Community legislation

In the European Community legal framework, the directives that refer to or affect the regulation of the advertising of medicinal products are (in chronological order):

• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ¹⁰ , which, as mentioned above, defines the concept of advertising of medicinal products in Article 86. In addition, Articles 87 to 90 define which medicinal products are totally prohibited from being advertised and the requirements that must be met for those that are authorised ¹¹ . In Articles 97 to 100, it makes the marketing authorisation holder responsible for advertising, giving the courts and administrative bodies of the Member States the power to require advertising that complies with the regulations in force.

• Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising ¹² .

• Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services ¹³ .

Regulations at national level

With regard to national regulations affecting the advertising of medicines, we find, in chronological order, the following:

• The Order of 10 December 1985, of the Ministry of Health and Consumer Affairs, which regulates advertising messages referring to medicines and certain health products ¹⁴ .

• Law 14/1986, of 26 April 1986, General Health Law (LGS, add abbreviation) ¹⁵ . Article 27 refers to health advertising, addressing the control of the veracity of commercial advertising and propaganda in the field of health. This article establishes that the public administrations shall control commercial advertising and propaganda to ensure that they comply with truthfulness criteria, within the scope of their competences, in order to limit anything that could be detrimental to health. This article was modified by Law 33/2011, General Law on Public Health, which maintains the provisions of the LGS, but adds "with special attention to the protection of the health of the most vulnerable population".

• Law 34/1988, of 11 November 1988, General Law on Advertising, as mentioned above, refers to the concept of advertising of medicines, and for its regulation it refers to the specific legislation on medicines.

• Law 3/1991, of 10 January, on Unfair Competition ¹⁶ , establishes the prohibition of acts of Disloyal Competition, including unlawful advertising under the terms of the General Advertising Law.

• Royal Decree 1416/1994 of 25 June 1994, which regulates the advertising of medicinal products for human use ¹⁷ .

• Circular 6/95, of the Directorate General for Pharmacy and Medical Devices of the Ministry of Health and Consumer Affairs, clarifications to Royal Decree 1416/1994, of 25 June 1994, regulating the advertising of medicinal products for human use, amended by Circular 7/99, of 27 May 1999, of the Directorate General for Pharmacy and Medical Devices. ¹⁸ .

• Royal Decree 1345/2007 of 11 October 2007, which regulates the procedure for the authorisation, registration and conditions of dispensing of industrially manufactured medicinal products for human use, in article 25, establishes three requirements to be met by medicinal products whose advertising is intended for the public. ¹⁹ .

• Law 29/2009, of 30 December, which amends the legal regime of Disloyal Competition and advertising to improve the protection of consumers and users ²⁰ .

• Royal Legislative Decree 1/2015, of 24 July, approving the revised text of the Law on guarantees and rational use of medicines and health products ²¹ .

4. SPECIFIC REGULATION: ROYAL DECREE 1416/1994 OF 25 JUNE 1994, REGULATING THE ADVERTISING OF MEDICINAL PRODUCTS FOR HUMAN USE.

The provisions included in the Royal Decree 1416/1994 of 25 June 1994, which regulates the advertising of medicinal products for human use ²² , apply to the advertising of industrially manufactured medicinal products for human use.

The principles of this Royal Decree can be summarised in four. Firstly, advertising of a medicinal product that has not obtained the corresponding marketing authorisation is prohibited. Secondly, all elements of the advertising of a medicinal product must comply with the information contained in the product's technical data sheet. Thirdly, advertising must always promote the rational use of the medicinal product by presenting it objectively and without exaggerating its properties. Finally, it prohibits misleading advertising by mentioning article 4 of Law 34/1988 of 11 November 1988, General Advertising Law, on the prohibition of subliminal advertising. ²³ .

The regulation in this law is made by distinguishing between two types of advertising: advertising aimed at the public and advertising aimed at persons authorised to prescribe. Given the importance of both types of advertising, we will see how they are regulated.

Advertising to the public

Advertising of medicinal products to the general public shall be understood to be that which, having been duly authorised, is addressed to the public for promotional and informative purposes, always promoting the appropriate use of the medicinal product ²⁴ . It must clearly state the advertising nature of the medicinal product, in addition to containing information identifying the medicinal product and the recommendations determined by the Ministry with competence in health to prevent the risks derived from the normal use of the medicinal product.

