Apotex

'Hippocratic obligation to shareholder profit? Medical treatment patents and the Australian High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50' by Tim Vines in (2014) 21(4) Journal of Law and Medicine 797-809 comments

The method of treatment of suffering in patients, including through surgery and the administration of therapeutic drugs, are essential features of medical professionalism. Few, if any practitioners committed to developing the core professional virtue of loyalty to relief of patient suffering through consistently implementing the basic principles of medical ethics, would consider that such beneficial methods of practice are, or should be, the subject of a patent--requiring the practitioner utilising them to pay a royalty or risk infringement proceedings. Indeed a formal opinion of the American Medical Association declares "the use of patents, trade secrets, confidentiality agreements, or other means to limit the availability of medical procedures places significant limitation on the dissemination of medical knowledge, and is therefore unethical". Yet this could be the direction in which Australian patent law is heading. The decision of the High Court of Australia in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50, upholding a patent over a method of using a known drug to prevent or treat psoriasis, may ultimately force practitioners to re-consider whether their basic ethical obligations to patients are secondary to a requirement to maximise profit for shareholders in companies holding medical patents. This column reviews this decision and its possible implications for health practitioners. It places it in context of other recent court decisions that have expanded the intrusion of corporate-owned intellectual property monopolies into Australian medical practices, and how legislative restrictions upon them in the Patents Act 1990 (Cth) places practitioners and patients at risk of more costly, ineffective or restricted health care. This column concludes by cautioning that Australia's scope to address policy problems caused by this case may be limited should it sign up to the Trans-Pacific Partnership Agreement, particularly if that preferential trade and investment deal includes an Investor-State Dispute Settlement clause that creates a mechanism for multinational corporations to challenge offshore, Australian federal and state policy decisions they perceive undercut their investments.

OAIC Estimates Hearing

From this week's Legal and Constitutional Affairs Legislation Committee Estimates hearing regarding the  Office of the Australian Information Commissioner

CHAIR: Welcome. Do either of you want to make an opening statement? 

Mr Pilgrim : Yes, thank you. I would like to make a very short opening statement. I would like to possibly assist the committee on some developments with the Office of the Australian Information Commissioner since we last appeared before the committee in December of last year. I am appearing today as the acting Information Commissioner as well as in my usual capacity as Privacy Commissioner. Professor McMillan has asked me to extend his apologies to the committee for not being here as he is currently on leave, which was planned some time ago—last year, in fact. 

The committee will be aware that the bill to disband the OAIC was not considered by the Senate before it rose on 5 December 2014. So the office is continuing to discharge its functions under both the Privacy Act and the Freedom of Information Act. This work has continued but in changed circumstances. The Canberra office of the OAIC was closed on 5 December 2014 and all Canberra based staff except for the Information Commissioner have left or have taken up work in other government areas. The Information Commissioner himself continues to work from both the Sydney office and a home base in Canberra, with office assistance and IT support. He has, for example, worked in the Sydney office in three of the first six weeks of 2015. The office continues to receive inquiries, complaints and IC review applications under the FOI Act, and these are dealt with under arrangements that we have published on our website. FOI matters are currently being handled by a small team in the Sydney office under the supervision of the assistant commissioner for dispute resolution and the Information Commissioner. 

In summary, FOI complaints are being transferred to the Ombudsman's office; Information Commissioner reviews are being triaged by our office so that where we can expedite a matter we do so; and, for the more complex or voluminous ones, we work with the applicants for these to be referred to the AAT. The privacy functions are being undertaken by the majority of the staff in the Sydney office. And I would just like to add that over the past 12 months these staff have implemented some of the most significant reforms to the Privacy Act since its commencement and have done so at a time when we have seen quite a significant increase in privacy matters and complaints coming to the office. But in respect of all of our functions, I would personally like to take this opportunity to acknowledge the ongoing commitment and professionalism of the staff in our office, who have continued to work tirelessly during very uncertain times. And I will add that in my 31 years in the Public Service I have not seen a better demonstration of and upholding of the Public Service values. Thank you. 

CHAIR: Thank you, Mr Pilgrim, and that last statement you made is very good, and we join you in acknowledging the work that your people have done. 

Mr Pilgrim : Thank you. 

Senator JACINTA COLLINS: Welcome, Mr Pilgrim. Can you refresh my memory as to what was occurring with your role, other than now acting Information Commissioner? 

Mr Pilgrim : Do you mean the position of Privacy Commissioner under the bill? 

Senator JACINTA COLLINS: Yes. 

Mr Pilgrim : The bill proposes that the Privacy Commissioner be established as an independent statutory officer but sitting within the Human Rights Commission but not— 

Senator JACINTA COLLINS: Ah, yes: you are the boy in the bubble! Mr Pilgrim : Yes, as we discussed at that hearing. I would be sitting with the Human Rights Commission but not as a Human Rights Commissioner; I would be independent to the Human Rights Commission. I would have responsibility for the functions under the Privacy Act. However, the resources and staff would be supplied to me through the Human Rights Commission. 

Senator JACINTA COLLINS: And this is once this FOI bill is resolved, is it? 

Mr Pilgrim : Yes—should the bill pass the Senate; that is correct. 

Senator JACINTA COLLINS: What happens in the meantime? Do you stay— 

Mr Pilgrim : At the moment the OAIC—the Office of the Australian Information Commissioner—is continuing on until such time that there is legislation passed to disband it. 

Senator JACINTA COLLINS: Where is your work base? 

Mr Pilgrim : Our office is now solely based in Sydney. 

Senator JACINTA COLLINS: And you are working from Sydney. 

Mr Pilgrim : Yes. I have always worked from Sydney. 

Senator JACINTA COLLINS: And Professor McMillan is still working from or based in Canberra? Mr Pilgrim : As I said in my opening statement, he has been spending time in the Sydney office over a period of the first few weeks of the year, and he has a home based office here in Canberra as well. 

Senator JACINTA COLLINS: Home based—I think it was kitchen based, if I recall correctly. 

Mr Pilgrim : I cannot recall that, but he has a home office. 

Senator JACINTA COLLINS: It led me to wonder whether he has a Thermomix! He would be very efficient at home. The evidence we received in the last round of estimates indicated that the government was not looking at re-funding the Office of the Information Commissioner, as the status of the bill would be resolved in February this year. So, further to your comments about late last year, to this point in time—including what sittings the Senate has had in February—it still remains unresolved. When will the government be bringing the bill on for debate in the Senate, Minister? 

Senator Brandis: That is a matter for the Manager of Government Business in the Senate, isn't it? 

Senator JACINTA COLLINS: You are not aware of when it may be scheduled? 

Senator Brandis: I am not aware of the date, no. 

Senator JACINTA COLLINS: It seems that the government is not in a position to pass legislation any time immediately. I think last time we had a discussion about what discussions had occurred with the Attorney-General's Department about ongoing funding arrangements. Mr Pilgrim, can you update me on that from your end? 

Mr Pilgrim : We are having continuing discussions with the Attorney-General's Department on what funding arrangements may need to be made, and the department is exploring those options and would be best placed to answer the question in any more detail. 

Senator JACINTA COLLINS: Yes, because I think that is what Mr Minogue essentially told us on the last occasion, except I think he was optimistic about February. I was less so. Can you give me an update, Mr Minogue, about the Attorney-General's Department's understanding of the ongoing funding arrangements? 

Mr Minogue : At the moment the funding that has been made available by government in the budget for the continuing privacy functions has been appropriated to the Human Rights Commission. That money is still to be made available for those continuing functions. So, it is a question of financial mechanics as to whether it is reappropriated back to the Office of the Information Commissioner—which, on the books as at today, because the bill has not passed, remains—or whether it is some other arrangement between the Human Rights Commission and the OAIC for the provision of that funding. But essentially the resourcing that has been appropriated by government for the functions of the OAIC will be made available—are available—for the OAIC to continue its functions. The precise mechanics about how that is returned or how it reflects that fact that the organisation, the entity, still exists is still to be finalised and published by government. But there is no risk to the ongoing funding for those functions, in line with the budget decision government took. 

Senator JACINTA COLLINS: Are we talking about this fiscal year? 

Mr Minogue : Yes. Senator JACINTA COLLINS: So, since July of last year, there has as yet been no reappropriation and the department is still exploring the mechanics of how such might occur. 

Mr Minogue : There has been no further budget cycle that would allow that to be affected, given that the government's intention is still that the bill be brought on at a time that the government chooses or decides. The bill still reflects government's policy. If the bill passes, then the budget decision reflects the will of parliament. If the bill does not pass, then an alternative arrangement would need to be found. But that crossroad has not been crossed yet. The bill still reflects the government's position. 

Senator JACINTA COLLINS: I understand that the bill still reflects the government's position, but these functions are being carried out under the existing legislative position under funding arrangements that have remained unresolved now for around eight months. 

Mr Minogue : That timing might be right, but the uncertainty surrounding the future of the bill has not been unresolved for that long. 

Senator JACINTA COLLINS: Sorry—the uncertainty has not been unresolved? 

