From Borderline to Border Area
Traditionally the borderlines between different categories of regulated products (medicinal products, medical devices, food, cosmetics, etc.) have been looked at as strict lines. More and more however it becomes evident that although the binary decision whether a product is on one side or the other is complicated because science can support a border area in which the same product may be classified under different regimes, depending on what science can support in the particular case. I am writing “can support” because even big pharma companies recognize that our understanding of the human biochemistry is still very limited, as Mr Niese, Head of Development at Novartis, explained in a lot of detail at the last DIA Euromeeting. This, and the increasing convergence of products, gives companies a significant room to manoeuvre with positioning of their products, as was recognized by Ms De Vries of the Dutch Ministry of Health at that same session at the DIA Euromeeting (Session 1101, presentations can be downloaded as of today by DIA attendees).
I myself presented on the underlying EU Court case law on the subject, which, as you will see from my presentation, is surprisingly modern and flexible in that it proceeds from the fact that the determining factor for application of borderline criteria should be what science as it stands can support with respect to a particular product. That means that application of the hierarchy clause in the Medicinal Products Directive (art. 2 (2)), is not as automatic as is often assumed. Under the recent case law of the EU Court, there can only be doubt as to the regulatory regime if the science supporting a particular product is inconclusive.
As a result, companies have on the one hand perhaps greater insecurity about what regulatory regime governs their products and they may be prone to at claims that the product has been admitted under the wrong regime and although governments are making a push at EU level to facilitate approval of combination products there are also statements made by regulators that the Recast of the EU Medical Devices Directive will address borderline problems one way or the other (although we won’t be sure until the proposal is published beginning of 2012). On the other hand however companies have greater flexibility and increased choice in the regulatory regime that they choose to make their product available under. There may be important strategic reasons to choose one regime or the other, e.g. reimbursement possibilities, time to market, etc. This is a good opportunity as long as a company has the scientific proof to support it.