Pharma transition: European court ruling allows medicine brand names a 2022 claims exemption

By Emma Jane Cash

- Last updated on GMT

Pharma transition: European court ruling allows medicine brand names a 2022 claims exemption

Related tags: Health claim, European union

Medical products looking to transition to the food supplements space could benefit from exemptions to health claims regulations until 2022, after a court ruling allowed current rules to be extended.

Within the 1924/2006 nutrition and health claim regulation, a buffer period was created for trademarks and brand names which implied a banned health claim but existed before January 1st 2005.

Rather than issuing a straight ban, names and trademarks that implied a banned health claim but were in use before 2005, have been allowed until 2022 to either build evidence and attain an EFSA approved claim or change their branding.

Until now, however, this rule has only applied to trademarks and brand names in use for foods and food supplements – with a history of use for pharmaceutical and medical trademarks and brand names excluded.

The new European Court of Justice (ECJ) ruling extends this use to include these products, and could allow medical products to transition to the food supplement space with existing trademark names, according to Luca Bucchini, food risk scientist and managing director of Hylobates Consulting. 

He told NutraIngredients the ruling has been “overlooked in its importance.”

Court ruling

In its ruling the ECJ said that medical brands looking to transition in to the food supplements space can benefit from existing exemptions from health claims legislation until 2022 - providing they were implemented in the EU before 2005.

The ruling came after proceedings over bach flower remedies marketed under the name “Rescue” by German company, Nelsons GmbH and Ayonnax Nutripharm GmbH.

The product was originally marketed as a medicine until 2008, after which it was marketed as a food.

“One could say that the years before 2008 did not count as the claim was not used on a food, and the name did not qualify for the exemption,” ​said Bucchini.

“The court, instead, said that – as long as the composition stayed the same – the period before 2008 was to be taken into account, and that – in essence – the name “Rescue” could benefit from the exemption,”​ he explained.

Bucchini added that due to the composition of the product, it would be very difficult for it to be granted an authorised health claim ordinarily.

The ruling also means that food supplements with alcohol levels above 1.2% can use claims if within the scope of the transitional provision, without needing to provide scientific evidence to back the use of such terms.

However, products will still need to comply with EU food laws to prevent consumers from being misled.

Transition trend

Bucchini said the ruling is also significant as it facilitates the transition of some medicines to food supplement status.

“This has been an observable trend across the EU, including products with botanicals and vitamins, as businesses seek to enjoy the flexibility offered by food supplement law and consumers are offered less expensive products with the same composition,” ​he added.

Bucchini commented that ruling should ultimately convince more businesses to make the transition from medicine to food supplement for borderline products, and to invest in human trials to back up health claims.

Related topics: Regulation & Policy

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