Advertising on medicines in Spain is governed by the following laws and regulations, through which the principles on the subject, established by the Directive 2001/83/EC on the Community code relating to medicinal products for human use, have been incorporated into Spanish law:

• General Law 34/1988 on Advertising.
• Law 3/1991 on Unfair Competition.
• Royal Legislative Decree 1/2015 approving consolidated Law on Guarantees and Rational Use of Medicinal Products and Medical Devices.
• Royal Decree 1416/1994 regulating the 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 medicines directed to the general public.

In addition, instructions issued by the health authorities of the 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).

a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?

Spanish trade associations of pharmaceutical industries have adopted their own self-regulatory codes of conduct:

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

b) What is the legal status of the self-regulatory codes?

The above-mentioned codes are self-regulatory instruments adopted by the pharmaceutical industries in Spain, and they are binding only for companies that are members of the associations that have adopted them (also affiliates and third companies under their control) as well as for companies that do not belong to these associations but have formally committed themselves to respect the rules established in the codes.

The codes are not binding on healthcare professionals (HCP) or patients. Nor are they binding on central government health authorities or the autonomous region’s health authorities. Nevertheless, in practice, the authorities often apply the same criteria as the codes when interpreting the rules on advertising on medicines.

a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?

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 product in Spain” shall considered to be advertising of medicines. Advertising of medicines includes:

• Advertising directed to the general public.
• Advertising directed to HCPs qualified to prescribe, administer, or dispense medicines.
• Visits by sales representatives or informative agents of the companies to such HCPs.
• Supply of samples of medicines.
• Sponsorship of promotional meetings where HCPs qualified to prescribe administer or dispense medicines attend.
• Sponsorship of scientific meetings attended by HCPs qualified to prescribe, administer, or dispense medicines, as well as payment of their 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.

In practice, the Spanish authorities consider advertising of medicines to be any information or informative activity of a pharmaceutical company concerning its medicines, except for the following materials and/or activities:

• 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 medicine, 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 medicines, 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 medicine is included.
• It also does not cover information on medicines prepared by the companies, due to the complexity of dosage, route of administration, etc. of the medicine. The information, aimed to improve adherence to treatment, must be facilitated to the patient trough their doctors.
• Information on human health or diseases, provided there is no reference, even indirect, to specific medicines.
• Corporate advertising from companies.
• Texts written and produced by journalists in their professional work, provided that an agreement does not exist between the company holder of the medicine and the journalist and/or the firm responsible for editing the information.
• Press releases from the companies as regards relevant new facts related to the development and/or registration status of their products.

b) Does the definition apply equally to all target audiences?

Yes. The definition of advertising applies to any material or activity described above, irrespective the material or activity is directed to HCPs, healthcare organizations (HCO), patients or patient organizations (PO).

According to the Code of FARMAINDUSTRIA, press releases from the companies are allowed provided that:

• They must correspond to one or more newsworthy facts connected with the medicine, based on proven scientific data, and including references to the original information on which they are based (if any), in order to allow the journalist and general public to ascertain their veracity by their own.
• It must be quite clear which company is disseminating the information, irrespective of whether this is done directly or through third parties. Press releases must indicate the contact details of the responsible person of the company in charge of confirming the information.
• The trademark of the medicine should only be cited after the positive opinion from the EMA. For information prior to the positive opinion from the EMA, only the active ingredient should be used, with the Official Spanish Designation taking priority. If this does not yet exist, then the International Non-proprietary Name (INN) could be used. Lastly, only in those cases where the WHO has not yet granted the compound an INN, use could be made of the pharmaceutical company’s own designation or, if preferred, the IUPAC nomenclature
• The trade name or active ingredient must be cited in moderation (preferably once or at the most twice) aiming to replace this with generic terms such as medicine, drug, innovation, molecule, etc. and normally avoiding any mention to the trademark in the headlines.

The company’s scientific service should check and approve promotional materials before dissemination. Companies that apply the Code of FARMAINDUSTRIA, in addition, have to appoint a duly qualified person in charge of internal oversight of compliance with the code.

