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Notes 271 to high-levels of research and development into down-stream innovations. Of course not all other things are equal, but to the extent that this competition is already taking place, the winner seems to be the country with the broader patent system: the United States. Time will tell. 31 Common practice for the Food and Drug Administration in the United States is 5 years, which is also the period agreed upon in many of the bilateral free trade agreements it has recently signed. 32 Potential cost savings for companies relying on data would be in the order of $450 million, the average costs associated with clinical trials for each approved drug. Some estimates show that these costs have more than tripled in the past fifteen years. 33 When data exclusivity is weak, it can also drive research-based pharmaceutical research industries out, as has happened in the past few years in Israel. A once thriving research destination, the lack of data exclusivity – the result of a powerful generics lobby – had driven research elsewhere. In September 2005, the legislation was changed to provide some data protection. 34 In legal terms, the specific element that is crucial to the firm’s ability to price differentiate within a market is the international patent exhaustion principle. If patent rights are exhaustible the patentee must renounce the right to its product the moment it is first sold, giving the first purchaser the ability to potentially resell at a higher price. The TRIPS agreement does little to clear up this pressing issue. (http://www. wto.org/english/tratop_e/trips_e/factsheet_pharm02_e.htm) 35 A good example of successful price discrimination without re-exportation comes from the example of bronchodilators in South Africa. Here, Government purchases accounted for 66 per cent of sales volume, but only 33 per cent of revenues. In this case patents show that, if parallel importation is controlled for, good health can be promoted. Reekie, W.D., “South Africa’s Battle with AIDS and Drug Prices”, National Center for Policy Analysis, Dallas, TX, Brief 334, 2000. 36 http://www.freemarketfoundation.com/ ShowArticle.asp?ArticleType=Publication&ArticleID=1093 37 The most recent example comes from Brazil, where the head of the country’s AIDS program cited an increasingly high percentage of its AIDS budget, which is designed to offer Brazilians with the disease (some 600,000) free treatment, had to be devoted to pharmaceutical purchases. Because of this, Brazil threatened to issue compulsory licenses on the key drugs that combine to form anti-retro viral treatments. http://news.bbc.co.uk/1/hi/health/4059147.stm, accessed 06/01/2005 38 ‘Neglected diseases’ are defined by the WHO as African Trypanosomiasis, leishmaniasis and Chagas disease. 6 Cost effective means of fighting the diseases of poverty 1 Alternate Solutions Institute, Pakistan. 2 Imani, Ghana. 3 Free Market Foundation, South Africa. 4 Global Biosciences Development Institute, USA.
272 Fighting the Diseases of Poverty 5 ESEADE University, Argentina. 6 Instituto Libertad y Progreso, Colombia. 7 Liberty Institute, India. 8 Minimal Government, Manila, Philippines. 9 Fundación Atlas 1853, Argentina. 10 International Policy Network, UK. 11 Instituto Libre Empresa, Peru. 12 Instituto Liberdade, Brazil. 13 Africa Fighting Malaria, South Africa. 14 http://www.who.int/hiv/AAI_fs_4Q2005.pdf 15 United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003. 16 http://online.wsj.com/article/0,,SB111644800426237250,00.html 17 WHO/CDS/WHOPES/GCDPP/2004.6, A generic risk assessment model for insecticide treatment and subsequent use of mosquito nets. 18 http://www.cdc.gov/malaria/control_prevention/vector_control.htm 19 http://www.rotavirusvaccine.org/vaccine-facts.htm 7 Counterfeit medicines in LDCs: problems and solutions 1 http://www.who.int/mediacentre/factsheets/fs275/en/ 2 Liza Gibson, “Drug regulators study global treaty to tackle counterfeit drugs,” British Medical Journal Volume 328, Number 486 February 28, 2004. 3 European Federation of Pharmaceutical Industries and Associations, “Counterfeit medicines”, available at http://www.efpia.org/2_indust/counterfeitdrugs.pdf 4 http://www.manilatimes.net/national/2005/aug/16/yehey/life/20050816lif1.html 5 http://bmj.bmjjournals.com/cgi/content/full/327/7424/1126-a 6 Fackler M (2002 July 29) China’s fake drugs kill thousands. San Francisco Examiner 7 http://www.who.int/entity/bulletin/volumes/81/12/WHONews.pdf 8 http://bmj.bmjjournals.com/cgi/content/full/327/7412/414-b 9 http://pharmalicensing.com/articles/disp/1120475327_42c918bf09048 10 Selling cheap generic drugs, India’s copycats irk industry, available at http://chakra.org/articles/2000/12/03/indian/drugs 11 Latin America Battles Counterfeit Drug Threat, Daily International Pharmacy Alert: Washington Business Information, 2(292), 2006. 12 http://www.efpia.org/2_indust/counterfeitdrugs.pdf 13 Fake drugs worry authorities, firms, The Russia Journal, 2000, 3(4) 47 14 South China Business Journal, June/July/August, 2002. 15 http://www.prospect.org/web/page.ww?section= root&name=ViewWeb&articleId=10650 16 http://www.freemarketfoundation.com/ShowArticle. asp?ArticleType=Publication&ArticleID=1093 17 Very often, the supply of drugs is reduced by the Byzantine and tortuous regulations that emanate from local drug approval agencies. These regulations make it very difficult for manufacturers wishing to export to overseas markets
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