Organ Donation (Deemed Consent) Bill

Paul Flynn Excerpts

2nd reading: House of Commons
Friday 23rd February 2018 Commons Chamber

[Mr Robinson]

It was because the figure was so low in 2013 that the Welsh Government decided to move to an opt-out system. I agree with the right hon. Lady, and disagree with those who, for some reason or another, will not look at the most recent facts and move with the situation that is developing. The situation in 2013 was bad, which the Welsh Government recognised and they then went for an opt-out system. Then there was a period of bedding-in and there appeared to be no change, but the most recent figures for 2018—as opposed to 2017 or ’16—are showing a marked improvement, and I am sure we can all rejoice at that. This is not a matter of trading economic figures across the Chamber; that is a sheer fact and one that I think we can all take great satisfaction from.

[Paul Flynn (Newport West) (Lab)]

My interest in this matter arose from a constituent—a young man—who came here and lobbied. A year later I attended his funeral because, sadly, he did not get the transplant he wanted, but he had suffered enormously in the preceding period. We have now had the opt-out in Wales, however, and, regardless of what people can do with the statistics, the fact is that people in Wales are still alive who would have died before the law was passed, and people are dying unnecessarily in England.

[Mr Robinson]

I am grateful to my hon. Friend. It was his Bill that sparked my personal interest, and I pay great tribute to the work he did in preparing that Bill, which we have adopted almost in its entirety. He will be pleased to know that we are hopeful that his Bill—from the beginning, as it were—will now find its way alongside my own on to the statute book; I know that will give him great pleasure. What he says about that individual case is certainly true. The positive news from a cautious assessment from the NHS is that, provided the opt-out system—the quintessential starting point for all these forward projections—is introduced and backed up with the necessary limited revenue and capital spending, up to 500 lives a year could be saved by deemed consent.

Draft Pharmacy (Preparation and Dispensing Errors - Registered Pharmacies) Order 2018

Paul Flynn Excerpts

Monday 4th December 2017 General Committees

[Paul Flynn (Newport West) (Lab)]

This is a fascinating piece of legislation in that by far the greatest pressure on us in most areas of law is to make punishments more severe, but here we have an order that calls for an intelligent approach of drawing back from what appear to be excessively severe punishments for errors, mistakes, crimes or whatever they may be, in the knowledge that, human nature being what it is, there will be an atmosphere of more openness. That seems an entirely beneficial and persuasive argument and a good reason for putting the order forward.

We have clearly had a legacy of excessive and unreasonable punishments hanging over pharmacies, but that is not to say that all is well in the prescription of drugs in this country. In 2003, a COX-2 inhibitor drug called Vioxx was identified as a problem in America because the Food and Drug Administration there published a report saying it believed that the drug, which was not a life-saving one at all, had caused 120,000 heart attacks and strokes, many of which had led to death. I wrote to the regulatory body here asking why we did not spot that and how many prescriptions had been issued in 2003. I was told that there were 4,500 prescriptions, but there had been only half a dozen reports of bad reactions. We have errors and weaknesses in our system for spotting issues of that kind, and I believe that if we are doing something wise, generous and sensible as far as pharmacists are concerned, we might look to them to play a fuller part in future as the frontline in identifying bad reactions to drugs such as the COX-2 inhibitors. They can also help us to avoid the great scourge in America at the moment, which is now coming here: the misuse and overuse of opioid drugs. That has become a greater killer in America than traffic accidents or gun crime, and we are seeing an increase in deaths from opioid drugs and addiction to them here.

I believe we would all say that we welcome the order, but there is a great deal more to be done to protect the public from the dangers of prescribed drugs, and pharmacists could play a major role in that.

Hormone Pregnancy Tests

Paul Flynn Excerpts

Thursday 16th November 2017 Commons Chamber

[Steve Brine]

I take the comments of my hon. Friend and parliamentary neighbour on board. As I have already said, my hon. Friend Lord O’Shaughnessy is meeting the all-party group on 6 December, and I am sure that she will be more than welcome to attend that meeting.

