A Law Regulating Medical Experiments Creates Controversy
A new Egyptian law had the goal of protecting the human subjects of medical research, but it has kicked up a storm of debate by, among other things, requiring some research to be sent out for security review.
Worldwide, governments have to balance the desire to make advances in the treatment of disease with the need to protect people who are the subjects of medical research. In the past, unscrupulous researchers have used prisoners, the poor and vulnerable minorities in medical experiments that have exposed them to significant risk without their consent, including the risk of getting sicker instead of healthier.
In Egypt, legislators on the issue emphasized the importance of developing research in a country that ranked 105 out of 127 last year in the Global Innovation Index. Egypt’s parliament passed the new law last month, and it will regulate clinical medical research.
“The new law is aimed at protecting the rights of citizens and at organizing scientific research in the medical field,” said Ahmed Emadeddine, minister of health and population, addressing the parliament. “Medical research is divided into pre-clinical research conducted in laboratories, with tests on animals rather than humans, to be followed by clinical trials on human beings.”
Egypt is ranked second in Africa—after South Africa—in the number of clinical drug trials that it hosts that are run by international corporations, according to a December 2016 report by the Egyptian Initiative for Personal Rights (EIPR) and a database of the U.S. National Library of Medicine. According to the EIPR report, the lack of clear legislation regulating drug experiments on human beings has transformed Egypt into a global theater for conducting this sort of research and led to the exploitation of patients. The report attributed Egypt’s popularity as a site for clinical trials to the ignorance of drugs and treatments among Egypt’s population and the low cost of conducting such experiments in Egypt.
The general provisions of the law include standards and controls necessary for the conduct of clinical medical research and rules for the protection of subjects in a wide variety of medical experiments. Under the law, a Higher Council for Research will be established, with members appointed by the minister of health. The council will set out detailed rules for medical research with human subjects and ethical principles governing such research. The law requires the council to send proposals for medical research to the General Intelligence Service to assess experiments in the light of national security. The law also governs the use of human samples for medical research, such as blood and tissue, and lays out rules for setting up other ethical commissions at institutions where medical research takes place.
In an effort to avoid the abuse of vulnerable people in medical research, the law states that “Medical research shall not be restricted to a particular group of persons or to groups entitled to additional protection, unless the research is necessary and related to their own diseases with the availability of scientific and ethical justification for their use, and the need to get the informed consent of each of them or their legal representative, all in accordance with the controls and procedures prescribed by the regulations.”
Critics of the new law suggest that while it is well intentioned, it has serious flaws. “We have a large number of international companies operating in Egypt unchecked and without anyone’s knowledge,” said Khalid Samir, a professor of cardiosurgery at Ain Shams University. “Hence the importance of a law regulating the subject and protecting human beings. But talking about reviewing all the research by the General Intelligence Service is illogical and will block and halt a lot of research.”
Samir pointed out that the wording of the law gives power to the Ministry of Health but excludes the Ministry of Scientific Research. “The law did not include any reference to the rights of the researcher regarding confidentiality and intellectual property rights and damage that [the researcher] might be exposed to,” he said.
Hossam Abdel Ghaffar, assistant secretary for university hospital affairs at the Supreme Council of Universities, believes that the new law does not differentiate between ordinary medical research and pharmaceutical research. “In 2016, more than 17,000 instances of medical research were conducted in Egypt, and today the law sets up a higher council for medical research to review the research plan for each of those instances of research; a review of about 17,000 experimental trials annually,” he said. “This is impossible and disrupts work.”
Associations representing physicians and pharmacists have objected to some of the law’s provisions and have demanded amendments before the law is applied. The physicians’ association, known as a syndicate, has asked that the law include language about combatting human trafficking and that physicians be better represented in those bodies that will be making decisions on medical research, including the Supreme Council of Medical Research Ethics. “The mechanisms for forming institutional committees for medical research ethics and national monitoring bodies were neglected,” the physicians’ syndicate said in a statement. “The law also overlooks the role of the state in sponsoring researchers and their research, in protecting their innovations and implementing them, as well as intellectual property rights.”
Legislators defend the existing law as a strong step forward.
Azza Saleh, a professor of clinical and chemical pathology at the Ministry of Health and a member of the committee that prepared the law, said it primarily protects the rights of human subjects and sets the conditions and procedures that must be met by researchers, including the need to obtain what is referred to internationally as “informed consent,” in which those agreeing to participate in research fully understand the possible risks and benefits. Saleh said the law also makes it possible for anyone to withdraw from medical research at any time, provided the researcher has explained to them the possible medical harm that might come to them from stopping in the middle of an experimental treatment.
The law, Saleh says, stipulates conditions for the researchers conducting experimental trials, including their being qualified to conduct scientific research, as well as requiring them to abide by Egyptian law.
As researchers and lawmakers debate the law’s value, patients’ reactions vary.
Leila, a patient who suffers from breast cancer and asked not to share her full name, does not mind participating in clinical trials to treat her illness, although the results might not be guaranteed.
“I do not have health insurance because I was working in the private sector,” she said. “I spent all my money on the treatment and when I got an offer from the therapist to participate in a new clinical trial, I agreed immediately. There is no other way for me.”
Leila did not benefit from the therapeutic experiment. She suffered from skin burns and found no noticeable improvement. “But I will agree when I am offered to undergo a new experiment,” she said. “I am unable to treat myself and I agree to any possible chance to recover.”
But Omar, a patient with a hepatitis C infection, refuses to undergo any clinical trials. How long someone lives, he said, is “in God’s hands. I will not make my body a field for tests.”