Pharmaceutical Advertising Laws and Regulations Report 2024 Spain

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Pharmaceutical Advertising Laws and Regulations Report 2024 Spain

1. General – Medicinal Products

1.1        What laws and codes of practice govern the advertising of medicinal products in your jurisdiction?

Advertising of medicinal products in Spain is governed by a combination of laws, guidelines of the regulatory authorities, and codes of conduct adopted on a voluntary basis by the pharmaceutical industry.

General rules on advertising are comprised in General Law 34/1988 on Advertising and Law 3/1991 on Unfair Competition.  The principles on the subject, established by Directive 2001/83/EC on the Community code relating to medicinal products for human use, have been incorporated into Spanish law through the following regulations:

  • Royal Decree-Legislative 1/2015 approving consolidated text of the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices.
  • Royal Decree 1416/1994 on advertising of medicinal products for human use.
  • Instruction 6/1995 of the Ministry of Health on Royal Decree 1416/1994.
  • Guideline 2019 of the Ministry of Health on advertising of medicinal products directed to the general public.

Additionally, instructions issued by the health authorities of the Autonomous Regions (Spain is a decentralised state, divided into 17 Autonomous Regions), which are the competent authorities for controlling the advertising of medicinal products in their respective territories, should also be considered (e.g., Instruction 1/2000 of the Autonomous Region of Madrid and Guidelines 2019 of the Autonomous Region of Catalonia).

Moreover, Spanish trade associations of different sectors of pharmaceutical industry have also adopted their own self-regulatory codes of conduct, which are applicable and have binding effects on the companies that are members of the issuing trade association and on companies that have voluntarily adhered to a code.  These self-regulatory codes are currently the following:

  • Code of Good Practices of the Pharmaceutical Industry of FARMAINDUSTRIA (the main Spanish trade association of the innovative pharmaceutical industry).
  • Code of Conduct on Interactions with the Health Community of AESEG (Spanish generic pharmaceutical industry trade association).
  • Code of Ethics for the Marketing, Promotion and Advertising of Medicinal Products for Selfcare of ANEFP (Spanish trade association of the non-prescription medicinal products industry).

Companies subject to a self-regulatory code are also responsible for their affiliates and third parties acting on their behalf complying with the code when they perform promotional activities in Spain and/or they interact in any way with healthcare professionals (HCPs), healthcare organisations (HCOs) and/or patient organisations (POs) in Spain.

1.2        How is “advertising” defined?

Spanish law provides that “any form of informative offer, commercial research or inducement designed to promote the prescription, dispensation, sale or consumption of the medicinal products in Spain” shall be considered advertising of such a product.

In particular, the advertising of medicinal products includes:

  • Advertising directed to the general public.
  • Advertising directed to HCPS.
  • Visits by sales representatives or informative agents of the companies to such HCPs.
  • Supply of samples of medicinal products.
  • Sponsorship of promotional meetings attended by HCPs.
  • Sponsorship of scientific meetings attended by HCPs, as well as payment of their registration, travel and accommodation expenses in connection therewith.

Any inducement to prescribe or dispense medicinal products by granting, offering or promising any benefit, in money or in kind, except when its actual value is minimal.

However, in practice, the Spanish authorities consider advertising of medicinal products to be any information or informative activity of a pharmaceutical company concerning its medicinal products, except for the following materials and/or activities, which, as indicated in Royal Decree 1416/1994, shall not be considered advertising of medicinal products and, therefore, shall not subject to the rules that apply to such advertising:

  • Correspondence, accompanied, where applicable, by any document of a non-promotional nature (for example, scientific articles) that is needed to respond to a specific question about a particular medicinal product, but only if it refers to the question that is the subject of inquiry and is accurate and not misleading.
  • Specific information and relevant documents related to, for example, labelling of the medicinal products, leaflets, changes in packaging, adverse reaction warnings in the framework of pharmacovigilance, and/or sales catalogues and price lists, provided no additional information on the medicinal product is included.
  • Information on human health or diseases, provided there is no reference, even indirect (for example, by mentioning its active substance), to specific medicinal products.

Additionally, FARMAINDUSTRIA’s Code states that the following informative activities will not be considered advertising of medicinal products:

  • Information provided by an HCP to patients on certain medicinal products that, due to the complexity of dosage, route of administration, etc., require additional information, and only if such information is intended to improve treatment adherence.  Such information could be prepared by the company who commercialises the medicinal product, but in all cases must be provided to the patients through their doctors.
  • Corporate advertising, meaning advertising that relates to the company and its activities, provided there are no references, not even indirect, to specific medicinal products.
  • Texts written and produced by journalists within the scope of their professional work, provided that there is no contractual relationship between the firm responsible for editing or the author of the information and the owner of the medicinal product and/or its trademark.
  • Press releases made by companies regarding relevant new facts related to the development and/or registration status of their medicinal products.

1.3        What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as “sign off” of promotional copy requirements?

Under Royal Decree 1416/1994 and FARMAINDUSTRIA’s Code, the marketing authorisation holder (MAH) must have a scientific department or service in charge of managing the information related to the medicinal products marketed by the company.

The scientific service of the company must fulfil the following obligations:

  • Review and, if needed, revise and control any promotional materials to ensure they comply with the legal and code requirements.
  • Ensure that the medical sales representatives and any personnel involved in promoting medicinal products or interacting with HCPs, HCOs and/or POs have been adequately trained.
  • Compile all information regarding the medicinal products marketed, including the maintenance of a registry of the requests for and supply of samples.
  • Supply regulatory authorities with the information and assistance they require regarding their control of the advertising activities of the company and ensure that the decisions of the regulatory authorities on these matters are immediately and thoroughly complied with.

1.4        Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities or to employ personnel with a specific role? If so, what aspects should those SOPs cover and what are the requirements regarding specific personnel?

Under FARMAINDUSTRIA’s Code, companies must (i) have a SOP to monitor compliance with the code, as well as (ii) appoint at least one employee or manager with sufficient qualifications who will be responsible for internal oversight of compliance with the code.  Additionally, FARMAINDUSTRIA’s Code recommends that the different departments (marketing/sales, medical, regulatory, legal, finance/administrative) get involved in the committees, policies or internal procedures that the company implements on these matters.

1.5        Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?

Except in the case indicated in the last paragraph of this answer, advertising directed to HCPs does not need to be approved in advance by a regulatory or industry authority.  However, companies must send a copy of the advertisement to the health authority of the Autonomous Region where the company is located, assuming the responsibility for ensuring that only HCPs entitled to prescribe or dispense medicinal products have access to the relevant publication.

Also, advertising directed to the general public does not need to be approved in advance by regulatory authorities (and this has been the case since July 2013).

