Slovenia has adopted legislation establishing a dedicated fund to finance rare disease treatments available only abroad, addressing a long standing gap that was previously covered through public fundraising campaigns. The public health insurance fund Health Insurance Institute of Slovenia will manage the scheme, which will cover costly healthcare services and imported medicines for life threatening conditions where no equivalent treatment exists domestically. The fund is expected to primarily support children whose therapies can cost up to one million euros or more.
The law allows financing of advanced medicines that may not yet have full EU marketing authorisation but are approved by equivalent regulatory bodies in third countries with comparable standards, as well as drugs in phase three clinical trials.
Parents will also be able to request the inclusion of a foreign specialist from European Reference Networks or OECD rare disease networks on the medical board assessing individual cases. The fund will be financed through compulsory health insurance, private donations and state budget allocations if needed.
The legislation follows several high profile crowdfunding campaigns, including the case of Urban, a six year old boy with CTNNB1 syndrome who became the first patient in the world to receive a pioneering gene replacement therapy developed at UKC Ljubljana. While the law received broad cross partisan support in parliament, disagreements emerged over proposals to expand coverage regardless of expert medical opinion. Advocacy groups welcomed the move as progress but warned that its real impact will depend on how the measures are implemented in practice.
