Annex III – QUERIES (Questions and Answers) on the interpretation of the Code of Practice
ARTICLE 11. SCIENTIFIC AND PROFESSIONAL MEETINGS
45. According to the Code, could a pharmaceutical company organise a scientific meeting in Cairo, where the physicians will also be able to take advantage of the location to visit the pyramids at Giza after a three hour working day?
No. The organisation of Events outside of Spain when participants are solely or mainly Spanish physicians is considered unacceptable unless there is a justified reason (article 11.10), which is not provided in the question. Furthermore, this would be a breach of the Code, since scientific aims must constitute the main focus in the organisation of these meetings (the scientific con- tent must represent at least 60% of the working day, and 3 hours only represent 37%) and, also, hospitality cannot include sponsorship or organisation of entertainment activities (sport, leisure, etc.).
46. According to the Code, would it be acceptable to allow the return trip of a physician take place two days after the ending date of the meeting? What rules should apply to accompanying persons?
Hospitality may only be extended to the day before or after the Event, in accordance with an efficient planning of travel. Physicians may extend their stay in the location, provided that additional costs of accommodation, travel and upkeep resulting from such extension are paid for by themselves and do not cause a modification on the initial programme of most of the participants.
In the Events organised or sponsored by industry, presence of accompanying persons should not be permit- ted, even if paying for their own expenses, as this may damage the image of the pharmaceutical industry.
47. According to the Code, would it be permitted to hold a scientific meeting in March in Sierra Nevada with a daily 7 hour sessions programme?
This is not permitted, because, as a general rule, locations that may convey an inappropriate image (as is the case of locations linked to sporting or leisure activities during peak season) must be avoided, even when the duration of the scientific programme does comply with the Code.
48. A pharmaceutical company invites a group of 90 physicians to a scientific meeting in Barcelona followed by attendance to a football match. Would it be breaching provisions of the Code?
Yes. Hospitality offered by a pharmaceutical company can under no circumstances include the sponsorship or organising of entertainment events (sporting, leisure, etc.).
49. The company’s parent company decides to invite a group of researchers to an important scientific Event in San Francisco to which doctors of different countries are to attend in order to learn the latest data of the American Cancer Society. Would the company be breaching the Code?
No. As an exception, in the case of international official congresses or independent international Events, attendance of Spanish professional doctors outside of the European Union may be sponsored provided that provisions of the Code are met.
50. According to the Code, could a pharmaceutical company invite a group of doctors to dine at a restaurant offering a price per guest of 100 Euro?
No. According to the contents of the Code, hospitality within a scientific context shall always be moderate and this type of gatherings would damage the image of the pharmaceutical industry. A lunch/dinner of this kind and price does not fall within what may be considered as a regular working lunch/dinner in the carrying out of promotional activities.
For those Events taking place in Spain, the Code establishes a maximum threshold of 60 Euro (tax included) per guest for any form of hospitality associated with meals. For Events taking place outside of Spain, the maximum threshold established by the National Association of the country where the Event occurs will apply.
In all cases, the payment of any form of hospitality to Healthcare Professionals taking place outside of a scientific-professional context is considered a practice contrary to the Code.
51. What are the criteria for sponsoring meetings or Events organised by scientific societies?
Although the organisation of Events corresponds to scientific societies, companies must always take into account the image that these Events transmit as well as the Code provisions. In this way, industry shall not sponsor meetings where the scientific-professional nature does not prevail or that do not respect the criteria required for the meetings organised by industry it- self. It is permitted to sponsor or finance logistical elements necessary to carry out the Event (rooms, meals, materials, etc.) and, in general, anything that may be considered as reasonable and moderate hospitality in the sense of the Code. In the Events organised by third parties, the pharmaceutical industry should not participate or collaborate when these promote attendance of accompanying persons.
52. Is it possible to sponsor attendance of Spanish doctors to a meeting in an EU country, out- side of Spain, that has speakers and is organised by scientific or medical societies from both countries?
