Vaccine Supply and Innovation (1985) / Chapter Skim
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From page 1... ...
In light of that experience, the committee chose to emphasize the need for establishment of a continuing body to anticipate and resolve problems in vaccine development, supply, and use; it recommends the creation of a national vaccine commission. To aid in the activities of such an oversight body, the committee conducted a broad analysis of current scientific, economic, legal, and ethical concerns related to vaccine availability.
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From page 2... ...
The committee's investigation showed that the handling of vaccine-related injury liability by the courts has left manufacturers apprehensive and uncertain about the extent of their responsibilities beyond proper manufacturing and labeling. These apprehensions act as a deterrent to vaccine production and thereby threaten the public's health, particularly because the nation is dependent on sole distributors for many of its most-used vaccines.
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From page 3... ...
Early in the history of vaccine development, physicians and others recognized that vaccine administration, like most medical procedures, carried risks as well as benefits. To reduce these risks, first local and then federal regulatory bodies established safety standards.
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From page 4... ...
Public Health Service, the Committee on Infectious Diseases of the American Academy of Pediatrics, and the Committee on Immunization of the Council of Medical Societies, American College of Physicians. The Department of the Army oversees efforts to develop vaccines needed to protect military personnel (and others at risk)
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From page 5... ...
It regards this possibility with grave concern because of the threat of resurgence of these infectious diseases should vaccines become unavailable. Sole reliance on foreign manufacturers for vaccines does not offer a practicable solution: problems could arise from geographic distance, with related communications and distribution delays; from possible language barriers, which could hamper the resolution of highly technical issues; from political considerations; and from differences in regulatory requirements.
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From page 6... ...
It recommends, however, that the national vaccine commission proposed in Chapter 7 should develop contingency plans and recommendations, on a case-bycase basis, for ensuring vaccine availability. These plans should include the possibility of direct federal involvement in vaccine supply if commercial manufacturers find continued "open market" operation no longer viable.
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From page 7... ...
Economic disincentives to vaccine innovation and production include: · the complexity of development, production, and quality control · the cost of research and development in relation to anticipated sales · a perception that vaccines historically have received less effective patent protection than drugs · apprehension over the liability situation The effects of recent changes in the patent law and in government funding policies (related to patents) are difficult to predict, but should generally enhance protection of innovations.
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From page 8... ...
Even if reporting were mandatory, however, the data would not allow determination of the number of events actually caused by, rather than coincidental to, the administration of vaccines because information on similar events in unvaccinated individuals is not collected. Conclusions about cause and effect and rates of adverse reactions to vaccines should be drawn only from carefully designed and controlled epidemiological studies.
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From page 9... ...
Tracking shifts in litigation and recommending remedial action would be one of the functions of the proposed vaccine commission {Chapter 7~. CONSEQUENCES OF THE STATE OF VACCINE INJURY LIABILITY LAW FOR VACCINE PRODUCTION AND INNOVATION Clear legal rules notwithstanding, the manner in which claims against manufacturers alleging liability for suspected vaccine-related *
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From page 10... ...
Time series information supplied by two manufacturers indicated a sharp increase in the number of claims filed: their experiences varied considerably, but the total number of reported claims filed against them in 1983 was more than twice that filed in 1980.
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From page 11... ...
Proposals to remedy the compensation and liability problems connected with vaccine injury are discussed below. A NATIONAL VACCINE COMMISSION The lack of a formal mechanism to promote cooperation in the innovation, production, and use of vaccines limits the benefits obtainable from existing immunization programs and hampers the development of new programs.
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From page 12... ...
The mode of operation of the commission should be determined by the commission itself. Possible activities include monitoring the availability of existing vaccines; monitoring the need for improvement of existing vaccines and setting priorities in this area; monitoring vaccine innovation activities in the public and private sectors; monitoring the vaccine needs of developing countries and promoting efforts to meet those needs; evaluating the potential applications of advances in basic biotechnology to vaccine development; evaluating the application of knowledge from the behavioral sciences in the design of campaigns to promote vaccines; reviewing the effectiveness of promotional campaigns; monitoring and evaluating patterns of infectious disease as an aid to determining priorities; monitoring the training of personnel needed to ensure continued vaccine innovation; and monitoring and evaluating legal issues related to vaccine development and use.
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From page 13... ...
· federal assumption of liability for all vaccine-related injury acceptance of vaccine price increases to cover liability costs The committee believes that the goal of advancing the control of infectious diseases with vaccines should be pursued in as just and fair a manner as possible. Those who respond to the government's promotion of or legal requirement for vaccination confer benefits on other members of society because they reduce the risk of disease in the community.
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