Annex III – QUERIES (Questions and Answers) on the interpretation of the Code of Practice
SCOPE OF THE CODE
2. Within the context of educational meetings or courses endorsed by scientific societies dealing with general aspects of certain pathologies and of interest due to their programme, could persons not authorized to prescribe or dispense medicines, but relevantly linked to the handling of these diseases, be invited or have their attendance sponsored in case of a prior request? For example: psychiatric disorders – psychologists (belonging to multidisciplinary psychiatric treatment teams); muscular disorders – physiotherapists; diabetes – educators; in general – nurses or others.
The invitation to persons not authorized to prescribe or dispense medicines that are considered Health- care Professionals by the Law 44/2003 of 21 November on the Organization of Health Professions is permitted, provided that the same criteria that apply to Healthcare Professionals authorized to prescribe or dispense medicines in compliance with provisions of the Code of Practice are applied.
Paragraph 3 of art. 6 of the above law establishes that those in possession of an official degree of specialist in Health Sciences for psychologists are also Healthcare Professionals of licentiate level.
In the same way, art. 7 of the Law recognises that physiotherapists and nurses are Healthcare Professionals of graduate level.
Consequently, psychologists, physiotherapists and nurses are Healthcare Professionals according to the Law mentioned and invitations aimed at them shall respect the Code’s provisions.
3. Would the following promotional practice be compliant with the Code’s provisions? When prescribing a non-reimbursed medicine, a doctor hands out to the patient its mandatory medical receipt together with an informational material detailing the product’s administration and a coupon to be filled out by the patient in case the medicine does not have the expected results after its first administration. In ex- change for its delivery in the pharmacy where the product was acquired, the price paid when picking up the product would be returned. The company, in turn, when receiving the filled out coupon from the pharmacy would refund the product’s cost.
No. This kind of promotional practices cannot be carried out due to the very own nature of medicines. It must be taken into account that the therapeutic or adverse side effects of medicines may not appear after the first administration and that marketing authorization of medicines is granted by the regulatory organisms (AEMPS in Spain) and, consequently, any information about them must be made following the legally established procedures (summary of product characteristics or leaflet).
4. Owing to its 50th anniversary, could a pharmaceutical company invite a group of Health- care Professionals to an activity of an exclusively corporate/institutional nature in, for example, a (i) golf tournament, (ii) classical mu- sic concert or sports event, (iii) banquet?
No, entertainment activities are not appropriate in the context of an interaction between the pharmaceutical industry and Healthcare Professionals.
Institutional events may include a hospitality section, which shall respect the limits defined in the Code of Practice for the Pharmaceutical Industry.
5. Are provisions of the Code (including compulsory notification) applicable to market research studies or services carried out by companies when not directly related to a prescription-only medicine? (For example: a market study to find out what the company’s image is among doctors, or hiring of a Healthcare Professional to participate as a speaker in a corporate/institutional activity?
Yes, the Code of Practice includes all aspects of the interaction between Healthcare Professionals and the pharmaceutical industry.
6. The scope of the Code excludes the commercial transactions of companies with distributors and pharmacy offices. Does this mean we can keep carrying out direct marketing campaigns with pharmacy offices and, if so, is it only if no medicine is mentioned or also if it’s related to a medicine?
The concept "direct marketing" allows for different interpretations. In all cases the activities related to the promotion of prescription-only medicines or interactions with Healthcare Professionals are within the scope of the Code. Commercial transactions (discounts and commercial conditions legally pro- vided) are outside the scope of the Code.