Assessment of potential barriers to medicines regulatory harmonization in the Southern African development community (SADC) region

[摘要] BackgroundThe World Health Organization (WHO) defines medicines regulation as the'promotion and protection of public health by ensuring the safety, efficacy andquality of drugs, and the appropriateness and accuracy of product information”(1). Medicines regulation is a key function in the realisation of the right toessential medicines. However, a satisfactory level of harmonization of regulatoryactivities has not been achieved in the Southern African Development Community(SADC) region as yet.ObjectivesThe study evaluated the current status of medicines regulatory harmonizationwithin the SADC region, as well as explored perceived barriers to regulatoryharmonization and potential strategies to address these.MethodsA cross-sectional exploratory study design with qualitative techniques, as well asan inductive approach was used. In-depth, semi-structured, face-to-face interviewswith interviewees from the SADC Secretariat, the African MedicinesHarmonization (AMRH) Initiative and the Southern Africa Regional Programmeon Access to Medicines and Diagnostics (SARPAM) was used, involvingsecondary formal qualitative approaches to identify the emergent themes, wasutilised initially. A questionnaire was formulated and adapted using secondarydata collected from the face-to-face interviews, then piloted. Questionnaires weresent to senior members of all 15 regulatory authorities belonging to SADC,including registrars and deputy registrars.Theoretical and analytical codes were identified from repeated ideas, concepts orelements. Codes were grouped into concepts, and then into categories. Trendanalysis was conducted, involving an in-depth analysis of patterns.ResultsBarriers to regulatory harmonization in the SADC region perceived byparticipants included i) deficiencies in governance and leadership within theSADC Secretariat, ii) human resource and technical capacity constraints, iii)limited financial resources, iv) lack of political will within SADC governments, v)lack of intra-SADC relationships, vi) risk-benefit analysis differences inassessment of applications and bias according to local population needs, as well asvii) different guidance documents and legal frameworks among membercountries. Strategies identified to address these included i) using otherharmonization initiatives as models, ii) application format harmonization andAfrican Union (AU) Model Law adoption, iii) redirecting focus of harmonizationto information sharing and technical matter rather than complex legislativeframeworks, iv) regulator initiatives of harmonization instead of SADC secretariatreliance, v) World Bank Agreement adoption, vi) human resource capacitydevelopment and vii) convergence of guidelines instead of completeharmonization of all regulatory requirements.ConclusionsThe findings in this study suggest that it may be necessary to redirect the focus ofharmonization to more readily achievable activities and aim for convergence ofguidelines. Regulatory harmonization is possible if barriers to it are addressed.

[发布机构] University of the Witwatersrand