The document summarizes an expert panel discussion on EFPIA transparency and physician consent management. The panel will discuss practical experiences implementing transparency solutions, legal risks in consent management, and the impact of transparency on stakeholders. They will also cover upcoming regulation changes and expected consent rates. The panel will address manufacturer reporting, consent collection, physician engagement, report production, and policies/procedures. They will discuss the impact on business practices, physician-manufacturer relationships, industry associations, and the public. The panel will provide recommendations to improve consent collection and address risks of paper-based processes and lack of revocation options.

1. EFPIA Disclosure and Consent
Management

2. Speakers
Ned Mumtaz
Practice Leader Life Science, qordata
Brian P. Sharkey
JD; Vice President, Porzio Life Sciences, LLC (TBC)
Elisabeth Kohoutec
Associate, King & Spalding (TBC)
Moderator

5. Takeaway From This Webinar:
Attendees of the webinar will acquire detailed insight into issues related to
transparency and consent management in Europe. The topics in the
webinar include:
•Practical experiences with implementing a transparency solutions.
•The biggest legal risks in managing transparency.
•Impact of transparency on stake holders.
Related topics that would be covered:
•Upcoming changes in consent management regulation
•Expectations of consent rates in the next round of disclosures

6. Expert Panel discussion on EFPIA Transparency
and Physician Consent Management

7. Expert Panel discussion on EFPIA Transparency and
Physician Consent Management
• In your opinion what worked well for the manufacturers in reporting
spend transparency information in 2015 and 2016 and where do you
see opportunities for improvement?
• Collecting Spend Information
• Receiving Physician Consent
• Engaging Physicians
• Producing Transparency Reports
• Adopting Policies and Procedure
• Others

8. Expert Panel discussion on EFPIA Transparency and
Physician Consent Management
• I would like to next discuss your opinion on the impact of EFPIA
Transparency on:
• Manufacturer’s business practices, physician relationship with
manufacturers, Industrial Associations and Public at large.
• We will cover each in turn.

9. Expert Panel discussion on EFPIA Transparency and
Physician Consent Management
• Manufacturer’s business practices:
• Has the spend reporting and consent collection process affected
pharmaceutical manufacturers business policies and practices in your
opinion?

10. Physicians or Physician Organizations:
• Have the physicians or physician
associations or organizations
responded to the reporting of
spend or collection of consent. Do
you have an opinion on the drivers
for the range of variation in consent
approval. For example according to
EFPIA varied from nearly 95% in
Latvia, 65% in Italy and 20% in
Spain?
Expert Panel discussion on EFPIA Transparency and
Physician Consent Management

11. EFPIA believes that interactions between the pharmaceutical industry and
healthcare professionals have a profound and positive influence on the
quality of patient treatment and the value of future research. At the same
time, the integrity of the decision of a healthcare professional to prescribe a
medicine is one of the pillars of the healthcare system.
• Industry Associations:
• Did EFPIA succeed in meeting its transparency goals in 2015 and
2016? What about the member organizations?

12. Other Stakeholders:
• What has been the reaction of patients, patient organizations,
public at large, and legislature?
The General Data Protection
Regulation (GDPR) (Regulation
(EU) 2016/679) is a regulation by
which the European Parliament,
the European Council and the
European Commission intend to
strengthen and unify data
protection for individuals within
the European Union (EU).
Barcelona, May 26th 2016. Farmaindustria reinforces its
commitment with transparency by approving the individual
disclosure of transfers of value to healthcare professionals

13. Expert Panel discussion on EFPIA Transparency and
Physician Consent Management
What recommendations could you share for the manufacturers to
improve their consent collection process?
• Most manufacturers have not provided for consent
revocation. Is there a risk?
• Many manufacturers have managed the process on paper.
Is there a risk of loosing the paper documents or failing to
retain them?

14. Expert Panel discussion on EFPIA Transparency and
Physician Consent Management
Resources being endless – what in your judgment might be the
best practice to manage consent, consent record keeping, consent
revocation and consent sharing with physicians?

15. Expert Panel discussion on EFPIA Transparency and
Physician Consent Management
If time permits:
Kindly share any general thoughts or opinions you have as learnings
from your roles as a business practitioner and legal practitioner
supporting the manufacturers in pharmaceutical industry.

16. Thank You