The Spanish life sciences sector comprises pharmaceutical, biotech, and medical device companies, as well as a wide range of industrial and health care service providers. The medicines sector is one of the most highly regulated national markets and can appear complex due to authorities at different national and regional levels. However, the Spanish pharmaceutical and biotechnology industry has become one of the most dynamic and competitive markets globally.

In 2021, the pharmaceutical market in Spain reached EUR20.9 billion, of which:

Growth was around 7%, with expenditure in hospital products exceeding 6.8% in 2020, while growth in retail pharmacies was 7.2%. In 2022, figures (until March 2022) show a 5.1% increase in the hospital market and a 7.1% increase in the retail market for the same period in 2021.

According to data published by Farmaindustria, the Spanish innovative pharmaceutical industry association, the pharmaceutical industry is Spain's most productive sector (double the industry average) and an export leader (with exports exceeding EUR14.9 billion per year).

There are around 425 pharma companies in Spain, with 60% of them being foreign. Biotech and life science start-ups raised about EUR225 million in 2020. Compared to other sectors, the life sciences sector is a source of stable, qualified, and diverse employment (93% of its workers are permanent, 64% have university studies, and 53% are women).

Another key aspect of the pharmaceutical industry in Spain is its commitment to R&D. It is considered the industrial leader by volume of spending on research, and accounts for over 20% of total private R&D investment in Spain. In 2021, pharmaceutical industry investment in drug research and development in Spain exceeded EUR1.16 billion, with almost half in collaboration with hospitals and public and private research centres.

Spain has positioned itself among the countries with the best conditions to develop clinical drug trials worldwide and has the third highest number of clinical trials in the EU. Despite the COVID-19 pandemic, the Annual Report of the Spanish Agency of Medicines and Medical Products (Agencia Española de Medicamentos y Productos Sanitarios) (Medicines Agency) put the number of clinical trials authorised last year at 1,027.

In addition to pharmaceutical and biotech companies, there are at least 80 science and technology parks, research centres, technology institutes, and universities in Spain offering state-of-the-art research technology. In October 2021, the first non-industrial CAR-T developed entirely in Europe was authorised by the Spanish regulatory agency.

In the health sector, private funding, especially non-bank finance, is the main funding alternative for most business projects. Although public funding exists it is generally insufficient on its own. Venture capital is the most prevalent form of investment in terms of the volume of existing investment.

Overall, the volume of private capital raised by the Spanish health biotech sector has progressively increased each year (during 2020 it increased by 46% compared to 2019, as shown by the ASEBIO 2020 Report).

Catalonia is one of the most dynamic regions in the life and health sciences space, with 1,300 life and health science companies with an aggregate turnover of EUR21.33 million (in 2020).

Average annual growth in the last five years was 4%. Venture capital funding raised EUR187.4 million (34% more than in 2020) in 36 operations (14% less) in 2021. Four out of ten rounds had foreign participation, representing 62% of the total venture capital invested by funds, which were mainly from Europe and the US.

The Spanish national health care service (NHS) is based on the principles of universality, free access, equity, and fairness of financing (Article 2, Law 16/2003). This aligns with Article 43 of the Spanish Constitution, which establishes the right to health care as a basic principle requiring action by all public administrations.

Some measures by the Spanish government during the economic crisis of 2008 to 2014 affected universal access to health care and imposed some conditions on access to health care benefits. Co-payments by patients were also redefined (see Royal Legislative Decree 16/2002). The Constitutional Court declared these limits valid, but many regions declared the right to health care as universal in their territory and the matter became very controversial. In July 2018, Royal Decree Law 7/2018 on Universal Access to the NHS restored universality to the NHS.

The NHS is mainly financed from general taxation. The NHS is usually classified as a gatekeeper system, where primary care physicians authorise access to speciality care, hospital care, and diagnostic tests. Most hospitals offering public health are publicly owned, with some exceptions.

The NHS co-exists with mutual funds for civil servants, mutual funds for accidents and occupational disease, and private insurance.

Spain has two initial stages at national level for market access:

The regions have an important role in market access because, although the Ministry of Health decides which therapies are financed, the regions allocate the budget to finance them. The regions can also establish specific procedural rules on how patients access reimbursed products.

Alternative pricing and reimbursement rulings, such as payment based on results, are increasingly popular. These may be approved by the Ministry of Health in its pricing and reimbursement resolutions or negotiated between companies and hospital or regional authorities. Such payment systems play an important role in pricing and reimbursement decisions and in hospitals' purchasing decisions, especially for medicinal products with high clinical uncertainty or high costs.

The way the pharma industry engages with the NHS is evolving in Spain, especially for new and highly innovative products. For mature products, the relationship between the pharma industry and public entities managing the NHS still focuses on prices and discounts. For innovative products, aligned with the "beyond the pill" movement, the industry is moving away from being a mere product supplier to gradually being a true partner of the NHS. The industry seeks to deliver not only the product or treatment but also systems and value-added services to optimise the product's use throughout the entire duration of patient treatment. This is driven by shared interests between the industry and the NHS, such as obtaining best possible health care outcomes due to, among other factors, the proliferation of pay-for-performance schemes.

A marketer of medicinal products cannot freely set prices for reimbursed medicinal products (see below, Reimbursement), as this requires prior approval from the Ministry of Health.

If there are legitimate public health reasons, the Ministry of Health can also control the price of medicinal products that are not reimbursed.

Royal Decree 271/1990 states that the maximum ex-factory price of a reimbursed medicinal product must be equal to the cost of the product plus a given margin (12% to 18% on capital allocated to exploitation). However, in practice, setting the price of a reimbursed medicinal product involves negotiating the price with the public authorities.

In addition, unless the medicinal product is subject to the reference pricing system, companies must grant a discount on the maximum ex-factory price for the product approved by the authorities.

A product is subject to reference pricing if either:

The price of products in the same reference pricing group are lowered to the level of the lowest product in the group.

