Date of Award

11-2025

Degree Type

Thesis

Degree Name

Master of Health Policy and Management

First Advisor

Dr Irfan Khan

Second Advisor

Professor Syed Ather Enam

Third Advisor

Professor Kulsoom Ghias

Department

Community Health Sciences

Abstract

Background: Stem cell based therapeutic products (SCTPs) represent a revolutionary front in modern medicine. However, rapid advancements in the field confront ethical and regulatory concerns, particularly regarding the unscrupulous and premature clinical use and commercialization. In low-and-middle-income countries such as Pakistan, which face a high burden of non-communicable diseases, these therapies offer significant therapeutic opportunities. Nevertheless, Pakistan’s regulatory landscape governing the field remains unclear.
Objective: This study aimed to examine the national policy landscape for stem cell research (SCR) and therapy in Pakistan. The objectives were (1) to map the landscape of SCR and therapy in Pakistan with attention to its policy context, decision making process and stakeholder dynamics, and (2) to compare existing guidelines with established frameworks of the United States and European Union.
Methods: A qualitative exploratory research design guided by the Walt and Gilson Policy Triangle, was employed. To achieve objective 1, key informant interviews (KII) and focus group discussions were conducted. KIIs involved researchers, clinicians, bioethicists, social scientists, and other relevant institutional experts. While FGDs aimed to seek perceptions of stem cell researchers, clinicians and members of the general public. The data of KIIs and FGDs were thematically analyzed. To achieve objective 2, document analysis involved comparison of key regulatory and policy instruments issued by regulatory bodies of Pakistan, US and EU.
Results: The study revealed key gaps in the SCR policy landscape in Pakistan. These include outdated and non-binding guidelines, weak regulatory and institutional infrastructure, limited GMP-certified facilities, inadequate funding, and insufficient oversight of early commercialization and direct-to consumer marketing of stem cell interventions. Public awareness is low. Document analysis showed Pakistan lacks risk-based and product-specific classification and governance, and existing guidelines are inconsistent for all phases of product lifecycle.
Conclusions: The issues brought to light call for an urgent need to update the existing guidelines and bring institutional reforms as a prescriptive and diligent approach to maximize the benefits of SCTPs to public health and ensure responsible scientific innovations.

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