Access to medications and conducting clinical trials in LMICs

Nature Reviews Nephrology

Volumn 11, Issue 3, 2015, Pages 189-194

  Okpechi, Ikechi G ^a   Swanepoel, Charles R ^a   Venter, Francois ^b  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b UNIVERSITY OF THE WITWATERSRAND   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

AFRICAN MEDICINE; ANTIHYPERTENSIVE THERAPY; BRAZIL; CHINA; CHRONIC KIDNEY DISEASE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CONFIDENTIALITY; COST EFFECTIVENESS ANALYSIS; DEVELOPED COUNTRY; DEVELOPING COUNTRY; DISEASE REGISTRY; DRUG INDUSTRY; DRUG SURVEILLANCE PROGRAM; ECONOMIC DEVELOPMENT; FOOD AND DRUG ADMINISTRATION; GOOD CLINICAL PRACTICE; GOVERNMENT; HEALTH CARE ACCESS; HEALTH CARE POLICY; HEALTH CARE QUALITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INDIA; INFORMED CONSENT; INSTITUTIONAL REVIEW; KIDNEY FUNCTION; LABORATORY; LAW; LOW TO MIDDLE INCOME COUNTRY; MEDICAL LITERATURE; MEDICAL TECHNOLOGY; MIDDLE EAST; NIGERIA; ORGANIZATIONAL STRUCTURE; OROPHARYNX CANDIDIASIS; PATENT; PATIENT AUTONOMY; PHARMACEUTICAL CARE; POVERTY; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; RESEARCH ETHICS; RESPONSIBILITY; REVIEW; SCIENTIST; SOCIOECONOMICS; SOUTH AFRICAN; SOUTH AMERICA; TELECOMMUNICATION; TRANSLATING (LANGUAGE); UNITED STATES; ZAMBIA; HEALTH CARE DELIVERY; STATISTICS AND NUMERICAL DATA; SUPPLY AND DISTRIBUTION;

PRESCRIPTION DRUG;

CLINICAL TRIALS AS TOPIC; DEVELOPING COUNTRIES; HEALTH SERVICES ACCESSIBILITY; HUMANS; POVERTY; PRESCRIPTION DRUGS;

EID: 84923797042     PISSN: 17595061     EISSN: 1759507X     Source Type: Journal    
DOI: 10.1038/nrneph.2015.6     Document Type: Review

References (32)

