The need to reform current drug registration processes to improve access to essential medicines in developing countries

Pharmaceutical Medicine

Volumn 22, Issue 4, 2008, Pages 207-213

  Van Roey, Jens ^a,b   Haxaire, Myriam ^a  

^a Virco BVBA   (Belgium)

^b TIBOTEC BVBA   (Belgium)

Author keywords

Artesunate amodiaquine, general; Essential drugs; European Medicines Agency; Food and Drug Administration; Health services accessibility; Miconazole, general; Regulatory process; Research and development

Indexed keywords

AMODIAQUINE PLUS ARTESUNATE; ANTIMALARIAL AGENT; CRYSTAL VIOLET; KETOCONAZOLE; MICONAZOLE; MICROBICIDE; NYSTATIN; UNCLASSIFIED DRUG;

CLINICAL TRIAL; DEVELOPING COUNTRY; DRUG EFFICACY; DRUG INDUSTRY; DRUG LABELING; DRUG LEGISLATION; DRUG QUALITY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HEALTH CARE SYSTEM; HUMAN; MALARIA; OROPHARYNX CANDIDIASIS; PRESCRIPTION; PRIORITY JOURNAL; REGISTRATION; REVIEW; WORLD HEALTH ORGANIZATION;

EID: 52449127785     PISSN: 11782595     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF03256705     Document Type: Review

References (43)

