(3 years, 9 months ago)
Lords ChamberMy Lords, I am delighted that my noble friend Lord Marks of Henley-on-Thames tabled this amendment and the noble and learned Lord, Lord Garnier, added his name, as did I.
I will not speak for long—just a few minutes—but I would like to give this amendment some context. Just over a year ago, my noble friend was approached by a concerned mother about the “treatment” of her adult daughter by a person who described themself as a psychotherapist. This treatment would not have been recognised by any professional body and did a disservice to the regulated profession of psychotherapy. Such an individual is able to walk into a stranger’s home after being contacted on the strength of an advertisement in a shop window, local newspaper, magazine or online. Counterfeit certificates, business cards and brass plaques are easily obtained to give undeserved credibility.
The phoney therapist broke no law, but the treatment was unrecognised by any regulating body and did great harm to the young woman. She was turned against her family by coercive behaviour and a catalogue of lies. She was turned inside out emotionally and her family were left distraught. I was somewhat taken aback to receive letters from other families whose adult children had been in receipt of similar coercive treatment, leaving them a shadow of their former selves.
This amendment sets out to right these wrongs and ensure that the therapist would not be able to practise in future. I thank my noble friend Lord Marks of Henley-on-Thames, who spoke in that debate, as did the noble and learned Lord, Lord Garnier. The amendment sets out clearly what is an offence in this context, and how to determine that the perpetrator’s behaviour had a serious effect. It also sets out what would count as a defence for the person purporting to be the therapist, and, if found guilty, what the maximum terms of imprisonment would be.
Having listened to my noble friend Lord Paddick last week at the beginning of the debate, I think it worth mentioning that, although the original case concerned a young woman, there is no reason why it should not apply to a vulnerable young man. The amendment is gender neutral and goes a long way to right the wrongs in the case that brought me to this Bill in the first place. I am delighted to support it. I say to the Minister that the coercion was carried out in the victim’s home. It was abuse in a domestic setting and should have been a crime. This amendment will stop others being controlled or coerced by bogus therapists and, if they are sentenced, the punishment will fit the crime.
I wonder whether, before Report, the Minister would be willing to meet some of those who have spoken in this debate.
My Lords, I welcome the amendment of the noble Lord, Lord Marks, and the opportunity to talk about the role of psychotherapists. As I will be discussing regulatory issues, I declare my membership of the GMC.
I have no doubt about the value of psychotherapists and the beneficial impact of their work for so many people. But there are potential risks, which the noble Lord, Lord Marks, referred to eloquently when we last debated the amendment. Also, in a Lords debate on 2 March last year, he said:
“We have heard harrowing accounts of victims, often young, brainwashed by unscrupulous and controlling individuals. These charlatans play on their clients’ suffering, deluding them into a false belief in their treatment, often conjuring up in them fake memories about their early years and inducing unhealthy long-term dependence on the therapist and rejection of families and friends.”—[Official Report, 2/3/20; col. 477.]
That was reinforced by the case the noble Baroness, Lady Jolly, just referred to.
Patients and clients can be vulnerable, and an insensitive, critical or sexually exploitative therapist could increase the risk of the patient having a poor—and potentially damaging—outcome from their therapy. The big problem is that the terms “psychotherapist” and “counsellor” are not protected. Any one of us could call ourselves one of those titles and advertise our services to unsuspecting and sometimes vulnerable people. I have long had worries about this, going back to when I was a Health Minister, some 20 years ago.
In 2001, the noble Lord, Lord Alderdice, introduced a Private Member’s Bill to provide for the regulation of psychotherapists and make provisions to enable the registration of the profession. Since then, we have established workstreams to look into regulation, but, unfortunately, the profession found it difficult to reach a common cause, principally because there were so many different, and sometimes conflicting, schools of thought.
