The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) released a new Industry Code of Practice, to take effect in less than one month, on January 1, 2019. IFPMA is hoping that this revision will align the rest of the world with rules already in place in the United States and the European Union, establishing an effective global ban on gifts and promotional aids for prescription medicines for its member companies.
The Code, initially drafted and released in 1981 and most recently revised in 2012, notes that, “Gifts for the personal benefit (such as sporting or entertainment tickets, electronics items, social courtesy gifts, etc.) of HCPs [health care professionals] (either directly or through clinics and institutions) are prohibited. Providing or offering cash, cash equivalents or personal services is also prohibited.”
“Any exceptions based on the custom of gifts to mark significant national, cultural or religious events (for example, mooncakes or condolence payments) have also been removed,” IFPMA said. In addition, providing or offering promotional aids, which are nonmonetary gifts, for the promotion of prescription-only medicines is prohibited. However, the Code does allow for “Promotional aids of minimal value and quantity may be provided or offered to HCPs solely for the promotion of over-the-counter medicines if relevant to the practice of the HCP.”
Another caveat under the Code is that pens and notepads may be provided to HCPs “in the context of company organized events for the purpose of taking notes during the meeting. They must not bear the name of any medicine but may bear the name of the company providing them. In addition, they must be of minimal value and only the necessary quantity are distributed. Examples of banned promotional aids include sticky notes, mouse pads, calendars, etc.”
CME Guidance
Not to be left out, IFPMA released a Note for Guidance on Continuing Medical Education (CME) on December 5, 2018, which notes that CME may be funded by industry but the scientific program and content must always be decided independently from industry influence, and that the audience be identified and invited by the organizer, not the pharmaceutical company. If a pharmaceutical company wishes to sponsor a CME event, the role of the company must be declared as required by the Code.
No company shall be permitted to organize or sponsor an event for HCPs that takes place outside the HCP’s country of practice unless it is appropriate and justified to do so from the logistical or security point of view. Therefore, international scientific symposia and congresses are justified and permitted as they typically have participants from many different countries.
Further, refreshments and/or meals incidental to the main purpose of the Event are permitted so long as they are only exclusively provided to the participants of the event and are moderate and reasonable as judged by local standards. No entertainment or other leisure than be provided or paid for by member companies.
Interestingly, while it has been reported that the IFPMA is banning all gifts, the Code does not ban services or meals – only cash gifts and promotional aids. This definition of gift is clearer and more insightful than current definitions proposed by individual cities and states attempting to ban gifts.
“The very nature of our business requires us to earn and maintain the trust of the people we serve. Our Ethos ensures we have a solid foundation on which to build trust with doctors, nurses, patients, and those who care for patients as well as groups that represent them. We also seek to build trust within the pharmaceutical industry’s ecosystem – our staff, scientists, suppliers, etc. Trust is essential to achieving our industry’s noble mission of discovering and delivering medicines to patients who need them.” said Melissa Barnes, chair of the IFPMA Ethics and Business Integrity Committee, senior vice president for enterprise and risk management and chief ethics and compliance officer of Eli Lilly & Co.