Spain. Distribution and Marketing of Drugs

Pre-conditions for distribution

1.What are the legal pre-conditions for a drug to be distributed within the jurisdiction?

Authorisation

In order to be placed on the Spanish market, drugs must obtain a prior marketing authorisation from the Spanish Medicinal Products and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS) or the European Medicines Agency (EMA) and be registered with the medicines registry within the AEMPS. Before marketing a prescription medicine, the pharmaceutical company must have offered it to the national health authorities for inclusion in the reimbursed medicines public health system.

Drugs can only be sold by pharmaceutical companies holding the appropriate marketing authorisation and their local representatives, or by licensed wholesalers.

Exceptions

As an exception to the requirement of holding a marketing authorisation as a precondition for its distribution in Spain, the AEMPS can authorise the prescription and use (and import, where necessary) of investigational medicines (for compassionate use) or of medicines authorised in countries other than Spain.

2.Do any types of named patient and/or compassionate use programmes operate? If so, what are the requirements for pre-launch access?

Unauthorised medicines can be supplied in special situations (Article 5(1), Directive 2001/83/EC). Accordingly, further to Article 24 of Royal Legislative Decree 1/2015, (approving the revised text of the Law on Guarantees and Rational Use of Medicines and Medical Devices (Medicines Law), as developed by Royal Decree 1015/2009 on the availability of medicines in special situations (Royal Decree 1015/2009)) the Spanish Medicinal Products and Medical Devices Agency  (AEMPS) can authorise:

Access to unauthorised medicines that:

• have been the subject-matter of an application for a marketing authorisation; and
• are undergoing clinical trials.
• Access can be authorised for patients suffering from chronic, severely debilitating or life-threatening conditions that cannot be satisfactorily treated with authorised medicines.
• Access to medicines that are not authorised in Spain, provided that there is no authorised medicine in Spain with the same composition or form and there is no appropriate alternative medicine authorised in Spain (this includes supply shortages).

In both cases, the AEMPS can grant authorisations on a named patient only basis or under a general protocol applicable to a category of patients.

Licensing

3.What is the procedural structure regarding licensing a drug for distribution?

Structure

The national authorisation procedure is regulated by Royal Decree 1345/2007 on the procedure for the authorisation, registration and conditions for dispensation of industrial human medicines and requires the submission of a detailed application that covers all aspects of the medicine and the results of preclinical, clinical and pharmaceutical investigations, as well as relevant expert reports. The documentation is evaluated by the Spanish Medicinal Products and Medical Devices Agency (AEMPS), which can request additional information. The AEMPS issues a reasoned evaluation report that, if unfavourable, is submitted to the applicant before the adoption of the decision.

In accordance with EU law, as implemented in Spain, the AEMPS decision must be issued within 210 calendar days following the submission of a valid application. This term can be extended for three, or, exceptionally, six months, if additional documentation is requested from the applicant.

Regulatory authority

The AEMPS is in charge of granting national marketing authorisations for medicines in Spain and can do so under the national, mutual recognition or decentralised procedures. Drugs can also be licensed by the European Medicines Agency (EMA) (see Question 1).

4.Is there a simplified licence proceeding, or relaxed licensing conditions, for drugs which have already been licensed for distribution in another jurisdiction?

Medicines that have been authorised in another EU member state can be authorised in Spain following the mutual recognition procedure. Additionally, simplified procedures are in place under the Spanish legislation implementing EU Directive 2001/83/EC for:

• Generics of medicines that have been authorised in other jurisdictions for at least eight years (even if not authorised in Spain).
• Active principles that are regarded as having had a "well-established use" in the EU for ten years and are acknowledged as being effective and safe.

See Question 3.

5.Is virtual drug distribution possible from your jurisdiction?

Royal Decree 782/2013 on the Distribution of Medicines (Royal Decree on Distribution) established, for the first time, obligations to be fulfilled by "brokers", that is entities that are involved in the sale and purchase of medicinal products without selling or purchasing the products themselves and without owning or physically handling the medicinal products. The Royal Decree on Distribution is in line with Directive 2011/62/EU of the European Parliament and of the Council, amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use, as regards preventing falsified medicines from entering the supply chain. According to this regulation, brokers must notify their activity to the Spanish Medicinal Products and Medical Devices Agency (AEMPS) and comply with specific obligations concerning:

• Traceability.
• Record keeping.
• Complaints handling.
• Quality management.
• Management of recalls.

Anyway, neither a Spanish marketing authorisation nor a Spanish distribution or brokering authorisation covers the activity of distributing medicines beyond Spain's borders. The necessary authorisations must be assessed based on the legislation of the countries where the marketing and distribution takes place.

6.What is the procedure to appeal (legal remedy) a licensing decision?

As with any other decision taken by a public body, the decisions of the Spanish Medicinal Products and Medical Devices Agency (AEMPS) on medicine marketing authorisations can be challenged. An administrative claim can be filed before the Ministry of Health within one month from the date the AEMPS's decision is notified to the applicant. The decision settling this claim can also be appealed before the contentious-administrative courts within a term of two months from its notification to the claimant.

