The Hungarian Government posted draft decrees on its homepage that envisage a very significant restructuring of authorities and Governmental agencies in the healthcare sector as of 1 March 2015. The primary aim of the restructuring is cost saving and the rationalization of the operation of the sectorial authorities and agencies.
Currently, there is a "super" authority, the National Institute of Quality and Organizational Development in Healthcare and Medicines ("GYEMSZI") which is responsible for several public tasks and has authority powers in various fields within healthcare, including the licensing of medicines.
Starting on 1 March 2015, the following major changes will take place in the operation of healthcare authorities:
- several public tasks and powers of the GYEMSZI will be transferred to currently existing or newly established authorities or agencies;
- a couple of other currently existing agencies of the Ministry of Human Resources and the public health authority will terminate their operations and merge into other or newly established authorities;
- the Government will establish the following new authorities: the National Institute of Pharmacy and Food, the Healthcare Registration and Training Center and the National Healthcare Supply Center.
The National Institute of Pharmacy and Food will be responsible for the authorization of medicines and the licensing of clinical trials, the manufacturing and the wholesale distribution of medicines. The new authority will issue the license of pharmacies and will also supervise the retail distribution of medicines. Also, the current National Institute for Food and Nutrition Science ("OÉTI") will merge into this new authority, therefore, the National Institute of Pharmacy and Food will engage in tasks relative to food, food supplements and cosmetic products, including the registration of certain products, the provision of scientific advice, testing and market surveillance. The National Institute of Pharmacy and Food will provide expert opinion on the classification of trials and research activities on humans including advice on the distinction between interventional and non-interventional trials as well as clinical trials and other research on humans.
The Healthcare Registration and Training Center will be the legal successor of the Healthcare Licensing and Administrative Institute ("EEKH") and the Human Resource Directorate of the GYEMSZI. The Healthcare Registration and Training Center will be responsible for management of healthcare training, the registration of healthcare professionals and various tasks and authority powers relative to medical devices.
The National Healthcare Supply Center will take over various tasks from the GYEMSZI, including certain management powers over state-owned healthcare institutions and the organization of centralized public procurements of medicinal products and medical devices for the supply of hospitals.