National Issues

In light of the fact that the Minister has established a
number of compensation schemes in the last
year, if he will outline the reason for the delay in establishing a
compensation scheme for vaccine damaged children, which has been considered by
his Department for the last decade.

The Joint Oireachtas Committee on Health and Children in its
report on Childhood Immunisation (July 2001) considered that “….. in the
light of the huge benefits of immunisation and the small number of children who
experience serious adverse reactions that a no-fault compensation scheme should
be introduced in Ireland”. They recommended that legislation to provide
for a National Vaccine Injury Compensation Scheme should be drawn up.

In April 2002 the former Minister for Health and Children
met with representatives of the Irish Vaccine Injury Campaign and agreed that
the Department would examine the issues raised.

The Vaccine Damage Steering Group was established by the
Department of Health and Children in 2007 to examine this issue.  The Group included representatives from the
Department of Health and Children, the Health Service Executive (Health
Protection Surveillance Centre, National Immunisation Office and Quality and
Risk), the Irish Medicines Board and the State Claims Agency.

The terms of reference were to identify and define the
adverse events following immunisation with certain vaccines, the feasibility of
estimating the number of recipients of vaccination programmes who experienced
adverse reactions, identify the most relevant model of vaccine damage
compensation, likely cost and make recommendations.  The terms of reference did not include an
examination of whether or not a compensation scheme was warranted.  The Vaccine Damage Steering Group submitted
its report in September 2009.

The report recommended the introduction of a no fault
vaccine damage compensation scheme. All vaccines provided as part of public
immunisation programmes in line with NIAC guidance would be part of the scheme,
including future vaccines.

Eligibility criteria were defined as a specific list of
adverse effects exhibited for each vaccine. Furthermore the specified effect
must occur within a specific period of time dependant on which vaccine was
used, have lasted more than six months after the vaccine was given or resulted
in hospital stay and surgery or resulted in death.

The Group recommended a three tiered ex-gratia payment
scheme be established with payment dependant on the severity of damage; Minor
Damage €15,000, Moderate Damage – €75,000, Severe Damage – €200,000. The group
recommended that the scheme should be administered by the Department of Social
and Family Affairs.

The Clinical Indemnity Scheme (CIS) was established in 2002,
in order to rationalise pre-existing medical indemnity arrangements by
transferring to the State, via the HSE, hospitals and other health agencies,
responsibility for managing clinical negligence claims and associated risks.  This scheme is managed by the State Claims
Agency (SCA). The clinical activities of public health doctors, nurses and
other community-based clinical staff are included.

The CIS covers claims alleging medical malpractice or
clinical negligence and the associated risk management issues.  The CIS does not cover Employer’s Liability
or Public Liability claims against health agencies or claims against product
manufacturers or distributors such as vaccine suppliers.

Although legal advice received by this Department stated
that the State does not have a legal liability for the injuries suffered by the
survivors of thalidomide, the Minister in March 2012 amended the National
Treasury Management Agency Delegation of Claims Order, 2005 to allow the State
Claims Agency manage claims in relation to the medicinal products thalidomide
and nimesulide.

Consideration is being given to how best to address the long
term health and social needs of people who may have been adversely affected by
State funded vaccination programmes.

Extract from committee meeting

…..Deputy Denis Naughten:…… Question No. 6 relates to a no-fault
compensation scheme for the vaccine damaged children. This refers to a
recommendation 11 years ago from the predecessor of this committee. A report
was presented to the Minister’s predecessor in September 2009. The report made
a recommendation to introduce a no-fault compensation scheme. It is now the
middle of 2012 and we are still considering the issue. Can the Minister provide
some certainty for the families involved? They have been waiting for 40 years for
some acknowledgement from the State that their children were damaged by
vaccination programmes. They are now elderly individuals and are concerned
about what will happen when they pass away. Surely, at this stage there must be
some recognition of the issue and some certainty in respect of the care of
their sons or daughters when they are no longer around.

…. Deputy James Reilly: ……As regards the remainder of the questions, I am
still very much committed to vaccine damage no-fault compensation. It is a difficult
situation and the legal advices are complex, but I have not given up on making
some inroads into that matter.

---

747. Deputy Denis Naughten asked the Minister for Health the position regarding the establishment of a compensation fund for the parents of
vaccine damaged children; when a decision will be made on the implementation of
the recommendations of this report; if in view of the State’s pressure on
families to drop legal claims, he will expedite this issue which has been
ongoing for the past decade; and if he will make a statement on the matter. [36355/12]

Minister for Health (Deputy James Reilly):

My Department is currently examining the recommendations of the Vaccine Damage
Steering Group. However, this issue is complex and needs to be considered in
the wider context of how best to address the long term health and social needs
of people who may have experienced adverse outcomes from other health services.

