EIPR: Launch of the executive regulations for clinical trials A model of community participation in legislation to replicate
The Egyptian Initiative for Personal Rights welcomes the issuance of the executive regulations for the law regulating clinical medical research on March 12, 2022, after more than a year since the law was issued in late December 2020. The law and its regulations represent a sound regulatory and legal framework to protect the rights of patients and volunteers in clinical trials that will take place in any health or research facility inside Egypt.
EIPR has been advocating in recent years for a full review of the regulatory framework that governs the conduction of clinical trials in Egypt. This began in 2016 when EIPR, in collaboration with several local and international research organizations, released its report “Ethical Questions on Clinical Trials in Egypt.” This report had a wide societal and media reaction locally and internationally, as it clarified that the existing laws were not sufficient to protect Egyptian patients subject to clinical trials sponsored by international companies in Egypt, and were marred by many defects that were not in line with global laws and ethical guidelines.
Following the release of this report, decision-makers responded by taking active steps in updating the legal framework regulating clinical medical trials in Egypt. Discussions were held within the House of Representatives to discuss the draft law regulating them. On April 12, 2018, EIPR attended a hearing held by the Parliament's Health Committee, during which it presented its recommendations and suggestions.
The debate over the law passed through many stages, perhaps the most prominent of which was the approval of the draft by the House of Representatives on the 14th of May 2018 session. However, that draft presented many pitfalls at the time due to the exaggerated involvement of security authorities in the approval process for conducting medical research, and the unjustified obstacles to the process of sending biological samples for testing abroad, in addition to the poor representation of researchers, bodies concerned with scientific research and civil society in the bodies and committees established by law. In view of those objections, the President returned the draft law regulating medical and clinical research to Parliament again for review of these particular points.
When Parliament approved the latest version of the law on August 24, 2020, EIPR welcomed it, as "the law, in its latest version, held 85% of its recommendations issued in its 2016 report.
On March 12th this year, the executive regulations of the law were issued and clearly stipulated the rights of research subjects (patients/volunteers) in Article (20) “The respondent enjoys the following rights: 1- The right to withdraw from the medical research whenever he/she wants and without being obligated to provide any reasons for that, and the principal investigator must inform the subject of the medical damages resulting from his/her withdrawal in writing. 2- Not disclosing the identity or any information about the subjects’ data except after fulfilling the conditions of the scientific justification approved by the competent institutional committee and endorsed by the Supreme Council and with a written consent by the subject or his/her legal representative. 3- Obtaining a written copy of the informed consent form in the subject’s mother tongue with the researcher’s extensive explanation of the nature and purpose of the research and the benefit that the research will add to the disease as well as the side effects that he/she may be exposed to with an approximate explanation of the incidence of side effects on the research subject”.
Why is EIPR interested in the clinical trial file?
It was necessary to establish a strong legislative and legal framework, backed by an effective and independent monitoring system, to ensure that citizens benefit from clinical trials taking place in Egypt, respect the patient’s right to continue treatment after the trial, and ensure that patients are given the opportunity and are empowered to give informed consent voluntarily. Perhaps the clinical trials conducted with COVID-19 vaccines have clearly demonstrated the paramount importance of having a legislative system governing clinical trials. The Egyptian Ministry of Health, in partnership with the Chinese government, and the UAE health care company G42, has already participated in the third phase of clinical trials on two vaccines for the Corona virus, "Sinopharm". You can read EIPR's comment on this experiment here. Concers from citizens about participating and volunteering in the Sinopharm vaccine trial proves the importance of having independent scientific bodies that monitor and regulate the conduct of clinical trials.
While recognizing that both the law and its executive regulations represent good steps towards preserving the rights of those subject to clinical trials, the main drawback remains the absence of representation of civil society associations working in the field of the right to health, patients’ associations and other stakeholders concerned with the executive and supervisory framework in the law and regulations.
The Supreme Council for the Review of Clinical Medical Research Ethics of the Council of Ministers is composed of three university faculty members chosen by the Minister of Higher Education and Scientific Research, two research professors in relevant research centers, institutes and bodies chosen by the Minister in charge of Higher Education and Scientific Research, two representatives from the Ministry of Health and Population chosen by the Health Minister, a representative of the Pharmaceutical Authority, and representatives from the Ministry of Defense, Interior and Intelligence (the law and the regulations indicate the obligation to consult with the General Intelligence Service in the event of research conducted with foreign bodies and joint international studies), in addition to one of the Vice-Presidents of the State Council chosen by the President of the Council, and 3 experienced public figures, two to be chosen by the Minister of Higher Education and Scientific Research, and one by the Minister of Health.
On the other hand, the law divides the authority to regulate the conduct and control of clinical trials between three bodies:
The Supreme Council for the Review of Clinical Medical Research Ethics; its role includes the following:
Creation of a database for medical research that includes all documents, data and information.
Setting standards, controls and regulations for the ethics of medical research to protect the rights of the trial/volunteer subjects.
The final review of the research plans (protocols) that include the use of new pharmaceutical compounds, new indications for use, or medical supplies or devices that have not been used on humans before, and the issuance of the final decision for any of them to approve or reject these plans and any suggested amendments, as well as a survey of the opinion of the General Intelligence in the case of research conducted with foreign bodies and joint international studies.
Periodic review and inspection of research bodies in which clinical medical research is conducted.
Examining and deciding on complaints received from individuals or related entities to the Council regarding clinical medical research.
Institutional Committees to Review Clinical Medical Research Ethics:
Within each research body, an institutional committee is formed within each research body by a decision of the competent authority in this body, on condition it is registered with the Supreme Council. The committee’s role is to overview the rights of research subjects, to review the research plans submitted to it and informing the Supreme Council of all submitted research as well as monitoring the main researcher and the sponsor of the research (the body funding the research). The committee reviews the protocol and approves it permanently without the need for ratification from any other party in the case of non-invasive or invasive research that does not include the use of new or biological medicinal compounds, new indications for use, or forms, supplies and medical devices that have not been used on humans before. These include master’s and doctoral theses and free research.
The Egyptian Pharmaceutical Authority:
The Egyptian Pharmaceutical Authority is concerned with inspecting research bodies which conduct clinical medical research for the purpose of verifying good medical practice, examining and reviewing documents, equipment, records and other sources related to medical research, as well as monitoring any observations or irregularities, preparing a report on the result of the inspection and notifying the Supreme Council thereof, and follow-up and evaluation of the periodic reports of the clinical medical research under study.
The executive regulations defined international bodies as health authorities outside the Arab Republic of Egypt responsible for approving medical interventions such as: the European Pharmaceutical Agency (EMA), the US Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), the health authority in Canada (Health Canada), the UK Medicines and Healthcare products Regulatory Authority (MHRA).
Finally, the law and its regulations are a good example of cooperation with civil society, paying attention to its recommendations and involving it in making legislation that meets existing social needs, when such cooperation is allowed. There is also a need to allow civil society and associations working in the field of the right to health to monitor implementation. For example, when a clinical trial such as the one with the two Sinopharm vaccines is conducted, it is given that civil society will be allowed to monitor the experiment, especially in the aspect related to the extent of commitment to the rights of volunteers and patients. It is also important to warn of the danger of expanding the use of security restrictions set by the law in the case of studies conducted in cooperation with "foreign bodies and joint international studies" because it may prevent benefiting from the regulatory and legislative progress that has taken place, and hinder scientific research.