The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has recently published a new version of its Code of Practice that will come into force on January 1, 2019, updating the current Code of 2012. IFPMA members, including the EFPIA and PhRMA, must incorporate the new provisions into their own codes by this date, to the extent necessary.
In addition to the text of the Code, the IFPMA has provided detailed guidance on the key amendments made. First, the Code is now underpinned by a guiding Ethos that replaces the previous iteration’s ‘Guiding Principles’. Secondly, several provisions have been updated, notably the section on gifts. We highlight the key changes below.
It is hoped that the introduction of a Code ‘Ethos’ that places patient trust at its center will facilitate a shift from a rules-based approach to a Code based on values, principles and good judgment. The Code Ethos is built upon four main pillars: care, fairness, honesty and respect that should guide the industry conduct and interactions with patients and other stakeholders. The IFPMA believe that this framework will help members make the right decisions, even when faced with tough questions that are not explicitly covered by the rules.
The aim of the changes to this section is reflected in the new wording added to chapter 7.5 (Gifts):
“Items in this section, where permissible, must never constitute an inducement to prescribe, recommend, purchase, supply, sell or administer a pharmaceutical product.”
The 2012 edition of the Code, which addressed for the first time interactions between companies and other stakeholders, had already banned gifts for personal benefit. The new requirement tightens the limited exceptions to this ban further. ‘Social courtesy gifts’ (e.g. mooncake gifts or condolence payments in China) whether received directly or indirectly, are no longer permitted. This move clarifies the requirements regarding this category of gifts and helps to align the Code with the codes of its member associations, and ties in with its commitment to patient trust. The new requirement recognizes that even small cultural gifts may have an influence on doctors.
Along the same lines, the Code specifically bans promotional aids, or non-monetary reminder items, such as post-its and calendars, in relation to the promotion of prescription-only medicines. Promotional aids related to the promotion of over-the-counter medicines can still be used if relevant to the practice of the Health Care Professional (HCP). Pens and notepads at company organized or third-party events are allowed, but only if of minimal value and in the necessary quantity for the event.
The new Code provides further clarification on items of gifts of medical utility, such as inhalation devices, devices intended to assist patients to learn how to self-inject, or mobile apps. These items can include the company name, but must not be product branded, unless the product’s name is essential for the correct use of the item by the patient. In addition: the item must be of modest value, only offered occasionally, beneficial to enhancing the provision of medical services and patient care, and should not be expected to be supplied by the HCPs themselves. Member associations are expected to provide guidance using local currency on acceptable monetary amounts for “modest”, “minimal” and “reasonable” value.
‘Informational or Educational items that enhance Patient Care’ may be provided to HCPs for their education or for the education of patients, provided that the items are primarily for educational purposes and do not have independent value. Examples provided are journal subscriptions and memory sticks pre-loaded with educational data (provided its storage capacity is commensurate with the materials provided). Companies providing gifts should consider the cost as well as the overall benefit to an individual HCP in a given year.
- The Complaint Procedure has not changed in scope but the procedure has been updated. Changes include:
- An oral hearing in the context of the Appeal Procedure is now possible.
- Time limits will now be counted by calendar, rather than working, days.
- Adjudication and Appeal groups will be elected for two, rather than one year.
- A section has been added on anonymous complaints, which are still accepted but the provision of contact details is encouraged.
- A Second Review is now possible by the Appeal Group.
- A series of minor changes clarifying issues such as the rules on events involving foreign travel have been made.
The IFPMA introduced in June 2018 a separate Note for Guidance on Fees for Services; which adds points to consider for advisory boards and it updated its Note for Guidance on Sponsorship of Events and meetings.
These notes of guidance are not binding but the IFPMA encourages its member companies and member associations to take them into account when implementing the Code in their daily practice.
The Questions & Answers section of the Code that was introduced in 2006 and expanded in 2012, has now been adapted to the Code revisions.
The process for and implications of enforcement of the Code remain the same. The IFPMA Statutes require all IFPMA member associations and companies to adhere to the provisions of the Code. This means that the promotion of any medicine, anywhere in the world, by a company member of IFPMA or any company that is a member of a IFPMA association, should be in accordance with the provisions of the Code or more stringent local codes.
IFPMA member associations, under their own codes, handle alleged breaches occurring in their respective national territories. Complaints occurring in countries where there is no national code, appropriate laws or regulations, or where a member company is not a member of the local or regional association, fall within the scope of the IFPMA Code. In these cases, the IFPMA investigates and processes the complaints. If the IFPMA Code is found to have been breached, IFPMA will publish the name of the company concerned and its offences.
Where no breach is ruled, a summary of the case will be published on the IFPMA website. The information disclosed will include the relevant country and a brief summary of the key facts. The respondent company, the complainant, and products are not named.
The IFPMA is planning to publish a new Note for Guidance on Medical Education by December 2018.