This month, AmCham Healthcare Committee has reinitiated the dialogue with authorities on the need to have national regulations regarding ethical drug promotion practices to healthcare professionals, which would be in line with the Directive 2001/83/CE and international best practices.
The Committee has continued negotiating amendments to the governmental regulation on medical public procurement, in order to ensure a balanced reduction of delay penalties imposed on suppliers. A draft regulation incorporating the proposals has been put forward for public consultations in late March 2018.
At the beginning of April, the Committee has addressed a letter to the National Health Insurance Company, asking for the list of priority diseases for 2018 to be approved and published, enabling the pharmaceutical companies to submit applications for the inclusion of necessary drugs in the public reimbursement system.
A position paper has been sent out to the Medicines and Medical Devices Agency, highlighting matters that need to be addressed for correct implementation of regulations on marketing authorization and registration of pharmaceuticals.
If you would like to find out more about the committee’s activities, please contact Elena Popic.