That, I am afraid, was the start of a long and unhappy journey. In 2007, the then Government published a White Paper which included plans to introduce statutory regulation for psychotherapists and counsellors. But, unfortunately, by 2010, this did not import into statute, even though, by then, the noble Lord, Lord Alderdice, had done a sterling job in pulling the different psychotherapy schools together and getting agreement on the way forward. We then had the coalition Government in 2010, which announced a new approach to regulation and a belief that centralised statutory regulation was not always the most effective or efficient way of ensuring high-quality care. That, essentially, is where it stayed.
The debate in the name of the noble Baroness, Lady Jolly, last March, induced the following response from the Health Minister, the noble Lord, Lord Bethell:
“The Government are committed to a proportionate system of safeguards for the professionals who work in the health and care system … Where practitioners pose a direct risk of harm to the health and well-being of patients, legal avenues will and must be explored … However, more rules are not always the answer to every problem. While statutory regulation is sometimes necessary where significant risks to users of services cannot be mitigated … it is not always the most proportionate or effective means of assuring the safe and effective care of service users.”—[Official Report, 2/3/20; col. 480.]
He also referred to the more than 50,000 talking service professionals on the registers accredited by the Professional Standards Authority. That is welcome, but it is not statutory regulation, nor is it protection of title, which means any of us could, if we wanted to, continue to call ourselves a psychotherapist or counsellor.
The big problem here is that the Government are basing this on a risk assessment for which there is little evidence. There is a real lack of hard research in this area. I am grateful to the Library for unearthing a 2019 article, published in Frontiers in Psychology, which provided a potential explanation of why there may currently be a lack of quantitative research. It said:
“Although the broad topic of negative outcomes has been extensively discussed, empirical research on patient safety, directly examining the causes and prevention of harm, is not well established. Because harm … is relatively rare, and not amenable to experimental manipulation, such research is difficult.”
In 2017, the Brighton Therapy Partnership, a continued professional development and training organisation for counsellors and psychotherapists, said:
“There is very little research into the harm that properly executed therapy can cause. This is an unusual anomaly for a medical field, as in every other area research is abundant into both efficacy and failure of all treatment options.”
When the Government say, as I have no doubt the Minister will today, that it is not proportionate to regulate psychotherapists, there is an absence of evidence to base that on. In the meantime, in the absence of statutory regulation, the amendment of the noble Lord, Lord Marks, is essential. I hope he is prepared to support this all the way in the Bill. There is a dangerous gap, and some action needs to be taken.
(3 years, 10 months ago)
Lords ChamberAmendment 68, in the name of the noble Baroness, Lady Cumberlege, requires the Secretary of State
“to create redress schemes for those who have already suffered avoidable harm”
related to hormone pregnancy tests, sodium valproate and pelvic mesh. The Minister has told us that there will be no redress agency. The noble Lord spoke passionately about suffering without redress. A significant amount will need to be paid through NHS Resolution to the women affected by these three interventions. Who will ensure that the women affected receive proper recompense? As the noble Baroness, Lady Cumberlege, has said, they have had to pay out for travel for treatment and payment for carers, and they are seriously out of pocket for what they originally thought was standard, straightforward NHS treatment.
I fear that, if there is no scheme, the NHS will have to pay more than it would through a properly managed redress scheme. This and the previous amendment are powerful signals to the Government that they must act on this issue of redress. I hope that, in summing up, the Minister will be able to share the Government’s plans with us. If they have no plans, what would he suggest that these women should do? The noble Lord, Lord O’Shaughnessy, put the case very powerfully.
I very much agree with the noble Baroness, Lady Jolly, that this afternoon we have given a powerful signal to the Government. Certainly, from these Benches, we very much support her amendment and her efforts to get redress for people who were grievously damaged by procedures undertaken in the National Health Service.
