Canada’s “health leaders” sponsoring the Open Pharma campaign should have checked with the Patented Medicine Prices Review Board (PMPRB) before advocating their ill-conceived and impractical proposal to have the federal government amend the Patented Medicines Regulations to force drug manufacturers to disclose payments to physicians via the PMPRB.
An August 11th article in The Globe and Mail headlined “Force drug firms to reveal payments to doctors, health leaders urge” reported:
“Some of the biggest names in Canadian medicine are calling on Ottawa to use the power it already has under the Patent Act to force drug companies to reveal their payments to doctors.”
The health leaders’ un-dated letter to the (former) Minister of Health extol examples of other countries’ requirements to disclose manufacturer payments to physicians, including the US Physician Payments Sunshine Act. The merit of this concept is not discussed here, rather it’s the suggested mechanisms for such a program – the PMPRB and the Patented Medicines Regulations – which are certainly not the appropriate ones to implement a Canadian Sunshine policy.
The policy objective of a sunshine list is transparency – a transparent dataset of all payments to physicians by drug manufacturers so that patients can know how much their physician has received and from which drug companies. What Open Pharma fails to realize is that the desired transparency is not possible with simple amendments to the Regulations alone, but would also require significant amendments the PMPRB’s governing legislation, the Patent Act.
In its letter to the Minister, Open Pharma proposes that the government amend the Patented Medicines Regulations (which are currently subject to proposed amendments) as an “obvious” mechanism to implement a Canadian Sunshine policy.
“Fortunately, there is an obvious mechanism to mandate disclosure at the national level without trespassing on provincial jurisdiction over health care. Under section 80 of the 1985 Patent Act, the Patent (sic) Medicine Prices Review Board [PMPRB] has statutory authority over “the costs of making and marketing the medicine where that information is available to the patentee in Canada or is within the knowledge or control of the patentee”. Given this jurisdiction, all that is needed now is an amendment to the Patented Medicines Regulations that legally obliges patentees to disclose payments to prescribers, health care institutions, societies and organizations. While the manufacturers of generic drugs would be excluded, the bulk of the payments of greatest interest involve drugs that are subject to patent protection.”
While many of the letter’s signatories are well recognized in Canadian health care, the letter itself exhibits little discernible understanding of the PMPRB, the Patent Act or the Patented Medicines Regulations. Nor does there appear to be any understanding of the legal and policy framework for making regulations that must be followed by all federal government departments and agencies.
First and foremost, the authors did not consider section 87 of the Patent Act which treats all information filed by manufacturers as confidential and cannot be revealed by the PMPRB with few exceptions.
87 (1) Subject to subsection (2), any information or document provided to the Board under section 80, 81 or 82 or in any proceeding under section 83 is privileged, and no person who has obtained the information or document pursuant to this Act shall, without the authorization of the person who provided the information or document, knowingly disclose the information or document or allow it to be disclosed unless it has been disclosed at a public hearing under section 83.
Under sections 87 (2) and 100 of the Act, the PMPRB may summarize the information filed by manufacturers in its Annual Report (which former Health Minister Philpott appeared reluctant to release) but the Patent Act clearly precludes any release of company identifiable information other than each company’s annual R&D to sales ratios (under section 88 of the Act).
The Regulations are constrained by the Act and therefore transparency (i.e., identifying payments to individual physicians) is not possible solely through amendments to the Regulations – the Act would also need to be amended to explicitly permit the collection and publication of manufacturers’ payments to physicians.
The proposal is also troubling for several other reasons – not the Sunshine policy per se, but the proposed mechanism using the PMPRB, the lack of consultation and the absence of any consideration of the logistical and resource challenges associated with implementation and administration.
The PMPRB (as empowered by the Act and Regulations) has no jurisdiction over physicians and yet individual physicians would be become important stakeholders that must have rights to review, and if necessary, appeal any erroneous payment information filed by drug manufacturers.
The Open Pharma proponents have evidently not contemplated the role and rights of individual physicians in this process – a critical issue that needs to be addressed and not just as an afterthought with a throw away reference to the Privacy Act as they do in the letter. Physicians would have to be consulted formally (including national and provincial medical associations, professional colleges, and individual physicians) with respect to any provisions in regulation that impact physicians – that Open Pharma thinks it is a good idea is not a substitute for formal consultation. There are more than 82,000 physicians in Canada according to CIHI – all of whom would have rights under any new Sunshine regulations (whether or not they receive payments) – they would have to be consulted in a meaningful way.
Furthermore, using the PMPRB and the Patent Act and the Regulations as the vehicle for collecting and disseminating information on payments to physicians may be subject to legal challenges as being ultra vires (beyond the scope or authority of) the Patent Act, unrelated to the price regulation powers of the PMPRB or possibly unconstitutional as health care (and regulation of physicians) is a provincial – not federal – jurisdiction.
In addition, the Open Pharma letter doesn’t contemplate the practical and logistical considerations that would need to be addressed. What is the budget? How many staff would need to be hired? What would be the enforcement mechanisms? What would be the appeal and dispute resolution mechanisms? How would payments to physicians be defined? Would there be an online searchable database? Who would maintain it? How would privacy be protected? Etcetera.
In summary, if transparency of physician payments is the objective, then amending the Patented Medicines Regulations is not a realistic or even a desirable approach.
The better approach is to develop a Canadian “fit for purpose” policy for manufacturers to report payments to physicians with appropriate consultation, legislation and regulations. A policy that embraces the best elements and protections of similar legislation in other countries and that addresses the unique multi- and inter-jurisdictional issues of the Canadian health care system. It matters less which government department or agency administers a Canadian Physician Payments Sunshine Act, as long as there is a solid legislative and regulatory foundation supporting the policy.
Finally, a prospective Canadian Sunshine policy should be considered not only within the federal policy framework for regulation but also from an academic, evidenced-based policy perspective that examines the scientific literature and research studies that have assessed Sunshine regulations in other jurisdictions. Canadians need to understand the likely benefits and be assured these benefits outweigh the costs and potential impacts on physicians, health care and health research in Canada.
In the postscript of an earlier version of this blog I associated the Open Pharma organization described above with the website openpharma.ca, a site that claims to be pursuing the same mission and objectives but without identifying its membership or financial support. In fact, the correct website is open-pharma.org where the membership and sources of financial support are clearly outlined.
Neil Palmer is the Founder and Principal Consultant at PDCI Market Access Inc. and a former staffer at PMPRB. The views expressed are his own. No financial support was received from any organization for the preparation of this article.
 Un-dated letter to form Open Pharma to federal Minister of Health sourced from Globe and Mail website. https://www.theglobeandmail.com/incoming/article35955985.ece/BINARY/Open-Pharma-Open-Letter.pdf
 Privy Council Office – Guide to Making Federal Acts and Regulations: Part 3 – Making Regulations http://www.pco.gc.ca/index.asp?lang=eng&page=information&sub=publications&doc=legislation/part3-eng.htm
 Patent Act – Section 87 (1) http://www.laws-lois.justice.gc.ca/eng/acts/P-4/page-17.html#docCont
 Canadian Institute for Health Information https://www.cihi.ca/sites/default/files/infographic_physicians_2015_en_web.pdf