Mr Minogue : The time period that would be relevant is the time from when there was a clear indication that the bill was or was not going to pass parliament. If the bill is not going to pass parliament then yes, government should act to conclusively reflect that new reality. If the bill is going to pass, it would be premature to appropriate moneys to one organisation and then back to another and then back to another as the bill goes through parliament. So, for the moment, it is unresolved only because the future of the bill is unresolved. 

Senator Brandis: And of course if these are perceived to be problems, then these perceived problems would all disappear if the opposition would support the bill so it could be passed.   

Senator JACINTA COLLINS: Well, if the government did not pre-empt the will of the Senate then it would not be a problem. 

Senator Brandis: I think you have it around the wrong way. 

Senator JACINTA COLLINS: I am sure you do think that. That is no surprise to me. 

Senator Brandis: Yes, I do, and it is no surprise to me that you have rudely interrupted me once again. As I was saying, if the government had an indication from the opposition of what its position was, and if the opposition, which has had plenty of time to consider this, indicated its support for the bill, then the bill could be progressed through the Senate very soon. 

Senator JACINTA COLLINS: I do not think there has been any uncertainty about the opposition's position here. I think the issue is—well, I will ask: is it true that the government has offered crossbenchers a comprehensive review of the FOI system if they support the bill? And why instead will you not conduct that review before you abolish the Information Commissioner? 

Senator Brandis: Surely you would not expect me to reveal private conversations that the government might have had with individual Senators. Surely you would not expect that. 

Senator JACINTA COLLINS: I would not be surprised by anything that you might do after today, Senator Brandis. I would not be surprised by anything. 

Senator Brandis: Yes, Senator Collins. Move on to your next question. 

Senator JACINTA COLLINS: I am just looking at the remainder of the questions I had for Mr McMillan. I was not aware that he was on leave, so, thank you for that explanation, Mr Pilgrim. Can you tell me what the impact has been of these uncertain funding arrangements in terms of your capacity to meet the functions? 

Mr Pilgrim : As I said, we have moved to having only one site, in the Sydney building, and we are looking at processes to try to streamline the FOI functions we are undertaking by triaging Information Commissioner reviews that come in. For example, we are assessing those matters to see whether there are any that we can deal with quite quickly, whether that be over the phone with the applicant or with the respondent organisation. Otherwise, we are looking at the larger, more voluminous and more complex matters and we are working with the applicants to refer those on to the AAT. 

Senator JACINTA COLLINS: Are you able to fulfil your ongoing statutory obligations without further funding or staffing arrangements being settled? 

Mr Pilgrim : At the moment, as I said, we have had to streamline the process with the use of the power we have under the FOI Act to move more of the more complex and voluminous matters that we do not believe we would be able to get to in a timely fashion onto the AAT by way of assisting the applicants. 

Senator JACINTA COLLINS: But for how long is that streamlining sustainable? 

Mr Pilgrim : At the moment we are waiting to see what happens with the bill, but we are working on the basis that that process will go on until such time as there is resolution around the bill. 

Senator JACINTA COLLINS: So, you do not have any confidence in Mr Minogue's missions around finding mechanics or reappropriation of the funds that went to the Human Rights Commission? 

Mr Pilgrim : No, that is not what I am saying. We are working constructively with the department in terms of finding out those mechanisms to see if we do reach a point where we need to have those appropriations returned to the OAIC. 

Senator JACINTA COLLINS: Well, that is why I am asking how long the current arrangements are sustainable for. 

Mr Pilgrim : At the moment we are working on the basis that we have, if I can put it this way, cash reserves to be able to maintain the status quo as we have it now, through for some months to come. 

Senator JACINTA COLLINS: Mr McMillan referred I think on the last occasion to some cash reserves. Mr Pilgrim : That is correct. 

Senator JACINTA COLLINS: So, what you are telling us is that you still have some cash reserves to access. 

Mr Pilgrim : Yes. 

Senator JACINTA COLLINS: And I am not going to pressure you, but you are not providing any specific sense of how long that position is sustainable for. 

Mr Pilgrim : We are going to be reviewing that situation once we get more information on what is likely to happen with the bill, but I am confident that we can go on for a number of months more on the cash reserves that we do have. 

Senator Brandis: Senator Collins, this matter lies entirely in your hands. It is the opposition that is declining to pass the bill. The government wishes to pass the bill. If the bill were to be passed, this problem would not exist. But the government does not have a majority in the Senate. If you, Senator Collins, as the shadow Attorney-General's spokesperson in the Senate, were to give an indication that the opposition will pass the bill, this problem would disappear immediately. A solution lies entirely and exclusively in your hands. 

Senator JACINTA COLLINS: Oh, Senator Brandis, if politics were only that simple! 

Senator Brandis: It sounds pretty simple to me, Senator Collins. If you pass the bill, it will be passed. 

Senator JACINTA COLLINS: Oh, dear. If you give me what I want, everything will be fine! Mr Pilgrim, will the cash reserves last you until the next budget? 

Mr Pilgrim : I would like to take that on notice. 

Senator JACINTA COLLINS: Sure. 

Mr Minogue : It might assist, if I just mention—and I might have misunderstood the import of what you are saying, Senator—that it is not that the OAIC is only operating on the available cash reserves. Money that is appropriated to the Human Rights Commission for OAIC purposes remain available—and that was in the order of $19 million over four years. I just did not want there to be a misunderstanding that it was only the underspend or the reserves that were available to the OAIC at the moment. 

CHAIR: Thanks for clarifying that, Mr Minogue. 

Senator JACINTA COLLINS: Mr Minogue, you referred to re-appropriations and sorting through proper mechanics. What you are saying to me is that some of the funds that are currently available, other than the cash reserves, are already being utilised by the office of information commissioner, and there are other funds that you need to look for a mechanism or re-appropriation. Is that correct? 

Mr Minogue : Forgive me if I have made this messier that it needed to be. 

Senator JACINTA COLLINS: It is all right. It is after 10 o'clock. 

CHAIR: I may not forgive you. Mr Minogue : It is always dangerous to volunteer. I know that. 

CHAIR: Yes. 

Mr Minogue : The moneys that the government decided, in the budget, were to be made available to the office of the information commissioner for its ongoing functions were in the order of $19 million over four years. Because of the government's decision that the OAIC would be restructured and the Privacy Commissioner would move as an independent statutory officer to the Human Rights Commission, those moneys were appropriated not to the OAIC, but to the Human Rights Commission. Given that the bill has not passed, those monies are still in the appropriation of the Human Rights Commission, but only for OAIC purposes. The mechanics that I was talking about was that, if the bill passes, that remains a proper reflection of the government decision. If the bill does not pass, then a decision will need to be made by the government not to find new money for the OAIC, but to recognise the fact that under the first proposition the OAIC would no longer continue. Under the second alternative, if the bill is defeated, the OAIC does continue, so those monies would need to be re-appropriated back to the entity that will continue, whereas the decision of government was that it be initially appropriated to an organisation called the Human Rights Commission because the OAIC, in its current form, would not continue. 

Senator JACINTA COLLINS: But are there other funds, other than the cash reserves, currently available to the office of the information commissioner? 

Mr Minogue : Yes. The money that is made available to the OAIC for this financial year, which is probably in the order of some $5 million, remains available to the OAIC. 

Senator JACINTA COLLINS: Okay. Thank you. 

Senator LEYONHJELM: Mr Pilgrim, what is the staffing situation in relation to the OAIC resources? How many people are working on FOI in the office? 

Mr Pilgrim : We have approximately nine staff working on FOI matters. 

Senator LEYONHJELM: How does that compare with 12 months ago? 

Mr Pilgrim : Twelve months ago we had approximately 20. 

Senator LEYONHJELM: And the decline is attributable to the anticipated restructure and abolition of the function? 

Mr Pilgrim : That is correct. We took steps last year, on the basis that the government's intention was for the office to wind up by 31 December, and worked with our staff to make sure that we could place those staff in other positions where we could assist them in that process. 

Senator LEYONHJELM: How readily would you be able to get the office back on foot at short notice? 

Mr Pilgrim : The office is already undertaking some, although limited, FOI functions. It is a question I would have to take on notice, but the office is already undertaking certain functions. We already have the systems in place for putting that work into our complaints management system. Those sorts of structures already exist. 

Senator LEYONHJELM: To what date is Professor McMillan officially contracted? 

Mr Pilgrim : Professor McMillan was appointed for a five-year term. That term expires in November of this year. 

Senator LEYONHJELM: Am I right in understanding that he is moving to the AAT himself? 

Mr Pilgrim : No, that is not correct. The former Freedom of Information Commissioner, Dr James Popple, moved to the AAT on 1 January this year. 

Senator LEYONHJELM: Okay, I had the wrong person. You are probably the wrong person to ask this of, but it strikes me that there is the potential for that gentleman to be hearing appeals against his own decisions. How would that be dealt with? 

Mr Pilgrim : That would be a matter for the AAT. 

