Pharmaceutical Regulation in Niger in 2021: Significant advances with the Harmonization Process

  • Fatima GUIET MATI pharmacist. Directorate of Pharmacy and Traditional Medicine, Ministry of Public Health, Population and Social Affairs of Niger Republic; Laboratory of Health Law and Economics, EA7307-CEIE, University of Strasbourg – France
  • Abdoulaye Ousmane pharmacist, Faculty of Health Sciences of the Dan Dicko Dankoulodo University of Maradi, Niger
  • Anne Cinthia AMONKOU - N'GUESSAN pharmacist, UFR in Pharmaceutical and Biological Sciences, Félix Houphouët-Boigny University of Cocody, Abidjan- Côte d’Ivoire; Directorate of Pharmaceutical Activity, Ministry of Health, Public Hygiene and Universal Health Coverage Republic of Côte d’Ivoire
  • Jean-Marie TRAPSIDA pharmacist, international consultant in pharmaceutical policies and regulations, Niamey, Niger
  • Issaka SONDE
  • Maty ELH MAMANE pharmacist, public health pharmacist, Niamey, Niger
  • Serge Antoine AMARI professor, Department of Galenic Pharmacy, Cosmetology and Legislation, UFR Pharmaceutical and Biological Sciences, Félix Houphouët-Boigny University of Cocody, Abidjan- Côte d’Ivoire; Directorate of Pharmaceutical Activity, Ministry of Health, Public Hygiene and Universal Health Coverage Republic of Côte d’Ivoire
  • Jean-Yves PABST

Abstract

The pharmaceutical sector is governed in Niger by a number of scattered texts. After the independence, it was only in 1988 that the National Council of the Order of Medical doctors, Pharmacists and Dentists (CNO/MPCD) got created, then in 1995, the adoption of the national pharmaceutical policy (NPP). The NPP laid the foundations for the development of specific pharmacy and drug legislation and led to the adoption of the law and its subsequent implementing texts. This article aims to make an inventory, an analysis of texts relating to pharmacy and medicine in Niger, areas for improvement with regards to the application of these texts and the contributions of community texts in strengthening national regulations and the preservation of public health.

Keywords: Pharmaceutical law and regulation, Niger, Harmonization, WAEMU, ECOWAS, African Union (AU)

Downloads

Download data is not yet available.

References

1. Republic of Niger. Constitution of the VIIth Republic, promulgated by decree n°2010-754/PCSRD of November 25, 2010; Special JORN n° 19 of November 29, 2010. p. 46.
2. Republic of Niger. Ordinance No. 97-002 of January 10, 1997 on pharmaceutical legislation; JORN n° 4 of February 15, 1997. p. 153.
3. Republic of Niger. Politique_nationale_justice V1_3.pdf [Internet]. [cited 2022 Apr 06]. Available from:
http://www.justice.gouv.ne/images/2019/PDF/Politique_nationale_justice%20V1_3.pdf
4. Bello Mahamadou Boubacar. UPDATE: A Look at the Legal and Judicial System in Niger - GlobaLex [Internet]. [cited 2022 Apr 06]. Available from:
https://www.nyulawglobal.org/globalex/NIGER1.html
5. Bashir TI. What law applies to the family in Niger? Legal pluralism in question. Ann Afr Nouv Srie Rev Fac Sci Jurid Polit - UCAD. 2015;1:295-332.
6. Republic of Niger. Law No. 2018-37 of June 1, 2018, establishing the organization and jurisdiction of courts in the Republic of Niger; 2018 Jun 01.
7. Republic of Niger. Organic Law No. 2004-50 of July 22, 2004, establishing the organization and jurisdiction of courts in the Republic of Niger. JORN of August 20, 2004 p.10.
8. Republic of Niger. Law n° 61-27 of July 15, 1961 establishing the penal code (article 221: disclosure of secrets); JOSP n° 7 of November 15, 1961.