Promotional materials for HCPs do not need to be approved by health authorities or by a self-regulatory body of the industry trade associations before dissemination.

Nevertheless, companies must submit to the health authority of the Autonomous Region where the company is located a copy of any advertisement directed to HCPs, with a file indicating the recipients, the mode of dissemination and the date of the first broadcast. This submission must be done no later than the day on which the company starts the dissemination of the promotional material.

In addition, it is necessary to submit an annual summary to the health authority of the Autonomous Region of all advertisements and/or promotional activities on medicines performed by the company during the previous year.

In exceptional cases, for the protection of public health, the Ministry of Health may establish that promotional materials on a particular medicine have to obtain authorization of the relevant health authority prior to its dissemination. Such a decision from the Ministry of Health would affect all products having the same active substances.

Comparative advertising for medicines is allowed, provided that:

1. It is directed to HCPs only.
2. The characteristics of the products compared are comparable and relevant.
3. The comparison does not denigrate the competitors’ product.
4. The comparison is based on published adequate scientific evidence (it is not accepted any comparison based exclusively on pre-clinical studies). The company must provide such evidence to HCP upon request.

Companies cannot promote the use of a medicine which is not authorized in Spain (even being authorized in another country) nor the use of an authorised medicine for indications or conditions of use other than those expressly provided for in its Summary of Product Characteristics (SmPC).

However, companies are allowed to provide information on their medicines not authorised in Spain or on indications or conditions of use not authorised in Spain in response to spontaneous questions from HCPs or patients (in these cases, patients should be also advised to consult their doctors).

At congresses and meetings organized by third parties (professional and scientific associations) companies can also disseminate information concerning their research lines and pipeline on their medical stand (which must be physically and clearly separated from the commercial stand), but only in an objective and prudent manner, and without including any claim or element of a promotional nature.

In addition, at international congresses and meetings organised by third parties, attended by a large number of HCPs from other countries, companies may distribute promotional materials on medicines or on an indication not authorised in Spain but authorized in a third country, provided that:

1. the information provided is in English or in any of the languages of the countries where the medicine it is authorised, and
2. there is a visible warning indicating that the medicine or indication is not authorised in Spain.

Advertisements may not be directed to the general public when the medicine is reimbursed by the Spanish National Health System or when its dispensing is subject to medical prescription (prescription-only medicines).

In addition, advertisements may not be directed to the general public for any of following therapeutic indications:

1. tuberculosis;
2. sexually transmitted diseases;
3. other serious infectious diseases;
4. cancer;
5. chronic insomnia; and
6. diabetes and other metabolic illnesses.

Advertisements must contain at least (a) the complete name of the medicinal product; (b) the name and/or logo of the MAH; (c) the therapeutic indication of the product; (d) the composition of the product; (e) an invitation to read the instructions of the leaflet and to consult a pharmacist; and, (f) any additional recommendations that the Ministry of Health may determine in order to prevent risks and to promote the rational use of the product.

On the contrary, advertising to the general public may not include any element that:

1. Attributes to the medical advice or surgical intervention, a superfluous nature, especially by offering a diagnosis or advising a treatment by correspondence.
2. Suggests that its effect is guaranteed, has no side effects or it is better or equal to other treatment or medicinal product.
3. suggests that the consumer’s health may improve by its use or may be affected if it is not used; however, the last prohibition shall not apply to the vaccination campaigns.
4. Suggests or indicates that its use enhances sports performance.
5. It is directed exclusively or mainly to children.
6. Refers to any recommendation made by scientists, HCPs or other persons who may, due to their notoriety, encourage the consumption of medicinal products.
7. Equates the medicinal product with food product, a cosmetic product or any other consumer product.
8. Suggests that the safety or efficacy of the medicinal product is due to the fact that it is a natural substance.
9. May, by means of a detailed description or representation of the anamnesis, lead to a false self-diagnosis.
10. Refers in an abusive manner, alarming or misleading references to claims of recovery.
11. Use in an abusive, alarming or misleading way visual representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts of the human body.
12. Mention that the medicinal product has received health or another authorisation.

