PREFACE This report is the second in a series documenting the activities of the National Institutes of Health in respect to research involving recombinant DNA molecules. Volume 1 of the series, prepared in August 1976, covered events from February 1975--the Asilomar conference--through June 1976--the issuance of NIH Guidelines. Volume 2 covers subsequent events culminating with those surrounding (but not including) the publication of proposed revisions to the Guide lines on September 27, 1977. During the period covered here, NIH undertook an evaluation of HEW's patent policy, with a view to deciding whether a change was in order for recombinant DNA inventions made under Departmental support. The present volume includes an analysis of current policy by the Director, NIH, and the comments on this analysis by members of the Recombinant Advisory Committee, the Director's Advisory Committee, and pharmaceutical companies. In July 1976 a letter from Senators Javits and Kennedy to President Ford recommended that the NIH Guidelines be extended to the entire Nation's research community by appropriate executive or legislative action. In response, the Secretary of HEW, with the approval of the President, convened an interagency committee to review and coordinate the activities of Federal agencies and to conduct other related inquiries. The Federal Interagency Committee has held eight meetings, and two subcommittees met to review patent policy and international safety measures. Included in the present volume are the minutes of the Committee's meetings and various Committee documents relating to the above subjects and to recombinant DNA activities in other government agencies, the private sector, and abroad. The Committee's recommendations on the matter of legislation are also reported. A staff review of congressional action, documented by the major bills of 1977, is included. Up to February 1978, no law regulating recombinant DNA activities has been enacted. Compliance with the NIH Guidelines, however, extends throughout private industry on a voluntary basis and is compulsory under the far-ranging NIH awards system. A bibliography of popular literature on recombinant DNA and a selection of typical news articles have been included to illustrate the diverse interests and points of view that have attended this controversial subject. Finally, the NIH Environmental Impact Statement on "NIH Guidelines for Research Involving Recombinant DNA Molecules," in two parts, supplements this volume. It will accompany the volume except in our distribution to those who have already received it. To ensure wide availability of Volumes 1 and 2 and the Environmental Impact Statement, the Superintendent of Documents has placed them on sale at the Government Printing Office, Washington, D. C. 20402, and has deposited them in about 600 public libraries throughout the country. For further information, write to the Office of Recombinant DNA Activities, Room 4A52, Building 31, National Institutes of Health, Bethesda, Md. 20014. Donald Fordivekan Donald S. Fredrickson, M. D. March 1, 1978 *The Stock Numbers for purchasing Volume 1 and the EIS are 017-040-00398-6 and 017-040-00413-3, respectively. DHEW PATENT POLICY AS RELATED Letter from Donald S. Fredrickson to The Patenting of Recombinant DNA Research Letter from Donald S. Fredrickson to List of Correspondents on DHEW Patent Letters on DHEW Patent Policy (Chronological). 1 |