9. Republic of Niger. Ordinance no. 99-35 of September 3, 1999 relating to the use of substances of human origin. 1999 Sep 03.
10. Republic of Niger. Ordinance No. 99-46 of October 26, 1999 creating a Public Institution of an industrial and commercial nature called the "National Office for Pharmaceutical and Chemical Products" (ONPPC EPIC). JORN no 23 of 1 December 1999. p. 1018.
11. Republic of Niger. Law No. 2008-32 of July 3, 2008 creating a public industrial and commercial establishment called “Société Nigérienne Des Industries Pharmaceutiques” (SONIPHAR); JORN n° 16 of August 15, 2008.p.744.
12. Republic of Niger. Ordinance No. 96-77 of December 11, 1996 creating a Public Establishment of an Administrative Nature called the “National Laboratory for Public Health and Expertise” (LANSPEX); JORN no 2 of January 15, 1997.p.75.
13. Republic of Niger. Ordinance No. 99-036 of September 3, 1999 creating a Public Establishment of an Administrative nature called the “National Center for Blood Transfusion” (CNTS); 1999 Sep 03.
14. Republic of Niger. Ordinance No. 99-42 of September 23, 1999, relating to the fight against drugs in Niger; JORN n° 23 of December 1, 1999.p.1003.
15. Republic of Niger. Law No. 2018-19 of April 27, 2018 on the National Customs Code; JORN special n° 14 of 2018. p.558.
16. Republic of Niger. Order No. 0460/MF/DGD/DRRI of 11 November 2020 defining the list of goods referred to in Article 246 of the National Customs Code. 2020 No 11.
17. Republic of Niger. Decree No. 2015-295/PRN/MISPD/ACR of 5 June 2015 determining the missions, organization and functioning of the Central Office for the Repression of Illicit Drug Trafficking (OCRTIS); JORN n° 15 of 2015 p.1000.
18. French Republic. Decree No. 51-1322 of 6 November 1951 codifying legislative texts concerning pharmacy; JORF n° 274 of November 20, 1951.p.11491.
19. French Republic. Decree No. 53-591 of June 25, 1953, setting the code of ethics for pharmacists pursuant to Article 28 of the Pharmacy Code (Decree of November 6, 1951); JORF n° 149 of June 27, 1953.p.5736.
20. French Republic. Law No. 53-662 of August 1, 1953 amending and supplementing the provisions of the Pharmacy Code concerning the order of pharmacists and making them applicable to overseas territories, Togo and Cameroon; JORF n° 180 of August 2, 1953p.6784.
21. French Republic. Law No. 54-418 of April 15, 1954 extending to overseas territories, Togo and Cameroon certain provisions of the Public Health Code relating to the practice of pharmacy; JORF n° 0089 of April 16, 1954 p.3668.
22. Republic of Niger. Decree No. 62-127/MTS of May 26, 1962, setting the reimbursement rate for the day of hospitalization in hospitals in the Republic of Niger; JORN of June 15, 1962.
23. French Republic. Provisions of deliberation No. 30-58/ATN of June 14, 1959, setting the reimbursement rate for the day of hospitalization at Niamey hospital, made enforceable by decree 58-281/SPCG of June 21, 1959 and Decree n°59-71 of May 14, 1959 fixing the tariffs of hospitalization and transfers to the hospital of Zinder; 1959.
24. World Health Organization. WHO Drug Dictionary Enhanced Guide [Internet]. WHO; 2005 Aug 15[cited 2022 Apr 08]. Available from:
http://www.pharmadhoc.com/uploads/3/2/7/4/3274790/who_drug_enhanced.pdf
25. Republic of Niger. Ordinance No. 99-42 of September 23, 1999 relating to the fight against drugs in Niger. JORN n° 23 of December 1, 1999. p. 1003.
26. Republic of Niger. Order No. 0195/MSP/DPHL of July 8, 1998 setting the conditions and destination of sample seizure; 1998 Jul 08.
