In the landscape of pharmaceutical regulation in Senegal, a fundamental issue remains: the procedure for issuing Marketing Authorizations (Amm). This situation regularly constitutes a bottleneck for the supply of medicines and weakens a strategic sector both for public health and the national economy. However, a solution exists and has proven itself elsewhere: delegate the signing of marketing authorizations to the Pharmaceutical Regulatory Agency. Since March 2024, we have been in a context of renewal of practices in the management of public affairs, made of transparency and virtue in management. But this delegation, in addition to its effectiveness, would be part of a vision of efficiency and responsibility, in harmony with the guidelines of rigor and transparency advocated by the new authorities. We only have seven (07) local pharmaceutical industries which only supply 05% of the market!
Despite institutional progress, notably the transfer of the Directorate of Pharmacy and Medicines (Dpm) to an agency and the obtaining of maturity level 3 from the World Health Organization (WHO), delays in the issuance of marketing authorizations are screaming. On average, members of the Senegalese Society of Medical-Pharmaceutical Promotion Agencies (Soseap) wait between 18 and 24 months to obtain a ministerial signature, even after a favorable opinion from the competent commission. These delays have multiple consequences. Indeed, the pharmaceutical supply is disrupted while 95% of drugs in Senegal are distributed by promotion agencies, a sector highly dependent on the rapid obtaining of marketing authorizations. This also results in a loss of competitiveness which sees Senegal, the second largest economy in UEMOA, falling behind in this area by countries in the sub-region having adopted more agile models by authorizing their regulatory agencies to sign AMMs. Finally, the local economic impact is proven because the delays slow down job creation, affect the turnover of companies in the sector and lead to a drop in revenue for the ARP. However, it is necessary to recall the organization of the sub-sector to understand the scale of the issues.
A crucial contribution from Soseap
Soseap, a pivotal entity bringing together major players in pharmaceutical promotion, plays a central role in the Senegalese health system. In 2023, it contributed 700 million FCFA to the budget of the ARP (Pharmaceutical Regulation Agency), or almost a third of the latter, mainly thanks to fees linked to the registration of medicines. Promotion agencies are not limited to supply: they are also the link between foreign laboratories (India, Europe, Middle East, etc.) and local wholesalers, while ensuring the dissemination of therapeutic information through the through medical representatives. Their expertise and network are invaluable assets for the development of the local pharmaceutical industry. It must be said that we have inspiring international experience. In countries like Ivory Coast, Niger and France, pharmaceutical regulatory agencies are authorized to sign marketing authorizations, a system which has shown its effectiveness. This delegation makes it possible to shorten administrative times while maintaining rigorous control over the quality and safety of the products placed on the market.
By drawing inspiration from these models, Senegal could not only overcome the current delays, but also strengthen its position in the pharmaceutical field within the UEMOA. Rapid access to MAs is an essential condition for attracting foreign investment and encouraging joint ventures between local and international players, thus contributing to the vision of pharmaceutical sovereignty of the President of the Republic and his government. This is the place to salute the supervision of the Ministry of Health, to encourage the Director General of the Arp and his team on the progress obtained in his mission. In the same vein, we must also highlight the quality of the collaboration of the strategic partners, the Delevery unit (it is an entity of the Msas responsible for coordinating the implementation of projects included in the recovery plan of the local pharmaceutical industry ) and other stakeholders for the projects initiated in correlation with the “Senegal 2050” vision.
Furthermore, given the urgency of inscribing the paradigm of sovereignty in this industry, we must welcome the clearly expressed political will to accelerate the development of the national pharmaceutical industry. To support this dynamic, it is essential to simplify administrative procedures in order to attract strategic partners. SOSEAP, with its expertise and network, is ready to play an active role in this process by facilitating joint ventures and promoting investments in local production. To remove current obstacles and maximize the effectiveness of pharmaceutical regulation, it is crucial to make the marketing process smooth. This measure would make it possible to reduce administrative delays and improve the supply of medicines, strengthen Senegal’s competitiveness in the pharmaceutical field, and optimize the use of ARP resources, which is closely dependent on the contributions of promotion agencies. This would be a decision reflecting a desire for modernization and accountability, while meeting the expectations of players in the sector.
Mouhamadou Bara Mbaye
President of the Senegalese Society of Medical-Pharmaceutical Promotion Agencies (Soseap)
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