Contributed By Faus & Moliner
Advertising of medicinal products in Spain is regulated 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 provisions contained in EU Directives on advertising of medicinal products have been implemented in Spain through Royal Decree 1416/1994. The Ministry of Health issued an Instruction in 1995 (Circular 6/1995, amended by Circular 7/99) regarding the interpretation of such Royal Decree.
In addition, Spanish autonomous regions (Spain is divided into 17 autonomous regions) are competent for the implementation of rules on advertising of medicinal products; in this regard, some autonomous regions have adopted guidelines reflecting the position of the regional authorities on the advertising of medicinal products (the most remarkable guidelines are the ones issued in the regions of Madrid and Catalunya). Furthermore, Ministry of Health has issued a Guide on the advertising of over-the-counter medicinal products (last updated version published in 2019). Royal Legislative Decree 1/2015, approving the consolidated text of the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices is also noteworthy as it sets forth the sanctions for breach of the rules on advertising of medicinal products.
Codes of Conduct
Spanish trade associations of different sectors of the pharmaceutical industry have adopted codes of conduct regulating interactions with healthcare professionals (HCPs), healthcare organisations (HCOs), and patient organisations (POs). Farmaindustria, the Spanish innovative medicinal products industry association, has issued a Code of Practice for the Pharmaceutical Industry (Code of Farmaindustria) regulating the advertising of prescription-only medicinal products as well as interactions between pharmaceutical companies and HCPs, HCOs and POs.
The Code of Farmaindustria has been recently updated by a 2021 version, introducing some new aspects regarding areas such as social media and the digital environment, relationships between companies and HCPs, POs, and the media. Conversely, AESEG, the Spanish generic medicinal products industry association, and ANEFP, the Spanish over-the-counter medicinal products industry association, among others, have also published their own codes of conduct on the promotion of medicinal products.
Self-regulatory codes of conduct apply and have binding effects on companies that are members of the trade association that issued them and on companies that have voluntarily adhered to a code. 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 HCPs, HCOs and/or POs in Spain.
According to Royal Decree 1416/1994, advertising of medicinal products includes any form of informative offer, commercial research or inducement designed to promote the prescription, dispensation, sale or consumption of medicinal products.
In particular, advertising of medicinal products includes:
Royal Decree 1416/1994 states that the following informative activities will not be considered as advertising of medicinal products and, therefore, that they are not subject to the rules that apply to such advertising:
In addition, the Code of Farmaindustria states that the following informative activities will not be considered as advertising of medicinal products:
Finally, the description of research initiatives in corporate brochures or other informative documents accessible to the public is also commonly accepted as information by the Spanish authorities, as long as such description is objective and reasonable according to the usages of the sector and non-promotional in tone.
Press releases are a controversial issue in Spain and should be analysed on a case-by-case basis. According to the Code of Farmaindustria, and the rulings of the Jury of Advertising, a specialised body within an association for self-regulation in advertising called Autocontrol (the Jury of Advertising is responsible for hearing cases relating to the breach of provisions of self-regulatory codes, such as the Code of Farmaindustria), if the information on a medicinal product refers to a newsworthy event such as relevant step in the research and/or authorisation process of such medicinal product, which is relevant for the financial performance of the company, is clearly directed to potential investors, shareholders and/or future employees, and has a non-promotional tone, then it may be considered as corporate information, and, therefore, may be published in non-scientific journals directed to the general public as it is not considered as promotion, but information.
Determining Whether a Press Release is Advertising
However, if there is a contractual relationship between the company and the media where a press release is published, the press release will be deemed to be an advertising material and must therefore be subject to the rules regarding this activity. Besides considering whether or not there is a contractual relationship with the media, there are other factors to bear in mind in order to determine whether or not the press release has a promotional nature. These include the following:
Guide for Interacting with the Media
The Code of Farmaindustria includes, as Annex III, a Guide with a list of recommendations for companies when interacting with the media. When certain conditions are met as explained in this Guide, press releases may be considered as having an informative nature (not promotional). For instance, it is recommended that the trademark of the medicinal product, or its active ingredient, is only prudently and proportionately mentioned: twice maximum and not in the headings.