1. Ayodele, O. E. & Alebiosu, C. O. Burden of chronic kidney disease: an international perspective. Adv. Chronic Kidney Dis. 17, 215-224 (2010).
2. World Trade Organization. Agreement on Trade-Related Aspects of Intellectual Property Rights. wto.org [online], http://www.wto.org/english/tratop-e/trips-e/t-agm0-e.htm (1994).
3. World Trade Organization. Declaration on the TRIPS Agreement and public health. wto.org [online], http://www.wto.org/english/thewto-e/minist-e/min01-e/mindecl-trips-e.htm (2001).
4. Bird, R. C. Developing nations and the compulsory license: maximizing access to essential medicines while minimizing investment side effects. J. Law Med. Ethics. 37, 209-221 (2009).
5. Reichman, J. H. Comment: compulsory licensing of patented pharmaceutical inventions: evaluating the options . J. Law Med. Ethics. 37, 247-263 (2009).
6. Siva, N. Tackling the booming trade in counterfeit drugs. Lancet 376, 1725-1726 (2010).
7. New Partnership for Africa's Development. Historical context: origins and influences. NEPAD Transforming Africa [online], http://www.nepad.org/history (2012).
8. Ba, D. Senegal president slams Nepad. IOL News [online], http://www.iol.co.za/news/africa/senegal-president-slams-nepad-1.357495 (2007).
9. Narsai, K., Williams, A. & Mantel-Teeuwisse, A. K. Impact of regulatory requirements on medicine registration in African countries-perceptions and experiences of pharmaceutical companies in South Africa. South. Med. Rev. 5, 31-37 (2012).
10. SADC Business Barriers: Case Study 04, access to medicines in Southern Africa. SAIIA [online], http://www.saiia.org.za/doc-details/608-sadc-business-barriers-case-4-access-to-medicines-in-southern-africa (2014).
11. Goldacre, B. Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. (Fourth Estate, 2012).
12. Orizio, G., Merla, A., Schulz, P. J. & Gelatti, U. Quality of online pharmacies and websites selling prescription drugs: a systematic review. J. Med. Internet Res. 13, e74 (2011).
13. Khan, T. Proposed law on medical devices 'could cost lives'. BD Live [online], http://www.bdlive.co.za/national/health/2014/10/30/proposed-law-on-medical-devices-could-cost-lives (2014).
14. US National Library of Medicine. clinicaltrials.gov [online], https://www.clinicaltrials.gov/ct2/results/map?term=Chronic+kidney+disease (2014).
15. Jha, V. et al. Chronic kidney disease: global dimension and perspectives. Lancet 382, 260-272 (2013).
16. World Medical Association Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. WMA [online], http://www.wma.net/en/30publications/10policies/b3/17c.pdf (2008).
17. World Medical Association Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. Amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. WMA [online], http://www.wma.net/en/30publications/10policies/b3/ (2013).
18. Venter, F. in South African Health Review 2012/13 Ch. 3. (eds Padarath, A. & English, R.) 37-47 (Health Systems Trust, 2013).
19. Ready, T. Pfizer in "unethical" trial suit. Nat. Med. 7, 1077 (2001).
20. Hyder, A. A. et al. Ethical review of health research: a perspective from developing country researchers. J. Med. Ethics 30, 68-72 (2004).
21. Roey, J. V. & Haxaire, M. The need to reform current registration processes to improve access to essential medicines in developing countries. Pharm. Med. 22, 207-213 (2008).
22. Harris, D. C. H., Dupuis, S., Couser, W. G. & Feehally, J. Training nephrologists from developing countries: does it have a positive impact? Kidney Int. Suppl. 2, 275-278 (2012).
23. Dixon, J. R. Jr. The International Conference on Harmonization Good Clinical Practice guideline. Qual. Assur. 6 65-74 (1998).
24. Ndomondo-Sigonda, M. & Ambali, A. The African medicines regulatory harmonization initiative: rationale and benefits. Clin. Pharmacol. Ther. 89, 176-178 (2011).
25. Cohen, E. R., O'Neill, J. M., Joffres, M., Upshur, R. E. & Mills, E. Reporting of informed consent, standard of care and post-trial obligations in global randomized intervention trials: a systematic survey of registered trials. Dev. World Bioeth. 9, 74-80 (2009).
26. Gabble, R. & Kohler, J. C. To patent or not to patent? The case of Novartis' cancer drug Glivec in India. Global. Health 10, 3 (2014).
27. Medicines and Related Substances Act 101 of 1965-Regulations and Notices-Government Notice R510. SAFLII [online], http://www.saflii.org/za/legis/consol-reg/ marsa101o1965rangnr510723/ (2014).
28. Chatterjee, P. India tightens regulation of clinical trials to safeguard participants. BMJ 346, f1275 (2013).
29. Sackett, D. L. Six pairs of things to celebrate on International Clinical Trials Day. Trials 14, 128 (2013).
30. Rosenblatt, M. How academia and the pharmaceutical industry can work together. Ann. Am. Thorac. Soc. 10, 31-38 (2013).
31. African Medicines Regulatory Harmonization Programme. Update on the First Biennial Scientific Conference on Medicines Regulation in Africa "Building Partnerships for Sustainable Capacity Development in Medicines Regulation in Africa", 2-3 December 2013, Johannesburg, South Africa. amrh.org [online], http://amrh.org/update-on-the-first-biennial-scientific-conference-on-medicines-regulation-in-africa-building-partnerships-for-sustainable-capacity-development-in-medicines-regulation-in-africa-2-3.html (2013).
32. NEPAD establishes centres of excellence to help strengthen regulatory capacity development. PharmaAfrica [online], http://www.pharmaafrica.com/nepad-establishes-centres-of-excellence-to-help-strengthen-regulatory-capacity-development/ (2014).