1. PRECONDITIONS FOR DISTRIBUTION
1.1 What are the legal preconditions for a drug to be distributed within the jurisdiction? Does the drug need to be licensed (authorised) for distribution? Are there exceptions or different categories?
In order to be placed on the Spanish market, drugs must obtain a prior marketing authorisation from the Spanish Agency on Medicinal Products and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) or the European Medicines and Medical Devices Agency (EMEA). Before marketing any medicine, companies must follow the reimbursement and pricing procedures with the national health system.
As an exception to the above, the AEMPS may authorise the prescription and use (and import, where necessary) of investigational medicines (compassionate use) or of medicines authorised in countries other than Spain.
1.2 Are any kinds of named patient and/or compassionate use programs in place? If so, what are the requirements for pre-launch access? (for EU countries only: has Article 5 (1) of Directive 2001/83/EC been transposed by your national legislator?)
Article 5(1) of Directive 2001/83/EC was transposed into Spanish law by Article 24 of Law 29/2006 on the Guarantees and Rational Use of Medicines and Medical Devices (the Medicine Law), and further developed by Royal Decree 1015/2009 on the availability of medicines in special situations (Royal Decree 1015/2009).
According to this regulation, the AEMPS may authorise:
access to non-authorised medicines that (i) have been the subject-matter of an application for a marketing authorisation, or (ii) are being subject to clinical trials. This use may be authorised for patients suffering from chronic, severely weakening or life threatening conditions, which may not be satisfactorily treated with an authorised medicine;
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.
In either case, the AEMPS may grant its authorisations on a named patient basis, or under a general protocol applicable to an undetermined group of patients.
1.3 What is the structure of the procedure regarding licensing a drug for distribution? Which national body (agency) is responsible for licensing?
The AEMPS is in charge of granting marketing authorisations for medicines in Spain. The 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, through an official form including all the details of the medicine and the results of the preclinical, clinical and pharmaceutical investigations conducted, as well as the relevant expert reports. The documentation will be evaluated by the AEMPS, which may request additional evidence. The AEMPS will issue a reasoned evaluation report which, if unfavourable, will be submitted to the applicant prior to 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, but this term may be extended if additional documentation is required from the applicant, for three or, exceptionally, six additional months.
1.4 Is there a simplified license proceeding or are there relaxed licensing conditions for drugs which have already been licensed for distribution in another jurisdiction? What about parallel imports, is there a simplified procedure for these?
Medicines that have been authorised in another EU member state may be authorised in Spain following the mutual recognition procedure. Simplified procedures are in place under the EU Directive 2001/83/EC, as implemented by Spanish legislation, for generics of medicines that have been authorised in other jurisdictions for at least eight years (even if not authorised in Spain), and for active principles of well established use. Please see EU Laws section for details.
As regards parallel imports, this activity is subject to specific authorisation by the AEMPS. The applicant will need to show, among other things, that the medicine in question has the same composition as the medicine authorised in Spain or, if different, that the differences are insignificant from a health perspective. Moreover, if any conditioning, packaging or re-labelling activity is to be carried out in Spain, the applicant will need to be an authorised pharmaceutical manufacturer. If these activities are not to be carried out, the applicant will need to be an authorised pharmaceutical distributor.
1.5 Is it possible to distribute drugs ‘virtually’ from your jurisdiction (i.e., the physical products never enter the country but are distributed using the authorization obtained in your country).
Neither the marketing authorisation of a medicine obtained in Spain nor the distribution authorisation obtained in Spain would cover products not marketed in Spain or distribution activities carried out beyond Spanish borders. The necessary authorisations should be assessed based on the legislation of the countries where those activities are carried out.