It is possible, provided that the scientific programme is appropriate and doctors from both countries attend; with the aim of boosting scientific exchange. In all cases, the basic criteria that have to be taken into account in each circumstance are mainly: the scientific-professional content of the meeting and the appropriateness of the location, together with an adequate and reason- able hospitality level.
53. Can educational courses be sponsored or provided to doctors in Spain on clinical topics or professional abilities, such as: IT courses; how to make presentations in public; how to produce slides; how to perform clinical studies; how to prepare a poster; biostatistics course; health management course; scientific presentations in English; how to write an article for publication in scientific journals, etc.?.
Educational activities must contribute positively to the training of the Healthcare Professional and to the development of abilities that benefit his healthcare activity, even if these have a more general scope and content.
Companies must, in all cases, adopt all measures necessary to avoid that their collaboration in educational activities and initiatives constitute an inducement to the recommendation, prescription, purchase, supply, sale or administration of medicines.
Companies, prior to making a decision about the appropriateness of collaborating or not in this type of educational activities shall, among other aspects, assess the following internally:
- The prestige, rigour, seriousness, duration, cost and contents of the activity, as well as the usefulness it represents to the continued medical education of the Healthcare Professional, it being advisable that it be- long to a programme with a credit recognition system.
- Its compliance with the Code and current legislation.
Collaboration of pharmaceutical companies in the educational activities dealt with in this query is not subject to the communication procedure described in article 33 of Title II of the Code, Rules of Procedure for the Control Bodies.
Also, these educational activities shall not be object of publication in the third-party Event listing available in Farmaindustria’s website.
54. What criteria should be taken into account by companies regarding hotel use?
The typology and characteristics of hotels that pharmaceutical companies may use to accommodate Healthcare Professionals are issues widely regulated in the Code.
As a general rule, 4* hotels are considered the appropriate standard for the holding of scientific-professional meetings.
Notwithstanding the above, a 5* hotel may be exceptionally used if all of the following circumstances are met: (i) venue hotel or there were no availability in the venue hotel, (ii) business non-ostentatious hotel in developed metropolitan area, and (iii) participation of at least 200 Healthcare Professionals.
Finally, there is a hotel typology whose use will in no case be justified. This includes: (i) regardless of their official category: sports resort hotels (with golf course, etc.), theme park hotels, winery hotels, and (ii) 5* grand luxury hotels. Within these establishments companies shall not: install commercial stands, use their rooms or installations to carry out any kind of activity (symposia, conferences, seminars, meals, etc.), nor accommodate Healthcare Professionals.
For those establishments having more than one official rating, the company shall take into account whichever category is the highest.
The same philosophy shall apply to Events held outside of Spain, notwithstanding that additional criteria may be taken into account, such as security, local criteria of rat- ing and classification, etc.
55. What would the practical recommendation be to define the hotel and/or location of a meeting?
Criteria such as number of participants and their origin, availability of other hotels in the meeting location that conform to the appropriate conditions to hold the meeting, ease of travel or connection, distances, costs, participants’ convenience regarding logistical aspects, etc. may be used.
56. Would it be appropriate to hold a scientific meeting in a location that is well-known as a tourist destination, such as the Canary Islands, when, due to other reasons, and together with an appropriate scientific programme, it is advised the meeting take place in that Autonomous Community?
We must insist upon the necessity of preparing a good scientific programme, assessing as a whole the Event and level of hospitality. Holding an Event in the Canary Islands does not constitute a problem in itself, provided that the selection of the location is accounted for and that all other aspects of the Event convey an appropriate image of the pharmaceutical industry.
57. How to reconcile the scientific nature of an action, the involvement of local participants and the consideration of tourist destination of that city? Can you pose some examples of justified cases where it is considered acceptable to organise Events outside of Spain?
