A voice for women's health

Research Ethics, Medical Injury and Pharmaceutical Companies - October 2018

From the AWHC October 2018 Newsletter

New Zealand has a universal no-fault accident and injury compensation system the envy of much of the rest of the world. The Accident Compensation Corporation (ACC) provides financial coverage and compensation to people injured in a wide range of situations, from the workplace to the sporting field, including at home and traffic-related injuries. ACC also compensates people injured by their medical treatment, and in medical research… but only if that research is not commercially sponsored, that is, funded by a pharmaceutical company.

Essentially what this means is that, if you participate in research in New Zealand that is not commercially sponsored – so, entirely funded by non-pharmaceutical, non-commercial sources, such as universities, hospitals, philanthropic organisations and the Government – and you suffer injury or an adverse event as a result of the research, ACC will provide you with cover and compensate you (for example, medical costs, rehabilitation, loss of earnings, lump sum compensation for permanent impairment, etc.). But, if you participate in research run or sponsored by a pharmaceutical company you are at the mercy of that pharmaceutical company for compensation and recompense.

While pharmaceutical companies are supposed to have insurance that will cover participants’ claims to compensation and rehabilitation entitlements in the event of suffering research related injury or harm, the reality is that participants often have to fight to get what they are entitled to, sometimes costing them in legal fees, and they often don’t get the compensation they should, if any. The key reason why compensation is not available is because the arrangements put in place in pharmaceutical industry-drafted guidelines governing payment of compensation for injuries suffered in research, state that the sponsoring company’s obligation to pay compensation is “without legal commitment.” Potential participants, considering whether to enrol, are not required to be given the guidelines, and so are usually ignorant of this crucial fact. The fight for compensation can be protracted and unsatisfactory, and many research participants are poorly informed of their rights or the lack of ability of New Zealand’s system to protect them in the event of research-related injury.

The inequities in the rights to compensation between participants in publicly funded research and commercially funded research in this country have been discussed in this Newsletter in the past. Lynda Williams was made aware of the situation several years ago through her attendance at the Health and Disability Ethics Committee (HDEC) meetings. In her tribute to Lynda last year (AWHC September 2017 newsletter), Prof. Jo Manning wrote:

 

“I don’t know exactly when it was – maybe about two years ago – when Lynda said to me that she had learned from a meeting on research ethics she had attended in Dunedin about the case of a man, a builder, who had suffered some kind of injury to his heart in a pharmaceutical drug trial, such that he could no longer work. The drug company had successfully resisted paying him any compensation for his injury to that point (they later did reach a confidential settlement with him).”

“Lynda urged me (being an academic medical lawyer) to research the legal and ethical issues relating to the compensation rights of people who are injured in medical research trials... What I was to find shocked us both, more so than either of us expected.”

In August 2018 the HDECs amended the recommended wording in their patient information sheet (PIS) template on their website (https://ethics.health.govt.nz/), and in their Winter Newsletter said “We have recently updated the suggested compensation wording for “commercially sponsored” intervention studies. Please use the updated wording in future Participant Information Sheets.” (see the boxed section below for the full updated wording).

AWHC attends the Northern A HDEC meetings on a regular basis and we have noted that researchers have been directed to the updated wording for the PIS template. This is noted in the minutes of recent Northern A HDEC meetings and to a lesser extent the minutes of the other three HDECs.

However, AWHC is concerned that even the new wording is insufficient protection for participants, and furthermore, most potential research participants would not be aware of just how vulnerable and unprotected they would be in the event of harm or injury caused in a study. The current recommended wording states:
“If they decide not to compensate you, you may be able to take action through the Courts for compensation, but it could be expensive and lengthy, and you might require legal representation. You would need to be able to show that your injury was caused by participation in the trial.”

The recommended wording also points out to participants that, on their own, the Industry Guidelines are not legally enforceable, and may not provide ACC equivalent compensation.

We are concerned that potential participants may not understand the import of these statements, and believe that only a law change to enforce compensation for harm and injury in commercially sponsored research is acceptable.