A draft royal decree on the Distribution of Medicines that is currently going through the approval process [Note: it would not be strictly correct to refer to legislation, as the decree does not have the force of a law, and is part of the adminsitrative regulatory process] refers, for the first time, to certain obligations for entities that are involved in the sale and purchase of medicinal products without selling or purchasing the products themselves, and without owning and physically handling the medicinal products (brokering). This draft 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 the prevention of the entry into the legal supply chain of falsified medicinal products. According to this regulation, entities brokering medicinal products will be subject to certain provisions applicable to wholesale distributors, as well as to specific provisions applicable to brokering. These obligations refer to registration with the health authorities, traceability, record keeping, complaints handling, quality management and management of recalls.
1.6 Is there a legal remedy (appeal) against licensing decisions?
As with any other administrative decision, the decisions of the AEMPS on the marketing authorisation of medicines may be challenged before the administrative courts.
1.7 What are the costs of obtaining licensing?
The administrative fees payable for the procedure for the application of a marketing authorisation of a medicine from the AEMPS and its registration are EUR 20,325.91. For generics, traditional herbal medicines, homeopathic medicines, and medicinal gases the fees are EUR 8,268.03. Changes to a marketing authorisation, transfers and renewals, certain ongoing obligations (such as the submission of periodic safety reports) and the authorisation for parallel distribution also entail specific fees.
2. DISTRIBUTION TO CONSUMERS
2.1 What are the different categories of drugs for distribution?
Medicines for distribution can be divided into two main categories: (i) prescription medicines, and (ii) non-prescription medicines.
Prescription medicines may, in turn, be classified as:
medicines subject to a renewable prescription;
medicines subject to a special prescription. Medicines subject to this regime will be those that: (i) contain any amount of a substance considered a narcotic or psychotropic according to international conventions; (ii) if used incorrectly, may result in a substantial risk of medicine abuse that could ultimately lead to addiction or to other illegal uses, or; (iii) contain any substance which, due to its novelty or properties, should be included in this category for precautionary reasons;
medicines subject to restricted prescription. This category includes: (i) medicines for use in hospitals; (ii) medicines used in hospitals’ diagnosis and that need to be prescribed by specialist doctors; and (iii) medicines that require specific medical control.
2.2 Who is entitled to distribute prescription drugs to consumers? What authorization do they require?
The dispensing of medicines to patients is reserved to:
legally authorised retail pharmacies open to the public; and
the pharmacy departments of hospitals, health centres and primary care structures of the National Health System.
Only individual pharmacists can own and run retail pharmacies. In addition, the establishment of retail pharmacies is subject to the authorisation of the relevant authority of the autonomous region in which it is located, and subject to a quota system based on geographic location and population.
2.3 Who is entitled to distribute over-the-counter drugs to consumers?
The distribution of over the counter drugs to the public is also reserved to legally authorised retail pharmacies and hospitals.
2.4 Which drugs may be distributed by the attending physician, and under what circumstances?
Except within the framework of healthcare assistance provided at hospitals (whether public or private), attending physicians (e.g., those in private individual practice) are not entitled to distribute or administer medicines to patients.
The draft royal decree on the distribution of medicines for human use currently going through the approval process (see question 1.5) addresses this matter for the first time. According to the draft, healthcare professionals and dental practitioners would be entitled to purchase from retail pharmacies (but not from manufacturers or wholesalers) the medicines they need to carry out their activities.
2.5 Who may prescribe prescription drugs to consumers?
Public or private medical prescriptions can only be issued by doctors, dental practitioners or chiropodists.
The Medicine Law states that nurses may be authorised to apply and use certain prescription medicines, although the framework within which they may do so will be specifically set out in developing regulations. To date, these regulations have not yet been enacted, except by a Decree issued by the region of Andalucía (which is, however, under appeal before the courts for alleged invasion of state powers).
In 2011, the Ministry of Health published a draft royal decree on the regulation of the prescription, use and authorisation to provide medicines and medical devices for human use by nurses. This draft states that nurses may perform these activities in accordance with applicable guidelines and protocols which should be published by the Quality Agency of the national health system.
