Despite industry objections, alcohol and pregnancy warnings will be mandatory in Australia and New Zealand

The food regulator, Food Standards Australia New Zealand (FSANZ) has finalised the form of the alcohol and pregnancy warning label that will be mandatory on packaged alcohol sold in both countries.

Assuming the States do not request a further review, the new warning will be added as an amendment to Standard 1.2.7 of the Food Standards Code and will become mandatory after a two year transition period (see pp 6, 78 here).

Here it is.

It’s been a long time coming

In 2011, the Australian and New Zealand Food Regulation Ministerial Council commissioned a review of food labelling law and policy, chaired by Neil Blewett AC.

The committee’s report, co-authored by Australian public health law pioneer Chris Reynolds, is a terrific document, although increasingly difficult to locate online.

The Committee saw no reason to exempt alcohol from labelling requirements, in view of evidence relating to the risks of binge drinking and longer-term over-consumption.

(In 2015, alcohol use was responsible for more than 6,300 deaths in Australia, or 4% of total deaths – see AIHW, Australian Burden of Disease Study 2015, Table D2, p 167)

Amongst many sensible recommendations, the report recommended that “generic alcohol warning messages should be placed on alcohol labels” as part of a broader, multifaceted, national campaign addressing alcohol-related harm [recommendation 24].

Secondly, it recommended that a mandatory warning about the risks of drinking while pregnant should be included on “containers of alcoholic beverages and at point of sale for unpackaged alcoholic beverages” [recommendation 25].

Thirdly, it recommended that alcoholic beverages should not be exempt from energy labelling requirements that apply to packaged food under Standard 1.2.8 of the Food Standards Code [recommendation 26].

The Government’s response to the review is here.

Added momentum for a warning label about the risks of drinking while pregnant came from a Parliamentary inquiry in 2012 into the Prevention, Diagnosis and Management of Fetal Alcohol Spectrum Disorders.

The Foreword to this report, from the House of Representatives Standing Committee on Social Policy and Legal Affairs, states:

“FASD [fetal alcohol spectrum disorders] is an entirely preventable but incurable condition caused by a baby’s exposure to alcohol in the womb. The consequences are expressed along a spectrum of disabilities including: physical, cognitive, intellectual, learning, behavioural, social and executive functioning abnormalities and problems with communication, motor skills, attention and memory.”

The lifetime cost of for one person with FASD in the United States is at least UD$2 million (see FASD Strategic Action Plan 2018-2028, p 8).

The Standing Committee recommended that the Commonwealth implement – by 1 October 2013 – a mandatory warning label advising women not to drink when pregnant or planning a baby on packaging of all pregnancy test kits (Recommendation 7).

This recommendation has not been implemented.

The Committee also recommended implementation – by 1 January 2014 – of a warning label for all alcoholic beverages advising women not to drink while pregnant or planning pregnancy (Recommendation 11).

FSANZ has now finalized this warning – for packaged alcohol.  A warning about drinking while breastfeeding was outside the scope of this work.

It should have been a non-brainer

The Australian Institute of Health and Welfare reports that in 2016, around 35% of Australian women drank while pregnant.  One in four women who were unaware of their pregnancy continued to drink after they found out.

In this age of personal responsibility, alcohol and pregnancy warning labels ought to be a no-brainer, but it has taken until 31 January 2020 for Food Standards Australia New Zealand to approve a mandatory health warning and graphic for alcoholic beverages that contain more than 1.15% alcohol by volume.

For detail of the amendment to Standard 2.7.1, which governs labelling of alcoholic beverages, see here (pp 100-104).

The Australian and New Zealand Ministerial Forum on Food Regulation, which is responsible for developing food regulation policy, had earlier, in October 2018, requested FSANZ to consider options for mandatory alcohol and pregnancy warning labels.

Getting FSANZ involved was a good idea – long overdue.  FSANZ is a technical, a-political agency that reviews evidence, considers options and develops the mandatory technical standards that make up the Food Standards Code.

A methodical, evidence-based, bureaucratic process has significant advantages in areas of regulation prone to lobbying and interference from well-resourced industries.

The internet remembers

Draft (updated) National Health and Medical Research Council (NHMRC) Guidelines clearly state:

“A To reduce the risk of harm to their unborn child, women who are pregnant or planning a pregnancy should not drink alcohol.

