Draft Law on the amendment and supplementation of Law No 95/2006 on healthcare reform
Products Concerned
Advertising for:
- Medical devices regulated under Council Directive 93/42/EEC concerning medical devices;
- Active implantable medical devices regulated under Council Directive 90/385/EEC relating to active implantable medical devices;
- Medical devices for in vitro diagnosis regulated under Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices.
A new field is being regulated: advertising for medical devices, following numerous referrals from certain competent authorities monitoring the legality of advertisements for products intended for the public (for example: the National Authority for Consumer Protection [ANPC], the National Audiovisual Council of Romania [CNA], etc.), noting the lack of a legal framework (the provisions of Articles 924 and 931 to 936 of Law No 95/2006 on healthcare reform do not govern which acts constitute infractions regarding the advertising of medical devices, or the sanctions applicable in respect of these infractions).
It thus provides that the National Agency for Medicines and Medical Devices (NAMMD) is the competent authority regarding the evaluation and endorsement of advertising materials and any other kind of publicity for medical devices. Advertising should be understood as any means of delivering information through direct contact, as well as any form of promotion intended to encourage the distribution, sale or use of medical devices.
It is forbidden to advertise a medical device when the way in which it fulfils its proposed purpose cannot be backed up with clinical evidence, or to advertise specialised medical devices that should only be used with medical guidance.
Similarly, it provides that any advertising for a medical device must encourage rational use of the medical device by presenting it objectively and without exaggerating its properties; it must also not be misleading.
At the same time, non-criminal sanctions are introduced for failure to comply with the provisions regarding the advertising of medical devices.
Brief Statement of Grounds
At present, advertising for medical devices is unregulated, which could affect the patient’s right to be correctly informed regarding these products. Due to the non-existence of any endorsement and control system for advertising materials for medical devices, the public is exposed to some particularly serious health risks.