The noble Lord, Lord O’Shaughnessy, talked about one woman’s experience of the impact of surgical mesh, and the huge pain and damage inflicted. I was very grateful to him when I had a Question on surgical mesh, which he answered, as watching it from the Gallery were a group of women from Sling the Mesh, who I had brought in. He gave a lot of time to them afterwards; perhaps it paved the way to the inquiry established under the chairmanship of the noble Baroness, Lady Cumberlege. Like him, meeting those women and talking to them about what they had suffered made me absolutely determined to do anything I could to raise the issue.
We were very fortunate that the noble Baroness, Lady Cumberlege, accepted the chairmanship of this inquiry, given the quality of her team and the extraordinary lengths to which she went to produce its very fine report. Anyone who has met the people involved and listened to the suffering that they have undertaken is left with a feeling that it is awful. Something must be done for them and I very much hope that the Minister will be sympathetic.
My Lords, it is a great pleasure to follow the noble Lord, Lord Patel.
What does one say to the people of Northern Ireland? They voted to remain in the EU, their vote was ignored by the DUP, and they have been duped by the Government, who continue to deny that there is a border in the North Sea—when today we are debating ample evidence of such a border. As the noble Lord, Lord Patel, identified, the distinction the MHRA is now having to make between the EU market, the British market and the market for Northern Ireland, as well as the bureaucracy involved and the cost for British-based companies, is undeniable.
These two very modest amendments seek to ensure that Parliament gets a regular report on how this is working in relation to medicines and medical devices regulations, and that various bodies should be consulted. However, over and above that, the Minister owes the House some explanation of how we have ended up in this bizarre situation, where Northern Ireland, which wanted to be in the EU and wanted to be listened to, has ended up in this rather parallel existence, with a border down the North Sea, food shortages in its supermarkets, and in a right mess. I hope the Minister can answer that.
My Lords, the amendments in this group relate to reporting requirements and consultation. The noble Lord, Lord Hunt of Kings Heath, has just put the political case very clearly; the noble Lord, Lord Patel, looked at the technical and regulatory issues; I will look at the practical issues around health services on the island of Ireland.
Amendment 69 from the noble Baroness, Lady Thornton, would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK. Can the Minister tell us when the first report would be published, whether the Republic would be part of this consultation, and if not, why not? The noble Baroness, Lady Thornton, and I tabled this amendment to require the relevant authority to consult with patients and healthcare and industry stakeholders when preparing a report under Clause 44.
Divergence is inevitable. The situation for healthcare on the island of Ireland could become extremely complicated. In the past, patients have travelled north or south to receive treatment wherever the appropriate treatment is available. Will citizens from Northern Ireland and the Republic have to use the new GHIC, or do the Government have an agreement with the Republic so that business as usual will be the new norm—no change?
Government Amendments 75 to 77 and 79 to 85 extend the reporting requirements under Clause 44 so that they apply to regulations made by a Northern Ireland department and in respect of regulations under Clause 18. However, we cannot ignore the Republic when we talk about health in Ireland.
(3 years, 10 months ago)
Lords ChamberMy Lords, I must say that I very much disagree with the noble Lord’s remarks. If we want certainty, we need legislation that is well grounded and which has had thorough scrutiny in Parliament. The problem with this Bill is that it essentially gives a blank cheque to Ministers to change the regulatory regime for medicines and medical devices. If this was just to deal with the aftermath of Brexit, that, of course, would be understandable. But it was made clear in Committee and at Second Reading that the Government are wedded to this way of doing legislation. As the Minister said in Committee,
“this is a modern and fast-changing industry … we may still need to preserve our ability to amend and update regulations.”—[Official Report, 19/10/20; col. GC 328.]
The noble and learned Lord, Lord Judge, referred to two of our most distinguished Select Committees. We need to return to what our Constitution Committee said:
“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made … The Government has not provided the exceptional justification required for this skeleton approach.”
As the noble and learned Lord, Lord Judge, has said, the Government have form. We are increasingly seeing the use of skeleton Bills and Henry VIII clauses. We really must come to a point where we say to the Government that we will not put up with this any longer.
I listened to the Minister in the last debate: what did he offer the House in respect of further scrutiny? It seemed to me he offered a debate or two, and that was it. The Government do not have an answer; they are refusing to budge on a principle which I believe is fundamentally wrong.
The noble Lord, Lord Naseby, talked with joy about the effectiveness of affirmative statutory instruments. This is nonsense. I think eight SIs have been defeated in your Lordships’ House in history; the last one led the Government to threaten to abolish the House of Lords. Unfortunately, the affirmative procedure is hardly any better than the negative procedure, and they do not allow this House to really exert any change on the orders going through.
We have to stand up on this matter. It is much more important and much wider than the issue of medicines regulation. I very much support the amendment moved so effectively by the noble Lord, Lord Sharkey.
My Lords, these amendments, led by my noble friend Lord Sharkey with eminent cross-party support, replace the affirmative procedure for delegated powers in the Bill with the super-affirmative procedure.
Because of the skeleton nature of the Bill, outlined in the previous group, it is key to ensure that Parliament is able to properly scrutinise regulations made under the Bill. The super-affirmative procedure, which affords a committee of either House the opportunity to comment on a draft of the regulations and make representations, is in our view the best way to do it.
The past year has made clearer than ever the need for outward-facing health policy with public health and safety at its heart. The regulations brought forward under this Bill are central to doing this, and the highest level of scrutiny is needed to ensure their success.
One of the first things I had to learn when joining the House was the sovereignty of the House. My 10 years in your Lordships’ House have taught me to spot Henry VIII powers and call them out. As the noble Baroness, Lady Andrews, said, these amendments are hardly revolutionary, so I urge the Minister to accept them.
We need well-grounded legislation, and this Bill gives the department carte blanche to do what it likes. The amendments tabled by my noble friend give Members of the House the opportunity to scrutinise in a proper way and that, after all, is what the public expect of us.
My Lords, this amendment would require the appropriate authority to have regard to the protection of the environment when making regulations about human medicines. We have left the EU and need to be sure that our replacement regulations are fit for purpose. Many of us have spent a lot of time checking that these replacements are in such a fit state; but, while the health and safety of patients remain paramount, it is reasonable and, indeed, important, given the climate crisis, to consider the environmental implications of any policy stemming from these regulations.
The manufacture of human and veterinary medicines, and medical devices, does not happen in an environmental vacuum. Manufacturers have a duty to protect their environment—and manufacturers of medicines will need to be open about how they deal with chemical and other waste. I live in Cornwall where oestrogen has found its way into local rivers, ecosystems and oysters. Wastewater from pharmaceutical manufacturers could also find its way into local waterways. Will the Minister outline how this is dealt with by regulators, and how it is covered by the Bill?
Much waste from pharmaceutical plants is toxic and dealt with appropriately by manufacturers but, in a Brexit world, the regulation regime will have different regulations from the very strict ones that applied when we had to follow EU regulations. We can buy our medicines and medical devices from all over the world; we know that not everyone has the same high environmental standards governing manufacture that we have. What criteria are appropriate in the commissioning and purchasing of medicines from the rest of the world? Can the Minister please outline for us the nature of discussions with regulators about these issues?
My Lords, this debate follows a very interesting one in Committee, in which the noble Baroness, Lady Bennett, posed some searching questions about the potential for designing new drugs that are less harmful for the environment, whether in their composition, their impact when they escape into the environment, or in their packaging. Today, she also argues that the expectation of this approach should be built into legislation.
In Committee, the noble Baroness gave some very interesting examples. I was particularly interested to hear that in Sweden—
(4 years, 1 month ago)
Grand CommitteeMy Lords, given that we are in Committee, I will not be making lengthy speeches, but I will raise what I think are the key issues in each of the groups. The amendments to the Bill relate to some of the constitutional issues. As a general rule, noble Lords do not much care for delegated powers because it is not considered good practice or procedure to give a Secretary of State carte blanche in any area. There are some areas in this Bill where the Secretary of State is being given powers that we would rather that he or she did not have.
As the Bill is skeletal and consists mostly of delegated powers, it is important and a good idea to ensure that appropriate steps are taken to set an end date on these, so sunset powers are being proposed. The noble Lords, Lord Lansley and Lord Kakkar, and the noble Baroness, Lady Thornton, have requested the Secretary of State to publish draft legislation to consolidate the legislation relating to human and veterinary medicine within three years of the Bill being enacted.
My noble friend Lord Sharkey and I have put our names to several amendments in this group. My noble friend calls for the super-affirmative procedure so that all powers given in the Bill will elapse after three years. I confess that this is the first time that I have seen that being used. The super-affirmative procedure involves an additional stage of scrutiny where Parliament considers a proposal for a statutory instrument before it is formally laid. This procedure is used for those instruments that are considered to need a particularly high level of scrutiny, which I think is certainly the case with this Bill.
Some of the amendments call for consolidation within three years, but in general what we are saying to the Minister is that there are not enough checks and balances. Please use the time between now and Report stage to look again, speak to Members of the Committee and bring forward government amendments—otherwise, I suspect that we may be voting on Report.
My Lords, I have added my name to Amendments 1 and 140 tabled in the name of my noble friend Lady Thornton. As we are at the start of the Committee stage, perhaps I may remind the House of my membership of the board of the General Medical Council and my role as president of GS1 and the Health Care Supply Association.
I agree with my noble friend Lady Thornton about the clash between the first day of the Committee stage of this Bill and the Second Reading of the United Kingdom Internal Market Bill in the main Chamber. Today we are dealing with some of the most important debates in the whole Bill and when we come back on Report there will be a need to give more time to allow those people who could not be present today to make a full contribution to these debates. I hope that the usual channels will take that away. I am not quite sure about the procedure in these unusual circumstances, but in normal times I would have asked that the Committee stage procedure be used for these introductory debates on Report in order to allow for interventions. However, since interventions are now limited, that may not run well, although I think that noble Lords will understand what I am getting at.
This is an important Bill on patient safety and the health of our life sciences sector. It is striking in its brevity and in the extensive powers to be given to Ministers. The noble Lord, Lord Patel, has spelled out the wide range of delegated powers contained in the Bill, while a pungent analysis by my local university, the University of Birmingham, points out that, while delegated powers may be needed to ensure responsiveness in the EU exit transition period and to meet the challenges of technological change, they should not be used indefinitely or relied on to implement matters of policy. I am not going to repeat what the Delegated Powers Committee or the House of Lords Select Committee on the Constitution have said, but it is rare for two Select Committees to comment at the same time and in such a critical way about the skeletal nature of a Bill. It is to be hoped that the Government will listen carefully to what is being said.
At Second Reading, the Minister suggested that the sunset clause as proposed by my noble friend would emasculate legislation
“meant to give regulators the powers to be effective and to future-proof medical regulation in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.”—[Official Report, 2/9/20; col. 433.]
I have to say to the Minister that most of the regulatory uncertainty has been caused by the Government’s failure to be clear about what regulatory regime they want for medicines and medical devices. They have now had four years to think about this and we are still nowhere near knowing what regulatory system they want to put in place. Are they going to go for alignment with the European Medicines Agency or do they want to strike out on their own? Do they want to ally with the US FDA? What on earth are the Government’s aims? The industry is at risk because of this huge uncertainty. The idea that we should allow the Government willy-nilly to get this Bill through and make whatever changes they want without the House treating it as primary legislation simply will not wash. I am absolutely convinced that the long-term regulatory system must be subject to detailed primary legislation. As far as I can see, the amendment to bring in a sunset clause is probably the most appropriate vehicle to ensure that that happens.