A Look at the “Sunshine Act” Across the World
One of the major provisions of the ACA is being implemented around the world.
It appears that we in the USA are not the only ones grappling with core-shaking healthcare changes. Sweeping measures are quickly reshaping the way we look at data, technology, privacy and relationships in healthcare.
One of the key mandates of the Patient Protection & Affordable Care Act is the “Sunshine Act.” The Sunshine Act requires US drug, device and medical supply manufacturers to report financial support exceeding $10 to physicians—from dinners to samples to education and consultation—to a centralized, online database.
Pharmalive’s “Pharma Grapples With Sunshine Disclosure In Australia And Europe” describes how Europe and Australia are dealing with comparable measures, noting, “Not surprisingly, the process is moving along more smoothly in some places than others.”
On July 2, 2013, the European Federation of Pharmaceutical Industries and Associations released a “voluntary code” to monitor transfers of value. This will become compulsory for EFPIA member companies and associates. These efforts are praised by consumer and patient advocates, and watchdog agencies.
Transposing of code starts at the end of this year, but the program won’t be officially put into place until 2016. Data won’t appear to the public until this time, and only data from 2015 onward will be formally gathered and disclosed. This means companies could potentially amp up campaigns and promotions until that time, and will not have to report it.
Europe’s law is vague and disjoined in some respects—each member association, for example, will set a threshold for definitions like “modest meal”—and language barriers will certainly add to the complexity of it all.
In Australia, reporting remains voluntary, although the Australian Medical Association supports the measure, and is increasingly sharing financial relationships between physicians and pharmaceutical companies.
Pharmalive reports that while this is a start, some shortcomings that need to be addressed. These include:
- Priority on making this a mandatory measure.
- Heftier fines for non-compliance (the maximum is currently $275,000.)
- Focus on disclosure of payments to individuals, as opposed to companies.
- Applying the law to all medical companies and industries.
Europe and Australia both have universal healthcare systems in place, while the US is struggling to define and reform its healthcare system. Theoretically, this could make the transition smoother abroad.
In both Europe and Australia, reporting remains voluntary. The US’s strategy has not been implemented yet, but is required. Europe’s plan is more gradual, and will become compulsory, but it will be difficult to enact because of language barriers and a hodgepodge of different and complex healthcare systems. A major challenge will be introducing one relevant coding system to meet the needs of many members.
In each case, more clarification is needed. The US, for example, specifies that every transaction over $10 must be reported. Objective and concrete language will only help to make the transition smoother and more accurate and honest.
The Bottom Line.
It’s clear that there needs to be intelligent action in regards to quantifying and understanding the relationships in the medical industry. Countries around the world are quickly recognizing this, and various government actions show the growing need for and commitment to gathering, analyzing and comprehending data in the medical world.
Send us a message. We'd love to hear from you.
60 Leo M Birmingham Parkway
Boston, MA 02135