Senator Brandis: That could not really happen. 

Senator LEYONHJELM: He would recuse himself? How would it work? 

Senator Brandis: This is hypothetical of course, but you would expect that whoever arranged the AAT lists would ensure that that matter did not come onto his docket. 

CHAIR: In an area like Townsville, when barristers are appointed to the bench, they of course do not deal with cases that they had an interest in when they were barristers. 

Senator LEYONHJELM: I assumed that was the case but I just wanted confirmation.

APEC Privacy Framework

The APEC Data Privacy Subgroup meeting in the Philippines earlier this month featured a "comparative review" [PDF] by Australia, Canada and New Zealand of the 2013 changes to the OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data in relation to the APEC Privacy Framework. The review is "a contribution to the APEC Privacy Framework Stocktake".

The review document comments that in updating the APEC Framework

The approach to be taken in any concrete proposals need not be identical to the approach taken by the OECD Guidelines as they must suit APEC conditions and objectives. However, the DPS should give some weight to the benefits of maintaining consistency with the OECD where that enhances interoperability and the facilitation of data transfers beyond the APEC region. 

The document offers the following findings

A. The 1980 OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data were the foundation and starting point for developing the APEC Privacy Framework.

B. The OECD Guidelines and APEC Framework have the same objectives and contain many similarities in terms of structure and content.

C. After 30 years of operation, the OECD Guidelines underwent a major review by experts resulting in the adoption of significant updating changes in 2013.

D. The 2013 changes modernised and supplemented the Guidelines, to make them more effective for the changed technological and business environment, while maintaining the 1980 principles unchanged and basic structure of the Guidelines intact.

E. Given that the origins of the APEC Framework lie in the 1980 version of the OECD Guidelines that are now superseded, and that substantial effort and expertise has gone into updating those Guidelines, it is fitting that the Stocktake should be based on an understanding and consideration of the 2013 updates to the 1980 OECD Guidelines.

F. As a result of the 2013 changes, there are several areas in which the APEC Framework is now lacking counterpart content to the OECD Guidelines.

G. The review has identified several areas where the APEC Framework may benefit from updating in areas where changes have been made to the OECD Guidelines.

It accordingly recommends the development of "concrete proposals" for updating the APEC Privacy Framework, in particular through -

a. Incorporation of the concept and elements of a privacy management programme into the APEC Framework Part IVA (Guidance for domestic implementation).

b. Adding breach notification into the APEC Framework at Part IVA(V) (Guidance for domestic implementation: Providing for appropriate remedies in situations where privacy protections are violated).

c. In Part IVA (Guidance for domestic implementation), include new content promoting:

i. Economy privacy strategies.

ii. Technical measures that will help protect privacy.

iii. The establishment of privacy enforcement authorities with reference to their role and the attributes and support needed for such authorities.

d. In Part IVB (Guidance for international implementation), include text promoting:

i. Interoperability with privacy frameworks based outside the APEC region.

ii. Internationally comparable metrics to inform policy making in relation to privacy.

e. In Part IVB (Guidance for international implementation), in existing part (III) or as a new part (IV), outline the factors to be considered in balancing trade considerations when restricting cross‐border transfers for reasons of privacy.

f. Make suitable updates to the preface and facing page commentary.

Food Systems

'Food Systems Law from Farm to Fork and Beyond' by Stephanie Tai in (2015) 45(1) Seton Hall Law Review comments 

In urging “responsible eating,” food writer Wendell Berry once wrote,“I begin with the proposition that eating is an agricultural act.” Yet the legal world has long treated food and agriculture as separate spheres. Food law in the United States has traditionally been viewed as the area of law related to the development and marketing of final food products, while agricultural law has been viewed as the area of law relevant to farmers and rangers,agri-businesses, and food processing and marketing firms. But more recently, both policymakers and scholars have been taking a more systems-oriented approach to food regulation through the re-framing of food and agricultural law into a broader food systems law. In particular, a number of legal scholars working in these areas have begun merging the fields of food law and agricultural law — as well as components of other fields of law — into something perhaps greater than the sum of its parts: a field of law that examines food systems as an interactive whole, rather than as individual components of the farm-to-fork process.

This Article is the first of a two-part project.This part explores trends in agricultural and food law scholarship to argue that a nascent integrated approach, one that is more systems-oriented, is developing within current legal scholarship. The Article begins by providing some broader context on systems-oriented approaches to understanding food, drawing from food policy and environmental policy literature. It next briefly describes the different origins and coverage of early agricultural law and food law, situating the distinct historical and theoretical foundations of agricultural law and food law into the broader literature of legal taxonomy. It then illustrates developing trends in scholarly articles, legal casebooks, and other law school institutional coverage to suggest the convergence of these two areas into a broader, more systems-oriented approach. Finally, the Article highlights distinctive features that might arise out of a more deliberate development of systems-oriented approach in this legal field. It argues that such an approach may provide insights into other cross-cutting areas of legal scholarship that the separated areas of food law and agricultural law cannot provide. In doing so, this Article lays the groundwork for the next part of this project, which presents case studies to provide a more complete an analysis of the benefits that would arise from such an approach and uses systems theory to develop important considerations for the deliberate cultivation of food systems law as a field of law.

Clinical trials and pharmaceutical access

'Clinical Trials Abroad: The Marketable Ethics, Weak Protections and Vulnerable Subjects of EU Law' (Queen's University Belfast Law Research Paper No. 1) by Mark Leslie Flear explores 

how the EU is a largely overlooked exporter of normative power through its facilitation and use of clinical trials data produced abroad for the marketing of safe pharmaceuticals at home; a move that helps to foster the growing resort to the latter as a fix for public health problems. These are made possible by the EU’s (de)selection of international ethical frameworks in preference to the international technical standards it co-authors with other global regulators. Clinical trials abroad underscore how ethics are contingent and revisable in light of market needs, producing weak protections and the vulnerable subjects of EU law. I argue that these components and effects of the regime are ultimately about that which undergirds, shapes and directs regulatory design. That is, I point to the use, infiltration, perpetuation and extension of market-oriented ideas, values and rationalities into formally non-market domains like biomedical knowledge production and public health. I explain how these are central to efforts at producing and legitimating the EU, its related imagined socio-political order based on a more innovative, profitable and competitive pharmaceutical sector in order to foster economic growth, jobs and prosperity, and with them the project of European integration. ‘Bioethics as risk’ is highlighted as a way to reshape and redirect the regulatory regime in ways that are more consistent with the spirit and letter of the ethical standards (and through them the human rights) the EU claims to uphold.

'A 'Duty' to Continue Selling Medicines' by William M Janssen in (2014) 40 American Journal of Law and Medicine comments

With disappointing frequency, shortages occur in the supply of prescription pharmaceuticals. Sometimes, those shortages persist for months (even years), and can implicate the only known medicine to treat a life-threatening medical condition. Sometimes, those shortages may also be due to avoidably negligent decisions in manufacture. Twice in the past two years, seriously ill patients — confronting just such medicine supply shortages — have resorted to the courts, demanding a judicial remedy for negligently caused supply interruptions to critically needed medicines. In doing so, they have asserted a bold litigating position: the law ought to impose upon drug manufacturers a legal duty to continue selling their medicines. In other words, once a pharmaceutical manufacturer enters a medicine market, it is obligated by law to remain there and preserve perpetually its medicine’s supply. This claim of compelled-access-to-pharmaceuticals pushes to the very frontier of drug law in America. 

This Article begins by tracing the two cases (one in Utah, the other in Florida) that confronted these creative compelled-access-to-medicines arguments. Earlier cases, resolving a distinctive but thematically similar compelled-access argument in the context of experimental drugs, are introduced as well. The discussion explains how each claim lost in court. The Article next performs an independent survey of a wide range of legal theories — in constitutional principle, enacted law, regulatory law, and case law — that could be cited as alternative potential sources for imposing a duty on manufacturers to continue selling their drugs. It demonstrates that none is likely to be a credible source for that duty. Finally, the Article examines the competing policy considerations that would be implicated by “inventing” such a duty, finds that a judicial invention is unwise, but offers a potential statutory amendment designed to strike a sound balance between the legitimate proprietary and autonomy interests of manufacturers and the health and survival interests of critically ill patients.

Anonymity

'Reasonable Expectations of Anonymity' by Jeffrey M. Skopek in (2015) 101 Virginia Law Review argues 

The Supreme Court has concluded that the Fourth Amendment's protections do not apply to information that has been exposed to the public. This conclusion is deeply flawed and derives from the mistaken conflation of anonymity and privacy. Although anonymity and privacy are similar in that both maintain the secrecy of personal information, they differ in a fundamental and legally relevant way: privacy hides the information, whereas anonymity hides what makes it personal. Understanding this difference reveals compelling substantive and formal reasons for interpreting the Fourth Amendment to protect not only reasonable expectations of privacy, but also "reasonable expectations of anonymity." Further, the incorporation of this new analytic concept into Fourth Amendment jurisprudence yields significant value: first, by identifying otherwise-unrecognizable ways in which new techniques of big data implicate the Constitution, and second, by delivering on the unfulfilled promise of the Supreme Court's teaching that the Fourth Amendment "protects people, not places."

