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

03.21.18 | By Prianka Patel, Chrisoula Nikidis and Amy Greenstein

In June 2017, Ontario Health Minister, Eric Hoskins introduced the Strengthening Quality and Accountability for Patients Act 2017 (the “Transparency Act”).

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.  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.

Moreover, certain provisions in the Transparency Act remain unclear and may make the reporting process difficult in the short term.  For example, a payor is required to report all direct and indirect payments made by itself or indirectly through an intermediary, and the intermediary or affiliate may be asked to report a specific transaction at the request of the Minister.  When the Minister does in fact request the intermediary to report a TOV in addition to the payor reporting, this creates a potential for double reporting.  Additionally, an intermediary can itself meet the definition of a payor, and therefore, indirect TOVs made from a manufacturer to an HCP through an intermediary would be double reported. Furthermore, the Transparency Act outlines 15 categories of TOVs, further complicating the way manufacturers will have to capture the payments.

What does this mean for your company?  These new and more robust requirements outlined in the Transparency Act warrant Canadian pharmaceutical and medical device companies to conduct an in-depth review of their policies, processes, aggregate spend systems, and implement employee training to ensure that they are in compliance with the Transparency Act. During this in-depth review, companies will need to identify any gaps that will prevent them from meeting the requirements of the Transparency Act and any other transparency legislations that may be enacted in the future, and make updates accordingly. For example, company policies should be updated to include the 15 categories of TOVs identified in the Act, so employees are aware of what constitutes a transfer and what must be documented for reporting purposes thereafter. Furthermore, companies will need to develop robust fair market value methodologies and develop rates for all types of recipients, outside of just HCPs (e.g. patient organizations and advocacy groups). Canadian companies may also need to reconsider their strategies for engagement with advocacy groups and patient organizations to remain compliant with the heightened regulations under the Transparency Act.  Many companies may have some of these processes in place, however the significantly broader scope of the Act will require them to reassess their abilities to respond to this legislation and any future transparency legislations that may be enacted.

It is important to note that the Transparency Act was created by the Ontario Ministry of Health and not by the Health Canada.  However, recent statements give reason to believe that it is only the beginning of transparency legislation.  In October 2017, Council of the Federation noted “Following the example of other jurisdictions, Health Ministers are exploring options to strengthen transparency on the pharmaceutical industry’s provision of payments…so that Canadians are aware of these financial relationships and can make informed decisions about their health care.”  Furthermore, in February 2018, Ontario Health Minister, Eric Hoskins, resigned from his Ontario cabinet post and noted “In leaving, I am determined to continue building better health care for all Canadians.” Thus, despite the relatively limited geographic scope of the Transparency Act, it is clear from Hoskin’s remarks and the statement given by the Council that the potential for future regulations in Canada is promising. Canadian companies will therefore benefit from proactively implementing or enhancing existing transparency programs now.

Below is a summary comparison of all three pieces of legislation:

The journey to transparency is progressing rapidly throughout the world. The movement is gaining strength and we will continue to see more transparency, creating additional reporting obligations and compliance challenges for life science companies. Canada is not immune, and Canadian companies must therefore be prepared to comply with increased transparency regulations.

Not sure how ready your company is to deal with the upcoming changes? Take this short self-evaluation.

Polaris and IQVIA can make sure you and your team are compliant with the Transparency Act and other transparency legislation around the world by sharing our roadmap to transparency readiness. Schedule a conversation with Chrisoula Nikidis, our Canadian Head of Compliance and Ethics Solutions by clicking here. Learn about all our compliance consulting and technology solutions at www.polarismanagement.com.

 

[1] EFPIA consists of 33 member countries. The Association is a representative body of the pharmaceutical industry in Europe.

[2] http://www.ontariocanada.com/registry/view.do?postingId=26846&language=en

[3] Complete list of 26 specialties: http://www.health.gov.on.ca/en/pro/programs/hhrsd/about/regulated_professions.aspx

[4] List of TOV categories: http://www.ontariocanada.com/registry/showAttachment.do?postingId=26846&attachmentId=37129

[5] EFPIA does not provide a monetary threshold for TOVs that must be reported