The issue of mail-order dispensing of medical devices has been an evergreen in recent years. While mail-order dispensing of prescription medicines is prohibited, it is allowed for medical devices with some minor exceptions. These exceptions are devices prescribed on a so-called safety voucher and include copper IUDs, sleep-disordered breathing devices, injectable implantable devices and hearing aids.
However, there are also a number of question marks associated with mail order and it is the responsibility of the Ministry of Health and the State Institute for Drug Control to find reasonable and workable solutions in the application of the current legislation. One of the problematic aspects is the subsequent transport from the mail-order dispenser to the customer, i.e. to the patient. For the purposes of this article, we will leave aside the safety aspects relating to compliance with established requirements, e.g. temperature or humidity. Instead, we will focus on the competitive struggle of mail-order dispensers, which has recently included advertising of free shipping as a patient benefit, who chooses a particular dispenser for the dispensing of a prescribed reimbursable medical device. This is a relatively common practice, but at first glance it offers the question of whether such a practice is ethical and, above all, legal for medical devices reimbursed by the public health insurance system.
In this context, we are pleased to share with you a fresh opinion from the Ministry of Health. The ministry states on this issue that "to advertise transport free of charge to a mail-order of medical device in the form of an advertisement could be considered a violation of Article 32(4) of Act No. 48/1997 Coll., on Public health insurance (...) the situation described could therefore be considered as an offer advantage in connection with the dispensing of a medical device covered by the health insurance ...'. It is therefore an illegal commercial practice for medical devices reimbursed from public health insurance, which should be avoided.
Author: Jakub Král