The International Federation of Pharmaceutical Manufacturers and Associations' Code of Practice (the "Code") has been amended for the first time since 2012. The Code applies to IFPMA's members and anyone acting on their behalf. The amended Code came into effect on the 1st of January 2019 and comprises two important changes in relation to its previous version. First, it bans gifts and promotional aids for prescription medicines. Second, the Code presents a shift from a rules-based to a values-based approach.
As the introduction indicates, several provisions have been updated, in particular on gifts and promotional aids. These, so-called "goodies", are now fully banned for prescription-only medicines (POMs). Although the 2012 Code banned gifts for the personal benefit of healthcare professionals (HCPs), it did permit exceptions like customary gifts for significant national, cultural or religious events (for example mooncakes and condolence payments). Such exceptions have now been removed. The ban also includes stationary items such as pens, post-it's and block notes (when not being offered for the sole purpose of taking notes during a conference). The aim of this change is to avoid "any perception of potential influence" of an HCP while prescribing a POM.
Further, a new category of informational and educational items has been added to the Code. This category includes scientific books, journal subscriptions and memory sticks with educational data. These items may be provided to HCPs for their own education or for the education of patients, provided that the items do not have independent value and are not branded. The same applies to products of medical utility used to train patients (such as inhalers or self-injectors) which also may not be branded.
Over-the-counter (OTC) products, when not prescribed by an HCP, are of lower concern, since it is the patient itself who makes the choice whether or not to buy a particular product. Therefore, the Code still permits promotional aids of minimal value and quantity, related to OTC products, to be provided by member companies to HCPs, but only if it is relevant to their practice.
Already in 2014, the European Federation of Pharmaceutical Industries and Associations (EFPIA), updated their code to ban gifts in relation to prescription medicines. This tightening of the rules to fully ban gifts by IFPMA brings its code into line with current US and European guidance and rules.
The second reason given for amendment of the Code is the introduction of an IFPMA Ethos to shift from a rules-based approach to a code based on values and patients' trust. According to the IFPMA's news release, the new ethos aims to go beyond and seeks to promote a culture of ethics and integrity. This new ethical framework must guide business behaviors and interactions between IFPMA members and the healthcare community, no matter how testing the circumstances.
Thomas Cueni, who became Director General of IFPMA in 2017, states in the foreword of the Code that the new Code represents IFPMA setting the bar higher, and that the new code "seeks to embody a deeper and broader appreciation of business integrity", being "principle-based".
Many national and regional pharmaceutical trade associations rely on the IFPMA Code for their own codes of conduct, and, whilst companies may also be following their local codes, the IFPMA Code acts "as a default" for any complaints about the activities of member companies in countries where there is no national code, no appropriate regulations, or where a member company is not part of the local association.
This was first published in Lexology.com.