My Lords, I express at the outset my gratitude to many organisations, including the BHF, PSA, Birmingham University and of course our own House of Lords Library for their insightful briefings. The Bill seeks to keep high standards and safeguard patient safety as paramount considerations and to propel the UK as a standard bearer of new innovations. Like other noble Lords, I am uncomfortable about the extensive range of delegated powers afforded to the Government over medicines and medical devices and I would have liked, given time, to have elaborated
further on the implications of Clauses 2, 4, 15 and 16 on the regulatory requirements during public health emergencies. I can only hope and pray that the other place and this House will ensure continuous scrutiny, with an agreed timeframe for a review of this legislation.
While I appreciate the legislative context of the Bill and the need for it, I wish to make some general points and do so as a grass-roots advocate who has campaigned for more than four decades for accountability and equity within healthcare and social services. I spent years working in this field and recall supporting many women who had experienced untold misery as result of medical intervention; I therefore welcome the sensitive way in which the Minister in the other place, Nadine Dorries, acknowledged that women’s voices and informed choices continue to be discarded and not believed, as has gone on for decades. This recognition is critical, as the noble Baroness, Lady Cumberlege, so powerfully and lovingly spoke of: women cried out for help to alleviate the massive damage caused to them by the medicines and medical devices deemed safe for years by health institutions and professionals. Women have endured countless years of unnecessary pain and injury, leaving many with insurmountable psychological, physical and financial scars. Even the most outspoken champions for their needs found it difficult to be heard, while women awaited justice.
The report from the noble Baroness, Lady Cumberlege, First Do No Harm, must be at the forefront of the Government’s mind as we look to safeguard and embed patient safety with this Bill. We have an opportunity to ensure that this legislative framework is watertight against any such injustice and costly negligence occurring again.
I support the creation of patient safety commissioners to improve patient safety and represent patient interests. In this Bill, glaring fragmentation remains; no clear pathways are indicated in the regulatory system to where patient safety is located. The Paterson inquiry referred to these anomalies as a “jigsaw of organisations” to keep patients safe without sufficient clarity. In this context, I would have wished for clarity on further safeguarding of informed consent.
Can the Minister say how the Government intend to complete this obligation for consultation with patients and the wider healthcare sector, as called for in the most recent proposals, including the Cumberlege Report, in order to rebuild trust and confidence that another set of disasters is not in the making as we proceed rapidly to create a new vaccine in the face of this horrendous pandemic?
Of equal significance, but which appears to be absent, is reference to safeguarding informed consent. I therefore welcome the Minister’s willingness to listen. Would the Minister consider that the proposed commissioner be supported by a diverse group of experts to ensure that women, as well as minority groups, have full confidence that their voices and needs are not overridden by the Government’s rush for central decision-making? Prioritising patient safety must not be compromised. The noble Baroness, Lady Cumberlege, has reminded us of the thin wedge where the medical profession and women patients, in particular, interact. There is urgent need for a robust regulatory framework
for medicine and medical devices with the principal aims of serving and protecting patients and users of our service.
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