Intellectual Property Protection

Under the current Tunisian patent law, pharmaceutical products are unpatentable. The law provides patent for process for preparation of pharmaceuticals with a term of 20 from the date of application.

Due to the lack of patent protection for pharmaceuticals, dozens of unauthorized copies of top selling medicines continue to circulate in the market. This lack of any meaningful patent protection for pharmaceuticals jeopardizes the ability of the pharmaceutical industry to service the Tunisian market.

Other Barriers

Monopoly of imports, pricing problems and requirement for local manufacturing

In Tunisia the sole importer of pharmaceuticals is the Government-owned PCT ("Pharmacie Centrale de Tunisie"). The PCT supplies hospitals and approximately 60 private wholesalers who in turn supply the retail sector. The PCT is a key player in the Tunisian market in all respects. Its officials sit on regulatory committees, influence policy vis-á-vis local manufacturing and handle tenders in a monopoly fashion for the institutional sector.

The major issues impacting the industry in Tunisia are:

Therefore, due to these unfair pricing and regulatory decisions, access of or clear guidelines for U.S. pharmaceutical products to the Tunisian market can be denied. There is no transparency the access to this important market.

Potential Exports/ Foreign Sales

PhRMA cannot provide a reasonable estimate at this time of potential exports and foreign sales in Tunisia.