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Policy and Regulatory Issues, Community and Social Dimensions

Significant policy, regulatory, community and social issues arise across the HIV vaccine continuum, including intellectual property rights, market incentives, regulatory preparedness, measures to ensure equal access to clinical trials, community attitudes and knowledge towards vaccines, and measures to ensure access and acceptance when HIV vaccines become available for those who need them the most.

Key objectives in this program area include strengthening vaccine policy approaches that promote global access to HIV vaccines; enhancing the regulatory pathway and processes for HIV vaccines in low-and-middle-income countries; collaborating with partners in Canada and low-and-middle-income countries to advance legal, ethical and human rights dimensions of HIV vaccines; and strengthening existing mechanisms to support community involvement in vaccine research and development, clinical trials and activities related to public awareness, education and participation. In this light, the CHVI will:

  • support the development and analysis of strategic policy options and approaches focussing on critical questions regarding the legal, ethical and human rights dimensions of HIV vaccine development, clinical trials, delivery and access. The knowledge produced will inform collaborative networks of researchers in Canada and in low-and-middle-income countries. Support will also be provided for the development of evidence-based “best practice” resources to inform and strengthen existing mechanisms to advance community involvement in vaccine research and development, and clinical trials and activities related to public awareness and education.
  • undertake several HIV vaccine policy and community engagement initiatives - on the policy development front, support will be provided for policy dialogues and a new HIV Vaccine Policy Development and Community Engagement Funding Program.
  • support capacity-building activities (e.g., workshops, training and guideline development) to improve regulatory capacity in low-and-middle-income countries, especially those where clinical trials are planned or ongoing. The Canadian Development Agency (CIDA) will consult with international organizations to establish priorities for these activities, including countries of focus and appropriate recipients.

CHVI Funding Commitment: $8.46 million over 5 years.

Expected Outcomes:

  • improved domestic and international policy development models, capacity and tools to address HIV vaccine-related issues;
  • enhanced global access to evidence-based tools and knowledge regarding the community and social dimensions of HIV vaccine research; and
  • improved regulatory capacity in low-and-middle-income countries, especially those where clinical trials are planned or are ongoing;
  • enriched policy dialogue and discourse surrounding the legal, ethical and human rights dimensions related to the HIV vaccine;
  • greater meaningful engagement and participation of local communities in all aspects of the HIV vaccine research and development continuum; and
  • greater awareness amongst local communities of their rights and the benefits and potential risks associated with HIV vaccine research.