The unresolved issue of NZ research participants taking part in clinical trials sponsored by international drug companies but not being entitled to ACC coverage should they be harmed as a result of being in a clinical trial, is described in an essay in a recently published book ”Law, Ethics, and Medicine.”1 The book was written in honour of Professor Peter Skegg, New Zealand’s founding professor of medical law.
Associate Professor Jo Manning’s essay begins by describing how two people involved in two different commercially-sponsored clinical trials suffered serious harm in 2012. They then spent years fighting for compensation from the drug companies involved. While one finally achieved a financial settlement with the drug company’s insurers the other is still fighting for his compensation.
“The first trial involved a man who suffered injury in a large, Phase III, multi-country, double-blind randomised controlled trial of patients with type-2 diabetes who had never before taken insulin, comparing a new insulin variant medicine with an existing insulin treatment. The aim of the trial was not to treat participants for their condition but to demonstrate that the investigational medicine was not inferior to an existing insulin treatment, and to compare the efficacy and safety of the new drug.”
The second trial involved a man who suffered atrial fibrillation (an irregular and often rapid heart rate) days after taking a new drug for gout. The aim of the study, known as the CRYSTAL study, was to compare the effectiveness and safety of the investigational drug taken in combination with a standard gout medicine alone.
While the Participation Information Sheet (PIS) for those agreeing to take part in commercially-sponsored clinical trials is required to state that if a person suffers harm or an injury as a result of participating in the trial they will not be eligible for cover under the Accident Compensation scheme, few if any participants understand what this really means. This is partly because the PIS usually includes a reference to the sponsor’s obligation to pay compensation, in accordance with the NZ Researched Medicines Industry “Guidelines on Clinical Trials – Compensation for Injury resulting from Participation in Industry-sponsored Clinical Trials.” It is not made clear that this is not a legal obligation and they will find themselves having to take on the might of an international drug company and its insurance company’s lawyers.
As Jo Manning’s essay revealed:
“Both companies, at least initially, disputed that the men’s injuries were caused by the investigational drug. It was not until approximately three years later in 2015 that the participant in the CRYSTAL trial finally reached a confidential settlement with the sponsor of his claim for compensation, having suffered significant loss of income in the meantime and after having engaged a high profile lawyer to act for him. A major obstacle to achieving a settlement was that the sponsor’s insurance company took over management to the claim, and it took a strict commercial approach to the claim.”
At the date of writing, the second man, despite also getting legal help has still not received any compensation from the sponsoring company.
Some historyAs a result of drastic cuts made to ACC’s budget research participants have been excluded from being able to apply for ACC compensation for injuries suffered as a result of participation in commercially-sponsored clinical trials in New Zealand since 1992. In contrast, participants in non-industry trials are covered by ACC.
The Ministry of Health and the Health and Disability Ethics Committees have been aware of the problem for more than a decade. In 2007 the Chairs of the ethics committees called for the repeal of this statutory exclusion. In 2010 the National Ethics Advisory Committee (NEAC) added its voice to the need to review and change this unfair and unethical situation. NEAC repeated its call to repeal the exclusion again in 2014. After learning about the experience of the two men mentioned above, the committee wrote to Peter Dunne, the Associate Minister of Health in November 2014.2
In December 2015, NEAC received a response to the advice they had given to Peter Dunne. Both their report to the Minister and his belated response were placed on the NEAC website in April 2016.2 It is difficult not to see this as a demonstration of their disappointment in his response.
Jo Manning reports that NEAC’s suggestion “that some companies conducting clinical trials in New Zealand may be ‘failing to comply with NEAC’s and Medicines New Zealand’s (MNZ) guidance to provide compensation cover for study participants to at least ACC-equivalent standard, and to do so in an expeditious manner.’
Its efforts did not meet with success. Some analysts within the Ministry of Health were concerned about the significant impact on injured individuals from inability to or delay in accessing compensation and agreed that the problem was best addressed by extension of ACC cover to include commercial trials. But officials from ACC and the Ministry of Business, Innovation and Employment briefing Dunne and the Minister for ACC, Hon Nikki Kaye, did not support a law change, and their view prevailed.”1
This is a very disturbing example of how ensuring that research participants are protected, once the core function of ethics committees, is no longer their main purpose.
Jo Manning requested that the following comment be added to this article which appeared in the November 2016 issue of the AWHC newsletter:
“It was Lynda Williams who picked up intelligence about this issue and alerted others, including myself, to it. Without NGOs monitoring the activities HDECs and researchers, (Lynda has attended HDEC monthly meeting for over a decade), worrying matters such as this will be swept under the carpet, as government and drug companies certainly have no incentive at all to bring them to light."
Jo Manning's excellent expose of the issues is divided into four parts. Part 1 describes the consensus among commentators that there is a moral obligation to compensate injured research participants. Part 2 outlines the current law and compensation arrangements. Part 3 describes the deficiencies of the MNZ Guidelines, and Part 4 outlines possible responses and alternative options that participants, ethics committees and the Government might adopt to address this most unsatisfactory situation. This essay is a must read.