Notwithstanding, any advertising directed to HCPs or to the general public may be subject to control ex post by the regulatory authorities and by the industry authorities.  Additionally, according to Royal Decree 1416/1994, companies must send an annual index summarising all of their advertising activities to the health authority of the Autonomous Region where the company is located.

The Ministry of Health may also, in exceptional circumstances, make advertising of specific medicinal products subject to prior approval by regulatory authorities.  Any decision of this nature must be duly justified and shall affect all medicinal products having the same composition.

1.6        If the authorities consider that an advertisement which has been issued is in breach of the law and/or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal?

Regulatory authorities of the Autonomous Region where a company is located have control over advertising materials and can suspend any advertisement if it violates the applicable rules.  Additionally, if an advertisement poses a risk to the health or safety of consumers, regulatory authorities can require a corrective statement and the publication of their ruling where the advertisement was originally published.

Decisions adopted by the regulatory authorities can be appealed through administrative channels and judicial review.  In some cases, an administrative appeal is mandatory to start the appeal process and must be filed within a month of receiving the decision notification.  However, when the administrative appeal is optional, the interested party may directly go to court within two months from the date the decision was notified.  During the court case, an injunction may be requested.  However, the chances of such injunction being granted depend on whether the applicant can demonstrate that irreparable harm will occur if it is not granted.

Moreover, the bodies of the industry associations responsible for ensuring the compliance with the codes of conduct of FARMAINDUSTRIA, AESEG and ANEFP can order the cessation of advertising and impose sanctions on member companies that violate these codes.  However, these bodies cannot require the company responsible for the advertising to adopt corrective measures.

1.7        What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? If there have not been such cases, please confirm. To what extent may competitors take direct action through the courts in relation to advertising infringements?

Not complying with the regulations regarding advertising for medicinal products can result in administrative penalties.  The amount of the fine depends on several factors, including whether the breach was due to negligence, intentional, fraud, wilful misconduct, if there was a failure to comply with prior requests from authorities, the company’s turnover, the number of people affected, the harm caused, and the profits gained from the infringement.  In some cases, breach of applicable law on advertising may be considered a criminal offence.  Spanish health authorities have sanctioned pharmaceutical companies for offering excessive hospitality to HCPs in the context of promotional meetings organised by these companies.  In one case, the sanction was imposed because the company offered the attending HCPs a catering dinner whose cost per person (including taxes and other ancillary costs) exceeded the amount of 60 Euros.  In another case, the sanction was imposed because the company organised the meeting outside Spanish territory despite the fact that all the attendees were exercising their profession in Spain.  These conducts were considered serious infringements of Spanish regulations and were subject to a fine of between 30,000 and 50,000 Euros.

Under the Codes of FARMAINDUSTRIA, AESEG and ANEFP, the procedure may conclude with the declaration of the unlawfulness of the advertising, as well as with a fine, the amount of which will be set considering a variety of factors.  The damage that a breach of the rules may cause to the industry’s image is one of the criteria to which FARMAINDUSTRIA’s Code refers.  The competent body to impose these measures and sanctions is the Jury on Advertising, a specialised body within AUTOCONTROL (Spanish Association for Self-regulation in Advertising).  The rulings of the Jury of Advertising are made public through its website.  The Advertising Jury has also imposed sanctions on several pharmaceutical companies for distributing promotional materials that did not accurately reflect the available scientific evidence, or for promoting the use of the medicinal product under conditions other than those for which it is authorised.  The largest fine ever imposed by the Advertising Jury for this type of conduct amounted to 200,000 Euros for multiple infringements of the FARMAINDUSTRA Code.

Companies that are members of FARMAINDUSTRIA, AESEG and/or ANEFP, or who have voluntarily adhered to their respective codes, undertake not to bring claims or lawsuits to regulatory authorities or the courts without having first followed the procedure provided for claims before the bodies responsible for ensuring code compliance.

1.8        What is the relationship between any self-regulatory process and the supervisory and enforcement function of the competent authorities? Can and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self-regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body?

The Codes of FARMAINDUSTRIA, AESEG and ANEFP state that, before raising the issue before the regulatory authorities or the courts, the companies who adhered to these codes must first file their claims against the advertising practices of other companies before the bodies in charge of enforcing these codes of conduct.

Notwithstanding the foregoing, regulatory authorities may investigate matters on their own initiative, even if any self-regulatory body is assessing them.  They may also take up matters based on an adverse finding of any self-regulatory body.  On the other hand, the Jury of Advertising must refrain from assessing any issue that the regulatory authorities or the courts have assessed.

1.9        In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action?

According to General Law 34/1988 on Advertising, advertising activities that breach the general or sector-specific rules on advertising are considered unlawful.

In response to a competitor’s unlawful advertising, companies may start one or several of the actions foreseen in Chapter IV of Law 3/1991 on Unfair Competition, which can lead to the court:

  1. Declaring that the promotional activity involves a competitor’s unfair conduct.
  2. Prohibiting the competitor from performing the promotional activity, ceasing it if it has already commenced, and/or prohibiting the competitor from repeating it in the future.
  3. Ordering the competitor to eliminate unfair conduct effects, including rectification of misleading, incorrect or false information.
  4. Requiring the competitor to compensate the claimant company for the damages caused by unfair conduct, provided the competitor’s conduct was wilful or negligent.
  5. Imposing measures to prevent the competitor from being unjustly enriched due to its infringing conduct.

The court may also request the publication of all or part of the judgment at the expense of the convicted party that has been ruled to have performed an activity considered unfair competition.

Such actions in court may also be brought by consumers or other associations whose members’ interests are affected by the unfair competition practice but are not entitled to claim damages.

Notwithstanding the above, companies that are members of FARMAINDUSTRIA, AESEG and/or ANEFP, or who have voluntarily adhered to their respective codes, undertake not to bring claims or lawsuits before the courts without having first followed the procedure provided for claims before the bodies responsible for ensuring code compliance.

2. Providing Information Prior to Authorisation of Medicinal Product

2.1        To what extent is it possible to make information available to healthcare professionals about a medicine before that product is authorised? For example, may information on such medicines be discussed, or made available, at scientific meetings? Does it make a difference if the meeting is sponsored by the company responsible for the product? Is the position the same with regard to the provision of off-label information (i.e. information relating to indications and/or other product variants not authorised)?

Companies are prohibited from promoting the use of a medicinal product that is not authorised in Spain, even if the product is authorised in another country.  Furthermore, they cannot promote the use of an authorised medicinal product for indications or conditions of use that are not those expressly provided for in its Summary of Product Characteristics (SmPC).

