Intellectual Property Protection
Romania has made progress with respect to intellectual property protection and has implemented a Transitory Pipeline Patent Protection Law as of May 1998. In September 1998 the rules for its implementation were also published. Under the Law products are protected for a period of 20 years. Drug authorities are taking into consideration transition protection when implementing registration procedures. However, there is still room for improvement with respect to the protection of data, and the need for a period of data exclusivity, with particular emphasis on clinical data.
Prices for imported products are frozen at their January 1996 CIF value and controlled by MOH. Local manufacturers, however, are permitted price increases according to foreign exchange variances; the permission is given by the Office of Competition. Prices are also controlled through differing wholesalers and pharmacy margins. In both cases they are different for local versus imported products. Local manufacturers are given advantages. This creates an artificial price differential between local and imported (i.e. foreign) products.
Registration and Reimbursement
Local manufacturers are in both cases privileged through the entire registration and reimbursement process. Until the year 2000, for registration purposes, the dossiers of local manufacturers do not need to comply with EU regulations. The absence of clear criteria for reimbursement favors local manufacturers.
Potential Exports/Foreign Sales
PhRMA is not able at this time to provide any reliable estimates of the increase in our industry's sales that would accompany the removal of the aforementioned trade barriers.
For all the aforementioned reasons, PhRMA believes that Romania should be listed as a Watch Country under Special 301 in 1999.