By Amira Sayed The Health Committee recently announced its preliminary approval of some amendments to the clinical trials law to regulate clinical research here. The bill aims to put in place a legal framework and strict regulations for this process in a way that does not hamper the development of scientific research or harm citizens' health. The step has triggered great public controversy with many proposals submitted to the committee to amend the potential law before its final approval. The clinical trial is a type of research that tests the effectiveness and safety of new medical devices and newly-developed medicines on a group of people prior to their approval. "This bill should have been issued a long time ago. It aims to protect human rights besides paving the way for scientific development in a way that does not harm people," Ahmed Hassan, a senior member of the parliament's health committee, told The Egyptian Gazette. There will be a meeting between the chairmen of the health and scientific research committees to decide whether to introduce some amendments to the draft law before its discussion in the general session for final approval or disapproval, MP Hassan added. "The bill is to be passed within the current term of the parliament," he said, adding the bill aims to protect Egyptians from being experimental mice. According to the Health Ministry statement, around 57 active clinical trials were conducted in February 2016. The majority of them were to test cancer treatments. The clinical trial law was first discussed in 2006, sparking severe outrage. This led to its suspension. Later, in 2014, the bill was issued without being amended. Now, a heated debate over this critical issue has followed the health committee's decision to amend the law. Egypt's Medical Syndicate voiced its concern, submitting many amendments to the committee. "Newly-developed drugs should first be tested in the manufacturing company's country. "Citizens here should not be exploited by foreign companies. As for local companies, there should be clearer and stricter regulations," Mohamed Ali, a member of the syndicate, said. "There is," he said, "a social element that should be taken into account in discussing this issue, especially in developing countries. As many people are grappling with deplorable economic conditions, they may expose their lives to hazards in return for money. The consent of the individual is not enough. The authorities concerned should play a role to protect citizens from any kind of exploitation." Egypt's Constitution, Ali continued, prohibited any assault on the human body or any act that may distort it. "Therefore, the bill should emphasise that such tests will be held in accordance with the standards of Good Clinical Practice." GCP is a standard for the design, conduct, performance and monitoring of clinical trials. Such trials should not be conducted on pregnant women and mental health patients. Also children under 18 years old shall not be subject to such trials unless the medicine is related to the disease they are suffering from, according to Ali. Ali said that this bill, if all the amendments were introduced, would help boost the country's ranking on the scientific research map. "It would also help thousands of people to get medicines at reduced prices." The Pharmacists Syndicate also said that such trials must be conducted in public and university hospitals under the supervision of the authorities concerned. The head of the syndicate, Mohie Ebeid, also said that the Medical Research Ethics Committee (MREC) should be a separate body affiliated to the Cabinet and should include representatives of the Health Ministry, universities, scientific research centres and all entities involved in this process. The bill should also help the copyright of such research and help researchers protect and apply their inventions.
