My Lords, I would like to support Amendments 10, 12, 74 and 75, in the name of the noble Baroness, Lady Cumberlege, and in so doing recognise the very powerful and thoughtful interventions by many noble Lords on this group.
It is clear that there is really no dispute in recognising that safety, availability and attractiveness are all important elements in securing, promoting and safeguarding public health. The question simply is whether safety should be given priority. The report of the noble Baroness, Lady Cumberlege, is clear in having identified, in a
number of specific instances, why the system failed because safety was not at the forefront of the obligation and, in particular, the regulatory obligation.
The question is how best to ensure safety going forwards when as a country we have the opportunity to establish a new regulatory environment for medicines, medical devices and veterinary medical products. The four amendments in the name of the noble Baroness, Lady Cumberlege, and other noble Lords provide the opportunity to explore the Government’s thinking in this regard.
Why would Her Majesty’s Government not prioritise safety over the other two important objectives? The noble Lord, Lord O’Shaughnessy, in his thoughtful intervention, has suggested that there may be potential for patients to be denied experimental or targeted interventions as the result of inadvertent limitation by way of the regulatory regimen. At present, of course, we have the capacity to intervene with such medicinal products to ensure that, where it is appropriate, sensible and in the interests of the individual patient, interventions can be provided with less extensive clinical evaluation. However, as a general rule, for the entirety of the population where there is broad and relatively unfettered prescription, surely it is right that fellow citizens should expect that interventions—medicinal or medical devices—that are available to their clinicians for a prescription in their individual cases are, first and foremost, safe.
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In that regard, could the Minister explain where the anxiety is in terms of giving safety a priority above the other two important elements, which are availability and attractiveness? Is it because clinical trials methodology—[Inaudible.]