Counter Terrorism Strategy and Law Enforcement White Paper

The 56 page Review of the Commonwealth’s counter terrorism arrangements from the Department of the Prime Minister and Cabinet states that

The Commonwealth has strong, well‑coordinated counter‑terrorism (CT) arrangements. Overall, these have been quite successful – although the Martin Place siege and the stabbing of police in Melbourne raise questions.

The threat of terrorism in Australia is rising and it is becoming harder to combat.

Responding to this worsening threat picture, on 4 August 2014 the Government boosted funding to CT activities. National security agencies are significantly bolstering their capabilities to detect and disrupt the threats we face.

Every dollar must be spent wisely. We face a new paradigm that demands ever more careful prioritisation. National security agencies must come together seamlessly around shared priorities.

A restructure or reshuffle of national security agencies is not the answer. But more must be done to strengthen cross-agency coordination and leadership.

Whatever we do, there is no short‑term solution to our evolving terrorist challenge. It is almost inevitable that we will have more terrorist attacks on Australian soil.

Long term, we must put a greater effort into reducing – rather than managing – the pool of terrorists, their supporters and sympathisers.

The report states - 

• Many plots – some quite major – have been disrupted.

• There have been 35 prosecutions and 26 convictions.

• There has been no large scale terrorist attack on Australian soil in the post-2001 period.

The three fatalities within this period all happened in the Martin Place siege. The two terrorist attacks in that period – the stabbing of two policemen in Melbourne and the Martin Place siege with its two tragic victims – were carried out by individuals who planned and acted alone. Crimes planned like this are, by nature, always extremely difficult for police and security agencies to prevent.

In the years since 11 September 2001:

• many more departments and agencies have been drawn into the CT effort. Coordination is better than ever

• new legislation has been progressively introduced to provide the legal tools to prosecute terrorists and better disrupt support to terrorism

• modest efforts to counter violent extremist ideology and to promote community cohesion are now underway.

After that, we're into cliches - rising tides and so forth

The rising tide of terrorism

The threat of terrorism in Australia is rising and it is becoming harder to combat.

• There are an increasing number of Australians joining extremist groups overseas.

• There are an increasing number of potential terrorists, supporters and sympathisers in our community.

• There is a trend to low tech ‘lone actor’ attacks which are exponentially harder to disrupt: there may be no visibility of planning and no time delay between intent and action.

• There is now an intergenerational dimension, with the families of known terrorists increasingly radicalised and involved.

• The international forces driving terrorist ideology and capabilities are stronger, and extremist narratives have increasing appeal in the Australian community.

• Terrorists are using sophisticated technologies and methodologies to stay under the radar.

• Terrorists are now adept at exploiting social media to distribute polished propaganda products.

Reflecting this environment, there is an increasing requirement for early disruption of terrorist plans to best ensure public safety. This comes at the cost of securing sufficient evidence to prosecute.

• This leaves potential terrorists at large. It also erodes trust, confidence and relationships with at risk communities. It may also undermine public confidence in national security agencies and the Government generally.

 No discussion, alas, of distrust induced by institutional overreach and hyperbole on the part of Government Ministers and associates.

Winning many battles – but not the war

Despite improvements in CT capability, a terrorist attack is possible. All of the terrorism related metrics are worsening: known numbers of foreign fighters, sympathisers and supporters, serious investigations.

We are not ‘winning’ on any front. The Martin Place siege and the Melbourne attack on police are examples of a global trend: we face an increasing number of potential terrorists who are hard to detect and often willing to attack using quickly implemented, low tech tactics.

Responding to this worsening threat picture, on 4 August 2014 the Government boosted funding to CT activities. National security agencies are significantly bolstering their capabilities to detect and disrupt the threats we face.

Every dollar must be spent wisely. We face a new paradigm that demands ever more careful prioritisation. National security agencies must come together seamlessly around shared priorities. A restructure or reshuffle of national security agencies is not the answer. But more must be done to strengthen cross-agency coordination and leadership. Whatever we do, there is no short term solution to our evolving terrorist challenge. It is almost inevitable that we will have more terrorist attacks on Australian soil. Long term, we must put a greater effort into reducing – rather than managing – the pool of terrorists, their supporters and sympathisers.

The community is key.

To counter violent extremism we must work with our at risk communities. We must build resilience to terrorist ideology and assist individuals to disengage and de radicalise from violent extremist beliefs and influences.

Future direction 

To combat the challenge most effectively, we need to:

5. acknowledge that we have entered a new, long-term paradigm of heightened terrorism threat with a much more significant ‘home grown’ element

6. further improve and broaden the scope of our national CT strategy to provide a clear direction to the national security community and to improve our cooperation with at-risk communities

7. strengthen further cross agency leadership and coordination by designating a National CT Coordinator as the Government’s leading advisor on CT

8. develop a COAG strategy to counter violent extremism, increasing Australia’s national commitment to this work

9. better manage increasing resource pressures by tightening priorities and lessening the burden of the efficiency dividend on some areas of national security agencies

10. improve our communication with the public on CT threats by introducing a single threat level system to improve usability and to give the public more meaningful information.

The recommendations (on the US model) are -

1. The Government, in close consultation with states and territories through the ANZCTC, develop a new national CT strategy which appropriately coordinates and balances our efforts to counteract the various threats we face, including from home-grown lone actors and radicalisation in our community.

2. The Government implement the following arrangements to provide strong, clear and co ordinated leadership to ensure agencies respond effectively and appropriately to terrorism:

a. designate a senior official as the National CT Coordinator.

b. establish and expand an Executive Group at the Secretary/Agency Head level, chaired by the CT Coordinator, to set the strategic direction for the Commonwealth’s CT efforts

c. mandate that the Australian Counter-Terrorism Centre draw together policy and operational agencies, including secondees from the states and territories, to work together closely on operations, policy challenges and capability development.

The Australian Strategic Policy Institute has meanwhile called [PDF] for a Commonwealth law enforcement white paper, commenting

Strong international, technological, political and social forces are changing the criminal challenge to Australia. These forces mean that the Australian Government will to need to take a greater role in law enforcement in the future.

So far, the Commonwealth’s responses to these challenges have been evolutionary, reactive or incremental. While those responses include excellent innovations, some change occurs because events make recent decisions redundant - a concern amply demonstrated by the recent funding top-up for counterterrorism spending. There are also questions about where national leadership is needed to meet these challenges, and whether our current responses, particularly to serious and organised crime, are still optimal. All our law enforcement agencies face important organisational challenges, especially with sharing information, getting people with the right skills, and incorporating technology into their work.

An examination of these factors shows that it’s time for the federal cabinet to take a coordinated and strategic look at its law enforcement responsibilities, starting with a review. While a national review covering all areas of law enforcement would be preferable - so that state and territory law enforcement agencies could be included - that’s probably not practical yet. So the initial step should be a review of how today’s Commonwealth law enforcement system needs to adapt to the anticipated operating environment over the next 10–20 years.

The review should examine the interdependencies within the Commonwealth system, its links with the state and territory law enforcement systems, international partnerships and capacity building, and the relationship between the Commonwealth agencies and the private and community sectors.

The review should lead to a statement of the desired policy, organisational, legislative, operational and resource landscape for law enforcement out to 2020–30. Such a statement should leverage and institutionalise relationships between all agencies with a stake in making Australia a ‘just and secure’ society.

A major policy statement is needed now because it would explain what the Australian Government intends to do in the law enforcement space in the future, and how it will work with the other jurisdictions to achieve those aims. A law enforcement white paper process, which would help inform the Federation White Paper that’s now under development, would be a good way to assemble the arguments and allow the federal cabinet to decide on what role it will take in this central policy area. It would also provide the clear policy lead for all federal law enforcement and related agencies to do their own forward planning, based on the understanding they are contributing to Cabinet’s aims and working as part of an interdependent system.

Refugee children and barbed wire

Catching up with the Australian Human Rights Commission report The Forgotten Children: National Inquiry into Children in Immigration Detention.

The report states

Australia currently holds about 800 children in mandatory closed immigration detention for indefinite periods, with no pathway to protection or settlement. This includes 186 children detained on Nauru.

Children and their families have been held on the mainland and on Christmas Island for, on average, one year and two months. Over 167 babies have been born in detention within the last 24 months.

This Report gives a voice to these children.

It provides compelling first-hand evidence of the negative impact that prolonged immigration detention is having on their mental and physical health. The evidence given by the children and their families is fully supported by psychiatrists, paediatricians and academic research. The evidence shows that immigration detention is a dangerous place for children. Data from the Department of Immigration and Border Protection describes numerous incidents of assault, sexual assault and self-harm in detention environments.

Importantly, the Government recognises that the fact of detention contributes significantly to mental illness among detainees.

