Life Science Compliance Update

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April 13, 2016

EFPIA Disclosure “Sunshine Act – Lite”

For the first time, on June 30, 2016, pharmaceutical companies will be forced to disclose full data on payments made to doctors across Europe. Starting then, all pharmaceutical companies will be required to publish payments they made in the previous year to physicians, nurses, and other healthcare professionals (HCPs), identifying them by name when possible. The rules will also encompass payments made to hospitals and other healthcare organizations (HCOs) across thirty-three European countries.

This move is huge for the industry's relationship with doctors, and reflects a global move toward greater transparency – for better or for worse – following in the footsteps of countries such as the United States and Australia.

What Will Be Disclosed?

The following items will be required to be disclosed: payments made to healthcare professionals (including sponsorships to attend meetings, speaker fees, consultancy and advisory boards), donations and grants paid to HCOs, and payments made for research and development. The disclosure will include full names, addresses, and specialties of each HCP. Some country regulations go a step further, requiring unique, country-specific identifiers.

Generally, if an HCP does not consent to his or her personal data being disclosed individually, their expenses shall be reported in the aggregate. If an HCP revokes their consent after the report has been published, the company is not required to remove the data from the published report, but instead, for subsequent reports, must anonymize the HCPs data and move it to the aggregate section.

However, unlike the Sunshine Act, the EFPIA Code does not require disclosure of payments made for meals and drinks below a certain value. EFPIA felt that doing so, as the United States Sunshine Act does, would create a "disproportionate administrative burden" on both industry and HCPs. A threshold for hospitality costs has been fixed in each national code of practice.

Uniformity

While the EFPIA Code lists the regulations, given the diversity of cultures and practices across Europe, the patterns and levels of disclosure are sure to vary. Andy Powrie-Smith, the head of communications at EFPIA, believes that naming HCPs in a disclosure is a large step, but also thinks it is a "natural evolution for pharma that reflects a societal shift towards ever more transparency in public life."

Powrie-Smith believes that by shedding light on the relationships between HCPs and the pharmaceutical industry will allow society to understand that the interests of patients, HCPs, and pharma are actually aligned. "We need to move from a conflict of interest to a confluence of interest, and transparency helps to do that."

Under the EFPIA agreement, companies are required to make their "best efforts" to achieve full compliance and full disclosure, but companies may sometimes have no choice but to make payments anonymous when physicians make such an above-board request. EFPIA hopes that once HCPs who prefer to remain anonymous see the system in action, they will be "won over" to the principles of transparency, and wish to participate fully, giving rising participation rates across Europe.

As previously mentioned, cultural differences will likely play a large part in the levels of disclosure achieved across Europe. There is essentially a sliding scale of openness and positive attitudes about transparency: Scandinavia is the most open to the change, whereas eastern and southern European countries tend to be more resistant to disclosure.

Different Mindsets

Association of Innovative Pharmaceutical Industry

This Czech Republic group has made it possible to make use of a legal dispensation from the obligation to obtain consent from an HCP, as long as there is an agreement between the HCP and the AIFP Member that has a provision outlining that the processing of personal data is necessary for the purposes of the agreement. If such written agreement is provided, the HCPs consent is not needed.

Spain

In Spain, there is a unique number that identifies the HCP with the DNI or CIF. In order to maintain privacy when the report is published, the number is anonymized using the same encryption procedure used by tax authorities (partially masking the number).

Australia

In Australia, authorities rely on the pharmaceutical industry to establish a process for obtaining consent. Additionally, reporting payments and transfers of value must be consistent with the Commonwealth Privacy Act 1988.

Association of the British Pharmaceutical Industry

The United Kingdom is adding a unique spin, where payments to physicians will be listed on a publicly searchable database known as Disclosure UK and will be hosted by the Association of British Pharmaceutical Industry (ABPI), the trade association of companies in the UK that produce prescription medicines. Keep your eyes peeled for a separate story on this database in the coming days.

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