2.6 Is direct mailing/distance selling of drugs permitted? Under what conditions, by whom, and to whom? Might sales be made beyond the borders of your country?
Direct mailing, distance or online selling of prescription medicines is prohibited under Article 2 of the Medicine Law. This provision also states that regulations will be developed that will set out the conditions under which non-prescription medicines can be sold through these channels, provided that at all times those sales are made by an authorised retail pharmacy and that the professional intervention and advice of a pharmacist is guaranteed. No regulation in this regard has to date been enacted.
2.7 Which body (agency) is responsible for supervising distribution activities regarding consumers? How is supervision implemented? Is there a legal remedy (appeal) against decisions?
The health authorities of the autonomous regions (Spain is divided into 17 autonomous regions) are in charge of supervising the dispensing of medicinal products (i.e., retail supply to patients). They generally determine their inspection priorities annually. Inspectors may visit the relevant pharmacy premises unannounced and carry out any inspections deemed necessary to monitor compliance with the applicable regulations. They may take product samples, request the originals and copies of documentation, conduct personal interviews, etc.
Any decisions of the health authorities (including penalties) may be challenged before a higher administrative body and, ultimately, before the courts.
2.8 What are the legal consequences in case of non-compliance?
The breach of regulations regarding the distribution and dispensation of medicines may results in fines, the amount of which will depend 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 may be penalised with fines ranging from EUR 6,000 to EUR 30,000. Hindering the inspections of the relevant authorities is an example of a minor infringement;
serious infringements may be penalised with fines ranging from EUR 30,000 to EUR 90,000. Dispensing medicines without being in possession of the relevant authorization is an example of a serious infringement;
very serious infringements may be penalised with fines ranging from EUR 90,000 to EUR 1,000,000 or even up to five times the value of the products or services subject-matter of 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, benefits gained through the offence, persistence or duration of the risks and recurrence.
Infringements may also be penalised with the confiscation by the Public Treasury (Tesoro Público) of the unlawful profits obtained as a consequence of the infringement. For very serious infringements, the establishment or premises may even be temporarily closed for up to five years.
3. WHOLESALE DISTRIBUTION
3.1 What is the legal regime regarding wholesale of drugs? Under what conditions, by whom, and to whom is wholesale of drugs permitted?
According to Article 68 of the Medicine Law, medicines may be distributed by wholesale distributors or directly by the manufacturer holding the marketing authorisation.
The Spanish health authorities and the courts have repeatedly expressly recognised that the commercialisation of medicinal products through wholesalers is free and voluntary, and pharmaceutical companies may, if they so decide, operate with or without the use of services of intermediary wholesalers, and directly meet the demand of pharmacies. Both pharmaceutical companies who supply their products directly, and wholesalers, are subject to certain public service obligations with respect to the medicines that they distribute.
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. Moreover, wholesale distributors must notify their activities to the health authorities of all autonomous regions in which they carry out these activities. In addition, both wholesale distributors and manufacturers holding the marketing authorisation must directly notify the Spanish Agency for Medicinal Products and Medical Devices of the start of their distribution activities.
Finally, medicines may only be distributed to entities that are legally authorised to acquire them (pharmaceutical wholesalers, pharmacies and hospitals).
As mentioned in question 1.5 a draft royal decree on the distribution of medicines for human use is underway, which also includes, for the first time, certain obligations for entities that are involved in the sale and purchase of medicinal products without selling or purchasing the products themselves, and without owning and physically handling the medicinal products. It also reinforces control in case of engagement of third parties to perform parts of the distribution activity, and pharmacovigilance obligations.
3.2 Which body (agency) is responsible for supervising wholesale distribution activities? How is supervision implemented? Is there a legal remedy (appeal) against decisions?
The same inspection regime and decision making process apply as with respect to pharmacies. Please refer to question 2.7.
