Juries and Disability

In Lyons v State of Queensland [2016] HCA 38 the High Court has dismissed an appeal from the Court of Appeal of the Supreme Court of Queensland regarding discrimination and jury service.

The High Court held that the Court of Appeal did not err in holding that the appellant - who is profoundly deaf - was not discriminated against when she was excluded from jury service.

Lyons had been summoned in 2012 for jury service by the Deputy Registrar of the Ipswich District Court. She contacted the Ipswich Courthouse advising that she would require the services of two Australian Sign Language (Auslan) interpreters. In response the Deputy Registrar indicated that there was no provision under the Jury Act 1995 (Qld) to administer an oath to an interpreter for a juror. It was not possible for an interpreter to be present in the jury room during its deliberations.

Lyons' complaint to the Anti-Discrimination Commission of Queensland was referred to the Queensland Civil and Administrative Tribunal (QCAT). She asserted in Lyons v State of Queensland (No 2) [2013] QCAT 731 that the Deputy Registrar contravened prohibitions under the Anti-Discrimination Act 1991 (Qld) regarding direct and indirect discrimination in the performance of a function or the exercise of a power under Queensland law.

She asserted that her dignity had been affronted. She asserted that exclusion on the basis of her impairment constituted direct discrimination. She also asserted that the Deputy Registrar had imposed a condition on her participation in the jury process, constituting indirect discrimination. She souight compensation of $20,000.

In considering the assertions QCAT found that the Deputy Registrar's understanding of the Jury Act was incorrect. However it accepted that the Deputy Registrar had not unlawfully discriminated against the appellant. Lyons appealed to QCAT's Appeal Tribunal, which dismissed the appeal and held in Lyons v State of Queensland [2014] QCATA 302 that the Deputy Registrar's understanding of the Jury Act was correct. The Court of Appeal refused leave to appeal from the Appeal Tribunal's decision. By grant of special leave, the appellant then appealed to the High Court.

The High Court today held that, absent specific legislative provision, Queensland law did not permit an Auslan interpreter to be present during jury deliberations. Accordingly, Lyons was not qualified to serve as a juror. The Deputy Registrar was required to exclude her from the jury panel.

As a consequence, the Court held that exercise of the Deputy Registrar's powers in conformity with the Jury Act 1995 (Qld)  did not infringe the relevant prohibitions under the Anti-Discrimination Act against discrimination.

It may be, as the appellant submits, that the secrecy of the jury's deliberations would not be compromised by the presence of an accredited Auslan interpreter in the jury room during the jury's deliberations. Nonetheless, Douglas J was right to hold that, absent specific legislative provision for that to occur, Queensland law does not permit an Auslan interpreter to be present during the jury's deliberations.

Data Mining Advocacy

In tweeting yesterday I noted the launch of Data Governance Australia (DGA), the 'data governance industry association'.

DGA is described as

a not-for-profit association, established to promote the responsible use of data.

Our role is to help build consumer trust through industry standards, whilst maintaining a legal environment that allows Australian businesses to thrive.

We are committed to creating industry standards and bench marks around the collection, use and management of data in Australia. DGA provides you and your organisation with education, thought leadership and advocacy services. At the same time we'll help you to comply with all data regulatory requirements.

You’ll be kept up to date on global trends, industry events and knowhow across all aspects of data governance, driving customer trust and better business outcomes

Unsurprisingly, its board appears to have no consumer representatives. The Directors instead come from Quantium, Signal, NAB, Westpac, Scentre, Veda (Equifax), Woolworths, Data Republic, IAG, Qantas Loyalty, Allens and Flybuys/Coles.

DGA is described as intended to

provide advocacy, education, support and thought leadership on all aspects of data usage and will operate alongside its sister associations ADMA, AIMIA and IAPA, all of which operate as separate associations, powered by a central expert team and resource base.

Given the problematical practice of some of those organisations the new body might more effectively "build consumer trust" through a close engagement with consumer advocates and representation by such advocates.

I remain perplexed by what appears to be a London street scene as the background graphic on the DGA site.