Promotional materials directed to the general public do not need to be authorised prior to dissemination by health authorities or responsible bodies to ensure compliance with the codes of conduct. However, companies must send an annual index summarising all their advertisements and promotional activities as regards medicines to the health authority of the Autonomous Region where the company is located.

In exceptional cases justified on public health grounds, the Ministry of Health may consider that promotional materials on a particular medicine must obtain, prior to their dissemination, authorization by the relevant health authority. Such a decision shall affect all products having the same active substances.

Spanish laws and regulations do not establish restrictions on interactions between patients or patient organisations (PO) and the pharmaceutical industry. However, both the codes of FARMAINDUSTRIA and AESEG provide that agreements between companies and PO must be formalised in writing, describing at least: the activities performed, funding sources, the purpose of such funding, relevant indirect support (e.g., provision of services provided by their public relations agencies available free of charge) and any other relevant non-financial collaboration. Companies should establish an approval procedure for such collaborations.

In addition, according to the Code of FARMAINDUSTRIA the recruitment of patients to provide a service to the company must always be performed through the relevant PO. The agreements between the company and PO shall comply with the following conditions:

1. clear identification of the legitimate need for these services
2. the written agreement must specify, as a minimum, the nature of the services to be provided and the criteria on the basis of which the remuneration for their provision is calculated
3. the criteria used to select the consultants are directly related to the identified need and the person responsible for their selection has the necessary expertise to evaluate whether the chosen consultants meet these requirements
4. the number of consultants contracted does not exceed the number that would be reasonably necessary to achieve the planned objective
5. the contracting company must maintain documentary support for the services provided by the consultants and use these services for the intended use
6. the engagement of patient organisations for the provision of such services does not constitute an inducement to recommend a particular medicinal product
7. the engagement of a patient organisation by a pharmaceutical company should in no case be linked or related to its participation in a promotional event for a medicinal product
8. the remuneration for providing these services 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 formalized
9. the remuneration must be monetary. In exceptional cases and with the prior authorization of the Code of Practice Surveillance Unit, the remuneration may be provided in kind
10. the agreement should be approved, prior to engagement, by the company’s Compliance Officer.
11. it is recommended that companies include a clause in which the patients’ organisation undertakes to declare that it provides services or consults the company whenever it writes or makes public statements on any subject related to its agreement or to the company.

The use of any logo, brand, identifying mark, registered material, etc., that is property of a PO will require prior consent.

When companies sponsor a material or publication from a PO, they will not intend to influence the content in favour of the company’s own commercial interests.

Hospitality offered to patients in the context of congresses and meetings should be moderated to the same standards and limits as hospitality offered to HCPs.

Gifts for personal benefit (such as entertainment or sports tickets, gifts of social courtesy) should not be given to patients or representatives of PO.

Information included in promotional materials must be accurate, balanced, fair, objective and based on adequate scientific evaluation.

Promotional materials may not rely on data on file nor refer to medicines or indications not authorised in Spain. However, promotional material may rely on studies not included in the SmPC of the product, provided that: (a) the results of such studies complement or clarify the information included in the SmPC, without contradicting it; and (b) the authorities that evaluated the medicinal product did not expressly or implicitly reject the inclusion of such studies in the SmPC of the product.

Promotional materials must always include the following information:

1. Essential information consistent with the data contained in the current SmPC, specifying the date on which it was prepared or last reviewed.
2. The medicine’s prescribing and dispensing conditions.
3. The different presentations of the medicine and the dosage and/or pharmaceutical form.
4. The public sale price, the conditions for reimbursement by the National Health System, where applicable, and, whenever feasible, the estimated cost of treatment.
5. Studies must be adequately referenced in a way HCPs could verify themselves information’s’ veracity and objectivity.

