Overview of regulations on medicines derived from traditional Pharmacopoeia in Benin and Burkina Faso
Abstract
The success of the promotion policies of the Medicines Derived from Traditional Pharmacopoeia (MDTPs) requires a regulation that is adapted to realities and guarantees their quality, efficiency and safeness. This study aims to analyze the legal texts and the current guiding principles obtained from the heads of the departments in charge of traditional medicine in Burkina Faso and Benin.
The documents collected from the two countries have been analyzed comparatively and also in relation to WAEMU regulations and the WHO recommendations.
Several texts, dealing with the activity, products, facilities and advertisement related to traditional medicine, have been recorded in both countries. The regulation battery of Burkina Faso is more extensive than that of Benin, especially on traditional medicine and pharmacopoeia facilities. In addition, unlike biomedicines, the West African Economic and Monetary Union (WAEMU) and the West African Health Organization (WAHO) have not yet passed community laws on MDTPs.
To limit disparities in legal frameworks between the countries of the same sub-region, it is important that the WAEMU or WAHO be involved in the harmonization of pharmaceutical regulations by setting Community rules in the domain.
Keywords:
WHO, MDTPs, WAEMU, WAHO, Traditional medicine, medicine, regulation, Burkina Faso, Benin
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References
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25. Republic of Benin. Ministry of Health. Decree 2001-036 of 02/15/2001 establishing the principles of ethics and the conditions for the practice of traditional medicine in the Republic of Benin. Cotonou: Ministry of Health; 2001.S
26. Republic of Benin. Ministry of Health. Decree Year 2017 n ° 046 / MS / DC / CTJ / SGM / DNSP / DPMED / DRFMT / PNPMT / SA / 022SGG17 relating to the powers, organization and functioning of the National Commission for the Regulation of Traditional Medicine in Benin (CNRMT). Cotonou: Ministry of Health; 2017.
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30. Burkina Faso. Ministry of Health. Decree No. 2004-569 / PRES / PM / MS / MCPEA / MECV / MESSRS of 12/14/2004 authorizing the marketing of medicines from the traditional pharmacopoeia in Burkina Faso. Ouagadougou: Ministry of Health; 2004.
31. Republic of Benin. Ministry of Health. Order No. 2017-017 / MS / DC / SGM / CTJ / DPMED / DA / SA016SGG17 of 05/02/2017 laying down procedures for the approval of herbal medicinal products in the Republic of Benin. Cotonou: Ministry of Health; 2017.
32. Burkina Faso. Ministry of Health. Order No. 00-069 / MS / CAB of 02/22/2000 relating to the conditions for opening and operating a pharmaceutical preparation establishment. Ouagadougou: Ministry of Health; 2000.
33. Burkina Faso. Ministry of Health. Decree No. 2012-1035 / PRES / PM / MS / MICA / MATDS / MEF of 12/28/2012 laying down conditions for the opening and operation of a traditional medicine and pharmacopoeia establishment in Burkina Faso. Ouagadougou: Ministry of Health; 2012.
34. Burkina Faso. Ministry of Health. Order No. 2013-550 / MS / CAB of 06/21/2013 relating to the opening and operating of a traditional medicine and pharmacopoeia establishment in Burkina Faso. Ouagadougou: Ministry of Health; 2013.
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http://www.uemoa.int/sites/default/files/annexe/annexe_dec_06_2010_cm_uemoa.pdf
36. Burkina Faso. Ministry of Health. Order N ° 2005-231 / MS / CAB of 06/07/2005 relating to the conditions for issuing marketing authorizations for medicines from the traditional pharmacopoeia in Burkina Faso. Ouagadougou: Ministry of Health; 2005.
37. Bouzabata A. Herbal medicines in Algeria: regulation and registration. Phytotherapy. Dec 1 2017; 15(6):401 8.
38. Republic of Benin. Ministry of Health. Decree Year 2015 N ° 0239 / MS / DC / SGM / CTJ / DPMED / DA / SA 17/06/2015 relating to the creation, attribution, organization and functioning of the National Medicines Commission. Cotonou: Ministry of Health; 2015.
39. Republic of Benin. Ministry of Health. Order No. 2012-0343 / MS / DC / SGM / CTJ / DPMED / DA / SA of 07/10/2012 relating to the approval of nutritional supplements in the Republic of Benin. Cotonou: Ministry of Health; 2012.
