Egypt Cabinet Approves Draft Law Governing Clinical Trials in Egypt

Egypt Cabinet Approves Draft Law Governing Clinical Trials in Egypt TrialsiteN

Egypt is the second-biggest destination for clinical trials in Africa. And, Egypt has seen ever-growing numbers of clinical trials conducted in this country on the southern Mediterranean sea. With nearly 1,000 active clinical trials in the country, the Egyptian cabinet moved this past week to draft new laws governing the organization of clinical research. Originally passed in 2006 and inclusive of 18 articles, the society rejected the law, and it was suspended for nearly a decade. The law was reissued in 2014 with fewer amendments to its articles. Will it pass comprehensive and modern law to guide robust, safe, and ethical research to advance medical care?

A Struggle to getting Legislation Done

According to news reports, the cabinet moves forward again as it seemingly is a recognition of the rapid expansion of clinical trials within that country reported Egypt Today. The law should be aligned with international standards, including informed consent. As similar news was reported within that country last year, there appears to be tension between more conservative elements of the culture versus those that might be more supportive of scientific and medical advancement. Moreover, the Egyptian president last year offered a number of objections to the draft law.

Cancer Research as a Care Option 

Cancer research appears to be a prominent topic, as according to Cairo University Professor of Oncology Heba Khafagy, cancer patients there can participate in clinical trials and receive advanced therapies and treatment for free—as compared to the high cost of going to a regular clinic which can equal nearly $3,000 per month; a lot for the average middle-class person in Egypt.

SOMO Report

Back in 2016, the Centre for Research on Multinational Corporations (SOMO)—a critical independent, not-for-profit—produced a study on clinical research in Egypt. They noted that Egypt fit in the category of low-and middle-income environment often sought out for clinical trials outsourcing by large multinational clinical research sponsors. They noted its “attractive research infrastructure, fast-growing and largely treatment-naïve population, and lower costs” were favorable for clinical research and representative of one of the more desirable locations within the Middle East and Northern Africa (MENA) for clinical trials outsourcing.

A Struggling Population

SOMA also identified that Egypt’s population was challenged for every day essential medicine access. About 50% of the population has no access to health insurance, and about 72% of health care costs are covered by out of pocket expenses. Poor patients bear the brunt of such a system and, according to SOMA, indicative of a red flag situation or clinical trial outsourcing dynamics.

Two Sponsors Prominent

According to the SOMA report, Roche and Novartis sponsored nearly 50% of all internationally-sponsored clinical trials by 2016. The “Arab Spring” revolt period during 2011 did little to impact the growing demand for clinical research there.

Lack of Unified Legislation

The advocacy group identified a lack of comprehensive unified legislation as a problem for ensuring ethics and patient safety in Egypt. Without such broad and comprehensive legal framework, there is a lack of clear guidance to those bodies charged with overseeing clinical trials—hence introducing gaps in understanding and interpretation, which can lead to loopholes and nebulous practices.

An Egyptian Clinical Trials Registry Profile

In late 2015 researchers from Cairo University published a study covering clinical trial registries in Egypt. They noted that registering clinical trials in public domains increases transparency, and hence trust in research; not to mention supports more participation and encourages more safeguards against publication bias. The researchers focus on three registries, including 1) the WHO International Clinical Trial Registry Platform (ICTRP), 2) the continental Pan-African CT Registry (PACTR), and 3) the US (CTGR) registry. They found that by late 2014 there were 686 clinical trials conducted in ICTRP, 56 in PACTR, and 548 in CTGR. (note the number in CTGR is approaching 1,000). A majority of the clinical studies were performed in universities and sponsored by a university/non-profit organization, industry, or individual researchers. A majority of the clinical trials identified were in the Phase 3 category. The researchers concluded that potentially many more clinical trials were occurring than were being reported on registries. Moreover, they declared that an Egyptian Clinical Trials registry is needed and recommended.

Time to Move Forward

At 100 million, Egypt is the third most populous country on the African continent and is the third wealthiest nation in Africa, as measured by GDP. It is purported to be the second busiest clinical research center on this vast and promising continent. A modern, comprehensive, and unified legislation that aligns with international standards (e.g., GCP, ICH, GAMP) will benefit all. Making Egypt a center of clinical research in the region will drive greater healthcare outcomes, improve the economy, and contribute to dynamic collaboration catalyzing even more opportunity for positive results.