EFPIA Disclosure and Consent Management

Speakers

Ned MumtazPractice Leader Life Science, qordata

Brian P. SharkeyJD; Vice President, Porzio Life Sciences, LLC (TBC)

Elisabeth KohoutecAssociate, King & Spalding (TBC)

Moderator

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

Expert Panel discussion on EFPIA Transparencyand Physician Consent Management

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

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.

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?

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

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?

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

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?

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?

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.

Thank You