3.3 What are the legal consequences in case of non-compliance?
Distributing medicines without holding the necessary authorisation, or to persons not authorised to purchase them, are considered serious administrative infringements, and distributing medicines without observing the required conditions is considered a very serious infringement. The same penalisation regime applyes as with respect to infringements by pharmacies. Please refer to question 2.8 regarding the applicable penalties.
4. PROMOTION (MARKETING)
4.1 What is the general legal regime regarding marketing of drugs (overview)? What are the general limits to marketing activities?
The scope for pharmaceutical companies’ promotional activities, including interactions with healthcare professionals is generally quite restrictive according to the legal and, particularly, self-regulatory framework in Spain.
The main regulations governing the promotion of medicines in Spain are contained in the Medicine Law and Royal Decree 1416/1994, which governs the advertising of medicines for human use, 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 implementation guidelines of certain provisions of Royal Decree 1416/1994 regarding promotion activities.
The basic framework provided in these regulations can be summarised as follows:
The advertising of medicines to the public is only allowed with respect to certain specific categories of medicines (see question 5.1) and requires prior authorisation.
With respect to the promotion of medicines vis-à-vis healthcare professionals, the main purpose of these regulations is to ensure that healthcare professionals are not influenced in any improper way by their relationships with any pharmaceutical company when performing their duties (particularly when prescribing or administering medicines).
In order 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, medical visits (visitas médicas) by sales representatives to healthcare professionals, sponsoring of promotional meetings and scientific meetings addressed to healthcare professionals and, in particular, the bearing of associated travel and hotel expenses and the offering or granting of certain kinds of benefits.
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, presenting it in an objective manner and without exaggerating its properties. Promotional materials must provide the technical information necessary for its addressees 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 guidelines of the autonomous regions provide detailed explanation in this regard. For instance, they regulate the use of certain terminology or phrases, how to reproduce bibliographic references in the promotional materials, or how to manage the delivery of information that refers to indications or characteristics not contained in the SPC approved in Spain (so-called ‘off-label’ information) in international scientific meetings.
The purpose of the visits by medical sales representatives (sales calls) must be the transfer of 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 medicinal products 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 pharmaceutical company’s relevant department (scientific service). Some autonomous regions have restricted the number and frequency of these visits.
The basic nature of promotional materials (including both published advertising and brochures delivered to healthcare professionals e.g., during visits by medical sales representatives) must be scientific, and those materials must be communicated to the regional authorities before their distribution, attaching an express declaration that they have been reviewed by the company’s relevant department (scientific service) and are compatible with the information contained in the SPC.
Any kind of incentive, discount, reward or gift to healthcare professionals involved in the prescription, dispensation and use of medicines is forbidden. Royal Decree 1416/1994 clarifies that this prohibition is not an impediment for pharmaceutical companies to offer reasonable hospitality within the framework of scientific professional meetings.
4.2 Besides the legal regime, are there other codes of conduct, e.g. by professional or industry organisations? How are they implemented? What is the relationship between the industry code (if any) and the legal regime?
Self-regulation has further construed and elaborated on the scope of the general regulations mentioned in our answer to the preceding question. In particular, in 1991, the Spanish Pharmaceutical Companies Trade Association (Asociación Nacional Empresarial de la Industria Farmacéutica, Farmaindustria) approved the Code of Good Practice for the Promotion of Medicines (the Code), which has subsequently been amended on a number of occasions, most recently in November 2010.
The scope of the Code not only covers the promotional practices referred to in our answer to the preceding question, but also to other kinds of interactions with healthcare professionals that could result in any kind of payments, such as, for instance, services agreements or the performance of observational studies. In this regard, the Code also sets out detailed rules regarding, for instance, (i) contents of the promotional documentation; (ii) pecuniary or in kind benefits granted to healthcare professionals; (iii) hospitality and meals; (iv) consultant relationships and other kinds of relationships that could result in payments to doctors (which must be reasonable, adjusted to market value, and documented in writing with certain minimum contents); or (v) the performance of observational studies (which may not be aimed at promoting the prescription or use of a given medicine, and where the involvement of sales representatives will be limited to purely logistical aspects).