Medicinal product substitution rules also apply. These use the concept of homogeneous groups of reimbursed products with the same active substances, dosage, composition, and route of administration, that are essentially interchangeable. Pharmacists must supply the product that has the lowest price in its homogeneous group.

In relation to clawbacks, an agreement between Farmaindustria and the government was in place until June 2020, which contemplated chargebacks paid by pharmaceutical companies where pharmaceutical expenditure exceeded the agreed ratio of real GDP growth. Farmaindustria and the government are negotiating to extend this agreement. No agreement has yet been reached.

Health technology assessments (HTAs) are important in pricing and reimbursement decisions and market access. An HTA occurs first at national level, in the context of a Therapeutic Positioning Report (Informe de Posicionamiento Terapéutico) (IPT) (see below, Reimbursement). Subsequently, the regions and hospitals may undertake their own HTA to decide whether to include the medicinal product in clinical practice.

Under Royal Legislative Decree 1/2015, the criteria used by the Ministry of Health to decide whether a product is reimbursed include:

The Ministry of Health must also consider the cost-efficiency ratio of the product, based on the IPT prepared by expert groups from the Medicines Agency, the Ministry of Health, and the regions.

In 2020, the Permanent Pharmacy Commission of the NHS Interterritorial Council approved a Plan to Consolidate Pharmaceutical IPTs. This plan, presented in November 2020 by the Ministry of Health General Pharmacy Directorate, aims to review the HTA process and consolidate IPTs as a key element of HTA. It includes two major action lines:

As of July 2022, the REvalMED network has been established and is operating. Some newly released IPTs under REvalMED include health economic evaluations as stated in the 2020 Plan to Consolidate Pharmaceutical IPTs. However, many IPTs still lack this economic evaluation. This is expected to change in future because the trend is to increase the number of economic evaluations in IPTs.

The pricing authorities may also consider the product's contribution to the Spanish economy and return mechanisms proposed by the marketer (such as discounts, price reviews, and so on).

Once the Ministry of Health decides to reimburse a certain medicinal product, the patient obtains the medicine from a pharmacy and, if applicable, pays the pharmacist a set co-payment.

The pharmacy then charges the sale price of the medicinal product (the maximum ex-factory price approved by the Ministry of Health) (see above, Price Regulation) to the government of the region where it is established, plus the margins set by law for the wholesaler and the pharmacy, less the amount paid by the patient.

If medicinal products are administered to patients in public health care centres and hospitals, the products are not paid for by patients but financed from the institution's own budget.

Pharmacists are compensated for dispensing services through a price margin on each product dispensed. This margin is set by Royal Decree 823/2008 on the margins for the dispensation of medicinal products. The margin rises as the price of the medicine increases.

The sale of medicinal products to the public can only be carried out by duly authorised pharmacies. This applies to both over-the-counter (OTC) and prescription-only medical products. The term OTC product includes both:

Medicinal products require a valid marketing authorisation to be placed on the Spanish market (Royal Legislative Decree 1/2015).

Medicinal products can only be distributed by (see Question 6):

The distribution regime is the same for OTC and prescription-only medical products.

Selling prescription medicines online is strictly forbidden. However, under Royal Decree 870/2013, online sales of OTC medicinal products are permitted for authorised physical pharmacies.

A pharmacy website that sells OTC medicinal products must comply with certain requirements, such as:

In Spain, the wholesale distribution of medicinal products refers to any activity consisting of obtaining, storing, holding, supplying, or exporting medicinal products, excluding the dispensing of medicinal products to the public. Wholesale distribution is regulated by Royal Legislative Decree 1/2015 and Royal Decree 782/2013.

Before commencing activities, wholesalers and other distribution entities must apply for authorisation from the regional health authorities where their premises are located and where their activities will be carried out. For warehouses under customs supervision, authorisation is granted by the Medicines Agency.

To obtain a distribution authorisation, an applicant must comply with the conditions in Article 69 and following of Royal Legislative Decree 1/2015 and Royal Decree 782/2013, which include:

In addition, wholesalers must have a current certificate of compliance with good distribution practices (GDP) issued by the Ministry of Health.

Being authorised as a wholesaler is not sufficient to import medicinal products (see Question 8). Importing of medicinal products can only be performed by entities with an importer's authorisation from the Medicines Agency. Authorised importers can distribute the imported medicines through wholesalers or request authorisation as a wholesaler to carry out distribution activities directly.

Wholesalers must notify the Medicines Agency 15 days in advance of the introduction into Spain from other EU member states of medicinal products not authorised in Spain.

The distribution of medicines is supervised by the Medicines Agency and the regional health authorities. Regional health authorities can carry out regular inspections of premises where distribution activities are performed to verify compliance with authorisation conditions, legal requirements, and GDP (Royal Legislative Decree 1/2015; Royal Decree 782/2013).

Once compliance with those conditions is verified, the health authority will issue a certificate of compliance with a determined validity period.

Failure to comply with the requirements can lead to precautionary measures and administrative sanctions (Article 110 and following, Royal Legislative Decree 1/2015), as well as, depending on the case, civil and/or criminal liability.

The amount of the fine depends on the case and whether the infringement is minor, serious, or very serious:

In addition, the authorities can impose further measures such as:

If an infringement procedure is initiated against a distributor, it can first contest the decision at administrative level. Once an administrative procedure is concluded, an appeal can be lodged with the Spanish courts.

Medicinal products must have marketing authorisation in Spain to be imported. All imported batches must be subject to a complete qualitative analysis of all active substances, and any other tests that may be necessary to ensure their quality. This analysis must be carried out in an EU member state. The importer's qualified person must issue a certificate for each imported batch before its release.

The importer must have an importer's authorisation from the Medicines Agency to import medicinal products and carry out the related analysis and tests. Authorised importers can distribute the imported medicines through wholesalers or request authorisation as a wholesaler to carry out distribution activities directly (see Question 6).