Copyright as Distributive Justice

'Copyright and Distributive Justice' by Justin Hughes and Robert P. Merges in (2016) 92 Notre Dame Law Review comments 

 When concerns about copyright’s effect on distributive justice are raised those concerns typically focus on access to information. Most of these discussions assume that by conferring control over access to copyrighted works, copyright in general concentrates wealth with corporations and a few individuals. This article takes a different perspective, proposing that copyright has been and remains an important tool for wealth distribution to a large and diverse group of individual creators. Our focus is not on the distribution of copyrighted works – who controls them and who has access to them. Instead, we concentrate on the distribution of income that flows from sales of copyrighted works. The income streams created by copyright, we argue, constitute another of copyright's contributions to distributive justice. Using a Rawlsian framework for distributive justice, we consider – both theoretically and empirically – how copyright law allows individuals to earn income and build wealth. We provide a sketch of Rawls’ theoretical structure for distributive justice, including a detailed look at Rawls’ canonical “Difference Principle.”

With Rawls’ framework in the background, we first show that copyright contributes vitally to the incomes of average-earning creative professionals (with a focus on the music industry). Second, we argue that copyright is a uniquely effective institution in providing “equality of opportunity” in wealth accumulation. In this regard, we propose that copyright has been central to whatever limited “equality of opportunity” African-Americans have enjoyed in the United States. Indeed, for the wealthiest African-Americans, copyright has been the most important form of property for social and economic advancement. This is so, we argue, because copyright is one of the few social institutions that permit a person to turn labor directly into economic assets (in the form of copyrighted works), and hence to create real, sustainable wealth starting only with personal labor. This, we conclude, is an important dimension of copyright’s role in overall distributive justice.

The authors conclude -

The dominant discourse in copyright scholarship has treated creative individuals only as a means to an end: generation of original expression. When scholars have expressed any concern at all about distributive justice, it has been only about fair access to information and material, in other words, as a bookend to the dominant utilitarian analysis. But when we turn our attention away from considerations of fair access to works, and to- ward considerations of a fair distribution of income and wealth, we come to see a neglected side of copyright. Our main point throughout has been this: from the limited evidence available, the copyright system appears to contribute positively and significantly to economic distributive justice in the U.S. economy.

Using the framework of John Rawls’ principles of justice, we have explored how copyright increases the income of middle tier members of society who are trying to support themselves in creative professions, professions we all – everyone from politicians to law professors – laud as part of the desirable ‘information economy’ future. We have also reviewed mechanisms in existing copyright law – from minor procedural speed bumps to termination of transfer – that show copyright’s orientation to protect the prospects of creative individuals. We have also discussed other tools in the copyright toolbox to improve the distributive footprint left by copyright, including droit de suite for artists and equitable remuneration mechanisms used in other developed economies.

Another requirement of Rawlsian distributive justice is that all individuals have fair equality of opportunity for all “offices and positions.” There is no question that American society as a whole has failed to provide such equality of opportunity for women and minorities, particularly for African-Americans. In that context, copyright has been a rare if not unique institution providing opportunity for African-Americans to achieve the greatest economic success: the list of the wealthiest black citizens of the U.S. is utterly dominated by people whose fortunes are rooted in the copyright industries: entertainment, music, sports, publishing, and the like. Given the massive economic barriers facing the African-American community generally, this is a striking realization. Not that copyright in itself is an effective anti-poverty program; not that it offsets structural racism in its myriad forms. Our point here is simply that copyright has been uniquely effective in permitting African-Americans something closer to fair equality of opportunity to achieve the highest levels of wealth.

In the end, our argument is simple: copyright, though a form of property, does not only or disproportionately reward large corporate interests. Copyright is, and can be, an important tool to promote a just distribution of income and wealth in society.

This has political as well as economic ramifications. The historian and biographer A.N. Wilson wrote in the 1980s that “[p]roperty never has been abolished and never will be abolished. It is simply a question of who has it. And the fairest system ever devised is one by which all, rather than none, [are] property owners.” That sentiment certainly comports with the vision of the Framers of the American Republic. These were individuals who saw property ownership as a bulwark against tyranny and a mechanism to advance the individual. The little dollop of economic power copyright confers helps creative people support themselves and a thriving creative class feeds our culture and ultimately our polity. In helping distribute income to creative individuals and supporting them as a professional class, copyright forms part of a thriving democratic republic and a just society

Terror and Intention

In R v Mohamed [2016] VSC 58 Melbourne man Amin Mohamed - a New Zealand citizen - has been sentenced under Crimes (Foreign Incursions and Recruitment) Act 1978 (Cth) s 7(1)(a) to 5 years and 6 months' imprisonment (non-parole period of 3 years and 6 months) for making preparations to travel to a foreign country to engage in hostile acts.