As regards the information to be included as a minimum in the advertising under consideration, it is the name of the medicinal product ²⁵ , the information necessary to promote its rational use and an express invitation to read carefully the instructions contained in the medicinal product.

It should be noted that advertising of a medicinal product to the public may include only the name of the medicinal product when the sole purpose of the advertising is to recall the name of the medicinal product, provided that the medicinal product is sufficiently well known to the public and has been used in promotional campaigns for at least two years. The advertising message shall include the words: "if in doubt, ask your pharmacist" or a similar expression.

The advertising of a medicinal product to the general public may not include any element which ²⁶ :

a) Attributes to the medical consultation or surgical intervention an unnecessary character, offering a diagnosis or advising a treatment by correspondence.

b) Suggests that its effect is guaranteed, that it has no side effects or that its effects are superior or equal to those of another treatment or medicine.

c) Suggests that the user's health can be improved by it or that the user's health may be affected if it is not used. ²⁷ .

d) Suggests or indicates that its use enhances sporting performance.

e) Is directed exclusively or mainly at children.

f) Refers to a recommendation made by health professionals or other persons who may, by virtue of their position or prestige, encourage the use of medicinal products.

g) Compares the medicinal product with a foodstuff, cosmetic or any other consumer product.

h) Suggests that the safety or efficacy of the medicinal product is produced by a natural substance.

i) May encourage a false self-diagnosis, either by a detailed description or representation of the anamnesis.

j) Refers to claims of cure in an abusive, alarming or misleading manner.

k) Uses visual representations of changes in the human body caused by disease, injury, or the action of a medicinal product on the human body.

l) Mention obvious characteristics of the medicinal product, such as that the medicinal product has received health authorisation or any other authorisation.

Advertising to healthcare professionals

The information that healthcare professionals obtain about medicines is one of the factors that can influence whether they prescribe one medicine or another, which is why it is essential that the advertising of medicines is regulated by law. This type of advertising must contain complete information so that healthcare professionals can judge the therapeutic value of the medicine. To this end, the Royal Decree 1416/1994 of 25 June 1994, which regulates the advertising of medicinal products for human use ²⁸ , establishes the minimum technical-scientific information that advertising must contain: the essential information on the product according to the data contained in the technical data sheet ²⁹ , its prescription and dispensing regime and the different presentations of the product, and the dosage and pharmaceutical form.

There are different ways of advertising to healthcare professionals who are authorised to prescribe or dispense medicinal products. One form is the medical visit, whereby a medical visitor goes to health professionals to provide them with technical knowledge about the medicinal product being advertised. This type of advertising requires that the medical representatives receive appropriate training from the laboratory marketing the medicinal product. Each visit shall include the retail price, the conditions of the pharmaceutical presentation financed by the National Health System, if applicable, and, where possible, the estimated cost of the treatment ³⁰ . In addition, at each medical visit, they shall provide the healthcare professional with a technical file on the advertised medicinal product. Finally, they shall notify the scientific service ³¹ of any information they receive from the health professionals visited.

Another type of advertising aimed at healthcare professionals authorised to prescribe or dispense is the so-called "documentary advertising". This is done through publications such as magazines, bulletins, books and similar (scientific), or incorporated in audiovisual media on optical media, or similar, provided that they are aimed exclusively at persons authorised to prescribe or dispense medicinal products.

Advertising may also be carried out by means of free samples. These shall be made exclusively to persons authorised to prescribe medicinal products, a maximum of ten samples of each medicinal product may be distributed per year and per medical practitioner, and for a maximum period of two years, starting from the date of authorisation of the medicinal product.

Finally, it is worth mentioning two other types of advertising, on the one hand, incentives ³² , which are prohibited, and, on the other hand, sponsorship of scientific meetings. These are permitted, in certain cases, as long as the recipients are clinicians or the organisations with which they are associated.

5. SPECIFIC REGULATION INCLUDED IN THE ROYAL LEGISLATIVE DECREE 1/2015, OF 24 JULY, APPROVING THE REVISED TEXT OF THE LAW ON GUARANTEES AND RATIONAL USE OF MEDICINES AND HEALTH PRODUCTS.

