EU court decides another borderline case regarding “pharmacological effect”

Een bijdrage van Erik Vollebregt, Axon Lawyers.

Last Thursday the EU Court rendered judgment in the mouthwash case, C-308/11 Chemische Fabrik Kreussler vs Sunstar [red. LSenR 257]. The judgment immediately brought one of my favorite Yogi Berra quotes to mind:

“You’ve got to be very careful if you don’t know where you are going, because you might not get there.”

This statement is spot on for this much anticipated judgment, which, as I already predicted, did not turn out as interesting as one had hoped because the EU Court does not have the competence to dive deep into the facts and resolve a preliminary reference on the facts. I predicted the court was very likely not going to give a useful answer to this question that would shed more light on how to answer the scientific questions as to how to demonstrate the absence or presence of a pharmacological effect and that is more or less what happened.

What was this about again?

We are dealing with an indirect pharmacological effect situation. As the court describes the facts:

“It is apparent from a monograph dating from 1994, on the properties, effects and possible applications of chlorhexidine, that mouthwash solutions containing a chlorhexidine solution of 0.2% reduce salivary bacteria and, in this way, have a therapeutic or clinical effect in cases of gingivitis.”

Kreussler argued that as a result of this indirect effect, there was a pharmacological effect that caused the mouthwash to be a medicinal product.

So what do we know more after this judgment?

In my opinion, not that much unfortunately.

First, we know now that a court can use MEDDEVs and other Commission guidance documents to resolve a problem of interpretation, and that a national court should stay within the boundaries of the law (i.e. the Medical Devices Directive or any other applicable directive) when interpreting such guidance. And we know that you should preferably use the relevant guidance, so you should use cosmetics guidance to resolve a cosmetics borderline dispute. So far nothing new or even remotely exciting.

Secondly, this case looked interesting because of its potential to really learn something about the interpretation of the concept ‘pharmacological’, one of key concepts determining the borderline between medical devices and medicinal products (as well as between medicinal products and other products). As you know, the last paragraph of the definition of medical device in article 1 (2) (a) of the Medical Devices Directive relies on it to demarcate devices and medicinal products. The question posed to the court was a rather technical one: the German judge dealing with the dispute asked whether

“for a substance to be regarded as exerting a ‘pharmacological action’ within the meaning of that provision, it is necessary for there to be an interaction between the molecules of which it consists and a cellular constituent of the user’s body, or whether an interaction between that substance and any cellular constituent present within the user’s body may be sufficient.”

Given the fuzziness and apodictic nature of its case law on the demarcation of medicinal products against other products so far the EU court was not going to allow itself to be painted into a corner by limiting the concept of pharmacological mode of action only to products that directly impact on the human biochemistry because, in the court’s words:

“that it is not apparent either from Directive 2001/83 or from the guidance document on the demarcation between the Cosmetic Products Directive and the Medicinal Products Directive that the molecules of the substance in question must necessarily interact with a human cellular constituent in order for it to be regarded as a substance which exerts a ‘pharmacological action’.”

and that

“a substance the molecules of which do not interact with a human cellular constituent may nevertheless, by means of its interaction with other cellular constituents present within the user’s organism, such as bacteria, viruses or parasites, have the effect of restoring, correcting or modifying physiological functions in human beings”

Further on in the judgment the court carefully repeats its case law that the effect must be “appreciable” and that this must follow from “an assessment, with due diligence, of each product individually, taking account, in particular, of that product’s specific pharmacological, immunological or metabolic properties, to the extent to which they can be established in the present state of scientific knowledge”.

For the effect to count as pharmacological we already knew that we must look at (as the EU Court dutifully repeats for us in the judgment):

1. an effect, which must be appreciable
2. all the characteristics of the product, including, inter alia, its composition, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail
3. composition – including its content in active substances
4. use as intended

What we know more now is that we should still look at all of the above, but that the effect does not necessarily need to be direct (“ it is not necessary for there to be an interaction between the molecules of which it consists and a cellular constituent of the user’s body, as an interaction between that substance and any cellular constituent present within the user’s body may be sufficient”).

The net result is a careful partial falsification of the concept “pharmacological” by the court by explanation of ‘what you cannot a priori exclude it to include’, but still no actual explanation of the concept that a scientist, regulatory professional or lawyer can really work with in day-to-day practice. Of course, falsification is sound scientific reasoning and yes, it does add some knowledge, but we would have liked more guidance from the court. However, with the other pending cases a pattern starts to emerge that will help manage the borderline of the medical devices regulation better. I will of course revisit this when judgments in the other cases have been rendered. Future developments in legislation will not change this I expect, because as far as I know from what is going on behind the scenes neither the definition of medical device nor that of medicinal products seem about to change. So, to get back to Yogi Berra: the EU Court took the fork in the road when it arrived at it, but we still don’t know where we are going- and if we will ever get there.