Imports of medicinal products, their intermediate materials, and bulk materials must be authorised by the Medicines Agency. Imports are authorised for a period of one year, which can be made in several shipments.

Authorisation to import finished medicinal products must be obtained from the Medicines Agency by the importing pharmaceutical laboratory or the marketing authorisation holder, in accordance with the marketing authorisation.

For intermediate or bulk products, import authorisation must be requested by the manufacturing or importing laboratory in accordance with the marketing authorisation.

Importers who carry out the required analyses to import medicines or investigational medicinal products from third countries and their facilities must obtain a manufacturing authorisation from the Medicines Agency.

If medicinal products are not authorised in Spain but will be subject to any phase of their manufacturing in Spain before being marketed in another EU member state, this must be authorised in advance by the Medicines Agency.

Importers of medicinal products and manufacturers must have insurance or equivalent financial guarantees to cover damage to health arising from medicinal product safety issues.

The import of active ingredients intended to be used in Spain to manufacture medicinal products does not require a specific authorisation (except for blood-derived active ingredients). However, active ingredients can only be imported if they:

Companies importing active ingredients must annually notify to the Medicines Agency imports made during the previous year.

Spain does not have any mutual recognition agreements for medicinal products but does have some for medical devices (such as with Switzerland).

Under Royal Decree 1785/2000, parallel imports are allowed into Spain from other EU member states, subject to the following requirements:

IP rights cannot be used to oppose parallel imports. However, before marketing a medicinal product that is parallel imported into Spain, the importer must notify this to the holder of the marketing authorisation for the medicinal product in Spain and provide, if requested, a sample of the repackaged product to be marketed.

The rules on advertising medicinal products are set out in:

The regions of Madrid and Catalunya have adopted further guidelines on certain advertising matters.

Some industry associations have adopted codes of conduct that regulate, among other matters, interactions with health care professionals, health care organisations, and/or patient organisations.

Responsibility for enforcing advertising rules (other than under industry codes of conduct) lies with the health authorities of the regions and the courts.

Industry codes of conduct are enforced by industry association self-regulatory bodies in agreement with Autocontrol, a Spanish association acting as an independent tribunal in advertising self-regulation matters. For OTC products, the Association for Health Selfcare (Asociación para el Autocuidado de la Salud) (ANEFP) also acts as an independent tribunal for companies that submit their cases to it.

Autocontrol and ANEFP also provide supervisory services for promotional materials before they are distributed, allowing companies to ensure that they comply with advertising rules before disclosure of promotional materials.

Under Royal Decree 1416/1994, "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. This definition is consistent with the definition in Directive 2001/83/EC on the Community code relating to medicinal products for human use.

Advertising prescription-only medicinal products and/or public financed medicinal products to the general public is prohibited. There are only a few exceptions to this where information on pharmaceutical products can be provided to the general public, such as for vaccination and other health campaigns. However, non-prescription medicinal products that are not publicly financed (OTC medicinal products) can be advertised to the general public (see Question 17).

Marketing authorisation holders can only promote products that have obtained a marketing authorisation to health care professionals qualified to prescribe or dispense medicinal products (see Question 20).

Whether a particular communication, material, or information is deemed to be promotional is determined by whether its real purpose is the promotion of the prescription, dispensing, sale, or consumption of a medicinal product. It is not solely determined by the activity or channel where it is distributed (a wide range of different types of support activities have been considered promotional).

Certain activities are listed in Royal Decree 1416/1994 as a promotional activity and are therefore always considered promotion, including:

The following, among other things, are not considered promotional, due to their exclusively informative nature:

Pharmaceutical companies must have a scientific department in charge of managing information related to the medicinal products that they market. The scientific department of the company must:

Under the Farmaindustria code of conduct, companies must have a written procedure to monitor compliance. In addition, the code recommends different departments (such as marketing/sales, medical, regulatory, legal, and finance/administrative) to be involved in the committees, policies, or internal procedures that the company implements on these matters.

In addition, promotional material must not be disclosed without the final version being reviewed and controlled by the pharmaceutical company's scientific department. The same applies to the advertising of medicinal products through social media (see Question 15).

Advertising directed to health care professionals qualified to prescribe or dispense medicinal products does not need to be approved in advance by a regulatory or industry authority. However, companies placing such advertisements must send a copy of the advertisement to the health authority of the Spanish autonomous region where the company is located and must ensure that only health care professionals entitled to prescribe or dispense medicinal products can access the relevant publication.

Advertising directed to the general public does not need to be approved in advance by the authorities. However, all advertising is subject to control by the authorities, and sanctions may be imposed subsequently if the advertising is not compliant. The Ministry of Health may, in exceptional circumstances, make advertising of a specific medicinal product subject to prior approval.

In addition, under Royal Decree 1416/1994, companies must send an annual summary of all their advertising activities to the health authority of the Spanish autonomous region where the company is located.

Under Law 3/1991 on Unfair Competition and the Farmaindustria code of conduct, comparative advertising directed to health care professionals is allowed if the:

A competitor's brand name or trade mark can be used as part of the comparison, provided that such use is proportionate and not made to take unlawful advantage of the reputation of the competitor's brand name or trade mark.

However, there is no legal or ethical requirement for an express reference to the trade mark of a compared medicinal product, and comparative advertising can involve both explicit or implicit references to a competitor (Ruling of Jury of Advertising of Autocontrol in Sanofi-Aventis v Italfarmaco – Hepaxane®, 8 January 2020).

Advertising of medicinal products that have not obtained a marketing authorisation, or of unauthorised indications, is prohibited.

In some cases, the regulatory authorities and the Farmaindustria code of conduct allow companies to make information available to health care professionals and health care organisations before the medicinal product's approval where it is merely scientific information instead of an advertising activity. However, it is advisable to take a restrictive approach to these activities, as any materials containing promotional statements are considered advertising. For instance, objective and non-promotional scientific information on unauthorised medicinal products or unauthorised indications can be provided during conferences or meetings organised by a reputable scientific society where certain conditions are met. The distribution of promotional materials on medicinal products authorised in countries other than Spain is also permitted if certain conditions are met.