7.What are the costs of obtaining licensing?

The administrative fees for applying for a medicine marketing authorisation from the Spanish Medicinal Products and Medical Devices Agency (AEMPS) and its subsequent registration are EUR20,529.17. For generics, traditional herbal medicines, homeopathic medicines and medicinal gases, the fees are EUR8,350.71. Additional fees apply to:

Modifications.

• Transfers and renewals of marketing authorisations.
• Certain on-going obligations (such as the submission of periodic safety reports).
• Authorisations for parallel distribution.

Distribution to consumers

8.What are the different categories of drugs for distribution?

Medicines for distribution can be divided into two main categories:

• Prescription medicines.
• Non-prescription medicines (over-the-counter) (OTC) drugs.

Prescription medicines can be classified as:

• Medicines subject to a renewable prescription.
• Medicines subject to a special prescription. These are medicines that:
• contain any amount of a substance considered a narcotic or psychotropic according to international conventions;
• if used incorrectly, may result in a substantial risk of medicine abuse that could ultimately lead to addiction or to other illegal uses; or
• contain any substance that, due to its novelty or properties, must be included in this category for precautionary reasons.
• Medicines subject to restricted prescription, which includes:
• medicines for use in hospitals;
• medicines used in hospital diagnosis and that can only be prescribed by specialist doctors; and
• medicines that are subject to special medical controls.

9.Who is authorised to distribute prescription drugs and over-the-counter drugs to consumers?

Prescription drugs

The distribution of prescription medicines to patients (technically, "dispensing") is reserved by law to:

• Authorised retail pharmacies open to the public.
• Pharmacies in hospitals, health centres, primary healthcare facilities of the National Health Service and medicine deposits (botiquín).

In Spain, only individual pharmacists can own and run retail pharmacies. Retail pharmacies must be in possession of an authorisation granted by the appropriate authority in the autonomous region where the pharmacy is located, which is issued according to a quota system based on geographic location and population.

Over-the-counter drugs

There are no special regulations on over-the-counter (OTC) drugs. The rules for prescription drugs apply to all drugs.

10.What drugs can an attending physician distribute and under what circumstances?

Traditionally, except within the context of healthcare assistance provided at hospitals (whether public or private), attending physicians (for example, those in private individual practice) were prevented from dispensing or applying medicines to patients in Spain.

However, echoing reiterated requests from healthcare professionals, the Royal Decree on Distribution opened a window and instructed the Spanish Medicinal Products and Medical Devices Agency (AEMPS) to compile a list of medicines that can be sold directly to physicians, dental practitioners or chiropodists (among other healthcare professionals) within the framework of their professional activity, so that they can be administered to patients. On 11 March 2015, the AEMPS issued a resolution establishing the medicines that can be acquired by healthcare professionals for use in their clinics or health centres. This list includes, for example, local anaesthesia products used in odontology clinics.

Therefore, further to the Royal Decree on Distribution, healthcare professionals, dental practitioners and chiropodists are now legally entitled to purchase the medicines they need to carry out their activities from retail pharmacies, manufacturers and wholesalers.

11.Who is authorised to prescribe prescription drugs to consumers?

Prescriptions (both public and private) can only be issued by doctors, dental practitioners or chiropodists.

The Law on Guarantees and Rational Use of Medicines and Medical Devices (Medicines Law) states that nurses can indicate the use of, apply and authorise dispensation of non-prescription medicines and the government can pass further regulations on this. Royal Decree 1718/2010 on medical prescription and dispensation orders already establishes that nurses can issue "dispensation orders" for certain prescription medicines once the relevant nurses have obtained the corresponding accreditation. However, the framework within which nurses can carry out such activities (conditions and requirements) has to be further regulated.

Under no circumstances can professionals other than doctors, dental practitioners or chiropodists (for example, pharmacists or nurses) prescribe prescription-only medicines. However, in certain limited circumstances (medicines formally included in "homogeneous groupings" or during shortages) pharmacists can substitute the medicine prescribed by a physician and dispense a different one to the patient.

12. Is direct mailing/distance selling of drugs permitted in your jurisdiction?

Conditions

Direct mailing, distance and online selling of prescription medicines is prohibited (Article 3, Law on Guarantees and Rational Use of Medicines and Medical Devices (Medicines Law)). However, this does allow for sales of non-prescription medicines through these channels, subject to the approval of secondary regulations that define the applicable requirements.

These requirements were defined by Royal Decree 870/2013 of 8 November 2013 on distance selling to the public through websites of non-prescription human use medicines, which establishes the following regarding distance selling through websites:

• Authorised operators are authorised pharmacies that have notified the regional health authorities that they intend to engage in online sales.
• Sales must be made by a pharmacist from his pharmacy and only after appropriate advice has been given to the user.
• Medicine sales can only be made directly from the pharmacy, without any intermediaries.
• No gifts, discounts or bonuses can be given as a means of promoting medicines on a website.