[Paul Flynn (Newport West) (Lab)]

The report must be judged against the background of the fact that the thalidomide scandal involved only 20 birth defects in America and 2,000 in this country, that we are still misinforming and under-informing mothers and potential mothers about the valproate scandal and that GlaxoSmithKline was fined $3 billion for distorting the results of its research. The Minister must tell us how many members of the expert group are present or past employees of the pharmaceutical industry.

[Steve Brine]

I cannot give the hon. Gentleman that information at the Dispatch Box, but he mentions the thalidomide tragedy and I have already said that Nick Dobrik attended all the meetings of the expert working group as an invited expert at the request of the Association for Children Damaged by Hormone Pregnancy Tests. Nick is most certainly not a Government placeman or yes-man.

Valproate and Foetal Anticonvulsant Syndrome

Paul Flynn Excerpts

Thursday 19th October 2017 Commons Chamber

[Paul Flynn (Newport West) (Lab)]

It was heartbreaking and infuriating to read the news that 68% of the women who are taking valproate today were not aware of the risks. That is a failure for all of us. We debated this issue in March 2013, and we have put down early-day motions. There was a television programme, chaired by Huw Edwards, in which the victims took part. We thought we had cracked it: we thought we had advertised enough so that no one, after 2013, could be in the position of not realising the terrible risks caused by taking valproate in pregnancy.

I am not making any criticism of anyone, except the MHRA, and we must look at our relationship with the regulatory body. The former Minister, the right hon. Member for North Norfolk (Norman Lamb), did all he could. He has a great and honourable record as a compassionate campaigner on many issues. It is a shock to all of us in that we did not expect there to be compensation, but it should now be coming along. It is not compensation in any serious way, but it is some admission that a terrible mistake has been made—not by the mothers, but by the system.

It is helpful to look back at what happened with thalidomide, which I remember vividly. There were 2,000 cases of birth defects in the United Kingdom; there were 20 in the United States. Why? The reason is that we went on prescribing Destobel for a year after the birth defects were suspected, because the drug company was adamant about it. It had tested the drug on animals, including pregnant animals—pregnant rabbits, even—and only when it went back to do another test of a particular strain of the drug on pregnant rabbits were the birth defects reproduced. That shows the limits of animal testing. The real difference was that the regulatory body in the United States would not accept thalidomide in that form, and its use produced a very small number of cases: 20 compared with 2,000.

We have had the effect of a drug called Vioxx for arthritis sufferers. According to the Food and Drug Administration in America, it caused 60,000 deaths; imagine it—60,000 deaths. How many bad reactions did the MHRA have in this country? About six. We would still be using it if the FDA had not discovered that death was one of the side effects of the drug, which was taken by millions.

GlaxoSmithKline in America has been fined—it is hard to believe—$3.5 billion. What was the fine for? It had suppressed the evidence of the trials it had carried out. It did not publish any of the negative results of the trials it carried out, and only the ones that were neutral or favourable. Drugs that were killing people were getting on to the market—this is a British company. What did the MHRA do in this country? Nothing! I wrote to them saying, “For goodness’ sake, you have to act against GlaxoSmithKline.” It is no coincidence that the person who chaired the regulatory body for more than a decade was a previous employee of that company. I am not saying that in this instance the body did absolutely nothing; it did produce the tools and provided advice, but that clearly did not work—how could it have done if 68% of the women still taking the drug did not know?

This issue applies to all Governments; it has been raised many times before. What we need is a regulatory body that is not paid for or controlled by the pharmaceutical industry but is independent and controlled nationally. Some years ago in Italy, the system changed. The pharmaceutical industry still pays for running the body, but for the past 20 years each Government have said that they would not have a fully independent body because they did not want to pay for it, although it was fine if the burden was taken by the pharmaceutical industry itself.

I do not want to say that we are all against the pharmaceutical industry, which has produced miraculous results this century. Valproate is a very good drug: everyone I have spoken to who has used it says that it is very effective and that it reduces seizures, epileptic fits and the incidence of bipolar disorders. We do not want to stop its use at all and we want to appreciate its quality, but after these four years, when the evidence from parents who have suffered has been there, clearly nothing has worked. We must look to reform our regulatory system, appreciating the value of the drug but at least setting up a fund that can express the sorrow of the country and the regret that we have not sorted this matter out or given warnings to future parents. We must make sure that the reforms suggested by the right hon. Member for North Norfolk proceed as a matter of great urgency.