Press releases referring to unauthorised medicinal products may be considered corporate information (and therefore not subject to the advertising rules) if they refer to a newsworthy event such as a medicinal product authorisation process relating to the company's financial performance and have a non-promotional tone. Such materials can be published in non-scientific journals directed to the general public. However, this requires a case-by-case analysis to determine whether the press release is promotional. Relevant factors include, among others, the:

Advertising compassionate use programmes is prohibited under Spanish law. Royal Decree 1015/2009 regulating the use of medicinal products in special situations expressly prohibits the marketing authorisation holder in the country of origin from advertising the compassionate use of a medicinal product.

The Catalonia and Madrid regional authorities do not permit promotion of a medicinal product before its price and reimbursement decision has been issued (see Question 4). However, this area is unclear. The High Court of Justice of the Basque Country issued a ruling on 30 June 2021 stating that promotion before the price and reimbursement decision was not prohibited by Spanish regulations, and Farmaindustria subsequently amended its code of conduct to specifically allow such promotion. However, the Catalan and Madrid authorities have stated that they do not feel bound by this ruling and so it is advisable to take a restrictive approach to this activity.

Advertising though social media is subject to the same rules for other kinds of advertising. In particular, advertising prescription-only medicinal products is not allowed on social media that the general public can access.

In addition, the Farmaindustria code of conduct requires companies to adequately train their employees on how to behave in the digital environment. Pharmaceutical companies must have internal good practice guides directed to their employees and any person acting on their behalf or under their control due to an agreement. A 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.

In addition, under the Farmaindustria code of conduct, pharmaceutical companies must clearly and unequivocally inform health care professionals and employees attending meetings organised or sponsored mainly by the company about the prohibition of publishing promotional content related to the meetings on social media. It is also advisable to include safeguards in agreements with speakers and attendees.

The health authorities of the Spanish autonomous regions and courts enforce the rules on advertising, promotion, and inducements (except for rules resulting from industry codes of conduct).

Breaching these rules can result in administrative sanctions. The general rule is that a breach of the law on advertising can result in a fine. The amount depends on various factors including negligence, intent, fraud, collusion, and so on.

In addition, advertising in breach of General Law 34/1988 on Advertising is unlawful under Law 3/1991 on Unfair Competition. An action can be brought before the courts for advertising and competition breaches (individually or on a cumulative basis) for, among other things:

Compliance with the industry codes is enforced by self-regulatory bodies in agreement with Autocontrol, an association for self-regulation in advertising. Decisions by regulatory bodies can be challenged through an administrative appeal and judicial review.

Procedures under the industry codes may conclude with a declaration of unlawfulness of the advertising, as well as a fine set in-line with a variety of factors. The damage that a breach of the rules may cause to the industry's image is one factor referred to in the Farmaindustria code of conduct. The competent body to impose these measures is the Jury of Advertising, a specialised body within Autocontrol. Jury of Advertising rulings are made public on its website.

Under the Farmaindustria, Spanish Generic Medicines Association (Asociación Española de Medicamentos Genericos) (AESEG), and ANEFP codes of conduct, 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 that enforce these codes.

A procedure before the Jury of Advertising takes about four to six months from the complaint until it is resolved.

Recently, there have been few cases on medicinal product advertising before the Spanish courts and Autocontrol. The latest Autocontrol ruling under the Farmaindustria code of conduct was issued in July 2022, two years after the previous ruling in mid-2020.

Advertising prescription-only medicinal products and/or public financed medicinal products to the general public is prohibited.

Non-prescription medicinal products that are not publicly financed (OTC medicinal products) can be advertised to the general public.

Advertising messages must be precise, balanced, honest, objective, based on adequate scientific evaluation, sufficiently complete, and conform to the summary product characteristics (SmPC) or leaflet of the medicinal product.

Advertising medicinal products that have not obtained a marketing authorisation and a relevant price resolution is not allowed.

Promotional materials addressed to the public (which therefore must only refer to OTC medicinal products) must comply with the following principles:

Promotional materials addressed to health care professionals must also generally comply with these principles but with some differences. The principle of veracity and objectivity requires materials addressed to health care professionals to include concrete information not required for materials addressed to the public (see Question 20).

Under Royal Decree 1614/1994, the provision of free samples can only be made to health care professionals authorised to prescribe medicinal products and under certain conditions (see Question 21).

There are no provisions in Spanish law restricting interactions between patients, patient organisations, and the pharmaceutical industry.

However, under the Farmaindustria code of conduct, any collaboration between companies and patient organisations must be formalised in a written agreement setting out the:

In addition, companies must have an internal process for approval of these collaborations and must not be the exclusive sponsor of a patient organisation nor try to influence the content of publications it issues.

Meetings with patient support groups must be held at appropriate venues, not those that 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. Organising an event outside Spain due to a relevant resource being where the event is going to be held requires prior approval from Farmaindustria's Ethics Surveillance Unit.

The Farmaindustria code of conduct defines health care professional as any member of the medical, dental, pharmaceutical, nursing, or podiatric profession, any other person legally considered as such, or any other person who, in exercising their profession, can perform or participate directly or indirectly in the prescription, purchase, supply, dispensation, or administration of medicinal products for human use (veterinarian professionals are excluded). Pharmacists are therefore considered health care professionals.

The Farmaindustria code of conduct defines a health care organisation as a legal body or entity that is either:

Under Royal Decree 1416/1994, advertising directed to health care professionals legally entitled to prescribe or dispense medicinal products must include the:

In contrast with promotional materials addressed to the public (see Question 17):

Messages must be precise, balanced, honest, objective, based on adequate scientific evaluation, and sufficiently complete in relation to the product's therapeutic value.

