Legal Restrictions for Biotech increasing in certain countries, decreasing in others
This page is being edited by Ruth Donners EMBA09. In case of any questions/remarks contact me.
Description:
We are basically dealing with two driving forces in one here. New legislations particularly with regards to stem cell research have been implemented over the last years, whereby some countries have moved towards more restrictive rules and others towards more permissive ones. There are countries that basically allow therapeutic cloning to create stem cell material and that pursue and sponsor research in this area and there are countries whose legislation with regards to stem cell research is getting stricter. Some only allow to use existing embryonic stem cell material, others forbid to use embryonic material at all. The US, where a presidential veto is all blocking public funding for stem cell research in connection with therapeutic cloning. Moreover, as a consequence of increasing security concerns with regards to drugs, as a consequence of some spectacular withdrawals of drugs from the market, regulations for drug approval and monitoring of drugs, also after market launch, is likely to become more strict.
Enablers:
• Increasing Security concerns
• Recalls of drugs from the market (Vioxx, Tysabri)
• Approval Authorities getting more strict
• Monitoring requirements after market launch getting more strict
Inhibitors:
• Biotech is seen as a core topic and core industry in many countries economic policy
• Increasing competition from Emerging Markets (Production and R&D Outsourcing)
• National Prestige
Paradigms:
• What cannot be done in one part of the world can be done in another
Experts:
Timing:
• Tysabri: Suspension of sale per 28.2.05, eventually withdrawn form the market
• Vioxx: Withdrawn from the market per 30. 9.2004
• Veto of US President Bush against Stem Cell Research Bill: May 20, 2005
• 06/1995: Birth of Dolly
• 02/2003: Death of Dolly (normal life expectation of a sheep: 12-14 years)
• 2005: Birth of Snuppy, the cloned dog
Web Resources:
http://mbbnet.umn.edu/scmap.html