ZAGREB, April 3, 2018 – The Health Ministry will change the rules for clinical testing of medicines in Croatia to speed up approval and contracting procedures, increase the number of clinical trials in healthcare institutions and improve access to innovative therapies for patients.
Croatia is currently studying the models used by countries such as Hungary, Slovakia and Slovenia, Health Minister Milan Kujundžić told Hina.
The issue has become topical again after Prime Minister Andrej Plenković announced that 23 Croatian patients suffering from spinal muscular atrophy would be included in the clinical testing of a new drug against this condition, to be conducted by the Roche company.
The Innovative Pharmaceutical Initiative (iF!), an association comprising 23 innovative drug producers in Croatia, is also calling for change, warning that the process of approving and agreeing clinical trials in Croatia is too long compared with other European countries. On average, this process takes eight months in Croatia, twice as long as in Hungary.
Clinical trials are direct investments in Croatia and its healthcare system. They provide patients with quick and direct access to the newest medicines and keep doctors up to date with the latest knowledge and possibilities of therapy, iF! said.
This association has recently presented the Health Ministry with solutions which it claims might shorten the approval process to 28 days and make Croatia considerably more attractive for clinical trials.
Currently, 200,000 clinical trials are being conducted worldwide, with 16 billion euro invested in them annually, so it is worrying that only 40 million euro, or 9.2 euro per capita, is invested in Croatia annually, iF! said. By comparison, 161 million euro or 81 euro per capita is invested in clinical trials in Slovenia and 158 million euro or 16 euro per capita in Hungary.
According to the Health Ministry, 193 clinical trials are currently being conducted in Croatia and several are in the process of approval. Last year, 69 new clinical trials were approved and seven were approved in the first three months of this year. On average, 65 clinical trials have been approved annually since 2009, most of them relating to the testing of drugs for oncological diseases, chronic inflammatory diseases, cardiovascular diseases, multiple sclerosis and diabetes.
