National Content Requirement

On October 5, 1999, the Ministry of Health issued official guidelines (Circulaire No.002), whereby it informed the holders of pharmaceutical licenses (product registrations) that "the sale of pharmaceutical products will be subject in the future to their manufacturing in Algeria." The Circulaire is only four paragraphs long, does not provide for a specific deadline to comply therewith, and does not either specify what is meant by local manufacturing (primary or secondary packaging, or local formulation). However, it does provide that the Ministry of Health will be entitled to suspend or refuse to renew the marketing licenses held by companies that are not in compliance with the Circulaire, thus preventing any importation and marketing of the concerned products in Algeria.

The Circulaire is an unrealistic and overreaching attempt to fulfill a domestic industrial development agenda at the expense of health care and the foreign pharmaceutical companies. It is unrealistic, as there currently are very limited manufacturing capabilities in Algeria that would meet GMP requirements. Local manufacturing is therefore impossible to achieve in the short or middle term. It is overreaching, as it provides for sanctions that, if applied, would lead to the disruption of the supply of potentially critical products in contradiction with the health care needs of the Algerian people.

In addition, because of the vagueness of its provisions, the Circulaire opens the door to a case-by-case application, leaving very few hope to adequate and fair treatment to foreign companies.

At the very least, regardless of its actual implementation and enforcement, this Circulaire should be viewed as a dangerous path taken by the Algerian Government, leading to unfair international trade restrictions.

Potential Exports/Foreign Sales

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