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 |
| UCL | Human 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 | |
|
| 
