Denis Naughten (Roscommon-Galway, Independent) | Oireachtas source

I welcome the opportunity to speak on this important legislation. I want to reference correspondence I have received from constituents regarding correspondence from the Irish Council for Civil Liberties on the legislation. It has raised the following three particular points. The scheme should be expanded to all survivors and the six month threshold needs to be looked at; the legal waiver, criticised by the UN which has specifically asked for its removal, should be removed; and the compensation available should be increased.

I want to focus on the third of these, that the compensation should be increased, with regard to provisions that are missing from the Bill. These are with regard to the vaccine trials and the failure to be accountable of GlaxoSmithKline, GSK, the corporate successor to Wellcome which carried out many of these vaccine trials in mother and baby homes throughout the country. GSK, the successor to those responsible for carrying out the vaccine trials on toddlers in our mother and baby homes, must stand up and be held accountable. At this stage we will not get answers but we must have acknowledgement from GSK that what was done was completely unethical and, as a result, at the very least it should and must contribute to this redress scheme.

At least 13 vaccine trials were carried out on more than 43,000 children according to the commission of investigation. More than 1,000 of these children were in the institutions concerned. Survivors who were literally used as human guinea pigs in vaccine trials in the mother and baby homes must receive an apology from GSK and must have this acknowledged by the company. It should make an offer of compensation for practices that would not have been tolerated in the United Kingdom where the company was based at the time.

When the mother and baby homes commission of investigation reviewed the medical records available to it - and I repeat, the records that were available to it - it concluded there was no evidence of injury to the children involved in the vaccine trials. This conclusion was simplistic. These children were treated as little more than human pincushions by the companies and clinicians involved due to the large number of injections they received and blood samples taken. How can any of us be sure there was no delayed immunological impact from these formulations? This is particularly the case if no guardian was able to tell a subsequent doctor treating the children that they had previously received an experimental vaccine formulation. The children as adults would not be able to inform their treating doctors they were involved in an experimental trial. Each of these children should have been contacted and provided with their medical records. They should be contacted now. These records, combined with their subsequent medical history, should be independently reviewed and a full and transparent report published on the conclusion of these assessments. Only then can we honestly claim there is no evidence of injury to the children involved in these vaccine trials. At a very minimum this must now happen. This must be provided for in the legislation. The full cost must be borne by GSK.

The mother and baby homes commission of investigation report flagged the issue of consent and the failure to secure it. Why is the issue of consent so important? It is primarily because each and every one of us has a basic human right to our own bodily integrity. There is a need for informed consent in advance of any medical procedure or medical trial. While the particular processes and procedures were far looser in terms of the definition of medical consent in the era of these trials, the basic fact is consent was not sought despite it being a legal and regulatory requirement at the time.

Without engaging with the parents or guardians of the children, a clinician could not have deemed them to be suitable for inclusion in any trial. For example, paragraph 34.121 of the commission's report on the 1968 to 1969 measles vaccine trial states the trial should have excluded children with a personal history of convulsions or allergy, asthma or eczema or strong family history of same. Without consent, how could any of the clinicians have ascertained this in respect of those children in the mother and baby homes? Even at that time, consent was a standard procedure for vaccinations outside of clinical trials, at least in some of the mother and baby homes. For example, paragraph 34.71 states the Dunboyne institute records contain completed written consent forms relating to instances where infants resident there were presented for immunisation at the public health clinic. These consent forms were signed by either the mother or the matron. There were no consent forms available for the clinical trials.

It is also clear from the commission's report that the Department of Health itself had serious problems with the use of children in these homes for clinical trials. There were concerns raised in the UK.

However, paragraph 34.92 of the report states:

A Department of Health document dated 30 September 1963 dealing with this application noted that, in April 1962, Professor Meenan had asked to field-trial an Oral Polio Vaccine in Pelletstown. In that instance, it was noted that the Department of Health had no objection to the trial itself but raised concerns regarding the selection of Pelletstown: 'While the procedure proposed appeared to be a safe one, the selection of ... [a] group to participate was open to objection and approval was not given on that occasion.'