The particular aspects of each case must always be analysed. A good scale to assess an Event is to think whether the organising company would be willing to make all of the details of the Event widely known to the public. Some examples of Events that could take place outside of Spain would be: a visit to a scientific center or institution in the country holding the congress; the presence of a production plant or a research or development center of the organising company in the location holding the congress; attendance to the Event of doctors from different countries; bilateral meetings or cooperation agreements among institutions of two or more countries and, in general, whenever there are justified causes for the holding of the congress outside of Spain.
58. Are international Events organised by a company compliant with the Code? As in, for example, a new product presentation in an international destination, where doctors of several countries participate and to which Spanish doctors attend, invited by the company.
A product presentation is one of the possible scientific meetings foreseen in the Code. The organising of an Event such as the one described in the question seems reasonable if the product is authorized in Spain and most of the attendees are not Spanish.
59. Is it acceptable to provide a specific amount of money in advance as a travel grant for attendance to a congress in order to cover part of the costs of the Healthcare Professional, such as, for example, registration, hotel, etc., which consists in a money transfer or a personal cheque with the corresponding congress attendance travel grant invoice issued by the doctor?
Provision of a cash advance to a Healthcare Professional is not acceptable, not even if documented by a receipt or similar. All payments must be performed by directly covering the expenses. The existence of an invoice issued by the Healthcare Professional implies that a professional service has been rendered, service that must be duly indicated in the invoice. Mere attendance to a congress, symposium or scientific or professional meeting is not a professional service.
60. Can payments in the form of travel grants be made directly to travel agencies appointed by the doctor or the congress organiser to manage travel arrangements, hotels, tickets, registration, etc.?
As a general rule, payments must be made directly to the provider; it being possible to use intermediary agencies when the Event’s complexity so advises. The agency organising the congress or the agency with whom the company usually works are the acceptable intermediary agencies. In all cases, the pharmaceutical company shall be responsible of ensuring that the agency respects the Code’s provisions, safeguarding that the funds are indeed used for the purposes intended. Under no circumstance is it acceptable to make payments to travel agencies appointed by the doctor.
61. Should that be the case, must these contributions correspond to a given service (plane, hotel) or can they be partial amounts of the total cost of the trip the doctor is to make and that could eventually be covered by several companies?
That the contributions be of a given service is always preferred. Although, if this were not possible, it is permitted that some costs be partially sponsored by sever- al companies. An original invoice from the provider shall be required, including a precise indication of the service or concept paid for.
62. What is the supporting documentation required from travel agencies regarding the company’s contributions to congress attendance?
The original invoice; although the company must know the names of the Healthcare Professionals attending the congress, as well as the sponsored concept (plane ticket, registration, accommodation, etc.).
63. In the time calculation of a work day (8 hours), what consideration does time dedicated to lunch have?
Lunch shall not be considered time dedicated to scientific content. The 60% proportion established in the Supplementary Rules of article 11 shall be observed in all cases.
64. Should a company notify the meetings (national or international) it organises as a result of the planning, information and coordination activities of the multicentric clinical trials it pro- motes, when these involve medical researchers hired for those trials, who also receive fees from the company for their research activities?
The Code covers all forms of interaction between pharmaceutical companies and Healthcare Professionals or any other person who, in exercising their profession, may perform or participate in the prescription, purchase, supply, dispensation or administration of medicinal products for human use. Its terms and conditions thus apply to this kind of meetings.
Thereby, in compliance with article 33.1 of Title II of the Code, Rules of Procedure for the Control Bodies, prior notification shall be mandatory for those meeting the conditions foreseen in said article; that is to say, that they are organised – directly or indirectly – or sponsored – exclusively or in the majority – by the company, involve the participation of at least 20 Healthcare Professionals practicing in Spain and include at least one overnight stay.
65. Does the ban on the provision of travel grants in cash to Healthcare Professionals invited to congresses and meetings involve a ban on travel vouchers or bonuses issued by third parties, in so far as, directly or indirectly, they may be exchanged for cash or used by third persons or employees in other dates or for other destinations or ends?
