The Medicines and Medical Devices Agency, the regulatory authority for pharmaceuticals and medical devices in Turkey, recently announced that its information management system for medical devices will be updated. Given the changes that the announcement sets out, medical device sales centres should carefully assess their obligations in this regard in order to avoid any potential penalties.
The Personal Data Protection Authority recently announced that data controllers which employ fewer than 50 employees, have an annual turnover of less than TRY25 million and process no special categories of personal data as their main field of activity will be exempt from registering with the new Data Controller Registry (VERBIS). However, it remains to be seen how the authority will interpret the 'main field of activity' of pharmaceutical companies and how this will affect their obligations for registering with VERBIS.
Orphan medicinal products are used to prevent and treat rare diseases. However, approximately 95% of all rare diseases are yet to be treated effectively. Although access to medicinal products has improved, this remains an issue in the treatment of rare diseases. R&D in this field requires investment because these products appeal to a limited number of patient populations and R&D processes are long and costly.
The prices of pharmaceutical products in Turkey are determined through a reference pricing system in euro and converted to Turkish lira. The Price Evaluation Commission (PEC) is responsible for determining the periodic euro value used in this regard. Several important cases regarding PEC decisions have recently been finalised. The PEC was found to have violated its obligations under the law, thus allowing the parties that had suffered from the decisions to demand compensation.
The government aims to make Turkey one of the world's top 10 economies in the field of health services by 2023. As a result, Turkey's pharma industry is expected to reach $23 billion turnover by 2023 and imported products will continue to account for approximately half of the market share. The import of pharmaceuticals is expected to maintain its significant market share in the coming years.