Intellectual Property Protection
The current Egyptian patent law is based on the "Law on Patents, Designs, and Industrial Models 1949-1955." The current law has specific discriminatory aspects against pharmaceuticals.
While the basic patent term available in Egypt is 15 years from date of application (with possible extension of up to 20 years), pharmaceuticals, medicines and foodstuffs specifically are excluded from product patentability. Furthermore, while manufacturing processes for pharmaceuticals and medicines are patentable, the term for process patents is only 10 years, which poses an additional layer of discrimination. Given the long period of time between the grant of a patent and the commercialization of the product due to regulatory review, a 10 year process patent is virtually meaningless.
Egypt is a significant market -- indeed one of the largest -- in the Middle East/Africa region. The lack of any meaningful patent protection for pharmaceuticals jeopardizes the ability of the pharmaceutical industry to service the Egyptian market. Such lack of patent protection also leaves Egypt behind the trend of many other countries, such as Mexico, that have enacted effective intellectual property regimes to the benefit of their economies and healthcare systems.
A draft law has been prepared by the Government and is now awaiting two key Government recommendations before it is submitted to the Parliament: (1) on the length of any "transition" period before which product patent protection will be made effective; and (2) on whether pipeline protection will be included. Most of the substantive provisions are positive and reflect the standards established by TRIPs. Interestingly, a draft prepared more than four years ago did not contain a clause for delayed implementation and did include a pipeline clause. Due to influence from companies opposed to patent protection in Egypt, as well as influence brought to bear by anti-patent forces in Argentina, these two crucial issues are undecided.
Egypt maintains an onerous price control system that does not allow for price increases to compensate for inflation. Also, many regulations regarding manufacture and registration are opaque and vague. Furthermore, Egypt bans the import of many pharmaceuticals in finished dosage forms, and requires foreign companies to license the manufacture and sale of imported drugs to local companies. All of these requirements appear to violate Egypt's WTO commitments regarding national treatment of foreign investors.
Potential Exports/Foreign Sales
It is not possible to provide a reliable current estimate of the potential market size for PhRMA member companies in Egypt, if current deficiencies there were to be rectified.