Difference between revisions of "The Future of Biotechnology for Medical Applications in 2005, Governmental Issues"

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==Conclusion and answers to the research questions==
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5. What political developments occur that try to reduce the significant growth of healthcare cost?<br><br>
Gowernments are less and less willing to allow significantly higher drug prices in their countries, than in the rest of the world (This is especially true for the US and has to do with increasing healthcare costs). Also, e.g. in western European countries and in Japan government’s budgets are under pressure due to increasing social security costs because of an aging population. All this will lead to pressure to allow parallel import of drugs and to pressure to outsource even biotech research and production of biotechnology drugs to other, parts of the world, where it can be conducted for lower costs.
<br><br>
8. How will the FDA and EMEA authorities respond to the exponential growth of the biotech industry and how will their guidelines develop? <br><br>
On one hand, short track approval processes have been developed, on the other hand security concerns are increasing. At the moment it regulations, especially those of FDA seem to get more strict. Time needed to develop and especially to market new drugs could therefore increase and costs to get approval could do so too. In addition, guidelines regarding monitoring and control of drugs, after they have been introduced in the market are likely to get more strict too.  <br><br> 
<br><br>
18. What is the legal situation in those parts of the world which are relevant for biotech research?<br><br>
The hottest and most debated issue in correspondence with biotech for medical application is stem cell research. Many countries are restrictive in this context, not allowing stem cell research with cells taken from existing embryos. Others allow using cell material from “left over” embryos from in vitro fertilization and others are permissive and allow even therapeutic cloning. UK and South Correa are the leading and most permissive countries. In the US, attempts to allow federal- or state governmental funding of research on therapeutic cloning are currently blocked by presidential Veto. <br><br>
19. To what degree can governments control on whether laws on biotech research are being respected?<br><br>
Governments have 3 levers to control biotech research: (1) Public funding of biotech research, (2) prohibition of certain research and (3) approval respectively non-approval of certain drugs or therapies. <br><br>
However it will be hardly possible to control that people of a certain country do not get a cure which involves biotechnological research or production processes or even drugs which are illegal within the borders of their country. People will go to other countries where the respective drug, cure or therapy is legal, if they can be cured from their diseases. The protagonist in the respective interview (Fortune, 2005) said, that, if he is a criminal, when he cures goes to another country with his son where he can be cured with something that is illegal in his country, so he is willing to become a criminal. Thus governments can limit research, they can limit access to certain future cures for the broad mass of people but they cannot limit it entirely: What cannot be done in one place can be done in another. And those who demand it and can afford it will get it. <br><br>
32. Can the biotech development be stopped by imposing (general and international) laws? <br><br>
Borders do less and less matter. What cannot be done in one country can be done in another. What cannot be done by one company can be done by another. What cannot or will not be sponsored in one place of the world might get public support and sponsorship in another. Consolidation in the industry will lead to the fact that companies are big enough to conduct their research in any place in the world they like. Also increased venture capital – from any place in the world – will flow to those places in the world where governmental conditions for research on biotechnology are most favorable. It is therefore virtually impossible to stop biotechnology research by imposing laws in specific countries. <br><br>
International laws might slow biotechnology. However, we have seen that many countries, developed ones and emerging ones, consider biotechnology as one key focus of their economic strategy and that certain countries have gained an edge in biotech research which could not be conducted in other countries. It is therefore hardly imaginable, that international laws that ban certain research or techniques in biotechnology can be imposed on a worldwide basis. 
<br><br>
It is thus hard to stop biotechnology. 
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==References==
==References==
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Latest revision as of 01:42, 2 June 2010

==Biotechnology for Medical Application and Policy in 2015 – Governmental and regulation issues (Daniel)==

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References



UK Medicines Information (UKMi); 2003; The Licencing of Medicines; August

EMEA,European Medicines Agency, 2005, http://www.emea.eu.int; October

FDA, Food and Drug Administration; 2005 The new drug development process http://www.fda.gov/cder/handbook/develop.htm; October 10

WHO, World Health Organization; 2005; Country Information, http://www.who.int/countries/en/; October 10

University of Minnesota Medical Scholl; 2005; World Stem Cell Map, http://mbbnet.umn.edu/scmap.html; October 09

European Commission (Kommission der Europäischen Gemeinschaften); 2001; Eine Strategische Vision für Biowissenschaften und Biotechnologie; Brussels, September 4

Ernst & Young; 2005; Beyond Borders, Global Biotechnology Report 2005

Fortune Magazine, Betsy Morris, 2005; The Stem Cell War, September 5

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