27. Republic of Niger. Order No. 73/MSP/LCE/DGSP/ DPHL/MT of 06 May 2005 setting the method for calculating the sale price to the public of medicines, products and objects included in the pharmaceutical monopoly;2005 May 06.
28. Republic of Niger. Decree No. 97-301/PRN/MSP of August 6, 1997 setting the terms of application of Ordinance No. 97-002 of January 10, 1997 on pharmaceutical legislation; JORN n° 17 of September 1, 1997.p.979.
29. World Health Organization. WHO global model regulatory framework for medical devices including in vitro diagnostic medical devices (WHO Medical device technical series) Geneva: World Health Organization; 2019.
30. Republic of Niger. Order No. 884/MSP/SG/DGSP/DPH/ MT of October 15, 2020 on the creation, missions, composition and functioning of the National Commission for the Approval of establishments for the manufacture, import, export, promotion, distribution and maintenance of Medical Devices (CNA-DM) for human use; 2020 Oct 15.
31. Republic of Niger. Order No. 240/MSP/SG/DGSP/DPH/ MT of March 11, 2021 regulating Medical Devices (MD) for human use; 2021 Mar 11.
32. Dion H, Champagne X. Pharmaceutical law: pharmacies, industry, veterinary pharmacies and health establishments. Gualino. France; 2008. 278.p.(Master Pro).
33. Republic of Niger. Report of the evaluation of the pharmaceutical policy of Niger established in 2005. Niamey: Ministry of Public Health; 2005.
34. Republic of Niger. Central | SIPhN [Internet]. [cited 2022 Apr 08]. Available from:
https://www.dphmt-msp.ne/siphn/categorie/centrale
35. Republic of Niger. Order n° 0281/MSP/DPHL of November 18, 1998 instituting quality control of generic medicines before they are put into consumption; JORN n° 24 of December 15, 1998.p.1047.
36. Republic of Niger. Decree No. 2017-765/PRN/MSP of September 29, 2017 creating the National Order of Pharmacists (ONP); JORN no 22 of 15 November 2017.p.63.
37. Republic of Niger. Ordinance No. 88-31 of June 9, 1988 creating a National Order of Physicians, Pharmacists and Dental Surgeons; JORN of July 1, 1988.
38. Republic of Niger. Decree No. 88-207/PCMS/MSP/AS of June 9, 1988 approving a code of ethics for pharmacists; JORN n° 13 of July 1, 1988.p.577.
39. Republic of Niger. Order n° 253 /MSP/DGSP/DPH/MT of 22/07/2014, establishing, missions and organization of the bodies of the National System of Vigilance of health products for human use; 2014 Jul 22.
40. Republic of Niger. Collection of legislative texts and pharmaceutical regulations. 2019 edition. Niamey: Ministry of Public Health; 2019.
41. Treaty establishing the African Medicines Agency | African Union [Internet]. UnionAricaine; 2021 Jun 22 [cited 2022 Apr 26]. Available from:
https://au.int/fr/treaties/traite-portant-creation-de-lagence-africaine-du-medicament
42. Republic of Niger. Order No. 459 MSP/DGSP/DPHL/MT of December 17, 2013, listing Tramadol in group A of Table II of Ordinance No. 99-42 of September 23, 1999 relating to the fight against drugs in Niger; JORN special n° 27 of December 31, 2013.p.863.
43. Republic of Niger. Order No. 149/MSP/LCE/DPS/ES/ DPHL/MT of 26 July 1999 delegating signature to departmental prefects; 1999 Jul 26.
44. Republic of Niger. Order No. 0996/MSP/SG/DL of September 18, 2019 on the terms of application of Decree No. 2017-765/PRN/MSP of September 29, 2017 creating the National Order of Pharmacists; 2017 Sep 29.
45. Republic of Niger. Compendium of Sanitary Legislation. May 2015 edition. Niamey: Ministry of Public Health; 2015 May.
