Many stakeholders in the medical device market are unaware that the current Advertising Regulation Act prohibits the promotion of medical devices intended solely for use by healthcare professionals (commonly referred to as “hospital” medical devices) to the general public.
According to the current interpretation of this prohibition, this group of devices includes, among others, joint replacements, breast implants, and similar devices that are implanted into the patient’s body by a healthcare professional.
These devices cannot be promoted to patients, even though it would make sense for patients to have in this case sufficient information to choose the specific device (specific brand) that suits them.
The Health Ministry, which pushed for this prohibition three years ago, now recognizes its problematic nature and proposes its repeal in a draft amendment to the Advertising Regulation Act.
The explanatory report states: “For several medical devices and in vitro diagnostic medical devices, which are intended by the manufacturer for use by the healthcare professional only or are dispensed on a voucher basis, the patient has the option to choose which medical device or in vitro diagnostic medical device to use, after consulting a medical doctor or other healthcare professional. This is because the patient often bears the cost, either fully or partially, and procures the recommended device himself. Therefore, it is practical to allow the patient to access and review the information provided by the healthcare professional, verify it, and gain a deeper understanding of the available options for his condition in terms of prevention, diagnosis, or treatment. This enables him to make an informed decision based on his financial situation. It is also important to note that the purpose of this information is not solely to support business activities but to enable the patient to make an informed decision and to handle the device correctly and safely. Due to the regulation of access to verified information, the patient may turn to other, unverified sources or unprofessional translations, making him susceptible to manipulation. Therefore, it is in the public interest to change the strict division of provision of information about these devices.”
The draft amendment now needs to be discussed by the government and Parliament. Hopefully, this will lead to the repeal of the prohibition.