The advertising may include only the name of the medicinal product, whenever the advertisement is intended only as a reminder and the medicine has been authorized for at least two years in Spain. The brand name must be accompanied by the Spanish Official Name when the product only contains a single drug substance. The product logo and the name and logo of the company logo may also be included, but no other information.

In audio-visual materials the information will be included as technically possible and adapted to the chosen medium, but in a manner that guarantees rapid and comprehensible access to the current SmPC.

It also can be provided to HCPS originals, reprints and/or literal translations of scientific articles and/or abstracts published in scientific sources of established reputation or at congresses, provided that they do not include additional elements such as: (i) printed materials, recordings, electronic links or any other connection with the name of the medicine; (ii) highlighted phrases or paragraphs; (iii) brand names or advertising phrases, or any other advertising material, whether or not connected with the information.

According to Spanish law, gifts may be offered to HCPs provided that: (a) their cost is insignificant (their market price does not exceed 10 Eur); and, (b) the gift is relevant to the practice of medicine or pharmacy. The Code of FARMAINDUSTRIA, notwithstanding, establishes stricter rules: offering gifts to HCPs is only permitted provided that: (a) the items have stationary or professional use, (b) are not related to prescription-only medicinal products; (c) have a market price that does not exceed 10 Eur; and, (d) they are not offered to HCPs in the context of promotional visits and/or congress or meeting related with prescription-only medicinal products (as exception, in congresses or meetings related with prescription-only medicines, pens and notepads can be offered, provided that they do not include information regarding medicinal products).

In addition, it is also permitted to offer to HCPs:

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

Provision of this type of materials should not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer a medicinal product.

A limited number of free samples may be supplied to HCPs who are authorized to prescribe medicines, provided that such provision is in response to a request from them (samples will be provided directly to HCP who have requested them, or to individuals authorized to receive them on their behalf):

1. Samples may be provided for a maximum of two years from the date of its authorization 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 medicines that can lead to dependence or create public health problems due to their inappropriate use, and other medicines so determined by competent health authorities.
6. When distributing samples in hospitals, the requirements and procedures of the hospital in question must be respected.

Companies must have an appropriate monitoring and accounting system for the samples they distribute.

Hospitality may be offered to HCPs in the context of professional or scientific congresses and meetings. It must be reasonable and moderate, strictly limited to the logistical means necessary for the HCP’s attendance at the event: payment of real costs related to registration, travel, subsistence (meals cost cannot exceed 60 Eur, taxes included, unless the code of the country where the event is held allows a higher cost) and accommodation. Hospitality may be only extended to the day after or before the congress or meeting take place.

The company must pay these expenses directly to the services provider, except for minor travel costs dully justified.

Hospitality cannot be offered on the ground of virtual events, and neither could be extended to persons other than the HCP attendees.

Organising or collaborating in events that contain entertainment or recreational activities is not allowed.

This prohibition does not prevent companies for sponsoring welcome cocktails, working luncheons and gala dinners on the context of congress and meetings of scientific or professional nature, provided they do not include cultural, leisure or entertainment activities.

Companies must avoid organising or collaborating in events taking place in locations with tourist or leisure attractions that may create a negative perception of the pharmaceutical industry. Five-star hotels (except in justified cases where there are no other hotel vacancies), sport resorts hotels, theme park hotels and/or winery hotels, are not allowed.

Contracting HCPs on an individual or group basis to provide advice or counselling services is allowed. According to the Code of FARMAINDUSTRIA, the following requirements must be met:

1. The company identifies, prior to the HCPs contracting, the legitimate need for these services;
2. They are contracted for the purpose of collaborating with healthcare, research, teaching/training or the organisation of professional or scientific meetings;
3. They are approved, prior to contracting, by the pharmaceutical company’s scientific department or by the Compliance Officer;
4. The existence prior to providing these services of a written contract that specifies, at the least, the nature of the services to be provided and the criteria that form a basis for calculating the remuneration for their provision;
5. The criteria used to select the consultants are directly related to the identified need;
6. The number of HCPs contracted does not exceed the number that would be reasonably necessary to achieve the planned objective;
7. The contracting company must maintain documentary support of the services provided by the consultants and employ these services for the planned use;
8. Contracting HCPs does not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer a given medicine;
9. Remuneration must follow market criteria and be in accordance with the time spent, the work performed and the responsibilities assumed; and,
10. Remuneration must be monetary, except in exceptional cases.