In certain specific circumstances, Spanish authorities may allow companies to provide scientific information to HCPs and HCOs prior to the approval of the medicinal products if it is merely a transfer of scientific information, instead of an advertising activity.  However, it is recommended to approach these activities with caution, as any promotional material containing promotional statements will be considered advertising.

2.2        May information on unauthorised medicines and/or off-label information be published? If so, in what circumstances?

During scientific or professional meetings organised by reputable organisations, companies may provide objective and non-promotional scientific information about unauthorised medicinal products or indications, provided that certain conditions are met:

  1. At international meetings with HCPs from different countries in attendance, companies may distribute promotional materials related to medicinal products or indications that are authorised in a third country but not authorised in Spain, as long as the materials are written in the language of the country where the product is authorised or in English.  Additionally, these materials must indicate in Spanish that the medicinal product is not authorised or marketed in Spain.
  2. Companies may also share information about their research and products pipeline at their medical stands (which must be clearly separated from commercial stands), but such information must be objective and cautious, without any claims or other elements of a promotional nature.

2.3        Is it possible for companies to issue press releases about unauthorised medicines and/or off-label information? If so, what limitations apply? If differences apply depending on the target audience (e.g. specialised medical or scientific media vs. mainstream public media), please specify.

Companies may issue press releases about unauthorised medicinal products and/or off-label information – both through specialised medical media and through mainstream public media – provided that they (a) refer to a relevant step in the research and/or authorisation process of a medicinal product, which is relevant for the financial results or performance of the company, and (b) do not have a non-promotional tone.  However, if a contractual relationship exists between the company and the media where a press release is published, the press release will be deemed advertising material on the medicinal product and must therefore be subject to the rules regarding advertising.

2.4        May such information be sent to healthcare professionals by the company? If so, must the healthcare professional request the information?

Any company may respond to specific requests for information from HCPs.  Information must be provided reactively and not proactively.  However, it is more advisable to deal with these matters through the medical affairs department of the company rather than through its sales or marketing departments.

2.5        How has the ECJ judgment in the Ludwigs case, Case C-143/06, permitting manufacturers of non-approved medicinal products (i.e. products without a marketing authorisation) to make available to pharmacists price lists for such products (for named-patient/ compassionate use purposes pursuant to Article 5 of the Directive), without this being treated as illegal advertising, been reflected in the legislation or practical guidance in your jurisdiction?

Although companies are prohibited from promoting the use of a medicinal product that is not authorised in Spain, they can provide price lists to hospital pharmacists without violating this prohibition.  According to Article 1.4.c of Royal Decree 1416/1994, this activity is not considered illegal advertising of medicinal products and does not fall under the aforementioned prohibition, as long as no further information about the product is included.

2.6        May information on unauthorised medicines or indications be sent to institutions to enable them to plan ahead in their budgets for products to be authorised in the future?

There are no provisions in Spanish law or in the codes of practice of the industry regarding this matter.  In practice, Spanish authorities accept that objective information on a medicinal product may be provided to HCOs prior to its approval, in order to prepare their budget, provided it does not contain promotional statements.

2.7        Is it possible for companies to involve healthcare professionals in market research exercises concerning possible launch materials for medicinal products or indications as yet unauthorised? If so, what limitations apply? Has any guideline been issued on market research of medicinal products?

Yes.  According to FARMAINDUSTRIA’s Code, market research studies must meet the following requirements:

  1. A written protocol that clearly establishes the objectives, methodology, anticipated results and use must exist.
  2. Proportionality between the universe and the sample.
  3. Aggregate handling of the responses or data obtained.
  4. The pharmaceutical company will not have the ability to learn before, during or after the study, the identity of the individuals participating in the study.
  5. The individual who participates in the study does not know, a priori, and does not have the opportunity to link the study with the pharmaceutical company or with a specific product.  If for legal reasons the person participating in the study must be informed of the identity of the pharmaceutical company sponsoring the study (as the data controller), pharmaceutical companies shall adopt the necessary measures to ensure that such communication is limited to the extent strictly required and occurs at the end of their participation in the corresponding study.
  6. The pharmaceutical company’s sales network cannot play any role in developing and conducting the study.
  7. The results of the study and the data obtained will not be published or used in promotional materials.

To ensure that market research studies do not serve as an inducement to prescribe, the following conditions must also be met:

  1. Companies must communicate the study prior to its commencement to FARMAINDUSTRIA’s Code of Practice Surveillance Unit.
  2. Written agreements must be formalised with the HCPs and/or HCOs with whom the studies will be conducted on the one hand and the company sponsoring the study on the other, specifying the nature of the services to be rendered, the conditions for participation and remuneration to the professionals, etc.
  3. Remuneration to participating HCPs must follow market criteria and be in accordance with the time spent, the work performed, and the responsibilities assumed.  In addition, it must be appropriately formalised.
  4. The study must be approved, prior to execution, by the pharmaceutical company’s scientific department or by the compliance officer.

3. Advertisements to Healthcare Professionals

3.1        What information must appear in advertisements directed to healthcare professionals?

According to Royal Decree 1416/1994, advertising targeted at HCPs must contain specific information, including:

  1. The name of the product.
  2. The name and address of the MAH.
  3. The qualitative and quantitative composition of the product.
  4. Essential data according to the SmPC, such as clinical data, indications, cautions and contraindications.
  5. Different dosages and pharmaceutical forms available, the prescription and dispensation regime, the retail price, and the conditions under which the product is publicly financed.
  6. The estimated cost of treatment, if possible.

The messages in the advertisement must be accurate, fair, truthful, objective, scientifically based, and complete with regard to the therapeutic value of the product.

Reminder advertisements are only allowed for products that have been promoted for at least two years and are sufficiently well known.  Such ads can include only the name of the medicinal product and the International Common Denomination, as well as the product and company logos.  However, it is permissible to include pictures of the packaging.

3.2        Are there any restrictions on the information that may appear in an advertisement? May an advertisement refer to: (a) studies not mentioned in the SmPC; or (b) studies which have not been published either in peer-reviewed journals or at all (“data on file”)?

According to Spanish law, promotional use of data on file is not allowed.  However, advertisements may refer to studies that are not included in the SmPC of a medicinal product, as long as these studies do not contradict the information that is included in the SmPC.

3.3        Are there any restrictions to the inclusion of endorsements by healthcare professionals in promotional materials?

According to Royal Decree-Legislative 1/2015, HCPs may not act as commercial agents or representatives of pharmaceutical companies, and therefore, the inclusion of endorsements by HCPs in promotional materials is not permitted.

On the other hand, quotations from medical literature or from personal communications are allowed.  They must exactly reflect the opinion of the author.  In addition, quotations of comments made in public broadcasts, such as those made in radio and television shows, or those collected at meetings, must not be used without the formal consent of the person to be quoted.

