APIFARMA – Portuguese Pharmaceutical Industry Association (Apifarma) recently approved a revision to the Code of Ethics for Promotion Practices of the Pharmaceutical Industry and Interaction with Healthcare Professionals and Health Organisations (2023 Code of Ethics), effective in Portugal from 1st January 2023.
The 2023 Code of Ethics aims to align its wording with that of the EFPIA, IFPMA and MedTech Codes to create a uniform regime for the issues covered therein. Following criticism from the industry regarding the terms and application of the 2018 Code of Ethics’ rules on the promotion of medicinal products, Apifarma chose to clarify in the explanatory memorandum framing the 2023 Code of Ethics that the latter does not aim to restrict the promotion of medicinal products as to harm free competition, but to ensure that the promotion of products and services is carried out ethically, and in compliance with applicable laws and regulations.
Specifically, the 2023 Code of Ethics:
1. Assumes the founding principles of the MedThec Europe Code as an integral part thereof and as a framework for the interpretation of the rules comprised therein, including:
- the principle of the primacy of the patient in the activity of pharmaceutical companies;
- the principle of integrity;
- the principle of mutual respect and reciprocity;
- the principle of diversified financing;
- the principle of transparency.
2. Extends its application to the relations of the industry with Health Organizations, comprising legally established corporate bodies, regardless of their form of incorporation, which may or may not comprise health professionals, engaged in the provision of health care, research, teaching and scientific activities (with the exception of patients organisations), such as hospitals and clinics, public and private, scientific societies, foundations, medical associations, universities and other teaching institutions, professional associations in the health field.
3. Broadens the definition Health Care Professional, now including pharmacy technicians and, in the field of in vitro diagnostic medical devices, diagnostic technicians and laboratory technicians who, in their professional activities, may directly or indirectly prescribe, recommend, administer, use, supply, order or decide on the purchase or rental of in vitro diagnostic medical devices or related services.
4. Creates a definitions article, to assist on and clarify the interpretation and application of its rules.
5. Determines that information on efficacy and safety of medicinal products must reflect available proof and be capable of being substantiated through clinical data.
6. Broadens the acceptable basis for comparisons between different medicinal products and different in vitro diagnostic medical devices to include objective elements, such as the price.
7. Clarifies that pharmaceutical companies may reply to clarification requests from the general public on medicinal products if within the scope of the information included in the leaflet and labelling; in these cases, pharma companies must also recommend that a health care professional be consulted.
8. Determines that compensation for the sponsorship of events must be a tangible benefit, clarifying that the placing of a company's logo on the event's publicity materials or the receipt of written or verbal acknowledgements from the event organisers does not constitute a tangible benefit for the purposes of the Code.
9. Contains a provision on the e4ethics online event preassessment platform.
10. Determines pharmaceutical companies should not request or demand to be the sole funder or sponsor of a health organisation, or of any event or activity organised by it.
11. Contains rules on non-interventional studies of marketed medicinal products or in vitro diagnostic medical devices, defining them as the studies where the products are prescribed in a usual manner, according to the terms of the respective market authorisation, no additional diagnostic or monitoring procedures should be used and only epidemiological methods should be used for the analysis of the collected data. As per the applicable rules, non-interventional studies must have a study protocol and be submitted to and approved by the respective Ethics Committee. In addition, if the study reveals important results for the risk-benefit assessment of a product, the executive summary should be immediately sent to the competent authority.
The 2023 Code of Ethics is not applicable to the relationships between the industry and patients’ organisations, patient advocates, patient experts, patients, and carers, that are ruled by a specific Code of Conduct in effect from 1 January 2021.