Farmindustria releases updated Code Of Ethics
Published on 2nd Mar 2022
Italy's association for pharmaceutical companies has amended its Code of Ethics with 4 new articles on PSP and on the promotion of medicines.
The Board of Farmindustria, the Italian Pharmaceutical Companies Association, recently approved amendments to its code of conduct that are of interest in connection with information and promotion activities concerning therapies.
Patient support programmes
Article 4.7 updated the definition of patient support programmes (PSP) as an "initiative on the part of the pharmaceutical company with the aim of providing services in addition to, but not in substitution of, those provided by the HCO [health care organisation] or the National Health Service and for the direct benefit of the patient in treatment with a specific drug that has already been authorised to be placed on the market".
The article also reiterates that the material used must not be for promotional purposes, but must be used solely to communicate the information necessary for the appropriate use of the drug. It also confirms that the decision-making responsibility for the PSP must not lie with the marketing, business and sales functions and must be supervised by the company's compliance function.
Important changes include the duration of the PSP, which must be defined in advance and be consistent with the identified need and the desired benefit for the patient, and, in terms of data protection, the clarification that the pharmaceutical company is not responsible for processing the personal data of patients involved in the PSP.
Interactions with other non-prescribers
According to the new article 3.25, pharmaceutical companies are now allowed to provide training and information activities for non-prescribers involved in the administration of therapies, as long as the activities do not have a promotional nature and are specifically related to the role of personnel (for example, nurses) involved in the patient management process, the clinical research and/or the correct and safe administration of therapy. These professionals are permitted to participate in events, congresses and courses on non-drug-related topics within the limits provided for by law for health care professionals (HCP). Any form of advertising is prohibited, as established by the Italian Medicines Code "Decreto Legislativo 24 April 2006, n. 219".
Information to the public
The possibility for pharmaceutical companies to provide information to the public concerning the products and pathologies within their therapeutic areas of competence is now allowed by the new art. 3.26, provided that the information is not of a commercial nature and is derived solely from the patient information leaflets, institutional websites or registers managed by public bodies and institutions. This article also provides the possibility of publishing on the company website information relating to the brand name, an image of the patient information leaflet and of the packaging of the medicine, provided that this information is contained in a specific part of the website accessible only by means of an active search by the user. Therapeutic consultations or treatment recommendations to the general public remain prohibited.
Interactions other than drug promotion
Finally, article 3.28 allows pharmaceutical companies to provide information to various stakeholders (institutions, health professionals, non-health professionals, and health organisations). These interactions must not be promotional and must comply with the legislation and, in particular, with the prohibition on advertising medicines contained in Legislative Decree 2019/2006 (implementing EU Directive 2001/83/CE - Community code relating to medicinal products for human use European Code of Medicines).
This article regulates in detail the requirements applicable to non-promotional interactions such as:
- Access and institutional affairs. Non-promotional interactions with institutions and operators are permitted, using materials having a pharmaceutical-economic content or content connected with the value of the product – describing the economic advantage and saving for the health system, healthcare policies, pathology and patient journey – provided always that these materials are differentiated in terms of form and content from those used for promotional activity and that the same do not contain any promotional elements.
- Account management. It is possible to carry out activities aimed at ensuring the application of commercial policies through interactions with public or private counterparties involved in the purchasing process for the medicines. Price lists may be used provided they do not contain any promotional elements.
- Scientific exchange by MSL. For medical affairs divisions, it is possible to effect a reciprocal sharing with healthcare professionals of non-promotional information on issues related to the healthcare context and its dynamics.
Other types of information concerning the company's products may only be provided to healthcare professionals solely following a specific and unsolicited request from the HCP. Companies must adopt tools to ensure the traceability of requests.