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3 Legal Considerations for PublicPrivate Partnership Governance in Global Health
Pages 17-26

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From page 17...
... The partners include a philanthropic organization that makes strategic investments in children's health, a multilateral alliance representing country governments and their ministries of health that is the lead coordinating body for global vaccination programs, an NGO that implements programs on the ground, and a U.S. government agency that has an office dedicated to setting policy and providing foreign assistance for children's health.
From page 18...
... The routine due diligence search reveals several potential sources of conflicts of interest: the pharmaceutical company was recently involved in litigation related to its business operations; the undersecretary of the child health office at the U.S. Department of State owns stock in the pharmaceutical company; and the president and benefactor of the philanthropic organization is on the board of the NGO.
From page 19...
... Identifying contributions raises the question of how to value them and leads to discussion on whether the value of a contribution equates to voting power. In the hypothetical scenario, the pharmaceutical company wants to value the research and development that it put into the drug development.
From page 20...
... To value vaccines, for example, Gavi uses publicly available data posted on the UNICEF website. Gilead values its contributions using a set formula for calculating fair market value, said Brooks, and it follows a policy that its contributions will never be more than a small percentage of any organization's budget.
From page 21...
... However, "there is always the responsibility to share intellectual property developed under a federally-funded grant with the federal government," said Nathani, and there may be additional requirements to deposit data and the intellectual works that support that data with the Development Data Library and the Development Experience Clearinghouse of the U.S. Agency for International Development (USAID)
From page 22...
... This is a complicated process, he emphasized, because being a partner in a PPP can give a company a competitive advantage in a country over a company that makes a similar product but is not part of the PPP. Brown explained that partners agree to an MOU with aspirational goals on how the partner will use its expertise to help the PPP achieve its goals, while a procurement arrangement uses a formal contract with delivery terms and prices of goods and services.
From page 23...
... She also noted there could be additional issues regarding which organization is responsible for registering the drug with national regulatory authorities in the countries in which it is to be distributed. Miller said the Gates Foundation tries to structure agreements in a way that limits or eliminates its potential liability on the ground, typically by only providing funding and not being involved in operationalizing or implementing programs.
From page 24...
... Changing topics, Marks introduced the question of deciding on the appropriate governance structure for a partnership. "Do you create an independent organization or will it be nested within one of the partner organizations?
From page 25...
... Miller responded that in these situations, the foundation ensures that its funds are used to further charitable purposes and not create a profit motive for a commercial enterprise. Gavi, as well as the Global Fund, recognize that they often create market opportunities for a company, and they have a framework to evaluate these scenarios.
From page 26...
... The U.S. President's Emergency Plan for AIDS Relief, through its contributions to the Global Fund and the establishment of the Partnership for Supply Chain Management, has been instrumental in creating one of the largest markets in Africa and other parts of the developing world for antiretroviral medicines.


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