40. Republic of Benin. Ministry of Health. Decree Year 2014 No. 249 / MS / DC / SGM / CTJ / DPMED / DA / SA establishing, assigning, composing and operating the committee of experts responsible for assessing applications for approval of medicinal products for human use. Cotonou: Ministry of Health; 2014.
41. Burkina Faso. Ministry of Health. Order 2013-243 / MS / CAB / of 03/13/2013 establishing, attributions, composition and functioning of the registration commission for health products for human medicine use. Ouagadougou: Ministry of Health; 2013.
42. Burkina Faso. Ministry of Health. Order No. 2014-009 / MS / CAB of 01/10/2014 appointing members of the registration committee for health products for human use. Ouagadougou: Ministry of Health; 2014.
43. Burkina Faso. Ministry of Health. Order 2013-244 / MS / CAB of 03/13/2013 establishing, attributions, composition and functioning of expert committees for the evaluation of applications for approval of health products for use in human medicine. Ouagadougou: Ministry of Health; 2013.
44. Burkina Faso. Ministry of Health. Order No. 2014-010 / MS / CAB of 10/01/2014 appointing members of expert committees to assess applications for the approval of health products for human use. Ouagadougou: Ministry of Health; 2014.
45. Republic of Benin. High Council of the Republic of Benin. Law N ° 90-005 of May 15, 1990 fixing the conditions for the exercise of commercial activities in the Republic of Benin. Cotonou: Ministry of Health; 1994.
46. World Health Organization Regional Office for Africa. Guidelines for registration of traditional medicines in the WHO African Region [Internet]. WHO; 2010 [cited 2019 Sept 27]. Available from:
https://apps.who.int/medicinedocs/en/m/abstract/Js20127en/
47. Republic of Benin. National Assembly of the Republic of Benin. Law N ° 97-020 of June 17, 1994 laying down the conditions of the exercise in private customers for the medical and paramedical professions. Cotonou: Ministry of Health; 1997.
48. Republic of Benin. Ministry of Health. Order No. 2018-262 / MSP / DC / SGM / DPED / C-PMT / SA of June 28, 2018 prohibiting advertising in the medical professions, medical activities, drugs and other medicinal products. Cotonou: Ministry of Health; 2018.
49. Burkina Faso. National Assembly of Burkina Faso. Law n ° 080-2015 / CNT of November 23, 2015 relating to advertising regulations. Ouagadougou: Ministry of Health; 2015.
50. Burkina Faso. Ministry of Health. Decree N ° 2010-244 / PRES / PM / MS of May 20, 2010 advertising drugs and other pharmaceutical products. Ouagadougou: Ministry of Health; 2010.
51. Burkina Faso. Ministry of Health. Decree 2013-069 / MS / CAB of 03/13/2013 modifying the decree N ° 2010-294 / MS / CAB of October 07, 2010 establishing, attributions, composition and functioning of the advertising control commission on medication. Ouagadougou: Ministry of Health; 2013.
52. Burkina Faso. Ministry of Health. Order N ° 2010-294 / MS / CAB of 10/01/2010 establishing, attributions, composition and functioning of the technical commission for the control of drug advertising. Ouagadougou: Ministry of Health; 2010.
53. Burkina Faso. Ministry of Health. Order N ° 2010-291 / MS / CAB of 01/10/2010 relating to the conditions of advertising on drugs and other pharmaceutical products. Ouagadougou: Ministry of Health; 2010.
