For most pharma companies in the EU, seeking the consent of the HCP’s/HCO’s that they indulge in transactions is the most appropriate means of ensuring compliance with data protection laws when disclosing their spending under the EFPIA disclosure code.
Indeed, the Code comes with guidance notes that place special emphasis on pharmaceutical companies seeking consent from HCPs and HCOs. Apart from that, certain national associations (including the ABPI), have also proposed model consent wording that should be used for the attainment of consent from HCPs and HCOs.
The fact of the matter is that consent helps pharma companies develop a rather strong basis when making data disclosures. Once consent is obtained, it becomes less likely for individuals and authorities to later object to disclosures. However, with all the benefits that consent has to offer, there are countless challenges involved, too.
A practical difficulty
The attainment of valid consent doesn’t come easy. Summarised by the Article 29 Working Party in its Opinion 15/2011 on the definition of consent, it is necessary for consent to be ‘informed’, ‘specific’, ‘freely given, and ‘unambiguous’.
Apart from that, it is vital for pharma companies to provide clear information to HCPs and HCOs with regard to the scope of consent. This is meant to make sure that all the parties involved have a clear understanding of what they are actually agreeing to.
As for HCO’s and HCP’s, it is necessary for them to signify their agreement to the said process in a clear manner. With that, they must also be given the power to withdraw or revoke their consent at any given point in time.
Communication of information
The number one challenge faced by pharmaceutical companies is hence related to the communication of information to concerned HCPs and HCOs. This needs to be achieved in a format that meets all the pre-set requirements of local data protection laws.
After that, pharma companies need to implement a process through which the choices made by HCPs and HCOs can be recorded (whether they give consent or not). For this purpose, it is vital for them to establish a business process through which larger companies can acquire the ability to deal with countless individuals in any given year.
Valid consent needs to be given ‘freely’
It is necessary for valid consent to be freely given. What this means is that a genuine choice should be available for HCOs and HCPs, and their consent must not be ‘forced’ due to a fear of adverse consequences that may be triggered due to refusal to consent.
For this reason, it is best for pharma companies to refrain from taking an approach wherein they refuse to work with HCPs/HCOs who refuse to consent to the disclosure. In such a case, they would risk invalidating the consent of those that agree to data disclosure.
Dealing with anonymization
The next challenge faced by pharma companies in the EU revolves around ensuring that disclosures are pursuant to the Code while taking the choices made by HCPs and HCOs into consideration. This deems it necessary for them to anonymize, by means of aggregation, the details of annual payments and transfers of value made by category instead of by individual HCPs and HCOs.
For this, it becomes necessary for reporting entities to develop a system to ensure that they have detailed knowledge as to whether the data of a specific HCP/HCO can be disclosed or not. This system will further help them ensure that the disclosure data of non-consenting HCPs and HCOs is disclosed only on an aggregated basis.
