Medical assessments: Permitted reasons

Nominal Defendant v Adilzada [2016] NSWCA 266 is of interest as the Nominal Defendant had requested that the respondent undertake a Functional Independence Measure (FIM) assessment to determine his eligibility for the Lifetime Care and Support Scheme.

The respondent did not do so. The Nominal defendant filed a Notice of Motion for a determination of whether such a request was within, and engaged the application of, s 86 of the MAC Act. The primary judge found that s 86(1) had no application to the LCS Act. Accordingly he answered the question raised by the Nominal Defendant in the negative.

The Court granted leave to appeal because the question raised is of general application and importance. Although relevant to a statutory scheme, the court’s approach may have some relevance in other disputes over medical assessments in the context of personal injury claims.

The issue in the proposed appeal was:

Whether on proper construction of s 86 of the MAC, the purposes for which the insurer may make a request that a claimant undergo a medical examination include to assess that person’s eligibility for lifetime participation in the Lifetime Care and Support Scheme.

The Court held (per Meagher JA, McColl and Gleeson JJA agreeing), granting leave to appeal and allowing the appeal:

The insurer or a person against whom a motor accident claim is made may under s 86(1) of the Motor Accidents Compensation Act 1999 (NSW) request the claimant to undergo a medical examination or assessment for the purpose of determining that person’s eligibility for participation in the Lifetime Care and Support Scheme. If the claimant fails without reasonable excuse to comply with such a request court proceedings cannot be commenced or continued in respect of the claim where the failure continues: [36].

Approvals for medications of doubtful efficacy

Writing today on the Harvard Law Bill of Health blog, Associate Professor Rachel Sachs reports on the accelerated approval (by the US Food and Drug Administration (FDA)) of a medication for the treatment of Duchenne Muscular Dystrophy. She writes:

As regular FDA observers already know, Exondys’ path to approval has been highly contentious.  The key clinical trial used to support approval contained just twelve patients and no placebo, and the FDA Advisory Committee voted against both full approval of the drug and accelerated approval.  …  FDA staff scientists charged with reviewing the drug recommended against approval but were overruled by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research.  FDA Commissioner Califf deferred to her decision.

Associate Professor Sachs expects that other companies developing rare disease drugs to submit clinical trial data for approval by the FDA that, until today, had seemed insufficient in terms of demonstrated efficacy.

Sarepta is reported to have announced that Exondys would cost on average $US300,000 per patient per year, in line with other rare disease drugs but lower than what some Wall Street analysts had estimated.

Chemotherapy dosing report: NSW

Now available online is a further report on chemotherapy under dosing in New South Wales, entitled Prescribing of Chemotherapy – Report on patients treated at Western NSW Local Health District (16 September 2016).

A series of 16 recommendations appear on page 16 – 17 of the report. The recommendations include:

  • People whose care has involved reduced doses of chemotherapy (off-protocol 100 mg flat dose carboplatin, reduced dose capecitabine in the setting of the neoadjuvant or adjuvant treatment of bowel (colorectal) cancer) are contacted by the LHD in order to receive an apology for the added uncertainty regarding the likely effect of their treatment on their clinical outcomes.
  • The LHD must put in place systems to ensure that the oncology pharmacist and the head of medical oncology review any overrides in the electronic prescribing system that may suggest patterns of off-protocol prescribing.
  • Where multidisciplinary cancer care teams (MDTs) have a single member from a discipline, clinicians consider joint minuted meetings with at least one other MDT after relevant national or international meetings as seminal new evidence emerges that could influence practice.

Two earlier reports remain available online.

 

Health professionals & suicide

Published today in the Medical Journal of Australia is an article by Milner, Maheen, Bismark and Spittal entitled Suicide by health professionals: a retrospective
mortality study in Australia, 2001 – 2012.

  • Suicide rates for female health professionals were higher than for women in other occupations:
  • Suicide rates for male medical practitioners were not significantly higher than for other occupations, but the suicide rate for male nurses and midwives was significantly higher than for men working outside the health professions;
  • The suicide rate for health professionals with ready access to prescription medications was higher than for those in health professions without such
    access or in non-health professional occupations.

Pharmaceutical product liability under Australian Consumer Law

Mabel Tsui (QUT School of Law) has today kindly made available online her recent Ph D thesis entitled A critical analysis of pharmaceutical manufacturers’ product liability claims under the Australian consumer law: Interpretation, operation and reform.

The opening to the abstract explains:

Contemporary literature about the Australian Consumer Law (‘ACL’) as applied to product liability claims have identified a problem as to how the ACL operates in respect of such claims. The existence of multiple grounds of actions within the ACL regime, operating alongside the common law of negligence, has resulted in inconsistent outcomes occurring within the same set of facts. The identification of this legal anomaly has resulted in calls for the selection of one ground of action, operating to the exclusion of all others within the ACL. This justifies a careful consideration of the relevant grounds of actions, and which one should be chosen to have that prevailing and pre-emptive operation. This thesis will attempt to resolve this question by examining the operation of the ACL through the lens of pharmaceutical product liability claims.

Home birth without medical assistance

Published on 14 September 2016 were the findings of the Inquest into the death of NA.

The child NA died following a home birth in which no doctor or midwife was present. The inquest considered various issues including:

  • The mother’s understanding of risks to the baby, before the birth
  • Advice given by a medical practitioner
  • The role of the Department of Family and Community Services and NSW Health

On the issue of the mother’s decision as to the manner of birth, the Coroner said:

It is essential to remember that women have a right to decide how they will give birth. At common law all competent adults can consent to and refuse medical treatment, which includes prenatal care. Unless a lack of capacity or some kind of coercion is established, an adult mother has a right to birth at home, even if the prevailing medical advice deems the birth “high risk”. Until the foetus becomes a person, the relevant medical care is understood as pertaining to the mother.