Under the Law 3/1991 and the Code of Farmaindustria, comparative advertising directed to HCPs is allowed provided that the products or characteristics compared are comparable, essential and relevant, the comparison is objective, scientifically proven and verifiable from sources immediately accessible to the competitor and the general tone of the advertisement is balanced and fair. The competitor’s brand name or trade mark can be used as part of the comparison, provided that such use is proportionate and is not made with the objective of taking an unlawful advantage of the reputation of the competitors’ brand name or trade mark. However, there is no legal or deontological provision requiring an express reference to the trade mark of the medicinal product, as comparative advertising allows to refer to a competitor either explicitly or implicitly (Ruling of Jury of Advertising of Autocontrol in Sanofi-Aventis v Italfarmaco – Hepaxane®, dated 8 January 2020).
Advertising of medicinal products which have not obtained a marketing authorisation is not allowed. In some specific cases, regulatory authorities, as well as the provisions of the Code of Farmaindustria, accept the possibility of companies making information available to HCPs and HCOs prior to the approval of the medicinal products if it is merely scientific information, instead of an advertising activity. However, it is advisable to take a rather restrictive approach regarding these activities, as any materials containing promotional statements will undoubtedly be considered as advertising.
Additionally, according to Royal Decree 1015/2009, which regulates the use of medicinal products in special situations, marketing authorisation holders must not distribute any type of information which may directly or indirectly stimulate the use of the medicinal product in conditions different from those resulting from its SmPC.
Objective and non-promotional scientific information on unauthorised medicinal products or unauthorised indications may be provided during congresses or meetings organised by a prestigious scientific society, provided certain conditions are respected.
Conversely, regulatory authorities and the provisions of the Code of Farmaindustria accept that promotional materials on medicinal products authorised in countries other than Spain may be distributed during international congresses or meetings held in Spain, provided that the congress or meeting is attended by numerous professionals from other countries, that the materials are written in the language of the country where the product is approved or in English, and that the materials include a clear warning indicating (at least in Spanish) that the medicinal product is not marketed or authorised in Spain.
Although the Code of Farmaindustria does not set a minimum font size for this warning, this is something that must be checked by comparing the letters used in the waring to the ones used in the rest of the messages. Including this warning as a footnote using a small font size is not enough (Ruling of Jury of Advertising of Autocontrol in Glaxosmithkline v Astrazeneca CD-PS 1/20 Symbicort®, dated 7 July 2020).
Any company may respond to specific requests for information from the HCPs, provided the conditions mentioned in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information are met. Information must be provided reactively and not proactively. It’s advisable to deal with these matters through the medical affairs department of the company rather than through its sales or marketing departments.
There are no specific provisions in Spanish law or in the Code of Farmaindustria regarding the provision of information on unauthorised medicinal products or indications to HCOs. In practice, regulatory authorities and the provisions of the Code of Farmaindustria 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.
Advertising compassionate use programmes is prohibited under Spanish law. Royal Decree 1416/1994 prohibits any advertisement of medicinal products which have not yet obtained a marketing authorisation. Also, even when referring to the access of a medicinal product authorised in another country (different than Spain), Royal Decree 1015/2009, regulating the use of medicinal products in special situations, expressly prohibits the holder of the marketing authorisation in the country of origin to make any advertising on the use of the medicinal product.
Advertising of prescription-only medicinal products and/or publicly financed medicinal products directed at the general public is prohibited under Royal Legislative Decree 1/2015, Royal Decree 1416/1994 and the Code of Farmaindustria.
On the contrary, non-prescription medicinal products which are not publicly financed may be advertised to the general public. Furthermore, advertising of medicinal products to the general public for any of following therapeutic indications is not allowed:
According to Royal Decree 1416/1994, any advertising material directed to the general public must clearly indicate that it is an advertisement and that the product advertised is a medicinal product.
Messages must contain at least the complete name of the product, the name and/or logo of the marketing authorisation holder, the therapeutic indication of the product, the composition of the product, an invitation to read the instructions of the leaflet and to consult a pharmacist, and any additional recommendations that the Ministry of Health may determine in order to prevent risks and to promote the rational use of the product.