The Code must be observed by all pharmaceutical companies that are members of Farmaindustria. In addition, 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 (particularly, visits by medical sales representatives). Despite the non-mandatory nature of the Code, Spanish courts have also in some cases relied on the Code to interpret more generic mandates set out in laws and regulations.
5. MARKETING TO CONSUMERS
5.1 What is the legal regime with respect to marketing to consumers (overview)? Which products might/might not be advertised to consumers?
Advertising to consumers always requires a prior administrative authorisation and is only allowed with respect to medicines that: (i) are not included in the public reimbursement system; (ii) are not subject to medical prescription; and (iii) do not contain narcotic or psychotropic substances.
Advertising must include: (i) the name of the medicine; (ii) the essential information to promote its rational use; and (iii) a specific message advising consumers that they should read the information leaflet for use and consult with 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 addressed to consumers cannot refer to recommendations of scientists, healthcare professionals, or other persons who could encourage the consumption of medicines, suggest certainty of the product's effects, lack of side-effects, or efficacy over other treatments, or to suggest that the use of the medicine may improve health or boost sport performance. Advertising addressed exclusively or primarily to children is not allowed.
The guidelines on medicines advertising to the public issued by the Ministry of Health provide additional detailed information on the content allowed in advertising messages addressed to the public. According to these guidelines, comparative advertising is only allowed in relation to medicines that belong to the same pharmaceutical company, and they may not suggest that the effect of a medicine is equal to or better than that of a different treatment or medicine.
5.2 What kinds of marketing activities are permitted with regard to consumers and the products which might be advertised to them?
Advertising medicines to the public may be carried out by means of inserts in published, audiovisual, or online media (newspapers, radio/TV, internet), leaflets, or outdoor advertising (provided, at all times, that the relevant administrative authorisation has been obtained).
5.3 Is it permitted to provide consumers with free samples? Are there particular restrictions on special offers e.g., ‘buy-one-get-one-free’?
The provision of free samples to consumers by pharmacies is not allowed.
Regarding special offers, pharmacies are only entitled to apply discounts of up to ten per cent of the retail price, and only on medicines that can be advertised to the public. No other offers are allowed.
5.4 Are there particular rules/codes of practice on the use of the Internet/Social Media in respect of drugs and their advertising?
There are no specific rules on the use of the internet/social media in respect of 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 should be password access only and the healthcare professionals should previously provide evidence of their condition as such.
5.5 Which body (agency) is responsible for supervising marketing activities to consumers? How is supervision implemented? Is there a legal remedy (appeal) against decisions?
The health authorities of each autonomous region are in charge of supervising marketing activities to consumers. Supervision is basically implemented through the prior authorisation procedure to which all promotional materials addressed to consumers are subject, regardless of how they are to be presented. Copies of the advertising materials must be attached to the authorisation application, together with information on the relevant medicine, its prospectus, the media to be used, and a report issued by the company’s scientific service explaining that the advertising message complies with the applicable regulations.
The health authorities must issue their decision on the granting of the authorisation within two months of the application.
In addition, on an annual basis, pharmaceutical companies must submit to the authorities a list of all marketing activities carried out. This applies both to consumer marketing and to promotional activities addressed to healthcare professionals.
The health authorities have the power to sanction advertising (see question 5.6) and may, through a reasoned decision, request the cessation or rectification of any advertising considered misleading, that causes a risk to health and safety, or otherwise infringes applicable regulations. They may also request the suspension of the advertising in the event of an imminent and extraordinary risk to health.
Any decisions of the health authorities on these matters may be appealed before the relevant higher administrative body [Note: it is the body from which the authoritiy which has issued the decision depends in each case]and, ultimately, before the courts.