3.4        Is it a requirement that there be data from any, or a particular number of, “head to head” clinical trials before comparative claims may be made?

There are no provisions in Spanish law or in the codes of practice of the industry regarding this matter.  Spanish regulations just state that the comparison must be scientifically proven and verifiable through sources immediately accessible to the competitor.

3.5        What rules govern comparative advertisements? Is it possible to use another company’s brand name as part of that comparison? Would it be possible to refer to a competitor’s product or indication which had not yet been authorised in your jurisdiction?

According to Law 3/1991 and FARMAINDUSTRIA’s Code, comparative advertising directed at HCPs is permitted provided that (a) the products or characteristics compared are comparable, essential and relevant, (b) the comparison is objective, scientifically proven and verifiable from sources immediately accessible to the competitor, and (c) the overall tone of the advertisement is balanced and fair.

The competitor’s trademark or brand name may be used as part of the comparison, provided that such use is proportionate and is not made for the purpose of taking unfair advantage of the reputation of the competitor’s trademark or trade name.  However, there is no legal or deontological provision requiring an express reference to the brand name of the medicinal product, as comparative advertising allows reference to a competitor either explicitly or implicitly.

Comparative advertising with a competitor’s product that is not yet authorised in Spain is not admissible, since Spanish rules prohibit advertising of products that do not have a valid marketing authorisation in Spain.

Comparative advertising to the general public is only allowed for products of the same pharmaceutical company.

3.6        What rules apply to environmental “green” claims made in relation to specific products in promotional material?

In Spain, “green” claims are made by the companies on a voluntary basis.  Communication of explicit environmental claims in promotional materials for medicinal products primarily falls under the general legislation for advertising, without specific rules directly addressing these claims in that context.

Furthermore, in Spain there exists the SIGRE System for environmental management of medicinal product waste and its packaging generated by medicinal products for home use (medicinal products used in hospitals have a different system).

As stipulated by the Spanish Agency of Medicines and Medical Devices (AEMPS) in Circular No. 3/2013, laboratories are required to submit a certificate to the AEMPS, confirming their participation in the SIGRE System, before they can market any new medicinal product.

Laboratories adhering to the SIGRE System are entitled to use the SIGRE Symbol in the package leaflets and promotional materials.

3.7        What rules govern the distribution of scientific papers and/or proceedings of congresses to healthcare professionals?

Companies are allowed to provide reprints of journal articles to HCPs, but FARMAINDUSTRIA’s Code prohibits the inclusion of printed, stamped or electronically linked trademarks or brand names of medicinal products, advertising slogans, or any other advertising materials that are related or unrelated to the information contained in the reprint.  The reprints may be accompanied by corporate advertising that is related to the pharmaceutical company, but the advertising must not be connected with the scientific information in the reprint.

3.8        Are “teaser” advertisements (i.e. advertisements that alert a reader to the fact that information on something new will follow, without specifying the nature of what will follow) permitted?

Teasers advertisements are not allowed.  In accordance with Spanish regulations, advertisements of medicinal products shall always be accompanied with the essential information referred in the answer to question 3.1.

3.9        Where Product A is authorised for a particular indication to be used in combination with another Product B, which is separately authorised to a different company, and whose SmPC does not refer expressly to use with Product A, so that in terms of the SmPC for Product B, use of Product B for Product A’s indication would be off-label, can the holder of the MA for Product A nevertheless rely upon the approved use of Product B with Product A in Product A’s SmPC, to promote the combination use? Can the holder of the MA for Product B also promote such combination use based on the approved SmPC for Product A or must the holder of the MA for Product B first vary the SmPC for Product B?

Yes.  The Jury on Advertising of AUTOCONTROL has stated that the MAH of Product A may rely upon the approved use of Product B with Product A in Product A’s SmPC to promote the combination use.  The MAH of Product B may also promote such combination use based on the approved SmPC for Product A without prior variation of the SmPC for Product B (Ruling of the Jury of Advertising of AUTOCONTROL in the “Cellcept®” case, dated 3 May 2006).

4. Gifts and Financial Incentives

4.1        Is it possible to provide healthcare professionals with samples of medicinal products? If so, what restrictions apply?

Spanish rules allow for a limited number of free samples to be supplied to HCPs who are authorised to prescribe medicinal products, provided that such provision is in response to a request from them (samples will be provided directly to HCPs who have requested them, or to individuals authorised to receive them on their behalf).

The following requirements must be met:

  1. Samples may be provided for a maximum of two years from the date of its authorisation in Spain.  A maximum of 10 samples for each HCP per year may be distributed within this period.
  2. A sample of a medicine must not be larger than the smallest presentation of the medicine available in Spain.
  3. Each sample must bear the statement “free medical sample – not for sale”, and the coupon must be crossed out or removed.
  4. Each provision of samples must be accompanied by a copy of the current SmPC, together with updated information on the price, reimbursement conditions of the National Health System, where applicable, and whenever possible, the estimated cost of treatment.
  5. The provision of samples that contain psychotropic or narcotic substances as defined in international treaties is prohibited, as is the provision of samples of medicinal products that can lead to dependence or create public health problems due to their inappropriate use, and other medicinal products so determined by competent health authorities.
  6. When distributing samples in hospitals, the requirements and procedures of the hospital in question must be respected.
  7. Companies must have an appropriate monitoring and accounting system for the samples they distribute.

4.2        Are there any restrictions on the value of payments or benefits that may be provided to healthcare professionals or healthcare organisations for consultancy services? Is it necessary to obtain advance approval from the authorities for the arrangements? 

Payments provided to HCPs and/or HCOs for consultancy services must follow the fair market value of such services.  Companies shall also include internal procedures for establishing objective remuneration criteria.  Advance approval from the authorities is not needed.

4.3        Is it possible to give gifts or donations of money to healthcare professionals? If so, what restrictions apply? If monetary limits apply, please specify.

According to Spanish law, gifts may be offered to HCPs, provided that: (a) their cost is insignificant (their market price does not exceed 10 Euros); and (b) the gift is relevant to the practice of medicine or pharmacy.

FARMAINDUSTRIA’s Code establishes stricter rules than Spanish law.  Under the code, offering gifts to HCPs is only permitted provided that:

  1. The items have stationary or professional use.
  2. Are not related to prescription-only medicinal products.
  3. Have a market price that does not exceed 10 Euros.
  4. They are not offered to HCPs in the context of promotional visits and/or congress or meeting related with prescription-only medicinal products (as an exception, in congresses or meetings related with prescription-only medicinal products, pens and notepads can be offered, provided that they do not include information regarding medicinal products).