Additionally, Royal Decree 1416/1994 states that advertising to the general public must not contain any statement which:
Reminder advertisements, the purpose of which is merely to remind the target audience about the name of the medicinal product, is acceptable only for products sufficiently known and which have been promoted for at least two years, can only include the name of the medicinal product. According to the Guide on advertising of OTC medicinal products published by the Ministry of Health, a blurred image of the packaging is also acceptable in such kind of advertising, provided that the only information clearly visible is the name of the product, the logo of the pharmaceutical company, and the identifying colours of the product.
There are no provisions in Spanish law regarding restrictions on interactions between patients or patient organisations and the pharmaceutical industry.
However, the Code of Farmaindustria states that any collaboration between companies and POs must be formalised in a written agreement, stating the purpose of the collaboration, the activities to be performed by each of the parties, 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. Additionally, companies must have an internal process for the approval of these collaborations, and must not be the exclusive sponsor of a PO, nor try to influence in the content of the publications issued by a PO.
Meetings with patient support groups must be held at appropriate venues, avoiding those which are extravagant or renowned for their entertaining facilities. It is not acceptable to organise events at venues outside Spain, unless most of the participants come from outside Spain, or a relevant resource or expertise is located abroad. However, organising an event outside Spain due to a relevant resource being located at the place where the event is going to be held, requires the prior approval by the Farmaindustria’s Deontological Surveillance Unit.
Hospitality offered by the company must comply with the same requirements referred to in 9.1 Gifts to Healthcare Professionals.
Hospitality must only be made available to accompanying persons if they attend as helpers of patients. Payment of such kind of expenses has to be made through the PO. Hospitality cannot include social, entertaining or cultural events, except for reasonable welcome cocktails, working meals and gala dinners.
In case of virtual meetings, all kinds of hospitality are forbidden.
It is forbidden to offer money to merely compensate the time spent by patients to attend the meeting.
It is also possible to pay PO for expert services (for example, participating in advisory boards, acting as speaker/moderator at scientific meetings, educational activities, etc), provided that the following requirements are met:
The Code of Farmaindustria
According to the Code of Farmaindustria, offering money or any kind of gift or services for personal benefit to patients or the representatives of POs is forbidden.
Also, the Code of Farmaindustria contemplates that any material or publication directed to patients must comply with the following requirements:
Additionally, under the Code of Farmaindustria 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 sufficiently detailed description of the support provided by the company to each PO and the amounts annually paid to each PO for its services.
According to Royal Decree 1416/1994, advertising directed to HCPs legally entitled to prescribe or dispense medicinal products must include:
Messages must be precise, balanced, honest, objective, based on adequate scientific evaluation, and sufficiently complete as regards the therapeutic value of the product.
Reminder advertisements, acceptable for products sufficiently known which have been promoted for at least two years, can only include the name of the medicinal product and the International Common Denomination if the product contains only one active substance, as well as the logo of the product and the company. No other statements may be included, but the regulatory authorities and the bodies in charge of enforcing the rules of the Code of Farmaindustria do accept including pictures of the packaging.
Under Spanish rules, using data on file is not allowed for promotional purposes.
However, an advertisement may refer to studies not included in the SmPC of the product, provided that such studies do not contradict the information included in the SmPC (Ruling of Jury of Advertising of Autocontrol in Gilead v ViiV Healthcare New 2DR Era, dated 14 February 2019). In any case, studies must be adequately reflected in the promotional material, in a way that its addressee may by themselves verify the truthfulness and accuracy of the information.
Advertising the use of one medicinal product in combination with another one is legally permitted as long as the advertising materials/message are consistent with the SmPC of both products. It is not required for the SmPC to include a specific reference to studies regarding the combined use of medicinal products, as long as such use is compatible with the SmPC (Ruling of Jury of Advertising of Autocontrol in Gilead v ViiV Healthcare New 2DR Era, dated 14 February 2019).
Also, it is legally permitted to advertise medicinal products that include a medical device, provided that the advertisement is consistent with the SmPC of the medicinal product and with the intended purpose of the medicinal device.
Companies can provide reprints of journal articles to HCPs. However, under the Code of Farmaindustria, reprints cannot contain printed, stamped or electronically-linked trade marks or trade names of medicinal products, advertising slogans, or other advertising materials related or not to the information.
