The impact of measures set by national regulatory authority to enhance affordability of medicines in Sudan: when good intention leads to worse outcomes

Abstract

Introduction: The aim of this paper is to assess the impact of the measures and procedures imposed by the National Medicines and Poisons Board (NMPB) on the availability of safe, effective and quality medicines of affordable price on the Sudanese market. Methods: This is a descriptive study in which pharmacists, who were responsible for the regulatory affairs within their importing and locally manufacturing medicine companies, were asked to complete a 45-question online survey using the Google application, covering relevance and challenges of medicines quality and pricing system. A link to the data collection tool website was sent to all members of the Sudanese Society of Regulatory Affairs Pharmacists through WhatsApp. The survey was available on 6th May 2020 through 6th June 2020. Descriptive statistics were used to report results. Results: Survey respondents were 70 regulatory affairs’ pharmacists. 38% of participants believe that the technical procedures adopted by the NMPB do not achieve the goal of establishing Medicine Regulatory Authorities as described by World Health Organization. Almost all respondents believe that Sudan current economic situation, including the scarcity of foreign currency, has greatly impacted the availability of quality-assured medicines in pharmacies. Participants said that the situation is exacerbated by the intervention of NMPB in determining the exchange rate and controlling the medicine prices. Conclusion: The NMPB should consider options for balancing patient access to quality medicines, and reasonable pricing policies that encourage the local pharmaceutical manufacturing to flourish and a steady flow of quality-assured medicines from abroad to the Sudan market.