.

Advertising activities remain subject to ex post control by the authorities, and sanctions may be imposed in the event of non‑compliance with the law.

Additionally, according to Royal Decree 1416/1994, companies must submit an annual report summarising certain advertising activities to the relevant regional health authority.

Royal Decree 1416/1994, as well as the Code of Farmaindustria, requires the MA holder to have a scientific service responsible for managing information related to its medicinal products.

The scientific service must fulfil the following obligations:

• revise and control all promotional materials to ensure compliance with the law;
• ensure that medical sales representatives and any personnel involved in the promotion of medicinal products or interactions with HCPs, HCOs and/or POs have been adequately trained;
• maintain records of information regarding the medicinal products marketed, including a registry of requests for and the supply of samples; and
• provide regulatory authorities with the information and assistance they require, ensuring prompt compliance with their decisions.

In addition, the Code of Farmaindustria requires companies to have a written procedure to monitor compliance with the Code. It also recommends the involvement of different departments (marketing‑sales, medical, regulatory, legal, and finance‑administrative) in the internal committees, policies, or procedures on these matters.

Online advertising of medicinal products is subject to the same legal requirements as advertising through traditional channels. Advertising prescription‑only medicinal products to the general public via the internet is prohibited. Such advertising may, however, be directed at HCPs, provided that it is disseminated through restricted‑access channels (as described in 7.2 Restrictions on Access to Websites Containing Material Intended for Healthcare Professionals) and presented within a scientific and professional context. Companies must ensure that access is genuinely limited to HCPs. They are also responsible for the content of any external websites to which they link from their own website.

Advertising to the general public via the internet is permitted only for non‑prescription medicinal products that are not publicly funded. In this context, certain provisions of Royal Decree 870/2013, which regulates the online sale of OTC medicinal products, may also apply.

The use of influencers in the promotion of medicinal products is strictly prohibited. Royal Decree 1416/1994 states that medicinal products may not be promoted through individuals who, due to their notoriety, could encourage the use of such products. The only exception is when the influencer is a healthcare professional participating in a controlled scientific or professional setting, such as a congress or scientific meeting.

Companies must ensure that any section of their website containing advertising or information aimed at HCPs regarding prescription‑only medicinal products is accessible only to HCPs who are entitled to prescribe or dispense such products.

To this end, under the Code of Farmaindustria, the company may either (i) include a clearly legible warning stating that the information is intended exclusively for authorised HCPs and requires specialised training for its proper interpretation, or (ii) implement an HCP‑status verification or self‑declaration system.

As an exception, and based on guidance from the Ministry of Health’s Pharmaceutical Committee, the unmodified and unabridged publication of information authorised by the relevant authorities (eg, the SmPC, the package leaflet, public assessment reports, and price lists) is not considered advertising and may therefore be published openly on the internet.

Companies may provide corporate or disease‑awareness information to the general public online, provided that this complies with the principles set out in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient‑Facing Information.

In addition, according to guidance issued by the Catalan health authorities, the use of influencers for disease‑awareness activities is not permitted when such influencers are neither HCPs nor patients.

Any information or material provided online to patients must also comply with the requirements referred to in 4.3 Restrictions on Interactions Between Patients or Patient Organisations and Industry.

Spanish regulations and the Code of Farmaindustria do not distinguish between national or international scientific meetings when these are held in a virtual format. The Code of Farmaindustria states that companies cannot offer any form of hospitality in connection with virtual meetings. In addition, notification of online scientific meetings to Farmaindustria’s Surveillance Unit is not required.

Social media advertising is subject to the same legal requirements as advertising through traditional channels, taking into account the specific considerations set out in 7.1 The Advertisement of Medicinal Products on the Internet.

According to the Code of Farmaindustria, companies are responsible for the content disclosed through social media that they control (directly or indirectly) or finance (exclusively or as a majority partner). This responsibility includes oversight of both the means of dissemination and any third parties acting on their behalf.

