At a time, when the Government of Pakistan has finalized to initiate a massive public health PKR 68 billion project, it is important to analyze how Egypt successfully carried out its HCV elimination program. In 2008, the Egyptian Demographic Health Survey (EDHS) reported an HCV prevalence of 14.7% among individuals aged 15–59.
Egypt successfully reduced HCV prevalence from 7% to less than 0.5% through mass screening, free treatment, and local drug manufacturing.
This high prevalence rate was primarily due to the past health campaigns targeting bilharzia (schistosomiasis), particularly before 1985. These campaigns involved the use of poorly sterilized needles, which significantly contributed to the widespread transmission of HCV.
In 2014, Egypt embarked on an ambitious, yet attainable national strategy to eradicate HCV by 2021 completely. This campaign was known as “100 Million Healthy Lives” and was reinforced in 2018 with a countrywide effort to offer free testing and treatment for HCV. Key elements of this campaign encompassed extensive screening of people, free treatment, and concurrently the use of Direct-Acting Antivirals (DAAs).
As part of this campaign, over 60 million people were screened for HCV, and more than 4.1 million patients received free treatment, significantly reducing the prevalence of the virus. Egypt’s HCV prevalence decreased significantly, from around 7% in 2015 to less than 0.5% by 2021, making it a leader in HCV elimination efforts. More importantly, this campaign utilized domestically manufactured DAAs, which not only reduced the treatment cost of HCV but also saved millions of dollars in foreign exchange.
Leadership in Egypt showed its will and commitment to emphasize the importance of strategic planning in terms of achieving the elimination of HCV. Resultantly, Egypt became the first country in the world to achieve WHO validation on the path to HCV elimination, having diagnosed 87% of people living with HCV while the country was able to provide 93% of diagnosed patients with curative treatment. Furthermore, Egypt has now aspired to treat over 250,000 people chronically infected individuals annually, with the sole objective of lowering the prevalence rate to 2% by 2025.
Egypt’s journey towards HCV elimination serves as a model for the Government of Pakistan. While the state has announced a massive budget of PKR 68 billion for the Prime Minister Hepatitis C Eradication Program, the leadership lacks political will while the institutions lack the capacity and motivation to implement this program with full commitment and determination. Such a large-scale project contains discrepancies in its PC-1, as decision-makers have structured the conditionalities to favor specific manufacturers in the health industry; thereby, completely overlooking the domestic industry.
Pakistan’s PKR 68B Hepatitis C Eradication Program lacks institutional capacity, political will, and transparency in procurement policies.
In Vitro Diagnostics (IVD) and pharmaceutical industries in Pakistan stand to benefit greatly from this program. However, the PC-1 lacks provisions for locally manufactured products beyond medicines. Modeled after Egypt’s approach, Pakistan has an advantage with an already established local industry for both medicines and diagnostics. Egypt’s success underscores that supporting local manufacturing ensures sustainability, affordability, and reduced import reliance.
Integrating local products into the program will drive industry growth and long-term cost-effectiveness. Moreover, PC-1 of the project states that it requires WHO-certified RDTs for the program, however, the procurement document states the requirement of WHO-prequalified kits. The difference between WHO-certified RDTs and WHO-prequalified kits lies in the level of assessment, approval, and regulatory requirements by the World Health Organization (WHO). “WHO-certified” does not refer to an official WHO process; however, it involves a National Regulatory Authority, issuing a ‘Certificate of Pharmaceutical Product (CPP)’ under the WHO Certification Scheme.
This certification process is for individuals or organizations meeting specific criteria. However, it does not necessarily relate to the product quality assessment like prequalification does. In many cases, it implies that the product meets WHO standards or guidelines, but it has not undergone the rigorous WHO Prequalification (PQ) process. On the other hand, “WHO Prequalified” means the diagnostic kit has undergone the WHO Prequalification (PQ) Programme, a stringent assessment process that evaluates product safety, Performance (sensitivity, specificity), Manufacturing quality, and compliance with global regulatory standards.
This technical contradiction may not be obvious, yet this may eventually lead to exceptional benefits for certain groups/ people. A WHO List of prequalified companies for in vitro diagnostic products, released on 2nd December 2024 shows no local manufacturer, that is pre-qualified for HCV rapid testing; thereby, furthering the prospects for international companies to win this project.
It needs to be realized that the state of Pakistan is presently at a critical juncture; wherein the government regulations tend to lead the country towards further progress or exceptional downfall. Decision-makers of the Egyptian Public Health program prioritized their national interest in terms of addressing their health emergency while concurrently benefitting the local manufacturers of the testing kits; thereby, contributing to the socioeconomic progress of the country.
The program’s PC-1 favors international manufacturers by requiring WHO-prequalified kits, limiting opportunities for local industries.
Subsequently, decision-makers in Pakistan seemingly lack the vision to prioritize their national values and aspirations. Moreover, discrepancies in a project of this magnitude undermine the credibility of the institutions. If the Government of Pakistan is fully committed to making this project successful, Prime Minister Shehbaz Sharif must inquire about this pertinent issue, or else the country may fall into another disastrous public health emergency program.
Disclaimer: The opinions expressed in this article are solely those of the author. They do not represent the views, beliefs, or policies of the Stratheia.
