Contents
- Attendance
- Continued Petition
- New Petitions
- Continued Petition
New Petitions
Pluserix Vaccine (PE1658)
Agenda item 2 is new petitions. The second petition on our agenda is PE1658, which calls for compensation for those who suffered a neurological disability following administration of the Pluserix vaccine between 1988 and 1992. We have the opportunity to hear from the petitioner, Wendy Stephen, whom I welcome to the meeting. It is good that she has been able to come along.
We will start with a brief opening statement of up to five minutes and then move to questions from members. Once we have concluded our questions, we can consider action that we may wish to take.
Good morning and thank you for inviting me to address the committee.
I make it clear that the brand of measles, mumps and rubella vaccine that is the subject of my petition is not in use today and has not been used in the United Kingdom since 1992. The issues that I have raised are historical in nature, but are nevertheless of huge significance to the young people in Scotland who received Pluserix MMR and as a consequence still suffer lasting neurological disabilities.
In October 1988, despite the fact that the Urabe-containing Trivirix vaccine had been introduced and almost immediately removed from use in Canada in 1986 following concerns that it was causing mumps meningitis in recipient children, the Scottish home and health department supported and implemented the marketing of a Urabe-containing brand of MMR—Pluserix—in Scotland. After the Canadian authorities had stopped using the vaccine to await laboratory-confirmed test results to conclusively determine whether it was the cause of the meningitis and the manufacturer had voluntarily ceased marketing it, Pluserix was introduced in Scotland.
Despite a number of early indications that a similar problem to that encountered in Canada was occurring here, the Scottish home and health department continued to support the use of Pluserix for four years, two of which were after the Canadian licence was cancelled in 1990, when it was conclusively proven that the Urabe mumps strain had been isolated from the cerebrospinal fluid of the Canadian children. At that time, the Canadians concluded that the vaccine
“was not considered safe for immunization of Canadian children.”
One has to wonder how anyone could have thought that the vaccine was safe for Scottish children.
Eleven months after the introduction of the vaccine here, in September 1989, the Committee on Safety of Medicines reported 10 cases of mumps meningitis. Dr Alistair Thores was the senior medical officer and named point of contact in the Scottish home and health department circulars that advised that Pluserix was to be one of the MMR brands to be introduced into Scotland. He also represented the department on the joint committee on vaccination and immunisation and the sub-committee of the JCVI on adverse reactions to vaccination and immunisation, and he was present when committee members reported on the high incidence of mumps meningitis.
In April 1990, despite the fact that the Scottish home and health department wrote to the JCVI to outline its concerns about the incidence of mumps meningitis and to question whether an alternative brand of vaccine should be used, it still continued to support the use of Pluserix on Scottish children. Dr Thores was also present when, in May 1990, the JCVI heard that three districts had switched from Urabe-containing MMR to the alternative brand. One has to wonder why Scotland, with the very obvious heightened concerns, did not do likewise.
The JCVI’s statutory functions do not extend to Scotland and the authorities were not bound to comply, either in part or in total, with any advice given to them by the JCVI. It was, at all times, open to the Scottish home and health department to cease using Pluserix and to switch to an alternative brand.
In September 1992, the Department of Health removed Pluserix from use, and it became the subject of an import ban in 2002, at which time the CSM chairman spoke of the risk of “potentially serious neurological complication” to children.
Pluserix was insufficiently attenuated and considered to be a defective product within the meaning of the Consumer Protection Act 1987. It was originally estimated to cause mumps meningitis at a rate of one case per 100,000 doses, but scientists in Nottingham provided a laboratory confirmed rate of one case per 3,800 doses, a significant difference.
The Department of Health commissioned a study, conducted by the British paediatric surveillance unit, of all reported cases of mumps meningitis, which included a follow-up study a year later to determine any lasting sequelae in the children. Nine cases of sensorineural deafness, a condition which is included in the manufacturer’s list of possible adverse reactions to Pluserix, were detected in the cohort and reported on in a paper by Stewart and Prabhu.