The aims of the Inquiry have been to:

• Assess the impact of prolonged immigration detention on children’s health, wellbeing and development by collecting the evidence of children and their families, scholarly research, Department of Immigration and Border Protection data and the views of medical experts and the Australian community 

• Promote compliance with Australia’s international obligations to act in the best interests of children.

There is nothing new in the finding that mandatory immigration detention is contrary to Australia’s international obligations. The Australian Human Rights Commission and respective Presidents and Commissioners over the last 25 years have been unanimous in reporting that such detention, especially of children, breaches the right not to be detained arbitrarily. The aim of this Inquiry was not to revisit the Commission’s settled view of the law, but rather to assess the evidence of the impact of prolonged detention on children.

As the medical evidence has mounted over the last eight months of the Inquiry, it has become increasingly difficult to understand the policy of both Labor and Coalition Governments. Both the Hon Chris Bowen MP, as a former Minister for Immigration, and the Hon Scott Morrison MP, the current Minister for Immigration, agreed on oath before the Inquiry that holding children in detention does not deter either asylum seekers or people smugglers. No satisfactory rationale for the prolonged detention of children seeking asylum in Australia has been offered. ...

This Report is fundamentally different from previous reports by the Commission as it focuses in both a qualitative and quantitative way, on the impact of immigration detention on children as reported by children and their parents. The Commission conducted interviews with 1129 children and parents in detention, providing a much needed foundation for objective research findings. Standard questions were used in all interviews so that the reported impacts are measurable. The evidence documented in this Report demonstrates unequivocally that prolonged detention of children leads to serious negative impacts on their mental and emotional health and development. This is supported by robust academic literature.

It is also clear that the laws, policies and practices of Labor and Coalition Governments are in serious breach of the rights guaranteed by the Convention on the Rights of the Child and the International Covenant on Civil and Political Rights. The United Nations High Commissioner for Human Rights also suggests in his opening address to the Human Rights Council that Australia’s policy of offshore processing and boat turn backs is ‘leading to a chain of human rights violations, including arbitrary detention and possible torture following return to home countries’.

The Commission comments -

The overarching finding of the Inquiry is that the prolonged, mandatory detention of asylum seeker children causes them significant mental and physical illness and developmental delays, in breach of Australia’s international obligations.

The following is a snapshot of the findings:

• Children in immigration detention have significantly higher rates of mental health disorders than children in the Australian community. 

• Both the former and current Ministers for Immigration agreed that holding children for prolonged periods in remote detention centres, does not deter people smugglers or asylum seekers. There appears to be no rational explanation for the prolonged detention of children. 

• The right of all children to education was denied for over a year to those held on Christmas Island. 

• The Minister for Immigration and Border Protection, as the guardian of unaccompanied children, has failed in his responsibility to act in their best interests. 

• The Commonwealth’s decision to use force to transfer children on Christmas Island to a different centre breached their human rights. 

• The numerous reported incidents of assaults, sexual assaults and self-harm involving children indicate the danger of the detention environment. 

• At least 12 children born in immigration detention are stateless, and may be denied their right to nationality and protection. 

• Dozens of children with physical and mental disabilities are detained for prolonged periods. 

• Some children of parents assessed as security risks have been detained for over two years without hope of release. 

• Children detained indefinitely on Nauru are suffering from extreme levels of physical, emotional, psychological and developmental distress.

The Commission notes

It is troubling that members of the Government and Parliament and Departmental officials are either uninformed, or choose to ignore, the human rights treaties to which Australia is a party. The High Court of Australia in Teoh has confirmed that, when making decisions that affect children, government officials should take account of the rights guaranteed by the Convention on the Rights of the Child.

It accordingly recommends -

• All children and their families be released into community detention or the community on bridging visas with a right to work. 
• Legislation be enacted to ensure that children may be detained under the Migration Act for only so long as is necessary for health, identity and security checks. 
• Assessment of refugee status be commenced immediately according to the rule of law. 
• No child be sent offshore for processing unless it is clear that their human rights will be respected. 
• An independent guardian be appointed for unaccompanied children seeking asylum in Australia. 
• An independent review be conducted into the decision to approve the use of force to transfer unaccompanied children on Christmas Island on 24 March 2014. 
• All detention centres be equipped with sufficient CCTV or other cameras to capture significant incidents in detention. 
• ASIO review the case of each parent with an adverse security assessment in order to identify whether their family can be moved into the community. 
• Alternative community detention be available for children of families assessed as security risks. 
• Children in immigration detention be assessed regularly using the HoNOSCA mental health assessment tool. 
• Children currently or previously detained at any time since 1992 have access to government funded mental health support. 
• Children in detention who were denied education on Christmas Island for a year be assessed to determine what educational support they require. 
• Children and families in immigration detention receive information about the provision of free legal advice and access to phones and computers. 
• Legislation be enacted to give direct effect to the Convention on the Rights of the Child under Australian law. 
• A royal commission be set up to examine the continued use of the 1992 policy of mandatory detention, the use of force by the Commonwealth against children in detention and allegations of sexual assault against these children and to consider remedies for breach of the Commonwealth’s duty of care to detained children. 
• An independent review of the implementation of these recommendations be conducted in 12 months.

Childcare Inquiry

The Government has released the Productivity Commission report on the Commission's Inquiry into Child Care and Early Childhood Learning.

The report notes that

 The market for child care and early childhood learning services is large, diverse and growing, and it touches the lives of practically every family in Australia. Almost all children in Australia participate in some form of child care or early learning service at some point in the years before starting school. In 2012, around 19,400 child care and early learning services enrolled over 1.3 million children in at least one child care or preschool programme (comprising around 15,100 approved child care services and 4,300 preschools). The Australian Government is the largest funder of the sector, with outlays exceeding $5 billion a year and growing. It is important that this expenditure achieves the best possible impact in terms of benefits to families and children as well as the wider economy. The child care and early learning system can be improved because:

• families are struggling to find quality child care and early learning that is flexible and affordable enough to meet their needs and to participate in the workforce 

• a small but significant number of children start school with learning and developmental delays 

• there are shortfalls in reaching and properly supporting the needs of children with disabilities and vulnerable children, regional and rural families and parents who are moving from income support into study and employment 

• services need to operate in a system that has clear and sustainable business arrangements, including regulation, planning and funding 

• there is a need to ensure that public expenditure on child care and early childhood learning is both efficient and effective in addressing the needs of families and children.

The Inquiry objectives were

to examine and identify future options for a child care and early childhood learning system that: • supports workforce participation, particularly for women • addresses children's learning and development needs, including the transition to schooling • is more flexible to suit the needs of families, including families with non-standard work hours, disadvantaged children, and regional families • is based on appropriate and fiscally sustainable funding arrangements that better support flexible, affordable and accessible quality child care and early childhood learning.

The Commission was to  make recommendations about -

1. The contribution that access to affordable, high quality child care can make to: (a) increased participation in the workforce, particularly for women (b) optimising children's learning and development.

2. The current and future need for child care in Australia, including consideration of the following: (a) hours parents work or study, or wish to work or study (b) the particular needs of rural, regional and remote parents, as well as shift workers (c) accessibility of affordable care (d) types of child care available including but not limited to: long day care, family day care, in home care including nannies and au pairs, mobile care, occasional care, and outside school hours care (e) the role and potential for employer provided child care (f) usual hours of operation of each type of care (g) the out of pocket cost of child care to families (h) rebates and subsidies available for each type of care (i) the capacity of the existing child care system to ensure children are transitioning from child care to school with a satisfactory level of school preparedness (j) opportunities to improve connections and transitions across early childhood services (including between child care and preschool/kindergarten services) (k) the needs of vulnerable or at risk children (l) interactions with relevant Australian Government policies and programmes.

3. Whether there are any specific models of care that should be considered for trial or implementation in Australia, with consideration given to international models, such as the home based care model in New Zealand and models that specifically target vulnerable or at risk children and their families.

4. Options for enhancing the choices available to Australian families as to how they receive child care support, so that this can occur in the manner most suitable to their individual family circumstances. Mechanisms to be considered include subsidies, rebates and tax deductions, to improve the accessibility, flexibility and affordability of child care for families facing diverse individual circumstances.

5. The benefits and other impacts of regulatory changes in child care over the past decade, including the implementation of the National Quality Framework (NQF) in States and Territories, with specific consideration given to compliance costs, taking into account the Government's planned work with States and Territories to streamline the NQF.

6. In making any recommendations for future Australian Government policy settings, the Commission will consider options within current funding parameters.

