Annex III – QUERIES (Questions and Answers) on the interpretation of the Code of Practice
ARTICLE 17. INTERRELATIONSHIP WITH PATIENT ORGANISATIONS
88. May materials or publications targeted at patients and sponsored by a pharmaceutical company include a section concerning treatments? If so, what requirements must be fulfilled?
Materials or publications targeted at patients may be connected with patient health, with specific disease, with hygiene-healthcare measures, or with healthy lifestyles. In short, such materials must serve to help patients better understand the course of their disease and to enhance their quality of life.
Their content, text, design and characteristics in general must clearly demonstrate their main objective and purpose: a support tool for people affected by a particular disease. They will in any event include visible warning messages/disclaimers stating that: (i) their contents must not be construed as a potential substitute for a diagnosis performed by a Healthcare Professional, and that in the event of any query regarding their contents, the recipient should contact their Healthcare Professional, and (ii) that the publication is intended to offer explanatory guidance, and that the recipient must therefore not undergo treatments or follow advice without first contacting a Healthcare Professional.
In the event that this type of educational and/or informative materials include a section concerning treatments, the recommendation is furthermore to comply with the following requirements:
- Include balanced, accurate and objective information about the available authorised treatments for the disease/pathology in question.
- The reference made to available treatments should be general in nature. For example, in the event that there are authorised medicines they must be referred to as "pharmacological treatment". References to specific medicines, active ingredients, trade marks or similar must not be included.
- Have in place multiple sponsors or collaborators (such as healthcare authorities, pharmaceutical companies, Patient Organisations, scientific societies, companies belonging to other sectors, etc.).
- The content, text, design characteristics of the material must not give rise to doubts as to its intended recipients (patients), and the educational and/or informative nature, character and purpose thereof (non-promotional).
- In the event that such materials or publications are to be distributed at public health centers, their contents should first be shared with the healthcare authorities.
89. May pharmaceutical companies sponsor and collaborate with charitable sporting activities conducted or promoted by Patient Organisations?
One of the aims of the Code is to ensure that the interaction/relationship between pharmaceutical companies and Patient Organisations is conducted in accordance with the strictest ethical principles of professionalism and responsibility.
The need is in this regard to distinguish between Patient Organisation activities intended for patients and their carers and that have an educational and informative nature and purpose (governed by article 17.8 of the Code), and those other activities intended for the general population, with a charitable nature and purpose.
To the extent that the Patient Organisation adopts the necessary measures to maintain and respect this distinction, pharmaceutical companies may collaborate with charitable sporting activities. In any event, the sponsorship or collaboration must be corporate or institutional.