Cross-border sales

Distance selling to purchasers in other EU member states must comply with the above requirements and those applicable under the corresponding local laws.

13. What regulatory authority is responsible for supervising distribution activities?

Spain is divided into seventeen autonomous regions that have broad powers in relation to healthcare matters and are responsible for, among other things, supervising the dispensing of medicinal products (that is, retail supply to patients).

The regional health authorities generally establish their inspection priorities on an annual basis. Inspectors can visit pharmacy premises unannounced and carry out any inspection they deem necessary to monitor compliance with applicable regulations. Among other things, they can:

• Take product samples.
• Request originals and copies of documentation.
• Conduct interviews.

14. What is the procedure to appeal (legal remedy) a distribution decision?

As with any other decision of a public body, the decisions of the regional health authorities regarding dispensation, supervision and licensing (including penalties) can be challenged before a higher administrative body. This appeal must be filed within one month from the date the decision is notified. The decision settling this claim can also be appealed before the contentious-administrative courts within a term of two months from its notification.

15. What are the legal consequences of non-compliance with consumer distribution laws?

The breach of regulations regarding the distribution and dispensation of medicines can result in fines and the amount depends on how serious the infringement is (and could vary from one autonomous region to another). According to the general regulations applicable on a national scale:

• Minor infringements can be penalised with fines ranging from EUR6,000 to EUR30,000. Dispensing expired medicines is an example of a minor infringement.
• Serious infringements can be penalised with fines ranging from EUR30,000 to EUR90,000. Dispensing medicines without holding the relevant authorisation is an example of a serious infringement.
• Very serious infringements can be penalised with fines ranging from EUR90,000 to EUR1,000,000 or even up to five times the value of the products or services involved in the infringement. The distribution of medicines by retail pharmacies to other pharmacies, wholesalers or the shipment of medicines by pharmacies beyond national borders are examples of very serious infringements.

Each level of offence has minimum, standard and maximum penalties, which depend on elements such as:

• Negligence.
• Intention.
• Fraud.
• Connivance.
• Breach of prior warnings.
• Turnover.
• Number of persons affected.
• Harm caused.
• Profits made from the offence.
• Persistence or duration of the breach.
• Recurrence.

Infringements can also be penalised with the confiscation by the Public Treasury (Tesoro Público) of the profits obtained as a consequence of the infringement. For very serious infringements, the establishment or premises can even be closed for up to five years.

Wholesale distribution

16. What is the legal regime regarding wholesale distribution of drugs?

The Royal Decree 782/2013 on the Distribution of Medicines (Royal Decree on Distribution) regulates the obligations of entities involved in the distribution of medicines, including wholesalers and pharmaceutical companies and third parties that undertake distribution activities on behalf of wholesalers and pharmaceutical companies (almacén por contrato).

The Royal Decree on Distribution regulates the brokering of medicines for the first time, establishing the requirements that must be met by those involved in the distribution chain but that do not acquire or physically handle medicines (see Question 5).

Wholesale distributors of medicines and medical substances that supply pharmacies require the prior authorisation of the health authorities of the autonomous region in which their main place of business is located. Wholesale distributors must also notify their activities to the health authorities of all autonomous regions in which they carry out these activities.

The Royal Decree on Distribution further develops Article 67 of the Law on Guarantees and Rational Use of Medicines and Medical Devices (Medicines Law), acknowledging that medicines can be distributed by wholesale distributors or directly by the holder of the marketing authorisation. The health authorities and the courts have repeatedly and expressly stated that the commercialisation of medicinal products through wholesalers is free and voluntary, and pharmaceutical companies can, if they so decide, operate without the services of intermediary wholesalers and directly supply pharmacies and hospitals. Both pharmaceutical companies that supply their products directly and wholesalers are subject to certain public service obligations for the medicines that they distribute.

The Royal Decree on Distribution details the basic obligations of entities involved in the distribution of medicines (be it wholesalers or pharmaceutical laboratories that carry out distribution activities). Supplying pharmacies in the national territory is established as the priority and the essential function of these entities, which must ensure that all orders are delivered to pharmacies and other pharmaceutical services within 24 hours.

The Royal Decree on Distribution also establishes a restriction with unquestionable practical significance: wholesalers can only accept returns from pharmacies and pharmaceutical services if they previously supplied the relevant medicines directly to the returning entity. This restriction has been imposed to tackle a rather widespread practice that hindered the traceability of medicines.

Medicines can only be purchased from and distributed to entities that are legally authorised to acquire them (that is, pharmaceutical wholesalers, pharmacies and hospitals).

The Royal Decree on Distribution also reinforces the control, monitoring and pharmacovigilance measures that must be put in place if third parties are engaged to perform parts of the distribution activity.