A travel voucher or bonus that, once given to the Healthcare Professional, can be used without the company’s knowledge for purposes different from that of attendance to the meeting or congress for which it was issued, does not guarantee the appropriate use of the funds and, in this sense, is comparable to a travel grant in cash. Its use is, consequently, not acceptable.
66. Can activities of a short duration (for example, an hour and a half) with a scientific or professional content, followed by a cocktail or dinner, be organized, even if they do not take up 60% of a work day?
In general, when two overnight stays are included in an Event, this will be considered a full-time Event, in which case the scientific content of the programme shall be at least 4 hours and 45 minutes long.
There can be half-day Events (those including only one overnight stay for out of town attendees), in which case the scientific content shall be of at least 2 hours and 20 minutes.
Finally, talks or conferences of a shorter duration may be organised, provided that the hospitality level is reasonable and no overnight stay is offered.
67. Can a foreign entity, linked to or sponsored by a company based in Spain, invite Healthcare Professionals practicing in Spain to an Event of a scientific and promotional nature taking place in Spain or abroad?
Yes, provided that the scientific and promotional Event complies with the Code of Practice for the Pharmaceutical Industry. In such cases, companies based in Spain, linked to foreign entities that have invited Healthcare Professionals practicing in Spain to an Event of a scientific and promotional nature, shall provide prior notification of such activities to the Surveillance Unit when these meet the conditions for compulsory notification stated in article 33.1 of Title II of the Code, Rules of Procedure for the Control Bodies.
68. Can a foreign pharmaceutical company invite, within the context of an international congress taking place in San Francisco, a group of Healthcare Professionals including doctors practicing in Spain to an excursion to the Grand Canyon in Colorado?
The pharmaceutical company inviting a doctor to that excursion would be in breach of the Code and, consequently, according to article 11.7, responsibility of such breach would fall upon the linked company based in Spain (for example, one that belongs to the same business group).
69. What conditions must "rest areas" meet according to provisions of the Code?
Rest areas, understanding as such those spaces pro- vided in scientific Events or meetings with the aim of allowing, during the holding of the Event, attending Healthcare Professionals to make use of an area near the rooms where the meeting is being held and where refreshments are served during the Event, must meet the following conditions:
- They shall contribute to professional scientific ex- change among Event attendees.
- They shall be aimed solely at Healthcare Profession- als, not allowing entrance of non-participants, such as accompanying persons.
- The hospitality offered shall be moderate; not moderate meaning services such as massages, etc. or offering of refreshments exceeding the usual ones in a meeting (alcoholic beverages, excessive appetizers). In short, companies must endeavor to avoid elements that may damage the image of the pharmaceutical industry.
- They shall not be used to carry out promotional activities related to medicines. As an exception, corporate/ institutional advertising is allowed.
70. Should a company provide prior notification to the Surveillance Unit of a scientific Event if: it has a duration of a work day (starting early in the morning and ending in the evening), there are at least 20 professionals participating, none of them staying overnight, but there are also, for example, 8-10 speakers, who will be staying overnight the day prior to the meeting?
In compliance with art. 33.1 of Title II of the Code, Rules of Procedure for the Control Bodies, Events directly organised by pharmaceutical companies shall be subject to compulsory prior notification when- ever at least 20 Healthcare Professionals practicing in Spain are participating and an overnight stay is included. Consequently, in compliance with provisions of the Code, the Event shall be notified whenever attendees are offered an overnight stay.
In any case, it is recommended to make voluntary prior notifications of any kind of Event to be organised by a company or in which participation is foreseen.
71. Are the following selection criteria for appropriate venues to hold promotional meetings organised by pharmaceutical companies in compliance with the Code of Practice for the Pharmaceutical Industry?
a) 4* hotels as a general rule.
b) Possibility of holding the meetings or Events anywhere in Spain, except for the following seasonal limits:
- Avoid towns in the coast during July and August.
- Avoid mountain areas related to skiing during December, January, February and March.
1. - A 4* hotel is indeed the appropriate standard for the holding of scientific-professional meetings.
