How this law can help Egypt in clinical trials amid COVID-19 crisis

The Egyptian parliament approved a bill regulating clinical medical research, in the hope that it would contribute to revitalizing the pharmaceutical industry and bring Egypt into the race of developing a coronavirus vaccine.

al-monitor An Egyptian medical worker checks the blood of a man who recovered from the coronavirus, at the National Blood Transfusion center, Cairo, Egypt, July 22, 2020. Photo by KHALED DESOUKI/AFP via Getty Images.
أحمد جمعة

أحمد جمعة

@AhmedGomaa252

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Coronavirus

سبت 3, 2020

CAIRO — Egypt’s parliament approved Aug. 24 a bill regulating clinical medical research. The bill is known in the media as the Clinical Trials Law that regulates scientific research and subjects patients to clinical trials and research.

In May 2018, parliament had approved a bill governing clinical medical research, but President Abdel Fattah al-Sisi rejected some of its articles, including those requiring researchers and scientists to obtain prior approval from several bodies to conduct medical research and clinical trials. According to the draft law, these bodies include the Supreme Council of Universities (a governmental body), the General Intelligence Service and other oversight bodies. Sisi referred the draft law back to parliament for review in early October 2018, after it stirred controversy in the scientific and medical quarters in regard to ethics and legalities.

In a speech to parliament on Oct. 2, 2018, Sisi said, “Research includes master's, doctoral, free and funded research in the faculties of medicine and pharmaceutical sciences. That means it is impossible to follow up on these huge numbers of research studies carried out every month, only by committees in every research entity.”

Subsequently, the parliament formed Oct. 21 a special committee to consider the president's objection to the bill. The committee remained in session to amend the 19 articles subject of contention, according to the statements of its chairperson, Al-Sayyed al-Sharif to Sky News Aug. 15. 

Parliament approved the amended version on Aug. 24, 2020.

The head of the parliamentary Health Committee, Mohammed al-Amari, told Al-Monitor, “The law regulates clinical research procedures in the health and scientific research system so as not to prejudice morals and ethics.”

According to him, after the bill was approved in 2018, some objections were raised against it. Sisi returned it to parliament again, and it was referred to a special committee that held several sessions in the presence of the ministers of health and higher education, along with a group of experts and specialists. “The committee reached understandings regarding some of the disputed provisions, such as the multiplicity of authorities whose approval is required. These were narrowed down to the National Organization for Drug Control and Research and the Supreme Council for the Review of Clinical Medical Research Ethics. Also, penalties that were too stringent were alleviated,” he noted.

Amari argued that the timing of the issuance of the law coincides with global efforts to come up with a vaccine against the novel coronavirus. Amari added, “This law is expected to contribute to providing the legislative and legal cover to bring Egypt into multinational clinical trials in a manner that would pave the way for the provision of a vaccine at a fair price. This would also prevent patients and citizens from being exploited in studies and trails outside the legal framework.”

In turn, the Egyptian Center to Protect the Right for Medicine (ECPRM), a nongovernmental organization, said in a statement Aug. 24, of which Al-Monitor obtained a copy, that the approval of the law regulating clinical medical research “confirms the entry of Egypt as a regional power in the fields of public, pharmacological and medical research, and establishes a new stage for the scientific research system.” ECPRM affirmed this would be a national asset and a national wealth that must be encouraged and supported by all means.

It noted that Egypt should have seized the opportunities to attract investments in the field of pharmacological research years ago. This would allow Egypt “to write history in the pharmacological scientific research system.” It continued that the law criminalizes any illegal experiments or trials, preserves the dignity and humanity of the human being, and prevents turning citizens into guinea pigs.

Egyptian media had long criticized the lack of a law regulating research and clinical trials of drugs in Egypt. In an investigative report published in mid-2016, Shorouk newspaper reported that “brokers” exploited patients’ need to receive free treatment and funds to enter clinical trials for new drugs, in the absence of a clear law regulating that process.

In this vein, Osama Rostom, deputy head of the Pharmaceutical Chamber of the Federation of Egyptian Industries, told Al-Monitor, “Drug manufacturers have been waiting for years for a law regulating clinical trials. Amid the absence of a law that regulates the relationship between the researcher and the donor, Egypt was denied any role in both global and local researches.”

He praised the newly approved bill as opening new horizons for the pharmaceutical and research industry in Egypt. “This is especially true now as the world needs to produce a vaccine and treatments for COVID-19. The approved bill allows Egypt to be among the countries that are chosen to conduct these trials to ensure the effectiveness of the vaccine — if used.”

In conjunction with the approval of the bill, Egypt’s Ministry of Health announced in a statement Aug. 25 the signing of a cooperation agreement with China for manufacturing coronavirus vaccines in Egypt as of September.

In regard to the crises hitting drug manufacturers, Al-Monitor spoke to Jamal al-Laithi, a member of the Pharmaceutical Chamber of the Federation of Egyptian Industries. “Registering new medicines used to be very difficult in Egypt. The matter needed an external validation such as by the American Food and Drug Administration,” he said. “We are still behind in this industry. We cannot register the innovative brands in our country, despite having qualified experts and capabilities.”

Laithi concluded, “With the new law, Egypt will be able to manufacture drugs locally and conduct their clinical trials. This will break the country’s pharmaceutical industry’s reliance on the outside world.”

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