Intellectual Property Protection
Product patent protection became available in 1992, however, the patent law does not provide pipeline protection, thus pharmaceutical products will not enjoy patent protection until approximately 2005. This lack of protection continues to permit local companies to routinely pirate U.S. patented pharmaceuticals. Enforcement measures such as preliminary injunctions, reversal of burden of proof, etc. have been repeatedly denied by the Slovenian courts.
Data exclusivity has been included in the new Slovenian Medicinal Law. However, although the period of protection for confidential data is a maximum of six years, protection terminates at the end of the patent period. In addition, there is a serious problem with effective protection of proprietary commercial data in Slovenia. PhRMA has received reports that the Ministry of Health routinely gives U.S. company product dossiers to the local companies for review with the reasoning that the government lacks the "expertise" to review the dossiers.
As local copiers export about 90 percent of their production, patent and data exclusivity shortcomings affect market conditions in other countries of the region and beyond.
Slovenia applies up to 4.5% custom duty on pharmaceutical products of EU origin and has agreed to eliminate these tariffs under the "Europe" Agreement with the EU. However, it applies a 10 - 15% duty on non-EU products, including U.S. products, in violation of the MFN provisions under WTO.
Pricing and Reimbursement
In April 1998 Slovenia adopted a reference-price based regulation which, by its very nature, on average represents a price reduction for imported products of 30 - 40%. To enforce the April regulation, in July 1998 the Slovenian government removed over 300 pharmaceutical products from the reimbursement list, the majority of which are foreign products, mostly of U.S. corporate origin. Foreign manufacturers are not willing to decrease the price to the level of cheapest generic or pirate copy.
Pricing and reimbursement decisions are non transparent and are taken without consulting the affected companies. Decisions of the reimbursement committee are influenced by the CEO of one of the two powerful local manufacturers in his function as president of the sickfund association, which approves decisions of the reimbursement committee. No appeal procedure exists.
Product registration in Slovenia lacks transparency and discriminates against foreign products. For new product applications under review, the Slovenian MOH requirements for product prescribing information are frequently inconsistent and often require more extensive information from foreign companies than from local firms.
- The MOH does not accept foreign clinical data for product registration, but insists upon a local expert report. In addition, the Ministry accepts only original documentation and certificates. These requirements are not based on scientific principles, but are clearly discriminatory and intended to delay the time to market foreign products.
- Local testing of foreign products takes up to one year despite the fact that the products are manufactured according to the international standards and are accompanied by the manufacturer's Certification of Quality Assurance. The local trials offer no additional verification of safety, quality and efficacy beyond those already established by the manufacturer's initial clinical trials conducted abroad.
- Every batch of imported products must be tested, causing further delays in receiving import documentation and additional costs.
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.