The vaccine damage payment scheme only provides financial assistance to applicants who can satisfy the assessors that they have experienced a 60 per cent disability. Some applicants seeking compensation for sensorineural deafness following the administration of Pluserix have been acknowledged as vaccine damaged, but not damaged enough to qualify for a payment.
Despite the fact that the Scottish home and health department was aware of both the historical background to Pluserix from Canada and the fact that identical problems had been and were occurring here, parents bringing their children for the measles, mumps and rubella vaccine vaccination were entirely unaware. It is difficult to see how informed consent could have arguably been obtained in those circumstances.
Unfortunately, in 2008, Miss Nicola Sturgeon, the then health minister, acknowledged:
“Senior medical officer files were not held centrally within the Scottish Home and Health Department but retained by individual doctors during their period of employment and destroyed thereafter.”
It follows that relevant files on Pluserix MMR have been destroyed and are not available to the committee.
I respectfully request that the committee consider how this highly problematic dangerous vaccine was able, first, to enter the Scottish market, and secondly, to remain there for four years despite the obvious concerns and problems identified by the Scottish home and health department.
To date, the children who have suffered lasting neurological disability following the administration of the Pluserix vaccine in Scotland have received neither acknowledgement nor compensation. In 1982, Lord Campbell of Alloway in the House of Lords advocated that where a child has been damaged through vaccination, in the interests of the community there should also be
“absolute liability and fair compensation.”—[Official Report, House of Lords, 1 December 1982; Vol 436, c 1241.]
Today, on behalf of those who have suffered lasting neurological disability following use of the Pluserix vaccine, I seek both.
Thank you very much for that statement. There is obviously a lot in it. Although you have alluded to this issue, in order to capture it better, will you provide a picture of the scale of the problem and how it might be addressed? Do we know how many people in Scotland have been adversely affected by the vaccine? I think you said that a person had to have more than a 60 per cent disability before they were counted. Are there others who were affected to a lesser extent? How should the level of compensation be calculated?
I have no way of knowing the numbers affected. No one has ever collated that information.
Do you have any idea how the levels of compensation should be calculated? How would that be done?
The vaccine damage payment unit, as I have said, only pays money to applicants who are more than 60 per cent disabled. Therefore, there will be people under that 60 per cent threshold who are acknowledged as vaccine damaged, but who do not receive payment.
You think that they should.
We have a situation where a party is saying to an individual, “You have been damaged. We acknowledge that you have been damaged. We acknowledge that the vaccine has damaged you but, in our opinion, after assessment, you are not damaged enough to qualify for payment.” I do not know of many circumstances in life in which someone can say to a party, “My product or something that I am party to has damaged you, but not to the extent that I have to acknowledge that, deal with it and compensate you.”
Can you think of any examples of someone who has been damaged not having to meet that threshold? Is there anything comparable that you can think of or any other cases of people being treated differently?
No.
It just does not seem fair if there are examples of people being treated more fairly.
10:45
The committee understands that payments can be made under the Vaccine Damage Payments Act 1979 and that that does not prejudice a person’s ability to claim compensation through the courts. Can you give us your thoughts on how the payments scheme under that act has worked for people who have been adversely affected by these vaccines?
I do not think that it is addressing the problem, because it applies only to those who can meet the 60 per cent threshold and beyond. You have the unsavoury situation in which the VDPU acknowledges to people that they have been damaged by the vaccine but in its opinion, following assessment, they have not been damaged enough to qualify for a payment.
Thank you. I think we need to get some more clarification on that 60 per cent threshold.
It is non-negotiable; the 60 per cent threshold is for everyone across the board. It used to be 80 per cent, and it dropped to 60 per cent, but that still means VDPU assessors examining individuals and saying what percentage of disability they feel that person has.
