03/05/2012  |  Posted By:

Late last week (March 1), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) issued an updated Code of Practice, extending its guidance to include all interactions with healthcare professional groups, medical institutions and patient organizations. 

The code now incorporates specific guidance on engaging with patient advocacy organizations, a key area of interest for JPA clients, which is outlined in brief below.

Key Highlights – Article 11 – “Interactions with Patient Organizations”:

11.1 – Scope: All interactions with patient organizations must be ethical, and the independence of the patient organization must be respected.

11.2 – Declaration of Involvement: Companies must ensure that the nature of their involvement with patients organizations is clear from the outset, and no company may require that it be the sole funder of a specific patient organization program, activity or initiative.

  • It is permissible, however, for a company to be the sole funder of a patient organization program if the organization makes the decision to only accept funding from one company.

 

11.3 – Written Documentation: When a company provides financial support or in-kind contributions to patient organizations, it must execute written documentation outlining the nature of support, including the purpose of any activity and its funding.

11.4 – Events: Companies may provide financial support for patient organization meetings if the primary purpose of the meeting is professional, educational and scientific in nature, or if the meeting otherwise supports the organization’s mission.

  • Venue and location must be appropriate and conducive to communication.
  • Meals and refreshments provided must be “modest as judged by local standards.”

 

At JPA, we are working to ensure this new guidance is kept under close consideration as our Industry clients engage with patient advocacy organizations, in addition to regional and local standards previously established by other organizations and regulatory agencies.  IFPMA members must implement these standards by September 1, 2012 to ensure compliance.