GENTECH archive 8.96-97


Plethora of genetic privacy bills in usa


      BioWorld via Individual Inc. : WASHINGTON _
      Before cloning grabbed the spotlight,
      genetic discrimination was the biotech
      ethics issue capturing the most public

      Even though the future potential for
      cloning a human has played on the public
      imagination of late, the risk of losing
      health insurance or employment as a result
      of "flunking the gene test" _ as National
      Human Genome Research Institute Director
      Frances Collins calls it _ remains very
      much in the here and now.

      Both federal and state legislators in 39
      states have proposed a variety of
      legislation ranging from granting people
      ownership of their genetic information to
      requiring informed consent for any use of
      the genetic information. As well- meaning
      as these provisions appear, many of them
      could bring medical research to a grinding

      "The potential for genetic information to
      be used to discriminate against people was
      really the first bioethics issue to show up
      as a priority for us one and a half years
      ago," said Carl Feldbaum, president of the
      Biotechnology Industry Organization (BIO).
      "Genetic privacy is essential to our
      industry, but we need to be very careful
      how genetic privacy laws are written in
      order to protect research."

      As a result, BIO and the Pharmaceutical
      Research and Manufacturers of America
      (PhRMA) joined forces to educate
      legislators both in Washington and in
      individual states about the untoward
      consequences their bills may have on

      The risk to research was first realized
      last year, when a bill unanimously passed
      in the New Jersey state legislature that
      would have granted ownership rights to
      genetic information. Intense lobbying by
      BIO and PhRMA resulted in Governor
      Christine Todd Whitman vetoing the bill and
      the provision was eliminated.

      Establishing that people own their genetic
      information may seem a reasonable way to
      assure that individuals maintain control
      over that information, but as Ann Oman,
      vice president for communications at PhRMA,
      noted, "The provision could inhibit
      clinical trials and ultimately result in
      preventing patients from having access to
      these clinical trials."

      The problem with granting ownership of
      genetic information and the samples from
      which the information was derived is that
      it would mandate record-keeping to identify
      the sample and the donor. Such a provision
      would not only be extremely expensive, but
      would conflict with the goal of protecting
      privacy because all samples would have some
      sort of potentially accessible "deed"
      associated with them.

      In addition, if property laws were brought
      to bear on medical samples and genetic
      information, there could be a torrent of
      litigation over the rights blood relatives
      have over medical information obtained from
      other family members as well as royalty
      litigation for drugs developed from
      information obtained in clinical trials.

      Nevertheless, this year, New Mexico,
      Nebraska, Maryland and Florida among others
      had bills proposed that would have granted
      property rights.

      The vast majority of the 91 state bills
      (some of which are dead) that addressed
      issues related to genetic information
      viewed it as a separate issue from medical
      information. Both BIO and PhRMA oppose such
      efforts to dissect genetic information away
      from general medical information.

      Because most diseases have a genetic
      component, Feldbaum pointed out that
      genetic information is part of the
      continuum of medical information. For
      example, a person's cholesterol level is
      determined by both eating and exercise
      habits and by the persons genetic
      predisposition to high cholesterol. That
      predisposition can be easily inferred from
      an accurate family history. As such,
      Feldbaum noted that any distinction between
      genetic and non-genetic information is
      likely to be arbitrary at best.

      "Genetic information is extremely difficult
      to separate from medical information," Oman
      agreed. "That is why we support privacy
      protections for all medical records."

      Many of the state bills also had provisions
      that would require the destruction of
      samples used for genetic tests in order to
      prevent someone from testing the sample
      without the person's knowledge. Such a
      provision flies in the face of current FDA
      regulations regarding samples collected
      during clinical trials.

      A related provision found in several state
      bills requires that researchers obtain
      informed consent for every use of a stored
      sample. Oman noted that would stymie a
      great number of epidemiological studies
      that use anonymized information.

      "Any legislation must protect anonymized
      data bases," Oman said. "It is vital that
      scientists have access to this type of

      Feldbaum noted that most legislators are
      amenable to changes in their bills when
      they learn that the bills could jeopardize
      research in their states. Nevertheless,
      monitoring and contacting every state over
      problematic bills requires a Herculean
      effort. Both PhRMA and BIO would like to
      see federal legislation that protects the
      privacy of medical information.

      "Right now, we have a patchwork of laws
      that provide inconsistent protections
      depending upon which state you live in,"
      Feldbaum said. "We need a blanket law that
      standardizes this across the country."

      At the federal level, Sen. Pete Domenici
      (R-N.M.) proposed bill S. 422 that would
      prohibit genetic discrimination. Feldbaum
      noted that expanding the Domenici bill to
      encompass protections for all medical
      information remains a high priority at BIO.

      "We continue to work with Domenici's staff
      on this bill," Feldbaum said. "But we have
      not yet convinced him of the need to
      include all medical information into his
      bill." n


      [Copyright 1997, American Health