and use of existing technologies. It might be more important, for instance, to ensure that everyone is using two or three really good new tests than wondering how to encourage the use of another 100 that do not offer a significant advantage over existing technology.

Hogarth has been involved in a project to examine policy issues surrounding the evaluation and regulation of genetic tests. As part of the project, interviews and workshops were conducted with over 80 individuals from key stakeholder groups (industry, clinicians, patient groups, regulators, and policy makers) in Europe, Canada, the United States, and Australia.

The project classified policy issues into three areas: incentives and infrastructure for generating a robust evidence base for new innovations; regulatory mechanisms for the independent evaluation of evidence; and systems for ensuring that doctors, patients, health care policy makers, and payers have access to accurate and comprehensive information presented in a way that can be easily understood.

Other work in the area includes a project on information policy for pharmacogenetics and two reports for the Canadian government, one on regulating pharmacogenomics and another on the clinical application of molecular diagnostic technologies.

Genomic innovation transcends national boundaries. Multinational companies are involved, and there are global markets for the products. International research is being done by such organizations as the Human Genome Organisation (HUGO) and the Human Proteome Organisation (HUPO). There is transnational regulation and standard setting being carried out by such groups as the International Conference on Harmonization (ICH) and the International Organization for Standardization (ISO).

Innovations in genomics are affected by nongovernmental organizations, such as the Organisation for Economic Co-operation and Development and the World Health Organization, as well as by research funders with a global reach, such as the Bill and Melinda Gates Foundation. Innovation is also affected by transnational agreements such as the General Agreement on Tariff and Trade and the Agreement on Trade-Related Aspects of Intellectual Property Rights. The European Union crosses national borders and heavily influences innovation within Europe.

Genomics varies around the world in terms of the organization of health care delivery systems, the regulatory frameworks for innovation, and the economic incentives and infrastructure. On the other hand, there are a number of policy reports from across the world that express, in different ways, shared policy concerns.

The first such shared concern is that, in some cases, genomic innovations such as genetic tests have been moving into routine clinical practice too quickly and without enough independent evaluation.



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