[Dr Whitford]

Will the hon. Gentleman give way?

Organ Donation: Opt-out System

Paul Flynn Excerpts

Thursday 13th July 2017 Westminster Hall

[Fiona Bruce (Congleton) (Con)]

It is a pleasure to serve under your chairmanship, Ms Buck. I congratulate the hon. Member for Barnsley Central (Dan Jarvis) on securing the debate and on his sensitive and compassionate tone; I hope I can reciprocate. I agree with the hon. Gentleman that it is imperative to work to increase the number of organs available for donation, because every week people in this country die because there is a shortage of available organs. The critical question that we must ask today is whether presumed consent would help with that.

Presumed consent certainly seems an attractive proposition, but perhaps I may enter a note of caution, to aid our early deliberations on the matter. One of the key legal principles I was taught as a student lawyer was that silence is no reply, which means that, much as we might like to draw conclusions from silence, there are good reasons why it may be inappropriate to do so. Introducing the principle of presumed or deemed consent would involve a major change with respect to organ donation. It would effectively mean that even if someone did nothing at all—did not sign an organ donor register, or opt out or in—a consequence would be triggered. The person’s silence would trigger a quite major action. Their organs could later be taken and transplanted. Consent would be deemed, although they would have done nothing.

Of course, some people, on seeing the publicity that might surround the introduction of presumed consent, would deliberately and knowingly decide to do nothing, aware of the consequence; they would be comfortable with that. Those people would be aware that they had, in doing nothing, effectively chosen to donate. However, there would inevitably be a significant group of people who missed the publicity altogether. We need to be sensitive to that.

Informed consent is an important principle, undergirding the relationship between the citizen and the state, so it is right that the House should explore the issue carefully, which is why I welcome the debate. It is critical to explore whether, for example, it is right in this instance to undermine the principle of informed consent by introducing presumed consent. Is it possible that that could create a precedent that might be appealed to in future for less enlightened purposes?

Some practical concerns were highlighted during the debates in Wales that preceded the legislation there, some of which I did not feel were satisfactorily resolved at the time. When the Welsh Government made the case for introducing presumed consent, they based their case, at least in part, on a piece of research by two academics, Abadie and Gay:

“Evidence...suggests that introducing an opt-out type system could result in a 25 to 30 per cent increase in deceased organ donation rates which could equate to a further 15 donors each year in Wales, each of whom...on average might donate 3 organs. This means around 45 more organs could become available to the UK pool for transplantation.”

I understand that the research compared practices in other jurisdictions, and classified Spain, the country with the highest donation rate in the world, as a presumed consent country. Spain introduced presumed consent legislation in 1979, but the law has never been implemented; Spain is still in practice an informed consent jurisdiction like England. Indeed, rates of donation there started to increase only when, 10 years later, Spain made other changes, in particular investment in the organ donation infrastructure. It increased the capacity, training and availability of medical staff to talk to families about donating the organs of a loved one when a life has tragically been cut short.

A leading expert in the field, Professor John Fabre, unsuccessfully tried to point out to the Welsh Government their misconception. In an article entitled “Presumed consent for organ donation” in the journal Clinical Medicine, he referred to their explanatory memorandum, published in December 2012, to the Bill that became the Human Transplantation (Wales) Act 2013. It stated:

“For example, an opt-out system is operated in Spain and it has the highest donation rate in the world.”

As I have said, Spain, even today, does not operate an opt-out system, so I believe that that statement was incorrect, even though it was cited in official papers in Wales, underpinning the presumed consent legislation. The recognition that the country with the highest donation rate in the world does not in fact operate a presumed consent system is important in any assessment of the efficacy of presumed consent. It is also striking that some of the countries that are least successful with their organ donation rates, including Sweden, Greece and Bulgaria, operate presumed consent.

