Clinical research and biomedicine - Medical research using genetic technology and the influence of the Biotechnology Directive

7 important questions on Clinical research and biomedicine - Medical research using genetic technology and the influence of the Biotechnology Directive

What is the number of the biotechnology directive?

98/44

What is genetic medicine?

It's about genes, it contains inheritable information

What are the 4 perspectives of genetic medicine?

  1. Screen people for their vulnerability to diseases, predisposition to allergies
  2. Ban inherited disorders
  3. Created new drugs and expand lifespan
  4. Doctors can better diagnose and tailer treatment and drugs to a persons exact genetic profile
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What are the 4 concerns raised when speaking about genetical technology?

  1. Confidentiality, privacy and informed consent
  2. Protection from discrimination (they can calculate the risk)
  3. Commodification or commercialization of the human body
  4. Risk of use for eugenic purposes
    • linked to privacy reasons
    • genetic manipulation can have an impact on future generations
    • improving mankind

What is the difference between germ line gene therapy and somatic cell gene therapy?

Germ line gene therapy
  • = modifying material of an individual that has an impact on future generations

Somatic cell gene therapy
  • = only related to the person involved, does not have an impact on future generations
  • to cure a disease

How does the EU intervene in this field of genetic technology?

By using patents
  • EU does not constrain gene technology but it uses intellectual property law as a regulatory mechanism

Why is it that the EU regulates this field by using patents?

The availability of patens is essential in order to research into new technologies
  • return of investment
  • the inventor needs a reasonable prospect for commercial exploitation in order to make the investment

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