Performance of the MHRA
The UK’s medicines regulator—the MHRA—rightly has a strong and positive reputation amongst its peers in the EU for its contribution and expertise. Indeed, it is one of only four or five national medicines regulators to bear the brunt of work on applications for pan-European marketing authorisations, of which the generic sector is the greatest user.
We congratulate the Agency on bearing more than its fair share of the European load. But the disparity between supply of regulatory resource and demand for European approvals for generic medicines means that the industry has to wait up to two years just to get a slot for making an application for the marketing authorisation that it rightly needs before launching a new generic.
The Agency’s European work has also led to long delays in dealing with national procedures. These delays can result in generic medicines not being launched at the time an original brand loses its patent protection, leading to a loss of income for the generic industry and a loss of savings to the NHS.
This is coupled with high fees charged by the MHRA which do not incentivise innovative or efficient working, or recognise the contribution that generic medicines make to the sustainability of the NHS. We are working with the Agency to improve the situation in the interests of all concerned.