Reminder advertisements are acceptable for sufficiently known products promoted for at least two years and can only include the:

No other statements can be included but the regulatory authorities and the bodies that enforce the Farmaindustria code of conduct do accept pictures of the product packaging.

It is prohibited for any person with a direct or indirect interest in the production, manufacture, and placing on the market of medicinal products to directly or indirectly offer any kind of inducement, bonus, discount, reward, or gift to health professionals, their relatives, or cohabitants (Article 4.6, Royal Legislative Decree 1/2015). This prohibition does not apply to offering stationery or items for the practice of medicine or pharmacy, provided their price does not exceed EUR10. This prohibition applies to offers made to both private and public practitioners.

Royal Decree 1416/1994 only allows the sponsorship of events of a professional and scientifical character where:

Funds obtained and their sources must be stated for the publication of works or studies and presentations at meetings, conferences, and similar events. This extends to the means of communication through which such materials are made public and the obtaining of funds by or for their publication.

In addition, the codes of conduct of several industry associations (such as Farmaindustria and the Spanish Federation of Health Technology Companies (Federación Española de Empresas de Tecnología Sanitaria) (FENIN)) impose on their members further rules on dealings with health care professionals (including both public and private practitioners). For example, the Farmaindustria and FENIN codes of conduct establish rules on, among other matters:

FENIN's code of conduct prevents companies associated with FENIN from providing financial support directly to individual health care professionals to cover the costs of attendance at third-party organised educational events.

There are no specific anti-bribery regulations for the life sciences industry. However, breach of the above regulations can be a serious administrative infringement under Royal Legislative Decree 1/2015, which prohibits:

Serious infringement can incur fines between EUR30,001 and EUR90,000, and publication of the infringement in the Spanish Official Gazette.

In addition, bribery is sanctioned by the general rules of the Criminal Code, which defines a bribe as either:

If the bribe is aimed at a public official (including health care practitioners in the public health care system), the bribery is punishable with a:

If the bribery is aimed at a private or commercial operator (for example, a private practitioner), the bribery is punishable with a:

However, breaches are typically punished as administrative infringements and are only punished under the anti-bribery provisions of the Criminal Code in the most serious cases where there is irrefutable proof of bribery.

Spanish law does not require payments by companies to health care professionals or other interactions between companies and health care professionals and organisations to be publicly disclosed. However, the Farmaindustria code of conduct requires its members to publish each year on their websites certain information on interactions with health care professionals and organisations, which must:

The Farmaindustria code of conduct has implemented the European Federation of Pharmaceutical Industries and Associations (EFPIA) rules on disclosure of transfers of value from pharmaceutical companies to health care professionals, health care organisations, and patient organisations. Consequently, companies must document and publish on their website all such transfers of value made during the previous year. This includes any direct or indirect payment or grant, either cash or benefits in kind, regardless of its purpose, to a health care professional or health care organisation. The only payments excluded from this obligation are those associated with:

Disclosure must be made on an individual basis, except for transfers of value related to R&D.

The Spanish personal data protection authorities have ruled that companies must inform health care professionals on the disclosure of their personal data. However, there is no need for health care professionals to consent to the disclosure of their personal data.

The AESEG code also implements the Medicines for Europe rules on disclosure of transfers of value from pharmaceutical companies to health care professionals, health care organisations, and patient organisations.

There is no distinction in this respect between public or private providers.

Failure to comply with the rules on advertising medicinal products (included advertising addressed to health care professionals) is a serious infringement of Article 111 of Royal Legislative Decree 1/2015 that may result in a fine ranging from EUR90,001 to EUR1 million. The amount depends on various factors, including:

In some cases, criminal sanctions may apply.

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

However, the regulatory authorities can investigate matters on their own initiative, even if they are being assessed by a self-regulatory body, and can take up matters based on an adverse finding by a self-regulatory body. Conversely, the Jury of Advertising must refrain from assessing any issue that is being or has been assessed by the regulatory authorities or the courts.

The basic legal conditions to obtain a patent in Spain are that the invention must:

Novelty is fulfilled when the invention is not part of the state of the art. The state of the art is everything made available to the public in Spain or abroad (absolute novelty), through a written or oral description, use, or in any other way before the date of filing the patent application with the Spanish Patents and Trade Marks Office (Oficina Española de Patentes y Marcas) (SPTO). The state of the art also includes the contents of the following pre-existing patent applications:

An invention involves an inventive step if, having regard to the state of the art (as defined above), the invention is not obvious to a person skilled in the art. To decide an inventive step, the patent applications listed above are not considered.

For the invention to be susceptible to industrial application, the invention must be able to be exploited in any kind of industry.

The patent description must describe the invention in a sufficiently clear and complete way to allow a person skilled in the art in the appropriate technical sector to put the invention into practice.

The main patent legislation includes:

The available types of patent are:

The regulation does not define the term invention but states that the following is not an invention:

In addition, the following cannot be protected by a patent:

See above, Main Categories Excluded from Patent Protection.

The first medical use of an already known substance or composition can be patentable in itself. The second or a subsequent medical use of an already known substance or composition for use in the treatment of another disease (second medical indication) can be patentable if the second or subsequent use is new and inventive.

A patent application must be filed with the SPTO. Its website provides guidance on the application procedure and fees. An application must provide the following information:

When a patent application is filed with the SPTO, it will check if there are any defects in the application and, if necessary, grant remedy periods for the applicant to complete and/or correct the application. In particular, the SPTO will check if:

Once a filing date is obtained and the relevant fees are paid, the SPTO officers will carry out ex officio an in-depth examination of the application on the form, clarity, unity of invention, and substantive requirements for patentability (including exceptions or exclusions to patentability). If they find any defects, the applicant is granted a two-month remedy period.

