1. Predictive Testing & Insurance Law

2. Content of the Presentation: A. Predictive Tests B. Benefits of Predictive Testing C. Drawbacks of Predictive Testing D. Legislation around the World E. Conclusion

3. A. Predictive Tests

4. Predictive Testing & Insurance Law   Advances in molecular geneticsallowed development of new tests   Detects defective genes related to hereditary diseases before their outbreak.   Probability of development of a genetic condition. Predictive genetic testing = “The use of a genetic test in an asymptomatic person to predict future risk of disease.”

5. Predictive Testing & Insurance Law   Early identification and therapeutic intervention made possible.   Traditional medical diagnostic tests only examine current health.   Two categories: 1. 1. Pre-symptomatic testing predicts with 100% certainty of development. 2. 2. Susceptibility testing detects gene mutation which increases risk of development.

6. Predictive Testing & Insurance Law   Genetic data valuable for risk evaluation = predicting future risk allows to determine insurance premiums.   Free accessibility for underwriting procedures may have detrimental effects on ethical standards.   Conflicting interests of insurers and general public that need to be balanced.   No universal code of practice existing yet.

7. B. Benefits of Predictive Testing

8. Predictive Testing & Insurance Law Two main benefits within Insurance Industry: 1) Beneficial during Risk Evaluation of Insurers  Insurance = Pooling of modest premiums to provide compensation for suffering individuals. Predictive tests relevant for Life and Health Insurance.  Underwriting = Insurer assesses risk of any eventuality and potential financial consequences. Goal is to determine a fair premium rate.

9. Predictive Testing & Insurance Law  Interest of insurers to gain access to all predictive test results or to request applicant to undergo testing prior to offering insurance contract of ‘the utmost good faith‘.  Risk-equity principle : The greater the offset risk, the greater the required contribution. The more accurate the risk evaluation, the higher the risk-equity.   Free access beneficial for insurers financial position and also low-risk insured, that will only have to pay a small premium.

10. Predictive Testing & Insurance Law 2) Beneficial to avoid Adverse Selection within Insurance Industry  Restricting insurers access to genetic data from predictive tests increases potential for Adverse Selection =   Situation : Applicants have access to genetic data but insurers do not. Imbalance can lead to a vicious circle of worsening of the risk pool and increasing costs of insurance. „Actions taken by one party using risk characteristics or other information known to or suspected by that party that cause a financial disadvantage to the financial or personal security system“

11. Predictive Testing & Insurance Law  Result : Can lead to liquidation of insurance companies, as only unprofitable high-risk individuals will buy insurance.   Interest of insurers in predictive test results is only financial, but needs to be protected to avoid adverse selection. Insured also protected from general premium raises.

12. C. Drawbacks of Predictive Testing

13. Predictive Testing & Insurance Law Three negative consequences within Insurance Company: 1) Detrimental regarding Genetic Discrimination If insurers had free access to predictive test results, they would use the information during underwriting. If insurers had free access to predictive test results, they would use the information during underwriting. Selection process in which genetic data can be used to the disadvantage of an individual : Positive predictive result will likely lead to very high premium rate or denial of insurance contract. Selection process in which genetic data can be used to the disadvantage of an individual : Positive predictive result will likely lead to very high premium rate or denial of insurance contract.

14. Predictive Testing & Insurance Law Result : Genetic discrimination is at hand due to unrestricted use predictive genetic test results, if insurance becomes too costly or unavailable for some people only on the basis of their genetic traits. Result : Genetic discrimination is at hand due to unrestricted use predictive genetic test results, if insurance becomes too costly or unavailable for some people only on the basis of their genetic traits. Genetically related family members also affected, as genetic testing data works as a blueprint on family history. Genetically related family members also affected, as genetic testing data works as a blueprint on family history.

15. Predictive Testing & Insurance Law 2) Detrimental due to deterrence effect on genetic testing The fear of genetic discrimination gives rise to additional problem, as individuals may not undergo predictive testing, if results will have to be disclosed to insurers. The fear of genetic discrimination gives rise to additional problem, as individuals may not undergo predictive testing, if results will have to be disclosed to insurers. US Study : 85% of respondents would not take a genetic test if access of insurance companies to results was unrestricted. US Study : 85% of respondents would not take a genetic test if access of insurance companies to results was unrestricted. Disadvantageous to : Healthy person that gets no relief through knowing & high risk person that could opt for preventive medicine and therapy. Disadvantageous to : Healthy person that gets no relief through knowing & high risk person that could opt for preventive medicine and therapy.

16. Predictive Testing & Insurance Law 3) Detrimental to the ‘Right of not Knowing‘ Having to submit to predictive genetic testing before obtaining insurance can be mentally challenging: Confronted with possibly unwanted and life- changing knowledge. Having to submit to predictive genetic testing before obtaining insurance can be mentally challenging: Confronted with possibly unwanted and life- changing knowledge. UNESCO recognised Right not to Know UNESCO recognised Right not to Know In order to respect it, insurance companies will have to be prohibited from requesting predictive testing for the purpose of underwriting. In order to respect it, insurance companies will have to be prohibited from requesting predictive testing for the purpose of underwriting.

17. D. Legislation around the World

18. Predictive Testing & Insurance Law  New field of medicineNo uniform legislation yet.  Commissions and advisory groups attempted to codify the ethical evaluation of such tests in recommendations.  Governments responsible for fighting genetic discrimination & threat to genetic privacy. Balancing of insurers interests vs. insureds interests

19. Predictive Testing & Insurance Law  UNESCO Universal Declaration on the Human Genome and Human Rights – Article 6 : prohibits discriminatory actions against individuals based on their genetic characteristics.  EU : Most national laws restrict use of genetic information by insurers E.g. Prohibitions in France & Denmark ; Voluntary moratoria in Germany & UK. Moratorium = Self-regulating behaviour of insurance companies. Advantageous to new laws, as renegotiation is easier than repealing legislation.

20. Predictive Testing & Insurance Law  Example UK : In 1997 voluntary code of practice developed by the ABI and government (‘Concordat and Moratorium on Genetics and Insurance‘). Instruct ABI members not to ask for disclosure of predictive genetic test results. Exception = If certain financial limits of the insurance policies are exceeded. Protect both interests = Preserve access of applicants to insurance + recognise the insurers’ right of equal access risk information.

21. Predictive Testing & Insurance Law  Nuffield Council on Bioethics : Positively tested individuals shall be treated by insurer like anyone with a family history only. Negatively tested shall benefit from his result and be treated differently from family members.  Recommendations and legislation : Some aspects overlap, some are complementary. Goal = Establish a universal code of law regarding use of predictive genetic testing by insurance companies.

22. E. Conclusion

23. Predictive Testing & Insurance Law  If insurance companies were to be granted unrestricted access to genetic databreach in ethical principles & abuse of patient-related human rights.   Sometimes goverments only protect the private sector to the outside, however individuals benefit from a strengthened economy and sources of employment (long-run effect).   Threat of misuse of genetic data requires legislation before predictive testing becomes general procedure durin underwriting.