17. What regulatory authority is responsible for supervising wholesale distribution activities?

The same supervisory authority, inspection procedures and decision making processes apply as for dispensation activities. See Question 13.

18. What are the legal consequences of non-compliance with wholesale distribution laws?

Distributing medicines without holding the necessary authorisation or to those not authorised to purchase them are considered serious administrative infringements. Distributing medicines without observing the applicable conditions is considered a very serious infringement. The same penalties apply as for infringements by pharmacies (see Question 15).

Marketing

Promotion

19. What is the general legal regime for the marketing of drugs?

Legal regime

The statutory and self-regulatory frameworks are generally fairly restrictive in terms of pharmaceutical companies' promotional activities and their interactions with healthcare professionals.

The main regulations governing the promotion of medicines in Spain are contained in the Law on Guarantees and Rational Use of Medicines and Medical Devices (Medicines Law) and Royal Decree 1416/1994, which governs the advertising of medicines for human use (Royal Decree on Advertising), in line with Directive 2001/83/EC.

The Ministry of Health and the autonomous regions of Madrid and Catalonia (where most Spanish pharmaceutical companies are based) have approved guidelines on certain provisions of the Royal Decree on Advertising in relation to promotional activities.

With the promotion of medicines addressed to healthcare professionals, the main purpose of these regulations is to ensure that healthcare professionals are not influenced in an improper way by their relationships with any pharmaceutical company when performing their duties (particularly when prescribing or administering medicines).

To guarantee independence, the notion of "promotion of medicines" for the purpose of these regulations comprises, among other things:

• Promotion addressed to persons qualified to prescribe or dispense medicines.
• Sales calls by sales representatives to healthcare professionals (visitas médicas).
• Sponsoring promotional meetings and scientific meetings.
• Bearing associated travel and hotel expenses and offering or granting certain types of benefits.

Limits to marketing activities

The main limits to marketing activities under the current legal framework are the following:

• Only specific categories of medicines can be advertised to the public (see Question 21).
• All elements of the promotion of a medicine must be compatible with the approved summary of product characteristics (SPC) and must favour its rational use, present it in an objective manner and without exaggerating its properties. Promotional materials must provide the technical information necessary for the reader to be in a position to independently assess the therapeutic value of the medicine and must include the essential information on the product according to the information contained in the SPC.
• The autonomous regions' guidelines are very detailed and regulate, for example:
• the use of certain terminology or phrases;
• how to reproduce bibliographic references in promotional materials;
• how to manage the delivery of information that refers to indications or characteristics not contained in the SPC approved in Spain ("off-label" information) in international scientific meetings.
• The purpose of the visits by medical sales representatives (sales calls) must be to provide objective and technical knowledge. Medical sales representatives must be given adequate training and have sufficient scientific knowledge to be able to provide information that is as precise and as complete as possible about the medicines that they are promoting. Medical sales representatives must also relay any information about the use of the medicinal products they advertise and, in particular, adverse reactions, to the relevant department within the pharmaceutical company. Some autonomous regions have restricted the number and frequency of these visits.
• Essentially, promotional materials (including both published advertising and brochures given to healthcare professionals during visits by medical sales representatives) should be scientific. They must be notified to the regional authorities before their distribution, attaching an express declaration that they have been reviewed by the appropriate department of the pharmaceutical company and that they are compatible with the information contained in the SPC.
• No incentives, discounts, rewards or gifts can be offered by those who have direct or indirect interests in the production, manufacture or commercialisation of medicines to healthcare professionals involved in the prescription, dispensation and administration of medicines or any of their relatives. Not only physicians, but also pharmacies (as healthcare establishments) fall under the scope of this prohibition as, according to the law, they can only be owned and run by individual pharmacists (who are considered healthcare professionals). The Royal Decree on Advertising clarifies that this prohibition is not an impediment to pharmaceutical companies offering reasonable hospitality within the framework of professional scientific meetings.

By way of exception, wholesalers are expressly allowed to offer "volume and prompt payment discounts" to pharmacies, provided that all of the following conditions are met (Article 4.6, Medicines Law):

• For reimbursed medicines (therefore excluding, among others, non-prescription medicines), the discount cannot exceed 10% of the price.
• The discount does not encourage the purchase of a particular product over competing products.
• The discount is properly reflected in the relevant invoice.

 20. Are there other codes of conduct for the marketing of drugs (for example, by professional or industrial organisations)?

Self-regulation has further interpreted and elaborated the general regulations (see Question 19). In 1991, the Spanish Pharmaceutical Companies Trade Association (Asociación Nacional Empresarial de la Industria Farmacéutica; Farmaindustria) approved the Code of Good Practice for the Pharmaceutical Industry (the Code), which has subsequently been amended on a number of occasions, most recently in June 2014.

