Norgine is celebrating victory in a landmark case which has seen a German court rule that Novartis’ Hexal subsidiary has been distributing laxatives as medical devices, thus avoiding the scrutiny that selling them as pharmaceuticals would entail.

Norgine has obtained a court ruling preventing further distribution of two laxatives containing macrogol, the active ingredient found in the firm’s chronic constipation treatment Movicol. According to the ruling, Hexal and Cassella Med were illegally distributing their products, Macrogol Hexal and Laxatan respectively, as devices even though they need approval as medicinal products.

The ruling noted that all medicinal products “must undergo a thorough review of the product-specific dossier to ensure their quality, safety and efficacy. By incorrectly classifying their products as devices, Hexal and Cassella Med had avoided this important product specific scrutiny by the health authorities”.

The specialty pharmaceuticals firm, which was set up in Prague over 100 years ago but is now headquartered in Amsterdam, said that “after considering all of the evidence and consulting an independent professor of pharmacology as an expert”, the court said the laxatives were “clearly medicinal products within the scope of the law” and ruled that they can no longer be sold by Hexal and Cassella Med without a pharmaceutical marketing authorisation.

A point of principle
Norgine’s chief executive Peter Stein told PharmaTimes World News that his firm had brought the case as “a point of principle”, noting that some of the directives concerning devices and drugs is somewhat contradictory. “The borderline is blurred<” he acknowledged, but Hexal’s defence in the case did not stand up, he believes.

There is a problem of definitions and one interpretation of European directives could classify medical devices simply as articles which are intended to be used for a medical purpose. However, Mr Stein and the Hamburg court believe that any substance that has a pharmacological, immunological or metabolic action is a medicinal product, and to suggest otherwise is disingenuous.

He said: “I am surprised that companies of such standing did not comply with the processes required for a medicinal product which are there to ensure a detailed, independent, assessment of the safety, efficacy and quality of products before they are made available to patients.”

It has taken two years for Norgine to win this case and during that time, Hexal’s and other unlicensed products have accounted for 25% of sales in this market in Germany, ground that Norgine is confident of clawing back. Nevertheless Movicol has been driving sales growth for the company elsewhere in Europe. Group sales last year reached 188 million euros, the 20th consecutive year of double-digit growth.

Despite the Amsterdam headquarters, Mr Stein refuses to pin the firm down as being headquartered in one particular country and describes Norgine as a truly pan-European organisation. He says that the privately-owned group has a single integrated culture, with 380 sales and marketing staff, that covers all of the Old Continent, making it the perfect ‘one-stop shop’ for firms from abroad, notably from the USA, who want a partner capable of developing, manufacturing and marketing a drug.