Grants or donations for the personal benefit of an HCP are strictly prohibited, except for collaborations to attend professional and scientific congresses and meetings, as well as grants for studies and training that benefit patient care, and provided that such sponsorship does not imply the obligation of the beneficiary to recommend, prescribe or dispense products of the company sponsoring the activity.

4.4        Is it possible to give gifts or donations of money to healthcare organisations such as hospitals? Is it possible to donate equipment, or to fund the cost of medical or technical services (such as the cost of a nurse, or the cost of laboratory analyses)? If so, what restrictions would apply? If monetary limits apply, please specify.

Grants or donations to HCOs and POs are allowed.  According to the Codes of FARMAINDUSTRIA and AESEG, such grants or donations:

  1. May only be granted for the purpose of collaborating with healthcare, research, teaching/training or social or humanitarian care.
  2. Must be formalised in a written agreement.
  3. Must not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer the company’s medicinal products.

4.5        Is it possible to provide medical or educational goods and services to healthcare professionals that could lead to changes in prescribing patterns? For example, would there be any objection to the provision of such goods or services if they could lead either to the expansion of the market for, or an increased market share for, the products of the provider of the goods or services?

In accordance with the regulations in Spain, certain medical or educational products and services can be given to HCPs, which may influence their prescription decisions.  However, it is important to note that the provision of such materials or services must not be used as an incentive to recommend, prescribe, purchase, supply, sell or administer a medicinal product.

It is permitted to offer to HCPs:

  1. Informational or educational materials, provided that they meet the following three conditions: (i) their market price does not exceed 60 Euros; (ii) they are relevant to the practice of medicine or pharmacy; and (iii) they benefit patient care.
  2. Items of medical utility aimed at the education of HCPs and patient care, provided that: (i) their market price does not exceed 60 Euros; and (ii) they do not offset routine business practices of the recipient.

Furthermore, it is also permitted to sponsor educational courses to HCPs on clinical topics or professional abilities, such as: IT courses; courses on how to perform clinical studies; courses on how to prepare a poster; biostatistics courses; health management courses; scientific presentations in English; and courses on how to write an article for publication in scientific journals, etc.

4.6        Do the rules on advertising and inducements permit the offer of a volume-related discount to institutions purchasing medicinal products? If so, what types of arrangements are permitted?

Yes.  Regarding retail pharmacies, discounts based on volume and early payment are acceptable if they do not unfairly influence the purchase of the product over its competitors and are clearly stated on the invoice.  The validity of the discount should be examined on a case-by-case basis.  Additionally, companies must keep a record of all discounts given to pharmacies for National Health System-funded medicinal products, which must be linked to the Ministry of Health.

For hospital supplies, discounts are regulated by the public procurement system.

4.7        Is it possible to offer to provide, or to pay for, additional medical or technical services or equipment where this is contingent on the purchase of medicinal products? If so, what conditions would need to be observed? Are commercial arrangements whereby the purchase of a particular medicine is linked to provision of certain associated benefits (such as apparatus for administration or the provision of training on its use) as part of the purchase price (“package deals”) acceptable? If so, what rules apply?

Yes.  In accordance with the Codes of FARMAINDUSTRIA and AESEG, commercial agreements whereby the purchase of a particular medicine is linked to the provision of certain associated benefits (such as apparatus for administration or the provision of training on its use) as part of the purchase price are acceptable.

4.8        Is it possible to offer a refund scheme if the product does not work? If so, what conditions would need to be observed? Does it make a difference whether the product is a prescription-only medicine, or an over-the-counter medicine?

There are no provisions in Spanish law or in codes of practice of the industry regarding this matter.  In practice, to offer a refund scheme if the product does not work is accepted, and it has been considered recently as a common practice.  Nothing prohibits this kind of agreements to be subscribed both for prescription-only medicinal products and over-the-counter medicinal products.

4.9        Are more complex patient access schemes or managed access agreements, whereby pharmaceutical companies offer special financial terms for supply of medicinal products (e.g. rebates, dose or cost caps, risk share arrangements, outcomes-based schemes), permitted in your country? If so, what rules apply?

There are no provisions in Spanish law or in codes of practice regarding this matter.  In practice, patient access schemes or managed access agreements in which companies offer special financial terms for supply of medicinal products is acceptable and is becoming a common practice.

4.10      Is it acceptable for one or more pharmaceutical companies to work together with the National Health System in your country, pooling skills, experience and/or resources for the joint development and implementation of specific projects? If so, what rules apply?

Yes.  As per the regulations outlined in Law 49/2002, the company will be required to enter into a collaboration agreement with the competent public administration in connection with the project, with the latter agreeing to promote the fact that the project is wholly or partially funded by the pharmaceutical company.  The amounts contributed by the company towards this collaboration may be deductible for the purposes of the corporate tax.

4.11      May pharmaceutical companies sponsor continuing medical education? If so, what rules apply?

Yes.  Please see the answers to questions 4.4 and 4.5.

4.12      What general anti-bribery rules apply to the interactions between pharmaceutical companies and healthcare professionals or healthcare organisations? Please summarise. What is the relationship between the competent authorities for pharmaceutical advertising and the anti-bribery/anti-corruption supervisory and enforcement functions? Can and, in practice, do the anti-bribery competent authorities investigate matters that may constitute both a breach of the advertising rules and the anti-bribery legislation, in circumstances where these are already being assessed by the pharmaceutical competent authorities or the self-regulatory bodies?

In Spain, companies can be criminally liable if their employees, directors or those under their control offer or give bribes to public officials or private individuals.  The penalties for such offences, which are separate from those imposed on the individuals involved, can amount to as much as four times the profits gained by the company.

However, a company may be exempted from criminal liability if it can demonstrate that (a) it had a compliance system in place that met the requirements of the Spanish Criminal Code before the bribe was offered or given, (b) the individuals involved fraudulently evaded the system, and (c) there was no serious breach of the supervision and control duties set out in the compliance system.

The codes of conduct of FARMAINDUSTRIA, AESEG and ANEFP state that companies adhering to these codes must first file complaints against other companies engaging in these practices before the bodies responsible for enforcing the codes, before taking the issue to regulatory authorities or courts.  However, regulatory authorities are authorised to investigate matters on their own initiative, even if they are being evaluated by any self-regulatory body and may take action based on an adverse finding of any such body.  The Advertising Jury, on the other hand, must refrain from reviewing any matter that is being or has been assessed by regulatory authorities or courts.