There are two hurdles to overcome with the vaccine damage payments unit: first, establishing biological plausibility that the vaccine has caused the injury that is being complained about; and secondly, meeting the 60 per cent threshold. We have children meeting the biological plausibility factor and being acknowledged as vaccine damaged, but although they are struggling with their disabilities, they are not being assessed as viable for a payment.
Thank you.
Good morning. This situation is to some extent historical, in that it happened before devolution, but the Scottish Government can make voluntary payments to people who have been affected by the vaccine. Are you aware of anyone who has asked for payments from the current Scottish Government or indeed previous Administrations?
For this particular cause?
Yes.
No, I am not aware of that.
Do you know whether Governments in other countries have awarded compensation to people?
Again, for this particular cause?
Yes.
No, I am not aware of that. Not every country used Pluserix MMR; America, for example, only ever used MMR2 product. Three brands of vaccine were implemented in Scotland and, when the problem with Pluserix was discovered and it was eventually removed from use, people switched to an alternative brand.
I might have missed this in our papers, but how long have you been campaigning for this?
Approximately 25 years.
What bodies have you approached in that time?
I went through MMR litigation in the English courts, and I have approached many ministers. In the early 2000s, my MSP Mike Rumbles very kindly approached the justice minister at that time, Jim Wallace, and asked about the possibility of bringing litigation in Scotland. At that point, I was told no, but I was granted legal aid in Scotland to find out from a solicitor whether there was any viability in the claim. However, the answer came back that there was no possibility of bringing a case in Scotland.
Again, in 2007, I wrote to the then First Minister Alex Salmond to ask why we were not able to bring litigation in Scotland. At that time, I was advised that Scottish ministers do not give legal advice. I was not seeking any such advice—all I wanted was an understanding as to why we could not bring a legal action in Scotland for these young people.
Was the vaccine available across the United Kingdom? If so, are you aware of any cases in the rest of the UK that have been successful?
No. Nobody has ever brought an action specifically for Pluserix. The MMR litigation that was held in England included all vaccines and only addressed problems with autism and inflammatory bowel disease. Neurological problems that were specific to the Urabe mumps strain contained in the Pluserix vaccine were never looked at.
So yours is a very specific issue that is quite different from people making a connection between MMR and a consequent autism diagnosis.
It is quite different.
It is different because it has been established that the vaccine was a problem.
Yes.
Thank you for giving evidence.
I am struggling a little bit. I have looked through our papers and I am trying to come to grips with the amount of people you think have been affected by this. I understand that it is difficult to specify the amount because files have been destroyed and you do not have them, but do you have an indication of how many other people have suffered problems?
No. Nobody has ever brought these people together in one body. Nobody has ever counted the figure or attempted to see how many people out there have been affected by the vaccine.
I can tell you that the Medicines and Healthcare products Regulatory Agency has confirmed to me that it had 11 cases of sensorineural deafness reported to it in connection with the Pluserix vaccine, but that is only one type of condition.
Is deafness the only symptom? In your submission you alluded to the fact that it could be a side effect. Are there others?
I would imagine that there would be other side effects, but I have not been involved in any of that. My drive has been more to do with sensorineural deafness, which is listed in the product insert as a possible side effect of the vaccine.
The Department of Health study that was commissioned to investigate the children who developed meningitis after taking Pluserix determined, I think, nine cases of sensorineural deafness. Deafness has definitely appeared following the use of Pluserix.
Thank you. I may come back in at the end if that is all right, convener.
Good morning, Wendy. You explained in your evidence that, although compensation is available through the courts, people have experienced barriers to accessing it due to issues such as the limitation periods that apply. If the Scottish Government were to agree to make voluntary compensation payments, what principles should it adopt to ensure that the voluntary scheme is suitably accessible and fit for purpose?
