What you need to know about Egypt’s Clinical Trials Law

CAIRO – 30 April 2018: After Parliament's Health Committee initially approved on Wednesday the first draft law, known as the Clinical Trial Law, which governs the organization of clinical medical research in Egypt, many concerns have been raised over the ethical nature and legality of the process.

Clinical trials are the tests that are conducted on human participants, or groups of humans, in order to evaluate the effectiveness and safety of newly developed medications or medical devices.

As the second-biggest destination country for clinical trials in Africa, Egypt has witnessed a steady increase in the number of trials it hosts, which has pushed Parliament to discuss this law, potentially putting strict controls on experiments that are conducted in hospitals.

In February 2016, there were 57 active clinical drug trials, and over half of these trials were to assess cancer treatments.

Researchers’ concerns: Egyptians aren’t test mice

Researchers have raised concerns over the new draft law, asserting that specific standards should be stated to prohibit foreign companies from testing newly discovered drugs on Egyptian patients without testing them firstly in the company’s originating country; there should be strict rules for any local or foreign company that tests its drugs in Egypt.

Ehab El-Taher, secretary-general of the Doctors' Syndicate, stated to state-run Al-Ahram news website that the syndicate is keen to have a clinical testing law in Egypt so that citizens are not exposed to a field of experimentation by foreign companies. He asserted that 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.

“In addition, we have to analyze the components of any new drugs before experimenting with them on humans, and make sure that they are free of toxicity,” he added.

Taher also affirmed that these tests should not be allowed to be conducted except in governmental hospitals and research centers. The private sector is not allowed to carry out such experiments on its own.

The Doctors' Syndicate has implicitly approved the bill in general, but wants the defects solved.

Clinical trials are religiously haram

No one will forcibly be subjected to clinical trials, which are performed on a volunteer basis. Some people volunteer in order to aid a humanitarian cause, while some others do so for a financial return, Ahmed Abdel Latif El-Tahway, member of Parliament's Health Committee, told Al-Ahram.

Ahmed Karim, professor of Islamic Sharia at Al-Azhar University, stated that it is considered haram (religiously prohibited) to conduct clinical trials on human beings, as it may cause harm to them, justifying his position by the Quran verse {and make not your own hands contribute to (your) destruction; but do good} (2:195).

In addition, Karim also stated that a human does not own his or her body, but should treat it as a gift from God. {And do not pursue that of which you have no knowledge. Indeed, the hearing, the sight and the heart – about all those, [one] will be questioned} (Quran 17:36).

EIPR on clinical trails

The Egyptian Initiative for Personal Rights (EIPR) issued its report on clinical drug trials in Egypt in October 2016.

Cancer patients particularly take part in clinical trials, as they can receive drugs and treatment for free, due to the high costs of treatment, which can amount to LE 50,000 ($2,831) per month, according to Cairo University Professor of Oncology Heba Khafagy.

“The goal of the report is not to stop clinical trials, but to shed light on their ethical and legal aspects,” IPR researcher Ayman al-Sabaa said.

However, Khafagy stated that the problem lies in the absence of a “robust legislative framework with functioning independent control systems.”

This report was prepared over a year, from June 2015 to June 2016. It includes interviews with more than 30 Egyptian experts, in addition to a dozen clinical trial participants.

The clinical trial law, consisting of 18 articles, was first discussed by Parliament in 2006. As the society strongly rejected the law, it was suspended. It was issued again in 2014 without the amendments to its articles.