Pangaea Express: Ontario Health Sector Payment Act Update and Quebec INESSS Submission Fees

February 23, 2018

Ontario Health Sector Payment Act Update:
February 22, 2018, the Ontario Ministry of Health and Long-Term Care (MOHLTC) released an update to the Health Sector Payment Transparency Act, 2017 (HSPTA), passed December 12, 2017, requiring the pharmaceutical and medical device companies and other payers to report all transfers of value (above a minimum amount) that are provided to health care professionals and organizations or institutions. A key element in this update is the proposed minimum dollar figure of $10 above which a payor must report a transfer of value. Ontario's legislation defines a transfer of value as a transfer of any kind and includes payments, benefits, gifts, advantage, perquisite or any other prescribed benefit.
The provincial government is seeking input from the public on methods for ensuring these payments are transparent. A "Summary of the General Regulations" and the "General Regulations - Consultation version" can be found at
http://www.ontariocanada.com/registry/view.do?postingId=26846&language=en
Feedback will end April 6, 2018.

The Ministry of Health and Long-Term Care (MOHLTC) is also conducting a Regulatory Impact Analysis (RIA) of these proposed regulations. The ministry recognizes that in order to comply with the regulation, "prescribed payors will need to track, contextualize, and validate with recipients applicable financial transactions in the prescribed format to be published. As such, the government is seeking "comments and feedback pertaining to costs of any new equipment/IT purchases, training, recordkeeping, reporting, and other administrative activities required to comply with the regulation".

Unfortunately, the HSPTA could just be referred to as, "the Northern Sunshine Act" as it is looking more and more similar to U.S. regulations. With respect to the call for public input, it is interesting that there are no specific questions laid out for the public to address. Will the public input be posted on-line and transparent?

Also, will the RIA's conclusions actually identify some real costs to industry as opposed to the Federal Cost Benefit Analysis regarding the proposed amendments to the Patented Medicines Regulations? Biggest question is whether all this will come to fruition prior to the elections later this spring.

Quebec INESSS Update:
The Quebec government has released draft regulations regarding new INESSS submission fees for the scientific evaluation of a drug or stable blood product. The government has drafted various fees for the different types of scientific evaluations. For instance, a new drug or new indication for a drug currently listed will cost a fee of $38,921 per indication. Biosimilars and subsequent entry non-biologic complex drugs will have a reduced fee of $19,460 and new strengths or new forms of a currently listed drug will have a small fee of $3,892 per submission. For more information and details on fees, go to
http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=1&file=67951.pdf

This fee schedule is less than that for the CADTH CDR and pCODR drug reviews that request $72,000 for a new drug or a new indication of an existing drug. Feedback on these INESSS draft submission fee regulations will be open for 45 days from the date of publication February 21, 2018.

For more information, please contact Marla Weingarten at mweingarten@pangaea-consultants.com.