My aim is to secure perhaps an ex gratia payment for these children. The only way that we could go back to a legal process would be if we could lift the time bar, but that is a very lengthy, complicated and not always successful road to go down. Undoubtedly, time bars on bringing more legal action will have long since been reached, which is on top of the difficulties that I encountered in the early 2000s when I tried to bring litigation in Scotland. At that point, I was told that the Limitation Act 1980 would prevent me from going forward and that funding would also be a problem. If those issues were a problem back in the early 2000s, they would definitely be a problem for young people today and, as I said, we would probably have to go to court to ask for the time bar to be lifted to allow us to go forward in that way.
Have you thought of taking any action against the manufacturer?
That is what the litigation in England was. The only defendant in that litigation was the manufacturer of the vaccine. As we have discussed, that litigation was—
Did that come in under the time bar?
Yes.
You have not been given advice about the ability to take legal action against those who prescribe the vaccine, as opposed to the manufacturer. You confirmed that earlier.
We could not do that in early 2000s.
Your petition calls on the Scottish Government to acknowledge those who have been adversely affected by the vaccine. Will you elaborate on how you see that acknowledgement being made? How would you like to see it delivered?
Personally, I would like a statement acknowledging that there was a problem with the vaccine and that some, though not all, children who got it have been left with lasting disabilities because of it and they are still going about today with those disabilities. Nobody has ever mentioned Pluserix before; it has never been spoken about, approached or acknowledged. The children exist; they are now young people—young men and women—and this happened to them, but nobody has ever acknowledged that they exist, addressed their problems or said, “Let us have a look at this.”
I may be speaking for the committee when I say that this is not something that I was aware of until I read the papers on the petition. The petition raises a whole number of questions, including where the threshold lies and why a threshold is established that means that, although you have a problem, it is not enough of a problem. We can instinctively see that, from your perspective, that is something for us to ask further questions about. We are very grateful to you for lodging the petition.
Are there any suggestions about how we might take this forward?
First and foremost, we clearly need to seek the views of the Scottish Government. It might also be an idea to contact the JCVI and the MHRA, which have already been mentioned in evidence, and the Committee on Safety of Medicines, to get their views on the petition.
That would make sense. We would want to ask the Scottish Government whether it is aware of the circumstances; whether it has looked at the issue; whether it would contemplate voluntary ex gratia payments and how it thinks those would be calculated. Once we get a response we can think about whether to take more oral evidence. Wendy Stephen has posed a lot of questions on an issue that I do not think any of us were aware of. We get a very strong sense from her of the sense of injustice about what has happened. Part of the injustice may be that this is an issue that is not even being discussed.
The MHRA came into being only in 2003 and therefore was not around in 1988 to 1992 when the vaccine was on the market. The Committee on Safety of Medicines was replaced on 30 October 2005 by the Commission on Human Medicines.
That is useful for the clerks to know. We may want to know what was the predecessor body to the MHRA and take advice on which organisations we might get further information from.
I mentioned manufacturers earlier. Could we think about having the manufacturers appear in front of us?
Can we look to get advice on that?
There are some issues within that.
The only avenue that I think might be applicable for the committee to pursue would be to approach Dr Thores, who was in the Scottish home and health department at the time when the vaccine was very much in circulation and was being supported by the department? In view of the fact that the files have all been destroyed, we do not have the luxury of referring to them, but Dr Thores could be approached to give some background.
I suggest that we take advice about how best to get access to information about decisions that were made at that time—it might be through the chief medical officer. We are conscious of the difference between the role of the system and the role of individuals within it, and we would want to be careful about that. We certainly want to get a sense of how decisions about vaccines were made and what systems were in place to test those decisions.
Wendy Stephen mentioned in her evidence that a decision was made—was it made by Lord Gill?—in relation to people who had been injured as a result of being vaccinated in the community benefit for the eradication of disease.
It was by Lord Campbell of Alloway.
It would be useful for the committee to look at that and to have that information among our papers when we look at the next stage, because it would give us a steer on how to deal with the issue.
Because the papers have been destroyed and we do not have them, we should get some information from the Canadian medical authorities. Why did they stop the use of the product?
