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Food business making B2B medicinal claims

It is a commonly held view of many food businesses that making medicinal claims about their food products are possible provided they are between businesses. This applies to ingredient suppliers and wholesalers based on our experience of the market. Their view over enforcement is that as per the exemptions under the health claims regulation; making representations to health care professionals or B2B also applies to making medicinal claims. These are claims such as those offering to treat or impact a disease or a symptom of that disease.

Under UK law as in the rest of the EU, medicinal products which are placed on the market, are required to have a marketing authorisation (formerly a medicines product licence or PL number) in accordance with The Human Medicines Regulations 2012 (SI 2012/1916)(the "HMR").

As such without prior authorisation, it is an offence to sell, supply or advertise a medicinal product which does not have authorisation. As such if your firm is making medicines claims without a licence then you may be subject to the legal penalties of selling or advertising an unlicensed medicine. In addition, you could be presenting an easy target for your competitors to look to damage your brand by highlighting such non-compliance with competent authorities and self-regulatory organisations.

What is a medicine?

A medicine is defined in Article 1 of Council Directive 2001/83/EEC (implemented by Regulation 2 of the HMR in the UK). The definition is:

"Any substance or combination of substances presented as having properties for treating or preventing disease in human beings

or...

Any substance or combination of substances which may be used by or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis".

If a product is thus viewed to be "presented" and/or "functioning" by action as a medicine it may be classified as a medicine.

Advertising under medicines law

As this is a UK focused article then under Regulation 279 of the HMR which states;

"A person may not publish an advertisement for a medicinal product unless one of the following is in force for the product: -

a) a marketing authorisation

b) a certificate of registration

c) a traditional herbal registration; or

d) an Article 126a authorisation

"Advertisement" is defined in Regulation 277 to cover "every form of advertising whether in a publication or elsewhere." It should be noted that under EU law medicines law "Advertising" is further defined as:

"advertising of medicinal products" shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular:

  • the advertising of medicinal products to the general public,

  • advertising of medicinal products to persons qualified to prescribe or supply them,

  • visits by medical sales representatives to persons qualified to prescribe [or supply] medicinal products,

  • the supply of samples,

  • the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,

  • sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,

  • sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.

As such the term is broad and would capture marketing literature, own website and social media feeds and indeed B2B platforms such as Linkedin.

Case study: Damgaard (C-421/07)

There is a significant volume of evidence over medicines law and indeed borderline issues. However, to keep this new article brief we will cover one of the most famous cases, that of the Journalist Mr Damgaard.

In this case, a rosehip powder product previously viewed as medicinal due to the suggestion it may relieve pain caused by various diseases was promoted on the Journalists website and thus it was viewed that his statements were akin to an advertisement. Mr Damgaard did not receive any remuneration from the owner of the products the simple act of a third party disseminating information about a medical product, including its therapeutic effects may be regarded as "advertising" within that meaning under medicines law.

What to do next?

Of course, you could speak to an expert in food law to ensure you don't make medicinal claims or don't stock a product that maybe medicinal by function without a licence. Alternatively, you may seek guidance from the medicines agency in your Member State and in the UK this would be UK's MHRA and its borderline division.

Mark Tallon