46. World Health Organization. Evaluation of national regulatory systems of medicines and vaccines (GBT) [Internet]. WHO; 2021 May 10 [cited 2022 Apr 26]. Available from:
https://www.who.int/tools/global-benchmarking-tools/VI
47. Republic of Niger. Decree No. 2021-279 PRN/MSP/P/AS of April 29, 2021, adopting the national pharmaceutical policy; 2021 Apr29.
48. Africa, entry into force of the treaty establishing WADA [Internet]. Emergency Live; 2021 [cited 2022 Apr 8]. Available from:
https://emergency-live.com/fr/Actualit%C3%A9s/entr%C3%A9e-en-vigueur-du-trait%C3%A9-afrique-pour-la-cr%C3%A9ation-de-l%27agence-africaine-des-m%C3%A9dicaments-ama/
49. Republic of Niger. Law n° 2021-17 of June 23, 2021, authorizing the ratification of the treaty establishing the African Medicines Agency (AMA), adopted on February 11, 2019 in Addis Ababa (Ethiopia); JORN no 14 of March 18, 2022.p.5.
50. AMRH Partnership Platform – a game changer in the medicines regulatory space | AUDA-NEPAD [Internet]. AUDA-NEPAD 2018 Aug 03 [cited 2022 Apr 08]. Available from:
https://www.nepad.org/news/amrh-partnership-platform-game-changer-medicines-regulatory-space
51. West African Health Organization (WAHO) | Economic Community of West African States (ECOWAS) [Internet]. [cited 2022 Apr 11]. Available from:
https://ecowas.int/institutions-2/organisation-ouest-africaine-pour-la-sante-ooas/?lang=fr
52. Alloukou-Boka PM, Amari AS, Amonkou-N'Guessan AC, Pabst JY. Harmonization of pharmaceutical regulations in the ECOWAS region. Rev Droit Santé Rev Jurid Entrep Santé [Internet]. 2018 Jan [cited 2022 Apr 11];(#81):p.33-42. Available from:
https://www.bnds.fr/revue/rds/rds-81/harmonisation-de-la-reglementation-pharmaceutique-dans-l-espace-cedeao-7858.html
53. Amonkou-N'Guessan AC, Amari AS, Alloukou-Boka PM, Pabst JY. Descriptive study of the regulations relating to the pharmaceutical industry applicable in Côte d'Ivoire. Rev Droit Santé Rev Jurid Entrep Santé [Internet]. July 2018 [cited 2022 Apr 11]; (n° 84):p.553-560. Available from:
https://www.bnds.fr/revue/rds/rds-84/etude-descriptive-de-la-reglementation-relative-a-l-industrie-pharmaceutique-applicable-en-cote-d-ivoire-8206.html
54. WAEMU. Regulation No. 02/2005/CM/UEMOA on the harmonization of pharmaceutical regulations in UEMOA member states; 2005.
55. WAEMU. Regulation No. 04/2020/CM/UEMOA of September 28, 2020, relating to approval procedures for pharmaceutical products for human use in UEMOA member states; 2020 Sep 28.
56. ECOWAS. Guideline for the preparation and submission of dossiers in the Common Technical Format (CTD); 2017.
57. ECOWAS. Guideline for bioavailability and bioequivalence studies in the ECOWAS region; 2012.
58. ECOWAS. Guideline on the OOAS certification system for finished pharmaceutical products. An administrative and technical tool for the purchase of finished pharmaceutical products manufactured locally or imported for use in ECOWAS Member States; 2012.
59. WAEMU. Directive n°06/2020/CM/UEMOA on the status of the pharmaceutical regulatory authorities of the member states of the UEMOA; 2020 Sep 28.
60. African Union. African union model law on the regulation of medical products; 2016.
61. African Union. Treaty of February 11, 2019 establishing the African Medicines Agency; 2019 Feb 11.
62. Republic of Niger. National directive applicable to the quality surveillance plan for health products for human use; 2013.