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.

Grants or donations to healthcare organisations (HCO) and PO 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; and,
3. must not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer the company’s medicinal products.

Spanish regulations do not establish pharmaceutical companies’ obligation to disclose details of transfers of value to HCPs or HCO.

On the other hand, in accordance with FARMAINDUSTRIA’s and AESEG’s codes, companies that are members of these associations or that have adhered voluntarily to their codes of conduct 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; and/or
3. Certain transfers of value such as the provision of gifts, samples, dinners or luncheons.

In addition, companies will make public the list of PO with which they have agreements for the provision of services.

According to the Code of FARMAINDUSTRIA, the disclosure must be made on an individual basis in all cases, except for transfers of value related to Research & Development. On the other hand, 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:

1. 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.
2. Companies which do not yet have products in the Spanish market.

Promotional activities do not require prior approval by the health or deontological authorities. Control over such materials is performed after their dissemination by the health authorities of the Autonomous Region where the company is located, which may order the cessation of advertising and impose sanctions if necessary. The authorities responsible for ensuring the compliance of FARMAINDUSTRIA’s, AESEG’s and ANEFP’s codes can also decide the cessation of advertising and impose sanctions on member companies of these associations or that have adhered to their respective codes of conduct, when the promotional activity is the object of a complaint from another company or a third party through the procedures foreseen in their respective codes.

Advertising activities on the Internet (including social media) are subject to the same rules and requirements as those performed through other channels. FARMAINDUSTRIA’s Code also establishes that special attention should be paid to advertising performed on the Internet or social media in order to ensure that it complies with rules governing advertising in Spain, and that its contents are only accessible to HCPs.

According to the codes of conduct of FARMAINDUSTRIA and AESEG, to ensure that these contents are only disseminated among HCPs, there should be a verification system on the professional status of people gaining access or, at least include a clearly legible warning stating that the information on the web page is intended exclusively for such a HCPs and that specialised training is therefore required for the correct interpretation of the information. However, some Autonomous Regions (e.g., Madrid), consider the warning to be insufficient, and require companies established in their territory to implement the verification system on the HCP status.

Considering that communications between pharmaceutical companies and healthcare professionals or healthcare organizations may generate a risk of corrupt practices, the Code of FARMAINDUSTRIA, as well as the codes of other industry associations in Spain, stablishes provision that may be considered to, directly or indirectly, try to prevent the existence of bribery and other corrupt practices. In this context, for example, the Code of FARMAINDUSTRIA establishes a limit to the gifts that companies may give to healthcare professionals, sets forth an obligation to disclose certain relationships with healthcare professionals or healthcare organizations.

Additionally, the provision of art. 3.6 of the Royal Legislative Decree 1/2015 approving consolidated Law on Guarantees and Rational Use of Medicinal Products and Medical Devices, that prohibits that pharmaceutical companies offer or give, directly or indirectly, any kind of incentive, bonus, allowance, discounts, grant or gift to any healthcare professionals involved in the prescription, dispensation or administration of medicinal products, may considered to be established in order to prevent bribery or other form of corrupt practices between pharmaceutical companies and healthcare professional.

In any case, it must be noted that the Spanish Criminal Code prohibits bribery and any other forms of corruption and that under such Code legal entities may be subject to criminal liability for bribery and other corrupt practices of their managers, employees, or persons acting in the interest of the company. Such criminal liability of legal entities may consist in penalties of to four times the amount of the profit obtained as a result of the bribe or corrupt practices, the prohibition to operate for a certain period and/or to contract with public administrations or even the forced dissolution of the entity.

