Deputies are in the process of drafting a new law for the regulation of clinical testing of non-registered drugs IN Jordan, whereby pharmaceutical firms will be allowed to conduct research studies.
Once the draft is endorsed by Parliament, Jordan would be the first Arab country to test pharmaceutical products in development on paid voluntary patients.
“Such a law is a golden opportunity for Jordan,” said Maher Matalka, secretary general of the Jordanian Association of Manufacturers of Medical Appliances. “It will draw investors, strengthen the scientific base of research and development and allow the transfer of technology and know-how.”
Existing laws permit local drug manufacturers and research centers to test only registered versions of generic drugs on patients. They need the health minister's approval as well as the patient's consent.
Naji Najib, professor at the International Pharmaceutical Research Center, said the legislation will regulate the work of those in the profession while ensuring that drugs in the market meet specific standards.
While such testing is common abroad, some Jordanians said it would encourage people to become guinea pigs, considering the low per capita income in the country. “Clinical testing is unfair for humans,” said Abu Hamzeh, a resident of Zarka. “It should be only carried out on patients with terminal conditions.”
He said some Jordanians, desperate for income, sell their organs in neighboring countries to make ends meet. A mother in her late 30s said the practice is unethical, but said it is the only way to make sure that drugs are fit for human consumption.
Matalka explained that the clinical development programs seek to improve the safety and efficacy of new medicines, and to make drugs accessible in Jordan in shorter periods of time. The testing can be done in hospitals with patients' consent. Prior to studying a drug's activity in humans, it must undergo pre-clinical testing, involving animal efficacy and safety studies, among other testing.
Other phases include safety trials on a limited number of patients, followed by tests conducted on a wider sample of patients. The draft would subject companies to criminal liability penalties, that would penalize them by a three-year prison sentence and/or a JD 5,000-JD 20,000 fine. — ( Jordan Times )
By Suha Ma'ayeh
© 2001 Mena Report (www.menareport.com )