Application Regulations of the Code of Practic on the Promotion of Medicines

Approved by the Decision of the Meeting of AFA Members
4 April 2006

Issued in accordance with the Points No. 7, 9, 10, 11 and 12 of the
Code of Practic on the Promotion of Medicines of the
Association of International Research-Based Pharmaceutical Manufacturers

Preamble
I. General Provisions
II. Corporate Events
III. Sponsorship*
IV. Criteria of Choosing Health Care Workers and Sponsoring Their Participation in Events
V. Hospitality Allowances
VI. Gifts and Incentives
VII. Remuneration of Health Care Workers

Preamble
The Association of International Research-based Pharmaceutical Manufacturers (hereinafter referred to as ‘AFA’) has adopted these Regulations providing for application of the provisions of the Medicines Advertising Practice Code (hereinafter referred to as ‘Code’) and the current legislative acts of the Republic of Latvia in order:
- To promote introduction of the international and local ethical provisions and pharmaceutical industry’s enactments so that they may apply to all the participants of Latvia’s pharmacy market alike;
- To ensure a uniform application of the Code in Latvia;
- To facilitate elimination of any violations found and prevention of similar violations henceforth.

I. General Provisions
1. All promotional, scientific or professional meetings, congresses, conferences, symposiums and similar events (‘events’), which are organised or sponsored by a company, must be held at appropriate venues corresponding to the main aim of the event, and hospitality allowances may only be offered wherever appropriate and otherwise in compliance with the current provisions of the Code.
1.1. All hospitality allowances related to promotional, professional or scientific events must be restricted to travel, catering, living accommodation and payment for participation (check-in) in an event if any.
1.2. Hospitality may only be extended to such persons applying to participation by themselves (or invited). It is not allowed to cover the hospitality-related expenses to any other persons.
1.3. All kinds of hospitality allowances offered to health care workers must be in a reasonable amount and strictly confined to the main aim of the event.
1.4. It is generally accepted that the offered hospitality must not be in excess of such an amount that health care workers would otherwise afford to pay for their own account.
1.5. It is not allowed to offer compensation of the time spent by a health care worker when attending an event.
1.6. Hospitality must not cover sponsorship or organisation of any entertainment events (e.g., sports or recreational events).
1.7. The part of an event, which is not directly related to its main aim, must not exceed 30% of the whole duration of the event. A Program/Letter of Invitation to an event must contain a precise indication of the time allocated to the main aim of the event and the rime allocated to hospitality.
1.8. A Program/Letter of Invitation to an event must contain a precise indication of the event’s organizer and supporter and what exactly is supported.
1.9. A company must observe the criteria related to the choice of health care workers and sponsoring their participation in events as provided in the current Code or with regard to the same.
2. If in doubt about any event’s compliance with the Code or the present Regulations, it is desirable and advisable to turn to the AFA Ethics Commission with a request for comments on the current enactments of the Republic of Latvia, the Code provisions and these Regulations before organising such an event.

II. Corporate Events
3. Corporate events (events that are not related to distribution of information on medicines – for examples, firms’ anniversaries celebration parties, receptions in honour of business partners and the like, corporate parties before Christmas Eve, etc.) are allowed.
It is not allowed to invite medical practitioners or pharmacists to such events.

III. Sponsorship*
4. It is allowed to sponsor:
4.1. Legal persons only;
4.2. Only such matters and events that have a scientific and/or medical goal and directly promote and improve patient care;
4.3. Sponsorship must not provide any personal benefit to the representatives of the sponsored entity;
4.4. Sponsorship may not be related to prescription of medicines manufactured by the relevant firm.
5. An issue of sponsorship assignment shall be reviewed and a resolution shall be passed on the ground of a legal entity’s request (application) containing a substantiation of the necessity of sponsorship and advantages for scientific and medical development and patient care improvement.
*Note: This Chapter does not apply to sponsoring health care workers’ participation in events.
IV. Criteria of Choosing Health Care Workers and Sponsoring Their Participation in Events
6. A health care worker’s participation in events may only be sponsored if:
6.1. a participant directly represents the industry or industries related to the topic of the event;
6.2. a participant may ensure further application of the received knowledge (information) in his/her practice.
7. Sponsorship of participation in events shall not be related to prescription of the sponsor’s medicines.
8. An issue of sponsorship assignment for participation in events shall be reviewed and a resolution shall be passed on the ground of a health care worker’s request (application) containing a substantiation of the necessity of sponsorship and information about further application of the received knowledge in his/her practice.
If a health care worker is invited to take part in an event, sponsorship is assigned on the ground of a health care worker’s information about further application of the received knowledge (information) in his/her practice.

