GENETIC INVENTION LICENSING IN HEALTHCARE: AN ANALYSIS OF POLICY INSTRUMENTS

Abstract

While it may seem that genomic innovations recently burst upon the scene but they have actually been taking place since the early 1970s. Genomic research in microbes, animals, plants and humans have all triggered intrigue and controversy. This is perhaps best known in the field of plant sciences with the development of genetically modified plants and their resulting products. However, human genomic research, especially relating to disease research, has triggered its own share of debate.

Private firms undertaking biotechnology research on human diseases have invented a range of testing procedures and, in some cases, the patenting of these test procedures based upon individual human genes. Myriad Genetics has been involved in research on breast cancer. After the identification of two genes that coded for the presence of breast cancer in women, Myriad filled for, and received, patents in the United States and Canada for the breast cancer diagnostic test that the firm developed. Canadian provinces utilized this diagnostic test as part of the testing procedures for women and all was fine until Myriad started to enforce the patents rights on the test, which meant that all samples would need to be sent to Myriad’s laboratories at much higher cost to the Canadian provinces using this test.

The enforcement of patent rights is well within the law, but it was the enforcement of patent rights on a human gene patent that triggered considerable consternation. What was revealed to those interested in genomic research and the related aspects of this research, was the apparent conflict between the Canada Health Act and the Canadian Patent Act. While the Canada Health Act guarantees equal treatment for all Canadians, the ability for private firms to profit from basic health procedures, established the need for a fundamental review of this situation. Canadian health and genomic researchers were not alone in this review. Most industrial nations were part of this debate and dialogue process. The result was that the world’s industrialized nations agreed to develop guidelines for the patenting of testing procedures for human diseases.

Canada faces a policy quandary with the competing objectives of a publicly funded accessible and universal healthcare system and the right to a return on private investment from intellectual property and other rights associated with patents. The Canadian healthcare system and the delivery of services are based on innovative technologies. These innovative technologies have been patented and firms and investors expect a return on their investment. This thesis examines the conflict that Myriad created within Canada when it began to enforce their patent rights. In essence, what it examines is the right to profit from an innovative discovery and technology and how to balance that against the regulatory requirement to ensure that Canadians continue to get the best healthcare service possible.

Canadian policy makers face a choice of policy instruments to resolve this quandary through the implementation of the OECD Guidelines for Licensing of Genetic Inventions. This thesis also explores the implementation issues and feasibility of the choices of policy instruments for implementation of the OECD Guidelines and concludes that the soft law policy instrument is the most optimal choice for implementation of the Guidelines.