Medical science liasons (MSLs) must not proactively discuss scientific information on unauthorised medicines or indications with HCPs. MSLs can provide information to HCPs (provided the conditions mentioned in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information are met) in order to respond to specific questions asked by the HCPs. Information must be provided reactively and not proactively.
Advertising directed to HCPs qualified to prescribe or dispense medicinal products does not need to be approved in advance by a regulatory or industry authority. However, companies placing advertisements must send a copy of the advertisement to the health authority of the Spanish 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. The Ministry of Health may, in exceptional circumstances, make the advertising of a specific product subject to prior approval. Any decision of this nature must be duly justified and shall affect all products having the same composition.
Since July 2013, advertising directed to the general public does not need to be approved in advance by the authorities.
This is without prejudice of the fact that any advertising will be subject to control ex-post by the authorities and sanctions may be imposed if it does not comply with the provisions of the law. Additionally, according to Royal Decree 1416/1994, companies must send an annual index summarising all their advertising activities to the health authority of the Spanish autonomous region where the company is located.
Royal Decree 1416/1994, as well as the Code of Farmaindustria, state that the marketing authorisation holder must have a scientific service in charge of the management of the information related to the medicinal products marketed by the company.
The scientific service of the company must fulfil the following obligations:
Under the Code of Farmaindustria, companies are obliged to have a written procedure to monitor compliance with the Code. Additionally, the 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.
Broadly speaking, advertising activities on the internet are subject to identical requirements as those which are performed through traditional channels.
As regards advertising directed to HCPs through the internet, the company must use valid channels within a context that is basically scientific or professional. Those channels must be intended exclusively for HCPs authorised to prescribe or dispense medicinal products, and those HCPs should need to identify themselves in order to have access to the information. Pharmaceutical companies can also establish an HCPs status verification system in order for HCPs to have access to the information.
Companies will also be liable for the content of the websites accessed through links from the company’s website.
Some provisions of Royal Decree 870/2013, which regulates the sale of OTC medicinal products through the internet, may also apply.
The same rules applicable to other kinds of advertising apply to advertising through social media. In particular, advertising of prescription-only medicinal products on social media which the general public may access is not allowed.
The Code of Farmaindustria imposes on companies the obligation to adequately train its employees on how to behave in the digital environment. In this regard, pharmaceutical companies must have good-practice internal guides directed to their employees and any person acting on their behalf or under its control or by virtue of an agreement. The company must also train its employees to prevent them from posting inappropriate content on their personal social networks, such as comments on competitors' products or off-label promotion.
Also, under the Code of Farmaindustria, pharmaceutical companies must clearly and unequivocally inform HCPs and employees attending the meetings organised or sponsored mainly by the company, about the prohibition of publishing promotional content related to the meetings on social media. It is advisable including safeguards in the agreements entered with speakers and attendees.
According to the Spanish law, the company must ensure that those parts of its website which contain promotional information about prescription-only medicinal products may only be accessed by HCPs entitled to prescribe or dispense such products. Conversely, it has been commonly accepted, following the guidance issued by the Pharmaceutical Committee, that the unmodified and unabridged publication on the website of information which has been authorised by relevant authorities (for example, the SmPC, the package leaflet, the public assessment reports, price lists) will normally not be considered as advertising and can, therefore, be openly published on the internet.
Under the Code of Farmaindustria, a clearly legible warning must also be included in those parts of the website directed to the HCPs only, indicating that the information is intended exclusively for the HCPs legally entitled to prescribe or dispense medicinal products and, therefore, that specialised training is required for the correct interpretation of the information. Persons who access the content must identify themselves as HCPs entitled to prescribe or dispense medicinal products. Pharmaceutical companies can also establish an HCPs status verification system in order for HCPs to have access to the information.
Any information or material provided online to patients must comply with the requirements referred to in 4.3 Restrictions on Interactions Between Patients or Patient Organisations and Industry.
Spanish law does not include any provision regarding online scientific meetings.
According to the Code of Farmaindustria, scientific online meetings must comply with the same requirements applicable to non-virtual meetings.
In addition, the Code of Farmaindustria provides some specific requirements applicable to online scientific meetings:
Under the Spanish Criminal Code companies may be subject to criminal liabilities for bribes offered or given by their employees, directors or other persons under their control to public officials or to private persons.
