From Mr A. G. Kay, MRPharmS
SIR,—As reported in the PJ (November 20, p809), one of the more illuminating aspects of the recent House of Commons Health Select Committee inquiry into the supply of generic medicines concerned the reasons for the suspension of the manufacturer's licence of Regent Laboratories. I believe that, had this information been made available at the outset, the generics industry could have acted differently to the benefit of the supply situation.
Gearing up of production is not an overnight task, particularly if the acquisition of additional machinery is involved. The general industry assumption on Regent, given the lack of official comment, was that Regent would return to production sooner rather than later. The industry response was thus to increase output where capacity was available and to alter production schedules to address the changed circumstances. The Department of Health has confirmed that these steps did improve output and availability but did not completely resolve the difficulties. Problems have lingered on products where Regent previously held a high market share.
The nature and scale of the good manufacturing practice deficiencies now revealed in the Department of Health's evidence to the Select Committee make it obvious that Regent's absence would be prolonged. The earlier availability of this information might have persuaded manufacturers to invest in new capacity. It must be borne in mind that any return on this investment depends upon market conditions when the capacity comes on stream. It would be pointless to make the investment if at the time the opportunity had gone.
Two considerations for the future come to mind. First, a mechanism should exist for publicising in a timely manner detailed information from regulatory authorities that has the scope materially to affect the supplies of one or more medicines to the National Health Service. Secondly, I hope that the forthcoming OXERA study into the supply of generics to the NHS will consider what incentive can be provided to manufacturers to further develop capacity, given that no such incentive exists at present.
Andrew G. Kay
Managing Director, Approved Prescription Services Ltd