We are often asked what are the penalties in Europe for breach of advertising laws for a medical device or in vitro diagnostic (IVD). Even within the EU, enforcement is a matter for national law and national regulatory agencies. Advertising of medical devices is mentioned in Article 7 of the EU Medical Device Regulations 2017/745 or In vitro Diagnostic Medical Device Regulations 2017/746, but is often also the subject of separate national legislation. Actions can be instigated by or through the acts of competitors. If they want to hit hard and have the resources, competitors will take action in several countries. This can require as little as a letter to a regulator. Manufacturers might expect therefore for there to be multiple actions and multiple sanctions.
Penalties can be administrative fines, criminal fines, but also damages for unfair competition from competitors in some civil law countries. A summary of sanctions and penalties that might apply in different countries for breach of advertising laws for medical devices and IVDs is set out below.
Dealing with such claims can be expensive and time-consuming, taking up valuable resources. This makes it worthwhile for companies trying to comply with local advertising laws, with verification of all claims by their legal and clinical teams. These reviews might be used to build a claims bank which facilities future reviews. This, combined with the provision of clear guidance for teams developing advertising and marketing materials for each country, will go a long way to avoiding the imposition of sanctions. It will also mean that if the company complains about another manufacturer's advertising, they are less likely to suffer from retaliatory action for their own advertising.
| Country | Administrative fines and sanctions | Civil and commercial sanctions (unfair competition) | Criminal sanctions |
|---|---|---|---|
| Austria | Fine of up to EUR25,000 for a single occurrence, and up to EUR50,000 for recurrence. | Order for removal of the advertising material may be ordered, and/or an injunction may be brought to prevent the publishing of the advertising material. | None. |
| France | Fine of up to 30% of the turnover relating to the product or
product group concerned, up to a maximum of EUR1 million. In addition, a daily penalty of EUR2,500 per day may be imposed for failure to comply with the requests of the competent authority. Where the disputed advertising relates to a reimbursed medical device, a ban on the advertising may also result in a financial penalty being imposed on the company or distributor concerned by the Economic Committee for Health Products(Comité économique des produits de santé, CEPS). The amount of the penalty may not exceed 10% of the turnover, tax excluded, achieved in France by the operator or the distributor in respect of the products for which the advertising has been banned, during the six months preceding and the six months following the date of the advertising ban. Ban on the advertising concerned, after the ANSM has been given the company formal notice. Publication of the sanction on the ANSM's website. |
Failure to comply with the applicable regulations can lead to unfair competition cases being brought before the commercial courts, punishable by damages suffered by competitors bringing such cases. | Yes, fines of one year imprisonment and EUR150 000 for individuals and EUR750 000 for legal entities may be imposed for specific breach to French advertising provisions. |
| Germany | The administrative authority may impose a fine up to EUR30,000
according to the German Medical Devices Act and EUR50,000 according
to the German Drug Advertising Act. Up to EUR100,000 fine, or EUR300,000 in certain special cases for violation of the German Act against Unfair Competition. |
Competitors or particular competition associations may send out
a cease and desist letter and, if necessary, apply for a
preliminary injunction or file a lawsuit. In addition, it is
possible to claim damages under particular requirements. The competent administrative authority may issue particular orders, eg cease and desist orders. |
Yes, up to one year imprisonment and/or a fine, according to
the German Medical Devices Act as well as the German Drug
Advertising Act. Up to two years' imprisonment and/or a fine in certain special cases for violation of the German Act against Unfair Competition. |
| Italy | The Ministry of Health may issue fines in the range of EUR2,600
to EUR15,600. Order for immediate cessation of the advertising. |
The Italian Competition Authority may issue fines in the range
of EUR5,000 to EUR1 million. Publication of decisions by the Italian Competition Authority. Competitors can also claim damages, and cease-and-desist orders may be granted. |
No. |
| Netherlands | Supervisory authorities have extensive administrative powers and can impose an administrative fine up to EUR50,000. In addition, administrative sanctions can include orders to recall product and/or ban the advertising materials, and/or to issue a press release. |
Competitors can initiate summary
proceedings or proceedings on the merits based on unfair
competitions claims. In these proceedings, competitors can for
instance request and/or claim:
|
Criminal fines for individuals up to EUR90,000, and for legal
entities/companies fines up to EUR900,000 or 10% of the revenue of
the company. Sanctions may also include disqualification from practising the profession and imprisonment for up to four years. |
| Poland | Up to PLN2 million. Order to remove offending advertising materials and to cease further dissemination. Publication of the decision in the media. |
In case of an act of unfair competition, certain civil claims
can be brought before the commercial courts. Potential sanctions
include:
|
None. |
| United Kingdom | The Medicines and Healthcare products Regulatory Agency (MHRA)
may issue potentially unlimited fines, and also compliance
notices. The Association of British HealthTech Industries (ABHI) may issue a formal reprimand, recommending expulsion from the ABHI, as well as an order to pay the costs of the ABHI panel. The Advertising Standards Authority (ASA) may refer ongoing non-compliance to Trading Standards, who can seek criminal prosecution or a confiscation of assets. |
The Competition and Markets Authority (CMA) will soon have powers to fine companies up to 10% of global turnover. | Unlimited fine and/or six months' imprisonment. |
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
