View source for 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 [mailto:ruthdonners@hotmail.com contact me].
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==Description:==
This driving force relates to the legal restrictions imposed on biotech research in different countries.<br>
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 [1].<br>
Stem cell research looks like the next big thing for pharmaceutical industry (see [[The Future of R&D in Pharmaceutical Industry in 2025]], since stem cell lines grown in the lab provide scientists with the opportunity to "engineer" them for use in transplantation or treatment of diseases. For example, before scientists can use any type of tissue, organ, or cell for transplantation, they must overcome attempts by a patient's immune system to reject the transplant. In the future, scientists may be able to modify human stem cell lines in the laboratory by using gene therapy or other techniques to overcome this immune rejection. Scientists might also be able to replace damaged genes or add new genes to stem cells in order to give them characteristics that can ultimately treat diseases [2].
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.<br> 
The US, where currently a presidential veto is blocking federal funding for embryonic stem cell research in connection with therapeutic cloning. However, the individual states in the US have the authority to pass laws to permit human embryonic stem cell research using state funds. Unless Congress passes a law that bans it, states may pay for research using human embryonic stem cell lines that are not eligible for federal funding [2].<br>
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.<br>
On the other hand, if great breakthroughs will come from the R&D, it is more likely that countries will adopt a more lenient regulation.

==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	

==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:==
*[1] [http://mbbnet.umn.edu/scmap.html World map indicating which countries have a permissive additude towards stem cell research]
*[2] [http://stemcells.nih.gov/StemCells/Templates/StemCellContentPage.aspx?NRMODE=Published&NRNODEGUID=%7bA604DCCE-2E5F-4395-8954-FCE1C05BECED%7d&NRORIGINALURL=%2finfo%2ffaqs%2easp&NRCACHEHINT=NoModifyGuest#bestresearch US National Institute of Health FAQ site on stem cell research]
*[3] [http://nobelprize.org/educational_games/medicine/dna_double_helix/readmore.html Information on DNA and its discovery]