Title I - PROVISIONS OF THE CODE
CHAPTER II - Interaction with Healthcare Professionals and Organizations
10. GUARANTEES OF INDEPENDENCE4
10.1. Prohibition of Gifts
In order to avoid incentivizing the prescription, dispensing or administration of prescription-only medicines, the direct or indirect offering or provision of any type of incentive, prize or gift (in cash or in kind) to Healthcare Professionals is prohibited.
The above prohibition does not apply to the direct or indirect offering or provision of stationery or items for the practice of medicine or pharmacy that meet the following conditions: (i) is not related to a prescription-only medicine and (ii) the market price does not exceed 10 Euro.
10.2. Informational or Educational Materials and Items of Medical Utility
10.2.1. The direct or indirect provision of informational or educational materials to Healthcare Professionals will be permitted provided that they meet the following three conditions:
(i) Inexpensive. In this regard, the material is considered to be inexpensive when the market price does not exceed 60 Euro.
(ii) Materials directly relevant to the practice of medicine or pharmacy.
(iii) Materials that directly benefit patient care. Provision of this type of materials shall not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer a medicinal product.
10.2.2. Items of medical utility aimed directly at the education of Healthcare Professionals and patient care can be directly or indirectly provided to Healthcare Professionals if they are inexpensive (their market Price does not exceed 60 Euro) and do not offset routine business practices of the recipient.
10.1 In application of the principle of coherence and in order to avoid it being interpreted as an offering or provision of gifts related to prescription-only medicines, companies:
a) within the framework of medical visits mainly related to prescription-only medicines, shall refrain from the offering or provision of stationery or items for the practice of medicine or pharmacy.
b) within the framework of scientific and professional meetings organized by a third party, where promotion mainly pertains to prescription-only medicines, shall refrain from the offering or provision of stationery or items for the practice of medicine or pharmacy. Companies shall not offer or provide stationery or items for the practice of medicine or pharmacy in the exhibition stands. Pens or pads included in the congress bag shall not include any kind of promotional element or reference, that is to say, they shall not include corporate/institutional advertising or product advertising. Each company shall be responsible for individually assessing the scope and nature of each scientific and professional meeting, including the activities/practices it plans to carry out within its framework, in order to determine whether such meeting is mainly related to prescription-only medicines.
c) within the framework of scientific and professional meetings organized by a company, only pens and pads may be offered or provided; provided that they are not related to a prescription-only medicine and their market price does not exceed 10 Euro (tax included).
10.2. The provision of materials to Healthcare Professionals, including but not limited to those detailed below, is permitted provided they meet the requirements indicated in articles 10.2.1 and 10.2.2(*):
- Printed materials used to promote or provide information on medical practice and medicines. The contents of these materials must meet the requirements indicated in articles 2 through 7 (inclusive) of the Code.
- Reprints, supplements from scientific articles.
- Educational materials provided to the Healthcare Professional for use with patients.
In addition, companies must take into account:
a) In those materials aimed at patients, guarantee that these do not include elements that directly or indirectly relate to prescription-only medicines (for example: colours, logos, brand, active ingredient, claims/promotional sentences, etc.).
b) In those materials aimed at Healthcare Professionals (different from those used to promote their products), refrain from including elements directly or indirectly related to prescription-only medicines, unless such materials meet the conditions established by the competent health authorities for "valid means of delivery".
c) Regardless of their market price, refrain from directly or indirectly offering or providing to Healthcare Professionals items or articles necessary or essential to their professional practice, as such activity/practice offsets routine business practices, especially taking into account the individual and exclusive use of many of them. The Healthcare Professional or the organization where he provides his service are the ones that have to provide the resources and means necessary for the carrying out of his professional activity. Consequently, regardless of its market price and even if they could be considered medical utility items, stethoscopes, phonendoscopes, pulsioximeters, medical coats, medical clogs, surgical caps, globes, surgical goggles, tensiometers, masks, gauzes, bandages, dressings, etc. shall not be provided.
d) In all cases, the direct or indirect offering or provision to Healthcare Professionals of informational or educational materials and items of medical utility whose market price exceeds 60 Euros shall constitute a breach of the Code.
e) The offering or provision to Healthcare Organizations of items or materials not permitted mentioned in the above (c) and (d) sections shall constitute a breach of the Code when they involve an indirect offering or provision to Healthcare Professionals.
f) These requirements shall apply regardless of the means of delivery used to directly or indirectly offer or provide the informational or educational materials and items of medical utility (for example: on a physical medium – printed materials-, or on a digital medium – mobile apps-, etc…).
(*) As an exception, the provision of flash drives that contain scientific-professional content of an informational or educational nature is permitted, provided that its market price does not exceed 10 Euro.
4 Adapted to the new revision of articles 9 and 17 of the EFPIA Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals.