Legal issues in sharing the benefits of biodiversity prospecting.

The National Cancer Institute (NCI) is the US Government's principal agency for research on the prevention, diagnosis and treatment of cancer. A critical component of the Institute's mission is the identification and development of new and promising treatments for cancer and AIDS. For many years these efforts have included a program to investigate natural products for potential new therapeutic agents. In 1986, with the advent of new screening techniques, the National Cancer Institute stepped up its exploration of natural products and began world-wide collections of plants in tropical and subtropical regions. In recognition of the principles of the Biodiversity Treaty, NCI appreciates that continued access to the natural products of these countries depends on the Institute's ability to recognize the contributions of these source countries and their indigenous peoples, and to provide them adequate incentives to conserve their natural resources for the purposes of drug discovery. Accomplishing this goal presented several legal issues for the National Cancer Institute. As an agency of the US government, the NCI has an adjunct statutory mission to facilitate the transfer of technology developed through the Institute's programs into the private sector for further development and commercialization, and NCI operates under a national policy to use the patent system to transfer Federally supported research to the private domestic sector. Reliance on patent law may limit the Institute's ability to recognize the rights of source countries and their indigenous people and provide compensation for their contributions. However, other legal instruments, such as contracts, can serve as interim measures to provide compensation to source countries and indigenous populations. The National Cancer Institute's Letter of Collection agreement (LOC, formerly the "Letter of Intent'), is an example of an alternative means that "fills-in the gaps' created by patent law and through which source countries may share in the benefits of natural product development.

The first 15 years: what has been learned about the Cancer Information Service and the implications for the future.

The Cancer Information Service (CIS) has been in existence for over 15 years. During that period, lessons have been learned that have been used to increase the effectiveness of the network. This paper lists 12 of those lessons, covering issues such as giving sophisticated medical information; reaching diverse target audiences; using the mass media; developing systems needed for quality assurance, research, and information technology; and nurturing a local-national partnership. The paper also discusses major accomplishments of the program and lists recommendations for meeting the challenges to be faced by the CIS in the future.

The Cancer Information Service Telephone Evaluation and Reporting System (CISTERS): a new tool for assessing quality assurance.

With more than 500,000 annual telephone inquiries from the public, health professionals, and others, the toll-free telephone-based Cancer Information Service (CIS) has rapidly evolved into a primary contact point and resource for people seeking cancer-related information. As the CIS continues to grow, quality-assurance issues are increasingly important both to maintain a high quality of responses to callers and to ensure the accuracy of information transmitted. The Cancer Information Service Telephone Evaluation and Reporting System (CISTERS), a computer-based interactive interviewing system, is being developed to provide quantitative measures of various aspects of the quality of CIS responses to telephone inquiries. In addition to supplying quantitative feedback to both the National Cancer Institute (NCI) CIS office and the regional CIS offices, CISTERS also allows program managers to identify and provide for staff training needs. CISTERS is a substantial part of NCI's commitment to quality control and assessment of needs within the CIS network and may have significant implications for the growing number of other national telephone-based, health-information helplines.

History of the Cancer Information Service.

The Cancer Information Service (CIS) was established on July 1, 1975, following the mandate of the National Cancer Act of 1971 giving the National Cancer Institute (NCI) new responsibilities for educating the public, patients, and health professionals. Funded under a contract mechanism, the CIS has become one of the longest-running community programs in NCI. The CIS has been able to set up and maintain high-quality service, giving accurate, up-to-date medical information to cancer patients and their families and friends, to health professionals, and to the general public. The CIS network, which has taken more than 5 million calls since its inception, has weathered many changes, both at the national and the local level. Its current call volume, in excess of 500,000 calls per year, makes it one of the most heavily utilized health-related telephone helplines in the country. Using a standardized Call Record Form, data on calls have been recorded consistently since 1983; the dataset now contains information on more than 4.2 million calls. An outreach component that acts as NCI's field arm has been part of the CIS since its inception. The CIS has matured into a stable system that has been reconfigured into 19 regional offices, covering the entire country. These offices run the telephone service and serve as NCI's outreach arm, working with intermediaries to carry out NCI information and education programs in local communities.