1. World Health Organization. Access to medicines [online]. Available from URL: http://www.who.int/trade/glossary/story002/en/ [Accessed 2007 Dec 7]
2. Leach B, Paluzzi JE, Munderi P. Prescription for healthy development: increasing access to medicines. London: UN Millennium Project, 2005 [online]. Available from URL: http://www.unmillenniumproject.org/documents/TF5-medicines- Complete.pdf [Accessed 2008 May 29]
3. Department for International Development. Access to medicines in underserved markets: what are the implications of changes in intellectual property rights, trade and drug registration policy? London: United Kingdom Government Policy and Plans, 2004 [online]. Available from URL: http://www.dfid.gov.uk/pubs/files/dfidsynthesispaper.pdf [Accessed 2008 Jan 14]
4. Trouiller P, White N, Pécoul B, et al. Drugs for neglected diseases: a failure of the market and a public health failure? Trop Med Int Health 2001; 6: 945-51
5. Mrazek M, Mossialos E. Stimulating pharmaceutical research and development for neglected diseases. Health Pol 2003; 64: 75-88
6. Webber D, Kremer M. Perspectives on stimulating industrial research and development for neglected infectious diseases. Bull World Health Organ 2001; 79: 735-41
7. Fehr A, Thurmann P, Razum O. Drug development for neglected diseases: a public health challenge. Trop Med Int Health 2006; 11: 1335-8
8. Canning D. Priority setting and the 'neglected' tropical diseases. Trans R Soc Trop Med Hyg 2006; 100: 499-504
9. Ziemba E. Public-private partnerships for product development: financial, scientific and managerial issues as challenges to future success. The World Health Organization Commission on Intellectual Property Rights, Innovation and Public Health 2005 Mar [online]. Available from URL: http://www.who.int/ intellectualproperty/studies/public_private_partnership/en/index.html [Accessed 2008 May 29]
10. CMR International. Assessing the regulatory environment and its impact on patients' access to new medicines: Africa and Middle East. R&D briefing 48. 2005 Sep [online]. Available from URL: http://cmr.org/institute/pdf/RD48.pdf [Accessed 2008 Apr 14]
11. Tufts Center for the Study of Drug Development. EMEA meets performance goals, but lags U.S. FDA in drug approvals. Impact Rep 2007 Jan/Feb; 9 (1)
12. PhRMA. New drug approvals in 2006: biopharmaceutical companies gain approval for 29 new treatments in 2006 [online]. Available from URL: http://www.phrma.org/files/NDA2006.pdf [Accessed 2008 Apr 16]
13. Trouiller P, Orbinski J, Laing R, et al. Drug development for neglected diseases: a deficient market and a public-health policy failure. Lancet 2002; 359: 2188-94
14. Ford N, Darder M. Registration problems for antiretrovirals in Africa. Lancet 2006; 367: 794-5
15. Hamilton D. A "good deed" for AIDS drugs hits obstacles. Wall St J 2006 Jun 30, Sect B; 1 (col 5)
16. Oxfam International. Investing for life: meeting poor people's needs for access to medicines through responsible business practices. Oxfam briefing paper 109. 2007 Nov [online]. Available from URL: http://www.oxfam.org/en/policy/ briefingpapers/bp109_investing_for_life_0711 [Accessed 2008 May 29]
17. Milstien J, Belgharbi L. Regulatory pathways for vaccines for developing coun-tries. Bull World Health Organ 2004; 82: 128-33
18. Nuttall J, Romano J, Douville K, et al. The future of HIV prevention: prospects for an effective anti-HIV microbicide. Infect Dis Clin North Am 2007; 21: 230-2
19. Baker BK. Drug registration barriers and logjams. In: International Treatment Preparedness Coalition, editor. Missing the target #5: improving AIDS drug access and health care for all. 2007 Dec: 49-58 [online]. Available from URL: http://www.aidstreatmentaccess.org/itpc5th.pdf [Accessed 2008 May 29]
20. Matsoso P, Auton M, Banoo S, et al. How does the regulatory framework affect incentives for research and development? [online]. Available from URL: http://www.who.int/intellectualproperty/studies/regulatory_framework/en/ [Accessed 2007 Nov 14]
21. Coplan P, Mitchnick M, Rosenberg Z. Regulatory challenges in microbicide development. Science 2004; 304: 1911-2
22. Van Roey J, Haxaire M, Kamya M, et al. Comparative efficacy of topical therapy with a slow-release mucoadhesive buccal tablet containing miconazole nitrate versus systemic therapy with ketoconazole in HIV-positive patients with oropharyngeal candidiasis. J Acquir Immune Defic Syndr 2004; 35: 144-50
23. Tibotec Pharmaceuticals Ltd. Summary of product characteristics [online]. Available from URL: http://www.tibotec.com/bgdisplay.jhtml?itemname= products_characteristics [Accessed 2008 Jun 20]
24. Lynen L. Odynophagia and dysphagia. In: Clinical AIDS care guidelines for resource-poor settings. Brussels: Médecins Sans Frontières, 2001: 199-209
25. World Health Organization. The interagency emergency health kit 2006: medicines and medical devices for 10,000 people for approximately 3 months [online]. Available from URL: http://www.who.int/medicines/publications/ WHO_PSM_PAR_2006.4.pdf [Accessed 2007 Nov 14]
26. Bouckaert S, Schauttee H, Lefebvre RA, et al. Comparison of salivary miconazole concentrations after administration of a bioadhesive slow-release buccal tablet and an oral gel. Eur J Clin Pharmacol 1992; 43: 137-40
27. World Health Organization. Malaria [online]. Available from URL: http://www.who.int/topics/malaria/en/ [Accessed 2007 Jan 16]
28. Debt AIDS trade Africa. Why Africa [online]. Available from URL: http://www.data.org/whyafrica [Accessed 2008 Jun 20]
29. Drugs for Neglected Diseases initiative. Organizational website [online]. Available from URL: http://www.dndi.org/ [Accessed 2007 Jan 16]
30. Kiechel JR, Pecoul B. Innovative partnership brings new ACT free of patent. PLoS 2007 Feb 26 [online]. Available from URL: http://www.plos.org/cms/ node/208 [Accessed 2008 May 29]
31. DNDi, Sanofi-aventis. Position paper on Financial Times article by Andrew Jack, March 30 2007. Corners are cut in order to bring drugs to Africa: treatments against tropical diseases are being launched without western regulatory scrutiny. 2007 Apr 17 [online]. Available from URL: http://www.actwithasaq.org/pdf/Position_Paper_FTresponse_ASAQ.pdf [Accessed 2008 May 29]
32. Jack A. Corners are cut in order to bring drugs to Africa pharmaceuticals: treatments against tropical diseases are being launched without western regulatory scrutiny. Financial Times 2007 Mar 30: 13
33. Sanofi-aventis. Malaria: strong partnerships aiming to benefit patients in Africa. Press release: 2008 Apr 22 [online]. Available from URL: http://en.sanofiaventis.com/Images/080422_ASAQ_ONE_YEAR_ENG_tcm24-20770.pdf [Accessed 2008 Apr 25]
34. US Food and Drug Administration. CDER report to the nation: 2005 [online]. Available from URL: http://www.fda.gov/cder/reports/rtn/2005/rtn2005- 5.htm#PEPFAR [Accessed 2007 Nov 20]
35. Draft commission regulation on the conditional marketing authorisation for medicinal products falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and the Council of 31 March 2004 [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2004/ nov/draft-regulation_13-10-2005.pdf [Accessed 2008 Jun 20]
36. World Health Organization. Prequalification programme: a United Nations programme managed by WHO [online]. Available from URL: http://healthtech.who. int/pq/ [Accessed 2008 May 29]
37. World Health Organization. The WHO prequalification project [online]. Available from URL: http://www.who.int/mediacentre/factsheets/fs278/en/ [Accessed 2007 Dec 7]
38. Pignatti F, Boone H, Moulon I. Overview of the European regulatory approval system. J Ambul Care Manage 2004; 27: 89-97
39. Bertele V, Bassi LL. A critique to the European regulatory system. J Ambul Care Manage 2004; 27: 98-104
40. Southern African Development Community. Training workshop for medicines regulators [media release; online]. Available from URL: http://www.sadc.int/ news/news_details.php?news_id=988 [Accessed 2008 Jun 20]
41. Pan American Network for Drug Regulatory Harmonization. Fourth Pan American Conference on drug regulatory harmonization. Working Group on Bioequivalence (WG/BE) [online]. Available from URL: http://www.paho.org/ english/ad/ths/ev/be-backgr-engl.pdf [Accessed 2008 Jun 20]
42. CMR International. Global drug development and regulatory review: is there a new paradigm? R&D briefing paper 44. 2004 Dec [online]. Available from URL: http://cmr.org/institute/pdf/RD44.pdf [Accessed 2008 Apr 14]
43. Timmermans K. Harmonization, regulation, and trade: interactions in the pharmaceutical field. Int J Health Serv 2004; 34: 651-61