Tue, Aug 07, 2012

Minister for Health urged to act on steering group recommendation, writes GORDON
DEEGAN

THE MINISTER for Health, James Reilly, has been urged to put in place a
no-fault compensation payment scheme for children affected by serious adverse
reactions under State vaccine programmes.

Independent TD Denis Naughten said it was almost three years since the
Vaccine Damage Steering Group, established by the Department of Health,
recommended to Government that a scheme be put in place.

The steering group, which included representatives from the department, the
Health Service Executive, the Irish Medicines Board and the State Claims
Agency, recommended that payments should range from €15,000 for minor damage
caused by vaccines to €200,000 for severe damage.

The report concluded that there was an onus on the State to look
sympathetically at the very rare cases in which children suffer serious adverse
reactions because of their participation in State vaccine schemes.

The group recommended that payment should not be regarded as compensation
but rather a recognition that, in limited cases, an adverse event could take
place following immunisation and, “on the balance of probability”, damage
occurred as a result.

“The report is being allowed to gather dust,” said Deputy Naughten.

In response to a recent Dáil question from the deputy on the issue, Dr
Reilly said his department was currently examining the group’s recommendations.

“However, this issue is complex and needs to be considered in the wider
context of how best to address the long-term health and social needs of people
who may have experienced adverse outcomes from other health services,” said Dr
Reilly.

Deputy Naughten said more than 100 families were seeking compensation for
adverse reactions that date as far back as the 1960s. “Ireland is one of the
few countries where a no-fault compensation scheme is not in place,” he said.

Deputy Naughten, who said his three children had been vaccinated, said he
was not opposed to vaccination but it was wrong not to acknowledge that there
was a risk, “though the risk of not being vaccinated is far greater”.

Rita Duff, spokeswoman for Irish Vaccine Injury Support, which represents
120 families, said 80 per cent of the cases in which children suffered serious
adverse reactions to vaccines date to the 1970s.

Ms Duff said successive governments, “despite being requested to deal with
this issue, have failed to even recognise our children’s very existence,
leaving us as parents isolated and trying to cope with the catastrophic
injuries and, in some cases, death caused by vaccines promoted by the State”.

She said the support group was prepared to work with Dr Reilly and any State
agency to set up an agreed compensation scheme within a certain timeframe.

© 2012 The Irish Times

…..Deputy Denis Naughten:

I thank all the witnesses for coming before the joint committee.
As this meeting has shown, vaccines are an emotive issue. As Ms Paula Byrne
noted, parents need to be given information to allow them to make an informed
decision on whether to vaccinate. Sadly in this country, this basic requirement
is ignored at times.

Ms Hogan pointed out that adverse reactions to the HPV vaccine
have been recorded in Washington. How many such cases have been recorded and
what is the ratio of adverse reactions to the number of vaccinations
administered? It is important to have balance in this matter.

The officials from the Department will correct me if I am wrong
but I understand that in respect of all vaccines, decisions must first be taken
on the efficacy of the product in question, after which a cost-benefit analysis
is carried out. Senator Crown highlighted the significant benefits associated
with the HPV vaccine. One must weigh up the adverse reactions to the vaccine
and their incidence and scale against the risk of not vaccinating.

It is frustrating that medical policy makers in this country
ignore and are afraid to acknowledge that there are adverse reactions
associated with vaccination. It is a medical fact that no vaccine is 100% safe,
there are risks associated with vaccines and people are damaged by them. The
number of adverse reactions to vaccines is probably higher here than elsewhere
in Europe probably as a result of our limited genetic pool. The issue is the
scale of adverse reactions, that is, whether they are minor or severe.

Senator John Crown:

Does the Deputy have any facts to back up his assertions?

Chairman:
Senator Crown was not interrupted and should allow Deputy
Naughten to speak.

Deputy Denis Naughten:

As Senator Crown noted, the issue of enlightenment arises in
respect of vaccines and a full and open debate is needed on the issue. For the
record, I have three children, all of whom have been vaccinated with all of the
relevant vaccines. While I have no hesitation in having my children vaccinated,
parents need to be given all of the information to allow them to weigh up the
decision on vaccination. An issue arose recently in respect of a parent of a
child who had an adverse reaction to the second administration of a particular
vaccination. The child’s general practitioner refused to administer the third
dose and chose instead to refer the child to a specialist before a decision is
made on the issue. The position is changing in this country regarding vaccines.

