Legal Restrictions for Biotech increasing in certain countries, decreasing in others

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Enablers:

  • Biotech is seen as a core topic and core industry in many countries economic policy
  • Breakthrough in this technology
  • Increasing competition from Emerging Markets (Production and R&D Outsourcing)
  • National Prestige of a coutnry, willing to be the front-runner
  • Harmonisation efforts on a global level regardig approval authorities
  • The increasing globalization of markets

Inhibitors:

  • Increasing security concerns regarding biotech
  • Recalls of drugs from the market (Vioxx, Tysabri)
  • Approval Authorities getting more strict
  • Monitoring requirements after market launch getting more strict

Paradigms:

  • What cannot be done in one part of the world can (an will) be done in another
  • Biotechnology technological advances run in front of the ethical discussion on its use
  • Biotechnology solutions might be the next big thing for the pharmaceutical industry, eg. gene therapy

Experts:

  • Governmental regulatory bodies, eg Food and Drug Administration US
  • World Health Organisation
  • World Trade Organisation
  • Universities doing research in biotech
  • Pharmaceutical companies
  • Biotech startups

Timing:

  • 25.04.1953: Nature publishes Watson and Crick's article on the double helix of DNA [3]
  • 06.1995: Birth of Dolly
  • 02.2003: Death of Dolly (normal life expectation of a sheep: 12-14 years)
  • 28.2.05: Tysabri: Suspension of sale, followed by market withdrawal
  • 30.09.04: Vioxx: Withdrawn from the market
  • 20.05.05: Veto of US President Bush against Stem Cell Research Bill
  • 2005: Birth of Snuppy, the cloned dog
  • 2009: Barack Obama becomes president of the USA with a desire to reform the health system

Web Resources:

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