B For women who are breastfeeding, not drinking is safest for their baby.” (p 47)

In 2018, DrinkWise, a responsible drinking campaign largely funded by the alcohol industry, distributed a poster to hospitals and GP clinics around the country that said: “It’s not known if alcohol is safe to drink when you are pregnant”.

This was widely criticised; even the New York Times ran a story.

DrinkWise re-phrased its poster (see below).

DrinkWise now has a new campaign called “The internet remembers”.

Indeed.

Alcohol industry objections

The Approval Report for the new warning label lists the concerns raised by the alcohol industry, together with FSANZ’ response.  The warning FSANZ chose was: “Alcohol can cause lifelong harm to your baby” – which performed better in consumer testing than “Any amount of alcohol can harm your baby”.

For its part, the alcohol industry suggested that the text of the warning should be “It’s safest not to drink while pregnant” as “medical knowledge is not settled whether drinking small amounts [while pregnant] has a bad influence [on the foetus] (see p 44 here).

Industry was also concerned that the words “HEALTH WARNING” were “misleading, inflammatory and may alarm consumers” (p 26).  It recommended changing “HEALTH WARNING” to “DRINK RESPONSIBLY” (p 28).

FSANZ noted, unsurprisingly, that such a change would “not meet the intended purpose of the pregnancy warning label to reinforce public health advice and messaging not to drink alcohol while pregnant”.

Industry also objected to the red font required for “HEALTH WARNING”, on the basis that it would inflate costs.  It requested a monochromatic label (p 44).  It wanted the label to be smaller (p 29).  It felt the cost of the label was not proportionate to the benefit (pp 33-34).

Industry sought a longer phase-in period of up to 5 years, rather than the 2 years proposed by FSANZ (p 36).

Overall, while the alcohol industry was “fully supportive of interventions that are proportionate, well evidenced and shown to be effective at changing harmful consumption behaviours”, it was “concerned about the lack of rigour of the proposal in this regard” (p 43).

Its objections even extended to the ponytail in the graphic of the woman (p 24).

Overall, the impression you get is of an industry keen to reduce the consumer impact of the warning, keen to delay its implementation, and far more interested in revenue than the harm its products can cause the next generation.

No surprises there, unfortunately.

Legal management of the novel Coronavirus (2019-nCoV) in Australia

On 31 January the Director-General of the World Health Organisation, Dr Tedros Adhanom Ghebreyesus declared the novel coronavirus (2019-nCoV) a public health emergency of international concern (PHEIC), following the advice of the Emergency Committee.  (See here).

Under the International Health Regulations, which govern global management of infectious disease outbreaks, a declaration that a PHEIC exists is a prerogative of the Director-General, and triggers the requirement to issue temporary recommendations, after receiving information from the Emergency Committee (See IHR, Arts. 15, 49).

You can see the WHO Director-General’s recommendations to the People’s Republic of China here. (And see here for the most recent WHO situation reports).

2019-nCoV was first identified in Wuhan, China, around 12 December.

As at 6 February 2020, over 28,060 cases had been identified in China, with 564 deaths; 24 countries outside China have also identified cases, with one death confirmed in the Philippines.

In Australia, as at 6 February, 15 cases of 2019-nCoV had been identified in 4 States: 5 in Qld, 4 each in NSW and Victoria, and 2 in SA.  You can see latest updates for Australia, and other resources here.

You can see a timeline of events from Australia’s perspective here, and from a US perspective here.

From a legal perspective, how is Australia managing the risks posed by 2019-nCoV?

Australia has imposed travel restrictions on foreign nationals departing from or transiting mainland China.  These apply for 14 days from 1 February, and may well be extended.

There are no exceptions for Chinese (international) students studying at Australian universities or attending Australian schools: almost two thirds of the 190,000 Chinese students who have Australian visas are still overseas.

Australian citizens currently in China are permitted to re-enter Australia, but must self-isolate for 14 days.  This means not attending public places including work, school or university, or childcare, not allowing visitors into the home and wearing a surgical mask if it becomes necessary to leave the home for medical treatment.  See here.

With the exception of the blanket travel ban, which a number of other countries including New Zealand, and the United States have also imposed, Australia’s response remains low-key.

States and Territories are primarily responsible for managing outbreaks of infectious diseases within their territories, and this remains the case with 2019-nCoV.

