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In Egypt, Clinical Trials on the Rise Amid Ethical and Legal Concerns

In Egypt, Clinical Trials on the Rise Amid Ethical and Legal Concerns

Patients and their relatives waiting outside Qasr al-Ainy Hospital. Photo: Roger Anis
Patients and their relatives waiting outside Qasr al-Ainy Hospital. Photo: Roger Anis

By Nourhan Fahmy

The Egyptian Initiative for Personal Rights (EIPR) issued on Tuesday its report on clinical drug trials in Egypt, raising questions about the ethics and legality of the process.

As the second-biggest destination country for clinical trials in Africa, Egypt has witnessed a steady increase in the number of trials it hosts, with the number nearly tripling between 2008 and 2011, the report says.

The trials, which are sponsored by transnational pharmaceutical companies (TNCs), have considerably expanded in the past 20 years, shifting towards offshoring medicine testing in low- and middle-income settings.

Egypt is considered a popular destination for conducting clinical trials in the MENA region because of “an attractive research infrastructure, a fast-growing and largely treatment-naïve population and lower costs,” the report states.

EIPR researcher Ayman al-Sabaa explained during a press conference on Tuesday that “treatment-naïve” means individuals who have not received earlier treatment for a given illness, making them respond better to the medication.

Egyptian regulations allow a foreign drug trial to be conducted only if the product being tested has been granted market approval in the originating country, according to the report.

There were 57 active international drug trials in Egypt in February 2016, with the two Swiss companies Novartis and Roche responsible for almost half of the trials, according to report.

“Over half of all international active drugs studies in Egypt are cancer trials, followed far behind by infectious diseases and metabolic disorders,” the report states.

Cancer patients specifically take part in clinical trials where they can receive drugs and treatment for free due to the high costs of treatment which can reach EGP 50,000 per month, according to Professor of Oncology at Cairo University Heba Khafagy.

Investigating whether the medicines were approved and when, EIPR researchers found that nine out of 24 foreign medicines tested in Egypt had no date of marketing approval available, sparking controversy regarding their licences.

The report added, “of the 15 medicines for which a date of marketing approval existed, five were approved more than 10 years ago.” Two of the five now-expired medicines are still available in Egyptian pharmacies.

According to Egyptian regulations, drugs for medical use are registered only for 10 years, after which the approval theoretically expires.

“Many of the medicines given market approval are sold at really high prices, especially cancer treatments, reaching up to EGP 26,000, which is more than 20 times the minimum wage that stands at EGP 1,200,” researcher Nevin al-nadi said.

“The goal of the report is not to stop clinical trials but to shed light on their ethical and legal aspects,” Sabaa said as he explained how the trials are an important step in scientific research to discover ways to treat diseases.

The problem, however, lies in the absence of a “robust legislative framework with functioning independent control systems.”

EIPR researchers said that a comprehensive unified legislation should be adopted to serve as a guidance to the bodies charged with overseeing clinical trials.

“Regulatory and legislative bodies need to provide a motivating environment for scientific research without ethical violations,” Sabaa said, “While the government needs to remain vigilant over the clinical trials being conducted.”

In compliance with international standards, the report urged the pharmaceutical industry to make tested medications affordable to the public as investigation has shown that several medicines tested on Egyptians are unaffordable once they enter the Egyptian market.

The report was prepared over a year from June 2015 to June 2016. It was first published in English with the Center for Research on Multinational Corporations (SOMO) in the Netherlands and was launched in Geneva a month ago.

The study includes interviews with more than 30 Egyptian experts as well as a dozen clinical trial participants.

This content is from Aswat Masriya

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