The judgment states

The three charges of which you were found guilty by the jury were constituted by three discrete acts: On 6 September 2013, being a New Zealand citizen, you applied for a New Zealand passport from Melbourne; On 19 September 2013, from Melbourne, you booked plane tickets for Istanbul and Turkey from where you intended to enter the foreign state of Syria; On 19 September 2013, while in Melbourne you obtained from Hamdi Alqudsi the contact details of ‘Omar’, who was to act as a guide ensuring safe passage for you and others from Turkey to Syria.

It continues

In straightforward terms, the clear purpose of the provisions under which you were charged was to ensure that Australia discharged its international obligation to make criminal the activities of someone like you who proposed to engage in hostile activities in a foreign state and/or assist foreign fighters to do so. That purpose in itself demonstrates the seriousness of your conduct. Like contemporary terrorism offences, the CFIR Act made criminal not only the specific act of engaging in hostile activities in a foreign state but, separately, acts which are performed in preparation with that intention. ...

On the prosecution’s case, the acts committed by you were criminal in nature because they each represented acts in preparation for entry into Syria with the intention of you engaging in hostile activities in that country. Objectively, this is very serious offending as the circumstances demonstrate.

At your trial, most of the evidence was not in contention. You had made arrangements, with the assistance and advice from Hamdi Alqudsi to travel from Australia to Istanbul in Turkey and then travel by air from Hatay, a town and province of Turkey, to Syria with the assistance of a man named Omar who was a contact given to you by Alqudsi. Though you were organising your own travel with the knowledge of Alqudsi, you were also organising and coordinating others who, like you, were travelling to Syria. The intention was to meet up with your fellow travellers in Istanbul prior to your proposed entry into Syria where you would be guided to particular locations.

During the making of these arrangements, you reported back to Alqudsi on how many other individuals were travelling, not necessarily with you, and the arrangements that had been made so that that information could be relayed by Alqudsi overseas.

On 20 September 2013, you left Melbourne and travelled to Sydney in readiness for a flight to Brisbane the following day, from where you were intending to board an international flight to begin the international aspect of your travel to Syria. For some time you had been the subject of surveillance by law enforcement authorities. Although unknown to you, your passport was cancelled during these events and the result was that you were prevented from traveling from Brisbane to Singapore by members of the Australian Federal Police.

The only issue raised during the course of your trial was whether the prosecution could prove, beyond reasonable doubt, that upon reaching Syria you intended to engage in hostile activities within the legal meaning of that phrase.

Lasry J explains

Lawfully monitored telephone conversations in which you were involved at the time reveal a number of conversations with Alqudsi, from whom you were receiving advice and instruction and to whom you were reporting. There were also conversations between you and other men who would be your fellow travellers. During these conversations, you were referred to by yourself and others as Abu Bilal. Also, during these conversations, certain code words were used in relation to what was being discussed for the purpose of avoiding detection. During the period you used four telephones – two of those were registered in other names and addresses and one of those phones was that of a work colleague.

On 28 August 2013, you gave notice to your employer that you would resign on 18 September 2013. The reason you gave for that, concerning your mother and a terminal illness, was false.

The intercepted telephone conversations that you were involved in began on 5 September 2013. There were four phone calls on that day, with you using more than one phone to participate. You were told by Alqudsi to use a safe phone number. In the conversations that followed you were told that, in effect, there was to be a big operation, which was obviously in Syria and would involve martyrdom, and that there was an urgency about you and others from Australia getting over there [Syria]. You said you could be ready. There were extensive discussions about the arrangements. In a further conversation, there was more discussion about money and the idea that there was no turning back.

You said in your evidence before the jury that this conversation with Alqudsi just flowed and was moving along. You said you did not pause and think. You claimed that the evidence referred only to the plan to go to Syria and was not a reference to fighting. You said that the only reason you used coded language was because you did not want to be stopped from going to Syria but it was not your intention to engage in hostile activities. Clearly the jury rejected that, and did so beyond reasonable doubt.