All we can hope is that decisions are made with the benefit of high quality information and where necessary expert medical advice. In this case, it appears that F and P were firmly committed to a home birth or what was described by the Ministry of Health as a “freebirth” . While they were informed of the risks, they seemed unable to properly comprehend or take seriously what they had been told. It is extremely unfortunate that once the final scan had been done, they were not warned again in the firmest terms, either by the GP practice they had attended or by a worker from Community Services. It is now impossible to know if F would have changed her mind had that extra warning taken place or if she and her husband would have chosen to proceed with their original plans regardless.

In considering what recommendations can be made, it is clear that there is no easy solution. It is positive that the Local Health District is trying to address the desire for non-hospital births in the local area. This program should be supported and resourced. Counsel for the family sought a recommendation that such services be better resourced. In 2015 there was apparently capacity for only 200 women to choose this option. However, in the context of this inquest there was no evidence that the service was currently unable to meet the demonstrated need. It is likely that such a recommendation would go beyond the scope of this inquest.

Two recommendations were made by the Coroner:

1. That the Royal Australian College of General Practitioners consider developing policy guidelines to assist and support its members in advising patients in relation to requests for nonhospital births. Consideration could be given to the “National Midwifery Guidelines for Consultation and Referral”.

2. That the Northern NSW Local Health District consider implementing an information outreach program to local general practitioners about the services currently provided by Northern NSW Local Health District in relation to mothers wanting non-hospital births.

Access to medicines report, including innovation

Subtitled Promoting innovation and access to health technologies, the United Nations Secretary-General has now published its High-Level Panel on Access to Medicines report.

The High-Level Panel’s terms of reference (see page 66) called for it to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.

Michael Kirby, a former justice of the High Court of Australia, chaired the 25 person Expert Advisory Group. He was also a member of the 15 person High-Level Panel.

An executive summary sets out various convention, research and incentive recommendations. Legal recommendations include that:

  • Governments should strengthen national level policy and institutional coherence between trade and intellectual property, the right to health and public health objectives by establishing national inter-ministerial bodies to coordinate laws, policies and practices that may impact on health technology innovation and access. (Page 9)
  • Governments should require that the unidentified data on all completed and discontinued clinical trials be made publicly available in an easily searchable public register established and operated by existing mechanisms such as the WHO Clinical Trials Registry Platform, clinical trials.gov or in peer reviewed publications, regardless of whether their results are positive, negative, neutral or inconclusive.

The report is structured in four chapters:

  1. Health Technology Innovation and Access examines the problem at the heart of the High-Level Panel’s mandate: asymmetries of power between institutions and the incoherencies in law, policy and practice between the right to health, international trade and intellectual property rules and public health objectives and their effect on health technology innovation and access.
  2. Intellectual Property Laws and Access to Health Technologies discusses the prevalent international intellectual property regime, the flexibilities contained therein that can be used to promote access to health technologies and examines why flexibilities have not been systematically used, as well as developments such as free trade agreements that may impede the use of TRIPS flexibilities.
  3. New Incentives for Research and Development of Health Technologies highlights the role that increased coordination, priority setting and R&D can play in systematically addressing unmet health needs and examines some of the new models that can be used by various actors.
  4. Governance, Accountability and Transparency examines governance and accountability mechanisms needed to promote health technology innovation and access, including the roles of key stakeholders. It highlights the need for transparency in the various stages of health technology innovation and access in order to strengthen coherence at all levels of policies and actions.

“My DNA” tests: ACCC re Chemart pharmacies

The Australian Competition and Consumer Commission has accepted an administrative undertaking on behalf of Chemmart in relation to representations regarding the effectiveness of a myDNA genetic test in identifying an individual’s response to certain drugs.

The ACCC was concerned that statements in Chemmart’s catalogues, television infomercials, in-store brochures and other promotional materials about the myDNA test risked conveying a false or misleading impression regarding the usefulness of the genetic test, and the consumers for whom it may be appropriate…..

Chemmart withdrew all of the promotional materials containing the statements of concern to the ACCC following contact by the ACCC. Chemmart also agreed to refrain from making any statements in the future about the myDNA test that have the potential to mislead consumers about the applicability and effectiveness of the test.

Research related professional misconduct

Medical Board of Australia v Melhuish [2016] ACAT 29 is a somewhat unusual matter, in that the Medical Board did not seek to limit the respondent’s clinical practice as an anaesthetist, but rather sought and obtained an order that respondent must not practise as a medical researcher for a period of 12 months.

The relevant misconduct was said to be (at [6]) that:

  • On 23 June 2013, on or around 15 January 2014 and on 30 January 2014, the respondent engaged in misconduct by writing letters to four former patients at the Canberra Hospital claiming, that as a result of research undertaken at the Canberra Hospital, medical treatment details, identifiable as belonging to them, were available to persons and organisations outside the hospital, without any evidence that this allegation was true.
  • The respondent breached Principle 9 of the Health Records (Privacy and Access) Act 1998 (ACT) (the Health Records Act), the NHMRC Code, the ACT Health Research Practice Policy and acted inconsistently with Information Privacy Principle 11 of the Privacy Act 1988 (Cth) (the Privacy Act) by disseminating information he was provided with as a result of his involvement in a research project to persons and/or entities outside the project research team.
  • The respondent persisted in the conduct of writing to patients making allegations that their medical treatment details were being made available outside the hospital and accessing patient records without authorisation despite his employer’s direction not to do so after he wrote the first letter.

Medical & health law blog