The SPTO officers then draft:

If the review of the patent application is positive, the SPTO will publish a notice of the patent application in the IP Official Journal (Boletín Oficial de la Propiedad Industrial), stating that the patent application, and the report on the state of the art and the preliminary opinion, if available, are available to the public. The SPTO then has up to 18 months to grant the patent.

After publication of the notice of the patent application in the IP Official Journal and until the end of the examination proceedings, anyone can submit observations on the patentability of the application. Any observations will be provided to the applicant, who can file replies to them or amend (limit) the claims in the application.

The grant of the patent is published in the IP Official Journal. After publication of the grant of the patent, it is possible to file an opposition due to:

The opposition proceeding with the SPTO ends with a decision to grant or reject the patent, which can be appealed to the SPTO. A decision on the appeal can be subject to judicial review in the administrative courts.

A patent is granted for a non-renewable period of 20 years from the application filing date.

Although the patent is only effective from the date when the patent grant is published in the IP Official Journal, the application filing date is used to calculate the patent protection period.

For medicinal products, it is possible to extend patent rights through a supplementary protection certificate (SPC). This confers the same rights as those conferred by the patent and is subject to the same limitations and obligations.

The rules applicable to SPCs are in the Consolidated SPC Regulation (EC) 469/2009).

The Consolidated SPC Regulation includes the "SPC manufacturing waiver". This allows companies based in the EU to manufacture generics or biosimilars of a reference product protected by an SPC, if the manufacturing is for export to a non-EU market, or for stockpiling in the final six months of the SPC ahead of entry into the EU market.

An SPC starts from expiry of the relevant patent. Its duration is the period between the patent application filing date and the date of first marketing authorisation of the relevant medicinal product in the EU, less five years, up to a maximum of five years.

An SPC can be extended once by a period of six months if there is a paediatric investigation plan for the medicinal product, under the terms and conditions in the Paediatric Medicinal Products Regulation ((EC) 1901/2006).

An SPC is only available for one product. Other products require an application for a separate SPC, even if covered by the same patent.

A patent holder can bring actions to enforce its patent in the competent Spanish courts. The following remedies, among others, are available:

Interim relief can also be requested before, simultaneously, or after filing the main action on the merits. Such measures can be requested ex parte (without hearing the counterparty) in urgent circumstances.

Pre-trial discovery proceedings to gather facts necessary to prepare the claim on the merits are available.

A patent is infringed when there is an unauthorised use of the invention protected by the patent during its validity. Patent infringement can occur directly and/or indirectly.

Direct infringement occurs when there is an unauthorised use of the patented invention through any of the following actions:

Indirect infringement occurs when a person makes unauthorised use of a patented invention by giving or offering to give to other person(s) the means to put the patented invention into practice, if the following conditions are met:

Anyone who, before the patent application filing (or priority) date, worked the subject-matter of the invention in good faith in Spain, or had at that date already in good faith made serious and effective preparations for such use, can continue or commence the use, provided it is not extended or increased and only made if necessary to meet the reasonable needs of their business. Such a right of prior use can only be transferred together with the business.

It is not possible to enforce patent rights against acts relating to biological material obtained through reproduction or multiplication of biological material protected by a patent.

Research exemption. Patent rights do not extend to acts carried out for experimental purposes relating to the subject matter of the patented invention. In particular, patent rights are not infringed by acts relating to performing studies and trials necessary to obtain marketing authorisation for medicines in or outside Spain, and the practical requirements arising from them, including the preparation, obtaining, and use of the active substance for these purposes.

The Bolar exception, a special type of the experimental use exception, specifically relates to experiments and trials, both pre-clinical and clinical, conducted to seek regulatory approval for a generic or similar bio-equivalent medicinal product.

IP exhaustion. A patent holder cannot claim infringement against acts relating to a product that has been commercialised in the European Economic Area (EEA) by the patent holder or with their consent (patent exhaustion) unless there are legitimate grounds for the proprietor to oppose the marketing of the product.

Other exemptions. Other exemptions include:

Spain is a party to the:

Spain is a party to the:

Spain is a party to the Madrid Agreement Concerning the International Registration of Marks 1891 (Madrid Agreement).

Trade marks can be protected through registration with the SPTO. The trade mark legislation includes:

Unregistered trade marks that are "well-known" according to Article 6bis of the Paris Convention are protected in Spain.

Under Law 17/2001, a trade mark must be capable of distinguishing the goods or services of one person from those of others, that is, it must be distinctive and capable of representation so that any party can assess and analyse the trade mark (for example, to check whether a given sign used in the market may infringe the rights over a trade mark).

A trade mark can be any sign, such as words (including personal names), designs, images, symbols, drawings, letters, numbers, colours, 3D shapes of goods or their packaging, sounds, or any combination of them.

Certain signs cannot be registered as a trade mark on absolute grounds for refusal (legal prohibitions of registration on general interest grounds), including a sign that:

Medicinal brands can be registered as trade marks and are subject to the general requirements for registration. The regulations do not set out any images, symbols, or words specifically prohibited from use as a pharmaceutical trade mark.

Even if not statutorily excluded by Law 17/2001 on Trade Marks from registration as a trade mark, an International Non-proprietary Name (INN) for goods and services relating to medicinal products cannot be protected as a Spanish trade mark, since it is a generic sign lacking the required distinctive character.

The registry of trade marks in Spain is managed by the SPTO. Trade mark applications can be filed online or in different departments of regional authorities, which send the application to the SPTO.

The SPTO website provides guidance on the application procedure and fees.

Trade mark applications for pharmaceutical products are not subject to review by pharmaceutical product regulators.

When a trade mark application is filed with the SPTO, it checks if there are any formal defects in the application (such as non-payment of fees) and grants cure periods for the applicant to complete and/or correct the application if necessary.

Priority can be claimed for marks registered or applied for in Spain directly or under international treaties (see Question 28).

The SPTO carries out a search to identify any prior similar trade mark applications or registrations. The results are shared with the holders of such prior rights.

