The Polish Ministry of Health is currently working on new draft regulations on medical devices. According to plan the new law is set to come into effect in the third quarter of this year.
The draft was set into motion firstly as a required adjustment of Polish regulations to the Regulations of the European Parliament and the Council no. 2017/745 and 2017/746, and secondly as a completely new act which provides a decidedly wider scope of important provisions crucial to the medical devices market.
Why is the new draft necessary?
The objective of the new draft is to regulate the advertising aspect of the medical devices market, which was visibly neglected in regulations introduced in 2010.
This omission led to considerable freedom where marketing activities are concerned, and made possible the marketing of medical devices incompatible with accepted standards.
In order to acknowledge gaps in the existing regulations and to provide practical guidance, in some instances, analogies to the provisions of directive for medicinal products have been drawn.
Catching up to other EU countries
The Regulations on Medical Devices Act of 2010 has needed updating for some time now, especially considering how much more precisely the matter of advertising medical devices is regulated in other EU countries.
For example, the Association of British Healthcare Industries (ABHI) has had a Code of Business Practice since March 2016, the Netherlands issued the OTC Code in 2015, in Germany they must abide by the Medical Treatments Advertising Law from 1994 (and then updated in 2013) with the additional assistance of the Association for Fair Advertising of Medical Products, and in France there is a Pharmaceutical Products Advertising Law no. 94-43 of 18 January 1994.
New EU regulations
The new European Union regulation (MDR 2017/745) will take effect in spring 2020. This means that the market access framework for all member countries of the European single market will change significantly.
The aim of the new regulation (MDR 2017/745) is to eliminate any shortcomings in the old directives as well as manage the rapid evolution of science and technology in the field of medical devices.
In order to achieve that goal, the new regulations introduced a number of key improvements, such as:
- conformity assessment to the requirements with a declaration of conformity
- an "implant card" which contains information about implanted medical devices for a patient
- a comprehensive EU database on medical devices and a device traceability system based on Unique Device Identification, or the reinforcement of the regulations on clinical evidence (including an EU-wide coordinated procedure authorising multi-center clinical investigations).
The Polish take on the issue
The Polish draft includes a handful of solutions to the problems at hand. Firstly, the new draft includes a requirement for advertising to contain information on the:
- name of the device
- anticipated usage
- contra-indications
- possible risks connected with the use of the device
- the manufacturer and authorised representative (if appointed).
The above information will need to be visible and clear.
Secondly, public advertising will need to include a warning similar to the one used in commercials for medicinal products:
"Before using, read the product instructions and label or consult a physician (as this device may not be suitable for you as for devices with contra-indications).
It will need to be clearly legible in Polish, last at least eight seconds (audio-visual) and cover at least 20% (audio-visual) or 10% (visual) of the area of the advertisement."
Additionally, the draft contains a list of forbidden advertising features (analogous to those that are now binding), as well as the ability for the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to order:
- the remedy of observed breaches
- the cessation of publications, presentations or advertising that are not compliant with law
- publication of the decision in places or via mass media where the advertising appeared, or publication of a corrigendum.
Furthermore, the draft states that only a manufacturer or authorised representative may promote medical devices, and penalises the breach of advertising regulations with a financial penalty of up to PLN 2 million (approximately EUR 500,000).
A flawed improvement
Despite all the changes introduced in the new draft, there are some very questionable omissions in the document as a whole. The project fails to distinguish between advertising medical devices among professionals and the public, suggesting that regulations are only designed for the mass consumers.
A legal definition of "advertising" is also absent, leaving the exact meaning of the term ambiguous and open to interpretation.
Then there are the wide catalogue of financial penalties proposed in the draft, which run as high as PLN 5 million (approximately EUR 1.25 million).
Final remarks
Medical devices have become an extremely important component of the healthcare sector due to both their impact on individuals' health, as well as the large healthcare expenditure for medical devices. The overarching purpose behind revising the existing legal framework for medical devices is to improve health and safety aspects regarding medical devices.
With its aim of applying the same rigorous standards to advertising as are present in the other aspects of the medical devices field, the new draft definitely represents a step forward. The solutions it puts forward are bound to improve the monitoring aspects involved when a new medical device is introduced to the market.
However, the previously mentioned inadequacies – the absence of a legal definition of "advertising" and the lack of distinction between the professional and public market – are oversights that should not have occurred. These shortcomings provide an easy loophole which allows the manufacturers and vendors to circumvent the regulations.
In our view, medical devices that are subject to health insurance reimbursement, in whole or in part, should not be advertised to the general public unless they carry a low risk to health and are included in a list drawn up by the Ministry of Health.
What's more, advertising for certain medical devices (whether reimbursed or not) which carry a significant risk for human health and are included in a list drawn up by the Ministry of Health should be subjected to a prior approval.