A second objection raised during the debate in Wales was the fact that in some countries the introduction of presumed consent has been associated with significant numbers of people withdrawing from donation. Some people interpret the introduction of presumed consent, despite its noble motivation, as the state seeking to claim their organs without proper consent. Rather than seeing it as a mechanism for donation, they see it as a mechanism for bypassing consent to donation. There has been some evidence of that in Wales. Giving oral evidence to the Health and Social Care Committee of the National Assembly for Wales, organ transplant specialist Dr Peter Matthews, who was based in Morriston Hospital in Swansea, said:

“My own experience is that the British psyche has a particular view that what it should do is donate organs as an altruistic gift, and if it is felt that the state is going to take over the organs, then there is the potential that people who may have been willing to become a donor will not do so. We have seen two cases in Morriston where patients who were on the organ donation register, on hearing about this, said to their families that if the state was going to take their organs, they were no longer willing to give them. We lost two donations”.

During the debate on the Bill in Wales, three Assembly Members relayed similar stories from constituents.

I want to comment on the impact of presumed consent in Wales. NHS Blood and Transplant records donations on a yearly basis, from April to April, and the first full year of results that we have from Wales is for 2016-17. The data tell us two important things: first, in 2016-17, 61 deceased donors facilitated 135 organ donations. Far from representing the anticipated increase of 15 donors and 45 organs, that apparently constituted a decline by three donors and 33 organ donations from the previous year’s figures. That might come as something of a surprise, because some people have suggested that the system was a great success. However, under informed consent a family can donate the organs of a deceased person if the deceased has signed neither the organ donation register nor the opt-out register, which means that, as we have heard, in Wales prior to December 2015 the families or living representatives of the deceased could—as they can here—decide to donate their loved one’s organs. But under presumed consent those informed consent donations would be reclassified as presumed consent donations. Critically, that does not mean that those donations would not have happened under the old system.

Secondly, and not surprisingly, bearing in mind what Dr Matthews told the Assembly, there has been a huge increase in the number of people in Wales opting out. In 2016-17, 174,886 people in Wales were on the opt-out register. That figure far outstrips comparable figures for other parts of the UK, where consent is not presumed. Only 27,559 individuals in England, 1,834 in Scotland and 204 in Northern Ireland have opted out. That means that a staggering 85.5% of individuals in the UK who have opted out live in Wales, despite the population of Wales representing only 4.8% of the UK population.

I have cited a lot of figures, but I do so to get them on the record and to aid our debate. To appreciate fully the cost of the change in Wales, we must remember that prior to the introduction of presumed consent, people who had signed neither the opt-out register nor the opt-in register were potential donors.

[Paul Flynn (Newport West) (Lab)]

Does the hon. Lady agree with the Welsh Government’s conclusion that 40 lives have been saved under the presumed consent scheme that would have been lost under the previous arrangement?

[Fiona Bruce]

My concern is to demonstrate that we have to look very carefully at some of the evidence that the Welsh Government used to come to their conclusions.

Where someone has signed the opt-out register, conversations cannot even begin. That means that more than 174,000 of the Welsh population have effectively been removed as potential donors. Previously, in the absence of express direction to do otherwise, those people’s families, as their living representatives, might have been happy to donate their loved ones’ organs at their death. When Wales embraced presumed consent, the other UK jurisdictions said that they would wait to review the results in Wales before deciding whether they wanted to go down that path. I ask the Minister to look at the evidence.

We have significantly increased donation levels in England since implementing the recommendations of the organ donation taskforce in 2008, which of course came down very much against presumed consent. Rather than seeking to emulate Wales, England should perhaps seek to emulate Spain and put its emphasis on lowering the family refusal rate by increasing the number of clinicians who are trained and available to discuss this issue with families when the need arises—often at short notice.

Professor Fabre concluded his seminal paper in Clinical Medicine in the following terms:

“Rather than legislating for the consent of donors, we should be addressing the misgivings and misunderstandings of families so that they decline donation much less frequently, as has been done so successfully in Spain. An acceptance rate of 85% is a realistic and achievable objective for the UK over a 5-year period. As previously, we have the Spanish model to guide us. It will not be easy. It will require…a detailed plan at the national level”.

I very much hope that the Minister will consider all those points and confirm that the Government will take into account every possible consideration and concern about this issue before any legislation is introduced. I look forward to her response.

[Paul Flynn (Newport West) (Lab)]

I warmly congratulate my hon. Friend the Member for Barnsley Central (Dan Jarvis) on securing this debate and on the clarity and comprehensiveness of his speech. He covered the ground in commendable fashion and hit the significant factors involved.

