Thinking about the drive for personalised medicines (nutcrackers rather than sledgehammers), and given the increasing prevalence of advanced therapy medicinal products, companion diagnostic medical devices are likely to make an appearance in the care pathways of an increasing proportion of patients. It is therefore a bit weird (sorry, not a legal term) that the current UK regulations governing medicines and medical devices do not mention companion diagnostics.
The consultation on changes to UK medical device regulation contained specific questions on companion diagnostics, and the Government's published response to that consultation provided some useful indications about what is coming. Having reviewed the response to the consultation, the Government has pointed towards the following:
The Government's responses relating to IVDs indicate some reform themes that will be relevant to companion diagnostics and other IVDs, including:
The Government has said it will look at the EU IVDR. It has also generally proposed to take international approaches and standards into account. However, reading between the lines, it has been reluctant to commit to aligning to anything or any territory in particular. The Government's response shows a general preference for making the requirements clear in robust legislation rather than leaving too much either too rigid standards or to more flexible (but perhaps less predictable) regulatory guidance. To date, the MHRA has published precious little on companion diagnostics, so, at the very least, we can expect some legislation and some guidance.
For a product that is a combination of a medicinal product and a medical device in one item, the regulations in the UK and EU have some provisions that attempt to clarify what requirements apply and remove the full application of both regimes. This would not work for companion diagnostics because the diagnostic and its related medicine are separate items. But, the indication from the MHRA is that a risk-based proportionate approach should become the norm.
There are moving parts in the UK regulatory environment, but if you put them together, the direction of travel is clear. The Government and NHS believe in the power of diagnostics to improve healthcare in the UK; major reforms are in progress, some of which will have a significant impact on companion diagnostics; and, although the UK will look to the EU and international approaches, it is keen to stand out.
The next thing to look out for is the 'IVD Roadmap' and the stakeholder discussions on the anticipated future core regulations. If the Government's roadmap is anything to go by, 2024 will be a full and exciting year.