http://www.oapi.int/Ressources/Actes_OAPI/Initiative_Libreville.pdf
2. World Health Organization. WHO strategy for traditional medicine for 2014-2023 [Internet]. WHO; 2013 [cited 2019 Sep 11]. Available from:
https://www.who.int/publications/list/traditional_medicine_strategy/fr/
3. World Health Organization. National policy on traditional medicine and regulation of herbal medicines: report of a WHO global survey [Internet]. WHO; 2005 [cited 2019 Sept 16]. Available from:
https://apps.who.int/iris/bitstream/handle/10665/43229/9241593237.pdf;jsessionid=9B539D38DF419C4DE7747379208EF7A1?sequence=1
4. Sofowora A. Medical plants and traditional medicine from Africa. Paris: Karthala [u.a.]; 1996. 378 pp. (ISBN 2-86537-652-4)
5. World Health Organization. Traditional Medicine [Internet]. WHO; 2003 [cited 2019 Sept 11]. Available from:
http://apps.who.int/gb/archive/pdf_files/WHA56/fa5618.pdf
6. World Health Organization. Traditional Medicine: Growing and Potential Needs [Internet]. WHO; 2002 [cited 2019 Sept 10]. Available from:
http://apps.who.int/medicinedocs/fr/d/Js2294f/
7. Ministry of Health of Burkina Faso. National Health Development Plan 2011-2020 [Internet]. 2011 [cited 2019 Sept 11]. Available from:
https://www.uhc2030.org/fileadmin/uploads/ihp/Documents/Country_Pages/Burkina_Faso/Burkina_Faso_National_Health_Strategy_2011-2020_French.pdf
8. Republic of Benin. Ministry of Health. National policy of traditional medicine in Benin. Cotonou: Ministry of Health; 2013.
9. Ministry of Health of Burkina Faso. Pharmaceutical policy, 2nd Edition [Internet]. 2012 [cited 2019 sept 16]. Available from:
http://apps.who.int/medicinedocs/fr/m/abstract/Js23266fr/
10. World Health Organization. WHO Strategy for Traditional Medicine for 2002-2005 [Internet]. WHO; 2002 [cited 2019 Sept 11]. Available from:
https://apps.who.int/medicinedocs/pdf/s2298f/s2298f.pdf
11. World Health Organization. Strengthening the role of Traditional Medicine in health systems: a strategy for the African region [Internet]. WHO; 2013 [cited 2019 Sept 27]. Available from:
https://www.afro.who.int/sites/default/files/sessions/working_documents/nv-fr-afr-rc63-6-Renforcement-du-role-de-la-medecine-traditionnelle-dans-les-systemes-de-sante_0.pdf
12. Ordié L. Break the epistemological impasse. New medicines and TK. Social Sciences and Health. 2012; (2):93-103.
13. Pousset JL. Traditional medicines are placed in Africa.Med Trop. 2006; 66(6):606-9.
14. Kasilo MO, Kofi-Tsekpo M, Busia K. Towards sustainable local production of traditional medicines in the African Region. The African Health Monitor. Aout 2010; Special issue : African traditional medicine day. 2010; 80 8.
15. Republic of Benin. Ministry of Health. National list of essential medicines of Benin. Cotonou: Ministry of Health; 2018.
16. Burkina Faso. Ministry of Health. National list of essential medicines and consumables in Burkina Faso. Ouagadougou: Ministry of Health; 2016.
17. Burkina Faso. Ministry of Health. National Strategy for Traditional Medicine and Pharmacopoeia, 2nd edition. Ouagadougou: Ministry of Health; 2015.
18. World Health Organization. Primary health care [Internet]. OMS; 1978 [cited 2019 Sept 25]. Available from: https://apps.who.int/medicinedocs/documents/s21370fr/s21370fr.pdf
19. African Intellectual Property Organization. Repository for the harmonization of procedures for the approval of medicines from the traditional pharmacopoeia in OAPI member countries. Yaounde; 2003. 34 p.
20. West African Economic and Monetary Union. Decision No. 06/2010 / CM / UEMOA adopting guidelines for the approval of nutritional supplements in the WAEMU member states [Internet]. UEMOA; 2010 [cited 2019 Sept 27]. Available from:
http://www.uemoa.int/sites/default/files/annexe/annexe_dec_06_2010_cm_uemoa.pdf
21. Assembly of People's Deputies of Burkina Faso. Law number 23 / ADP on public health code. [Internet]. ADP; 1994 [cited 2019 Sept 27]. Available from:
https://sherloc.unodc.org/res/cld/document/bfa/loi-n-23-94-adp-portant-code-de-la-sante-publique_html/Burkina_Faso_Loi_N_2394ADP_portant_Code_de_la_Sante_Publique.pdf
22. Republic of Benin. Presidency. Order N ° 75-7 dated 27/01/1975 relating to the DAHOMEY medication regime. Cotonou: Ministry of Health; 1975.