The penalties that may be imposed on a company for a bribe, which are independent from the penalties that may be imposed on the persons that have committed or participated in the bribe, may be as high as four times the amount of the profit obtained by the company.
However, a company may be exonerated from criminal liability if it demonstrates that prior to the bribe being offered or given, it adopted a compliance system that satisfied the conditions and requirements of the Spanish Criminal Code, in order to offer or give the bribe the persons involved fraudulently eluded the compliance system and there was no serious breach of the supervision and control duties contemplated in the compliance system.
According to Royal Legislative Decree 1/2015 and the codes of conduct it is prohibited for any person with a direct or indirect interest in the production, manufacture and/or placing on the market of medicinal products to directly or indirectly offer to HCPs involved in the cycle of prescription, dispensing and/or administration of medicinal products (or to their relatives or cohabitants) any kind of inducement, bonus, discount, reward or benefit, except for gifts, hospitality and discounts which fulfil the requirements set forth in 4.3 Restrictions on Interactions Between Patients or Patient Organisations and Industry, 9.1 Gifts to Healthcare Professionals, 9.2 Limitations on Providing Samples to Healthcare Professionals, 9.3 Sponsorship of Scientific Meetings and 9.6 Restrictions on Rebates or Discounts to Healthcare Professionals or Healthcare Institutions. This prohibition will likewise apply when the offer is made to HCPs prescribing medical devices.
Offering benefits to HCOs and POs is acceptable, provided these benefits are not an inducement to buy, recommend and/or use the products of the company.
According to Royal Decree 1416/1994, a gift to HCPs entitled to prescribe or dispense medicinal products may only be offered when the cost of the gift is insignificant and the gift is relevant for the practice of medicine or pharmacy.
The Code of Farmaindustria offers further guidance and provides that offering gifts to HCPs is only permitted provided that the items have stationary or professional use, are not related to a prescription-only medicinal product and have a market price that does not exceed EUR10. Moreover, such gifts may not be given to HCPs in the context of the promotional and informative visits made by sales representatives of companies, nor in the framework of a congress or meeting organised by a third party, if such visit or event relates to prescription-only medicinal products.
As an exception, it is allowed to give memory cards containing informative or formative material, provided its value does not exceed EUR10. Pens and notepads can be provided in meetings organised by the company, provided that they do not include information regarding prescription-only medicinal products and that their market price does not exceed EUR10.
Educational materials and items of medical utility can be given as a gift provided that
The offer to HCPs of such gifts is excluded from the transparency obligations referred to in 10 Pharmaceutical Companies: Transparency.
Except in case of online events, hospitality may also be offered to HCPs at professional or scientific events, provided that it is reasonable and moderate, and strictly limited to necessary logistical means that allow HCPs to attend the event. Hospitality offered may only include payment of real costs of travel, registration and accommodation (hospitality may be only extended to the day after or before the event).
Payments for meals that costs more than EUR60 (taxes included) per person, as well as payments for five-star hotels, five-star grand luxury hotels, sports resort hotels, theme park hotels and/or winery hotels, are prohibited. Payment for cultural, leisure or entertainment activities is also prohibited.
The company must pay these expenses directly to the services providers. No monetary reimbursement can be made to the HCPs attendees for expenses incurred to suppliers, except in the case of minor travel costs (eg, taxis, mileage, etc), which are properly justified/evidenced. Hospitality may not be extended to persons other than the HCP attendees.
Royal Decree 1416/1994 states that delivery of free samples can only be made on an exceptional basis, and provided that the prior authorisation from the AEMPS is obtained. Authorisation by the AEMPS may be granted only for medicinal products which:
The following requirements/restrictions apply:
No samples of medicinal products containing psychotropic or narcotic substances may be supplied.
The provision to HCPs of samples is excluded from the transparency obligations for the companies of Farmaindustria referred in 10 Pharmaceutical Companies: Transparency.
According to Spanish regulations, companies may sponsor scientific meetings or congresses, as well as organise informative, professional and/or scientific meetings. Such sponsorship must be stated in all documents related to the event, as well as in any published derivative work.