The report offers the following 'key points' -

• Formal and informal Early Childhood Education and Care (ECEC) services play a vital role in the development of Australian children and their preparation for school, and in enabling parents to work. Many families use a mix of formal ECEC and informal, non-parental care. The number of formal ECEC services has expanded substantially over the past decade. Over the same period, Australian Government funding has almost tripled to around $7 billion per year, and now covers two thirds of total ECEC costs. Despite this, many parents report difficulties in finding ECEC at a location, price, quality and hours that they want. 
• Current ECEC arrangements are complex and costly to administer and difficult for parents and providers to navigate. There are over 20 Australian Government assistance programs, some poorly targeted. Assessing service quality is cumbersome and time consuming. 
• The benefits from participation in preschool for children’s development and transition to school are largely undisputed. There also appear to be benefits from early identification of, and intervention for, children with development vulnerabilities. 
• The National Quality Framework must be retained, modified and extended to all Government funded ECEC services. To better meet the needs and budgets of families, the range of services approved for assistance should include approved nannies and the cap on occasional care places should be removed. All primary schools should take responsibility for outside school hours care for their students, where demand exists for a viable service. 
• The Commission’s recommended reforms will achieve, at minimal additional cost, an ECEC system that is simpler, more accessible and flexible, with greater early learning opportunities for children with additional needs. The reforms would also alleviate future fiscal pressures, establish a system that is easier to adapt to future changes in ECEC, and tax and welfare arrangements. Assistance should focus on three priority areas: 
• mainstream support through a single child-based subsidy that is: means- and activity- tested, paid directly to the family’s choice of approved services, for up to 100 hours per fortnight, and based on a benchmark price for quality ECEC. In regional, rural and remote areas with fluctuating child populations, viability assistance should be provided on a limited time basis. 
• support the inclusion of children with additional needs in mainstream services, delivery of services for children in highly disadvantaged communities and the integration of ECEC with schools and other child and family services. 
• approved preschool programs funded on a per child basis, for all children, regardless of whether they are dedicated preschools or part of a long day care centre. 
• Additional workforce participation will occur, but it will be small. ECEC issues are just some of a broad range of work, family and financial factors which influence parent work decisions. The interaction of tax and welfare policies provide powerful disincentives for many second income earners to work more than part time. Shifting to the recommended approach is nevertheless estimated to increase the number of mothers working (primarily of low and middle income families) by 1.2 per cent (an additional 16 400 mothers). 
• Overall, more assistance will go to low and middle income families and their use of childcare is expected to rise. However, high income families who increase their work hours may also be better off. Enabling the lowest income families (those on Parenting Payments) some access to subsidised childcare without meeting an activity test may boost ECEC participation and improve child development outcomes for this group, but this comes at the cost of potentially higher workforce participation. 

The Commission makes the following recommendations and findings -

Families using mainstream services — improving accessibility, flexibility and affordability 

F11.1 The amount families pay for ECEC varies depending on their income, care use patterns and family size. For the vast majority of families, subsidies from the Australian Government cover more than half of their ECEC fees. Current subsidy arrangements make ECEC more affordable for families. However, there are a number of issues with the way Government support is delivered: • the existing system is complex and some families have difficulty understanding their entitlements under the Child Care Benefit and the Child Care Rebate • the design of these measures is resulting in a declining proportion of assistance to lower income families who are least able to afford ECEC services • the Jobs, Education and Training Child Care Fee Assistance program is not well targeted and the very high degree of subsidisation may encourage families to remain eligible for the program. 

R15.1 The Australian Government should combine the current funding for Child Care Rebate, Child Care Benefit and the Jobs Education and Training Child Care Fee Assistance to support a single child based subsidy, to be known as the Early Care and Learning Subsidy (ECLS). ECLS would be available for children attending all mainstream approved ECEC services, whether they are centre based or home based. 

R15.2 The Australian Government should fund the Early Care and Learning Subsidy to assist families with the cost of approved centre based care and home based care. The program should assist families with the cost of ECEC services: • supplied by approved providers that satisfy the requirements of the National Quality Framework • with a means tested subsidy rate between 85 per cent (for family incomes at or below $60 000) and 20 per cent (for family incomes at or above $250 000), with annual indexation of the thresholds • which is applied to an hourly benchmark price based on the median fees charged for the type of service, and differentiating by age of child for long day care • for up to 100 hours of care per fortnight for children aged 13 years and under of families that meet an activity test of 24 hours of work, study or training per fortnight, or are explicitly exempt from the activity test (recommendation 15.3) • paid directly to the service provider of the family’s choice on receipt of the record of care provided • be conditional on the child being fully immunised, unless care occurs in the child’s home. 

R15.3 The Australian Government should exempt families from the activity test in the following circumstances: • parents are receiving an income support payment, with those who receive only a Parenting Payment being exempt from the activity test for up to 20 hours only of ECEC use per fortnight • the primary carer is a grandparent or other non-parent primary carer • exceptional circumstances, including when a family has experienced a sudden change in employment circumstances that would mean they no longer satisfy the activity test, with the exemption to apply for a period of three months following this change in circumstances • the child has been assessed as ‘at risk’, with those who have had at least 26 weeks of being assessed as at risk exempt from the activity test for a further 18 months • the child is attending a service funded (in full or part) by the Community Early Learning Program • the child is attending a preschool program in an ECEC service, with the exemption to apply for the period of the preschool program (15 hours per week for 40 weeks per year). Unless otherwise stated, these families should still be subject to the same means test as applied to other families in determining the subsidy rate that applies to their use of the ECEC service. These activity test exemptions would replace the current Special Child Care Benefit, Grandparent Child Care Benefit, and Jobs Education and Training Child Care Fee Assistance arrangements and these programs should be abolished. 

R15.4 The Australian Government should establish a capped Viability Assistance Program to assist ECEC providers in rural, regional and remote areas to continue to operate under child based funding arrangements (the Early Care and Learning Subsidy), should demand temporarily fall below that needed to be financially viable. This funding would be: • accessed for a maximum of 3 in every 7 years, with services assessed for viability once they have received 2 years of support • be limited to funding the fee gap that arises from a decline in the number of children using the service relative to the previous 3 years • prioritised to centre based and mobile services that are viable in most years • be available to new services on the condition that they can demonstrate a business plan to be financially viable within two years. 

F10.1 The value of waiting lists to families would be increased if providers were to regularly publish on an appropriate platform: • information on the fees charged to join the waiting list • information on the number of families on the waiting list for each age group • statistics on the number of places offered to children on the waiting list over a given period. 

R10.1 The Australian Government should remove the ‘Priority of Access’ Guidelines once the proposed means and activity test requirements have been introduced. 

R10.4 The Australian Government should remove caps on the number of occasional childcare places and abolish operational requirements that specify minimum or maximum operating hours for all services approved to receive child-based subsidies. ECEC services to children under school age should be operational for at least 48 weeks per year in order to be approved to receive child-based subsidies. ECEC services for school age children should be operational for at least 7 weeks per year in order to be approved to receive child-based subsidies. The requirements for before and after school care services to operate on every school day should be abolished. 

R10.5 Governments should allow approved nannies to become an eligible service for which families can receive ECEC assistance. Assistance would not be available for use of nannies who do not meet the National Quality Standard. National Quality Framework requirements for nannies should be determined by ACECQA and should include a minimum qualification requirement of a relevant (ECEC related) certificate III, or equivalent, the same staff ratios as are currently present for family day care services, and be linked to an approved coordinator, as occurs in family day care. Assessments of regulatory compliance should be based on both random and targeted inspections by regulatory authorities. 

R10.7 The Australian Government should simplify working holiday visa requirements to make it easier for families to employ au pairs, by allowing au pairs to work for a family for up to the full 12 month term of the visa, rather than the current limit of six months per family. 

Additional needs — improving accessibility, flexibility and affordability 

F5.1 Generally, Australian children are doing well developmentally and most are well prepared to begin formal schooling. Those who are less well prepared tend to be Indigenous children, children living in socio-economically disadvantaged communities, children living in very remote areas and children from non-English speaking backgrounds. There is likely to be overlap across these groups. 

R5.2 Early intervention programs to address the development needs of children from disadvantaged backgrounds should be underpinned by research. Their impact on the development outcomes of the children attending ECEC should be subject to ongoing monitoring and evaluation, including through the use of longitudinal studies. 

F13.1 Having short-term arrangements that enable access to ECEC for children at risk of neglect and harm is an essential element of a wider solution to protect these children. Access for unlimited hours — in some cases 24/7 care — amounts to emergency care and is the responsibility of state and territory governments. 

R15.5 The Australian Government should continue to provide support for children who are assessed as ‘at risk’ to access ECEC services, funding an at risk children program that provides: • a 100 per cent subsidy for the benchmark price of ECEC services • up to 100 hours a fortnight, with exemption from the activity test • support initially for 6 weeks then in blocks of up to 26 weeks, on application by the relevant state or territory department and approval by the Department of Human Services • automatic extensions are to be provided for children for whom there is a current child protection order. Families who have had a child assessed as ‘at risk’ for a period of 6 months or more would be exempt from the activity test for on-going ECEC services for this child for a further period of up to 18 months. 

