Genetic testing and insurance

1
Genetic testing and insurance

• Jan Wahlström
• Professor
• Clinical Genetic Department at East Hospital

2
Genetic testing and insurance

• The insurance company does not request genetic
  testing before accepting a life insurance.
• However when a genetic test is performed in
  health care as part of diagnose or therapy there
  may be problems.
• Only presymptomatic testing is controversial.

3
The conflict

• Life insurance depend on risk calculations.
• All individuals in an insurance collective will
  have to pay their share of the risk.
• If the individual knows more about his risk then
  the insurance company then he has an advantage
  and will not pay his share of the risk.
• If there are many individuals in the insurance
  collective like this, then the company will have
  economical problems (adverse selection).
• Genetic integrity (personal integrity)

4
Genetic integrity

• Knowledge about an inherited disorder does not
  involve only the tested person but also all
  relatives.
• There are a copy of all genes in all cells in the
  body.
• In a simple blood sample contain all genetic
  information.
• A mutation can be found in all cells after
  conception.
• Inherited diseases can b diagnosed before there
  are any symptoms.
• Genetic integrity is a specially defendable
  intimate zone very close to the individual.

5
Genetic testing and insurance

• Presymptomatic testing can be performed only on a
  small number of monogenetic diseases.
• Huntingtons disease (7/100 000)
• The risk for adverse selection will therefore be
  very low.
• If testing will be possible on common diseases
  with complex inheritance then the problem
  increase.

6
The situation now

• There is an agreement between the insurance
  industry and the Swedish government.
• Only on life insurance larger then 550 000 SEK
  the companies will use information gained by
  genetic testing i health care.
• There is a parliamentary committee appointed and
  their suggestions will be presented in early
  2004.
• The companies will only use information on
  Huntingtons disease.

7
Patent on genes
8
The aim of patenting

• To support the development of inventions of
  importance for the society and to stimulate
  inventors and researchers.
• Will patent on DNA sequence as it is applied
  today fulfil this aim?

9
Advantage with patent

• Stimulates industrial development.
• A patent is made public known and this knowledge
  is made available to other researchers.
• Prevent development of costly duplicates

10
Myriad genetics

• Inherited cancer, two genes BRCA1 and 2
• Myriad genetics has received patent on diagnostic
  and treatment
• Does not admit any license
• May demand that all diagnostic analysis to be
  done on a laboratory in USA

11
Three reasons why patent on DNA can be
questioned.

• Patent on DNA is threatening human genetic
  integrity.
• Patent on DNA does not fulfil ordinary patenting
  criteria.
• new
• invention height
• a specified application
• Patent on DNA will give unwanted consequences on
  health care and research

12
Genetic integrity

• Genetic integrity
• People feel instinctively that my genes can not
  be owned by a company
• According to an actual EU directive you may
  patent my gene if it is done outside my body.
• The genes of mankind belongs to all people.
• Is the description of a gene an invention or a
  discovery?

13
Examples on genepatent

• DNA sequence
• promoters
• enhancers
• individdual exon
• EST
• cDNA
• transcripts of cDNA
• individual mutations
• individual polymorphisms

• cloned vector
• expressions vector
• isolated transformed cells
• proteins
• the use of proteins
• DNA probes
• antibodies
• whole genome

14
To be considered for patent on DNA sequence

• Conclusions are drawn from patent on chemical
  substances to patent on genetic information in
  the form of DNA sequence
• With the sequence available on a PC the invention
  height can be questioned
• Product patent demands a certain invention height
  which is missing for patent on DNA sequence
• An application for a patent must be concrete and
  not involve future hypothetical development.
• Patent on DNA sequence should be an exception and
  not a rule.

15
To be considered for patent on DNA sequence

• Patent on genes should only be given if it
  involves diagnosis of a specific diseases.
• When a product patent is already accepted a
  compulsory licence should be considered.
• Patent on a hypothetical future use of a DNA
  sequence will hinder research.
• The research exemption should be strengthened.
• Product patent should be avoided when future gene
  therapy is considered.

16
To be considered for patent on DNA sequence

• A specified DNA sequence could participate in the
  production of many proteins
• Refrain from giving broad product patent on a
  specified DNA sequence and its proteins
• Accept only user patent on the specific protein
  that one gene produces.
• Consider effects on the cost for health care.

17
Blair and Clinton 14/3 2000

• Raw fundamental data on the human genome
  including the human DNA sequence and its
  variations should be made freely available to
  scientists everywhere.
• Intellectual property protection for gene-based
  inventions will also play an important role in
  stimulating the development of important new
  healthcare products