The EFPIA Transparency Directive deems it necessary for all member associations within the EU to publish spend data by Pharma manufacturers on HCP/HCO. For this purpose, under the data privacy laws of the EU, it is necessary for pharmaceutical manufacturers to receive consent from HCPs prior to reporting any transfer of value details in the Transparency Directive EFPIA detailed report.
Even if the HCP refuses to provide consent to the manufacturer, it is necessary for the pharmaceutical to add his/her aggregate spend information to its EFPIA aggregate report and then publish the report on its website. Hence, to fulfill all EFPIA compliance needs, it is necessary for physician consent and data privacy laws in the EU to be taken into full consideration by pharma manufacturers.
EFPIA Transparency Directive – Ensuring Integrity and Transparency
The implementation of the EFPIA Transparency Directive is meant to ensure that all interactions and transactions that occur between pharmaceutical corporations and healthcare professionals do not exceed the boundaries of integrity and transparency.
Amongst the many different requirements of the implementation of EFPIA transparency is that of the management of the HCP/HCO expectations about the program. Effective communication, hence, is the main element that will assist in differentiating between a well-managed transparency program and one in which such queries remain unanswered, which in turn leads to a variety of conflicts of interest later on.
The Building Blocks of a Transparency System
There are three building blocks on which any transparency system needs to be based. These are:
– Introduction and information
– Addressing queries
– Establishment of a process for engagement
Introduction and Information
The fact of the matter is that there are mixed opinions among medical professionals with regard to disclosure initiatives. For this reason, it is necessary for manufacturers to inform healthcare professionals about the transparency directive AND the company’s policy as well. In the words of Andy Powrie-Smith, Communications Director at EFPIA,
“We need leadership in the industry to tell healthcare professionals and healthcare organizations why we are promoting transparency, and we need doctors to discuss their concerns. We have this relationship – we should collaborate on explaining why it’s important.”
Addressing Queries
Even after the physicians are onboard, it is necessary for pharma manufacturers to make sure that their queries and concerns are answered in detail. Some of the most common questions that pharma manufacturers should expect to answer are:
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Where will the reported payments be posted?
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How will the samples be reported?
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What level of detail will the reports have?
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Will my fee still be reportable by the transparency directive even if I am paid by a third-party vendor?
In order to ensure an efficient and adequate understanding of all different perspectives, it is necessary for all questions and concerns, including the ones mentioned above, to be answered in a timely and efficient manner. If anything, it is best for pharma manufacturers to provide HCPs with a detailed list of Transparency Directive FAQs to provide answers for any and all questions that might arise.
Establishment of Process for Engagement
No matter the business case, there will always be cases in which disputes and differences arise among all those involved. In case there is a lack of timely communication regarding issues, then there is always the chance that they will turn into bigger problems with the passage of time. For this reason, it is necessary for pharma manufacturers to use a dispute system that has the potential to address common concerns regarding payments. These include:
– Wrongly categorized payments
– Incorrect associations
– Incorrect amount, etc.
In an ideal situation, the dispute system should operate in a real-time environment, be web-based for easy access, and easy to use so that understanding its functionality doesn’t take time.
As long as these basic requirements are fulfilled prior to the development of a transparency compliance system, it is definitely going to be a success. The EFPIA transparency directive is a huge step towards bringing Pharma and healthcare professionals on the same page, allowing a healthy and positive environment, which is indeed the promise of Healthcare.