The scope of the Code covers promotional practices (see Question 19) except for those linked to commercial transactions by pharmaceutical companies with wholesalers, pharmacies or hospitals. However, the Code regulates other kinds of interactions with healthcare professionals that could result in any kind of payment being made, such as services agreements or the performance of observational studies. The Code also sets out detailed rules regarding:

• The contents of promotional documentation.
• Pecuniary or in kind benefits granted to healthcare professionals.
• Hospitality and meals.
• Consulting arrangements and other types of relationship that could result in payments being made to doctors (which must be reasonable, adjusted to market value and documented in writing).
• The performance of observational studies (which cannot be aimed at promoting the prescription or use of a given medicine and where the involvement of sales representatives is limited to purely logistical aspects).

The 2014 version of the Code has also incorporated the transparency rules adopted by the European Federation of Pharmaceutical Industry Associations (EFPIA) in the Code on disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organisations. These rules provide for the disclosure of any "transfers of value" by pharmaceutical companies to healthcare professionals and healthcare organisations. The first reporting period is 2015.

The Code must be observed by all pharmaceutical companies that are members of Farmaindustria. Although the Code is not binding, it is considered a useful tool to help interpret and flesh out the regulations in force.

Accordingly, the regulations contained in the Code, including its Implementation Guidelines and the FAQ Brochure, have been expressly endorsed by certain healthcare authorities, which have in some instances made adherence to the Code a prerequisite for pharmaceutical companies to be allowed to carry out certain promotional activities in their territories (particularly, sales calls). Despite the voluntary nature of the Code, there are cases where the courts have also relied on the Code to interpret more generic mandates set out in laws and regulations.

Marketing to consumers

21. What is the legal regime for marketing to consumers?

Legal regime

Consumer advertising is regulated in Article 80 of the Law on Guarantees and Rational Use of Medicines and Medical Devices (Medicines Law) and the Royal Decree 1416/1994, which governs the advertising of medicines for human use (Royal Decree on Advertising). Further to a recent amendment to the Medicines Law, advertising to consumers no longer requires prior authorisation.

Advertising must include the following:

• The name of the medicine.
• The essential information needed to encourage its rational use.
• A specific message advising consumers that they should read the information leaflet and consult their pharmacist if in doubt.

In any event, the promotional nature of the message and the fact that it refers to a medicine must be clearly stated.

Advertising aimed at consumers cannot refer to recommendations of scientists, healthcare professionals or other persons that could:

• Encourage the consumption of medicines.
• Suggest certainty as to the product's effects, lack of side-effects or enhanced efficacy as opposed to other treatments.
• Infer that the use of the medicine may improve health or boost sporting performance.

Advertising addressed exclusively or primarily to children is not allowed.

Guidelines on the advertising of medicines to the public issued by the Ministry of Health provide additional detailed information on the permitted content in advertising messages aimed at the general public. According to these guidelines, comparative advertising is only allowed for medicines that belong to the same pharmaceutical company and they cannot suggest that the effect of a medicine is equal to or better than that of a different treatment or medicine.

Products

Advertising to consumers is only allowed for medicines that:

• Are not included in the public reimbursement system.
• Are not subject to medical prescription.
• Do not contain narcotic or psychotropic substances.

22. What kinds of marketing activities are permitted in relation to consumers and the products which may be advertised to them?

Advertising can take the form of inserts in published, audiovisual or online media (newspapers, radio, TV or the internet), leaflets and outdoor advertising.

23. Is it permitted to provide consumers with free samples? Are there particular restrictions on special offers (for example, "buy-one-get-one-free")?

Pharmacies cannot provide free samples to consumers.

With special offers, pharmacies can only apply discounts of up to 10% of the retail price, and only in relation to medicines that can be advertised to the public. No other offers are allowed.

24. Are there particular rules of practice on the use of the internet/social media regarding drugs and their advertising?

There are no specific rules on the use of the internet or social media for medicines and their advertising. This practice is subject to the general rules governing the advertising of medicines to the public. Conversely, companies must ensure that promotional materials on medicines that are to be advertised solely to healthcare professionals are only accessible to them and not to the general public. It is generally considered that websites for healthcare professionals must be password protected and that the healthcare professionals must previously evidence their status as such.

25. What regulatory authority is responsible authority is responsible for supervising marketing activities to consumers?

Regulatory authority

The healthcare authorities of each autonomous region are in charge of supervising marketing activities aimed at consumers.

Supervision

Supervision is basically carried out through the monitoring of promotional materials aimed at consumers to ensure that their contents comply with regulatory requirements and that they respect the technical and scientific conditions imposed in marketing authorisations. The healthcare authorities can also limit, condition or prohibit the advertising of medicines to consumers on safety or public health grounds.

In addition to the monitoring measures, each year pharmaceutical companies must submit a list of all the marketing activities they have carried out to the authorities. This applies both to consumer marketing activities as well as to promotional activities addressed to healthcare professionals (see Question 32).

The healthcare authorities can impose sanctions for infringing advertising and can, through a reasoned decision, request the cessation or rectification of any advertising considered misleading that poses a risk to health and safety or otherwise infringes applicable regulations. They can also request the suspension of the advertising if it poses an immediate and extraordinary risk to health.

