After presidential objection to some provisions of the bill to regulate medical and clinical research: A vital law that bridges a long-standing legislative gap, and objections that comply with EIPR recommendations
The office of the presidency sent a letter to the Egyptian parliament outlining its objections to some provisions of the bill to regulate medical and clinical research, which was approved by parliament on May 14, 2018.
The proposed law comes amid major changes in the status of drug trials conducted by multinational pharmaceutical corporations. These trials are increasingly conducted in low- and middle-income countries, which also increases the chances of breach of the ethical standards governing such research.
In the Middle East and North Africa, Egypt is one of the more attractive venue for industry-sponsored clinical trials due to a suitable infrastructure, rapid population growth, and a widespread ignorance of medications and treatments, as well as the comparatively low cost of clinical trials.
After South Africa, Egypt is the second most common site in Africa for drug trials conducted by pharmaceutical multinationals. Many Egyptians find it difficult to access basic treatment. Some patients therefore participate in clinical trials despite the potential for exploitation because they hold the promise of free treatment, though the consequences of the treatment are unknown. This climate leads to the exploitation of the most vulnerable, needy citizens.
For this reason, the Egyptian Initiative for Personal Rights issued a joint report in 2016 titled “Industry-sponsored clinical trials: ethical considerations and local challenges.” The report offered a set of recommended actions for the Egyptian authorities and decision makers, including several recommendations for a new law.
The recommendations were consistent with Article 60 of the 2014 constitution, which states, “The human body is inviolable. Any assault, defilement, or disfigurement of it shall be considered a crime punishable by law. Trafficking in human organs shall be prohibited, and no medical or scientific experiment may be conducted without the documented free consent of the subject in accordance with accepted medical principles as regulated by law.”
A strong, uniform statutory framework, backed up by an effective, independent oversight system, was needed to ensure that citizens benefitted from clinical trials conducted in Egypt, protect patients’ right to continued treatment after the conclusion of the trial, enable patients to give free, informed consent, and affirm other basic ethical standards.
In April 2018, the EIPR was invited to a hearing convened by the parliamentary health committee to solicit opinions from various bodies about a bill to regulate clinical research that would soon be debated in the assembly.
The EIPR compared the law with its own recommendations, finding that the law, which was approved in May 2018, reflected the basic components of the law recommended by EIPR, responding to 75 percent of EIPR’s recommendations.
The most noticeable improvement in the law was the way it attempts to the current gap in legislation, which does not address the first and second phases of clinical trials for drugs produced by multinational firms prior to obtaining their market approvals in the country of origin.
EIPR also submitted several additional comments and recommendations to the parliamentary health committee which, if included in the bill, would remedy the fundamental flaws of clinical research in Egypt and enrich the research process in Egypt while protecting Egyptians’ rights and remaining consistent with the constitution. EIPR’s primary objections were the overrepresentation of the security bodies in the approval process for medical research, the unnecessary obstacles to sending samples abroad, and the poor representation of competent researcher bodies and civil society on the committees and agencies created by the law.
The reservations voiced by the office of the presidency earlier this month are largely in keeping with EIPR’s objections and comments. We applaud this step and look forward to seeing a new version of the law that engages with the recommendations submitted to the committee. We also stress on the importance of releasing drafts to the media and civil society, to enable the assembly to pass a law that receives the support of stakeholders and makes them partners in its implementation.
Finally, EIPR stresses the importance of issuing this law in a timely manner. The presidency’s objections should not be used to justify a delay given the importance of this legislation and its direct impact on the health and rights of Egyptians as well as scientific research.