While believing that the changed wording is an improvement, Prof Jo Manning still has considerable concerns, and believes that the wording still does not adequately explain to potential participants their true position. She says “It would be better to simply say: ‘Sponsors cannot be legally required to pay you compensation for your injury under these guidelines, because they clearly state that their payment of any compensation is without legal commitment.’

“It is incomplete to say that if you sued in a court, ‘You would need to be able to show that your injury was caused by participation in the trial.’ The injured participant would also have to prove that their injury was caused by the negligence of the sponsor or researcher, which is very difficult to establish.”

She goes on to say that she hopes “that potential participants decide that it is too risky to enrol, on learning that they have no legal right at all to compensation from the sponsor if they are injured, nor from ACC. That might prompt the industry to support ACC cover for commercial trials or to put in place access to legally enforceable compensation.”

In a recent submission that AWHC made to the National Ethics Advisory Committee on the Draft National Ethical Standards for Health and Disability Research we wrote:

“We believe that all commercially sponsored studies must be required to provide adequate no fault compensation and rehabilitation entitlements. Commercially sponsored research that does not include such provisions must not be approved in New Zealand. The provision of compensation must be legally enforceable and participants must not have to engage legal representation in order to obtain compensation for injuries or harm sustained as a result of participating in research.

While the guidance in the standards requires greater transparency on the part of researchers and their commercial sponsors, there is still a lack of compulsion or enforceability to provide compensation even if the sponsors are required to provide evidence of holding adequate insurance. Injured and harmed participants should not have to fight to get just and reasonable compensation for their injuries.

Under the current situation, we also do not believe that most participants/potential participants are made sufficiently aware - before they consent to participate - of their vulnerability in the event that they sustain an injury as a result of the research in which they participate. Recent changes in the PIS template text regarding compensation in commercially sponsored research have improved the situation, but this is still inadequate.

The underlying principle is that there should be no cost – financial or to their health and well-being – to participants for their participation in research no matter who is sponsoring the research, and in the knowledge that the risk of harm, no matter how small, still exists in each and every study, any participant harmed in any way should be compensated for that harm.”

 

The New Patient information Sheet recommended wording

In August 2018 the HDECs provided a new patient information sheet template for researchers with new suggested wording to cover injury in commercially sponsored intervention studies:

As this research study is for the principal benefit of its commercial sponsor [insert name], if you are injured as a result of taking part in this study you won’t be eligible for compensation from ACC.

However, [insert name] has satisfied the [ insert name] Health and Disability Ethics Committee that approved this study that it has up-to-date insurance for providing participants with compensation if they are injured as a result of taking part in this study.

New Zealand ethical guidelines for intervention studies require compensation for injury to be at least ACC equivalent. Compensation should be appropriate to the nature, severity and persistence of your injury and should be no less than would be awarded for similar injuries by New Zealand’s ACC scheme.

Some sponsors voluntarily commit to providing compensation in accordance with guidelines that they have agreed between themselves, called the Medicines New Zealand Guidelines (Industry Guidelines).These are often referred to for information on compensation for commercial clinical trials. There are some important points to know about the Industry Guidelines:

  • On their own they are not legally enforceable, and may not provide ACC equivalent compensation.
  • There are limitations on when compensation is available, for example compensation may be available for more serious, enduring injuries, and not for temporary pain or discomfort or less serious or curable complaints.
  • Unlike ACC, the guidelines do not provide compensation on a no-fault basis:
    • The Sponsor may not accept the compensation claim if:
    • Your injury was caused by the investigators, or;
    • There was a deviation from the proposed research plan, or;
    • Your injury was caused solely by you.
    • The injury was caused by <<NAME OF COMPARATOR DRUG>> (include only if holds true for specific study)

An initial decision whether to compensate you would be made the by the sponsor and/or its insurers.
If they decide not to compensate you, you may be able to take action through the Courts for compensation, but it could be expensive and lengthy, and you might require legal representation. You would need to be able to show that your injury was caused by participation in the trial.

You are strongly advised to read the Industry Guidelines and ask questions if you are unsure about what they mean for you.

If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover.

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