23. Burkina Faso. Ministry of Health. Decree N ° 2000-009 / PRES / PM / MS / MCPEA / MECV / MESSRS of 01/26/2000 establishing, attributions, composition and functioning of a national commission of traditional medicine and pharmacopoeia. Ouagadougou: Ministry of Health; 2000.
24. Burkina Faso. Ministry of Health. Order N ° 2013-549 / MS / CAB of 06/21/2013 creates and defines the attributions, the composition and the functioning of the technical commission for examining applications for authorization to practice traditional medicine. Ouagadougou: Ministry of Health; 2013.
25. Republic of Benin. Ministry of Health. Decree 2001-036 of 02/15/2001 establishing the principles of ethics and the conditions for the practice of traditional medicine in the Republic of Benin. Cotonou: Ministry of Health; 2001.S
26. Republic of Benin. Ministry of Health. Decree Year 2017 n ° 046 / MS / DC / CTJ / SGM / DNSP / DPMED / DRFMT / PNPMT / SA / 022SGG17 relating to the powers, organization and functioning of the National Commission for the Regulation of Traditional Medicine in Benin (CNRMT). Cotonou: Ministry of Health; 2017.
27. Burkina Faso. Ministry of Health. Order No. 2013-552-MS / CAB of 06/21/2013 relating to the procedures for the practice of traditional medicine in Burkina Faso. Ouagadougou: Ministry of Health; 2013.
28. Burkina Faso. Ministry of Health. Decree No. 2004-568 / PRES / PM / MS / MCPEA / MECV / MESSRS of 12/14/2004 laying down conditions for the practice of traditional medicine in Burkina Faso. Ouagadougou: Ministry of Health; 2004.
29. Burkina Faso. Ministry of Health. Order No. 2013-551 / MS / CAB of 06/21/2013 establishing, organizing and operating a referral and recourse system between traditional medicine and conventional medicine in Burkina Faso. Ouagadougou: Ministry of Health; 2013.
30. Burkina Faso. Ministry of Health. Decree No. 2004-569 / PRES / PM / MS / MCPEA / MECV / MESSRS of 12/14/2004 authorizing the marketing of medicines from the traditional pharmacopoeia in Burkina Faso. Ouagadougou: Ministry of Health; 2004.
31. Republic of Benin. Ministry of Health. Order No. 2017-017 / MS / DC / SGM / CTJ / DPMED / DA / SA016SGG17 of 05/02/2017 laying down procedures for the approval of herbal medicinal products in the Republic of Benin. Cotonou: Ministry of Health; 2017.
32. Burkina Faso. Ministry of Health. Order No. 00-069 / MS / CAB of 02/22/2000 relating to the conditions for opening and operating a pharmaceutical preparation establishment. Ouagadougou: Ministry of Health; 2000.
33. Burkina Faso. Ministry of Health. Decree No. 2012-1035 / PRES / PM / MS / MICA / MATDS / MEF of 12/28/2012 laying down conditions for the opening and operation of a traditional medicine and pharmacopoeia establishment in Burkina Faso. Ouagadougou: Ministry of Health; 2012.
34. Burkina Faso. Ministry of Health. Order No. 2013-550 / MS / CAB of 06/21/2013 relating to the opening and operating of a traditional medicine and pharmacopoeia establishment in Burkina Faso. Ouagadougou: Ministry of Health; 2013.
35. West African Economic and Monetary Union. Regulation No. 06/2010 / CM / UEMOA on the approval procedures for pharmaceutical products for human use in the member states of UEMOA [Internet]. UEMOA; 2010 [cited 2019 sept 27]. Available from:
http://www.uemoa.int/sites/default/files/annexe/annexe_dec_06_2010_cm_uemoa.pdf
36. Burkina Faso. Ministry of Health. Order N ° 2005-231 / MS / CAB of 06/07/2005 relating to the conditions for issuing marketing authorizations for medicines from the traditional pharmacopoeia in Burkina Faso. Ouagadougou: Ministry of Health; 2005.
37. Bouzabata A. Herbal medicines in Algeria: regulation and registration. Phytotherapy. Dec 1 2017; 15(6):401 8.
38. Republic of Benin. Ministry of Health. Decree Year 2015 N ° 0239 / MS / DC / SGM / CTJ / DPMED / DA / SA 17/06/2015 relating to the creation, attribution, organization and functioning of the National Medicines Commission. Cotonou: Ministry of Health; 2015.
