In Belarus retail sales of medicines are restricted to pharmacies; no such ban exists in respect of medical devices. But do non-traditional channels exist for retailing medical devices in Belarus?
Nowadays, new technologies and innovative business models are revolutionising most industries. E-commerce is already not new in the trade in clothing and other consumer goods. Attempts are under way to introduce automated trade in food stores and other places. Technology allows reduction in costs and prices, increases availability and accessibility, offers greater comfort and generates an invaluable bulk of data on consumer behaviour. Automation has been penetrating the medical devices market as well. However, this is at a slower pace since it requires adaptation of complex regulations, which takes time and effort in order to coordinate the positions of the various stakeholders. Nevertheless many countries nowadays have managed to find a balanced solution so that online pharmacies, vending machines and direct sales become legitimate channels for distributing medicines and medical devices at the same time preserving quality and safety standards.
Unlike pharmaceuticals in Belarus, where all types of non-traditional retail are banned, the medical devices market features a less stringent regulatory environment. Belarussian national laws neither explicitly prohibit nor regulate distribution of medical devices in general or via non-traditional channels in particular. Non-traditional forms of retail that are visible are online stores and vending machines, where examples include contact-lenses, support hose and boot covers.
Currently the Eurasian Economic Union (EAEU) single market for medical devices is on the eve of full-fledged functioning, so operators are waiting for adoption of second-level and third-level legislation. This in turn may lead to developments in regulations on distance sales ‒ via the Internet ‒ or use of vending-machines for distributing medical devices.
Additional limitations that may apply are contained in the Law on Advertising (the Law). Advertising of medical devices must follow certain rules laid down in the Law and by-laws adopted by the Ministry of Healthcare. For instance, the Law restricts advertising only to specialised printed media in respect of medical devices requiring special knowledge for their correct application. Disregarding the format for sales, general requirements for storing and transporting medical devices must be observed.
Last year contact-lens vending machines were in the news as they attracted criticism from the medical community, drawing the attention of the regulator. The type and size of lenses is prescribed by an ophthalmologist, while a lens-vending machine offers products without checking the prescription. Due to the risk of sight complications from wearing ill-fitting lenses, the regulator voiced concerns and directed that a warning sign about the need to consult a doctor must be placed on the machine and also warned that future regulations will set a requirement for these machines to be equipped with receipt-reading equipment to be allowed on the market. And online-stores must supply lenses only after the customer provides a doctor’s prescription.
These discussions indicate a growing demand for adapting regulations to current market needs. Moreover, automation of retailing in medical devices can not only be profitable to business but can also tackle social issues such as supplying medicinal products to vulnerable social groups or to remote destinations, and therefore be beneficial to society as a whole.