5.6 What are the legal consequences in case of non-compliance?
Advertising medicines in breach of applicable regulations constitutes a very serious administrative infringement, which may be sanctioned with fines ranging from EUR 90,000 to EUR 1,000,000 or even up to five times the value of the products or services the subject-matter of the infringement, and the confiscation by the Public Treasury (Tesoro Público) of unlawful profits obtained as a consequence of the infringement. In addition, for very serious infringements, the registered office or company premises may even be temporarily closed for up to five years.
6. MARKETING TO PROFESSIONALS
6.1 What kinds of marketing activities are permitted with regard to professionals?
The applicable regulations specifically refer to the following types of promotional activities addressed to healthcare professionals:
distribution of free samples;
visits by sales representatives; and
sponsorship of scientific or promotional events.
As a general rule, ‘promotion’ means any offer of information, exploration 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 which directly or indirectly refers to branded or unbranded medicinal products that may be considered promotional, and thus be subject to the rules and restrictions on the promotion of medicines.
For instance, publications in the form of ‘expert opinions’, ‘expert interviews’, ‘sections’, ‘lines of treatment’, ‘current situation in the treatment of ...’, etc., inserted in paper or any media format will be considered promotional, if there is a specific, either direct or indirect, contractual relationship between the pharmaceutical company which holds the relevant medicine and the author or the company responsible for the edition, and are therefore subject to all regulations governing promotion.
6.2 Are there particular types of marketing activities which are not permitted with respect to professionals (e.g. provision of reprints, non-interventional studies, provision of and type of gifts/ educational items)?
Gifts and hospitality
Article 3 of the Medicine Law sets out so-called ‘Independence Guarantees’ in the prescription and dispensation of medicines. Among these guarantees, this Article prohibits the direct or indirect offer of any incentives, bonus, discounts, premiums or gifts by those who have direct or indirect interests in the manufacture or commercialisation of medicines, to healthcare professionals involved in the prescription or dispensation of the same.
Royal Decree 1416/1994 clarifies that this prohibition is not an impediment to pharmaceutical companies offering reasonable hospitality within the scope of scientific professional meetings, provided that hospitality is reasonable, and is secondary to the main purpose of the meeting and does not extend to persons other than the healthcare professionals themselves.
In this regard, the Code has provided very detailed guidelines on what gifts can be provided to healthcare professionals (with a maximum market value of EUR 10 and related to the practice of medicine – office work being in practice accepted) Note: what is meant by GURID?]) and how much hospitality is allowed within the scope of scientific professional meetings, such as venue selection, hotel category, social programme and duration.
Non-interventional studies are allowed in Spain (subject to a specific legal regime), provided that they are not used as a tool to increase the prescription or sale of a particular medicine. Thus, they should not be considered or used as marketing tools.
The same applies with respect 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 if these rules are not expressly contemplated in the applicable regulations, it clearly stems from the spirit of the same, and has instead been expressly included in the Code.
6.3 Are there restrictions on how, when, where or how often professionals might be targeted by sales representatives?
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 (e.g., four yearly visits to each healthcare centre), while others merely establish specific days and hours where calls are allowed. Also, in some cases, sales calls must generally be made collectively to pannels of doctors..
To the best of our knowledge, the enforcement of these restrictions is generally loose. Also, some of these regional regulations have been annulled by the courts on the basis of formal violations.
6.4 What are the restrictions on meetings with groups of professionals and the provision of hospitality?
Article 18 of Royal Decree 1416/1994 states that hospitality offered within the scope of activities of a professional and scientific nature must be reasonable and secondary to the main purpose of the meeting, and may not extend to persons other than health professionals.
The Code provides detailed guidelines in this regard:
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 would be considered ‘reasonable’ if its cost does not exceed what recipients would normally be prepared to pay for themselves in the same circumstances.
