My Lords, I declare an interest in so far that my wife is employed by a university where research is conducted on animals, although she does not do that herself-except on me. I thank my noble friend Lord Carter of Coles for his generous comments. I should let him into the secret that you should make sure that you have enormously able Clerks and committee specialists behind you. In that, I was enormously fortunate. I have many happy memories of my time as chair of the sub-committee. Perhaps my most fond memory is of the refreshment-a Scottish term-that unfailingly appeared, thanks to the noble Earl, Lord Arran, when we went to Brussels. We had a wonderful refreshment to accompany our rather dry sandwiches.
The case for a new directive boils down to one simple argument; namely, that the old one failed. It failed because it was inconsistently applied across the EU. In judging the proposed new directive, the criterion must be whether it meets the test of being able to ensure consistent application across the EU. I wish to concentrate on two areas, authorisation and inspection.
Authorisation has two basic legs-ethical reviews and prior authorisation. Great emphasis rightly has been placed on ethical reviews, but ethical reviews in themselves cannot carry the whole burden of authorisation. There needs to be prior authorisation in order to get full and proper scrutiny of the details of the projects being considered. As my noble friend Lord Carter indicated, during the passage of the evidence that we took, we were particularly concerned that there was a weakening-a dilution-of prior authorisation, with the idea of tacit approval gaining currency. Fortunately, that has been rejected, but quite rightly.
However, it has been replaced by something which I understand is called simplified administrative processes. I have a concern when I read about such things in this context. Obviously, one wants the most simple administrative process available. But is it possible that we are opening the door to the very thing on which we tried to close it; namely, that by simplified administrative processes, inconsistent application will be allowed to rear its ugly head again? That is my concern. It is not necessary or inevitable, but we should be concerned about it and look at it. The test will be to ask when the simplified administrative process becomes an inconsistent application. We need to be alive to that issue.
As my noble friend has already indicated, the original text allowed or required two inspections at each establishment a year. It is quite worrying that that was viewed by many member states as being too onerous, too resource-intensive and too prescriptive. It is difficult to see how you can have an effective inspection regime unless there is a minimum requirement for the number of inspections that will be carried out and a number of inspections are carried out on an unannounced basis. That is fundamental and I am concerned that we seem to be moving away from it by introducing the concept of a risk-based approach. Again, that is something which needs a little more definition and a little more flexibility left in the hands of the domestic operators, if I may put it that way.
The most worrying thing of all is that the number of inspections, in terms of the proportion of unannounced inspections, is described as "appropriate". We all know that "appropriate" is one of the principal weasel words in the administrative lexicon. Can the Minister confirm that zero could be an appropriate proportion in some cases? If so, that is worrying. I am afraid that there is a need for a degree of specificity that the directive fails to deliver.
I turn now to the role of the Commission itself. It has a fundamental role to play in ensuring that although the enforcement processes and mechanisms are the responsibility of member states, to put it bluntly, the Commission ought to be making sure that they do the job by checking that there is an effective regime in place on the ground. During the latter part of the discussions under the Swedish presidency, that was significantly weakened. The amendment from the European Parliament quite rightly would have obliged rather than merely permitted the Commission to undertake control of the monitoring of national inspections throughout the member states, but it has not been adopted. Instead, the Commission will be under an obligation to carry out controls where there is reason for concern. Again, this is a slight weakening of the position. Given the fact that the Commission sees its role as one that ought to be resource neutral-so no more resources are going to be put into this activity-it is difficult to see how the Commission will play a stronger role now than it did in the past, yet in many ways it was the failure of the Commission to play an effective role that lay at the heart of the failure of the 1986 directive.
I make no apology for concentrating at some length on these two points because this is a fundamental issue that lies at the heart of whether the new directive will be as effective as we want. The rest of the detail set out in the draft directive is perfectly acceptable and commands general support but, in these two areas and particularly on inspection, there is a real concern that the very objective of trying to remove inconsistent application will actually bring it back into the system, and therefore the strength and justification for the directive will be fatally undermined.
In closing, I should say that this is not important only to this particular draft directive. It has a more general application throughout the EU. That is because what undermines confidence in the EU among its citizens is when it becomes clear that directives are being implemented in wholly inconsistent ways across the Union. That leads to scepticism and cynicism which undermines the very Union itself. The answer must be for a greater role for the Commission. I understand that some member states may not welcome that, but in this context it is worrying that the Commission itself does not wish to seize the challenge.