The Commonwealth, on the other hand, has “primary responsibility for international border surveillance and responding to public health events occurring at international borders”: see the National Health Security Agreement (para 22).

The Australian Government Department of Health website states that:

The Australian Health Protection Principal Committee has taken a highly precautionary approach in recommending the 14-day isolation period, with the aim of this policy being containment of novel coronavirus and the prevention of person- to-person transmission within Australia.”

Australia has not yet imposed centralised control or activated the coercive powers that are available if this outbreak were to gain momentum.

In Australia, the Australian Health Protection Principal Committee (AHPPC) is the peak body for national emergency health planning, preparedness, response and recovery during public health emergencies.  AHPPC is administered by the Office of Health Protection, a division of the Australian Department of Health.

The National Health Security Agreement identifies a number of potential triggers for a coordinated national response, led by the AHPPC, with operational control vested in the Director of Human Biosecurity.  However, it remains for the Commonwealth to assess whether the risks of disease transmission are so significant that they require a centralised, national operational response (see para 24).

An audit of the Health Department’s coordination of communicable disease emergencies notes the relative ambiguity of the conditions that would justify a national operational response (see pp 30-33, 47).

With travel bans keeping imported cases to a minimum, and limited scope for significant person-to-person spread within Australia, the States and Territories will very likely continue to retain operational control.

The Biosecurity Act 2015 (Cth) does give the Commonwealth a wide range of coercive powers, where necessary.

For example, under ss. 44-46, entry and exit requirements (as distinct from recommendations) may be imposed on classes of people to prevent the spread of a “listed human disease”, and there are civil penalties for failing to comply.

Similarly, individuals can be subjected to a “human biosecurity control order” containing any of a number of specific “biosecurity measures”, including isolation measures (s 97), restrictions on movement and behaviour (s 87), and the requirement to undergo examination and provide body samples (ss 90-91).

However, as s 44(1) and s 60 makes clear, these powers apply to a “listed human disease”: they exist to prevent a “listed human disease” from entering or spreading in Australia.

Section 42 contains the test that the Director of Human Biosecurity (the Commonwealth Chief Medical Officer) must apply before he or she lists a human disease.  (The test is whether the disease is communicable and may cause significant harm to public health, and if the Director of Human Biosecurity has consulted with the chief health officers of the States and Territories.)

While there is nothing in principle to prevent the Chief Medical Officer from issuing a legislative instrument making 2019-nCoV a listed human disease under s 42, I am not aware that this has happened.

Nor does it appear that 2019-nCoV has yet been added to the National Notifiable Disease List: the national set of diseases that is the result of national reporting arrangements by the States and Territories (see National Health Security Act 2007, s 11).

This does not mean that self-isolation “recommendations” are voluntary.  It simply means that cases or contacts entering Australia are subject to the relevant State or Territory legislative framework that governs disease spread.

In NSW, “Novel Coronavirus 2019” was scheduled under the Public Health Act 2010 (NSW) by executive order on 21 January.  As a result, a number of statutory obligations and public health powers thereafter apply to identified cases, and to those who have come in contact with a case.

For example, 2019-nCoV is notifiable by medical practitioners and laboratories (ss 54-55).  A person infected with 2019-nCoV who is in a public place must take reasonable care not to spread the condition (s 52), and the Secretary of the NSW Health Department may direct a person to undergo medical examination on reasonable suspicion that they represent a risk to public health (s 61).  There is a financial penalty for non-compliance.

If a person who is infected with or has been exposed to 2019-nCoV is behaving in a way that will likely endanger the public’s health, the Chief Health Officer of NSW can make a public health order requiring the person to refrain from behaviour that places others at risk and to undergo medical treatment and testing (s 62).

These are time-limited orders not exceeding 28 days (s 63) which can be reviewed by the Civil and Administrative Tribunal and, where necessary, extended (ss 65-66).  Failure to comply with a public health order may result in a substantial fine (up to $11,000) or imprisonment.

These muscular State (and Territory) laws are, of course, premised on an infectious condition being scheduled under the Act, and on there being an adequate case definition to identify cases and contacts.

Early on in an outbreak of a novel infectious disease, a precise, workable case definition may not exist, together with information about modes of transmission, incubation period (prior to symptoms) and capacity for pre-symptomatic transmission.  See here for the somewhat unwieldy definition of a “suspect case” of 2019-nCoV adopted in NSW, and Victoria, respectively.

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