R15.6 States and territories should nominate an agency for ECEC providers to contact where the provider has identified a child as at risk and applied for the initial six weeks at risk subsidy. This state or territory agency should be responsible for assigning a case worker to the child. If assistance is required beyond the initial period, this agency should also be responsible for making any applications for extensions for assistance on behalf of the child to support their attendance at the ECEC service. The application would require approval by the Department of Human Services. ECEC providers should be required to contact the designated state or territory department contact agency within one week of applying for the six week at risk assistance. Continuation of access to the subsidy would be based on ongoing involvement by a state or territory agency with the child and their family, and approval by the Department of Human Services. The processes for providers to notify the nominated state or territory agency, and for the agency to apply for an extension of the full subsidy on behalf of a child, should be trialled to establish an effective process before being fully rolled out. 

R15.7 The Australian Government should retain the Inclusion Support Agency, Inclusion Support Subsidy, Bicultural Support, and Specialist Equipment Support elements from the Inclusion and Professional Support Program to form the core of a new Inclusion Support Program. The National Inclusion Support Subsidy Provider should also be retained. The budget should be increased for: • the Inclusion Support Agencies to allow for ‘value for money’ contracting based on the number of services and child populations, with an adjustment for level of disadvantage in the communities in their allotted district • the Inclusion Support Subsidy to allow for up to 7 hours of funding a day for up to 10 days a fortnight and paid at the certificate III award rate • Bicultural Support to allow services access to at least 20 hours of support to settle new culturally and linguistically diverse families and their children into an ECEC service. The ongoing need for Inclusion Support Agencies should be reviewed in five years. 

R13.2 The application process for the Inclusion Support Subsidy should be streamlined through: • sharing of information across government agencies to reduce the administrative burden on families and ECEC services • an upgraded and more user friendly IT portal. 

F13.2 Funding to providers has an important role to play in improving accessibility to ECEC for children who live in disadvantaged areas without access to ECEC. There is scope to improve the current Budget Based Funded Programme which delivers assistance directly to providers in disadvantaged areas. Current funding precludes new services from opening up and does not encourage existing services to transition from provider-based funding to child-based assistance. 

F13.3 Block funding is problematic for the long term sustainability of integrated services — the loss of one service (if funding for that service is not continued) can threaten the viability of other providers in the service. While the ECEC component of integrated services can be funded through mainstream ECEC funding arrangements, block funding of coordination functions may be required to realise the value of integration. Non-ECEC services should be funded through the appropriate budget portfolio. 

R13.3 Governments should consider greater use of integrated ECEC and childhood services in disadvantaged communities: • to improve accessibility for families of ECEC and other childhood services • to help identify children that are at risk of abuse or neglect or have additional needs • ensure that the necessary support services, such as health, family support and any additional early learning and development programs, are available • to improve the efficiency of related service provision. 

R15.8 The Australian Government should establish a Community Early Learning Program (CELP) to fund ECEC services for communities where the children in the community are at a high risk of development vulnerabilities. The CELP would fund the: • establishment of new services that have a five year business plan to transition to mainstream funding • operation of these and current Budget Based Funded Programme services as they transition to mainstream funding, with a declining share of funding being provided by the CELP over time • on-going support to CELP services to meet any unavoidable higher costs of supply to children after transition • activities undertaken by an ECEC service to organise and manage integration of the ECEC service with other family and child services • Indigenous Professional Support Agencies to assist CELP services in Indigenous communities in the establishment and transition of these services. The Inclusion Support Agencies are to provide these services for those CELP services that target refugee communities. These agencies would also provide advice to mainstream ECEC services on culturally relevant inclusion planning strategies. 

R15.9 Budget Based Funded (BBF) Programme services that are unable to transition even with on-going assistance should be reviewed every three years and closed if there are better alternatives available to provide ECEC services to the children attending the service. Activities (such as playgroups) in the BBF Programme that do not involve non-parental care do not fit within the ECEC non-parental care and early learning objectives and should find alternative non-ECEC sources of funding. 

Preschool — supporting universal access 

F12.1 Whether preschool is the responsibility of the states and territories or the Australian Government needs to be resolved and could usefully be a consideration of the White Paper on the Reform of the Federation. 

F12.2 Participation in a preschool program in the year before starting formal schooling provides benefits in terms of child development and a successful transition to school. An analysis of the effectiveness of the existing arrangements in improving development outcomes and evidence drawn from relevant Australian and overseas research is necessary before any decisions can be made on the value of extending the universal access arrangement to younger children. 

R12.1 Payment of a portion of the Family Tax Benefit Part A to the parent or carer of a preschool aged child should be linked to attendance in a preschool program, where one is available. 

R15.10 The Australian Government should continue to provide per child payments to the states and territories for universal access to a preschool program of 15 hours per week for 40 weeks per year. This support should be based on the number of children enrolled in state and territory government funded preschool services, including where these are delivered in a long day care service. A condition placed on the per child payments is that they should be directed by the state or territory to the approved preschool service nominated by the family. The Australian Government should reduce the benchmark price for the hours of preschool provided by a long day care centre by an equivalent amount to the per child preschool funding.   

Outside school hours care — improving the accessibility, flexibility and affordability 

R10.2 State and territory governments should proactively encourage the provision of outside school hours care on school sites. At a minimum, this should involve: • ensuring outside school hours care services receive high priority on any guidelines on access to school facilities in non-school time • placing the onus on school principals to take responsibility for ensuring there is an outside school hours care service for their students on and/or offsite if demand is sufficiently large for a service to be viable. 

R12.2 The Australian Government should ensure that any requirements on the age of children able to attend an outside school hours care service be sufficiently flexible as to enable an outside school hours care service to include, or operate primarily for, preschool age children. 

R7.2 Governments and ACECQA should remove educational and child based reporting requirements for outside school hours and vacation care services, and consider other ways to tailor the National Quality Standard to suit different service types. 

R7.6 Governments should develop and incorporate into the National Quality Framework a nationally consistent set of staff ratios and qualifications for those caring for school age children in outside school hours and vacation care services. • The minimum staff ratio for school aged care should be no stricter than 1:15. • At most, one-third of staff should be required to hold or be working towards an approved qualification. Approved qualifications may be a certificate III and could also include those from other relevant disciplines such as sport and recreation. • Outside school hours and vacation care service directors should be required to hold or be working towards at least a diploma level qualification. Removal of ECEC assistance to some providers 

R5.1 Australian Government ECEC funding should be limited to funding approved ECEC services and those closely integrated with approved ECEC services, and not be allocated to fund social services that largely support parents, families and communities. Any further Australian Government support for the Home Interaction Program for Parents and Youngsters (HIPPY) should be outside of the ECEC budget allocation. 

R9.1 In line with the broad level recommendations of the Productivity Commission’s 2010 study into the Contribution of the Not for Profit Sector, the Australian Government should remove eligibility of not-for-profit ECEC providers to Fringe Benefits Tax exemptions and rebates. State and territory governments should remove eligibility of all not-for-profit childcare providers to payroll tax exemptions. If governments choose to retain some assistance, eligibility for a payroll tax exemption should be restricted to childcare activities where it can be clearly demonstrated that the activity would otherwise be unviable and the provider has no potential commercial competitors. 

R10.3 The Australian Government should abolish the Community Support Programme. 

R10.6 The Australian Government should remove the In-Home Care category of approved care once nannies have been brought into the approved care system. 

R11.1 The Australian Government should remove the registered childcare category under the Child Care Benefit. 

R13.1 The Australian Government should remove the category of ‘financial hardship’ as a justification for receiving fully subsidised ECEC services. 

R14.1 The Australian Government should amend the Fringe Benefits Tax Act 1986 (Cth) to remove section 47(2), that is, the eligibility for Fringe Benefits Tax concessions for employer provided ECEC services. Section 47(8), which enables businesses to purchase access rights for children of their employees without this being considered an expenditure subject to the Fringe Benefits Tax should be retained but better publicised. 

Workforce participation 

F6.1 The workforce participation rate of mothers with children aged under 15 years has grown substantially in recent decades, in line with that for all women. However, the participation rate of mothers is below that of fathers and women without children. The employment rate of Australian mothers is also below the OECD average. 

F6.2 Of employed mothers with children aged under 15 years, more work part time than full time. The part-time share of employed mothers is much higher than that of fathers and women without children. Australia has a higher proportion of couple families where one parent works full time and the other part time than the OECD average. 

F6.3 Roughly 165 000 parents (on a full-time equivalent basis) with children aged under 13 years who would like to work but are not able to because they are experiencing difficulties with the costs and accessibility of suitable childcare, could potentially be added to the workforce. 

F6.4 Secondary income earners in couple families and single parent families with children under school age could face a significant disincentive to work more than 3 days a week due to high effective marginal tax rates from the cumulative impact of income tax and the withdrawal of childcare assistance, Family Tax Benefits and the Parenting Payment. 

F16.1 Reforming subsidies for early childhood education and care services on their own can only partially address disincentives for mothers to work. Greater workforce attachment can be achieved by simultaneously reforming childcare subsidies, taxation, family income support and transfer payments. Other factors that can encourage greater workforce participation of mothers include fathers being willing and able to work flexibly and take on more child caring responsibilities and having ECEC services that offer rich and engaging experiences (particularly in relation to outside school hours care). 

