Advertising and promotion

Regulation

Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?

The advertising and promotion of medicinal products and medical devices are subject to the general rules on advertising in General Law 34/1988 on advertising and Law 3/1991 on unfair competition; the specific requirements are set out in Royal Decree 1416/1994 (the Decree on the Promotion of Medicinal Products). In April 2023, the Ministry of Health invited all interested parties to make their proposals regarding the preparation of a new draft bill on the promotion of medicinal products. This new regulation would repeal Royal Decree 1416/1994, which is currently in force. However, no further steps have been taken to date. The political situation in Spain (which has had an interim government since the last elections in July 2023) makes it difficult to expect a new regulation on the promotion of medicinal products in the near future. 

The advertising of medical devices is regulated under Royal Decree 1591/2009 and Royal Decree 1662/2000. 

The Law on Medicinal Products sets forth the sanctions for breach of the rules on advertising medicinal products and medical devices.

Some autonomous regions have adopted guidelines reflecting the position of the regional authorities on this matter (the most notable of which are those issued in the regions of Madrid and Catalonia). The Ministry of Health has issued a guide on the advertising of over-the-counter medicinal products (last updated in 2019). There are also codes of conduct adopted on a voluntary basis by the pharmaceutical and medical devices industry, such as:

• FarmaIndustria’s Code of Practice for the Pharmaceutical Industry;
• the code of the Spanish Association of Generic Medicines (AESEG), which applies to generic medicinal products; and
• the code of the Spanish Association of the Self-Care Industry (ANEFP), which applies to over-the-counter, cosmetic and self-care products; and
• the code of the Spanish Federation of Health Technology Companies (Fenin), which applies to medical devices.

 

Regarding when the provision of information will be treated as promotional, this is something that must be assessed on a case-by-case basis, considering whether the relevant activity fits the legal definition thereof. Spanish authorities are rather strict when interpreting these definitions.

On the one hand, the advertising of medicinal products is defined as any form of informative offer, commercial research or inducement designed to promote the prescription, dispensation, sale or consumption of medicinal products. There are certain activities included in this definition, such as visits by medical sales representatives to persons qualified to prescribe or dispense medicinal products, supply of samples of medicinal products, sponsorship of promotional or scientific meetings and, in particular, payment of travel and accommodation expenses in connection therewith.

There are activities expressly excluded from this definition, such as:

• the labelling and the leaflet of the medicinal product;
• the correspondence, together with any non-promotional documents needed to respond to a specific question about a particular medicinal product;
• information and documents specifically related to changes in packaging and adverse reaction warnings in the framework of pharmacovigilance;
• sales catalogues and price lists; and
• information regarding human health or diseases, provided that there is no reference to the medicinal product.

 

The FarmaIndustria Code further provides certain activities that are not considered advertising of medicinal products (eg, texts written and produced by journalists in their professional work, and literal translations of scientific articles and abstracts published in recognised scientific sources).

With regard to online advertising of medicinal products and medical devices, this is subject to the same rules applicable to such advertising through any other means.

Inducement

What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?

Under the Law on Medicinal Products, it is expressly prohibited to offer any sort of improper inducement to healthcare professionals involved in the cycle of prescribing, dispensing and administering medicinal products and medical devices. Violation of this prohibition is considered a serious breach and is sanctioned with fines of up to €90,000.

Notwithstanding the above, it is permitted to provide certain gifts to healthcare professionals when the cost of the gift is insignificant and the gift is relevant to the practice of medicine or pharmacy. The FarmaIndustria Code further provides that offering gifts to healthcare professionals is only allowed if the items have stationary or professional use, the items are not related to prescription-only medicinal products and their market price does not exceed €10, among further exceptions.

Reporting transfers of value

What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?

According to the FarmaIndustria Code, companies are obliged to document and publish on their website (the first publication was 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 their purpose – whose recipients were healthcare professionals or organisations. The only payments excluded from this obligation are:

• activities associated with commercial transactions with distributors and retail pharmacies, as well as certain transactions with healthcare organisations;
• activities related to non-prescription medicinal products; and
• activities not detailed in Appendix I of the FarmaIndustria Code (provision of gifts, samples, dinners or luncheons).

 

Disclosures must be made on an individual basis, except for transfers of value related to research and development, with no need for the healthcare professional to consent to the disclosure of their personal data (but they must be informed by the company about such disclosure).

In addition, companies adhering to Fenin’s code must also document, and publish on their website, all transfers of value made during the previous year to healthcare professionals and organisations, following the model in article 15 of the Code.

Enforcers

Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.

