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Comparing Transparency Reporting Requirements in Canada, the United States and Europe

The Strengthening Quality and Accountability for Patients Act 2017 (the “Transparency Act”) was passed in December 2017 and requires the reporting of transfers of value (“TOV”) from manufacturers (e.g., pharmaceutical, medical device, generics, medicinal marijuana, etc.), pharmacies, laboratories, organizers of continuing education events and “a prescribed person or entity” to prescribed recipients in Ontario.Pharma Compliance Digital CRM Marketing Transparence DMOS Canada Comparing Transparency Reporting Requirements in Canada, the United States and Europe
Like the U.S. Sunshine Act and the EFPIA reporting requirements, the Transparency Act was created with the goal of strengthening transparency by requiring companies to track and report certain payments and items of value. However, the reporting requirements under the Act are still somewhat unclear and are being discussed through the 40-day consultation period that ends on April 6th.
The Transparency Act, the Sunshine Act and the EFPIA requirements all impose strict reporting obligations, however the requirements under the Transparency Act go beyond those of the US and EU in many ways. For example, under the Transparency Act, marketing firms or individuals who perform activities for the purpose of promoting medical products are required to report, while in the US, the definition of payors is limited only to manufacturers and Group Purchasing Organizations (GPOs). The Transparency Act also expands the definition of recipients to include patient organizations, advocacy groups and students, while the Sunshine Act and EFPIA only cover HCPs and HCOs. Furthermore, the list of defined HCPs under the Transparency Act is quite expansive and includes dental hygienists, nurses, dieticians, and massage therapists, unlike the Sunshine Act which outlines only six HCP categories.

To read the artcle by Prianka Patel, Chrisoula Nikidis, Amy Greenstein, and to view a summary comparison of all three pieces of legislation

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