It is also possible to pay necessary travel, accommodation and enrolment costs to HCPs attending such congress or meetings. According to Royal Decree 1416/1994, hospitality must be reasonable in level (it must not exceed what recipients would normally be prepared to pay for themselves) and remain subordinate to the main scientific objective of the event. Recipients must indicate the funds received and the source of financing in the publication of papers and lectures in the congresses and meetings. A company may be held responsible for the contents and hospitality arrangements for a meeting or congress if such event has been organised and/or mainly sponsored by such company.
The Code of Farmaindustria provides further guidance:
The hospitality offered to HCPs cannot include the organisation of social, entertaining or cultural events, except for reasonable welcome cocktails, working meals and gala dinners.
According to Spanish regulations, grants or donations to individual HCPs are strictly prohibited, except for gifts, samples, and hospitality offered to HCPs provided such gifts, samples and/or hospitality fulfil the requirements set forth in 9.1 Gifts to Healthcare Professionals, 9.2 Limitations on Providing Samples to Healthcare Professionals and 9.3 Sponsorship of Scientific Meetings. Grants or donations to HCOs are acceptable, provided they are not offered as an inducement to buy, recommend and/or use the products of the company.
The Code of Farmaindustria provides specific rules as regards grants or donations to HCOs. The Code allows donations and/or the funding of the cost of medical or technical services to institutions, organisations, associations and foundations whose members are HCPs and/or which provide services of sanitary, social or humanitarian assistance, research or teaching, subject to certain conditions, the most relevant of which are that the gift or donation:
It is advisable to show these transactions in a written agreement so that the terms under which the funding is awarded are explicit and transparent. Companies must comply with the transparency obligations referred to in 10 Pharmaceutical Companies: Transparency regarding the offer of grants or donations to HCOs.
With regard to retail pharmacies, only reasonable volume-related discounts and discounts for early payment are acceptable, provided that such discounts do not induce the purchase of the product in prejudice of its competitors, and are reflected in the corresponding invoice. The reasonability of the discount must be analysed on a case-by-case basis. Companies must also keep a record, which has to be interconnected with the Ministry of Health, of all discounts offered to pharmacies for medicinal products that are financed by the National Health System.
With regard to supplies to hospitals, discounts are subject to the public procurement system.
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:
Annex IV of the Code of Farmaindustria includes a Guide for action for companies when contracting services to HCPs and HCOs. Annex IV includes a list with some of the different kind of services that may exist and the criteria that pharmaceutical companies must comply with.
In addition, this Guide establishes a series of questions (23 in total) that companies must be able to answer affirmatively, to ensure that they comply with the provisions of the Code regarding these contracts. These questions are set out in line with IFPMA's “Guidance on Fees for Services”.
According to the Spanish rules, HCPs which provide their services in HCOs depending on the public health system may be obliged to obtain an authorisation of their employer in order to accept the hospitality offered by a company or to provide a service for a company. HCPs are the ones affected by these obligations and not the companies.
Under the Code of Farmaindustria, the companies must inform Farmaindustria’s Deontological Surveillance Unit in the following cases:
In case of meetings or events that are part of projects that have already been notified by pharmaceutical companies, these do not need to be notified again in accordance with the principle of non-duplication.
Communication will be voluntary in case of training activities or scientific meetings that are carried out virtually.
The Code of Farmaindustria has implemented the EFPIA rules on disclosure of transfers of value from pharmaceutical companies to HCPs, HCOs, and POs. Consequently, since 2015, companies are obliged to document and publish on their website (first publication was actually made in 2016) all transfers of value made during the previous year – meaning any direct or indirect payment or grant, either cash or benefits in kind, and regardless of its purpose – whose recipient is a HCP or HCO. The only payments excluded from this obligation are:
Disclosure must be made on an individual basis, except for transfers of value related to R&D. Spanish authorities on personal data protection has ruled that companies must inform HCP on the disclosure of his or her personal data. However, there is no need that the HCP consents to the disclosure of his or her personal data.
AESEG has also implemented in its own Code the Medicines for Europe rules on disclosure of transfers of value from pharmaceutical companies to HCPs, HCOs, and POs.
There are no exceptions regarding the disclosure obligation due to COVID-19 incidences.
