Convergence is all around us. The traditionally well defined different groups of medical devices, medicinal products and biotechnology products are more and more moving closer and closer together to form a genuine ‘regulatory continuum’ rather than well-defined regulatory silos. This concept is illustrated well in the European Commission’s well-known ‘bridging the gap’ picture coined when the advanced therapies regulation was in the legislative process (however, if you are more medicinal products centered like the EMA, your picture would look more like this). Products designed for a particular therapy more often turn out to be borderline products, or rather, ‘border area’ products. This, of course, has consequences for the design of a product. Rather than designing a product assuming from the start that it fits a particular regulatory silo, companies should design and research with the end in mind: what type of product do I want to make, and for what reasons? Will it be reimbursed – and if it is not, will my business model still work? Better think about these things when you can still change direction.
Important reasons can be company strategy. If a company seeks to bring its first product to the market quickly with relatively low investments, it should definitely not design towards a medicinal product or an advanced therapy medicinal product. In the first case the burden of clinical proof is very high (and very costly and time consuming to meet), while in the second case the clinical burden of proof may not even be clear so you have to spend additional time in a scientific advice procedure to help the authorities establish a regulatory frame of reference to evaluate your product by. Medical devices are quicker to the market, but have their own problems, like a short life cycle that requires a relatively quick recoup of investments for a business model to work.
In all cases there is uncertainty about what the legal and regulatory horizon will look like in the short, middle and long term. Because if there is one certainty in the field of life sciences, it is that the rules are constantly changing.
These and other questions were discussed in a seminar I organized with Kempen & Co (a life sciences investment bank), DNage (a life sciences company) and JPS Advocatuur (lawyer and regulatory consultancy) at my law firm last 15 september, and this was my presentation.