Global Health Risk Framework Research and Development of Medical Products: Workshop Summary (2016) / Chapter Skim
Currently Skimming:
6 Manufacturing, Stockpiling, and Distribution
6 Manufacturing, Stockpiling, and Distribution
Pages 63-74
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 63... ...
. Decisions such as whether to use adjuvant or not in global pandemic influenza vaccines can significantly affect manufacturing capacity.
|
From page 64... ...
• Participants discussed the logistical and financial challenges of maintaining spare or idle manufacturing capacity for emer gency use. One approach is to establish a network of manu facturers (e.g., through partnerships with companies, contract manufacturing organizations, and publicly funded infrastruc ture)
|
From page 65... ...
POLICY PERSPECTIVE Some of the most significant global manufacturing capacity building and stockpiling efforts in the past several decades began with the preparations for pandemic influenza in the early 2000s, following the emergence of H5N1 influenza as a potential pandemic threat. Venkayya said that political leadership of countries around the globe recognized the potential for a health catastrophe to set off a cascade of events affecting every element of society.
|
From page 66... ...
Priorities for Preparedness Venkayya emphasized the need for a framework for global ongoing emerging infectious disease risk assessment, and collective agreement on medical countermeasures (MCMs) prioritization, target product profiles, and supply requirements.
|
From page 67... ...
Policy/Access • regulatory and legal frameworks • ensuring equitable access to MCMs • prioritization of populations to receive limited-availability MCMs • policy maker/public appetite for investing in "insurance policies" for poten tial unknown health threats SOURCE: Venkayya presentation, August 20, 2015. framework that will support swift evaluation, licensure, and deployment of novel medical products is also essential, he said.
|
From page 68... ...
WHO asks influenza vaccine manufacturers to make cash donations on the basis of their annual sales of seasonal influenza vaccine, to donate vaccine, to commit to providing a certain amount of vaccine at an affordable price, or other options. This will not meet the full need in developing countries, but it is an interesting first step, he said, adding that the approach needs to be expanded to other threats.
|
From page 69... ...
He and Hamburg agreed that this is an area of national need. David Ripin, Executive Vice President of Access and Malaria and Chief Scientific Officer of the Clinton Health Access Initiative (CHAI)
|
From page 70... ...
Pauwels emphasized the complexity of building manufacturing lines for diagnostics. He added that most diagnostic companies are developing products for the developed world and do not take issues such as availability of cold chain into account.
|
From page 71... ...
Products that pass testing are granted extended expiration dates, but they must undergo ongoing testing to monitor continued shelf life. Products that fail testing at any time are destroyed.
|
From page 72... ...
, and Ripin attributed their survival to a better care experience and access to basic medical supplies and diagnostics. Delivering Supplies in a Crisis UNICEF's support to national Ebola programs helped to provide supplies for primary health care facilities, treatment and holding centers, and community care centers, as well as supply kits for households and schools.
|
From page 73... ...
UNICEF continually assessed consumption levels and aggregated the data to develop countryspecific demand scenarios.4 She noted that Sierra Leone was well positioned for distribution efforts down to the district level as a result of a previous government health care and health supply chain initiative; however, this was not the case in Liberia and Guinea. Hall added that it is not just about delivering a supply.
|
From page 74... ...
He noted that the Ebola outbreak was geographically limited, and there was relatively free flow of commodities. However, a multicountry MERS outbreak might result in some sporadic border closures, and there would be a significant demand for PPE and the raw materials necessary to make PPE, and there are innumerable places where the supply chain could come up short and the response would suffer.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.