Tunisia

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:

• Monopoly on all imports of pharmaceuticals still exercised by the PCT("Pharmacie Centrale de Tunisie")

• Lack of clear pricing guidelines for imported finished products adding to the bargaining power of the PCT. For political reasons, the PCT's selling price into the market cannot be changed. Their profit margins tend to decrease over time due to inflation and the depreciation of the Tunisian Dinar. For this reason, once an imported product reaches about $1 million in import value, the PCT puts the corresponding molecule on their tender list. Several U.S. high volume products were lost in this way.

• Once a molecule is manufactured in Tunisia, its importation becomes restricted.

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.