s 9(2)(a)
Dear s 9(2)(a)
,
Thank you for your 6 June 2018 letter about the need for an urgent review of the Accident
Compensation Act 2001 (the AC Act) cover exclusion of commercial clinical trial related
injuries.
You suggest that removing the AC Act cover exclusion would provide commercial trial
participants with more certain compensation arrangements than those currently provided by
commercial trial sponsors. You also suggest that such reform could be funded by ACC
levies.
We agree with you that it is important that participants in commercial clinical trials have
appropriate protections, and where people are injured as a result of their participation that
they receive appropriate compensation.
We do not consider, however, that there is a sufficient case at this time to shift the
responsibility for compensating people injured in commercial trials from the commercial trials
industry to ACC.
It is not clear, for instance, that shifting the compensation arrangements to ACC would
necessarily offer additional certainty of compensation to trial participants. Injury claims not
accepted by sponsors under current arrangements, may equally be declined by ACC. Like
trial sponsors, ACC would have to determine the circumstances relating to the injury before
providing any assistance. For example, ACC would need to determine whether an alleged
injury was caused as a result of participation in a trial, or through underlying health factors
before accepting a claim. It is difficult to therefore know whether the unresolved case that
you note in your letter would have been covered by ACC in the absence of the exclusion
provision.
It is also uncertain whether the determination of cover for treatment injury claims would be
necessarily always faster if it was managed by ACC. Determining cover for treatment injury
claims can be more complex than for other claims, and the AC Act accordingly gives ACC a
longer period (nine months as compared to four months) to decide whether to accept a claim
of this nature (refer section 57).
Given the small number of known disputes in this area, it is not clear that commercial trial
sponsors are not taking responsibility for injuries relating to their trials and that people who
are injured are missing out on compensation.
If the accident compensation scheme was expanded to cover commercial clinical trials
participants, and a levy was introduced to cover the costs of those injuries, it would be
important but also challenging to establish levies that fairly reflect the differing risks of
different types of clinical trials. Appropriately risk adjusted levies would be important, for
instance, to avoid incentivising more risky as opposed to less risky trials seeking to be
located in New Zealand, which would place greater pressure on the regulatory system
governing trials. Setting such levies would be challenging, however, given the limited
information on the numbers and severity of trial related injuries, and the small scale of the
New Zealand trial industry.
More broadly, we are pleased to inform you that the Health and Disability Ethics Committees
have updated the informed consent template wording for commercial trials. We trust that this
will address the immediate issue of insufficient information on compensation arrangements
being provided to participants in clinical trials.
You may also be interested in a forthcoming exposure draft for a Therapeutic Products Bill
(the Bill) that the Ministry of Health is developing to update the regulatory scheme around
medicines, medical devices and other therapeutic products in New Zealand. The Bill would,
for example, strengthen the regulatory oversight of clinical trials and address a number of
issues in the clinical trial regulatory system, including gaps in the ethics approval coverage
of trials of therapeutic products other than medicines (e.g. devices). The consultation
process on the exposure draft will provide an opportunity for further discussion and
consideration of the issues.
We would like to assure you that the Government is committed to ensuring that health and
scientific research in New Zealand is done in a safe and responsible way.
We appreciate your interest in this important area, and that you have taken the time to write
to us.
Yours sincerely
Hon Iain Lees-Galloway
Hon David Clark
Minister for ACC
Minister of Health