As to the quote ‘front line’ referred to in that conversation, you claimed you thought that meant prayer not battle.  In a later conversation, Alqudsi again referred to the battlefield and martyrdom and you said you knew what was being said to you but did not agree that the conversations were being directed at you. Also, in that first conversation there was discussion about ‘red flags’ and about money being taken and also whether you ‘had the boys ready’.

On 6 September 2013, you rang the New Zealand Passport office and made arrangements to apply for a new New Zealand passport. You told the passport officer to whom you spoke that your passport had been lost. There were then conversations with other participants at that time about the arrangements for travel. These continued on the following day. Also on 7 September 2013 you purchased a sim card for a mobile phone in the false name of Chris Wright. Your application for the New Zealand passport constitutes charge one on the indictment.

On 9 September 2013, an application from you for a new passport was received by the New Zealand Passport office with the appropriate fee. As the evidence and Crown summary indicate, there were further phone calls with Alqudsi. You reported to him on the travel arrangements. There were discussions about altering the appearance of the travellers by shaving their beards and doing other things to avoid suspicion. You were warned not to refer to Hatay airport if questioned. The need for secrecy was emphasised. Later that day, the arrangements were altered with travel to be delayed because the passport of a man named Abu Dujanah had been confiscated by the authorities. Your original plan was to depart on 15 September 2013 but, in view of those developments and the risk of being observed, that departure was delayed.

The arrangements continued on 16 September 2013 and they began with a conversation with Alqudsi in which you told him that all was in readiness.

There were several other phone calls on 16 September 2013 between you and your fellow travellers during which respective travel arrangements were discussed.

On 19 September 2013, you booked a flight from Singapore to Istanbul via Doha. That conduct is the basis of charge two. On the following day, you booked flights from Sydney to Brisbane and from there to Singapore.

On the same day, you obtained the contact details for ‘Omar’ from Alqudsi. Omar was the person who would assist you to travel from Hatay airport into Syria. That is the basis of charge three. The details were provided by Alqudsi, who told you not to come and visit him in Sydney as to do so would endanger your trip. It was on this day, 19 September 2013, that your new passport was cancelled.

On 20 September 2013, you boarded a flight to Sydney from Melbourne Airport. On the following day, 21 September 2013, you travelled from Sydney to Brisbane and, at Brisbane Airport, members of the Australian Customs Service reacted to an alert that was attached to your record and you were stopped from checking in to the international flight. You were prevented from leaving the country because of the cancellation of your passport. Though prevented from travelling on that day, you were not arrested.

On 23 and 24 September 2013, you communicated with the New Zealand Passport office about the cancellation of your passport and gave detailed explanations, which you admitted were lies, about why you were travelling and where you were going. You had said that you were going to Denmark to meet your fiancé and that she would buy you a ticket to get from Turkey to Denmark.

From then on until your subsequent arrest you were in Melbourne and Sydney where you resumed working and seemed to have no further contact with Alqudsi.

On Tuesday 3 December 2013, you were arrested by police in Sydney. I will return to the circumstances of what followed, including your time in custody, shortly.

In discussing intention to engage in hostile activitythe judgment states

the main issue in your trial was whether or not the Crown could prove beyond reasonable doubt that your intention in going into Syria was to engage in hostile activity. In your sworn evidence at your trial, you denied that was your intention and said:

My intention was still the same when I had decided to go to Syria. That was the first make the migration for the sake of God, and with the migration also from our teachings is that the person who makes this migration if it is successful that all his sins behind him are wiped away, so for me it was migration redemption, go to Syria, be with my cousin. The only thing that had changed was the fact that now I had some few other guys come with me and the intention remained the same of going there, and at that time I never called it humanitarian work, but helping the people in the way that my cousin was at that time.

Clearly the jury rejected that evidence, and you must be sentenced on the basis that your intention in travelling to Syria was to engage in hostile activity. A question arises as to what that means for the purpose of sentencing you in this case.