Accordingly, companies must:

• adopt internal codes of conduct governing employees’ use of social media, including sanctions for non‑compliance;
• implement procedures to monitor content that they host, provide access to, temporarily store, or link to, and ensure that any irregularities are promptly corrected;
• establish clear rules of conduct for employees and third parties acting on their behalf or under their control, setting standards for responsible behaviour in digital environments – both when communicating in the name of the company and when using company‑provided channels; and
• train employees to prevent inappropriate content on their personal social media, such as comments on competitors’ products or off‑label promotion.

Under the Spanish Criminal Code, companies may be held criminally liable for bribes offered or given by their employees, directors, or other individuals under their control to public officials or to private persons.

The penalties that may be imposed on a company for a bribe are separate from those imposed on the individuals who have committed or participated in the bribe. These penalties can be as high as four times the amount of the profit gained by the company.

However, a company may be exempt from criminal liability if it can demonstrate that, before the bribe was offered or given, it had implemented a compliance system that met the conditions and requirements outlined in the Spanish Criminal Code. Additionally, the company must prove that the individuals involved fraudulently bypassed the compliance system and that there was no serious failure in the supervision and control duties established by the system.

According to Royal Legislative Decree 1/2015 and the applicable self‑regulatory codes, any individual with a direct or indirect interest in the production, manufacture, or marketing of medicinal products is prohibited from offering – directly or indirectly – any inducement, benefit, bonus, rebate, or advantage to healthcare professionals (HCPs) involved in the prescription, dispensing, or administration of medicinal products, as well as to their relatives or cohabitants. This prohibition likewise applies when the offer is made to HCPs who prescribe medical devices.

By way of exception, certain gifts, hospitality, and discounts may be permitted, provided they comply with the specific requirements set out in 4.3 Restrictions on Interactions Between Patients or Patient Organisations and Industry, 9.1 Gifts to Healthcare Professionals, 9.2 The Provision of Samples of Medicinal Products to Healthcare Professionals, 9.3 Sponsorship of Scientific Meetings, and 9.6 Restrictions on Rebates or Discounts to Healthcare Professionals or Healthcare Institutions.

Gifts

According to Royal Decree 1416/1994, gifts to HCPs who are entitled to prescribe or dispense medicinal products may only be offered when the value of the gift is insignificant and the item is relevant to the practice of medicine or pharmacy.

The Farmaindustria Code provides further guidance, stating that gifts to HCPs are only permitted if:

• the items have stationery or professional use;
• they are not related to a prescription‑only medicinal product; and
• their market price does not exceed EUR10.

Additionally, such gifts cannot be given during medical sales visits by company representatives, nor in the context of a congress or meeting organised by a third party when the visit or event relates to prescription‑only medicinal products.

As an exception, memory cards containing informative or educational materials may be provided, provided their value does not exceed EUR10. Pens and notepads may also be provided at meetings organised by the company, as long as they do not include information about prescription‑only medicinal products and their market price does not exceed EUR10.

Educational Materials

Educational materials and items of medical utility may be given to HCPs as gifts when all of the following conditions are met:

• they are relevant to the practice of medicine or pharmacy;
• they benefit patient care;
• they do not alter or modify the recipient’s routine business practice; and
• their market price does not exceed EUR70.

These types of gifts are excluded from the transparency obligations described in 10. Pharmaceutical Companies: Transparency.

Hospitality

Except in the case of virtual events, hospitality may be offered to HCPs in connection with professional or scientific events, provided it is reasonable, modest, and ancillary to the event’s primary scientific purpose. Hospitality must be limited to what is necessary for attendance and must not exceed what the recipient would normally pay themselves.

Hospitality may only cover real costs of travel, registration, and accommodation, and solely for the duration of the event – plus, where justified, one additional day either before or after. No payments may be made simply to compensate HCPs for the time spent attending. Reasonable fees may be paid to speakers and moderators, provided these comply with applicable rules.

Payments for meals costing more than EUR70 (including taxes) per person are prohibited, as are payments for five‑star/luxury hotels, sports resort hotels, theme park hotels, and/or winery hotels. Payment for cultural, leisure, or entertainment activities is also prohibited.

All such expenses must be paid directly by the company to the service providers. HCP attendees may not be reimbursed for expenses they incur themselves, except for minor travel costs (such as taxis or mileage), which must be properly documented.

Hospitality must not be extended to accompanying persons.