If the review of the application is positive, the SPTO publishes it in the IP Official Journal. Within two months of publication, a third party can file an opposition to the application on relative grounds for refusal relating to prior rights or other circumstances incompatible with the application. Third parties can also file observations on absolute grounds of refusal.

The SPTO will review the application ex officio, analysing it in depth to assess if the trade mark can be granted.

The SPTO may suspend the application if:

The applicant is notified of any such suspension and granted a month to reply. The SPTO will issue a decision to grant or refuse the trade mark once this period has elapsed.

A request to review the SPTO's decision can be filed with the SPTO within one month from publication of the decision.

A decision of the SPTO can be appealed to the administrative courts.

The competition law framework is contained in:

These have been reformed to transpose Directive (EU) 2019/1 to empower competition authorities in EU member states to be more effective enforcers and ensure proper functioning of the internal market (Directive ECN+) into Spanish law.

Article 101 of the Treaty on the Functioning of the European Union (TFEU) on restrictive agreements corresponds to Article 1 of the Competition Law.

Article 102 of the TFEU on abuse of dominant position corresponds to Article 2 of the Competition Law.

The Spanish competition authority is the National Commission on Markets and Competition (Comisión Nacional de los Mercados y la Competencia) (CNMC). Its main general function is to preserve and promote effective competition and defend proper functioning of all markets, in the interests of consumers and businesses.

Law 3/2013 on the creation of the CNMC, also modified to transpose Directive ECN+ into Spanish law, provides wide regulatory powers to the CNMC, including:

The CNMC also:

The CNMC has expressed a special interest in investigating and enforcing competition law in the pharmaceutical sector, due to its strongly regulated nature.

Investigations in the pharmaceutical industry are common in Spain. In March 2017, the CNMC launched a study on the market for wholesale distribution and marketing of medicinal products in Spain. This was a response to potential restrictions on competition arising from the functioning and structure of the market itself, and from potential regulatory restrictions on access to the market and market activity. The CNMC acknowledged that regulation of the pharmaceutical market was necessary to protect public health and the public interest. However, it also stated that pharmaceutical regulation must comply with the principles of necessity and proportionality.

As part of this study, in January 2021, the CNMC launched a public consultation on the marketing and wholesale distribution of medicinal products dispensed through pharmacy offices in Spain, which is now in its final stage of preparation. The CNMC received 33 answers from different market participants, including pharmaceutical companies, pharmacies, sectoral associations, consumers, patients, wholesalers, and independent experts and academics. Matters discussed included:

Generic entry of pharmaceuticals raises numerous issues under competition law but they have not so far been contentious in Spain. The EU and Spanish system is based on the principle that generic products should be able to access the EU market immediately after expiry of patent protection. This is an essential feature of the market and is important for the sustainability of the public health system.

The SPC manufacturing waiver (see Question 26) is a key issue going forward.

Abuse of dominance issues have appeared in various cases involving predatory pricing and refusal to supply to customers entering into parallel export arrangements. The CNMC has defined the relevant product market along the same lines as the European Commission, taking the Anatomical Therapeutic Chemical (ATC) Classification as an indicative criterion. It also considers the special nature of the pharmaceuticals market, where even companies with a large market share are not really able to operate independently from competitors or other relevant stakeholders, given the regulatory constraints.

In Case S/0027/19 of 20 April 2021, the CNMC investigated an alleged abuse of dominant position by AstraZeneca Farmaceutica SA, through implementing predatory prices for the SYMBICORT medicinal product, by offering it to hospitals at prices below their average variable costs or even marginal costs. The CNMC took the ATC4 criterion to define the relevant product market and found that AstraZeneca did not have a dominant position. The CNMC did not take any further action.

In Case S/0024/19 of 20 April 2020, the CNMC investigated an alleged abuse of dominant position by AbbVie Spain SLU, consisting of an exclusionary discount strategy offered to hospitals for the HUMIRA medicinal product. The CNMC took the ATC3 criterion to define the relevant product market and concluded that AbbVie did not have a dominant position. In addition, according to the CNMC, the discounts offered by AbbVie did not have an exclusionary effect. Consequently, the CNMC did not take any further action.

The CNMC is currently investigating possible abuses of dominant position in the market of immunosuppressive medicinal products for different autoimmune diseases. The CNMC suspects that some pharmaceutical companies have implemented an exclusionary commercial strategy in the supply of these medicinal products.

Parallel exports of pharmaceuticals from Spain to other EU countries have raised a number of competition law issues. Rulings in various cases show that, while imposing measures that may impact on parallel trade is not per se illegal, companies must be cautious because of the prohibitions in EU and Spanish law against:

Many companies operate a quota system where a company in Spain, usually part of a multinational group, has a certain amount of product available to distribute to customers based on sales history, to ensure that the local market is properly supplied as required under Spanish law. This approach has been upheld in various cases.

When setting up a quota system, key issues to consider are:

Competition law applies to the licensing of technology and patent agreements, which is very common in the pharmaceutical industry.

The competition issues arising in this area in Spain are the same as in the EU context. The general principles and rules in Regulation (EU) No 316/2014 on technology transfer agreements are commonly referred to when dealing with these agreements.

Analysis of these issues requires a case-by-case approach. Clauses that restrict the commercial freedom of a party do not necessarily restrict competition. Licensing deals frequently lead to substantial economic benefits such as costs savings, enhanced product quality and variety, and improved innovation. All these issues must be carefully considered when assessing the competition implications of the agreement as a whole.

There are no specific statutory restrictions on the licensing or transferring of patents to foreign parties. However, patent applications for inventions that are of interest for state defence are subject to certain restrictions limiting their disclosure.

All patent applications are kept confidential for one month from filing. This period can be extended by the SPTO to four months if the application is of interest for state defence.

Secret patents are registered in a separate, secret register with the SPTO. Secrecy must be maintained for a period of one year from grant. This period can be renewed annually by further terms of one year. The holder of a secret patent can claim compensation for every expired year during which the patent is kept secret.