I am sure that there must be evidence in the system, with reports on why they made that decision.
I can perhaps assist with that. The Canadians removed their product because it was causing what they thought at the time was mumps meningitis in the children, although they could not be sure, because there was no definitive test then to determine that it was undoubtedly due to the vaccine.
With the passage of time, a test was developed that could determine whether or not the vaccine was the sole cause of the meningitis that was being seen in the children. Once that was determined, with laboratory-confirmed proof that the meningitis that could be seen in the Canadian children came from the vaccine, the licence for the vaccine was taken away in Canada.
Thank you—that is very useful.
11:00
We will want to do a lot of information gathering ahead of our next consideration of the petition. We recognise what you have brought to the committee’s attention. Broadly, this issue has not been part of the conversation in public health. We will gather evidence and we will have a further session in consideration of the petition. Thank you very much for your attendance.
Forestry (Regulation) (PE1654)
The next petition is PE1654, by Ian Munn, on forestry regulation. Members have a SPICe briefing, a note by the clerk and a submission from the petitioner. The petition calls on the Scottish Parliament to urge the Scottish Government to develop a statutory code on stakeholder engagement for the forestry industry based on Confor guidance. It also calls for a Scottish Government body to oversee implementation of and compliance with the code.
The SPICe briefing explains that the Forestry and Land Management (Scotland) Bill was introduced on 10 May 2017 but that it does not include provision for a statutory code on stakeholder engagement for the forestry industry, as requested by the petition. Members will see that the petitioner’s submission sets out in more detail how local people can be affected by a lack of consultation by the industry.
Do members have any comments or suggestions?
I was struck by the petitioner’s comments on the degree of damage that can be caused, including damage to roads and verges. Forestry that has been planted many years ago is now being harvested, but there is no obligation to work with local communities on that, and we can understand the level of concern there. Do people have any views on what the petitioner says?
The issue is not covered at all in the Forestry and Land Management (Scotland) Bill, which the Rural Economy and Connectivity Committee has just started to consider. We have heard evidence and we have seen the damage that can be caused to roads as a result of forestry work. It is one of the issues that was brought before the committee on one of the forestry visits that we made. It is a genuine concern. As it falls outwith the scope of the bill, it may be the case that it is for the Public Petitions Committee to contact the Scottish Government and find out whether it would deal with the issue in regulations or in the guidance on the bill, where it is not covered at the moment.
Why do you think that the issue is outwith the scope of the bill? I accept that it is, but do you have a view on why it has not been included, if it was evident to the Rural Economy and Connectivity Committee that there is an impact?
It is probably too early to say and I probably should not answer for the committee. It was interesting to learn at yesterday’s evidence session that there is a lot about felling in the bill that was probably covered by regulation before, and the committee is still looking at why some things are within the bill or outwith it. The issue of consultation will probably fall under a regulation as far as grant schemes in the future are concerned, but I do not think that the bill covers the issue that the petitioner is bringing to the committee.
The petition refers to verges and roads but also to the impact of traffic, which is something that we already have examples of in other petitions.
I have some sympathy with the petition, and I have seen at first hand the damage that can be done by heavy trucks moving timber. There has been an attempt by the Scottish Government, as I recall, to move the transportation of timber from road to sea through an initiative called rathad na mara, which is Gaelic for road of the sea, and the Forestry Commission has been heavily involved in that. I have seen it in practice on Mull and at some other west coast sites, and it would be good to get more information on that. It is important to clarify that attempts have been made before now.
The very fact that there is a bill addressing the whole question of forestry tells us that the Scottish Government is aware of it. It would be useful to know about the initiatives and their benefits or limitations, so we should write to the Scottish Government to ask about that.