Transparency requirements described above apply to transfers of value to HCPs, HCOs, and POs performed by companies associated to Farmaindustria/AESEG and/or which have voluntarily adhered to the Codes of Farmaindustria/AESEG. They also apply to transfers of value to Spanish HCPs, HCOs, and POs performed by their affiliates, except for the case that such affiliates already publish such transfers of value in accordance with their national code of conduct. The fact that the company does not yet have products in the market is irrelevant for this purpose.
Except for the rules resulting from the industry codes of conduct, the responsibility for enforcing the rules on advertising and inducements lies with the health authorities of the Spanish autonomous regions and courts.
The Codes of Farmaindustria, AESEG and ANEFP are enforced by self-regulatory bodies in agreement with Autocontrol, an association for self-regulation in advertising.
Any advertising in breach of the General Law 34/1988 on Advertising will be considered as an unlawful act under the Law 3/1991 on Unfair Competition. The actions that may be taken before the courts for breach of the Law on Advertising and for breach of the Law on Unfair Competition (which may be taken individually or on a cumulative basis) have been unified in order to avoid any conflict between jurisdictions:
This is without prejudice of the right to claim damages, if the advertiser has acted wilfully or negligently and/or unlawful enrichment, if applicable.
The referred actions may be brought by any person or company who is affected by the unlawful advertising and, in general, those who have a legitimate interest. These actions may also be brought by consumer associations or other associations when the interests of their members are affected, but they will not have the right to claim damages.
The issues which have been discussed more frequently under these procedures involve the distinction between advertising and information on products, the conformity of advertising materials to the contents of the SmPCs, and the conditions under which comparative advertising is fair. Another area on which various rulings have been adopted refer to the limits on hospitality that may be offered to HCPs.
Under the Codes of Farmaindustria, AESEG and ANEFP, companies have agreed not to file complaints against each other directly before the ordinary courts or the health authorities without first raising the issue with the bodies in charge of enforcing these codes.
The regulatory authorities are rather strict in scrutinising materials which companies notify to them, and they may suspend an advertisement if they consider it to be in breach of the rules. Furthermore, if the advertisement constitutes a risk for the health or security of consumers, the authorities may order the publication of the ruling and a corrective statement where the advertisement was published.
Failure to Comply
Failing to comply with the rules governing the medicinal products advertising and/or inducements may also result in administrative sanctions. The general rule is that a breach of the law on this matter may result in a fine being imposed. The amount will depend on various factors including negligence, if the breach was intentional, if there was fraud or connivance, if a failure to comply with previous requests made by the authorities exists, the company’s turnover, the number of persons affected, the damage caused, and the profits obtained from the infringement. In some cases, criminal sanctions may apply.
Decisions taken by regulatory bodies may be challenged through an administrative appeal and through judicial review. In some cases, the administrative appeal is compulsory and has to be filed within a month from the date on which the decision was notified. When the administrative appeal is only optional, the interested party may go directly to court within two months from the date on which the decision was notified. During the court case an injunction may be sought. The chances of obtaining an injunction largely depend on whether the applicant shows that it will suffer irreparable harm in the event that the injunction is not granted.
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 image of the industry is one of the criteria to which the Code of Farmaindustria refers. The competent body to impose these measures and sanctions is the Jury of Advertising, a specialised body within Autocontrol. The rulings of the Jury of Advertising are made public through its website.
The Codes of Farmaindustria, AESEG and ANEFP state that, prior to raising the issue before the regulatory authorities or the courts, the companies 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, the regulatory authorities may investigate matters on their own initiative, even if they are being assessed by any self-regulatory body, and may also take up matters based on an adverse finding of any self-regulatory body. Conversely, the Jury of Advertising must refrain from assessing any issue which is being or has been assessed by the regulatory authorities or the courts.
During the last few years, there has been few cases regarding advertising of medicinal products in Spanish Courts.
In contrast, the Jury of Advertising of Autocontrol has been rather active during these last years. This has resulted in an increased number of cases where companies had to adopt corrective measures via settlement/mediation agreements. In some cases, these agreements included a voluntary economic contribution to be made by companies to the fund created by Farmaindustria to promote rational use of medicinal products.
In 2020, one of the main issues discussed in the rulings of Autocontrol has been press releases and how to determine whether they have promotional or informational nature (see 2.3 Restrictions on Press Releases Regarding Medicines).