IFPMA and the International Alliance for Patients’ Organizations (IAPO) launched an advisory Note for Guidance for IFPMA member companies and associations worldwide on best practices when dealing with patients, caregivers, and patient organizations. To mark this occasion, we sat down with David King, Co-Chair, IFPMA Ethics & Business Integrity Committee Patient Centricity Working Group, to discuss interactions between pharmaceutical companies, patients and patient organizations and the future development of IFPMA’s Code of Practice.

The new IFPMA Code of Practice has just celebrated its first birthday. Interactions with patients and patient organizations are only mentioned in one short chapter. Why is this so, given the crucial role that patients and patient groups play in advocacy, education, and research?

The IFPMA Code has evolved over time. From an initial focus on promotional interactions with Healthcare Professionals to later including provisions covering consulting fees, meals, gifts, as well as interactions with patient organizations. In my view, the current chapter on interactions with patient organizations in the IFPMA Code of Practice reflects consensus that existed many years ago, and even before the more recent focus by all stakeholders on the importance of bringing the patient perspective into everything that we do. The Code chapter on interactions with patient organizations was not updated last year and the Note for Guidance recently issued by IFPMA is a step towards strengthening the Code to address the ways the industry may interact with patient organizations.

It is essential to ensure that patients and patient organizations remain independent and interactions with them remain transparent. How is the industry addressing the issue of a potential ‘conflict of interest’ between the pharmaceutical companies and patient organizations in cases where they receive corporate funding?

I think it’s fair to say that in most cases corporate funding of patient organizations does not create a conflict of interest. There are many areas where the interests of patient organizations and the interests of the pharmaceutical industry are aligned, and industry funding enables many quality educational programs and activities carried out by patient organizations that would not otherwise exist. However, we need to ensure that the ethical basis for interactions between companies and patient organizations is well understood and transparent, in order to maintain trust. The IFPMA approach as outlined in the Note for Guidance is for companies and patient organizations to establish and adhere to clear ethical principles to govern their relationship. Not only is it important for patient organizations to be independent of industry, it is important for both sides to take formal steps to ensure that independence is maintained. The Note for Guidance recommends that companies generally avoid being the majority funder of a patient organization and that patient organizations seek a wide variety of support including from non-pharmaceutical industry sources. It further recommends meaningful disclosure of industry funding by both parties, and documentation in the form of a clear and concise written agreement.

Why is this guidance not binding? Are there any plans that it would be included in a future Code of Practice?

This guidance is a step in the process towards amending the Code of Practice. IFPMA has 50 member companies and 50 national and regional pharmaceutical industry associations. As the Co-Chair of the IFPMA Ethics & Business Integrity Committee Patient Centricity Working Group, I along with my colleagues are working towards ensuring that all members adopt these recommendations as a best practice, and use the Note for Guidance when considering code changes at the national or regional level. The Note for Guidance is a living document and will be updated in case any current recommendations require further thought and refinement. Through this approach I expect a consensus to emerge, which can be incorporated into the next edition of the IFPMA Code.

A recent analysis published in BMJ found that patient organizations are often not disclosing their corporate funding and lack policies concerning such financial transfers. Is the new IFPMA guidance intended to change this?

I believe it is vital for the ethical principles in the Note for Guidance to apply universally. We encourage patient organizations to develop internal guidelines and policies on interactions with the pharmaceutical industry, and to disclose industry support on their websites. Companies should encourage such disclosures by patient organizations and should likewise disclose on their company websites the names of patient organizations they support.

Looking ahead, what would you like to see in the next Code of Practice update?

I think a clear consensus is emerging in favor of meaningful disclosure of company support to patient organizations and that is probably one area of focus for the next Code of Practice update. I personally believe the most effective method is for disclosure at the time of an activity or publication. Additionally, I think the updated Code could potentially contain a requirement for companies to include on their websites a list of patient organizations they support. This is already required by several national and regional codes and is an effective way to ensure public knowledge of which patient organizations receive industry support. However, as I said, it’s a collaborative process and will require all stakeholders to work together to ensure patients’ interests remain at the centre of everything we do.

Author

• David King