Around the Globe: Africa
ECOWAS Joint Assessment Procedure: Industry Awareness and Perception of the Procedure
Kpatcha Tchamdja
Sybil N.A. Ossei Agyeman Yeboah
West African Health Organization, Burkina Faso
David Mukanga, Ian Hudson
Bill and Melinda Gates Foundation
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rom 2018 to April 2022, the regional ECOWAS Joint Assessment Procedure (JAP) under the West Africa Medicines Regulatory Harmonization (WA-MRH) Initiative received twenty-two (22) dossier submissions from manufacturers within and outside the ECOWAS region, a relatively lower number than anticipated.

A prospective study was conducted from August to September 2022 (eight weeks) among manufacturers of medicines eligible to submit their dossiers to the regional platform. The purpose of this survey was to enable the ECOWAS/WAHO (West African Health Organization) MRH Secretariat and relevant stakeholders to better understand the level of awareness of the ECOWAS Joint Assessment Procedure (JAP), its perceived value to industry in and outside of Africa, and to enable the Secretariat to understand the bottlenecks contributing to such low industry uptake of this regional procedure.

The West Africa Medicines Regulatory Harmonization (WA-MRH) was established in 2017 to improve the availability of medicines and vaccines of good quality, safety, and efficacy in the Economic Community of West African States (ECOWAS) pharmaceutical market, by strengthening and harmonizing drug regulatory systems to bring efficiency and transparency in the registration of medicines and vaccines.

A questionnaire was developed on Microsoft Form and distributed online to over 250 manufacturers located in West Africa and beyond. The questionnaire was developed by the WA-MRH Secretariat in consultation with project partners (including the World Health Organization, Swissmedic, and Bill & Melinda Gates Foundation) and addressed the following criteria:

  • The manufacturer’s location
  • Whether the manufacturer is aware of the process
  • Whether the manufacturer subsequently participates in a regional or international process like the ECOWAS process
  • The benefits expected by the manufacturer using the ECOWAS process
  • The difficulties encountered by the manufacturer in using the ECOWAS process
  • Suggestions to improve the process.

Industry contacts were obtained from industry associations in Africa and globally. The data was collected and analyzed in Microsoft Form and Excel. Sixty (60) responses were collected after the two-month survey period, representing a participation rate of approximately 24 percent.

Fig 1: general distribution of respondent provenance
Fig 2: distribution of respondent from West Africa
Of the 60 responses received, 51 percent (31/60) were from West Africa, including 18 from Nigeria, which represented 33 percent (18/60) of the overall responses and 58 percent (18/31) of responses from West Africa. Eighty-one percent (49/60) of survey respondents reported being aware of the regional procedure. The most cited sources of awareness were meetings organized by WAHO (59 percent, 29/59), webinars (33 percent, 16/49), and the WAHO website (27 percent, 13/49).
Fig 3: How did the Manufacturers first hear about the procedure?
Twenty-three percent (14/60) of the manufacturers listed the simplification of the national registration processes, building the capacity of the National Regulatory Authorities’ (NRAs) technical teams, and business opportunity for MA holders as the three major benefits of the WA-MRH JAP.
Fig 4: Benefits of the ECOWAS Joint Regional Assessment Process
The survey also provided insight into industry challenges with and expectations of this joint assessment. Industry expectations of the WA-MRH included a simplified registration process at the national regulatory agency level after WAHO had issued its positive opinion, increased business opportunities, accelerating access/availability of medical products, and reduction of regulatory timelines.

Challenges identified included lengthy timelines for both regional and national levels of the procedure, the high application fee to participate in the process, the varying (and in some cases unreasonably large) number of product samples requested by different national regulators, and inadequate communication between stakeholders. (The WA-MRH Steering Committee has since harmonized the number, timing, and disparities of samples required for testing by national regulators.)

In addition to optimizing the regional step to meet timeline commitments, WAHO is now actively following up with national regulators to ensure timely registration decisions after the company notifies the WAHO secretariat that the national filing has been completed; it is expected that timely national administrative actions will become institutionalized. In 2024, WAHO also plans to establish a platform that links regionally recommended products to pooled and national procurement through which these products will be recognized as quality products and preferred by regional and national procurers.

Fig 5: Difficulties identified at countries level
Fig 6: Difficulties identified at regional level

Conclusions

This data suggests that manufacturers are open to submitting to the West Africa regional platform but have high expectations of the procedure. The main challenge they identified is the unpredictability of timelines at both the national and regional level, which indicates that the timelines specified in the procedure are not being respected or met. To this end, timings must be tracked and results regularly published, and regular and predictably scheduled joint dossier assessment meetings held.

Applicants who use the WA-MRH procedure pay a single fee (between $8K and $12K) which covers both the assessment of the product and inspection of the manufacturing site. The WA-MRH Steering Committee has determined three different fees in this range, depending on the location of the applicant. This regional fee is unlikely to change, and WAHO believes that industry recognizes the value provided by this regional approach. While this is a modest fee for a service that provides market access to a region of 15 countries and close to 370 million people, we are now five years into this process and every pain point must be eliminated to enhance its value.

The WA-MRH Secretariat must explore more sources for disseminating and sharing information to make the benefits of this regional procedure better known to manufacturers and other stakeholders.

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