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The Impact of SMMP – The Sunshine Act Shines on EMEA


Posted by Kevin Iwamoto on 01/27/2016

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In 2014, a new code was passed by the European Federation of Pharmaceutical Industries and Association, requiring pharmaceutical companies in Europe to report transfers of value (ToV) for every healthcare professional (HCP) they have interacted with in the previous calendar year – to begin in 2015.

Meetings spend reporting is just one element of the ToV declarations, similar to the U.S.’s Physician Payments Sunshine Act. However, accurate ToV reporting is complicated in Europe because requirements vary by country.

Most countries restrict their ToV requirements for meetings to 3 main areas of spend: registration, accommodation and travel. However, under French regulations, pharmaceutical companies have to declare any expense above €10, including meals. Furthermore, some countries require reporting of transportation costs – specifically trains, taxis, Uber, etc.

Pharmaceutical companies haven’t adequately prepared for this new reporting, and therefore risk noncompliance. Especially vulnerable are those pharmaceutical companies who have developed antiquated, homegrown technologies that cannot keep up with – much less stay in front of – new laws and regulations. Those companies are setting themselves up for massive fines and penalties.

To make things even more complicated for these pharmaceutical companies, they now must manually check against invoices and receipts – requiring copious attention to detail to avoid any reporting errors, which could end up costing thousands, if not millions.

And if all of the above isn’t enough, pharmaceutical companies also have to review the respective data privacy requirements of each country, and build their program in that format.

Here’s the positive – European pharmaceutical companies’ required reporting can be rolled up and reported in aggregate or situational, whereas in the United States individual events must be reported.

Technology can solve most reporting issues (if set up correctly by pharmaceutical companies, healthcare providers and their intermediary partners) to significantly reduce the amount of manual work and potential errors.

The best way for these European companies to get started? Revise the U.S. pharmaceutical companies’ – who’ve already implemented The Sunshine Act – SMMP as a compliance framework. Not only will they be able to track healthcare professional expenditures, but they’ll also be able to gauge spend for all meetings, and ensure compliance to all policies and regulations. Check out how this pharmaceutical giant implemented their own SMM program.

It will be interesting to watch this space and see what happens. Hopefully European pharmaceutical companies can sort out their SMM programs before they run out of time.
 
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