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. 2021 May 7;11(5):382. doi: 10.3390/jpm11050382
1. Clinical Research and Diagnostic Testing Improved access to advanced diagnostics
  • Leveraging prenatal and newborn screening programs to overcome underdiagnosis in minority groups

  • Sequencing with ensured consent

Deliberate efforts to improve diversity in genetic databases
  • Training and infrastructure in marginalized communities to collect representative data

Deliberate efforts to improve diversity in clinical research
  • Report on race/ethnicity

  • Culturally sensitive trial designs and objectives

  • Language-accommodating consent forms and questionnaires

2. Regulatory Oversight ad Market Authorization Coordinated national approach to review and funding
  • Supplemental process for complex drugs

  • Pharmacare drug agency to evaluate price and effectiveness

  • International regulatory collaboration: worksharing, consideration of foreign reviews, etc.

  • Tailoring valuation to the nature of PMs

  • Structured value assessments that consider the rarity of conditions, the availability of alternatives, closeness to end of life, novelty, curative nature of treatment, societal impact and severity of illness

  • Transparency in decision making for predictability

Managing long-term uncertainty
  • Mandatory national registries

  • Post-market authorization renewal policies

3. Implementation into the Healthcare System Managing healthcare budgets
  • Additional layer of review: enhanced scrutiny, price negotiations and potential for restricted access for therapies that are expected to exceed a price threshold in annual spending for the first × amount of years

  • Payment plan options: price caps, volume caps, stepwise, subscriptions

Improving physical accessibility
  • National support for medical travel

  • Outreach care programs

  • Telehealth services

Managing jurisdictional disparity
  • Pan-Canadian programs/frameworks for reimbursement decisions

Alternative provision models
  • Licensing agreements

  • Social entrepreneurial models

  • Philanthropic undertakings