Expenses should 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 (e.g., the use of taxis). [Note: expenses may be paid by the pharmaceutical company, but only directly to the supplier. What is not permitted is to pay cash to the professional so that they pay for their trip]
Hospitality must always be secondary to the main purpose of the meeting: the scientific goals must constitute the main focus of the organisation of the meetings. Social or cultural aspects may never take precedence over scientific issues.
Hospitality should not extend to persons other than healthcare professionals who qualify as participants in the meeting in their own right. Spouses or other companions may not 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 duly evidenced that such payments are made to lease the room to be used for the relevant meeting.
Scientific goals must be the main focus of the meetings, and social or cultural aspects may not interfere or prevail over scientific issues. The scientific content of congresses and meetings should occupy at least 60 per cent of each work day (on an eight-hour work day basis, excluding travel time). The schedule of cultural or social programmes should not coincide with the scientific programme. In addition, hospitality provided by a pharmaceutical company must never include the sponsorship or organisation of leisure events (sports, entertainment, etc.).
Healthcare professionals should not be remunerated merely for attending the event. Only speakers and moderators may be paid reasonable fees.
As a general rule, pharmaceutical companies are not allowed to organise or promote events to be held outside Spain (international events) where the majority of attendees are practicing 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.
6.5 What information is it legally required to include in advertising?
Promotional materials addressed to healthcare professionals must include:
essential information on the product, following the SPC, including name, composition, full clinical data, incompatibilities, side effects and contraindications, instructions for use and handling, and 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; and
the selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies and, when possible, information on the cost of the treatment.
Reminder advertising (i.e., advertising that has the sole purpose of reminding people of the product’s name) is exempted from these rules. Reminder advertising is though only allowed once the product has been authorised for at least two years.
6.6 Are there rules on comparisons with other products that are particularly applicable to drugs?
Comparative advertising is indeed generally subject to the principles contained in unfair competition and advertising regulations. In addition, the guidelines issued by the Ministry of Health and some autonomous regions concerning advertising of medicines have introduced specific rules, namely:
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;
the 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 also, according to the Code, to competitors);
relevant information (such as the statistical relevance of results) may not be omitted;
results from different studies may not be compared in the same graph or chart, except if a meta-analysis has been conducted.
6.7 Are discounts permitted? If they are, under what conditions, by whom, and to whom?
As an exception to the general prohibition of any sort of gifts, bonuses, incentives and discounts, Article 3.6. of Law 29/2006 expressly allows volume and prompt payment discounts offered to pharmacies by wholesalers (which is understood to also include pharmaceutical companies that engage in the direct distribution of their products), provided that:
they do not encourage the prescription of a particular product instead of that of its competitors; and
the discounts are properly reflected in the relevant invoice.
In any event, these discounts may not exceed ten per cent of the regular price of the medicine.
6.8 Is it permitted to provide professionals with free samples?
Samples may only be offered during the first two years following the medicines’ marketing authorisation. Each healthcare professional may be offered a maximum of 10 samples per year (unless otherwise stated by the relevant authority).
Samples cannot be larger than the smaller presentation of the relevant medicine, must be labelled ‘free medical sample – not for sale’ and may not bear the reimbursement label.
Delivery of samples must include the authorised 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.
6.9 Is sponsoring of professionals allowed? Under what conditions, by whom, and to whom and for what purpose(s)?
Prizes, scholarships, contributions and financial assistance for attendance to meetings, congresses, and similar activities are allowed provided that they are applied exclusively to scientific activities and do not represent an incentive for the recommendation, prescription, purchase, supply, sale or administration of medicines. Sponsoring attendance by healthcare professionals to scientific events is allowed, subject to the hospitality rules described in question 6.4.
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, when any kind of prizes are granted, there should be publicly available rules through which, amongst other aspects, the entity/ies organising or sponsoring the prize, the conditions for participation, dates, kind and amount of the prize, entity responsible for selecting the winners, etc. are made known.
