CBI Scene Blog

EFPIA Transparency Directive and Data Privacy in EU: 3 Clear Patterns

Posted by Ned Mumtaz on Jun 15, 2015 3:26:17 PM


I recently had the pleasure of attending CBI’s Global Transparency Reporting Congress and wanted to share a few key takeaways from the event. This conference was attended by high-profile members of pharmaceutical industry national associations (ABPI, FarmaIndustria, others), EFPIA, clinical research organizations, compliance software suppliers, pharmaceutical consulting organizations and compliance law firms.

It is interesting to see that the conference presentations and attendee feedback showed three clear patterns; one for spend data collection, the second for data privacy management and the third for physician support. 

Pattern 1: Divide and Conquer

The EFPIA reporting pattern that emerges shows a distribution of responsibilities between the headquarters and affiliate countries. The EU headquarter is collecting and collating the spend data from each affiliate country to produce the final transparency report. Each affiliate country conversely is responsible to:

1) Collect their spend data

2) Verify the spend data for completeness and accuracy

3) Arrange the spend data in a predefined format

4) Ship the spend data to the central group by the scheduled date

5) Be accountable for any discrepancies, challenges or local fines stemming for data errors


Pattern 2: Establish Smooth Running Systems to Handle Physician Consent

Data privacy efforts are less mature and the pharmaceutical organizations are still looking to create a more reliable approach to handle physician consent. How?

1) Organizations are recording consent either through paper or digital physician signature.

2) Some organizations are planning to run a program to collect physician consent around May 2016 by postal mail or email.

3) Organizations are modifying their contracts to include consent in physician agreements.

4) Though the penalty of €500,000 for violating a physician’s data privacy is steep, many organizations don’t have a mechanism to handle multiple changes to the consent yet. For example, a physician may initially decline consent, then provide his consent in writing and finally revokes his consent in writing or verbally by informing his sales representative in the presence of his secretary. Most organizations are not prepared to handle such a situation.


Pattern 3: Educate physicians & Review Spend

Most pharmaceutical organizations have not initiated any campaign to inform the physician about the data transparency program, nor planned to solicit physicians review of his spend activities or handle physician disputes. It is notable that the subject of data transparency is the physician who, by definition, has a high risk of exposure, and as a sole entity, has few resources to support the program. Pharmaceutical companies would be best served to create a comprehensive program to inform, engage and support physicians.

To conclude, it is important to note what patterns emerge out of the EFPIA transparency reporting directive and data privacy laws – there is a clear distribution of responsibilities between EU headquarters and affiliate countries for EFPIA reporting; organizations are looking to create a more reliable approach to handle physician consent and physician education campaigns and analyzing spend are of prime importance. Understanding EFPIA reporting trends is one of the key steps to a successful reporting process for any pharmaceutical organization and will help establish the right solution in place. To this end, CBI continually plays a significant role in educating members of the pharmaceutical industry and creating much-needed industry awareness.

Ned Mumtaz, Practice leader US & EMEA, Streebo

Continue the conversations surrounding global and domestic transparency at two can't-miss events:

The 9th Annual Forum on Transparency and Aggregate Spend
August 17-19, 2015 | Washington, DC

2nd Annual Global Compliance Congress
November 18-19, 2015 | Munich, Germany



Topics: Compliance