The hon. Member for Congleton (Fiona Bruce) rehashed the debate in Wales. She mainly addressed opinions and fears that were expressed before the change was made in Wales. I am sure that those fears were sincere, but they have not been realised in the way that she suggests. It is not important that the Welsh Government might not have had entirely accurate evidence; evidence rarely is entirely reliable, and there may have been misunderstandings. What is crucial is the outcome, which is impressive. At least 40 lives were saved—at least 40 people are alive today who would not have been had the presumed consent Bill not passed. As my hon. Friend said, the figure for lives lost in England is 457. That is an extraordinary number of people. If there were an accident today in which that number of lives was lost, that would be our main concern.

My interest in this issue began in 2012, when my 22-year-old constituent Matthew Lammas came here to lobby me and my hon. Friend the Member for Newport East (Jessica Morden). That young man was in need of a heart transplant. He had a heartbreaking story of so many false alarms. He would get a call at perhaps 2 o’clock in the morning to drive to Middlesbrough or Birmingham, but halfway up he would get another call to say, “Sorry; somebody else got the heart—someone got here before you.” Six months after he visited me here, I attended his funeral. A 22-year-old man’s life was lost. I am absolutely convinced that, had we taken the bold decision to introduce presumed consent in Wales six years ago, we would be in a far better position and Matthew Lammas’s life would not have been lost in that way. Those are the simple facts.

There have been extraordinary changes in Wales since the passage of the presumed consent Bill. No one in Wales has died for lack of an organ since that system came into effect. In 2015-16, 214 organ transplants were carried out and 192 patients were on the organ donation waiting list. There was a great deal of concern in Wales, and we all understand that; we all know the feeling of wanting to treat the bodies of our loved ones with reverence and care. There is something that upsets us profoundly about the idea of organ transplantation. There are also genuine religious objections, which were played out again and again in Wales. But I come back to my point: look at the outcome.

There has also been a huge change in public opinion in Wales. In 2014-15, 48.5% of the people of Wales had consented to donating their organs. The figure leapt to 64% in two years. Public opinion has come around to this. We must congratulate the Daily Mirror, which demonstrated tabloid journalism at its very best. I am not sure that this sells many papers, but it has, for all the best reasons, boldly sought to ensure that this life-saving measure is introduced. We can now have great optimism, because my hon. Friend the Member for Coventry North West (Mr Robinson), who came sixth in the private Member’s Bill ballot, announced that he will take this issue up, and there is every chance that the spirit of this Parliament will take it forward.

We rejoiced this week when a decision was taken about the long-standing injustice of contaminated blood. We have come to a consensus about that, and the Government have shown themselves willing to move forward and introduce valuable reform. When I introduced my Organ Donation (Deemed Consent) Bill in the last Parliament, my contact with the Government was entirely friendly. They were reasonable; they were cautious in reaching conclusions but made it clear that the door was open for reform soon. We can change that figure of 457 avoidable deaths. We must move rapidly and find consensus among all parties to take the clear and unambiguous lesson from Wales that presumed organ donation consent saves lives.

NHS Shared Business Services

Paul Flynn Excerpts

Tuesday 27th June 2017 Commons Chamber

[Mr Hunt]

Quite the opposite. Those examples show that we take the contracts off the private sector when it lets us down. That is what happened in the case raised by the hon. Gentleman and with SBS.

[Paul Flynn (Newport West) (Lab)]

Shared services in my constituency saved £120 million in four years. When the system was privatised under Steria, it lost £4 million and goes on being inefficient. Can the Government escape from this paralysis of thought that is costing the country so much—that everything private is good and everything public is bad? Will they look to not outsourcing but insourcing services from the inefficient private sector back to our wonderful, efficient civil service?

[Mr Hunt]

I gently remind the hon. Gentleman that the last Government who had an active policy of increasing private sector market share in the NHS were the last Labour Government. This Government legislated to stop the Government nationally prioritising the private sector and made that a decision for individual doctors at a local level.

