Footnotes

1- Fatima al-Zinati et al: “Demographic Health Survey of Egypt” 2008 p.255  http://www.measuredhs.com/pubs/pdf/FR220/FR220.pdf

"Evidence of intense ongoing endemic transmission of hepatitis C virus in Egypt". Proceedings of the National Academy of Sciences. 22 June 2010
http://www.pnas.org/content/107/33/14757.full
 
2- World Health Organization. Global alert and response (GAR): Hepatitis C http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index4.html
 
3- "Epidemiological characteristics and response to peginterferon". Journal of Viral Hepatitis, 2007, 14, 460–467. http://www.ncbi.nlm.nih.gov/pubmed/17576387
 
4- No. 164. June 2011.  . "Hepatitis C Factsheet"World Health Organization (WHO).
http://www.who.int/mediacentre/factsheets/fs164/en/index.html
 
5- "Peginterferon and Ribavirin for Chronic Hepatitis C". Jay H. Hoofnagle, M.D., and Leonard B. Seeff, M.D. N Engl J Med 2006; 355:2444-2451December 7, 2006. http://www.nejm.org/doi/full/10.1056/nejmct061675

6- Administrative Court Ruling in case no.5792 for the 65th judicial year: department of economic disputes and investment, 7th district, issued on May 14th 2011, p.2

7-Notification issued of a dispute over the registration of the drug Reiferon Retard 160 mcg, Central Administration of Pharmaceutical Affairs, Ministry of Health, December 28th 2004
     
8- Administrative Court Ruling in case no.5792 for the 65th judicial year: department of economic disputes and investment, 7th district, issued on May 14th 2011, p.23
     
9- Peg-interferon alpha 2a
     
10-Peg-interferon alpha 2b

11- Al-Wafd newspaper, Sana Mustafa: 'Price of interferon reduced to 384LE', p.2, 20th May 2010
http://www.id3m.com/D3M/ShowFilesFoldersText.phpPage=Egy&tree_id=380&art...
     
12- Rose al-Yusuf, Zeinab Hamdy: 'Egyptian health insurance continues treatment with Egyptian interferon', 23rd April 2011 http://www.rosaonline.net/Weekly/News.asp?id=109395

Al-Borsa News, Mahmoud Salah al-Din: 'Holding company reduces the impact of the interferon ruling on its subsidiary company' http://www.alborsanews.com/D8%A7%D9%84%D8%A7%D8%AED8%A8%D8%A7%D8%B1/tabi...
     
13- Al-Dostour newspaper, Amaniya Talal: 'Abaza: the doctor who determines whether to treat with Egyptian interferon or imported', 21st May 2011 http://www.dostor.org/society-and-people/variety/11/may/21/42892
     
14- Al-Masry al-Youm newspaper, Tariq Amin, Mohamed Talat al-Hiwari and Darin Ferghali: 'Interferon: a new war between Egyptian drug companies...in health it is survival of the cheapest', 19th October 2009
http://www.almasry-alyoum.com/article2.aspx?ArticleID=229849&IssueID=1563     

15- This class of drugs are also known as 'small molecule drugs' or 'chemical entities'.

16-  "International Trade and Health: A Reference Guide".World Health Organization. Regional Office for South-East Asia. 2009. www.searo.who.int/LinkFiles/IPT_ITH.pdf
     
17- National Council for Drugs and Poisons: Conditions for Registering Saudi Biosimilars http://www.nmpb.gov.sd/Human%20Drugs/Registration%20requirement%20for%20...
 F Hincal (2009), “An Introduction To Safety Issues In Biosimilars/Follow-On Biopharmaceuticals”, JMedCBR 7, 1 September 2009, http://www.jmedcbr.org/issue0701/Hincal/Hincal_09_09.html
 
18- "Biosimilar medicines and safety: New Challenges for pharmacovigilance". Lemit Rago. World Health Organization (WHO), Geneva, Switzerland. International Journal of Risk and Safety in Medicine  (2009). pages 5-11.
http://iospress.metapress.com/content/gr5372164v55r442

19- According to the Malaysian Ministry of Health's presentation to the Fourteenth International Conference of Drug Regulatory Bodies in December 2010 in Singapore, the countries that have already issued regulatory guidelines for the registration of biosimilars are as follows: Canada, Guatemala, Mexico, Cuba, Brazil, Argentina, Switzerland, Croatia, the EU, Saudi Arabia, Turkey, Malaysia, Singapore, Japan, Korea, Taiwan, Indonesia, and Australia.
http://www.who.int/entity/medicines/areas/quality_safety/regulation_legi...
     
20- Ministry of Health decree no.297 of 2009: Egyptian Gazette, Issue 157, July 8th 2009
     
21- Personal interview with a source who resigned from the Central Administration of Pharmaceutical Affairs, who requested anonymity, June 2010

22- Factsheet on biosimilar products, European Medicine Agency, 2011
http://www.ema.europa.eu/docs/en_GB/document_library/Brochure/2011/03/WC...
23- Website of the European Medicine Agency
 
24- European Medicine Agency. Committee for Medicinal Products for Human Use (CMPH): "Reflection Paper: Non-clinical and clinical Development of Similar Medicinal Products Containing Recombinant Interferon Alfa". EMEA/CHMP/BMWP/102046/2006. London 23 April 2009.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin...
 
25- Questions and Answers on biosimilar medicines (similar biological medicinal products)""
European Medicine Agency (EMA). Doc. Ref. EMEA/74562/2006 Rev. 1, London, 22 October 2008.  http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12...
     
260 Ministry of Health Decree no.113 of 2004: 'On the system to obtain marketing approval for pharmaceuticals', Egyptian Gazette, Issue 117, 29th May 2004
     
27- Administrative Court Ruling in case no.5792 for the 65th judicial year: department of economic disputes and investment, 7th district, issued on May 14th 2011, p.15

28- 'Efficacy and safety of a novel pegylated interferon alpha 2a in Egyptian patients with genotype 4 chronic hepatitis C". Alaa Awad Taha MD, Ahmad El-Ray MD, Maged El-Ghannam MD, Bahaa Mounir MD. The Canadian Journal of Gastroenterology. October 2010. http://www.ncbi.nlm.nih.gov/pubmed/21037988
     
29- Al-Masry al-Youm newspaper, Nashwa al-Hofi: 'The battle of Egyptian interferon rages...and the Ministry of Health is absent', April 21st 2011
     

30- 'Epidemiological characteristics and response to peginterferon". Journal of Viral Hepatitis, 2007, 14, 460–467. http://www.ncbi.nlm.nih.gov/pubmed/17576387
     
31- Al-Shorouk newspaper, Khaled Abu Bakr: 'Ministry of Health forms an impartial committee to end the interferon war', 22nd September 2010
http://www.shorouknews.com/ContentData.aspx?id=299886
     
32- Al-Shorouk newspaper, Khaled Abu Bakr: 'Ministry of Health forms an impartial committee to end the interferon war', 22nd September 2010 http://www.shorouknews.com/ContentData.aspx?id=299886

33- Telephone conversation with one of the experts on the committee, 13th July 2011. The expert explained that such a study would take almost five years, as it is estimated that the selection of volunteers from hepatitis C patients will take around 18 months, then the treatment and monitoring will take another 18 months, then finally time for the researchers to analyse the results will bring the total to nearly five years.
     
34- General Comment 14,  E/C.12/2000/4, United Nations Committee for Economic, Social, and Cultural Rights
http://www.unhchr.ch/tbs/doc.nsf/%28Symbol%29/40d009901358b0e2c1256915005090be?Opendocument