Rights of appeal

All decisions of the health authorities on these matters can be appealed before the relevant higher administrative body and ultimately before the courts.

26. What are the legal consequences of non-compliance with consumer marketing laws?

Advertising medicines in breach of applicable regulations constitutes a very serious administrative infringement that can be sanctioned with fines ranging from EUR90,000 to EUR1 million or even up to five times the value of the products or services involved in the infringement and the confiscation by the Public Treasury (Tesoro Público) of unlawful profits obtained as a consequence of the infringement. For very serious infringements, the registered office or company premises can also be closed for up to five years.

Marketing to professionals

27. What kinds of marketing activities are permitted in relation to professionals?

The applicable regulations specifically refer to the following types of promotional activities aimed at healthcare professionals:

• Documentary advertising.
• Distribution of free samples.
• Visits by sales representatives.
• Sponsorship of scientific or promotional events.

Generally, "promotion" means any offer of information, prospection or encouragement regarding the prescription, supply, sale, administration or consumption of medicinal products. This definition is construed broadly, and any information provided by a pharmaceutical company that directly or indirectly refers to branded or unbranded medicinal products can be considered promotional, and is therefore subject to the rules and restrictions on the promotion of medicines.

For example, publications in the form of "expert opinions", "expert interviews", "sections", "lines of treatment" or "current situation in the treatment of…" published in any format are considered promotional if there is a specific, direct or indirect contractual relationship between the pharmaceutical company that holds the marketing authorisation of the relevant medicine and the author or the company responsible for the publication and are therefore subject to all regulations governing promotion.

28. Are there any restrictions on marketing to professionals?

Marketing activities

"Independence guarantees" apply to the prescription and dispensation of medicines (Article 4, Law on Guarantees and Rational Use of Medicines and Medical Devices (Medicines Law)). These guarantees prohibit the direct or indirect offer of any incentives by those that have a direct or indirect interest in the manufacture or commercialisation of medicines to healthcare professionals involved in the prescription or dispensation of the same.

The Code of Good Practice for the Pharmaceutical Industry (the Code) prohibits gifts to healthcare professionals, except for those related to the practice of medicine or consisting of stationery items provided that:

• They do not relate to a prescription-only medicine.
• They are worth no more than EUR10.

The direct or indirect provision of information or educational materials to healthcare professionals is also limited under the Code. For materials to be compliant with the Code, they must:

• Be inexpensive (that is worth less than EUR60).
• Relate to the practice of medicine or pharmacy.

Enhance patient care.

• With items of medical utility, they must:
• Be inexpensive (that is worth less than EUR60).
• Not alter routine professional practices of the recipient.

Non-interventional studies are allowed in Spain (and are specifically regulated), provided that they are not used as a tool to increase the prescription or sale of a particular medicine. Therefore, they should not be considered or used as marketing tools.

The same applies to the engagement of healthcare professionals to provide services to a pharmaceutical company or to grants and charitable contributions made by a pharmaceutical company to entities formed by healthcare professionals or engaged in the provision of healthcare assistance or research. Even though these rules are not expressly contemplated in the applicable regulations, they clearly stem from the spirit of the same and have been expressly included in the Code.

Frequency

Some autonomous regions have regulations limiting the number, duration and frequency of sales calls by sales representatives to healthcare professionals. Some of these regulations have established a quota of visits per pharmaceutical company and year (for example, four yearly visits to each healthcare centre), while others merely establish specific days and times when calls are allowed. Some regions require that sales calls be made collectively to panels of doctors.

It appears that enforcement of these restrictions is generally quite relaxed. Some of these regional regulations have also been annulled by the courts on the basis of formal infringements.

Provision of hospitality

The Royal Decree 1416/1994, which governs the advertising of medicines for human use (Royal Decree on Advertising) clarifies that the prohibition on gifts is not an impediment to pharmaceutical companies offering reasonable hospitality within the scope of scientific meetings, provided that the hospitality is reasonable and secondary to the main purpose of the meeting and does not extend to persons other than the healthcare professionals themselves.

The Code provides very detailed guidelines on how much hospitality is allowed within the scope of scientific meetings, including venue selection, hotel categories, entertainment programmes and duration:

Hospitability must be limited to the payment of travel, registration and maintenance expenses, which must be reasonable and not disproportionate and limited to the days when the scientific meeting is taking place. Hospitality is considered "reasonable" if its cost does not exceed what recipients would normally be prepared to pay for themselves in the same circumstances.

Expenses must be paid for directly by pharmaceutical companies. Travel grants in cash or the reimbursement of expenses in cash are not allowed, except for minor travel expenses (for example, taxi fares). This means that expenses can be paid by the pharmaceutical company but only directly to the supplier of the services.

Hospitality must always be secondary to the main purpose of the meeting so the scientific goals must constitute the main focus of the organisation of the meetings. Social or cultural aspects can never take precedence over scientific issues.