In directing the jury during the course of your trial, and pursuant to a ruling  I delivered before the trial started, I said:

The law says that engaging in a hostile activity in a foreign state consists of doing an act with the intention of achieving any one or more of the following objectives (whether or not such an objective is achieved): (a) the overthrow by a force or violence of the government of the foreign state or of a part of a foreign state; (aa) engaging in armed hostilities in the foreign states; (b) causing by force or violence the public in the foreign state to be in fear of suffering, death or personal injury; (c) causing the death of, or bodily injury to, a person who: (i) is the head of the foreign state; or (ii) holds, or performs any of the duties of, a public office of the foreign state or of a part of a foreign state; or (d) unlawfully destroying or damaging any real or personal property belonging to the government of the foreign state or of a part of a foreign state. Now in this case the particular form of hostile activity that the Crown rely on is engaging in armed hostilities in the foreign state being Syria. So, if you are satisfied that the accused intended to go to Syria to fight; to go to the ‘front line’ and/or to ‘be a martyr’ in all likelihood you would be satisfied that he intended to engage in armed hostilities. An intent to engage in armed hostilities does not require proof that the intention was to be involved in regular armed forces of a nation state. Nor does it require proof of the intention to pursue any particular political objective.

On the basis of the jury’s verdict, I propose to sentence you as a person who intended to go to Syria to fight in the conflict, which was going on in that country at that time, and to go to what you regarded as the ‘front line’ and, if necessary, to be a ‘martyr’, which may have involved your death in some form of armed conflict. The evidence does not support a conclusion which is any more specific than that. Whilst you were obviously willingly involved you did not declare any more specific intention. I do not think you would have lasted long. You do not seem to have any previous experience that would have equipped you for what you apparently wanted to do. That may be a clear indicator of how misguided your state of mind was at the time.

I accept your counsel’s point that the circumstances in Syria in 2013 were different from those that prevail at present, though there is no evidence about the detail of that before me. In my opinion, it is enough for sentencing purposes to act on the basis that Syria is a foreign state; there was and is a conflict going on in that country which you were intending to participate in. For these purposes, I make no further judgements about the nature of that conflict, either then or now. ...

Having been stopped from travelling in Brisbane on 21 September 2013 by virtue of your New Zealand passport having been cancelled, you were not charged with the offences until 3 December 2013. You apparently returned to Melbourne and stayed with your mother before returning to Sydney to obtain employment with your former employer.

On being charged you were admitted to bail without opposition from the prosecution, and that effectively lasted until 7 January 2014 when you were detained under the Migration Act 1958 and held at Villawood Detention Centre until you were transferred to Maribyrnong Detention Centre on 11 July 2014, where you remained until your trial, which began in October 2015 and where you continued to remain until today.

Chewing gum and string fixes for Privacy

In another instance of reactively fixing Australia's privacy regime with chewing gum and string (and offsetting news of another health data breach) the national Attorney-General has announced that the Privacy Act 1988 (Cth)

will be amended to improve protections of anonymised datasets that are published by the Commonwealth government". 

No news, alas, about improved protection for non-government data.

The media release states

The publication of major datasets is an important part of 21st century government providing a great benefit to the community. It enables the government, policymakers, researchers, and other interested persons to take full advantage of the opportunities that new technology creates to improve research and policy outcomes.

Our ability to deliver better policies and to solve many of the great challenges of our time rests on the effective sharing and analysis of data. For this reason, the Coalition Government has promoted the benefits of open government data, in accordance with the Australian Government Public Data Policy Statement, and published anonymised data on data.gov.au.

Minister Porter recently drew attention to the benefits of research with anonymised data for identifying risks of long-term welfare dependency and to help break the cycle of dependency.

In a unanimous report, the Senate Select Committee on Health drew attention to the opportunities for research and policy design from the government's data holdings, and recommended that open access to de-identified datasets should be the default position.

In accepting the benefits of the release of anonymised datasets, the Government also recognises that the privacy of citizens is of paramount importance.

It is for that reason that there is a strict and standard government procedure to de-identify all government data that is published. Data that is released is anonymised so that the individuals who are the subject of that data cannot be identified.

However, with advances of technology, methods that were sufficient to de-identify data in the past may become susceptible to re-identification in the future.