39. Republic of Benin. Ministry of Health. Order No. 2012-0343 / MS / DC / SGM / CTJ / DPMED / DA / SA of 07/10/2012 relating to the approval of nutritional supplements in the Republic of Benin. Cotonou: Ministry of Health; 2012.
40. Republic of Benin. Ministry of Health. Decree Year 2014 No. 249 / MS / DC / SGM / CTJ / DPMED / DA / SA establishing, assigning, composing and operating the committee of experts responsible for assessing applications for approval of medicinal products for human use. Cotonou: Ministry of Health; 2014.
41. Burkina Faso. Ministry of Health. Order 2013-243 / MS / CAB / of 03/13/2013 establishing, attributions, composition and functioning of the registration commission for health products for human medicine use. Ouagadougou: Ministry of Health; 2013.
42. Burkina Faso. Ministry of Health. Order No. 2014-009 / MS / CAB of 01/10/2014 appointing members of the registration committee for health products for human use. Ouagadougou: Ministry of Health; 2014.
43. Burkina Faso. Ministry of Health. Order 2013-244 / MS / CAB of 03/13/2013 establishing, attributions, composition and functioning of expert committees for the evaluation of applications for approval of health products for use in human medicine. Ouagadougou: Ministry of Health; 2013.
44. Burkina Faso. Ministry of Health. Order No. 2014-010 / MS / CAB of 10/01/2014 appointing members of expert committees to assess applications for the approval of health products for human use. Ouagadougou: Ministry of Health; 2014.
45. Republic of Benin. High Council of the Republic of Benin. Law N ° 90-005 of May 15, 1990 fixing the conditions for the exercise of commercial activities in the Republic of Benin. Cotonou: Ministry of Health; 1994.
46. World Health Organization Regional Office for Africa. Guidelines for registration of traditional medicines in the WHO African Region [Internet]. WHO; 2010 [cited 2019 Sept 27]. Available from:
https://apps.who.int/medicinedocs/en/m/abstract/Js20127en/
47. Republic of Benin. National Assembly of the Republic of Benin. Law N ° 97-020 of June 17, 1994 laying down the conditions of the exercise in private customers for the medical and paramedical professions. Cotonou: Ministry of Health; 1997.
48. Republic of Benin. Ministry of Health. Order No. 2018-262 / MSP / DC / SGM / DPED / C-PMT / SA of June 28, 2018 prohibiting advertising in the medical professions, medical activities, drugs and other medicinal products. Cotonou: Ministry of Health; 2018.
49. Burkina Faso. National Assembly of Burkina Faso. Law n ° 080-2015 / CNT of November 23, 2015 relating to advertising regulations. Ouagadougou: Ministry of Health; 2015.
50. Burkina Faso. Ministry of Health. Decree N ° 2010-244 / PRES / PM / MS of May 20, 2010 advertising drugs and other pharmaceutical products. Ouagadougou: Ministry of Health; 2010.
51. Burkina Faso. Ministry of Health. Decree 2013-069 / MS / CAB of 03/13/2013 modifying the decree N ° 2010-294 / MS / CAB of October 07, 2010 establishing, attributions, composition and functioning of the advertising control commission on medication. Ouagadougou: Ministry of Health; 2013.
52. Burkina Faso. Ministry of Health. Order N ° 2010-294 / MS / CAB of 10/01/2010 establishing, attributions, composition and functioning of the technical commission for the control of drug advertising. Ouagadougou: Ministry of Health; 2010.
53. Burkina Faso. Ministry of Health. Order N ° 2010-291 / MS / CAB of 01/10/2010 relating to the conditions of advertising on drugs and other pharmaceutical products. Ouagadougou: Ministry of Health; 2010.
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Dori, D., H. Ganfon, F. Gbaguidi, B. Evrard, J. Quetin-Leclercq, and R. Semde. “Overview of Regulations on Medicines Derived from Traditional Pharmacopoeia in Benin and Burkina Faso”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 4, Dec. 2019, pp. 8-13, doi:10.22270/ijdra.v7i4.361.
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