Draft Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2016

Paul Flynn Excerpts

Monday 25th April 2016 General Committees

[Paul Flynn (Newport West) (Lab)]

There is a concern about the operation of the MHRA. The organisation has not been regarded as the ideal body to carry out its functions because it is funded almost entirely by the people it is meant to regulate—the pharmaceutical industry.

There have been serious criticisms concerning the authorisation of a drug called Seroxat, an antidepressant that was found to cause or increase suicides among people who took it in its earliest days. When the MHRA went to investigate, it set up a committee and had to close it down six months later because a majority of its members were employed by the pharmaceutical industry, so the restriction on the use of Seroxat was delayed for a long time.

The main criticism of the organisation is that it is set up to police itself. In other countries, principally Italy, Governments have set up fully independent, free-standing bodies operated by a levy on the pharmaceutical industry, but not controlled by the industry. The MHRA had a chairman who was previously employed by GlaxoSmithKline for many years. Is the Minister happy that this measure is not an extension of that body policing itself and having an interest that is predominantly private and commercial, rather than that of the general public?

Junior Doctors Contracts

Paul Flynn Excerpts

Monday 18th April 2016 Commons Chamber

[Mr Hunt]

Absolutely. More to the point, any doctors who see an increase in their Saturday workload will see a significant increase in their pay, including their premium pay. The contract is designed to make sure that we reward people who work the longest and most antisocial hours, including women, but in a way that means that we can afford to deliver a seven-day NHS, which is why it is good for patients as well.

[Paul Flynn (Newport West) (Lab)]

Many weekend admissions are for urgent cases such as heart attacks and strokes, while many weekday admissions are for elective surgery and other non-life-threatening conditions. Is not that the main reason for the myth of excess weekend deaths?

Why will the anxiety of this strike be felt only by patients in England, while the other nations have settled? Is it because of bad negotiation or because the health service is never really safe in Tory hands?

[Mr Hunt]

I wonder whether the hon. Gentleman would have the courage to say that in Wales, but let me answer his question directly. The 15% increase in mortality rates for people admitted at weekends falls to 11% when we take account of the more chronic conditions, so there is a small reduction, but the mortality rate is still significant.

Junior Doctors: Industrial Action

Paul Flynn Excerpts

Thursday 24th March 2016 Commons Chamber

[Ben Gummer]

I agree entirely with my hon. Friend, and we need this new contract to help junior doctors to achieve a better work-life balance, so that they can maintain their studies, training and experience in a better way than is currently allowed. We must also ensure that they are not exhausted by the contract, which is what happens under the current failed contract. It is in their interest for the new contract to be introduced, and I hope that in the coming weeks they will revise their view of whether this industrial action is truly necessary.

[Paul Flynn (Newport West) (Lab)]

Thanks to the Welsh Assembly, my constituents will not suffer the anxiety caused by the future strike. Does the Minister expect the public to support doctors who dedicate their lives to the health service, rather than the nasty party that opposed the set-up of the health service, and whose support for it has always been half-hearted and grudging?

[Ben Gummer]

It is unfortunate that the hon. Gentleman needs to use such language. The Conservative party is achieving better outcomes for patients in every single metric than the Labour party in Wales, which is consistently letting down patients in the Principality—an appalling aspect for people who are in need of care in Wales.

Junior Doctors Contracts

Paul Flynn Excerpts

Thursday 11th February 2016 Commons Chamber

[Mr Hunt]

I believe my right hon. Friend the Minister of State is with the pharmacists now discussing that precise issue. My hon. Friend raises this issue regularly and rightly: pharmacists have a very important part in the future of the NHS.

[Paul Flynn (Newport West) (Lab)]

On Sunday, I witnessed the seven-day working at a Welsh hospital, where a clinic was held in Nevill Hall for the convenience of patients and to get maximum use of an expensive gamma camera. The Secretary of State constantly denigrates the work of the Welsh health service, but will he pause to congratulate the Welsh and Scottish Governments, who avoided the misery of the strike and will also avoid the poisonous legacy of resentment that he will face from junior doctors?

[Mr Hunt]

The Welsh and Scottish Governments may have avoided the difficult decision that we are taking in the NHS in England, but the longer they go on avoiding the issue, the longer they will have higher mortality rates at weekends, which we are determined to do something about.