Pricing and reimbursement of pharmaceuticals in the Baltic States

Simply achieving safety in the provision of pharmaceuticals is difficult for nations not party to the protection of the common European licensing process. Pharmaceuticals that have been voluntarily withdrawn for safety reasons in other markets may not be withdrawn in the Baltic States, manufacturers do not always supply information on safety concerns, and small agencies may not identify concerns from third-party sources. For example, the antipsychotic drug sertindole was not granted a licensed indication in USA in 1998 because of concerns about its ability "to cause serious cardiovascular events, including death".2 It has also been subject to a compulsory suspension of marketing authorisation in the EU.3 However, in February, 2001, the drug remained available on an unrestricted basis in Latvia, and the manufacturers negotiated a reduction in price in 2000, which made the drug less costly than alternative atypical antipsychotic drugs, such as risperidone and olanzapine. Similarly, the antihistamine astemizole was eventually voluntarily withdrawn by the manufacturers after a series of relabellings in the USA in 1999 because of concerns, primarily about the increased risk of death and arrhythmias when given in high doses or in conjunction with other drugs.4 However, astemizole remained available in Estonia without provision of safety information from the manufacturers until the marketing authorisation expired in 2000, at which point the manufacturers simply did not apply for an extension. In Lithuania the manufacturer did not share with the licensing authority information on safety concerns, but no application for the renewal of marketing authorisation was made in 1998.