The foregoing is provided, however, under Spanish law the adoption and implementation by the company of an adequate compliance system may allow the company to be totally or partially exempt of criminal liability. For this: (a) the compliance system of the company (including, the compliance system structures, policies, procedures, and controls, as well as its implementation) shall have to comply with the requirements of the Spanish Criminal Code and shall have been adopted before the bribe was offered (or, as the case may be, the other corrupt practice was initiated), and (b) the person involved in the bribe (or, as the case may be, the other corrupt practice) for which the company would otherwise be liable circumvented the system without the negligence on the persons of the company in charge for the supervision of the compliance system of the company.

According to Spanish law, as well as the codes of conduct, the direct or indirect offering or provision of any incentive, prize or gift (in cash or in-kind) to HCPs involved in the prescription, dispensing or administration of medicinal products is strictly prohibited.

The above prohibition does not apply in the following cases, provided that the limits and requirements mentioned in other questions are respected:

1. Stationery or items for the practice of medicine or pharmacy whose market price does not exceed 10 Euros (FARMAINDUSTRIA’s Code establishes stricter requirements – see the answer to question 12).
2. Informational or educational materials.
3. Items of medical utility aimed at the education of HCPs and patient care.
4. Free samples.
5. Hospitality offered at congresses and scientific or professional meetings.
6. Volume-related discounts and discounts for early payment offered to the pharmacist holder of a retail pharmacy, provided that the discount (a) do not induce the purchase of the medicinal product in prejudice of its competitors, and, (b) is reflected in the invoice. Companies should have a record of all discounts offered to retail pharmacies as regards medicinal products reimbursed by the National Health System.

The competent authorities to enforce Spanish laws on advertising and incentives are the health authorities of each Autonomous Region, as well as the courts.

Decisions and sanctions imposed by regional health authorities may be subject to an administrative appeal which must be submitted to the authority’s superior within one month. In case such appeal is rejected, or the authority has no superior, the company may submit an appeal to the courts within two months. In both cases, the company may apply for precautionary measures if it is proved that the immediate implementation of the decision would cause irreparable damages. In practice, it is difficult to obtain a precautionary measure if the only damage that can be claimed is of an economic nature.

The competent authorities for ensuring the compliance of FARMAINDUSTRIA’s, AESEG and ANEFP codes are the self-regulatory bodies of these associations in collaboration with the Jury on Advertising of AUTOCONTROL (an association for self-regulation specialized on advertising). In case the companies involved do not agree during the mediation phase handled by the self-regulatory bodies, the procedure ends with a decision of the competent section of the Jury on Advertising declaring whether or not the advertising is in breach of the code’s rules and, where appropriate, ordering the cessation of the activity and establishing a sanction.

Advertising activities in breach of the general or sector-specific rules on advertising are considered unlawful advertising (art. 2 of General Law 34/1988 on Advertising).

In response to a competitor’s unlawful advertising, companies may start one or more actions foreseen in Chapter IV of Law 3/1991 on Unfair Competition (art. 6 of General Law 3471988 on Advertising):

1. That court declares that the promotional activity involves a competitor’s unfair conduct.
2. The court prohibits the competitor from performing the promotional activity, ceasing the promotional activity if it has already commenced, and/or prohibits the competitor from repeating it in the future.
3. The court orders the competitor to eliminate unfair conduct effects, including rectification of misleading, incorrect or false information.
4. The court should require the competitor to compensate the claimant company for the damages caused because of the unfair conduct, provided that the competitor’s conduct was wilful or negligent.
5. The court may require measures to prevent the competitor from being unjustly enriched as a result of its infringing conduct.

The court may also request, if it deems it appropriate, the publication of all or part of the judgment at the expense of the convicted party.

Such actions may also be brought by consumers or other associations whose members’ interests are affected, but they are not entitled to claim damages.

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

Autonomous Regions health authorities supervise the promotional activities of companies based in their territory and may order the cessation of advertising activity if they consider that such activity infringes the rules governing advertising, as well as require the company responsible for performing appropriate actions to eliminate the effects of unlawful advertising.