6.10 Are other indirect incentives allowed? Under what conditions, by whom, and to whom?
As mentioned (in question 6.2), direct and indirect incentives are prohibited. The Code, however, allows the provision to healthcare professionals of objects such as books or other materials on optical, magnetic, electronic or similar supports on medicine or pharmacy topics. The provision of other gifts (which value exceeds EUR 10 or which are not of a scientific or technical nature) is not allowed. The direct or indirect provision of portable electronic devices susceptible to personal use, even if they may also have a professional use, is not permitted either.
6.11 Which body (agency) is responsible for supervising marketing activities regarding professionals? How is supervision implemented? Is there a legal remedy (appeal) against decisions?
The health authorities of the autonomous regions are responsible for the supervision of promotion and marketing of drugs generally.
Regarding marketing to healthcare professionals, pharmaceutical companies have the obligation to submit a copy of any sort of promotional material they use (printed, audiovisual, etc.) to the health authorities at the time of its publication or release, indicating its addresses, the mode of its publication and the date it is first released. In addition, on a yearly basis, pharmaceutical companies must submit to the authorities a list of all marketing activities carried out.
The health authorities are given inspection and sanctioning powers and may also decree provisional measures (see question 5.5).
6.12 What are the legal consequences in case of non-compliance?
As previously mentioned, advertising medicines in breach of applicable regulations constitutes a very serious administrative infringement, with the consequences outlined above (see question 5.6). The offering of bonuses, premiums, 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.
Infringement of the requirements that the autonomous regions may set out regarding visits to healthcare professionals constitutes a minor infringement, which may be sanctioned with fines ranging from EUR 6,000 to EUR 30,000. 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 may be sanctioned with fines ranging from EUR 30,000 to EUR 90,000.
7. ENGAGEMENT WITH PATIENT ORGANISATIONS
7.1 What kinds of activities are permitted with respect to engagement with patient organisations?
There are no specific Spanish regulations on interactions between the pharmaceutical industry and patient organisations.
Spanish law foresees certain ‘incentives for patronage’, which are tax benefits applicable to donors when contributions are made in favour of entities considered ‘beneficiaries of patronage’. Associations that have obtained a public interest declaration (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, whereby the organisation would receive funds to be used for its public interest activities, and would undertake to disclose the financial assistance received from the grantor for these activities.
Farmaindustria has approved a Code on interactions between the pharmaceutical industry and patient organisations, effective as of 1 July 2008, which sets out certain rules and standards aimed at guaranteeing the independence of these organisations and the transparency of their interactions with the industry. This Patients Organisation Code expressly contemplates, in addition to the provision of financial support:
contracts between companies and patient organisations under which they render any type of services to companies, provided that the services are rendered to support healthcare or research;
the engagement of patient organisations as experts and advisors for services such as participation at advisory board meetings and speaker services;
the sponsorship of events organised by patient organisations; and
the provision of hospitality in events organised by the patient organisation or by the pharmaceutical company.
7.2 What are the restrictions that are imposed on relationships with patient organisations?
According to the Patient Organisations Code:
Collaboration between pharmaceutical companies and patient organisations must be documented in a written agreement and state at least: the activities to be carried out, the amount and sources of funding, the purpose of funding, relevant indirect support and any other type of significant non-financial support.
Pharmaceutical companies must not seek to influence the text of patient organisation material that they sponsor in their own commercial interest. This does not mean that companies cannot correct factual inaccuracies.
The 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 and be proportionate to the time dedicated, the work done and the responsibilities assumed, and must be properly documented.
Companies must also make publicly available a list of patient organisations with which they have engaged to provide remunerated services.
As regards hospitality, in general terms, the standards established in the Spanish Code of Good Practices for the Promotion of Medicines and Interrelation of the Pharmaceutical Industry with the Healthcare Professionals must be observed. Companies must pay expenses directly through the patient organisations, and never directly to patients on an individual basis.