There are no express statutory restrictions related to transfers of inventions funded, or partially funded, by public entities. However, Law 24/2015 on Patents regulates patents of inventions developed by public institutions, including legal presumptions of ownership, potential remuneration for the inventors, and so on.

A patent or trade mark licence and payment of royalties under it to a foreign licensor does not have to be approved or accepted by a government or regulatory body.

Withholding taxes apply, depending on the country of destination.

A patent or trade mark licence does not have to be in writing to be valid. However, for evidentiary purposes most licences are in written form.

A licence of a Spanish patent or trade mark must be registered to grant active standing to the licensee and to be enforceable against third parties.

Any entity involved in placing goods and services at the disposal of consumers and users must withdraw from the market, suspend marketing, or recover from consumers or users any goods or services that do not meet the necessary conditions or requirements, or which represent a foreseeable risk to personal health or safety on any other grounds (Article 13, Royal Decree 1/2007).

The relevant public authority can order the precautionary or definitive withdrawal or recall of goods or services from the market on the grounds of health and safety (Article 51, Royal Decree 1/2007).

The intentional or negligent supply of defective products can be a criminal offence under the Criminal Code, and the persons responsible can be liable for damages.

The main regulatory authority on the technical aspects, safety, and surveillance of medicinal products is the Medicines Agency. Regional authorities can also perform necessary controls to ensure that the products comply with applicable regulations.

The specific procedure for product recalls of medicinal products is mainly regulated by Royal Legislative Decree 1/2015 and Royal Decree 1345/2007.

The general regime on liability for defective medicinal products is in Articles 128 to 146 of Royal Decree 1/2007.

Actions available under Royal Decree 1/2007 do not affect any other right to damages, including moral damages, that the injured party may have under contract law (based on non-compliance of the goods or services, or non-performance or defective performance of the contract) or other non-contractual liability.

The product liability regime in Royal Decree 1/2007 requires the claimant to prove:

To establish a causal link between the defect and the damage, the claimant must provide clear and substantial evidence of the link, and the damage must be an appropriate and sufficient result of the defect.

Occasionally, the courts may also accept that the causal link can be proven by presumptions or circumstantial evidence.

Disputes over liability can be settled by agreement between the parties. There is no obligation for such settlements to be made public.

Under the product liability regime in Royal Decree 1/2007, liability for a defective medicinal product is borne by the producer, that is:

Any producers responsible for the same damage are jointly and severally liable to the injured party. However, the producer who responded to the injured party can file an action for recovery against the other responsible producers, according to their participation in the damage.

If the producer cannot be identified, the supplier of the product (the distributor or retail supplier) is treated as the producer, unless it informs the injured party within three months of the identity of the manufacturer or the person who supplied the product to it. This rule has been clarified by a judgment of the European Court of Justice of 2 January 2009 (Case C-358/08) and judgments of the Spanish Supreme Court of 21 January 2020 and 20 July 2020.

In addition, the supplier of the defective product is liable to the injured party as if it was the producer if it supplied the product knowing that the defect existed. In this case, the supplier may have a right of recovery against the manufacturer.

Under Royal Legislative Decree 1/2015, manufacturers of medicinal products must take out civil liability insurance or an equivalent financial guarantee to cover damage to health derived from medicinal product safety problems.

In case of undue off-label use of medicinal products, a physician may be subject to general contractual and tort liability.

Under the product liability regime in Royal Decree 1/2007, a producer is not liable if it can prove that the product is not defective because it provides the safety that can legitimately be expected from it, taking all circumstances into account, including the time when the product was put into circulation, its presentation, and the use to which it could reasonably be expected to be put.

The producer is also not liable if it can prove any of the following:

The producer of a part integrated into a finished product is not liable if it can prove that the defect is attributable to the design of the product into which the part was integrated, or to the instructions provided by the manufacturer of the finished product.

The overall civil liability of a manufacturer for damages (death and personal injury) caused by identical products with the same defect is limited to EUR63,106,270.96.

Product liability derived from Royal Decree 1/2007 cannot be excluded or limited contractually. Any clause intended to exclude or reduce such liability is ineffective against the injured party.

The statute of limitation to bring proceedings to recover damages caused by a defective product under Royal Decree 1/2007 is three years from the date the damages were suffered by the injured party, provided that the identity of the liable party is known to the injured party. This period can be interrupted by the injured party by filing a claim before the courts or through an extrajudicial claim, or through an act of acknowledgment by the liable party.

In any case, the right to claim the recovery of damages as provided in the product liability regime of Royal Decree 1/2007 expires ten years after the defective product was placed on the market. The only way to stop this expiration date is to start legal proceedings.

Class actions for product liability claims are allowed but not common in Spain. Product liability claims are most commonly brought in Spain in individual lawsuits.

Article 11 of the Civil Procedural Code 1/2000 allows for collective legal proceedings. Legally constituted associations of consumers and users have standing in court to defend their rights and interests and those of their members, as well as the general interests of consumers and users, without prejudice to the individual legal standing of persons who suffer damage.

The Attorney General's Office also has legal standing to bring actions to defend the collective interests of consumers and users.

An injured party has the right to receive compensation as an economic indemnity for damage caused by a defective product.

The product liability regime in Royal Decree 1/2007 extends to personal injury (including death) and to property damage (if the damage is to goods for private use or consumption that are mainly used by the injured party for those purposes). This can include economic and consequential damage.

Moral damage, damage to commercial property or property intended for professional use, and damage to the product itself are not recoverable under Royal Decree 1/2007. The injured party can claim compensation for such damage under general civil and commercial law. Moral damages can be recovered under general civil law.

Punitive damages cannot be recovered under Spanish law. Only compensatory damages are available. However, the courts have some discretionary powers in awarding compensatory damages, and the defendant's conduct can be expected to have some impact on the amount of damages awarded.