WHO calls to end the global crisis of oral health

Dental care in Canada is primarily financed through private insurance plans and out-of-pocket payments. While Canada is internationally recognized for Medicare, a publicly-funded health insurance system that covers hospital and physician-provided services at the point of care, it remains one of the least equitable Organization for Economic Co-operation and Development countries in terms of affordable access to dental care. Approximately one third of Canadians do not have access to dental insurance, including half of low-income individuals, and individuals with the greatest dental care needs are often unable to reliably access dental services. Select populations-such as children, Indigenous peoples, seniors, and persons living with disabilities-receive some level of publicly-funded dental services, amounting to approximately 6% of total dental spending nationwide. Despite the evolution of Medicare, dental care has been largely excluded from federal health legislation following World War II. However, in March 2022, the Liberal Party of Canada partnered with the federal New Democratic Party to advance common legislative goals, including a long-term nationwide dental program for low- and middle-income families. As an interim measure, Bill C-31 was signed into law on 17 November 2022, and created the Canada Dental Benefit, which provides a fixed transfer payment to individuals with an annual household income under $90,000. This commentary reviews the origins of Canadian Medicare, discusses the factors that led to the continued exclusion of dental care from federal health legislation, examines the newly-minted Canada Dental Benefit, and explores the potential for expanded public funding in Canadian dental care.

Towards equitable dental care in Canada: Lessons from the inception of Medicare.

This article examines four mechanisms for establishing federal spending programmes despite tough opposition based on identity or ideological politics, as well as disputes between haves and have-nots. It contrasts the use of clocks (time limits), caps, compartments (special justification for spending that would otherwise have been rejected), and carve-outs (exemptions to federal spending programmes to buy off objecting veto players) to secure political support for national-level programmes, and asks under what conditions those limits might be breached. We look at the EU, Canada, and the US. These tactics are most successful at “getting to yes” for federal authorities when they can isolate individual objections. As long as those objections persist, the limits will persist as well.

Clocks, Caps, Compartments, and Carve‐Outs: Creating Federal Fiscal Capacity Despite Strong Veto Powers

In Australia, facilitated regulatory pathways (FRPs) became available with the introduction of priority review (PR) in 2017 and provisional approval (PA) in 2018, which aim to facilitate expedited review and approval for novel medicines. The pathways were developed in consultation with a wide range of stakeholders and have since been utilised by pharmaceutical companies for various therapeutic products. However, the perceptions of the firsthand users of these pathways have not been evaluated in Australia. We have conducted a survey of Australian regulatory professionals aiming to solicit the perceived benefits, barriers to utilisation, shortcomings and proposed modifications to utilising these pathways. We have also solicited the users’ perspective on key aspects of the pathways, including overall satisfaction, regulatory burden, availability and ease of use of guidelines, regulator support, impact on company strategy and recommendations for improvement. A survey was developed and distributed to Australian regulatory professionals from the pharmaceutical industry who had submission experience of new medicine applications via either PR, PA or the standard registration pathway to the Therapeutic Goods Administration (TGA). The questionnaire consisted of 44 questions with a skip logic and the option for free text comments. We received responses from 16/42 companies that had utilised these new pathways. Nine respondents had experience with the PR pathway and ten with the PA pathway. The respondents were generally satisfied with the effectiveness of the PR process in expediting registration approvals, but they were ambivalent towards the PA pathway in terms of overall satisfaction and timelines. Respondents expressed a desire for further improvements in the speed of approval, earlier access for patients across various pathways and introduction of new Health Technology Assessment processes for medicines approved under PA. While the FRPs have been an important and positive development in the Australian regulatory landscape, there remain opportunities for further improvements, some of which have been highlighted by this study and may help inform future regulatory decisions. 

/pdf/a-survey-of-industry-perceptions-of-facilitated-regulatory-13g4r086.pdf

A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia.

Getting the Price Right: Lessons for Medicare Price Negotiation from Peer Countries

In March 2022, the New Democratic Party (NDP), Canada's social democratic party, and the centrist Liberal government signed a supply and confidence agreement. In return for the NDP agreeing to vote with the government on all crucial issues until June 2025, the Liberals pledged to bring in both pharmacare and dental care programs. Pharmacare, universal public insurance coverage for prescription drugs, had been promised for more than 50 years but never implemented, while public dental care was an almost completely neglected issue. This article explains the long genesis of pharmacare, the need for public dental care, and the political circumstances that led to the agreement. However, at this point, details about both plans are largely absent. As a result, how well those plans will serve the needs of Canadians is yet to be determined. 

After More Than 50 Years, Pharmacare (and Dental Care) are Coming to Canada

Objective Examine the use of priority and provisional approval pathways by the Australian Therapeutic Goods Administration (TGA) for evaluating new medicines. Methods This observational study assessed all new medicines approved by the TGA between 1 January 2018 and 18 October 2021. It examined how frequently priority and provisional approval pathways are being used, the conditions which the medicines are being approved to treat, how long medicines are spending in the approval pathways, the additional therapeutic value of the medicines being approved through these pathways and how the use of the pathways compares with similar regulatory pathways used by Health Canada. Results The TGA approved 138 new medicines in the time period under study, of which 33 were approved through either the priority or provisional approval pathways. Sixteen were approved to treat cancer. It took the TGA a mean of 130 (95% CI 118, 143) and 144 (95% 101, 188) working days for priority and provisional pathways, respectively. Therapeutic evaluations were available for 16 of these medicines and 11 offered little to no therapeutic gain over existing medicines. There was moderate agreement between the TGA and Health Canada in their use of these pathways (Kappa = 0.5458, 95% CI 0.3900, 0.7016). Conclusions The priority and provisional approval pathways are now being used by the TGA for about one-third of all new medicine approvals. Although the medicines approved in these ways are moving through the review process more quickly than those approved through the standard approval pathway, the majority of these medicines, for which an evaluation of therapeutic value is available, do not offer any substantial additional therapeutic value over existing medicines. 

Use of priority and provisional approval pathways by the Australian Therapeutic Goods Administration in approving new medicines: a cross-sectional study

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After More Than 50 Years, Pharmacare (and Dental Care) are Coming to Canada

Use of priority and provisional approval pathways by the Australian Therapeutic Goods Administration in approving new medicines: a cross-sectional study