The amendment to the Privacy Act will create a new criminal offence of re-identifying de-identified government data. It will also be an offence to counsel, procure, facilitate, or encourage anyone to do this, and to publish or communicate any re-identified dataset.

The legislative change, which will be introduced in the Spring sittings of Parliament, will provide that these offences will take effect from today's announcement.

Disclosure

In Flori v Queensland Police Service [2016] QCA 239 the Supreme Court of Queensland  has upheld the decision of the Queensland Civil and Administrative Tribunal Appeals (QCATA) regarding Sch 1 of the Information Privacy Act 2009 (Qld).

QCATA affirmed QCAT's decision that the state's privacy principles did not apply to the appellant's personal information published in a news bulletin.

That personal information was obtained during an investigation of his misconduct regarding leaked CCTV footage of the arrest of a man at the police station where undue force was used.

The judgment states that the appellant, Mr Flori, a police officer in the Queensland Police Service, is

aggrieved by the publication of certain personal details contained in an Executive Briefing Note concerning him. The information was about a search warrant which was executed at his home address.

On 16 March 2012 the Executive Briefing Note (EBN) was prepared. An EBN is a document used to communicate important information to other officers in the QPS. The EBN was distributed to other officers in the QPS.

Mr Flori complained that the personal information in the EBN was released to a journalist, in breach of Privacy Principles 4 and 11 of the Information Privacy Act 2009 (Qld) (Privacy Act). The personal information was then the subject of a published article.

His complaint was dealt with initially by the Information Commissioner. The complaint was then referred to the Queensland Civil and Administrative Tribunal. It determined that the EBN was not subject to the privacy principles under the Privacy Act. Mr Flori appealed to the appeal division of QCAT.

QCATA dismissed the appeal, holding that on the proper construction of item 3 of schedule 1 to the Privacy Act, the EBN was a document which contained personal information arising out of a complaint, or an investigation of misconduct, under the Crime and Misconduct Act 2001.

Mr Flori seeks leave to appeal to this Court from the decision of QCATA.

The issue raised is whether the EBN is a document which contains personal information arising out of a complaint, or an investigation of misconduct, under the Crime and Misconduct Act 2001.

That is a question of the statutory construction of item 3 of schedule 1 of the Privacy Act. Section 16 of that Act provides that the documents mentioned in schedule 1 are not subject to the information privacy principles in the Act.

The respondent approached the hearing on the basis that if an error by QCATA could be established, leave was warranted.

Response to the Review of Medicines and Medical Devices Regulation

In reading the Commonwealth Government's response to the reports of the Expert Panel Review of Medicines and Medical Devices Regulation noted here observers might be forgiven for believing that the Government has once again deferred difficult decisions about the Therapeutic Goods Administration (TGA) and that the Medical Technology Association of Australia (MTAA) has escaped calls for a more coherent registration regime.

The response is described as presenting "a strategic and systems-based approach to achieve long-term sustainable reform to the regulation of therapeutic goods in Australia [with] ways to improve access to therapeutic goods for consumers and remove unnecessary red tape for industry whilst maintaining the safety of therapeutic goods in Australia".

The response indicates that  

The Expert Panel identified several significant trends in the regulation of medicines and medical devices internationally. In particular, the Panel noted international trends towards allowing earlier access to medicines and medical devices through the development of provisional approval pathways. Additionally, the Panel commented on the benefits of harmonising international regulatory frameworks, noting that there are benefits for consumers and efficiencies for industry from greater harmonisation.

After considering the current regulatory framework for therapeutic goods, the Panel found that the TGA has a strong reputation as a regulator both domestically and internationally, and benchmarks well against comparable overseas regulators. However, the Panel found that while the TGA performs well there are opportunities for reform and improvement in the regulation of therapeutic goods.

The Panel concluded that allowing for greater flexibility in approval pathways for medicines and medical devices (including greater use of overseas assessment reports and provisional approvals in certain circumstances) would expedite access to market without compromising the safety, quality and efficacy or performance of medicines and medical devices.

The Panel also identified areas of regulation where a more risk-based approach could be adopted to more appropriately align regulation with the risk posed by regulated products. The Panel was also of the view that the use of data was essential in assessments of therapeutic goods, and that better utilising existing data sets could lead to system enhancements and provide greater information for the regulator to base decisions upon.

