Tougher solutions to prevent pharma companies from influencing Slovak doctors
2012-01-30
In line with the new legal solutions, by 31 January each year, marketing authorisation holders (MAHs) providing human prescription medicines in Slovakia will be obliged to file with the Ministry of Health an annual report detailing expenditure on promotions, marketing and contributions in kind provided directly or indirectly to healthcare providers in the previous year. The reports will be published on the ministry’s website. The new medicines law entered in force on 1 December last year, so pharma companies should supply the required information for December 2011 by the end of this month.
MAHs will be also required to provide the National Centre of Healthcare Information with a list of healthcare employees who participated in events for professional, scientific or educational purposes that were financed by a given MAH or a third party.
In addition, in their tax reports healthcare providers will have to include as “other income” all benefits they receive from MAHs, distributors or manufacturers of medicines, medical devices and dietary foods.
The law also regulates non-interventional clinical studies, enabling health insurers to prevent induced prescriptions that are financially supported by MAHs or their representatives. All non-interventional clinical study protocols will have to receive prior consent and follow-up approval from the health insurer of the person involved in the study. The insurer will not issue its consent for the study if the medicine has been authorised for use in Slovakia for longer than two years.