The Royal Legislative Decree 1/2015 ³³ includes some specifications on the subject under study in this paper, specifically Article 80. In the first section of this article, it establishes the three requirements that must be met in order to advertise a medicinal product, which are also included in the Royal Decree 1345/2007 ³⁴ . Firstly, only medicines that are not financed by public funds may be advertised. Secondly, medicines that are intended for use without the intervention of a doctor who makes the diagnosis, prescribes or monitors the treatment, even if they require the intervention of a pharmacist. This requirement may be waived in the case of vaccination campaigns approved by the competent health authorities. Thirdly and finally, they do not constitute psychotropic or narcotic substances as defined in international conventions. ³⁵ .

It is worth noting Article 80 ³⁶ , according to which the advertising of medicinal products not subject to medical prescription shall not require prior administrative authorisation. The Ministry of Health, Consumer Affairs and Social Welfare shall establish controls to ensure that advertising to the public for them is evaluated (to be explained in section 6 on control and surveillance of health advertising). This article prohibits premiums, gifts, prizes, contests, competitions, bonuses or similar as methods linked to the promotion or sale of these medicinal products to the public, in any case. The remaining paragraphs of the same article contain specific prohibitions on medicinal products for which advertising to the public is not allowed.

Internal control

There are various means of internal control. For example, in Spain, there is a non-profit association called Asociación para la Autorregulación de la Comunicación Comercial (AUTOCONTROL). This association is made up of advertising agencies, advertisers, professional associations and the media. Its aim is to work for responsible advertising: legal, truthful, loyal and honest ³⁸ . Entre sus servicios encontramos consultas para analizar un proyecto antes de su emisión. Its services include consultations to analyse a project before it is broadcast. In this sense, it resolves, through the Advertising Jury, the complaints that are brought to it in relation to advertising messages aimed at the public on medicines for human use ³⁹ .

External control

In the first place, administrative control is based on article 30 of Law 14/1986, of 26 April 1986, General Health Law ⁴⁰ , according to which "all health centres and establishments, as well as promotional and advertising activities, shall be subject to inspection and control by the competent health authorities". Likewise, article 5 of Law 34/1988, of 11 November 1988, General Law on Advertising, in its first section, establishes that "the advertising of health materials or products and others subject to technical-health regulations, as well as that of products, goods, activities and services likely to generate health risks (...) may be regulated by their special rules or be subject to the system of prior administrative authorisation. This system may also be established when the protection of constitutionally recognised values and rights so requires". This article gives administrations the ability to control advertising before it is broadcast.

However, mention will be made of the controls that are carried out on advertising of medicines that do not require prior administrative authorisation, which are those that are not subject to medical prescription ⁴¹ .

These controls are carried out by the Ministry of Health in collaboration with other bodies also involved in this process, such as, for example, the Association for the Self-Regulation of Commercial Communication, which has been mentioned above. Its purpose has been to ensure that the advertising messages that are broadcast comply with each and every one of the conditions imposed by the legal system in this area, without prejudice to the exercise of any administrative powers that may correspond. Its main objective is to promote self-regulation in the field of advertising of medicinal products for human use to the general public ⁴² .

Secondly, in order to initiate legal action in matters of advertising of medicines, ordinary jurisdiction is used by means of a verbal trial as established in article 249.1.4 of Law 1/2000, of 7 January, on Civil Proceedings ⁴³ . Article 32 of Law 29/2009, of 30 December, which modifies the legal regime of Disloyal Competition and advertising to improve the protection of consumers and users ⁴⁴ regulates the different actions to be taken in cases of illegal advertising: action to cease the unfair conduct or to prohibit its future repetition; action to rectify misleading, incorrect or false information; declaratory action for unfairness; action to remove the effects produced by the unfair conduct; action to prohibit, if the conduct has not yet been put into practice; action for compensation for damages caused by the unfair conduct, if the agent has acted with malice or fault; and, action for unjust enrichment.

Any natural or legal person who is affected and, in general, those who have a subjective right or legitimate interest, associations, professional corporations or those representing economic interests, when the interests of their members are affected, are entitled to bring these actions. The control of advertising of medicinal products is generally carried out in defence of the general, collective or diffuse interests of consumers and users. Therefore, they also have standing to act: ⁴⁵ :

• The National Consumer Institute and the corresponding bodies or entities of the Autonomous Communities and local corporations competent in consumer and user protection.

• Consumer and user associations.

• Entities of other Member States of the European Community constituted for the protection of the collective interests and diffuse interests of consumers and users that are authorised by their inclusion in the list published for this purpose in the "Official Journal of the European Union".

• The Public Prosecutor's Office.