Hospitality must not extend to persons other than healthcare professionals that qualify as participants in the meeting in their own right. Spouses or other companions cannot attend these events even if they pay their own expenses.

Pharmaceutical companies cannot directly or indirectly pay physicians or groups of physicians the cost of renting rooms to be used for meetings unless it is evidenced that the payments are made to lease rooms for this purpose.

Scientific goals must be the main focus of the meetings, and social or cultural aspects cannot interfere or prevail over scientific issues. The scientific content of congresses and meetings should occupy at least 60% of each working day (presuming an eight-hour working day, excluding travel time). Cultural or social events must not coincide with the scientific programme. Hospitality provided by a pharmaceutical company must never include the sponsorship or organisation of leisure events (for example, sports or entertainment).

Healthcare professionals must not be remunerated merely for attending the event. Only speakers and moderators can be paid reasonable fees.

Generally, pharmaceutical companies cannot organise or promote events to be held outside Spain (international events) when the majority of attendees practise in Spain, unless an international location proves to be more convenient from a logistical standpoint.

The fact that the meeting is sponsored by a pharmaceutical company must be clearly disclosed in all documents relating to the meetings.

29. What information is it legally required to include in advertising to professionals?

Promotional materials addressed to healthcare professionals must include:

Essential information on the product, in line with the summary of product characteristics (SPC), including:

• its name;
• composition;
• full clinical data;
• incompatibilities;
• side effects and contraindications;
• instructions for use and handling; and
• the name and address of the holder of the marketing authorisation.
• The date on which the information was created or last reviewed.
• The different presentations, dosages and forms.
• The prescription and dispensation conditions of the product.
• The selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies and, where possible, information on the cost of the treatment.

Advertising for the sole purpose of reminding people of the product's name is exempted from these rules. However, reminder advertising is only allowed once the product has been authorised for at least two years.

30. Are there rules on comparisons with other products that are particularly applicable to drugs?

Comparative advertising is generally governed by the principles contained in unfair competition and advertising regulations. The guidelines issued by the Ministry of Health and some autonomous regions concerning the advertising of medicines have also introduced specific rules:

Comparative advertising that suggests that the effect of a medicine is equal to or better than that of a different treatment or medicine is not allowed.

A comparison must be scientifically evidenced and must refer to medicines of comparable safety and efficacy and equivalent therapeutic effect.

Sources of the data used must be readily available to the health authorities (and, according to the Code of Good Practice for the Pharmaceutical Industry (the Code) to competitors).

Relevant information (such as the statistical relevance of results) cannot be omitted.

Results from different studies cannot be compared in the same graph or chart, unless a meta-analysis has been conducted.

31. Is it permitted to provide professionals with indirect incentives?

There is a general prohibition set out in Article 4.6 of the Law on Guarantees and Rational Use of Medicines and Medical Devices (Medicines Law) on the direct and indirect offering of any incentives (including bonuses, discounts, premiums and gifts) by those that have a direct or indirect interest in the manufacture or commercialisation of medicines to healthcare professionals involved in the prescription or dispensation of the same.

Discounts

As an exception to the general prohibition on all incentives and discounts, wholesalers are expressly allowed (this is understood to include pharmaceutical companies that engage in the direct distribution of their products) to offer pharmacies volume and prompt payment discounts, provided that (Article 4.6., Medicines Law):

• They do not encourage the prescription of a particular product instead of a competing product.
• The discounts are properly reflected in the relevant invoice.

In any event, with reimbursed medicines, these discounts cannot exceed ten per cent of the regular price of the medicine.

Free samples

Samples can only be offered during the first two years following the granting of the medicines' marketing authorisation. Each healthcare professional can be offered a maximum of ten samples per year (unless otherwise stated by the relevant authority).

Samples cannot be larger than the smallest presentation of the medicine, must be labelled "free medical sample – not for sale" and cannot bear the reimbursement label.

Delivery of samples must include the authorised summary of product characteristics (SPC) and information on price, reimbursement conditions and, whenever possible, the estimated cost of treatment. Companies must have an adequate system in place to control and keep track of the samples distributed.

Sponsorship of professionals

Prizes, scholarships, contributions and financial assistance to attend meetings, congresses and similar activities are allowed provided that they relate exclusively to scientific activities and do not represent an incentive for the recommendation, prescription, purchase, supply, sale or administration of medicines. Sponsoring healthcare professionals' attendance at scientific events is allowed subject to the hospitality rules (see Question 28).

When meetings, congresses, symposia and similar events are sponsored by pharmaceutical companies, that fact must be disclosed in all of the papers relating to the meetings and in any published paper, speech or document related to such meetings.

