INTRODUCTION

  1.  The US is leading the world in the field of human genomics. This paper summarises the current activity in genetic databases, who is doing what in the US and why, the main focus of the current House of Lords Inquiry. This is only a very small part of total US activity in the field of human genomics.

THE PUBLIC SECTOR

Department of Defense DNA Specimen Repository for Human Remains Identification

2.  The Department of Defense (DOD) DNA Specimen Repository is the world's largest DNA databank. Since June 1992, the DOD has required all military personnel to provide blood and saliva samples for its DNA Specimen Repository at the time of enlistment, re-enlistment, annual physical or preparation for operational deployment. The Repository also contains samples from civilians and foreign nationals who work for the US military in arenas of conflict. The purpose of the DNA Registry is to identify the remains of soldiers killed in combat or missing in action. The military's policy ensures that specimens can be used only for remains identification and routine quality control, except when subpoenaed following an investigation or prosecution of a crime. The specimens cannot be used without consent for any other purpose such as paternity suits or genetic testing. The specimens are considered confidential medical information and military regulations exist to cover any privacy concerns.

Forensic DNA Banks

  3.  In 1989, the Virginia Division of Forensic Science became the first US state to pass laws that required certain classes of offenders to submit DNA samples for inclusion in a DNA databank. This law requires certain sex offenders and certain violent felons to provide samples for the state DNA databank. Presently it is estimated that Virginia authorities receive more than 20,000 DNA samples a year, which are added to the more than 150,000 samples that have been collected and stored since 1989. Following Virginia's example, the other 49 states have subsequently passed laws requiring the collection of DNA samples from certain criminals. All 50 states require DNA samples from convicted sex offenders, with some states collecting from all classes of felons. It is estimated that nationwide samples from about 400,000 offenders have so far been collected.

  4.  Through the DNA Identification Act of 1994, a national oversight committee was established to develop guidelines for DNA forensics and a five year $14 million grant programme was put in place to assist the state and local laboratories in developing and improving their forensic DNA testing capabilities. The DNA Identification Act also formally authorised the FBI to establish the Combined DNA Index System (CODIS) for law enforcement identification purposes.

  5.  These databanks have caused controversy however, and in 1997 the Attorney General directed the National Institute of Justice to establish and administer a commission on the future of DNA evidence, the purpose of which is to provide the Attorney General with advice on the use of current and future DNA methods in the operation of the criminal justice system. The Commission has already released reports on the use of DNA in post-conviction cases and the criteria for training and technical assistance for criminal justice professionals involved in the identification, collection and preservation of DNA evidence at the crime scene. The Commission is currently looking at the impact of future technological developments on the use of DNA in the criminal justice system.

National Institutes of Health (NIH)

  6.  A number of the Institutes at NIH have supported the establishment of DNA databanks to support their missions. The National Cancer Institute (NCI) has led in the establishment of such databases, the biggest of which is the NCI Breast Cancer Specimen and Data Information System which includes DNA from patients diagnosed with breast cancer, those at risk and unaffected individuals. The NCI is now working closely with the National Human Genome Research Institute on databases for colorectal and gynaecologic cancers.

  7.  The National Institute of Allergy and Infectious Diseases, the National Heart Lung and Blood Institute, the National Institute of Mental Health and the National Institute of Ageing have also established tissue banks which include DNA libraries and DNA clones.

THE PRIVATE SECTOR

  8.  Until recently, the Rare Diseases Community led US private sector activity. For example, work has been done for Huntington's disease, MS and PXE.

  9.  A number of small biotechnology companies are now moving into the genetic databases area. Many of these companies are in the growing area of pharmacogenomics. This is a fast-moving and highly-competitive sector, with a number of companies competing to provide services to the large pharmaceutical and biotechnology companies through the provision of new therapeutic candidates and/or through helping with clinical trials thus shortening time to market. The US Companies most active in this area are Incyte Genomics, Affymetrix, Double Twist, and DNA Dynamics (based in California), Genaissance (based in Boston) and Gene Logic, Celera and Human Genome Sciences (based in Maryland).

  10.  One company of particular interest is Myriad, based in Salt Lake City, Utah. The Utah population is fairly unique in that early settlers had very large families (12 or more children). These settlers therefore left thousands of descendants. Myriad has arranged exclusive access to three vast genetic databases on these families. Using these extensive family genealogy databases and DNA specimens Myriad is developing more targeted, effective diagnostics and therapeutics.

PUBLIC POLICY ISSUES

  11.  Privacy and confidentiality of genetic information and fairness in the use of such information, in particular by insurers and employers, are the main concerns in the US. A number of bills have been introduced at the State and Federal level to establish limitations on the disclosure and use of genetic information but to date none have been passed. Although no specific federal genetic non-discrimination legislation has been enacted the Americans with Disabilities Act of 1990 (ADA) provides some protections against disability-related genetic discrimination in the workplace. But it does not protect against discrimination based on unexpressed genetic conditions or protect potential workers from requirements or requests to provide genetic information to their employers.

  12.  But on 8 February 2000, President Clinton signed an executive order prohibiting every federal department and agency from using genetic information in any hiring or promotion action. This executive order, endorsed by the American Medical Association, the American College of Medical Genetics, the National Society of Genetic Counsellors, and the Genetic Alliance, prohibits federal employers from requiring or requesting genetic tests as a condition of being hired or receiving benefits and provides strong privacy protections to any genetic information used for medical treatment and research.