Genomic Medicine - Science and Technology Committee Contents


Annex 1

RCUK USA OFFICE INPUT ON US POLICY FRAMEWORK ON GENOMIC MEDICINE

  76.  The US government has powers to regulate the commercial development of genetic technologies. These include the laws governing the ability to patent gene sequences, laws regulating clinical laboratory quality, and laws regulating the safety and effectiveness of genetic diagnostics. In particular the Food and Drug Administration (FDA) has responsibility for assessing the safety and effectiveness of genetic tests used for diagnosis or prediction of disease. In recent years, several bills have been introduced into Congress to prohibit genetic discrimination although have yet been enacted into law. State legislatures also have broad powers to legislate to protect the health, safety, and welfare of their citizens, and these powers have begun to be exercised in the context of genetic technologies.

  77.  The US Genetics and Public Policy Centre has produced a good summary briefing on the law and genetics in the US at: http://www.dnapolicy.org/policy.law.php

FOOD AND DRUG ADMINISTRATION (FDA)

  78.  The FDA takes a leading role in working with the academic community and business to ensure that regulatory science and regulations are developed at a pace which responds to scientific and technological advances, particularly in relation to pharmacogenomics and the implications this has for personalized medicine.

  79.  To date the FDA has cleared a number of genotyping tests to enable doctors to determine whether patients have genetic mutations which could influence their ability to metabolise certain drugs.

  80.  The FDAs 2004 white paper "Stagnation or Innovation? Challenge and Opportunity on the Critical Path to New Medical Products" looks at the possible opportunities from genomic medicine and the challenges of developing these medical products as part of a wider study of the lag between discovery and product development. FDA also produced a good, plain English summary on the opportunities and challenges of genomics and personalized medicine in 2005.

  81.  White paper is at: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html

  82.  Consumer briefing is at: http://www.fda.gov/fdac/features/2005/605_genomics.html

  83.  The FDA has also produced guidance on the use of pharmacogenomics for regulatory decision making, and participates in a number of research projects to support and promote the translation of pharmacogenomics from basic research, drug discovery and development into clinical practice, focused on responsible use to protect public health.

NATIONAL INSTITUTES FOR HEALTH (NIH)

  84.  The NIH funds the National Human Genome Research Institute (NHGRI), whose activities are focused on understanding the structure and function of the human genome and its role in health and disease. NHGRI supports the development of resources and technology that will accelerate genome research and its application to human health. A critical part of the NHGRI mission is the study of the ethical, legal and social implications of genome research, as well as the training of investigators and the dissemination of genome information to the public and to health professionals.

  85.  On the policy side, NHGRI runs a policy and legislation database which contains federal and state laws, statutes, policies and other material covering: privacy of genetic information/ confidentiality; informed consent; insurance and employment discrimination; genetic testing and counseling; and commercialization and patenting. NHGRI also provides comprehensive policy briefings on its website, addressing current research, policy issues and legislation (including listings of significant research, policy reports and recommendations). Recent highlights include:

    —  Director NHGRI's address to the President's Council of Science Advisors on S&T on the science and policy of personal medicine (September 2007).

    —  Genomic medicine: a revolution in medical practice in the 21st century (presentation to Annual World Health Care Congress April 2006).

    —  The future of genomic medicine: policy implications for research and medicine (roundtable conference, 2006).

  All documents can be accessed at: http://www.genome.gov/PolicyEthics/

NATIONAL ACADEMIES

  86.  In 2005, NIH funded the US National Academies to undertake a study on IP issues related to genomic and proteomic research. The report "Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation and Public Health", reviewed US patenting practice in relation to genes and gene function and their use to diagnose and treat disease, and the implications and restrictions this could place of future research. It recommended that policy makers, courts and health patent officials should take steps to prevent increasingly complex IP protection hindering future breakthroughs in genomics and proteomics research for health. For example it recommended that NIH should continue to encourage researchers to freely exchange materials and data, and place their data in free public databases. Report is at: http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11487

NON-GOVERNMENTAL ORGANISATIONS

  87.  One of the leading US non-governmental organisations working in this area is the Genetics and Public Policy Centre. The Centre is supported by the Pew Charitable Trusts, with research funding from the NHGRI and the U.S. Department of Veterans Affairs.

