While many regulations around the world enforce public disclosure and transparency for healthcare companies related to payments for consultancy or sponsorship, the publication of individual names of healthcare professional could raise issues of data privacy and confidentiality in national legislations and EU directives. The EFPIA Code for public disclosure requires all members of EFPIA to disclose all transfers of value to HCP’s and HCO’s occurring in 2015 by 2016.

The Code mentions that “EFPIA recognises that disclosure can raise data privacy concerns…” The draft notes to Clause 21 of the Code state that: “Companies are encouraged to include a contract involving a transfer of value provisions regarding the consent of the recipient to its disclosure.  In addition, companies are encouraged to renegotiate existing contracts at their earliest convenience to include such consent to disclose.”

The article 29 WP of the EU Data Protection Directive underlines the fact that for disclosure of individual names, where Transfer of Value (ToV) to a HCP occurs in the context of a contract, the contract provides a ready mechanism to obtain the data subject’s consent to the processing of his/her personal data: the purpose of which is to meet that member’s obligations under the Code. As matter of good practice, data controllers should create and retain evidence showing that the consent was indeed given.

Looking at the EFPIA Disclosure Code on an EU-wide basis, there are other issues to consider:

  • Is it possible to obtain consent across the EU – for the purposes of the EFPIA Disclosure Code – and comply with the variations in approaches taken by national data protection regulators?
  • Will data collected for the EFPIA Disclosure Code be exported outside the EU, triggering further consent requirements from the healthcare professionals?

Pharmaceutical companies should consider the data protection implications of implementing the EFPIA Disclosure Code on a country-by-country basis for the EU jurisdictions in which they make payments to healthcare professionals or healthcare organisations.

The changes in the EFPIA Disclosure Code are to be applied to member associations’ local codes by the end of this year.