According to Royal Decree 1416/1994, the provision of free samples is permitted on an exceptional basis and is subject to prior authorisation from the AEMPS. Such authorisation may be granted for medicinal products that:

• have a new active substance;
• have a new pharmaceutical form, concentration, dosage, or administration route that represents a therapeutic advantage; or
• have new therapeutic indications.

The following conditions apply.

• Samples may only be supplied in response to a written request, signed and dated, from HCPs entitled to prescribe medicinal products.
• A maximum of ten samples for each medicinal product per HCP per year is allowed, and only for a maximum period of two years following the granting of the marketing authorisation.
• Companies must maintain appropriate control and record‑keeping systems.
• Samples must correspond to the smallest presentation of the product authorised in Spain.
• Each sample must be marked “free sample – not for sale”, and its reimbursement sticker must be annulled.
• Each sample must be accompanied by the SmPC and up‑to‑date information on price, reimbursement status, and, where possible, estimated treatment cost.

Samples of medicinal products containing psychotropic or narcotic substances may not be supplied.

The provision of samples to HCPs is excluded from the transparency obligations for companies under Farmaindustria referenced in 10. Pharmaceutical Companies: Transparency.

According to Spanish regulations, companies may sponsor scientific meetings or congresses and may also organise scientific, professional, or educational events aimed at healthcare professionals (HCPs). Hospitality may be provided to HCPs as set out in 9.1 Gifts to Healthcare Professionals.

Where a meeting or congress is organised or mainly sponsored by a company, that company may be held responsible for both the content of the event and the hospitality provided.

Under the Farmaindustria Code, scientific activities must represent at least 60% of an eight-hour working day. Tourist locations, sports resorts, and similar venues should be avoided. Events may not be held outside Spain unless most participants come from abroad, or the congress or expertise relevant to the event is located abroad. Prior approval by Farmaindustria’s Surveillance Unit may be required. When events take place abroad, the host country’s self-regulatory code applies unless Spanish rules are more restrictive (except for monetary hospitality thresholds).

Sponsorship must be disclosed in all documents related to the event, as well as in any resulting published materials. Recipients must also disclose the funding received and its source.

Finally, autonomous regions may impose additional organisational requirements related to interactions between sales representatives and public centres. For example, some regions require companies to submit visit schedules for subsequent validation.

Companies must comply with the transparency obligations referred to in 10. Pharmaceutical Companies: Transparency.

Hospitality offered to HCPs must not include social, entertaining or cultural activities, except for reasonable welcome cocktails, working meals and gala dinners.

Under Spanish law, grants or donations to individual HCPs are prohibited, except for gifts, samples, and hospitality that comply with the requirements set out in 9.1 Gifts to Healthcare Professionals, 9.2 The Provision of Samples of Medicinal Products to Healthcare Professionals, and 9.3 Sponsorship of Scientific Meetings.

Grants or donations to HCOs are acceptable, provided they are not offered as an inducement to buy, recommend, and/or use the company’s products.

The Code of Farmaindustria provides specific rules regarding grants or donations to HCOs. Donations or the funding of medical or technical services to organisations whose members are HCPs, or which provide healthcare, research, educational, or humanitarian services, are allowed, subject to the following conditions:

• the donation is not provided as an inducement to prescribe, recommend, or use any particular product;
• it must be intended for the use of the institution in general, and not for the use of an individual (eg, portable electronic devices would not qualify);
• the funds must not be directed to cover day‑to‑day ordinary expenses of the HCO, but must be allocated to specific projects aligned with the permitted purposes under the Code of Farmaindustria; and
• the donation must be recorded in a written document to be kept by the company.

Companies must also comply with the transparency obligations referred to in 10. Pharmaceutical Companies: Transparency with respect to the offer of grants or donations to HCOs.

Companies may grant rebates or discounts only in limited circumstances. For supplies to retail pharmacies, only volume‑related discounts and early‑payment discounts are acceptable, provided that they do not unfairly distort competition and are properly documented on the invoice. Companies must also maintain a record – interconnected with the Ministry of Health – of all discounts offered to pharmacies for medicinal products financed by the National Health System.

For supplies to hospitals, discounts are subject to public procurement rules.

