Egyptian Regulatory Reform: “Taming the Beast”

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Concerted efforts are, at last, being made to redraw the rulebook and tidy up a local regulatory landscape long renowned for its torpor, dysfunction and ineffectuality.

The Egyptian pharmaceutical market is currently regulated by the Ministry of Health itself, with all issues related to pharmaceuticals falling under the responsibility of the Assistant Minister for Pharmaceutical Affairs, Tarek Salman. On the topic of improving the pharmaceutical regulatory system that is currently in place, Salman explains that “registration timelines for new products have been quite long in the past, taking up to four or five years, however we have accomplished a significant reduction of the time it takes to process registration applications.” This reduction in times was motivated by a 2014 “ministerial decree [that] mandated that registration timelines be shortened to a maximum of 21 months, less than two years.” To achieve this acceleration, relevant ministry departments have begun to “carry out different core processes in parallel,” and the “Central Administration for Pharmaceutical Affairs (CAPA) leads the way in terms of regulatory processes in Egypt, and has achieved full automation of registrations inside CAPA.”

Pharmaceutical counterfeiting is also a significant challenge for Egypt, and the country has in fact been a leader in the fight against counterfeit products as “the first Arab country to develop guidelines to combat counterfeit products.” The ministry recently took a significant step forward in combating counterfeiting with a February 2016 ministerial decree that mandates introduction of a GS1 national serialized track and trace system. This will greatly enhance the government and industry’s ability to fight counterfeiting, and allow companies to recall specific batches of products much more effectively when necessary.

Structurally, the eventual development of an Egyptian Drug Authority, independent of the Ministry of Health, is seen as a necessary task if Egypt is to enhance its regulatory capabilities and keep up with evolving international standards. Salman explains that “the Ministry of Health is finalizing a final plan to create an Egyptian Drug Authority (EDA),” which “will focus solely on pharmaceutical products.” As per these plans, the EDA will bring together three separate bodies; the Central Administration for Pharmaceutical Affairs, the National Organization for Drug Control and Research, and the National Organization for Research and Control of Biologicals, under a single umbrella organization.”

Many industry stakeholders also feel that establishing an independent EDA would also help to improve regulatory responsiveness on the issue of pricing, which is a significant concern for manufacturers seeing as prices are essentially fixed in local currency terms, while that currency has been strongly devalued against the USD, dramatically increasing the cost of imports. Ahmed El Ezaby, Chairman of wholesaler Multipharma and Head of the FEI’s Pharma, Cosmetics and Medical products chamber, explains the importance of this initiative, saying “once the EDA is established it would have responsibility and power to ensure prices were sufficient to ensure the steady and reliable supply of medications, and minimize the risk of pharmaceutical shortages. Moreover, the establishment of the EDA would greatly increase trust in Egyptian made products both locally and internationally, which would be reflected in prices and support pharmaceutical exports, among other benefits. At present negotiations are underway between government, the Pharmacists Syndicate and industry associations for pharmaceutical manufacturers.

A separate, but similarly urgent, issue for many stakeholders is Egypt’s current lack of a clinical trials law. Eva Pharma CEO Riad Armanious explains that “currently, Egypt doesn’t have a law regulating clinical trials, which is a prerequisite for the European Medicines Agency to consider accrediting any facilities for clinical research.” As such, all Egyptian companies “seeking to develop a product that can be exported to a regulated market must complete bioequivalence studies outside of Egypt,” and no opportunities exist for multinational companies to phase globally recognized phase II and III trials at present. Thus, this legislative gap is limiting R&D investment from local and multinational pharmaceutical companies at present, and is also limiting Egyptian pharmaceutical manufacturers ability to compete in export markets.

Passing such a law is a priority for the industry, with Ashraf El Khouly of the Egyptian Society for Pharmaceutical Research and Osama Rostom of the FEI Pharma Chamber both listing the passage of such a law as a priority for their respective associations? Armanious explains that, “such a bill was presented to the pre-revolution parliament and a new version should soon reach the current parliament, so I am very hopeful that such a law will soon be passed, as it would significantly improve the research environment in Egypt and greatly facilitate export development.” ACDIMA Chairman Awad Tag Eldin, also a former minister of health, explains that the industry is currently “working with the Ministry of Scientific Research to finish a draft law for clinical trials, and now that our new parliament is in session it will be possible to get such a law passed soon.” He also highlights that while there may be some public resistance to passing such a law at first, many politicians “recognize that such laws already exist in neighboring countries like Jordan and Saudi Arabia,” and such examples will be assets to those pursuing the passage of such legislation.

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