Also, according to the Code of Good Practice for the Pharmaceutical Industry (the Code), when any kind of prizes are given, the rules governing the prizes must be publicly available and indicate, among other things:

• The entities organising or sponsoring the prize.
• The conditions for participation.
• Dates.
• Type and amount of the prize.
• The entity responsible for selecting the winners.
• Other indirect incentives

Direct and indirect incentives are prohibited (see Question 28). However, the Code allows objects such as medical or pharmaceutical books or other materials on optical, magnetic, electronic or similar media to be given to healthcare professionals. The provision of other gifts (whose value exceeds EUR10 or which are not of a scientific or technical nature) is not allowed. The direct or indirect provision of portable electronic devices for personal use, even if they may also have a professional use, is also not permitted.

32. What regulatory authority is responsible for supervising marketing activities regarding professionals?

Regulatory authority

The health authorities of each autonomous region are in charge of supervising consumer marketing activities.

Supervision

With marketing to healthcare professionals, pharmaceutical companies must submit a copy of all promotional materials they use (including printed or audiovisual) to the healthcare authorities at the time of their publication or release, indicating:

• Who they are aimed at.
• How they will be published.
• The date they will be first released.

Each year pharmaceutical companies must also submit a list of all the marketing activities they have carried out to the healthcare authorities.

The healthcare authorities can impose sanctions on infringing advertising and can, through a reasoned decision, request the cessation or rectification of any advertising:

• Considered misleading.
• That poses a risk to health and safety.
• That otherwise infringes applicable regulations.

They can also request the suspension of advertising if it poses an immediate and extraordinary risk to health.

Rights of appeal

Any decisions of the health authorities on these matters can be appealed before the relevant higher administrative body and ultimately before the courts.

33. What are the legal consequences in case of non-compliance with professional marketing laws?

Advertising medicines in breach of applicable regulations constitutes a very serious administrative infringement with various consequences (see Question 26).

The offering of bonuses, premiums, incentives, gifts or discounts linked to the promotion or sale of medicines to the public also qualifies as a very serious infringement with the same consequences.

The infringement of requirements imposed by autonomous regions regarding visits to healthcare professionals is a minor infringement that can be sanctioned with fines ranging from EUR6,000 to EUR30,000. Finally, the offering or granting of unlawful gifts or incentives to healthcare professionals in the framework of the promotion of medicines qualifies as a serious infringement, which can be sanctioned with fines ranging from EUR30,000 to EUR90,000.

Engagement with patient organisations

34. What kinds of activities are permitted in relation to engagement with patient organisations? What are the restrictions that are imposed on relationship with patient organisations?

There are no specific regulations on interactions between the pharmaceutical industry and patient organisations.

The law foresees certain "incentives for patronage", which are tax benefits applicable to donors when contributions are made to entities considered "beneficiaries of patronage". Associations that have been declared to be of public interest (declaración de utilidad pública), which is the case of most patient organisations, are considered "beneficiaries of patronage". These contributions could be channelled through donations, or through collaboration agreements, where the organisation receives funds to be used for its public interest activities and undertakes to disclose the financial assistance received from the grantor for these activities.

In 2014, Farmaindustria incorporated provisions in the Code of Good Practice for the Pharmaceutical Industry (the Code) on interactions between the pharmaceutical industry and patient organisations (that previously were the subject matter of another code specifically aimed at patient organisations). The Code sets out certain rules and standards aimed at guaranteeing the independence of these organisations and the transparency of their interactions with the industry. The Code expressly contemplates, in addition to the provision of financial support:

• Contracts under which patient organisations provide pharmaceutical companies with services related to healthcare or research.
• The engagement of patient organisations as experts and advisors for services such as participating in advisory board meetings and speaking at meetings or events.
• The sponsorship of events organised by patient organisations.
• The provision of hospitality in events organised by the patient organisation or by the pharmaceutical company.

According to the Code:

Collaboration between pharmaceutical companies and patient organisations must be documented in a written agreement that covers:

• the activities to be carried out;
• the amount and sources of funding;
• the purpose of funding;
• relevant indirect support;
• any other type of significant non-financial support.
• Pharmaceutical companies must not seek to influence the text of a patient organisation's materials that they sponsor. This does not mean that companies cannot correct factual inaccuracies.
• Arrangements that cover consultancy or other services must be documented in writing. A legitimate need for the services must have been clearly identified and documented in advance and the criteria for selecting services and their providers must be directly related to the identified need and assessed by persons who have the expertise necessary to evaluate whether the particular experts and advisors meet those criteria. The contracting company must keep a record of, and make appropriate use of, the services. Compensation for the services must be:
• based on market criteria;
• proportionate to the time dedicated, the work done and the responsibilities assumed;
• properly documented.
• Companies must also publish a list of patient organisations with which they have engaged to provide remunerated services.
• Generally with hospitality, the standards established in the Code on interactions with healthcare professionals must be observed. Companies must pay all expenses to patient organisations and never directly to patients on an individual basis.

Reform

35. Are there any plans to reform the law on the distribution and promotion of drugs in your jurisdiction?

No noteworthy changes are expected in the near future concerning the law on the distribution and promotion of drugs.