5. Hospitality and Related Payments

5.1        What rules govern the offering of hospitality to healthcare professionals? Does it make a difference if the hospitality offered to those healthcare professionals will take place in another country and, in those circumstances, should the arrangements be approved by the company affiliate in the country where the healthcare professionals reside or the affiliate where the hospitality takes place? Is there a threshold applicable to the costs of hospitality or meals provided to a healthcare professional?

Reasonable and moderate hospitality may be extended to HCPs at professional or scientific events, but it must be strictly limited to necessary logistical means that enable HCPs to attend the event.  Payments for meals costing more than 60 Euros per person (including taxes) and for stays at luxury hotels such as 5* grand luxury hotels, 5* hotels, sports resort hotels, theme park hotels and winery hotels are not permitted.  Cultural, leisure or entertainment activities may not be paid for either.

The company must pay these expenses directly to service providers, and HCP attendees may not receive any monetary reimbursement for expenses incurred, except for minor travel costs (e.g., taxis, mileage) that are properly justified and evidenced.

Hospitality may not be extended to anyone other than the HCP attendees.

5.2        Is it possible to pay for a healthcare professional in connection with attending a scientific meeting? If so, what may be paid for? Is it possible to pay for his expenses (travel, accommodation, enrolment fees)? Is it possible to pay him for his time?

Hospitality may only include payment of real travel costs, registration and accommodation (hospitality may only be extended to the day after or before the event).  In no case can money be offered merely for the time spent by the HCP regarding its attendance.

5.3        To what extent will a pharmaceutical company be held responsible by the regulatory authorities for the contents of, and the hospitality arrangements for, scientific meetings, either meetings directly sponsored or organised by the company or independent meetings in respect of which a pharmaceutical company may provide sponsorship to individual healthcare professionals to attend?

Companies are not responsible for the contents disclosed at independent events, except in cases where such content is disseminated in the context of a presentation given by an HCP engaged by a company to deliver such a presentation (Ruling of the Jury of Advertising of AUTOCONTROL in the “Allergan vs. Merz; Xeomin®” case, dated February 19, 2009).  Companies will be also responsible for the hospitality arrangements they agree to in order for a particular HCP to attend the event.

In the case of events organised or predominantly sponsored by a company, the company can be held responsible for any content disseminated during the event, as well as for the hospitality offered to HCPs in the context of such an event.

5.4        Is it possible to pay healthcare professionals to provide expert services (e.g. participating in advisory boards)? If so, what restrictions apply?

It is possible to pay HCPs for expert services (for example, participating in advisory boards, acting as speaker or moderator at scientific meetings, educational activities, expert meetings, etc.), under the following conditions:

  1. A written agreement must be entered into stating the nature of the services and the criteria to calculate the amount of payment.
  2. The legitimate need for such services must be clearly identified.
  3. The criteria used to choose the expert must be related to the identified needs, and the person in charge of the selection must have the necessary expertise to evaluate the candidates.  The experts hired must be approved by the scientific service of the company.
  4. The number of experts hired must not exceed the number reasonably necessary to achieve the identified objectives.
  5. The company must keep documental records of the services provided.
  6. The payment to the HCP must not entail an inducement to promote the prescription, dispensation, sale or consumption of medicinal products.
  7. The remuneration must be at market prices and taking into account the hours of work or service actually employed and the responsibilities undertaken by the expert.  Payments must be explicit and transparent, and a proper invoice must be issued by the HCP.  Payments in kind can only be accepted exceptionally upon prior authorisation from FARMAINDUSTRIA’s Deontological Surveillance Unit.
  8. It is recommended that the agreement must include a clause by means of which the HCP undertakes to declare that they provide services to the company every time they write or publicly assert any matter related to the company.
  9. Companies must comply with the transparency obligations regarding the payments made to HCPs related to said provision of services.

5.5        Is it possible to pay healthcare professionals to take part in post-marketing surveillance studies? What rules govern such studies?

Yes.  Please see the answer to question 5.4 above.

According to Royal Decree 957/2020, post-marketing surveillance studies must also comply with the following requirements:

  1. The study must have a protocol and a favourable opinion from a clinical research committee accredited in Spain.
  2. If the study involves conducting interviews with participating subjects or HCPs attending to them, the approval of the director of the HCO where the study is conducted must be obtained, as well as the consent of the interviewees.
  3. The results of the study must be published in the Spanish Registry of Clinical Studies.

5.6        Is it possible to pay healthcare professionals to take part in market research involving promotional materials?

Yes.  Please see the answer to question 2.7.

6. Advertising to the General Public

6.1        Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply?

Non-prescription medicinal products that are not financed with public funds can be advertised to the general public.

Advertising directed to the general public must meet certain requirements set by Royal Decree 1416/1994, such as clearly indicating that it is an advertisement, and that the product is a medicinal product.

Additionally, advertising of medicinal products to the general public is prohibited for certain therapeutic indications, including:

  1. Tuberculosis.
  2. Sexually transmitted diseases.
  3. Other serious infectious diseases.
  4. Cancer.
  5. Chronic insomnia.
  6. Diabetes and other metabolic illnesses.

Messages targeted at the general public must include essential information such as the product’s complete name, the name and/or logo of the MAH, the therapeutic indication, composition, and an invitation to consult a pharmacist and read the instructions on the leaflet.  The Ministry of Health may also require any other recommendations to prevent risks and promote the rational use of the product.

Moreover, according to Royal Decree 1416/1994, advertising aimed at the general public must not include any statement that:

  1. Gives the impression that a medical consultation or surgical procedure is unnecessary.
  2. Suggests that the effects of taking the medicinal product are guaranteed, does not have side effects or are better than, or equivalent to, those of another treatment or medicinal product.  Adjectives such as “perfect”, “maximum”, “uni-que”, “safe” or “total” are expressly prohibited.
  3. Suggests that a person’s health may be improved by taking the medicinal product or that it could be negatively affected by not taking the medicinal product.
  4. Suggests that the use of a medicinal product may enhance sports abilities.
  5. Is directed exclusively or mainly to children.
  6. Suggests that the medicinal product is a foodstuff, cosmetic or other consumer product, or that the safety or efficacy of the medicinal product is due to the fact that it is a natural substance.
  7. Could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis.
  8. Uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or by the action of the medicinal product.
  9. Includes promises of a cure, exaggerated testimonies on the virtues of the product, or recommendations of scientists, HCPs or celebrities.
  10. Mentions that the product has obtained a marketing authorisation in any country or any other authorisation.

Only medicinal products that have been promoted for at least two years and are sufficiently known can be the subject of reminder advertisements, which aim to remind the target audience of the product’s name.  These ads may only feature the product name and, according to the Ministry of Health’s Guide on advertising of non-prescription medicinal products, a blurry image of the packaging may also be included if it only shows the product name, the pharmaceutical company’s logo, and the product’s identifying colours.