The Scottish Government has a network of roads that are approved as forestry extraction routes and there are limitations on the roads, which I believe are agreed with local authorities, which are responsible for maintaining those roads in many cases. The committee may consider it appropriate to take up with the Scottish Government whether that arrangement needs to be reviewed as part of the Forestry and Land Management (Scotland) Bill in the wider scheme of things, but there is already a basic outline of routes that are available for people to use, although I do not know what the terms would be for it.
I have experienced the same thing in Argyll and Bute, where we have gone quite a long way with the Forestry Commission—I am sorry; I should have declared that I used to be a councillor in Argyll and Bute. A lot of timber has gone on to the sea, although there is still a fair amount travelling by road. We should certainly put the Convention of Scottish Local Authorities on the map here, but it is true to say that the situation has been improving.
Rather than contacting COSLA, would it be more logical to identify the local authorities for which this would be an issue and speak to them? The issue is whether consultation with local authorities extends to communities where timber transport might have a direct impact. Let us therefore write to the Scottish Government, Confor, the Forestry Commission Scotland, the various industry bodies and others with an interest, such as the Woodland Trust, and any other bodies that the clerks can establish have a view on the matter. We recognise that there may be an issue, and there may be an opportunity in the legislation, so we are trying to put the issue into context. If we make contact with the bodies that I have suggested, we can look at the issue further. Is that agreed?
Members indicated agreement.
Elected Members (Threats or Assaults) (PE1656)
The next petition is PE1656, by Rob McDowall, on threats to or assaults on sitting members of Parliament, their staff and their families. Members have a SPICe briefing, a note by the clerks and a copy of the petition.
The petition calls on the Scottish Parliament to urge the Scottish Government to bring forward specific legislation that would introduce a statutory aggravation for assaults on or threats against the safety or the lives of elected members and their staff and families. The petitioner highlights the fact that statutory aggravations exist in Scots law, in cases such as those involving assaults against police officers, for example, and in his view similar aggravations should be in place in relation to parliamentarians and their staff and families.
Do members have any comments or suggestions? It is kind of difficult to avoid sounding like we are engaged in special pleading, I suppose.
In this Parliament there has been a desire, through the Emergency Workers (Scotland) Act 2005, to identify groups of workers who put themselves at risk of assault. Cases of fire fighters being ambushed drove that legislative process early on, followed by discussions about the fact that there are other vulnerable groups of workers, such as shop workers who refuse to serve people because they are under-age or are under the influence of alcohol. The petition feels like an extension of that. I understand the motivation behind it but, when you start to identify groups of people who are vulnerable in this way, you have to think about who you are leaving out. Various people are often vulnerable in their workplace.
I am sure that we all understand the motivation behind the petition. We will all have had relevant experiences, particularly regarding threats to our staff—certainly, I have had to deal with such cases, regrettably. The question is whether having a statutory aggravation in this regard is worthy of pursuit. It might be worth seeking out the views of various organisations on the matter.
I agree. My concern is that the issue we are dealing with might already be dealt with under existing legislation, perhaps in a hidden way.
That is often the case in situations like this. However, I think that the motivation behind earlier legislation was to name the crime. In the context of the terrible things that have happened, such as what happened to Jo Cox, you can understand people recognising the vulnerability of elected representatives—I would extend that concern to local authority elected members and others who are often in the front line when people are feeling let down and frustrated by the system or have a hostility towards it. However, the question is whether, in reality, naming the crime gives any more protection to elected representatives or deters people from committing that crime. That is the bigger question that people have considered.
No one is disputing the motivation behind the petition, and we all recognise the vulnerabilities that we are talking about, particularly in relation to our staff; the question is whether there is a legal dimension to that or whether there are other things we can do to ensure that people are safe.
I do not think we should close the petition at this point. It might be worth seeking people’s views on it.
I think we should seek further information.
We could write to the Scottish Government, the Crown Office and other legal organisations, the police and the Scottish Sentencing Council. In doing so, we should emphasise that we are asking for their views merely to test the proposition in the petition, and that we have not yet taken a view on it. I think that would be fair. Is that agreed?
Members indicated agreement.
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