The Panel’s recommendations considered the following issues: the role of the Australian Government to make sovereign decisions regarding therapeutic goods; the medicines regulatory framework; the medical devices regulatory framework; enhancements to post-market monitoring; the complementary medicines framework; and the framework for advertising therapeutic goods to the public.

In considering the Panel's recommendations the Government’s "plan for reform" is described thus

Of the Review's 58 recommendations, 56 are supported by the Government. The majority of these recommendations are supported in full, while for some, the Government supports the intention of the recommendation but proposes to implement them in a different manner to that suggested by the Review.

Of the 56 supported recommendations, the Government has decided to defer two recommendations namely the:

establishment of registries for all high-risk medical devices (recommendation 22);

review of the Therapeutic Goods Administration's (TGA) funding arrangements (recommendation 32).

The two recommendations that the Government has rejected relate to the decision-making and governance arrangements of the regulator (recommendations 29 and 30). These recommendations were primarily rejected due to widespread stakeholder concerns that they would result in significant approval delays for new medicines and medical devices. In addition, the intention of these recommendations can be achieved through the implementation of the broader suite of reforms recommended by the Review.

The response states

The Government recognises that streamlining access to medicines and medical devices, including access to novel and life-saving therapies, offers significant benefits to consumers, health professionals and industry. The proposed reforms reflect the Government’s plan to boost competitiveness and lessen unnecessary regulatory burden through the Industry, Innovation and Competitiveness Agenda and encourage innovation through the National Innovation and Science Agenda.

The Panel has provided a strong case for the reform of the regulation of therapeutic goods in Australia - one that strikes a balance between supporting consumer choice, the safe and effective use of therapeutic products, creates flexibility for industry and ensures that regulatory settings are appropriately aligned to risk. The proposed programme of reform involves:

• increasing use of overseas assessments with comparable regulators, while maintaining sovereignty of regulatory decisions;

• increasing flexibility in pre-market assessment processes for medicines and medical devices, including expedited and provisional approval and allowing the operation of commercial assessment bodies in Australia for medical device assessments;

• taking a risk-based approach to variations to medicines and medical devices and access to products not listed in the Australian Register of Therapeutic Goods (ARTG);

• enhancing post-market monitoring and improving integration of administrative arrangements relating to pre- and post-market processes for subsidy and other purposes;

• simplifying processes by which advertising of therapeutic products to the public is regulated;

• working across government to consider incentives for innovation to improve the competitiveness of the Australian complementary medicines industry and increasing information available to consumers; and

• conducting further reviews on the Scheduling Policy Framework for substances in consultation with states and territories and on the appropriateness of the application of the therapeutic goods regime to a range of low-risk products.

Moving into Yes, Minister territory, the response states

 In order to progress this important programme of reform, the Government will take a strategic and systems-based approach. This will involve implementation of recommendations in a staged approach over the next three years in order to maintain continuity of business. The Department of Health will collaborate and consult across government and with consumers, health professionals and industry in order to progress these reforms. The TGA, where necessary, will cost recover from industry so as to ensure that it is adequately resourced to implement these reforms and undertake the ongoing work without interrupting business as usual. The Government understands that consumer, professional, and industry groups are looking for immediate action. Accordingly, the Department of Health will commence work on designing implementation of the recommendations, with a view to implementing early opportunities in 2016-2017. Implementation of this important programme of reform will deliver significant benefits for the Australian public and to the Australian medicine and medical device industries. ...

The reforms outlined in this response will improve access to therapeutic goods for Australian consumers, including the potential for expedited access to innovative and life-saving products, without compromising the integrity and safety of medicines and medical devices available in Australia. These benefits include:

• access to life-saving and innovative medicines and medical devices will be improved through the introduction of new, expedited pathways for approval. This will lead to earlier access to vital, life-saving therapies for patients with serious conditions;

• faster access for Australian consumers to certain medicines and medical devices that are approved based on assessments from comparable overseas regulators. This will reduce duplication of effort, leading to efficiencies, while ensuring Australian consumer protection is maintained through retention of oversight by the TGA as the final decision-making authority;