63. Republic of Niger. Order No. 58 /MSP/DGSP/DPH/MT of February 3, 2017 establishing the Commission for the Destruction of Pharmaceutical Products (CDPP); 2017 Feb 03.
64. ECOWAS. Guide to procedures for managing the regional safety stock of ARV drugs; 2013.
65. World Health Organization. Recommendations for post-market surveillance of medical devices including diagnostic devices [Internet]. 2021 [cited 2022 Apr 11]. Available from:
https://webcache.googleusercontent.com/search?q=cache:wruYibmu61AJ:https://apps.who.int/iris/rest/bitstreams/1399066/retrieve+&cd=20&hl=fr&ct=clnk&gl=fr
66. Republic of Niger. Order No. 0131/Rectorate of February 29, 2012, establishing and organizing pharmacy studies at the Faculty of Health Sciences of the Abdou Moumouni University of Niamey; JORN n° 6 of March 15, 2012.p.349.
67. Republic of Niger. Order No. 00095/MESR/I/UDDKM of August 18, 2014, establishing the organization, functioning of the organs and provisions specific to the Faculty of Health Sciences of the University of Maradi; 2014 Aug 18.
68. WAEMU. Directive No. 06/2008/CM/UEMOA relating to the free movement and establishment of pharmacists who are Union nationals within the UEMOA space; 2008.
69. ECOWAS. Harmonized training curriculum for doctors of pharmacy in the ECOWAS region; 2015.
70. ECOWAS. Harmonization of postgraduate training in pharmacy and training designed specifically in pharmaceutical sciences; 2011.
71. ECOWAS. Draft harmonized code of ethics for the practice of pharmacists in the ECOWAS region. Bobo-Dioulasso; 2011.
72. Republic of Niger. National directives applicable to the storage and distribution of health products. Niamey; 2013.
73. WAEMU. Decision No. 08/2010/CM/UEMOA adopting the Guide to Good Manufacturing Practices for Pharmaceutical Products for Human Use in WAEMU Member States / Annex to Decision No. 08/2010/CM/UEMOA; 2010 Oct 01.
74. WAEMU. Decision No. 09/2010/CM/UEMOA adopting the Guide to Good Practices for the Distribution and Importation of Pharmaceutical Products for Human Use in WAEMU Member States / Annex to Decision No. 09/2010/CM/ WAEMU; 2010 Oct 01.
75. ECOWAS. Guideline on the implementation of the OOAS certification system for pharmaceutical raw materials. An administrative and technical tool for the purchase of finished pharmaceutical products manufactured locally or imported for use in ECOWAS Member States; 2012.
76. ECOWAS. Guideline for implementing TRIPS flexibilities in national legislation to improve access to medicines in West Africa. Technical document 10.12, + appendix action plan for the implementation of TRIPS flexibilities; 2012.
77. ECOWAS. ECOWAS Regional Pharmaceutical Plan (PPRC) 2014-2020. Bobo Dioulasso; 2014.
78. ECOWAS. Guideline on the Implementation of the WAHO Prequalification System for Medicines: An Administrative and Technical Tool for the Prequalification of Finished Pharmaceutical Products Manufactured Locally or Imported for Use in ECOWAS Member States; 2012.p.40.
79. African Union. Pharmaceutical manufacturing plan for Africa, Business plan. [Internet]. Addis Ababa; 2012 [cited 2022 Apr 26]. Available from:
https://au.int/sites/default/files/pages/32895-file-pmpa_business_plan.pdf
Statistics
20 Views | 24 Downloads
How to Cite
GUIET MATI, F., A. Ousmane, A. C. AMONKOU - N’GUESSAN, J.-M. TRAPSIDA, I. SONDE, M. ELH MAMANE, S. A. AMARI, and J.-Y. PABST. “Pharmaceutical Regulation in Niger in 2021: Significant Advances With the Harmonization Process”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 4, Dec. 2022, pp. 75-87, doi:10.22270/ijdra.v10i4.566.