Reading Room Production — page 453

It was noted by Merck that adequate liability is afforded to the industry on childhood vaccines (National Childhood Vaccine Injury Act), but that similar liability protections are not provided for adult vaccines. Dr. George Korch asked for clarification regarding whether protections under the PREP Act were not sufficient for the industry concerns regarding liability of products for biodefense and pandemic disease threats. There was no further discussion of liability issues at this time, and a due out to industry would be more definition of the nature of liability concerns that remain. (Note regarding the Prep Act: "Passed primarily to address the pandemic influenza threat, the PREP Act provides liability protections after a Secretarial declaration of covered countermeasures for any disease or health condition that the Secretary views as constituting a public health emergency, either presently or in the future. Liability protections cover the manufacture, testing, development, distribution, or use of the designated covered countermeasure absent willful misconduct", source: http://www.hrsa.gov/countermeasurescomp/prep_act.htm as accessed on 30 January 2010) • An action item would be to have industry better define the nature of liability concerns that remain Partnering GSK commented on an issue regarding partnership models, and cited their ability to partner with the Defense Threat Reduction Agency as an example of how they are able to further progress on anti-infectives that may have dual utility for biodefense and for overall infectious disease markets. Another partnership example was the Wellcome Trust as a good example of effective partnership abilities. In this example, the company is covering costs of production of a malaria product, with an allowance for a small profit that is being turned back into research for additional malaria products. On a negative partnership experience, NKT pharmaceuticals described two examples of an inability to have easy access to National Institute of Health experts on an influenza antibody product and on an assay development (replacement of RBCs needed in hemagglutination assay) that took a great deal of time and paperwork to process and ultimately was resulted in no access. Someone pointed out one possible attributable factor is the stringent requirements by the NIH to avoid conflict of interest by employees. Novartis provided a suggestion on an tax credit incentive that would be viewed as favorable by big pharma and would stimulate partnerships with biotechnology companies. If the USG had a program where $ 40 M were available as tax credit to the company for partnering with biotechnology organizations to advance a promising technology or product within the biotech's inventory, then it would serve in a similar way to a grant, but would have other advantages. For the USG, it would be a cost neutral opportunity to stimulate added partnerships, with potential spin off in licensing and access to technology.