One of the reasons we invited departmental officials before the
joint committee was to receive an update on what has been done since the
committee reported on this issue in 2001. Its report stated that “in the
light of the huge benefits of immunisation and the small number of children who
experience serious adverse reactions a no-fault compensation scheme should be
introduced in Ireland”. Ireland is the only country in Europe that has not
introduced such a compensation scheme. Most countries have had such a scheme in
place for years, yet nothing has been done over the past 11 years to implement
the joint committee’s recommendation in this regard. In the United Kingdom, the
maximum possible payment under a compensation scheme is £120,000 and the
average payment is £3,800.

Anyway, there is a scheme in place and there is public acknowledgement
that some children are damaged by vaccines. The reality is that the risks of
having a vaccination programme rolled out are far less than the great benefit
to children and to society as a whole. However, some acknowledgement must be
given to this.

Previously, the committee made a recommendation to the effect
that there should be a link developed between the birth registers in the
country in order that the information technology system in place could trace
children. At the moment there are four separate information technology systems
with eight implementations throughout each of the former health boards. When
will we get our act together and have one information technology system for a
vaccination programme? When will we have a system in place whereby we can have
traceability through the children’s allowance system to know where children are
or where they have slipped through the loop? Such traceability is not in place
at the moment and it is undermining our vaccination programmes as a result.

…….Deputy Regina Doherty:

I thank the witnesses for coming here today and for presenting to
us. Notwithstanding the differences of opinion, I agree with my colleague who
said that parents have a choice. It is incumbent on all of us as parents to
ensure we are best informed before we make a choice. That is part of parenting.
I do not blindly accept other people’s opinions because opinions differ.
Anyway, it is incumbent on all of us as parents to ensure that we are as
educated as possible with regard to what we are providing for our children and
to make informed decisions in this regard. Against this backdrop we need to
recognise that with every vaccine there is a slight risk.

I am sorry if this is not the appropriate venue but I have
written many times to the Department of Health and to the Minister about it.
Reports were commissioned by previous Governments on the whooping cough
vaccinations scores of years ago. I genuinely believe they are sitting on
shelves. What genuine consideration has been given to the recommendations of
the previous Oireachtas committees and the reports issued by previous Ministers
with regard to setting up a no-fault compensation scheme for children who were
damaged by vaccines? This does not relate to cases that might arise in ten
years’ time or perhaps next year. It relates to children who were genuinely
damaged by previous vaccines. The responsibility on the State is to address
this issue and it is nothing short of a disgrace that we have had children who
were inflicted with this in an awful way in the 1970s and 1980s. It is now 2012
and we still have not addressed these issues. I would be grateful if the
delegations could address these points.

……. Dr. Colette Bonner:

In regard to a national vaccine injury compensation scheme, an
expert group was set up and has reported. However, the Department is still
looking at that report and trying to decide whether to establish a vaccine
injury compensation scheme or a system to deal with other adverse health care
events. We believe those two things cannot be separate from one another. It is
quite a complex area. We are having discussions and negotiations but to date we
have not provided any legislation for a national vaccine injury compensation
scheme. However, that does not mean it will not be part of our plan into the
future.

Deputy Regina Doherty:
I do not mean this to be disrespectful in any way, shape or form, and I am
just trying to understand the issue, but what does it mean when a
representative of a Department says that the Department has been looking at
something for three years? I have asked previously for details of the occasions
this matter has come up and been discussed and how it has been further advanced
in the past three years, but I have got nothing in response. I am left in a
vacuum, thinking this report is sitting on a shelf somewhere. What does it mean
that the Department is looking at it?

Just as Dr. Kelleher explained, we have all been involved in other things to
do with immunisation programmes for the past three years. We had the flu
pandemic vaccine, which took up a good deal of time and resources, we
introduced the HPV vaccine and we have made other changes to the schedule. It
is something that is still under consideration and we will get to it.

