POLAND MULLS ORPHAN DRUG REFORMS TO HEALTH LAW

The Polish Ministry of Health claims that the Pharmaceutical Act will be amended shortly in order make the reimbursement of drugs to treat rare diseases possible. Under the new system, hospitals will no longer have to take out additional insurance to cover patients taking drugs not currently reimbursed.

Presently, hospitals treating patients with rare diseases have had problems obtaining reimbursement from Poland's National Health Fund (NFZ), which has demanded additional insurance coverage. This has made the cost of treating such atypical illnesses prohibitive for many hospitals. According to current laws, the NFZ may only finance such therapies if used in medical experiments.

Meanwhile, there are also problems with Poland's drug registration regime, which many industry observers claim is not suitably flexible. There are reportedly widespread problems with paediatric uses of adult drugs. It is estimated that about 70% of these drugs are not officially indicated for treating children. However, proposed changes aim to reduce the time taken to assess new indications from three months to two weeks.