§ Mr. Ashleyasked the Secretary of State for Social Services (1) on what grounds he proposes to make the clinical testing of drugs easier; and if he will make a statement;
(2) what additional safety precautions he intends to take after his proposed simplification of clinical testing of drugs;
155W(3) what is his estimate of the number of drugs and companies that will be affected by the proposed changes in clinical testing of drugs;
(4) what is the estimated annual saving to the pharmaceutical industry of the proposed new system of clinical trials;
(5) what is the estimated number of people who annually take part in clinical testing of drugs; how this number will be affected by the proposed new scheme; and which drug or drugs he has in mind.
§ Dr. VaughanA copy of the Department's consultation letter has already been placed in the Library of the House, but since it contains the answers to the right hon. Gentleman's questions as to the purpose of the proposals and the safeguards, I reproduce it below.
The benefit to the pharmaceutical industry is not easy to quantify, as the major advantage of the new scheme will result from the reduction of unproductive time spent awaiting the outcome of the application. There will, however, be some direct financial advantage from savings in the reproduction of fewer copies of a smaller quantity of data.
During 1979, the last full year for which figures are available, 107 applications for clinical trial certificates were received—compared with 153 in 1972. All of these applications would have been potential candidates for the exemption scheme. If the proposals are implemented, and as a result there is a move back to conducting trials in this country rather than overseas, some increase in the number of applications is anticipated but this cannot at this stage be quantified.
The number of trials covered by certificates issued in 1979 was 97. The number of patients involved in a sample of these trials ranged from 30 to 860, the average number being 180. However, since not all the patients involved in trials take the new drug—some being given placebos or comparators—accurate estimates of the number of patients actually taking the new drug cannot readily be made. Again, any increase will depend on the extent to which the proposals succeed in encouraging development and trials in this country.
The consultation letter reads as follows: