Draft Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023

Karin Smyth Excerpts

Tuesday 5th September 2023 General Committees

[Karin Smyth (Bristol South) (Lab)]

It is a pleasure to serve under your chairship, Ms Nokes. The Opposition are supporting the regulations because they clearly represent the right thing to do for patients and constituents. Not only do they improve patient safety, which must be our priority, but they increase flexibility for pharmacists and patients alike. I am also pleased that valproate has been given due attention in this SI, following the important work by Baroness Cumberlege in the independent medicines and medical devices safety review; it is just a shame that it has taken two years following the Government’s own consultation on this matter to introduce this legislation.

Campaigners have long argued that it is key that medicines containing sodium valproate should be dispensed in the original manufacturer’s packaging to ensure that women and girls, particularly those of child-bearing age, always receive patient information about taking the medicine while pregnant. As we know from the many tragic impacts of foetal valproate spectrum disorder on our constituents and people around the country, this SI is long overdue. I pay tribute to those campaigners.

As the Minister would expect, I have some questions. The Medicines and Medical Devices Act 2021 requires that, when assessing whether regulations would contribute to the objective of safeguarding public health, the appropriate authority must have regard to three factors, one of which is the availability of medicines. It appears to me that the SI misses the opportunity to address the current shortage of medicines, including of those involved in hormone replacement therapy—something that has affected many women across the country.

Section 64(5) of the Medicines Act 1968 prohibits the sale or supply of a medicinal product where that product is not of the nature or quality specified in a prescription—for example, if a pharmacist dispenses two 50 microgram tablets against a prescription calling for a 100 microgram tablet, when the 100 microgram product is in short supply. The SI allows the dispensing of 10% more or less than the quantity prescribed of a medicine. Given that the SI is about flexibility, and given the campaigning on this issue, particularly by women, this could have been an opportunity to look again at packaging; women could then get the drugs that they are prescribed.

The professional judgment of pharmacists will remain a critical part of the dispensing process for all medicines. I am pleased that guidance on whole-pack dispensing of medicines containing valproate will be provided by the Medicines and Healthcare products Regulatory Agency before the instrument comes into force. What other support and guidance will be given to pharmacists to ensure that the SI is implemented effectively? Will the Minister give an indication of the timeline for the consultation on Pharmacy First, given that it is due to be implemented by the end of this year? Can she tell us about the contractual restrictions relating to NHS prescriptions? As I understand it, reimbursement is based on the exact product prescribed. Forgive me if I missed it, but I do not think that she addressed that issue.

Finally, I appreciate the publication of an impact assessment alongside this SI, but the section on reimbursement gives two alternative scenarios: either reimbursement based on the quantity written on the prescription, or reimbursement based on what was dispensed, rather than what was written on the prescription. Those necessarily have different impacts on the cost to pharmacies and the wider NHS. If the Minister could provide clarity on those issues, I would be grateful.

Draft Medical Devices (Amendment) (Great Britain) Regulations 2023

Karin Smyth Excerpts

Monday 22nd May 2023 General Committees

[Karin Smyth (Bristol South) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Stringer. This is one of those fairly innocuous-looking SIs that hides a multitude of problems and incompetence. Many people in our constituencies rely on these medical devices—some 600,000 every day—so it is important that they remain available on the UK market.

The Minister did not outline the range of devices that we are talking about. This is not some technical issue; devices range from blood tests to wheelchairs, contact lenses and scalpels. I am sure that hon. Members have all taken a chance to look at the list of non-invasive, invasive, surgically invasive and active devices. I will not delay the Committee by detailing all of them, but it is a long list, so it really is shocking that we are here once again. Although we have plenty of time, the Committee is being rushed by the Government to approve the draft regulations as some sort of last-minute extension of the existing regulations to mitigate the Government’s failure over exiting the European Union, some seven years after the vote. We are talking about plasters today, so the draft regulations are opportune: yet another sticking plaster over the problems that the Government have encountered and their inability to negotiate a settlement that took account of these important devices.

We will support the draft regulations because, without them, people across our country would suffer greatly from not having access to things coming on to the market and so on, but we need to ensure continuity of supply. I have a number of questions on which I hope the Minister will be able to shed some light, because I am sure she does not want to have rushed, unquestioned legislation. Turning to paragraph 7.3 of the explanatory memorandum, it would be helpful if the Minister could provide some detail on the steps being taken to build the approved body capacity to meet the demand for UK conformity assessments. With regard to paragraph 6, can the Minister share any details on the “significant amendments” that we should expect to the UK medical devices regulations, which have been discussed in this place before? Any details would be very welcome, because it is not only patients who could be affected if we fail to extend the legislation.

The Minister alluded to the number of businesses involved in this work, but manufacturers of these devices—both in the EU and here in the UK—need to have some sort of certainty. The lead-in time for some of this work is massive, as is the research and development capability needed to produce the devices. This last-minute rush is no good for businesses, and although the Minister tried to say that the draft regulations provide certainty, we contend that extending them for another few years, without a clear indication of the route to the full UKCA marking, does not provide certainty. Beyond the consultation, what conversations are the Government having with manufacturers to ensure that we have some realistic timescales about the future? As I said, this is a real worry for our constituents as well as medical professionals, people involved in prescribing the devices and those accessing them.

In paragraph 13.3 of the explanatory memorandum, the Government indicate that they do not

“expect a significant cost impact on small and/or micro businesses”,

because the draft regulations are a continuation of the “status quo”. Again, that is not good enough, because it contradicts the statement that the extended period is a “transition”. I am sure we all know that small businesses operate on tight margins. It is difficult to run a small business, so small businesses would welcome further details about what action will be taken to assist them in transitioning from CE marking to UKCA marking. I understand that there may be working groups looking at this issue, which is to be welcomed, but it would be very welcome if the Minister could inform us about that point.

It is vital that we get this right as we look to the future, so I ask the Minister: what is the Government’s long-term plan to ensure the success of the UKCA regime for medical devices? If this is the route we are going down, we want to make it a success. If the Minister could indicate—[Interruption.]

[The Chair]

Order.

--- Later in debate ---

On resuming—

[Karin Smyth]

To complete the point that I was making, we are interested in what the Government’s long-term plan is to ensure the success of the UKCA regime for devices.

It would also be helpful if the Minister indicated the Government’s view on alignment. What is their intention for future alignment with the EU? Is it their intention for us to be aligned with anyone but ourselves? What impact will that have on our future businesses?

The extension of acceptance of CE-marked medical devices will act as a transition, and we would all welcome clarification from the Minister of what that transition will look like. What steps will the Government take, in the time that we are allowing them, to support the manufacturers and supply chains that are indispensable to all those who rely on medical devices, to support jobs, and to preserve our global reputation for research, innovation and high standards?

Retained EU Law (Revocation and Reform) Bill

Karin Smyth Excerpts

Thursday 11th May 2023 Commons Chamber

[Kemi Badenoch]

No, I do not think that it has come out of any idleness. If anything, I would say that the civil servants have been working feverishly on this, and what they have been doing is preserving, not repealing and certainly not getting the reforms that we want. This approach means that they can now do that. I know that it is disappointing, because it is not what my right hon. Friend had wanted; it was not his approach. I have spoken to him about it and explained my reasoning. I do not think that we will come to an agreement on this, but I would like him to understand that I am doing this because I genuinely think that this is the best way to deliver what those of us on the Conservative Benches voted for.

[Karin Smyth (Bristol South) (Lab)]

The Secretary of State seems to say that we have intense excitement about being here today and she is surprised. Our law is the basis of our democracy, and the flippant and ill-prepared way in which this has been brought forward is a disgrace; it is not worthy of our Parliament or, indeed, of our country. In the Public Administration and Constitutional Affairs Committee, we are currently looking at international treaties. It is clear that our system for reviewing and monitoring international treaties per se is not up to scratch, and I hope that the Secretary of State will engage with that process. [Interruption.] She says that there is no time. She is in control of the time in this place as a member of the Government. It is not for me to speak for those on the Labour Front Bench, but I am sure that if there were discussions about giving the decision more time and perhaps to bringing it back, given the changes that are being made, that would be met favourably by Members on the Labour Benches. What lessons is she learning about the involvement of this place in the scrutiny of these treaties?

[Kemi Badenoch]

It is very surprising to hear the hon. Lady criticise the scrutiny process given that it was brought in by a Labour Government under the Constitutional Reform and Governance Act 2010. The CRaG process on international treaties, which is what she is talking about, was brought in, as I have said, not by a Conservative Government, but by a Labour Government. We are carrying out this process using parliamentary procedure and Government amendments in the House of Lords; we are doing things on the Floor of the House. We are making sure that Parliamentarians have transparency. That is the right way to do it and I will not apologise for that.

International Women’s Day

Karin Smyth Excerpts

Thursday 9th March 2023 Commons Chamber

[Karin Smyth (Bristol South) (Lab)]

International Women’s Day is a time to celebrate, and there is much to celebrate about being a woman in 2023. I always think at this time of my friends, many now spread across the country and some across the world, who I have spent time with in the past. They are now too busy with children, grandchildren, older parents and their own jobs to get together, but I know that they are always there for me, I know they are really proud of me being here, and I know that I would never have made it here without them.

This weekend, I am looking forward to joining Bristol Women’s Voice for a fantastic programme of events, in particular discussing social care and the role it could play in the Bristol economy if only it was run better. It will be chaired by my friend Diane Bunyan, who was Bristol’s first female Labour leader of the council only about 20 years ago. Many women have been at the forefront of Bristol’s long, radical history. I think of Dorothy Hodgkin, who was chancellor of the University of Bristol, Elizabeth Blackwell, who was the first woman to qualify as a medical doctor, the trade union activist Jessie Stephen and Mary Carpenter and Hannah More, who were involved in social programmes. Lady Apsley was Bristol’s first woman Member of Parliament. She was a Conservative who, after the death of her husband in 1943, won the seat. Three out of four of Bristol’s MPs are women. We allowed one man to take one of the positions, and I pay tribute to my hon. Friends the Members for Bristol West (Thangam Debbonaire) and for Bristol East (Kerry McCarthy), who are supportive colleagues.

The reality is that, like the rest of the country, we are nowhere near economic or political parity. Often we hear about the challenges, and I will move between the challenges and the opportunities. We remember that some good historic achievements have been made recently, whether that is the Lionesses’ incredible success last summer, the next generation of young women and girls getting into sport, or Kamala Harris being the first female vice-president in US history. We await the first woman US president.

Women are redefining culture with historic firsts in film, television, comedy and sport. Taylor Swift became the first woman to win a Grammy for best music video with sole directing credit, and films and shows are demonstrating the varied and multiple lives that women can lead, including “Am I Being Unreasonable?”, which was filmed in my constituency of Bristol South. Labour has led the way in women’s equality since 1923, when Margaret Bondfield became the first female Cabinet Minister. It is important that we celebrate the centenary of that accomplishment and the legacy that Margaret left for all women who have followed in her footsteps.

I am appalled by the pictures, even in 2023, of international summits and events in the UK full of men with very little female representation. If we think about the women leading political movements—as we have heard again today, we think particularly of those women in Iran, and in Afghanistan and Ukraine, too—women have always been at the vanguard of social change. However, quickly, as that change starts to happen, we become relegated to a back room—often back to the home—and are rarely represented in those photographs or at those summits.

This week, I was proud to chair a session of the British-Irish Parliamentary Assembly, which we held in Stormont on the 25th anniversary of the Good Friday/Belfast agreement. I was able to chair a session with some of the founding members of the Northern Ireland Women’s Coalition. Kate Fearon, Bronagh Hinds, Dr Avila Kilmurray and Jane Morrice were amazing activists well before the GFA, and they remain so today, many using that experience across the world. Women need to be represented in all aspects of politics, wherever and whenever. We are fed up with doing that service role and then not appearing in those photographs and leadership positions.

As chair of the women’s parliamentary Labour party, which makes up more than 50% of Labour MPs, I am proud to see the successes that Labour Governments have made in promoting equality, from introducing the Equality Act 2010 to championing all-women shortlists to increase female representation. Labour is the party of women and for women. I gently say to the hon. Member for Southend West (Anna Firth), who spoke about how lucky we are to be here and able to speak, that luck has had absolutely nothing to do with it. I take her point about recognising that privilege, but none of it has been luck; it has all been power that we have taken, and it always has to be underpinned by legislation, and I am afraid it is only Labour in government that has enacted that legislation.

[Dame Maria Miller]

The hon. Lady is rightly talking up her party’s role in all these issues, and I would expect her to do nothing less, but surely she would agree that this Government have done an enormous amount—more than any other—on the issues of domestic abuse and domestic violence and making women safer online, and I do not think she can simply ignore that. These are the issues of today, and this Government are tackling them.

[Karin Smyth]

I am not ignoring it, and I pay tribute particularly to the right hon. Member for Maidenhead (Mrs May) for the work she led in government, but we need to continue to use legislation to underpin, and it should be good legislation. I am not sure that in this week of all weeks we can be proud of what this Government have done. If we think about the trafficked women who are coming forward, that is deeply problematic, and it would be good if we could all work together to help those women.

People outside might not know this, but even on a very busy Monday, Tuesday or Wednesday in Portcullis House and so on, this place is overwhelmingly male. Although some great strides have been made in all these professions, we see that with journalists, lobbyists and even with the third sector people who come to see us. I think the environmental movement is overwhelmingly dominated by men. The camera people and the staff in most places are generally male. I had a message as we were sitting here today from my hon. Friend the Member for Wirral South (Alison McGovern) pointing out that yesterday at Prime Minister’s questions, all four leaders are of course male, but there were two questions from men for every one from a woman. That is the stark reality. As others have said, this place still remains 30% women.

We are celebrating how far we have come, but we recognise that more needs to be done. It is 52 years since that first women’s refuge was set up in Chiswick, and the issue of domestic abuse and violence, as we have heard again today, is still all too prevalent. Marital rape was only made illegal in the early 2000s, and the Office for National Statistics estimates that 1.6 million women experience domestic abuse in England and Wales in any given year. We know that, faced with the cost of living crisis and severe lack of funding, the number of refuge spaces in England is falling desperately short. Why, when this issue is affecting so many, is so little progress being made?

We need to work harder on this issue, and talking last week with those women from the Northern Ireland Women’s Coalition was certainly instructive. They were clear that they could only come forward, and that women in any conflict situation can only come forward, if there is an ecosystem of support that they can use, both statutory and non-statutory, operating behind the scenes, and that is sadly missing in many places today. We need to help fund those refuges, and they need to be places of safety for women to seek refuge.

We recognise the resilience and strength from women today, and we are so proud to be able to voice, on behalf of all those women, what they bring to us in our constituencies. To close, it is often our friendships with one another that prove to be our biggest strength. Outwith the fact that we disagree across the House, as is necessary, we are strong political women and we work together. It is a pleasure to be a part of this debate today, and when I look around the Chamber and up to the Gallery, I see the bonds of friendship that are made between colleagues who share the desire to make life better for women. Parliament will be safe in our hands.

--- Later in debate ---

[Anneliese Dodds]

Those are ONS statistics. We need proper action to eliminate that inequality for women, so I am delighted to be working with my right hon. Friend the Member for Leeds West (Rachel Reeves) and with Frances O’Grady to review how we can go further and faster to close the gap. We also need action so that flexibility for women in the workplace is not just in the hands of employers. We need equal pay comparisons between employers, not just within a single employer. We need a modern childcare system, as my hon. Friend the Member for Houghton and Sunderland South (Bridget Phillipson) has ably set out.

As I have the floor for a few more moments, I want to talk about a group of women who rarely get a hearing in this place. I am talking about midlife women: women in their 40s, 50s and 60s. They experience a series of immense pressures—they are often expected to hold down a job, care for elderly parents and support older children—but when we look at how they are faring economically, we can see that over recent years things have moved backwards for them. In the past decade, women in their 40s and 50s have seen their real wages fall by almost £1,000 a year. Since the pandemic, 185,000 women between 50 and 64 have left the workforce at a cost of up to £7 billion to the British economy.

[Karin Smyth]

My hon. Friend is making an excellent point. Does she agree that it is astonishing that the Government are not looking at the issue in the way that we have done? They are concerned about growth in the economy and particularly about the loss of women from the workforce, but they are not looking at social care or childcare. Does she agree that if they want to steal our plans, they are welcome to do so and we will cheer them on?

[Anneliese Dodds]

I would be delighted if the Government stole those plans. I would also be delighted if they looked at Labour’s measures for the NHS, because a fifth of the women I spoke about are on an NHS waiting list. I have been up and down the country talking to women on gynaecology waiting lists, women who are not getting breast cancer referrals on time and women who have not been able to access cervical cancer screening, for which rates have been falling. We can see how big a problem there is and we can see how our plan for the workforce is so urgently needed.

We would also love the Government to steal Labour’s plan for larger employers to have menopause action plans. Many businesses have welcomed that measure, but so far the Government have not yet adopted it, although the nodding of the Minister on the Front Bench leads me to hope that they may do so. We need action on that, and we need greater action for women.

Women need answers to these questions because, sadly, too many women will feel that they have little to celebrate on this International Women’s Day in our country. Sadly, that applies even more in many other countries, as hon. Members have discussed throughout this debate. Earlier this week, I had the immense privilege of taking part in a roundtable with women activists from Iran and Kurdish women. Their strength is inspiring, but what they have been through is horrendous. We must stand with them, as has been said. We must also stand with the women of the United States, following the attacks on their bodily autonomy. We must stand with the women of Afghanistan and of Ukraine. We must stand with women in countries subject to appallingly high rates of femicide, such as El Salvador. We must stand with women from all nations in which women’s lives are devalued.

My mission as shadow Secretary of State for Women and Equalities is to ensure that every woman is recognised, valued and empowered to reach their full potential. I want us to be able to look forward to a future in which our debates in the week of International Women’s Day can focus solely on the brilliant achievements of women and girls in all their diversity—those women and girls who make this country great—rather than on having to detail so many barriers holding them back.