The Department did not want clinical trials carried out on children in homes. However, whether the Department gave consent or not did not seem to make any difference to the clinicians involved. Indeed, paragraph 34.163 notes that permission was sought for a field trial using an oral polio vaccine on the children in Pelletstown, which was refused. The report goes on to state that the commission took the view that there was a high probability that Pelletstown was in fact used in the trial despite the refusal of the Department of Health.

GlaxoSmithKline has many questions to answer. Why did the scientific publications on the UK and Nigerian trials specifically refer to consent, yet these references were conveniently left out of the same publications on the trials based on Irish children? Why was Ireland seen as a soft option for trials involving children in institutions? Clearly, such trials could not take place in the UK, and that was also the case in Ireland, based on the regulatory and legal systems in place at that time. However, because of the lack of enforcement in Ireland, GSK was happy to proceed despite knowing there was no consent, as reflected in peer-reviewed academic journals that had to have secured authorisation from GSK's predecessors before publication.

It is also important to highlight that these scientific publications were peer reviewed in advance of publication. In the British Medical Journaland The Lancet, the academic publications of the British trials included an outline of the consent and confirmation that consent was obtained in line with law and ethical standards. However, this was not the case, as I have said, in the publication of the Irish trials. Why was this not set as a precondition of publication, when it should have been? If it had been, and if the academics were told that they must provide consent, maybe these children would not have been exploited and those institutions would not have been used again and again for trials. This culture of cover up went from the academic journals right up to the highest echelons in the State. The attitude was one of brushing the problem under the carpet and it would go away.

Paragraph 34.153 in the commission's report states that it had been flagged to the Department of Health in 1968 that Professor Meenan had conducted vaccine trials without the authorisation of the then Minister, yet nothing was done. When it comes to mother and baby homes, it was not just the State but reputable drug companies, academics and even academic journals such as the British Medical Journaland The Lancetthat were all prepared to turn a blind eye to the basic human rights of these children, purely because they were in institutions in Ireland that were not properly regulated and monitored by the State. There was a blatant policy of just ignoring consent where it could not be obtained.

Paragraph 34.122 of the commission's report states, "On 5 September 1968, Dr Coffey told Dr Burland [from Glaxo Laboratories] that she had come up against ‘the usual complications’ while trying to arrange to field-trial Glaxo’s measles vaccine in Dublin." The response from Glaxo was extremely interesting. According to the report, "Dr Burland advised Dr Coffey to liaise with Dr Hillery as 'she may be able to suggest a way in which you could overcome the problems you have encountered'." In other words, you could get around the law of the land and the refusal of the Department of Health to sanction this trial. There was a clear culture within the company, which has morphed into GSK, to circumvent the consent process.

Let us not forget that there was a clear benefit not just to GSK but also to the clinicians who participated in those trials. The commission's report refers to direct financial payments. At the very least, funding was provided to research facilities that would assist the researchers in securing scientific publications. This practice, along with the scientific publication of the trials, was facilitated by ignoring basic ethical consent in vaccine trials. All these scientific publications, those directly involved in the trials and those where funding was provided indirectly and directly by the predecessors of GSK, ensured the academics had scientific publications to their name, which secured them promotions and financial benefits as a result, as well as increasing their status within the scientific community. This was also of benefit to the universities involved, namely University College Dublin and Trinity College Dublin. They benefited indirectly by using these vulnerable children as guinea pigs without consent.

GlaxoSmithKline must clarify why these experimental vaccine formulations were not placed on the market on a commercial basis. Was it because they were not effective at preventing the diseases they were supposed to prevent? If that was the case, it would have impacted on the subsequent immunity of the children involved in these studies. Were the children outside of homes, either in Ireland or the UK, subjected to the same battery of needles that the children in the homes were subjected to? There was multiple administrations of vaccine doses and multiple blood sampling procedures. I doubt very much that any child outside of these institutions, either in Ireland or the United Kingdom, was forced into being used as a human pincushion on a regular basis to the benefit of the clinicians, institutions and GSK. That company benefited financially from this research. It was happy to conduct those trials, from which they benefited, without consent. Now, it must live up to its responsibilities to these children and their families.

See this speech in context