R6.1 The proposed White Paper on the Reform of Australia’s Tax System should include consideration of how taxation and the design of family income support and transfer payments impact on effective marginal tax rates. 

F6.5 The workforce participation of mothers of children aged under 15 years is affected by the preferences of parents to look after their own (particularly very young) children. These, in turn, can be affected by such factors as costs and availability of suitable childcare, the stresses of managing paid work and unpaid work at home, the provision of flexible work and other family-friendly arrangements by employers, the level of contact with the workplace, long-term career prospects and the effective marginal tax rates facing mothers. 

R6.2 Employer and employee associations, the Fair Work Ombudsman, the Australian Human Rights Commission and the Workplace Gender Equality Agency should all trial innovative approaches to: • increase awareness about legal rights and obligations with respect to flexible work • promote positive attitudes among employers, employees and the wider community towards parents, particularly fathers, taking up flexible work and other family-friendly arrangements. 

R6.6 Based on analysis in the Productivity Commission’s 2009 inquiry on Paid Parental Leave: Support for Parents with Newborn Children, it is unlikely that the Government’s proposed changes to the Paid Parental Leave scheme would bring significant additional benefits to the broader community beyond those occurring under the existing scheme. If the Government is seeking increased workforce participation, this may be achieved more effectively through additional funding of ECEC than through the modification of the Paid Parental Leave scheme. 

Quality assurance processes and regulation of ECEC 

R7.1 To simplify the National Quality Standard, governments and ACECQA should identify elements and standards of the National Quality Standard that can be removed or altered while maintaining outcomes for children. 

R7.8 Governments should: • urgently reconsider the design of the assessment and ratings system, giving particular consideration to finding ways to increase the pace of assessments • explore ways to determine services’ ratings so they are more reflective of overall quality • abolish the ‘Excellent’ rating, so that ‘Exceeding National Quality Standard’ is the highest achievable rating. 

R7.9 Governments, ACECQA and regulatory authorities, as applicable, should: • abolish the requirement for certified supervisor certificates • give providers more detailed and targeted guidance on requirements associated with Quality Improvement Plans, educational programming, establishing compliant policies and procedures and applying for waivers • identify and eliminate potential overlaps between the National Quality Framework and state and local government requirements • review ways that services with higher ratings (‘Exceeding National Quality Standard’) could be relieved of some paperwork requirements, where these are less important to ensuring quality given the service’s compliance history • remove the requirement for outside school hours care services operating on school facilities to provide site plans as a condition of service approval. 

R7.10 Governments should extend the scope of the National Quality Framework to include all centre and home-based services that are eligible to receive Australian Government assistance. National Quality Framework requirements should be tailored towards each care type, as far as is feasible, and minimise the burden imposed on service providers. In particular, child based educational reporting should not be required where children only attend services irregularly. 

R7.11 The quality standards in state and territory education legislation which apply to dedicated preschools should recognise those standards that are required to be satisfied under the National Quality Framework and any sources of inconsistency or duplication of requirements should be removed from the education legislation applying to preschools. 

R7.12 State and territory governments should, within two years, harmonise background checks for ECEC staff and volunteers by either: • advancing a nationally consistent approach to jurisdiction based ‘working with children checks’ as proposed in the National Framework for Protecting Australia’s Children, including mutual recognition of these checks between jurisdictions, or • implementing a single, nationally recognised ‘working with children check’. 

R7.13 Where there is an overlap with existing state and territory food safety requirements, Governments should exempt services from, or preferably remove, those requirements in the National Regulations. State and territory governments, in conjunction with Food Standards Australia New Zealand, should explore the possible exemption of childcare services from Standard 3.3.1 of the Australian food safety standards, as in New South Wales. 

R7.14 Local governments should adopt leading regulatory practices in planning for ECEC services. In particular, local governments should: • use planning and zoning policies to support the co location of ECEC services with community facilities, especially schools • use outcomes based regulations to allow services flexibility in the way they comply with planning rules, such as in relation to parking • not regulate the design or quality of any aspect of building interiors or children’s outdoor areas within the service property, where such regulation unnecessarily duplicates or extends the requirements of the National Regulations or other standards such as the Building Code of Australia • not impose regulations that interfere with the operation of the ECEC market, such as by restricting the maximum number of permitted childcare places in a service • provide clear guidelines for the assessment of development proposals in relation to ECEC services, and update these guidelines regularly. 

R7.15 State planning departments should, as in Victoria, develop flexible standard planning provisions that can be applied across local governments to ensure some level of consistency; and scrutinise amendments to local planning schemes that might seek the introduction of different standards, to guard against potentially costly requirements being imposed. 

ECEC qualifications and ratios 

F8.1 There are no significant regulatory or other impediments preventing the ECEC sector from addressing any recruitment, retention and workforce shortage issues through higher wages, better conditions and improved career opportunities. Some services have taken this approach. The use of wage subsidies to attract and retain staff is likely to be ineffective, inefficient and unsustainable. Implementing the required regulatory reforms around the NQF would increase the potential pool of eligible ECEC workers. 

R7.3 Where all children are aged 25 months and over, educator to child ratios for home based care services should be amended such that a ratio of 1 educator to 5 children is permitted for children aged from 25 months up to school age. 

R7.4 Requirements for educators in centre based services should be amended by governments such that: • all educators working with children aged birth to 35 months are, as a minimum, required to hold or be working towards at least a certificate III or equivalent and be under the supervision of at least a diploma qualified educator • services may determine the number of diploma qualified educators sufficient to supervise and support certificate III qualified educators, as is currently the case in family day care services • the number of children for which an early childhood teacher must be employed is assessed on the basis of the number of children in a service aged over 35 months. 

R7.5 Differences in educator to child ratios and staff qualification requirements for children under school age across jurisdictions should be eliminated and all jurisdictions should adopt the national requirements.

R7.7 To provide services with greater flexibility to meet staffing requirements: • all governments should amend the National Law and any other relevant legislation to allow ACECQA further flexibility in the way it approves qualifications — in particular to allow ACECQA to approve qualifications on a conditional or restricted basis • all governments should allow a diploma qualified educator to be replaced by a certificate III qualified educator for short irregular absences of up to half a day per week • ACECQA should continue to explore ways to make the requirements for approving international qualifications simpler and less prescriptive in order to reduce obstacles to attracting appropriately qualified educators from overseas • the New South Wales and South Australian Governments should allow a three month probationary hiring period in which unqualified staff may be included in staff ratios before beginning a qualification, as was recently adopted in all other jurisdictions. 

R8.1 Governments should ensure, through regulatory oversight and regular audits by the Australian Skills Quality Authority, that Registered Training Organisations maintain consistently high quality standards in their delivery of ECEC-related training. Where Registered Training Organisations are unable to rectify identified non-compliant processes, the Australian Skills Quality Authority should employ appropriate regulatory responses including the cancelling of registration. 

R8.2 ECEC employers should accept primary responsibility for the funding and support of ongoing professional development. • Funding for Professional Support Coordinators should be discontinued. That part of their function which relates to assisting services in the inclusion of children with additional needs should be provided through an inclusion support program. • Funding for the Long Day Care Professional Development Program should not be extended once the current funding arrangements have expired. 

R8.3 To retain skills and experience in those services being brought within the scope of the NQF, staff employed in the service at the time of transitioning to the NQF who have a minimum of five recent years of relevant practical experience should be considered as meeting the NQF minimum qualification and be included in the staff ratio requirements. Ongoing support for evaluation and ECEC policy assessment 

R17.1 The Australian Government should establish a program to link information for each child from the National ECEC Collection to information from the Child Care Management System, the Australian Early Development Census, and NAPLAN testing results to establish a longitudinal database. Where possible, this should also be linked to other key administration data sets and Censuses. A confidentialised file should be made available for statistical, research, policy analysis and policy development purposes. The ability of researchers to access unit record information should be permitted subject to stringent privacy and data protection requirements. The Australian Government agency that is the custodian of the Child Care Management System should provide a publicly available extract from the database each year for interested parties at a sufficiently detailed geographic level for planning purposes. 

R17.2 Centrelink and the Department of Human Services should clarify in the claim form for ECLS that parents have the ability to authorise ECEC providers to enquire or act on their behalf in relation to their claim. 

R17.3 The Department of Education should establish a complaints mechanism for parents to lodge a complaint about an approved ECEC provider with regard to pricing, accessability, and any other ECEC matter. The mechanism should include a referral of the complaint to the appropriate Australian Government or state and territory government agency. 

R17.4 The Australian Government should review the operation of the new ECEC funding system and regulatory requirements after they have been implemented. In particular: • within 2 years of introducing subsidies based on a benchmark price, any adverse unintended outcomes of the approach should be identified and resolved • within 3 years of extending the coverage of the National Quality Framework (including to current block funded services and to nannies), ACECQA should prepare a report identifying any legislative, regulatory or procedural difficulties arising from the wider coverage of the National Quality Framework • within 5 years of implementing the new ECEC funding system and regulatory requirements, the Australian Government should undertake a public review of the effectiveness of the revised arrangements.