Poland

Intellectual Patent Protection

A patent law was enacted in 1993 and a new draft law on industrial property rights is being discussed in Parliament. However, due to the lack of product protection prior to 1993, combined with the fact that it takes a long time to research and develop a new product, virtually all those products on the market today and those to be launched in the coming years (that have protection in the U.S.) are not adequately protected by patents. No adequate pipeline protection exists because the 1993 provision contains so many limitations that, in practice, pipeline protection is worthless. In particular, products which had a first marketing authorization anywhere in the world in the six months prior to December 1992 will only benefit from market exclusivity if the product is actually manufactured in Poland. In addition, the term for all process patents (new and existing patents) has not been extended to 20 years for all patents still in effect.

Data Exclusivity - Confidentiality

Current Polish law does not include any provisions meeting the requirements of Article 39.3 of WTO-TRIPs on the use of a previous applicant's documents, and in particular does not provide that in order to refer to documents submitted by a previous applicant, the applicant has to obtain the consent of the said previous applicant.

Poland does have provisions whereby, if a product has been on the market in Poland for more than three years, the normal requirement for clinical test results (phases III and IV) is lifted and only pharmacokinetic and bioequivalence data (from phases I and II studies) are required. Further, the requirement to provide any data from clinical trials may be lifted in justified cases - local advice is that this may apply if the applicant can show that the authorities are already in possession of the data.

Transparency

Registration and reimbursement and pricing systems lack transparency and the framework in which they are conducted undermines competition and penalizes foreign products. Even though the draft Ordinance effective as of January 1, 1999, will improve the transparency regarding criteria for establishing reference price groups for reimbursement, further improvements are required regarding the use of scientific evidence to support reimbursement decisions. Criteria to set prices and to classify groups of products for reference pricing are selective (e.g. Daily Defined Dose) and are used inconsistently. Furthermore, no transparent criteria exist to determine different levels of reimbursement.

Protectionism

Protectionism is evident in various forms:

• registration of original products generally takes twice as long as the registration of subsequent copy products by local producers for products still under patent in the EU

• local manufacturers can count on facilitation of registration for their products

• in order to be considered for reimbursement a product must be registered at least for one year, however, this rule is more often waived for local products

• prices of local manufactured products are set by the Ministry of Finance and then serve as reference price limits for reimbursement resulting in high patient co-payment and, therefore, constituting a trade barrier for U.S. pharmaceutical exports to Poland

• government representatives have publicly announced that tax breaks are being considered for 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.