Clinical Trials (Hansard, 21 January 1994)

§ Mr. Sackville

As part of the deregulation initiative task forces were set up to advise Ministers on priorities for the repeal of simplification of existing regulations so as to minimise the costs on business. The chemicals and pharmaceuticals deregulation task force identified clinical trial authorisation as an area of regulation that might be simplified.

Number of NHS sight tests paid for by financial year
Regional health authority	1984–85	1985–86	1986–87	1987–88	1988–89	1989–90¹	1990–91¹	1991–92	1992–93
Northern	592,050	599,980	627,570	697,970	740,420	336,840	275,590	314,710	345,890
Yorkshire	722,730	730,350	752,340	843,200	906,140	403,450	311,630	368,240	408,800
Trent	912,550	950,010	980,900	1,095,300	1,166,700	514,960	406,780	483,640	528,080
East Anglia	380,580	408,760	422,030	468,670	493,110	191,460	159,900	194,320	222,090
North West Thames	828,710	853,400	862,330	943,670	1,016,600	384,370	290,210	354,260	397,350
North East Thames	894,530	914,430	943,440	1,027,970	1,054,960	468,230	361,430	440,270	494,040
South East Thames	734,580	761,800	803,560	875,140	927,760	385,600	296,850	359,930	406,730
South West Thames	625,840	648,680	652,880	710,560	735,310	283,000	220,360	267,800	295,330
Wessex	619,230	645,870	697,710	739,430	806,250	343,160	257,990	312,010	348,770
Oxford	489,640	515,570	546,070	607,850	657,320	221,480	205,650	247,540	276,510
South Western	761,550	785,870	826,630	917,220	1,017,480	418,050	324,470	402,870	435,370
West Midlands	1,096,610	1,154,760	1,188,830	1,314,230	1,438,370	633,980	488,220	573,960	640,530
Mersey	449,750	465,660	473,640	531,580	562,130	259,840	204,910	246,340	271,730
North Western	773,810	810,630	837,510	922,020	970,270	435,340	349,690	413,550	456,360
England	9,882,150	10,245,780	10,615,430	11,694,800	12,492,830	5,279,750	4,153,660	4,979,420	5,527,590
Wales	570,860	600,710	626,590	697,280	733,470	292,060	271,170	332,240	372,590
Scotland	884,730	913,900	965,160	1,098,150	1,168,610	466,130	418,130	477,930	521,440
¹ From 1 April 1989 NHS sight tests were restricted to certain eligible groups in the population.
The figures for 1989–90 included 1.82 million sight tests paid for in 1989–90 but conducted in 1988–89 under the previous scheme. The remaining 4.22 million were conducted and paid for in 1989–90 which do not constitute a full 12 months of the new scheme. The figures for 1990–91 which do represent twelve months under the new scheme, are not therefore directly comparable with those for 1989–90.

894W

The Medicines Control Agency of the Department of Health is currently consulting on proposals to simplify the operation of the clinical trial exemption—CTX—scheme. Schedule 2 to the Medicines (Exemption from Licenses) (Clinical Trials) Order 1981 lists the areas about which the Licensing Authority must be informed forthwith if the supplier proposes to make changes to an approved CTX. It is proposed to ease these requirements by removing the need to notify the Licensing Authority of changes of investigators and to introduce a usage guideline. The usage guideline will allow the supplier to supply the product for use in a new clinical trial or an on-going clinical trial without the need to notify the Licensing Authority providing that the new conditions of the trial are within the scope of the information contained in the usage guideline. This will allow pharmaceutical companies to carry out clinical trials within defined criteria without the need to notify the Licensing Authority of each and every change before proceeding. Any changes that are outside the terms of the usage guideline will still have to be notified to the Licensing Authority as currently happens.

The consultation will close on 31 January. We will consider carefully the comments received and decide how to carry forward these proposals.

Copies of the consultation letter, MLX203, will be placed in the Library.