Life Science Compliance Update

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April 13, 2016

UK’s Version of EFPIA Disclosure: Bred with the Sunshine Act in Mind

Recently, we wrote about the transparency and disclosure changes coming to Europe, and promised a more in-depth view of the United Kingdom system. As we mentioned, beginning June 30, 2016, patients will be able to find out if their physician, pharmacist, or other healthcare professional has received payments from a pharmaceutical company. The payments include payments for attending a medical event to acting as an advisor to a company, and will be listed on a publicly searchable database, Disclosure UK. The database will be hosted by the Association of British Pharmaceutical Industry (ABPI).

While this move was prompted by EFPIA (the European Federation of Pharmaceutical Industries and Associations), thirty-three countries in Europe will apply the transparency goals and recommendations in different ways. Some countries are opting for a central platform database similar to the UK database, and others will allow for payment disclosures to be made on company's own websites. Some countries (i.e., France, Slovakia, Greece, Romania) have even passed legislation to make disclosures of payments to healthcare professionals mandatory.

ABPI believes that while the EFPIA requirement only mandates that payment information be available on the relevant Member Company's website, using a central database will make it easier for interested parties to access the information and to compare data.

In the United Kingdom, disclosures will be made by companies who pay the healthcare companies (similar to the requirements under the United States Physician Payment Sunshine Act), but payments may only be included in the public database if the healthcare professional gives their consent. Such data protection rules may help to protect physicians from some of the untoward effects we have seem stem from public disclosure of physician and pharma ties in the United States.

United Kingdom Health Secretary Jeremy Hunt, however, seems to be a fan of the Sunshine Act, because he is introducing a "sunshine rule," specific to dealings with National Health Service (NHS) personnel. If NHS staff are found to be abusing their position by taking extravagant gifts or hospitality and lobbying for unneeded or overly expensive drugs, negative consequences follow, ranging from disciplinary action to dismissal to imprisonment.

How Will the ABPI System Work?

As a broad brush overview, the system will first rely on companies to collect details of any relevant payments made to Health care providers (HCPs) or health care organizations (HCOs) and collate them into a standard template, which will be modeled after the EFPIA template. Then, the template will be uploaded through a secure system. Payment data from all companies will be consolidated and reconciled in a central location, with unique identifiers being added to all HCPs and HCOs. A third party provider will manage this aspect, ensuring the data is "clean, complete and up-to-date." The third party provider will then also maintain the centrally-hosted database where the information can be found.

ABPI will provide materials and training for Member Companies as to how the system will work as they begin to gather data. HCPs whose data will be disclosed will be personally and individually contacted throughout 2016, with notification of what data will be disclosed and when.

The very first disclosure will be available on the ABPI system by July 1, 2016, covering payments made through the entire year of 2015.

If you are an ABPI member company and you have questions, or would like more information, you may email disclosure@abpi.org.uk. ABPI members may also email disclosure@abpi.org.uk to be added to the Disclosure Network distribution list, where they will receive detailed operational updates on the project.

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