In a position paper authored by U.S. trained Gambian pharmacist, Dr Ismaila Badjie, the paper outlined very progressive ideas as solutions to the country's current medicines control landscape, taking cues from the issues and challenges the author faced with the regulator, in setting up a high standard, innovative medicines services in the country.
"The Medicines Control Agency (MCA) rules and guidelines for drug importation are largely based on models from more populous countries like Ghana and Nigeria, without adequately considering The Gambia's unique circumstances," Dr Badjie argued, indicating the Pharmacist-to-Population Ratio of The Gambia as 1 pharmacist per 62,500 people, while WHO Recommendation is 1 pharmacist per 2,000 people.
He also cited figures from such populous African countries like Ghana, Rwanda, and Senegal, where populations are in tens of millions on average, compared to Gambia’s 2.5 million people estimate.
"These regulations, designed for markets with local manufacturing capacity, are ill-suited for The Gambia's import-dependent pharmaceutical sector.
The current framework unintentionally restricts access to quality medications available in Western countries while inadvertently creating loopholes that may allow substandard drugs to enter the market," Mr Badjie charged.
He maintained that international regulatory approaches would include examining successful regulatory models in countries facing similar challenges, which can provide valuable insights for The Gambia.
"Several African nations have implemented innovative approaches to balance safety, quality, and access:
- Rwanda: Implemented a risk-based approach, significantly reducing registration times for SRA-approved medications. This model prioritises products with a proven track record of safety and efficacy, allowing for faster market entry while maintaining rigorous standards for less established products.
- Ghana: Established a separate fast-track process for products already approved by recognised stringent regulatory authorities (SRAs). This approach acknowledges the rigorous testing these products have already undergone, reducing redundancy in the approval process.
- Senegal: Developed regional partnerships to share regulatory resources and expertise. This collaborative approach allows for more efficient use of limited resources and promotes standardisation across the region," Badjie explained.
He said The Gambia faces a critical shortage of licensed pharmacists and allied professionals, with less than 40 serving a population of 2.5 million. According to him, such a scarcity leads to operational inefficiencies, potential conflicts of interest in regulation and distribution, and challenges in maintaining a robust regulatory framework.
Furthermore, Badjie said the requirement for importers to provide Certificates of Analysis (COA) and Dossiers assumes direct relationships with manufacturers, which is often not the case for distributors sourcing from reputable marketplaces in countries with stringent regulatory authorities (SRAs). The high fees for product registration ($300 per product) and annual listing ($25 per product) create significant financial burdens, especially for importers with large product portfolios. For instance, an importer with 500 products faces a potential cost
of $150,000 for registration alone. These costs can lead to reduced product ranges, higher consumer prices, or encourage non-compliance and lack of full disclosure from importers," he explained.
Dr Badjie’s comprehensive position paper went further to make recommendations for the Gambian authorities, as he prepares to submit the paper to the authorities.
"... the issue at hand now is between what the National Assembly Members say, was their intent in the amendment of [the Medicines Control Act] to give medications from SRA countries a easier pathway to The Gambia market... but the language used should have been 'SOURCED FROM' an SRA nation and not “manufactured or produced." Medicines Control Agency is therefore using their interpretation of what 'produced' means to them and essentially not recognizing medicines SOURCED from SRA nations”, he argued, nothing that over 90% of medications in the USA and Europe are not manufactured there.
