New IFPMA Code of Practice 2019
This oped was first published in the World Medical Journal (Vol. 64, September2018).
An efficient healthcare system depends on mutual trust between all parties – but how should that translate concretely into the day to day reality of whether a healthcare professional should be given a subscription to a journal or a box of chocolates by a pharmaceutical company? So while the most important part of the R&D-based pharmaceutical industry’s work is the discovery of new medicines and vaccines, it also needs to develop, promote, sell and distribute them in an ethical manner and in accordance with all the rules and regulations for medicines and healthcare. It’s not just what we achieve that matters, but also how we achieve it.
In today’s fast-changing world, what might have been considered normal business practice a few years ago may no longer be acceptable. For our industry, what is essential is to constantly try to live up to the trust that so many – patients, healthcare professionals, regulators, policy makers from all over the world – have in the medicines and vaccines we make.
Our R&D-based pharmaceutical industry Code of Practice was first drawn up in 1981, and it was the first one of its kind for any business sector. Indeed, it set a precedent for many other global self-regulation initiatives of industry practices that were to follow. Initially, correct information on the effects and side effects of medicines were at the core of the Code and was necessary to build trust among patients, healthcare professionals, and other stakeholders for the innovations we would bring to the market. Today, through periodic updates of the Code, expectations regarding compliance are much more comprehensive.
The last IFPMA Code revision in 2012 (current version, in force until 31st December 2018) saw its scope expanded beyond just focusing on our promotional practices to cover all our company members’ interactions with healthcare professionals, medical institutions and patient organizations. Over the past two years, we have been revising this Code by consulting with our members from all over the world. Our members are now getting ready to implement a new version of the global Code, which will be effective from 1st January 2019.
With this sixth edition of our IFPMA Code of Practice , we are again setting the bar higher than with previous Codes. The 2019 Code is marked by two important changes. First, several sections have been updated, including the introduction of a ban on gifts and promotional aids (for prescription medicines). Second, we have developed our “Ethos”, the ethical foundation of IFPMA. This addition aims to shift the approach to changing behaviors from a rules-based to a values-based Code. The intention is to ensure our members embrace the values and principles that underpin the requirements of the Code.
The new global Code has been aligned with current European and US guidance and resulted in a global ban on gifts and promotional aids for prescription-only medicines. Any exceptions based on the custom of gifts to mark significant national, cultural or religious events (for example, mooncakes or condolence payments) have been removed. IFPMA members are also banning all promotional items for healthcare professionals for use in their offices (including post-its, calendars, diaries, etc.). The only items that can be provided to healthcare professionals – in the context of company organized events – are company-branded pens or notepads in order to take notes during the meeting.
We have also added the new category of Informational or Educational items. These are things like scientific books, journal subscriptions or memory sticks with educational data that may be provided to healthcare professionals for their own education or for the education of patients, provided that the items do not have independent value. Product branding is not allowed, in the same way as for items of medical utility (such as inhalers, or devices to learn how to self-inject).
As R&D-based pharmaceutical companies are the innovators behind most new medicines and vaccines, they are best equipped to share much of the information on medicines and their application, and have the responsibility to share this scientific knowledge with healthcare practitioners. Today’s fast pace of medical innovation requires a continuous dialogue to ensure that patients have access to the treatments they need, and that healthcare professionals have up-to-date, comprehensive information about the medicines they prescribe. We think that the so called “goodies” or “promotional aids”, even if they are of minimal value, send the wrong message, as they trivialize the important, professional relationship that must exist between our representatives and the healthcare professionals. This relationship is based on a mutual exchange where both sides win by sharing expertise and scientific knowledge, enabling the development and effective use of new medicines.
The latest IFPMA Code emphasizes the educational nature of these important interactions and supports high-quality, patient-centered health services and further focuses on the value we bring to patients, and to society as a whole.
Trust remains the crucial bedrock of these exchanges and IFPMA encourages doctors, pharmacists, nurses and patients to become aware of our updated ethical standards. The better our stakeholders understand our standards and hold us to account, the easier it will be for us to live-up to our commitments.
By Thomas Cueni, IFPMA Director General and co-chair of the APEC Biopharmaceutical Working Group on Ethics