• consumer protection will be enhanced through the development of a more comprehensive system of post-market monitoring which will provide the TGA with better information about emerging safety issues. This will ensure that therapeutic goods in Australia continue to be safe for use, efficacious and of a good quality;

• access to products under the Special Access Scheme and the Authorised Prescriber Scheme will be streamlined, reducing burden for healthcare professionals and enabling ease of access to products not on the ARTG for individual patients who meet the relevant criteria;

• the process for managing complaints relating to advertisements of therapeutic goods directed at consumers will be simplified and streamlined, but with stronger compliance powers against misleading advertising;

• the regulation of complementary medicines will be reformed to provide new pathways where evidence of efficacy will be reviewed by the TGA prior to market and compliance powers strengthened, whilst recognising the low-risk nature of complementary medicines.

As Recommendation 22 the Panel recommended that:

1. All high-risk implantable devices are included in a registry that is compliant with the requirements for registries established by the Australian Commission on Safety and Quality in Health Care (ACSQHC).

2. Responsibility for ensuring that registries are operated consistent with the ACSQHC requirements should rest with the NRA [ie the TGA as Australian National Regulatory Authority].

3. Data collected by device registries should be made available to the NRA in a timely manner to inform post-market monitoring.

4. The NRA should implement an active programme of analysis and reporting on adverse events, and associated data, collected through registries or by other means.

5. The NRA should continue collaborative activities with overseas medical device regulators to actively share registry and other monitoring data, with a view to facilitating timely identification of emerging safety concerns and to inform better clinical practice. 

The Government's response is

The Commonwealth defers consideration of Recommendation Twenty-Two, as establishing and maintaining registries requires careful consideration of the range of registries managed by a variety of organisations and how they could be sustainably managed and funded in the future. Further consultation with stakeholders is required to adequately assess the risks and benefits of establishing registries, and to determine appropriate mechanisms to enable access to data. 

As Recommendation 32  the Panel recommended

 that the Australian Government review and enhance the NRA’s funding model, with a view to providing either a dedicated annual appropriation or other appropriate budgetary arrangements on an ‘as-needs’ or routine capacity basis, to enable it to more effectively fulfil its mandate to act in the public interest and to ensure that genuine and systemic improvements to its capacity, expertise and operation are achieved. 

The Government's response is

The Commonwealth defers consideration of Recommendation Thirty-Two. The Department of Health and associated agencies are scheduled to undergo a Portfolio Charging Review in 2017/18. A review of the regulator’s funding arrangements should not be conducted in isolation. Deferring consideration under the Portfolio Charging Review will ensure funding arrangements are fully considered and aligned within a whole-of-portfolio perspective.

As recommendation 29 the Panel recommended that:

1. The decision making process for the inclusion of medicines and medical devices in the ARTG be changed to provide for:

A. The Australian Government’s Chief Medical Officer to be the delegate for decisions.

B. The establishment of a statutory committee to make recommendations to the Chief Medical Officer about registration of a medicine in the ARTG (Advisory Committee on Medicines).

C. The establishment of a statutory committee to make recommendations to the Chief Medical Officer about inclusion of a medical device in the ARTG (Advisory Committee on Medical Devices).

2. Both Committees be composed of experts across relevant fields and consumer representation and have the authority to:

A. Consider information submitted by the product sponsor.

B. Consider evaluation reports prepared by or for the Australian NRA and comparable overseas NRAs.

C. Take evidence from sponsors, the Australian NRA, and any other parties which the committees consider may have a reasonable interest in the registration of the medication or medical device. D. Take into account any other information that the committees consider may be material in their deliberations. 

The Government's response is that

The Commonwealth rejects Recommendation Twenty-Nine. In consultation on the review recommendations, all stakeholders (industry, health professionals and consumer groups) strongly opposed this recommendation, as there was a consensus that delegating decision-making to a single person would slow approval processes and lead to a significant backlog of applications, thus potentially undermining efficiencies gained by implementing other recommendations in the Review. The Commonwealth notes that the stated purpose of the recommendation (which is to increase dialogue between the TGA and sponsors), will be achieved through implementation of the broad range of reforms the Commonwealth proposes to adopt, such as improving transparency of decision-making, developing an SME support function to provide regulatory advice and facilitating increased engagement between sponsors and the regulator.