A Research Report submitted to the Faculty of Health Sciences, University of the
Witwatersrand, in partial fulfilment of the requirements for the Degree of Master
of Science in Medicine (Pharmaceutical Affairs)
Johannesburg, 2016 / Background
The World Health Organization (WHO) defines medicines regulation as the
“promotion and protection of public health by ensuring the safety, efficacy and
quality of drugs, and the appropriateness and accuracy of product information”
(1). Medicines regulation is a key function in the realisation of the right to
essential medicines. However, a satisfactory level of harmonization of regulatory
activities has not been achieved in the Southern African Development Community
(SADC) region as yet.
Objectives
The study evaluated the current status of medicines regulatory harmonization
within the SADC region, as well as explored perceived barriers to regulatory
harmonization and potential strategies to address these.
Methods
A cross-sectional exploratory study design with qualitative techniques, as well as
an inductive approach was used. In-depth, semi-structured, face-to-face interviews
with interviewees from the SADC Secretariat, the African Medicines
Harmonization (AMRH) Initiative and the Southern Africa Regional Programme
on Access to Medicines and Diagnostics (SARPAM) was used, involving
secondary formal qualitative approaches to identify the emergent themes, was
utilised initially. A questionnaire was formulated and adapted using secondary
data collected from the face-to-face interviews, then piloted. Questionnaires were
sent 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 or
elements. Codes were grouped into concepts, and then into categories. Trend
analysis was conducted, involving an in-depth analysis of patterns.
Results
Barriers to regulatory harmonization in the SADC region perceived by
participants included i) deficiencies in governance and leadership within the
SADC 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 in
assessment of applications and bias according to local population needs, as well as
vii) different guidance documents and legal frameworks among member
countries. Strategies identified to address these included i) using other
harmonization initiatives as models, ii) application format harmonization and
African Union (AU) Model Law adoption, iii) redirecting focus of harmonization
to information sharing and technical matter rather than complex legislative
frameworks, iv) regulator initiatives of harmonization instead of SADC secretariat
reliance, v) World Bank Agreement adoption, vi) human resource capacity
development and vii) convergence of guidelines instead of complete
harmonization of all regulatory requirements.
Conclusions
The findings in this study suggest that it may be necessary to redirect the focus of
harmonization to more readily achievable activities and aim for convergence of
guidelines. Regulatory harmonization is possible if barriers to it are addressed. / MT2016
| Identifer | oai:union.ndltd.org:netd.ac.za/oai:union.ndltd.org:wits/oai:wiredspace.wits.ac.za:10539/21166 |
| Date | 28 April 2016 |
| Creators | Calder, Amanda |
| Source Sets | South African National ETD Portal |
| Language | English |
| Detected Language | English |
| Type | Thesis |
| Format | application/pdf |
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