6.2        Is it possible to advertise prescription-only medicines to the general public? If so, what restrictions apply?

Advertising of prescription-only medicinal products and/or publicly financed medicinal products directed to the general public is prohibited under Royal Decree-Legislative 1/2015, Royal Decree 1416/1994 and the industry codes.

6.3        If it is not possible to advertise prescription-only medicines to the general public, are disease awareness campaigns permitted encouraging those with a particular medical condition to consult their doctor, but mentioning no medicines? What restrictions apply?

This is a controversial issue that requires a case-by-case analysis.

Although disease awareness campaigns are allowed, they must not make direct or indirect references to a specific medicinal product.  Some of these campaigns have been questioned by health authorities because they inform recipients that there are medications available to treat their illness or symptoms and encourage them to consult their doctor.  The authorities’ position is that the combination of these elements amounted to indirect promotion of the medicinal product marketed by the company responsible for the campaign.

6.4        Is it possible to issue press releases concerning prescription-only medicines to non-scientific journals? If so, what conditions apply? Is it possible for the press release to refer to developments in relation to as yet unauthorised medicines or unauthorised indications?

Yes.  Please see the answer to question 2.3.

6.5        What restrictions apply to describing products and research initiatives as background information in corporate brochures/Annual Reports?

Spanish authorities generally accept the inclusion of descriptions of research initiatives in corporate brochures or other publicly available informational documents, provided that the descriptions are objective, reasonable within industry standards, and do not have a promotional tone.

6.6        What, if any, rules apply to meetings with, and the funding of, patient organisations?

According to FARMAINDUSTRIA’s Code, companies must formalise any collaboration with POs through a written agreement.  The agreement should state the purpose of the collaboration, the activities to be carried out by each party, the financial amount of the collaboration, a description of any relevant indirect support provided by the company, and the sources and purposes of the support.  Companies must have an internal process for the approval of such collaborations and must not be the exclusive sponsor of a PO or try to influence the content of publications issued by a PO.

Meetings with patient support groups should be held at appropriate venues and should not be organised at extravagant or entertainment-focused locations.  Events outside of Spain are not acceptable unless most participants are from outside Spain, or a relevant resource or expertise is located abroad.  If an event is organised outside of Spain due to a relevant resource being located at the event location, it requires prior approval by FARMAINDUSTRIA’s Deontological Surveillance Unit.  Also, any hospitality offered by the company must be reasonable and subordinated to the main scientific objective of the event.  It must be limited to travel, accommodation, meals and registration expenses, and must not include leisure or entertainment activities.  Hospitality can only be made available to accompanying persons if they attend as helpers of patients, and payment for such expenses must be made through the PO.

Expert services can also be paid for by POs, such as participating in advisory boards, acting as speaker/moderator at scientific meetings, educational activities, and more, provided that certain requirements are met:

  1. A written agreement stating the nature of the services and the criteria to calculate the amount of payment must be entered into.
  2. The purpose of the services must be cooperating with health assistance and/or research.
  3. The legitimate need for such services must be clearly identified.
  4. The criteria used to choose the expert must be related to the identified needs, and the person in charge of the selection must have the necessary expertise to evaluate the candidates.  The experts hired must be approved by the internal supervisor of the company.
  5. The number of experts hired must not exceed the number reasonably necessary to achieve the identified objectives.
  6. The company must keep documental records of the services provided.
  7. The payment to the PO must not entail an inducement for the PO to recommend the medicinal products of the company.
  8. The remuneration paid must be at market prices and taking into account the hours of work and the responsibilities undertaken by the expert.
  9. Payments in kind can only be accepted exceptionally upon prior authorisation from FARMAINDUSTRIA’s Deontological Surveillance Unit.
  10. It is recommended that the agreement includes a clause by means of which the expert undertakes to declare that he/she provides services to the company every time he/she writes or publicly asserts any matter related with the company.

6.7        May companies provide items to or for the benefit of patients? If so, are there any restrictions in relation to the type of items or the circumstances in which they may be supplied?

According to FARMAINDUSTRIA’s Code, providing or offering monetary or in-kind gifts to patients or representatives of POs is prohibited.

6.8        What are the rules governing company funding of patient support programmes?

Spanish law and industry codes do not have specific regulations regarding this matter.

However, according to Royal Decree 957/2020 on post-marketing surveillance studies, if a patient support programme involves planned interviews with patients benefitting from the programme to gather information about the medication being used, then the programme must have a protocol and aim to collect information on:

  1. The beneficial effects of the medication (including the patient’s perspective).
  2. Adverse reactions and other risks to patient safety.
  3. The effectiveness of risk management measures.
  4. Patterns of medication use in the population.

7. Transparency and Disclosure

7.1        Is there an obligation for companies to disclose details of ongoing and/or completed clinical trials? If so, is this obligation set out in the legislation or in a self-regulatory code of practice? What information should be disclosed, and when and how?

As per Royal Decree 1090/2015 regarding clinical trials with medicinal products for human use, the sponsor of the study is required to publish the results of the clinical trial, whether they are positive or negative.  The publication of these results must be done in scientific journals.  Additionally, the report of the results must also be published in the Spanish Registry of Clinical Studies.

7.2        Is there a requirement in the legislation for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations? If so, what companies are affected (i.e. do these requirements apply to companies that have not yet been granted a marketing authorisation and/or to foreign companies), what information should be disclosed, from what date and how?

Spanish regulations do not establish an obligation on pharmaceutical companies to disclose details of transfers of value to HCPs, HCOs and/or POs.

7.3        Is there a requirement in your self-regulatory code for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations? If so, what companies are affected (i.e. do these requirements apply to companies that have not yet been granted a marketing authorisation and/or to foreign companies), what information should be disclosed, from what date and how? Are companies obliged to disclose via a central platform?

As the Codes of FARMAINDUSTRIA and AESEG establish, companies that are members of these associations or that have adhered voluntarily to their codes must publish on their website all transfers of value made during the previous year for the benefit of an HCP or HCO, except for the following:

  1. Transfers of value associated with commercial transactions with distributors, retail pharmacies and HCOs (e.g., discounts on the selling price of the company’s medicinal products).
  2. Transfers of value related to non-prescription products only.
  3. Certain transfers of value such as the provision of gifts, samples, dinners and/or luncheons.

In addition, as stated in FARMAINDUSTRIA’s Code, companies must publish a list of the POs that the company supports, and the POs with which it has entered into a services agreement.  Such publication must include a detailed description of the support provided by the company to each PO and the amounts paid annually to each PO for services.