I thank the witnesses for their responses and thank Dr. Kelleher
in particular for his response. I put it to him that he is correct in that the
aforementioned recommendation regarding a no-fault compensation scheme was made
11 years ago. As he is aware, every other country in Europe and every other
developed country in the world has put in place such a system. Nevertheless,
Ireland still has not done so. It must be acknowledged publicly that in a
limited number of cases there are severe adverse reactions to vaccines, and
those children and their families should be treated in a humane manner. To
revert to the point made by Deputy Ó Caoláin, is it not true that in many cases
parents have been obliged to fight and are still fighting for a public
acknowledgement that their children were damaged by the vaccine or may have
been damaged by the vaccine? Is it not the case that they are subsequently
obliged to fight for even the most basic of services? Dr. Kelleher is aware the
State has acknowledged 16 cases. An ex gratia payment of £10,000, with a
confidentially clause tied into it, was made to those particular families when
Dr. Woods was Minister for Health. Does Dr. Kelleher not think this matter
should be getting a far higher priority within the Department and that there
should be public acknowledgement that these children and their parents should
be treated in a humane manner where, in all probability, they have been damaged
by the vaccine? This pertains to very small numbers and Dr. Kelleher’s point
regarding proportion is correct. However, while the benefits far outweigh the
risks, this does not mean one should shove the risks under the carpet or ignore
those families and parents. This issue has been considered and navel-gazed
within the Department since 2001. I met the Minister in April 2002 on this
subject. A report was produced, followed by an expert group report, which now
is gathering further dust, although the Department has stated consistently
since 2009 that it is considering it. It took a long time even to get the
aforementioned report published. When will actual action be taken in this area?

As my identifying label has fallen, I should clarify to Deputy Naughten that
I am from the HSE and not from the Department of Health. I totally agree and
have always stated that there should be a vaccine damage scheme in place in
Ireland. It is absolutely essential to the provision of an immunisation
programme. I have no doubts whatsoever about that and have said so repeatedly.
As the Deputy is aware, I made this point ten years ago and repeat that it is
an absolutely essential part of any immunisation programme to provide that sort
of thing. Most of our vaccines are now incredibly safe and
most of the history is there. I only came to the country in 1995, but I was
involved in the UK prior to that and we were probably not dissimilar.
Historically, we may not have dealt with people as well as we should have done.
I hope we are now dealing much better with people who have got problems.
Historically, some of our vaccines were very problematic. The vaccine we had
for smallpox did not just cause people problems, it also had a mortality rate.

When did it stop being used?

The most recent example is shown by a report that Dr. O’Flanagan has
produced and which is in the public domain. When we used the H1N1 pandemic
vaccine during the flu pandemic, it would appear that adverse reactions were
associated with a very small number of people. The numbers at the moment appear
to be around 30 to 40, although that could grow. Unfortunately, they developed
a severe form of narcolepsy. We are providing as much support as possible to
those people at the moment. We are paying for treatment and for them to visit
non-public services where appropriate. We are giving them support in different
ways. Where they request medical cards they are being given the discretionary
medical cards. We are also giving other costs. We have been working with our
colleagues in the Department of Education and Skills to provide educational
support for them. Therefore we are clearly committed to trying to support such
individuals. As the committee has heard, however, the vast majority of problems
that happen with immunisation are minor.

Having said that, we have heard that some people get anaphylactic shock. It
is uncommon but all our staff are regularly trained in how to deal with
anaphylactic shock. All of those are now dealt with immediately by the staff. They
are resuscitated immediately and looked after. We are careful about all these
issues.
With regard to Deputy Ó Caoláin’s question, we have tried to give as much
support as possible to the people who seem to have been affected by the H1N1
vaccine. I am not saying that we have done everything because that is never
possible, but we have made every effort to try to help them. We have brought in
colleagues from other Government Departments to support us as well. They have
been very helpful.

I ask the senator to brief as we are over time.

My question was how many cases does Dr. Kelleher believe have had
serious long-term damage as a result of vaccines in general in this country? He
said there may have been 30 to 40 with the flu vaccine.

From my understanding, one would then have to go back to the
people who were involved.

With ancient vaccines?

Yes, with the older vaccines. Most of the vaccines now in place are predominantly
produced to increase their safety. To an extent, that has caused some
difficulties in their efficacy.

We have had some problems with adverse events associated with the use of BCG
vaccination. Some of those have been severe and have necessitated surgery in
some of those children. That is probably our most problematic vaccine.

It is a very old vaccine.

Yes, but for the vast majority of vaccines the problems are minor, including
sore arms or local, short-term increasing fevers. It is rare to get a
long-lasting adverse event from vaccines.

We will now conclude this part of the meeting.

Dr. Bonner may want to come in concerning the report.

Yes. I just want to note the committee’s concerns that there is no vaccine
damage compensation scheme. There is an expert report which we are considering.
I will convey the committee’s concerns both to the secretary-general and the
Minister on this point.

The Minister is well aware that I gave evidence to the expert group, but we
need action on this. Senator Crown is right to say that the vast majority of
these cases are historic, but there needs to be an acknowledgement given to the
families concerned. Most of those children are now in their 30s and 40s. Their
elderly parents have fought for even the most basic acknowledgement from the
State that anything adverse happened to their children. This matter should be expedited
before it is too late for some of the families involved.

…..