  88.  The Centre works with policy leaders, decision makers, and the public to help all parties better understand the evolving field of human genetics and its application to healthcare. Specifically the Centre produces reports, issues briefs and holds policy seminars on range of issues, including genomic medicine. All reports and briefs can be accessed at the Centres website (http://www.dnapolicy.org/). Recent topics of relevance include: IP and the human genome; pharmacogenetics; the impact of genetic discrimination; and FDA regulation of genetic tests.

  89.  The Centre also undertakes surveys public attitudes about genetics issues, conducts analyses of the existing regulatory landscape, monitors the transition of genetic applications into clinical practice, and posits options and likely outcomes of key genetics policies.

US RESEARCH ON GENOMIC MEDICINE

NATIONAL ADVISORY COUNCIL FOR HUMAN GENOME RESEARCH

  90.  The US Government has established the National Advisory Council for Human Genome Research (NACHGR) to advise the Department of Health and Human Services, NIH and NHGRI on genetics, genomic research, training and programs related to the human genome initiative. NACHGR performs second-level peer review for grant applications, and determines the program priorities for NHGRI and the goals for the US efforts in the International Human Genome Project. The Council is appointed by the Secretary for Health and Human Services. As well as the Directors of NIH, NHGRI, the Chief Medical Director of the Department for Veterans Affairs and the Assistant Secretary of Defence for Health Affairs, the Council includes 12 scientists from a range of disciplines (including information and social sciences) and 6 members from the legal profession, health policy sector and economic sector (http://www.genome.gov/10000905).

NATIONAL HUMAN GENOME RESEARCH INSTITUTE

  91.  The NIH funded National Human Genome Research Institute (NHGRI) led the participation of NIH in the International Human Genome and now funds research on the genome's structure, function, and role in health and disease and supports studies on the ethical, legal and social implications of genome research. NHGRI's total budget in FY2008 is $487 million.

  92.  NHGRI funds research via extramural and intramural programmes and also coordinates related research activities across NIH's other institutes as well as maintaining an overview of international developments. The intramural programme ($100 million) consists of laboratory based and clinical research to translate genome research into a greater understanding of human genetic disease (http://www.genome.gov/10001634). Research includes work medical genetics (focused on disorders of human development), genome technology and social and behavioural research focused on communication of genetic risks, best practice in genetic counseling and integrating genetics into primary care (http://www.genome.gov/10000010). The clinical programme includes work to identify disease causing genes as well as studies aimed at examining the psychosocial, ethical and policy implications of genetics research (http://www.genome.gov/10000331).

  93.  The extramural research programme ($362 million for grants and contracts) includes a number of strands including large-scale genome sequencing activities, informatics and computational biology and legal, ethical and social research (http://www.genome.gov/10001092).

  94.  NHGRI also funds postgraduate training and fellowship awards ($7 million), and provides information on genetics diseases and genetic research to improve health for the general public (see: http://www.genome.gov/Health/)

US-UK RESEARCH COLLABORATION ON GENOMIC MEDICINE

  95.  The US (NJGRI) and the UK are partners in the International HapMap Project, which also includes scientists and funding agencies from Canada, China, Japan and Nigeria. The project aims to identify and catalogue genetic similarities and differences in human beings. Using the information in the HapMap, researchers will be able to find genes that affect health, disease, and individual responses to medications and environmental factors. All of the information generated by the Project will be released into the public domain. The UK partners in the project are:

    —  the Wellcome Trust Sanger Institute; and

    —  the University of Oxford (funded by the Wellcome Trust, NIH, and the SNP Consortium which comprises of a number of pharmaceutical companies, the Wellcome Trust, the Sanger Institute and a number of US universities).

  96.  The NHGRI extramural programme also directly funds some relevant research in the UK. Current awards include:


UK Institution
Award
Value

Wellcome Trust Sanger Institute Detecting human functional sequences with mircoarrays
$272k
UCLHuman genome nomenclature
$464k
European Bioinformatics Institute, Cambridge The UniProt protein sequence and function knowledge base
$5,872k
European Bioinformatics Institute, Cambridge The nomenclature of human genes
$340k

22 April 2008





 
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