V. Hospitality Allowances
9. Recommended venues of events:
9.1. conference-halls;
9.2. facilities of public organisations (associations, societies);
9.3. medical facilities;
9.4. pharmacies;
9.5. other such places as equipped with a conference-hall.
If an event is organized for the health care workers of a certain region of the country, the event may be held at public catering facilities if no such premises as mentioned in Paragraphs 9.1–9.5 above are available.
To hold events elsewhere is not allowed.
10. The following hospitality allowances may be offered in Latvia:
10.1. accommodation at the venue of the event;
10.2. catering;
10.3. transport to the venue of event and backwards.
11. No company is allowed to organise or sponsor an event, which is held outside the domicile region of the physician („international event”) except for such cases as follows:
11.1. If the event is closely related to improvement of the physician’s knowledge and skills needed for his/her work; and
11.2. The majority of guests come from foreign countries (it would be logical to hold the event in the country where the majority of participants come from); or
11.3. In view of the location of the relevant resources, i.e. the object of the subject of the event, it is logical to hold the event in other country, and such an event cannot be organised in Latvia. 12. It is allowed to make the following payments related to an international event (an event held abroad):
12.1. To pay economy class airfares, except cases when there are no available economy class tickets to the given flight;
12.2. To pay for bus (coach) tickets;
12.3. To pay for railroad tickets;
12.4. To pay no higher than a medium-class car rent or taxi services to get from the airport to the hotel and back.
12.5. Catering.
12.6. Hotel accommodation – not more than the price of a 4-star hotel at the corresponding dwelling place.
13. It is not allowed to offer such hospitality as:
13.1. sports and recreational events/activities;
13.2. entertainment events;
13.3. covering expenses on Spa and body care procedures;
13.4. excursions;
13.5. accommodation at resorts and recreational facilities;
13.6. covering expenses incurred by the specialist’s accompanying person;
13.7. accommodation/daily allowances;
13.8. other similar hospitality allowances.
Note: The prohibition is not limited to the examples listed in Paragraph 13.

VI. Gifts and Incentives
14. No gifts, materials advantages or benefits may be provided, offered or promised to a health care worker and his/her family members as an incentive to prescribe, deliver, sell or administer medicines.
14.1. When advertising a medicine to a health care worker, he/she may only be offered gifts, material advantages or benefits if such a benefit is to be used in medical or pharmaceutical activity and its total value does not exceed LVL 50 per annum. Gifts may only bear the Company’s name and logo, medicine’s brand name or international unpatented name, and other information if they comply with the current legislation.
14.2. It is not allowed to offer or present the following gifts to a health care worker or his/her family members:
14.2.1. tickets to entertainment and sports events;
14.2.2. alcohol;
14.2.3. cigarettes;
14.2.4. cash;
14.2.5. gift cards;
14.2.6. computers,
14.2.7. furniture,
14.2.8. telephones,
14.2.9. facsimile apparatuses,
14.2.10. TV
14.2.11. other similar benefits that are no directly related to health care.
Note: The prohibition is not limited to the examples listed in Paragraph 14.2.

VII. Remuneration of Health Care Workers
15. Cooperation between the pharmaceutical industry and physicians in clinical, epidemiological and genetic trials is essential for new medicines development, in-depth studies of medicines and gaining information on optimal administration of medicines to the patient’s best interests. All such trials and studies must meet the following principles:
15.1. A pharmaceutical company is only entitled to render financial, organizational and other support (incl., remuneration for a physician’s work during the trial/study) to such events as registered by the State Agency of Medicines. In such cases the firm’s contribution must be precisely indicated in the documentation to be submitted to the State Agency of Medicines, handed out to trial participants, trial subjects and so on.
15.2. Physician’s remuneration, whatever it may be, must be related to the work performed.
15.3. Remuneration must not be related to any expected trial result.
16. A physician may be paid the following remuneration for a lecture (amount before tax per academic hour):
16.1. up to LVL 80 – basic remuneration;
16.2. up LVL 130 – to a physician having an academic degree;
16.3. up LVL 200 – to a leading expert of the industry;
17. Physicians may be invited to work as consultants. In this capacity they may render services or give expert’s advice to the industry. Consultant’s remuneration must be directly related to the volume of the performed work:
17.1. up to LVL 40 per page for a consultation;
17.2. up to LVL 80 per page for a consultation rendered by a physician having an academic degree or by a leading expert;
17.3. up to LVL 100 for an oral consultation.