The responsibility for enforcing the rules on advertising and inducements lies with the health authorities of the Spanish autonomous regions and courts. With regard to the enforcement of rules resulting from industry codes of conduct, the codes of FarmaIndustria, AESEG, ANEFP and Fenin are enforced by self-regulatory bodies in agreement with AUTOCONTROL, an association for self-regulation in advertising.

Sanctions

What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?

The Law on Medicinal Products regulates the sanctions for breach of the rules on the advertising of medicinal products and medical devices. Breaches are classified as minor, serious or very serious.

Promoting or informing about unauthorised medicinal products or without complying with applicable provisions on advertising are considered very serious breaches, which can be subject to fines of up to €1 million.

Advertising medical devices to the public when not allowed is considered a serious breach, which can be sanctioned with fines up to €90,000, except for the promotion of medical devices for genetic diagnosis, in which case the breach will be considered very serious and fined up to €1 million. Other sanctions may be applied, such as publication of the infringement in the Official Gazette or cessation of the infringing activity.

Sale and supply

Regulation

Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?

General rules on the sale and dispensing of medicinal products and medical devices are set out in the Royal Legislative Decree 1/2015 (the Law on Medicinal Products). This Law provides specific rules depending on the type of product. For example, the dispensation of narcotic medicinal products requires a specific prescription note, and its dispensation must be notified annually to the Agency of Medicines and Medical Devices (AEMPS) for control purposes. Other medicinal products, such as medicinal gasses, can only be supplied to medical premises or hospitals.

Online supply

What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?

The online sale of medicinal products is governed by Royal Decree 870/2013 on the distance selling of medicinal products for human use not subject to medical prescription to the public through websites. Further, Aragonese and Catalan authorities issued specific guidelines governing the online sale of medicinal products in December 2018 and October 2021, respectively. The AEMPS has also provided a Q&A document on the online sale of medicinal products. The online sale of medicinal products subject to medical prescription is prohibited under the Law on Medicinal Products. Due to the emergence of several business ideas involving online or telematic sales, dispensation and/or shipment of medicinal products, including those subject to medical prescription, there has been a lot of discussion, at the judicial level, on what is considered to be an ‘online sale’. Spain is a rather conservative country in this regard and most of these businesses have not succeeded due to this prohibition.  

Regarding medical devices, the Decree on Medical Devices sets out the prohibition of online sale of medical devices subject to medical prescription.

Pricing and reimbursement

What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?

With regard to setting the price of reimbursed medicinal products (including both hospital use and retail products), it is important to distinguish between theory and practice.

In theory, Spain follows a cost-plus system, under which the maximum ex-factory price should be the cost of the product plus a given profit margin. This is what Royal Decree 271/1990 on the reorganisation of price intervention for medicinal products for human use contemplates in accordance with the provisions of Council Directive 89/105/EEC.

The cost of the product is to be determined through the analytical application of the complete cost, including research and development, manufacturing costs and allocations corresponding to commercial and administration costs. With regard to the profit component, the rule is that the target profit of each company shall be within a range of 12 per cent to 18 per cent of the capital allocated to exploitation, including own resources (share capital, update and revaluation accounts, reserves, etc) and external resources with financial costs.

As a matter of practice, it has always been known that the price-approval process entails negotiation with the authorities where the cost and the profit margin are not the variables that are considered. Companies should be prepared for prices to be determined by the following two points:

• comparative pharmacoeconomic evaluation of the medicine in which the advantages of the new product should be quantified; and
• the price of the product in other EU member states.

 

Health technology assessments also play an important role in the reimbursement and pricing process with therapeutic position reports (TPRs). TPRs are coordinated and prepared by a network called REvalMED, which comprises therapeutic evaluation groups (led by the AEMPS), economic evaluation groups (led by the Ministry of Health), and therapeutic area specialists.

In theory, TPRs should include an analysis of how the new product or new indication compares with the existing alternatives from both a therapeutic and economic standpoint. In practice, it is rare that the TPR includes an economic evaluation. This is expected to change in the near future because, in June 2023, the National High Court declared the plan that created REvalMED null and void. This judgment expressly stated that under the current laws on medicinal products, TPRs could not contain an economic assessment. However, this judgment is not final and may be appealed before the Supreme Court. If the judgment is confirmed, this will have a significant impact on national health technology assessment activity in Spain.

Spanish regulations do not set special rules for generics or biosimilar medicinal products. As a matter of practice, generics and biosimilars are at least expected to offer a 30 per cent cut on the price authorised for the reference product.

Finally, in July 2022, the Ministry of Health opened a public consultation on the first draft of the law that will amend the current Law 29/2006 on guarantees and rational use of medicines and medical devices. The new law (which still has a long legislative proceeding ahead) may introduce important modifications to the current rules governing the pricing and reimbursement of medicinal products.