HCPs may be remunerated for providing services to the company (such as participating in advisory boards, acting as a speaker or moderator at scientific meetings, engaging in educational activities, or taking part in expert meetings) provided that:

• a written agreement is entered into, clearly describing the services to be provided and the basis for remuneration;
• the legitimate need for such services has been clearly identified;
• the selection of experts aligns with the identified needs and is reviewed by the company’s scientific service;
• the number of experts engaged is limited to what is reasonably necessary to meet the identified objectives;
• the company keeps documentary records of the services provided;
• payment does not constitute an inducement to promote the prescription, dispensation, sale, or consumption of medicinal products;
• fees reflect fair market value, considering the actual hours or services provided, as well as the expert’s responsibilities (payments must be clear and transparent, with proper invoicing from the HCP – in‑kind payments are only allowed in exceptional cases with prior authorisation from Farmaindustria’s Surveillance Unit);
• it is recommended that the agreement include a clause requiring the HCP to disclose that they provide services to the company whenever they write about or publicly assert any matter related to the company; and
• Annex IV of the Code of Farmaindustria provides detailed guidance on engagements with HCPs and HCOs, in line with the International Federation of Pharmaceutical Manufacturers & Associations’ Guidance on Fees for Services.

Companies must comply with the transparency obligations referred to in 10. Pharmaceutical Companies: Transparency, regarding payments made to HCPs related to the provision of services.

HCPs working in public health system–affiliated HCOs may need their employer’s authorisation before accepting hospitality or providing services for a company. The responsibility lies with the HCPs to seek this permission, not with the companies offering the hospitality or services.

Under the Code of Farmaindustria, companies must inform Farmaindustria’s Surveillance Unit in the following cases:

• when the company organises attendance at a congress or event for 20 or more HCPs; and/or
• when the number of HCPs engaged by the company for a specific project exceeds ten.

In the case of meetings that are part of projects that have already been notified by the companies, these do not need to be notified again.

Communication will be voluntary for training activities or scientific meetings that are carried out virtually.

The Code of Farmaindustria has implemented the European Federation of Pharmaceutical Industries and Associations (EFPIA) rules on the disclosure of transfers of value (ToV) from pharmaceutical companies to HCPs, HCOs and POs. Consequently, since 2015, companies have been required to document and publish on their websites (with the first publication made in 2016) all ToV made during the previous year. This includes any direct or indirect payment or grant – whether in cash or benefits in kind, and regardless of their purpose – whose recipient is an HCP or HCO.

The only payments excluded from this obligation are:

• those associated with commercial transactions with distributors, retail pharmacies and certain transactions with HCOs;
• activities related to products or medicinal products that are not prescription-only medicinal products; and/or
• activities not detailed in Appendix I of the Code of Farmaindustria, such as the provision of gifts, samples, dinners or luncheons.

Disclosure must be made on an individual basis, except for ToV related to R&D. Spanish authorities on personal data protection have ruled that companies must inform an HCP about the disclosure of their personal data. However, there is no requirement for the HCP to consent to the disclosure.

AESEG has also implemented in its own code the Medicines for Europe rules on the disclosure of ToV from companies to HCPs, HCOs and POs.

The transparency requirements described in 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value apply ToV made to HCPs, HCOs, and POs by companies associated with Farmaindustria/AESEG and/or companies that have voluntarily adhered to the Farmaindustria/AESEG Codes. These requirements also apply to ToV made to Spanish HCPs, HCOs, and POs by their affiliates, except in cases where those affiliates already publish such ToV in accordance with their own national code of conduct.

The fact that a company does not yet have products on the market is irrelevant for the purpose of these transparency obligations.

Enforcement of pharmaceutical advertising rules in Spain lies with the regional health authorities, as well as with the courts. In addition, self-regulatory enforcement is carried out by the control bodies of the Codes of Farmaindustria (ie, Autocontrol’s Jury of Advertising), AESEG and ANEFP.

Advertising disputes may be brought before the civil courts under Law 34/1988 on General Advertising and Law 3/1991 on Unfair Competition, as such conduct is considered an act of unfair competition. The available actions, which may be brought either separately or cumulatively, include:

• cessation or prohibition of the unlawful advertising;
• a declaration that the advertising is unlawful;
• removal of the effects produced by the unlawful advertising; and
• rectification of any deceitful, incorrect or false information contained in the unlawful advertising, including publication of the court ruling.