According to FARMAINDUSTRIA’s Code, the disclosure must be made on an individual basis in all cases, except for transfers of value related to Research & Development.  The Code of AESEG accepts that the disclosure can be done in an aggregate way if the HCP does not expressly consent to its personal data being published.

These requirements also apply to (a) transfers of value to Spanish HCPs, HCOs and POs performed by foreign affiliates of the Spanish companies, except when such affiliates already publish such transfers of value in accordance with their national code of conduct, and (b) companies that do not yet have products in the Spanish market.

The requirement is to disclose in accordance with the national code of the country where the recipient conducts their professional activities or is legally based, using the Spanish language.  If a company does not have a subsidiary or an affiliate in that country, it must still disclose the transfers of value in a way that aligns with the national code applicable to the company.

7.4        What should a company do if an individual healthcare professional who has received transfers of value from that company, refuses to agree to the disclosure of one or more of such transfers?

In accordance with FARMAINDUSTRIA’s Code and the position adopted by Spanish authorities regarding the protection of personal data, the consent of the HCP is not required for a company to disclose the transfers of value made to that HCP on an individual basis.

However, the Code of AESEG states that the consent of the HCP is necessary in all cases for the company to publish the transfer of value made to that HCP in an individualised manner.  If the HCP refuses to give their consent to the disclosure, then the company must publish that information in an anonymised and aggregated form.

8. Digital Advertising and Social Media

8.1        How is Internet advertising regulated? What rules apply? How successfully has this been controlled?

The regulations for advertising activities, including those on the internet and social media, are the same as those applied through other channels.  Spanish authorities are currently investigating the information disseminated by pharmaceutical companies on social media for control purposes.

For advertising directed towards HCPs on the internet, the company must use valid channels that are mainly scientific or professional.  These channels must only be accessible to HCPs who are allowed to prescribe or dispense medicinal products, and they should be required to identify themselves to access the information.

Additionally, some provisions of Royal Decree 870/2013, which governs the online sale of over-the-counter medicinal products, may also be applicable.

8.2        What, if any, level of security is required to ensure that members of the general public do not have access to websites or digital platforms intended for healthcare professionals?

To prevent the disclosure of content to unauthorised persons, the FARMAINDUSTRIA and AESEG codes of conduct require a verification system to confirm the professional status of those accessing the content.  Alternatively, a clear warning should be included on the web page, indicating that the information is intended exclusively for HCPs and requires specialised training for correct interpretation.  However, certain Autonomous Regions, such as Madrid, do not consider the warning to be sufficient and require companies operating within their territory to implement a verification system for HCP status.

8.3        What rules apply to the content of independent websites or digital platforms that may be accessed by a link from a company-sponsored site? What rules apply to the reverse linking of independent sites to a company’s website or platform? Will the company be held responsible for the content of the independent site in either case?

Under the Codes of FARMAINDUSTRIA and AESEG, companies will be responsible for the content of any external websites that can be accessed through links on the company’s own website.

8.4        What information may a pharmaceutical company place on its website that may be accessed by members of the public?

Companies may place in their websites the following information in a way that may be accessed by members of the public:

  1. Specific information and relevant documents related to, for example, labelling of the medicinal products, leaflets, changes in packaging, adverse reaction warnings in the framework of pharmacovigilance, and/or sales catalogues and price lists, provided no additional information on the medicinal product is included.
  2. Information on human health or diseases, provided there is no reference, even indirect (for example, by mentioning its active substance), to specific medicinal products.
  3. Corporate advertising, meaning advertising that relates to the company, provided there are no references, not even indirect ones, to specific medicinal products.
  4. Press releases from companies regarding relevant new facts related to the development and/or registration status of their medicinal products.

8.5        Are there specific rules, laws or guidance, controlling the use of social media by companies?

FARMAINDUSTRIA’s Code establishes that special attention should be paid to advertising performed on the internet or social media to ensure that it complies with the rules governing advertising in Spain, and that its contents are only accessible to HCPs.

8.6        Are there any restrictions on social media activity by company employees using their personal accounts, including interactions with third parties through “likes”, “applauds”, etc.?

According to the Codes of FARMAINDUSTRIA and AESEG, companies may also be liable for the social media activity by company employees on the medicinal products of the company.

8.7        Are there specific rules governing advertising and promotional activity conducted virtually, including online interactions with healthcare professionals, virtual meetings and participation in virtual congresses and symposia?

According to FARMAINDUSTRIA’s Code, hospitality cannot be offered on the ground of virtual events nor be extended to persons other than the HCP attendees.

9. Developments in Pharmaceutical Advertising

9.1        What have been the significant developments in relation to the rules relating to pharmaceutical advertising in the last year?

There is still a debate in Spain regarding the legality of promoting a medicinal product authorised in Spain but still awaiting a decision from the Ministry of Health on whether it will be financed with public funds.

Traditionally, Spanish regulations have been interpreted to prohibit promotional activities before the Ministry of Health makes its decision.  However, in 2021, the High Court of Justice of the Autonomous Region of the Basque Country interpreted the regulations differently and allowed the promotion of the product as soon as it was included in the Spanish medicinal products register.  This led FARMAINDUSTRIA to modify its code of conduct to allow promotion at that point.

However, the High Court of Justice of Madrid reached the opposite conclusion in a similar case, leading to confusion.  The matter is expected to be settled soon by the Supreme Court, as appeals have been submitted.

9.2        Are any significant developments in the field of pharmaceutical advertising expected in the next year?

Last year, the Spanish regulatory authorities declared their plan to evaluate and modernise the regulations stated in Royal Decree 1416/1994, which regulates the advertising of medicinal products for human use in Spain.  They held a public consultation to gather the opinions of concerned parties for this purpose.  However, the proposal has not yet been approved.

9.3        Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

As regards the latest trends in enforcement, two issues related to the dissemination of information on medicinal products are currently under discussion:

  1. the question of whether promotion can take place before the decision of the Ministry of Health on price and reimbursement conditions of the medicinal product and after the marketing authorisation has been obtained (we do not yet have a final ruling or decision from the Supreme Court); and
  2. the question of whether the price financed by the Spanish authorities, which is fixed bilaterally between the companies and the Ministry of Health and is negotiated confidentially, should be made public based on Spanish transparency laws (we are also waiting for high-level tribunals to take a position on this).


Production Editor’s Note

This chapter has been written by a member of ICLG’s international panel of experts,
who has been exclusively appointed for this task as a leading professional in their field by Global Legal Group, ICLG’s publisher.
ICLG’s in-house editorial team carefully reviews and edits each chapter, updated annually, and audits each one for originality, relevance and style,
including anti-plagiarism and AI-detection tools.
This chapter was copy-edited by Oliver Chang, our in-house editor.

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