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Does the clinical trials law protect the sanctity of Egyptians?

Clinical trials in Egypt have been conducted on patients for years without real legislation regulating their dangerous and sensitive work, but under the supervision of the “Scientific Research Ethics” committee at the Ministry of Health, but they have remained out of the light, and some of them are conducted in secret and illegally.

That committee – which was established in 2005 – was the official body in the country entrusted with approving clinical trials in Egypt, and it follows up on them, and there is a similar committee in every research body.

Days before the end of 2020, Egyptian President Abdel Fattah El-Sisi issued the law regulating clinical medical research, known as clinical trials, to become the first law to regulate the work of clinical trials after leaving it for years.

Confusion and controversy

The law witnessed widespread controversy and controversy when it was first issued by the Egyptian Parliament in May 2018, due to the objections of civil institutions and civil society to many articles related to toughening penalties, restricting research work, involving the security services, and reducing the role of researchers and specialists.

The Egyptian President at the time refused to ratify it, and returned it to Parliament in October 2018, to deal with the contentious articles and make the necessary amendments, but it took about two years for Parliament to finally approve it in August 2020.

The issuance of the law regulating the conduct of clinical trials coincides with the outbreak of the Corona virus, the emergence of a new strain, and the need for Egypt to participate in clinical trials that some countries conduct in order to find a vaccine for the virus, and thus obtain a larger share of the vaccine.

Experiences in secret

Egyptian newspapers and media considered that it heralded the end of the era of trafficking in the bodies and health of patients, as some “national” newspapers revealed that “these experiments were practiced in secret without organizing or providing cover to protect patients, which was what made Egyptians experimental rats for medical and pharmaceutical companies through ( Business is confidential with some doctors. “

According to the US National Institutes of Health (NIH), Egypt is the second country after South Africa to attract foreign drug companies to conduct clinical trials in 2016, as it is fertile ground for the lack of real guarantees for patients, and the absence of legislation that includes deterrent penalties.

Major concerns

Although the law succeeded in establishing ethical and professional controls and deterrent penalties to regulate clinical trials and protect patients, up to imprisonment and the imposition of financial fines, there are several concerns related to two main issues, the first of which is the lack of strict enforcement of the law in a country that ranks behind in the “rule of law” index.

Last June, Egypt ranked last in the Middle East countries and ranked 125 out of 128 countries included in the report of the American “Global Justice” Foundation on the Rule of Law Index, which depends on several factors, including the absence of corruption, public order and security, And the power of law enforcement, civil and criminal justice.

The second thing is the exploitation of millions of patients in a country whose 30% of the population suffers from poverty – that is, more than 30 million lack an insurance umbrella for treatment and the ability to buy expensive medicine – as well as the low cost of experiments, and the spread of illiteracy that reaches about 25%, according to the Central Agency For statistics.

All these factors constitute direct and strong incentives for foreign companies, which was documented by the investigative investigation – which was broadcast on May 18 last, on Al-Jazeera channel, titled “The Epidemic Trade” – from cases in which the major companies were involved in the production of drugs and vaccines against previous epidemics.

The hidden side of the vaccine industry

The program revealed exclusive documents that show the hidden side of the work of the major companies that monopolize the market for the vaccines and medicines internationally and are currently working hard to produce a drug or vaccine against the Corona virus, and other documents that show the practices of drug companies and their controversial influence.

Redeem on the law

One of the deficiencies of the law, according to the Egyptian Initiative for Personal Rights (civil society), is that it does not stipulate in detail the conditions for “informed” consent that were referred to in the definitions, and which must be followed by the international definition according to the Helsinki Agreement with its various components.

For example, it should include giving enough time to make a decision and consult others, and the need to inform the patient of the proven alternative treatments that are available, as well as the need to know that the medicine he will take under test and that some medicines are placebo.

According to the initiative also, “despite the amendment made to the composition of the Supreme Council for Medical Research Ethics, it does not so far include a representation of civil society or associations working in the (right to health), patient associations or other stakeholders.”

Egypt is the second country after South Africa to attract foreign drug companies to conduct clinical trials in 2016 (Al-Jazeera)

The law between application and negligence

All of these data reinforced the concerns of the former Egyptian Ministry of Health agent, and epidemiologist, Dr. Mustafa Gawish, who warned of “the state of slackness in the strict application of the rules of laws with regard to poor and needy patients who cannot find the price of medical examination or treatment.”

In his speech to Al-Jazeera Net, he indicated that the law faced a lot of criticism since it was introduced many years ago in 2006, and then it was reintroduced several times before the Egyptian parliament approved it in 2018, and Sisi returns it again to parliament due to objections to many of its articles.

The main problem in the law – according to the health expert – was an important issue stipulated in the International Helsinki Agreement regarding “informed consent” from every individual subject to these clinical experiences and research, especially with the high rates of ignorance, illiteracy and poverty, which constitutes an important obstacle to the application of this necessary condition, which is What was revealed by the scandal of two foreign pharmaceutical companies (Roche and Novartis) in 2016 in Egypt.

The 2014 Constitution stipulates in Article 60 that “the human body is inviolable, and assaulting it, mutilating it, or mutilating it is a crime punishable by law. It is prohibited to trade in its organs, and it is not permissible to conduct any medical or scientific experiment on it without its free, documented consent, and in accordance with the established principles. In the field of medical sciences, as regulated by law. “




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