In addition, the claimant may seek damages if the advertiser acted intentionally or negligently, and also in cases of unlawful enrichment, where applicable.

These actions may be brought by any person or company whose interests are affected and, more generally, by those who have a legitimate interest, as well as consumer associations or other associations acting in defence of their members’ interests. However, such associations are not entitled to claim damages.

The most common issues addressed in these proceedings include the distinction between advertising and purely informational content – particularly in relation to prescription‑only medicines in the context of press communications – as well as alignment with the SmPC, the fairness of comparative advertising, and the limits applicable to hospitality offered to HCPs.

Regulatory authorities closely scrutinise advertising and may order the suspension of an advertisement or the withdrawal of unlawful advertising, as well as require the publication of corrective statements.

Failure to Comply

Infringements may also result in administrative sanctions, primarily fines. Under Royal Legislative Decree 1/2015, fines generally range from EUR30,000 to EUR1 million depending on the seriousness of the infringement. In practice, however, fines exceeding EUR90,000 are uncommon.

The amount of the fine is determined on a case‑by‑case basis, taking into account factors such as:

• negligence;
• whether the breach was intentional;
• whether there was fraud or connivance;
• whether there has been a failure to comply with previous requests made by the authorities;
• the company’s turnover;
• the number of persons affected;
• the damage caused; and
• the profits obtained from the infringement.

In exceptional cases, criminal sanctions may apply.

Challenging Decisions

Decisions taken by regional health authorities may be challenged by administrative appeal and/or judicial review. Mandatory administrative appeals must be lodged within one month; otherwise, judicial proceedings may be brought within two months from the notification of the administrative decision. A preliminary injunction may also be sought where there is a risk of irreparable harm.

The Codes of Farmaindustria, AESEG and ANEFP require member companies, or those adhered to the codes, to first submit their complaints for alleged breaches to the relevant self‑regulatory control bodies before bringing the matter before regulatory authorities or the courts.

Proceedings before these bodies may result in a declaration that the advertising is unlawful and, where appropriate, the imposition of a fine. When determining the sanction, various factors are taken into account, including the potential harm caused to the reputation of the pharmaceutical industry, as expressly recognised in the Code of Farmaindustria.

Notwithstanding the above, regulatory authorities retain the power to investigate matters independently, even when the issue is being examined by a self‑regulatory body. Autocontrol must refrain from assessing matters that are under investigation by, or have been brought before, the regulatory authorities or the courts.

In recent years, there has been limited publicly reported enforcement activity in Spain, both before the courts and within the self‑regulatory system. This should not, however, be interpreted as a relaxation of oversight, as regulatory authorities – and in particular the self‑regulatory bodies – continue to monitor compliance closely and to intervene promptly where potential breaches are identified.

The most recent decisions of Autocontrol concerning breaches of the Code of Farmaindustria date from November 2025 and April 2024, and primarily addressed inconsistencies between promotional claims and the authorised SmPC.

At the judicial level, the most significant recent development is the judgment of the Spanish Supreme Court referred to in 1.3 Regulatory Updates.

Royal Decree 1157/2021 regulates the advertising of veterinary medicines in Spain. It permits the advertising of prescription‑only veterinary medicines exclusively to veterinarians and authorised dispensers. However, there is an exception for immunological medicines, which may also be advertised to persons responsible for animals.

Advertising of veterinary medicines directed at the general public must comply with the following requirements:

• it must be consistent with the product’s SmPC;
• testimonials from veterinarians or well‑known individuals, as well as expressions that imply guarantees of healing, are prohibited; and
• claims suggesting that the product has been granted a marketing authorisation are prohibited.

In addition, advertising of veterinary medicines aimed at the general public (except in the case of advertising for branding purposes) must include the following information:

• name of the medicinal product and number of the marketing authorisation;
• identification of the marketing authorisation holder;
• composition of the active substance;
• indications for use and target species;
• contraindications, precautions and withdrawal periods, if applicable;
• any additional indications required in the marketing authorisation; and
• the statement, “If in doubt, consult your veterinarian”.