2. - Locations chosen to hold scientific meetings or Events shall portray an image that does not damage the pharmaceutical industry. In this sense, towns in the coast that are mainly touristic shall be avoided in peak season (second fortnight of June, July, August and first fortnight of September), as well as mountain locations related to skiing while ski resorts are open.
These same criteria shall apply to Events organised by a pharmaceutical company taking place both in Spain and abroad, where applicable.
72. Could a pharmaceutical company make avail- able to Healthcare Professionals its travel agencies so that they may benefit from their economic conditions in the hiring of services for the attendance of accompanying persons, even though the cost of the accompanying person would be covered by the Healthcare Professional?
Companies must manage directly the travel arrangements of those Healthcare Professionals they sponsor with the aim of ensuring that the money they provide is spent for the intended purposes. Consequently, in compliance with art. 11 of the Code, the Supplementary Rules implementing it and the reply to query nr. 61 of Annex II, Queries (Questions-Answers), it is not al- lowed to make available to the Healthcare Professional the company’s travel agencies so that he may organise attendance of others to the congress.
It is recalled that presence of accompanying persons in scientific Events or meetings is forbidden for Events organised by pharmaceutical companies and, for those Events organised by a third party, the pharmaceutical industry shall not participate or collaborate if these promote attendance of accompanying persons.
In any case, in compliance with the Supplementary Rules of art. 11.3 of the Code and the response to query nr. 52, companies shall not contribute to the presence of accompanying persons.
73. What does it mean to be a majority sponsor? Does the status of majority sponsor include sponsorship of congresses organised by a third party (scientific societies, professional organisations, etc.) and sponsored by a company? That is to say, should a congress organised by a third party and sponsored by several companies be notified when being a majority sponsor?
Firstly, the dictionary of the Royal Spanish Academy defines "sponsor" (2nd meaning) as: "said of a person or entity: that sponsors an activity, often for advertising purposes".
Secondly, according to the same source and 2nd meaning, the concept of majority refers to something that constitutes the majority.
Thus, a majority sponsor is one sponsoring an Event contributing over 50% of the total cost of the Event.
Continuing with the above definition of sponsor, sponsorship covers any activity of financing or support, regardless of, on the one hand, who the organiser is and, on the other hand, whether several companies are sponsoring it together.
Consequently, and in compliance with art. 33.1 of Title II of the Code, Rules of Procedure for the Control Bodies, if the company is the majority sponsor, it shall provide prior notification even if the Event is organised by a third party (scientific societies).
In any case, it is recommended to make voluntary notifications of any kind of Event to be organised by a company or in which participation is foreseen.
74. In the context of an international congress lasting 4 days, is it possible to take doctors to a theatre to see a play?
As relevant information, be it pointed out that such activity is not part of the official programme of the congress organisation, nor does it interfere or take place at the same time as the scientific programme and it would be the only cultural activity to be carried out by the pharmaceutical company for its own guests and during the projected trip. The cultural activity would not prevail over the scientific, which would still be the main focus of the Event.
Pharmaceutical companies sponsoring the attendance of Healthcare Professionals practicing in Spain to international congresses organised by a third party with Health- care Professional participants from different countries shall endeavour to ensure that hospitality offered is that of the congress official programme, provided this is reasonable and moderate. Situations that may constitute an inappropriate image for the pharmaceutical industry shall thus be avoided, in compliance with the Supplementary Rules. Consequently, offering invitations other than those of the organiser may damage the image of the pharmaceutical industry and breach provisions of the Code.
Secondly, invitation to spectacles, whatever their nature, aimed at Healthcare Professionals also constitutes an incentive in kind and, consequently, is not allowed in compliance with art. 10.1 of the Code of Practice.
Hospitality shall not include sponsorship or organisation of entertainment activities (sporting, leisure, etc.).
75. Is it possible to offer hospitality, as pictured in art. 11.3 of the Code, to biologists-geneticists, taking into account that they are part of multi- disciplinary work groups, carrying out a role of indication and follow up of specific protocols or therapeutic guides as well as management of pre- treatment information to the patient, but that do not prescribe directly?