They may also sanction. Infringements of the advertising or inducement rules are considered very severe infringements, with the sanction ranging from 600,001 EUR to 1,000,000 EUR (or up to five times the value of the products or services which are the subject of the infringement). The specific amount of the sanction is set according to the existence of aggravating circumstances, such as the intentionality of the infringement, the existence of fraud or connivance, the existence of previous injunctions by the authorities, the risk to public health, or the damage caused.

Finally, health authorities may also order the confiscation of the profits obtained from the infringing activity, the publication of the sanction in the official gazette of the Autonomous Region, and even the suspension of the infringing company’s activity for a period of up to five years (this last measure has never been adopted to date).

In the event the company concerned has submitted a complaint with the self-regulatory bodies of FARMAINDUSTRIA, AESEG or ANEFF, the Jury on Advertising may impose a sanction of between 6,000 and 360,000 Eur, depending on the existence of aggravating circumstances similar to those mentioned above, as well as the repercussion of the infringing activity on the medical or scientific profession or on society in general, unfair competition, generalisation of the breach, recidivism, damage to the image of the pharmaceutical industry, etc.

The rulings of the Jury on Advertising are made public through its website, as well as through the website of FARMAINDUSTRIA.

Member companies of FARMAINDUSTRIA, AESEG and ANEFP, or adherents to their respective codes of conduct, before being able to bring the case before the health authorities or the courts, are obliged to previously submit their complaints against the other companies of the same association to the self-regulatory body of the association in question.

In case the association’s attempt at mediation between the two companies is unsuccessful, then the complaint is referred to the Jury on Advertising, which decides whether the advertising activity is lawful or unlawful and, if necessary, orders the cessation of such action and imposes the corresponding sanction.

However, health authorities and courts are not bound by such rules and may investigate the advertising activities in question on their own initiative at any time. If this is the case, the Jury on Advertising abstains from assessing the lawfulness of the advertising activity in question.

While industry association codes of conduct recognise that congresses and meetings organised by recognised scientific and promotional societies are the appropriate contexts for the exchange of new scientific information between industry and the medical community, companies should adopt a cautious approach when sharing information on active substances or therapeutic indications that are not yet authorised.

In general, it is considered acceptable to cautiously disseminate objective information on new lines of research and the company’s pipeline on its medical stand, which should be physically and clearly separated from the commercial stand.

Dissemination of results of studies conducted under such conditions at a satellite symposium organised by the company in the context of a congress or third-party meeting is an even more sensitive issue. Authorities and code enforcement bodies tend to consider this as an unlawful promotional activity, rather than a legitimate informational activity, unless the company can duly prove that both the information disseminated and the context in which it was disseminated were strictly objective, informative, and devoid of elements of a promotional nature. In a ruling earlier this year, the Jury on Advertising concluded that information on the use of its medicinal product in conditions other than those authorised, which a company had disseminated in the context of a satellite symposium organised by that company, constituted an unlawful promotional activity due to elements such as the presence of the logo, colours and brand of the medicinal product in question, as well as the abundance of laudatory expressions in favour of the drug, and the lack of information on possible pharmaceutical alternatives.

Another issue currently under debate in Spain concerns the possible legality of performing promotional activities with a medicinal product already authorised in Spain, but for which the Ministry of Health still needs to take a decision on whether or not it should be financed with public funds.

Traditionally, the Spanish authorities have considered that Spanish regulations prohibit the promotion of medicinal products before the Ministry of Health has taken such a decision. However, in 2021, the High Court of Justice of the Autonomous Region of the Basque Country concluded that a comprehensive interpretation of the Spanish regulations allowed the conclusion that promotion of the medicinal product should be possible from the moment that its authorisation was included in the Spanish medicinal products register. This ruling led FARMAINDUSTRIA to modify its code of conduct, allowing promotion from that moment. The situation, however, has become more confusing since then, as earlier this year, the High Court of Justice of another Autonomous Region, in this case, the region of Madrid, reached the opposite conclusion in a case like the one mentioned above. It is expected that the matter will be definitively settled shortly because of one of the appeals submitted to the Supreme Court.