The Code defines Healthcare Professionals as "any member of the medical, dental, pharmaceutical, nursing or podiatric profession, any other person legally considered as such, or any other person who, in exercising their profession, may perform or participate in the prescription, purchase, supply, dispensation or administration of medicinal products for human use".
As a consequence, continued education of different professionals is justified, within a context where the professional exercise is carried out in an interdisciplinary manner, with professionals from several disciplines agreeing on objectives and participating in the decision making process. Consequently, it is legitimate to offer hospitality within scientific congresses to biologists-geneticists, provided it is reasonable and compliant with provisions of the Code.
76. Is there any case in which Events organised or sponsored in the majority by a pharmaceutical company – including Events organised by companies belonging to its group or entities under its control - may be held in a 5* Grand Luxury hotel?
No. A 4* hotel is considered the appropriate standard for the holding of scientific-professional meetings. 5* hotels may only be used as an exception when all the following conditions are met: venue hotel or there were no availability in the venue hotel, business non-ostentatious hotel in developed metropolitan area, and participation of at least 200 Healthcare Professionals. Under no circumstance will use of 5* G.L. hotels be permitted. This ban is not limited to lodging, but also includes the use of installations (meeting rooms, use of restaurants and other services).
77. According to the Code, would it be permitted to organise or participate in a scientific meeting (whose daily scientific sessions programme complied with provisions of the Code) held in:
- a location that, due to its characteristics – mountain area -, its situation – within a ski resort or less than 50 kilometers away from a ski resort-, its being related to the practice of this sport, etc. (for example: Jaca, Vielha, Andorra, Davos, Saariselkä, Inssbruck, etc.), and
- during the time period when the installations for the practice of such sport are open (in general, from December to March, both included).
No. The scientific objective and character of the Events must constitute the main focus for its organisation, prevailing over any social or cultural aspect, which shall result, in all cases, secondary and accessory.
In this sense, the choosing during Winter locations clearly related to the practice of a sport such as ski may in itself result in the scientific objective and character of the Event taking second place, the possibility to practice such sport becoming its main attraction, conveying thus an inappropriate image of the pharmaceutical industry.
It is important to assess the appearance and contents of the Event as a whole. There is no doubt that elements such as location, dates, ease of access for participants, etc., help assess the appearance of the Event. An unfortunate decision regarding any of them, which may create doubts about its intended scientific objective, would prevent potential participation of pharmaceutical companies in the Event.
78. In the case of Events of a short duration (for example, an hour and a half), followed by a cock- tail or dinner, to which a group of 10 or 15 Healthcare Professionals is invited for a new product presentation or to discuss aspects related to a product, being the intention also to obtain feedback from such professionals on the product and other aspects related to it:
Can attending Healthcare Professionals be paid amounts ranging from 300 to 600 Euro for their participation in this activity?
If the answer to the above question is "yes", can this activity be carried out in different areas or regions of Spain, inviting 10 to 15 professionals from each of the areas?
In compliance with article 11.6 of the Code, the execution of payment to Healthcare Professionals participating in scientific Events is only permitted when these are acting as speakers or moderators.
In any case, contracting of these services will be subject to provisions of article 16 of the Code.
The mere participation or attendance to an Event does not justify the payment of fees.
79. Are provisions of article 11 applicable to digital or multi-channel scientific and professional educational activities and initiatives such as videoconferences, courses or contents, both on- line and streaming or by download, virtual com- munities, etc.?
Although face-to-face meetings and Events are the most common, it is true that the present trend, fostered by new technologies and saving policies, aims toward distance learning activities in a digital environment. The content of these new activities is the principle that should govern them and, thus, they being educational activities, they are subject to provisions of the Code, article 11 "Scientific and Professional Meetings" and article 8 " Digital Environment", among others. In fact, the definition of "Event" at the beginning of the Code includes in-person or distance educational courses.