Access to Medicines report

The report of the United Nations Secretary-General's High Level Panel on Access to Medicines comments

 In September 2015, 193 Member States of the United Nations adopted the 2030 Agenda for Sustainable Development (2030 Agenda). This agenda includes Sustainable Development Goal (SDG) 3 that aims to ensure healthy lives and promote the well- being of all people of all ages. SDG 3 is an important vehicle for realizing the right to health and the right to share in the benefits of scientific advancements, whose affirmation dates back to the Charter of the United Nations (1945), the Universal Declaration of Human Rights (1948) and the Constitution of the World Health Organization (WHO) (1948). These rights are also enshrined in the International Covenant on Economic, Social and Cultural Rights (1966) and various other international treaties, declarations and national laws, including at least 115 constitutions. Consistent with the vision of the 2030 Agenda and a recommendation by the Global Commission on HIV and the Law that the United Nations Secretary-General establish a high- level body to propose ways of incentivizing health technology innovation and increasing access to medicines and treatment, Secretary-General Ban Ki-moon, in November 2015, announced the appointment of a High-Level Panel on Innovation and Access to Health Technologies.

In keeping with the commitment of United Nations Member States to enhance policy coherence for sustainable development, the High-Level Panel’s terms of reference called for it to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies,” among other things. In accordance with the principle of universality that underpins the 2030 Agenda and its aspiration to leave no one behind, the High-Level Panel views innovation and access to health technologies as a multi-dimensional and global problem that affects all countries.

Health technology innovation and access

Over the last few decades, medical innovation has dramatically improved the lives of millions of people across the globe. Vaccines have significantly reduced the prevalence of diseases, ranging from polio to human papillomavirus. Antiretroviral medicines have greatly improved the lives of people living with the Human Immunodeficiency Virus (HIV). Personalized strategies based on molecularly-targeted medicines are likely to become central to cancer treatment in the future. Despite this noteworthy progress, millions of people continue to suffer and die from treatable conditions because of a lack of access to health technologies.

Investment in research and development (R&D) of health technologies does not adequately address a number of important health needs. In some cases, the cause lies in inadequate resourcing of R&D for diseases where the market does not provide sufficient return on investment. Antibiotics typically offer little pecuniary reward for years of often costly research. In these circumstances, experts warn that drug- resistant viruses, bacteria, parasites and fungi could cause 10 million deaths a year worldwide by 2050. The current model of medical innovation is ill-equipped to respond to the increasing emergence of infectious diseases, such as Ebola and Zika. Meanwhile, neglected tropical diseases (NTDs) continue to receive inadequate funding for R&D and access to health technologies, despite more than a billion people living with one or more NTD. The situation is driven by the relatively low purchasing power of people disproportionately affected by such conditions. There are many reasons why people do not get the healthcare they need, including, inter alia, under-resourced health systems, a lack of sufficiently qualified and skilled healthcare workers, inequalities between and within countries, regulatory barriers, poor health education, unavailability of health insurance, exclusion, stigma, discrimination and exclusive marketing rights. The High-Level Panel acknowledges the importance of addressing these multiple determinants to health technology innovation and access. However, the High-Level Panel’s mandate is focused on one aspect of a complex challenge: the incoherencies between international human rights, trade, intellectual property (IP) rights and public health objectives.

Policies and agreements related to human rights, trade, intellectual property rights and public health were developed with different objectives at different times. State obligations include duties not only to respect, but to protect and fulfil the right to health. This requires taking proactive measures to promote public health. As reaffirmed by a recent Human Rights Council resolution, ensuring access to medicines, and particularly to essential medicines, is a fundamental element of these obligations. Trade rules and intellectual property laws were developed to promote economic growth and incentivize innovation. On the one hand, governments seek the economic benefits of increased trade. On the other, the imperative to respect patents on health technologies could, in certain instances, create obstacles to the public health objectives of World Trade Organization (WTO) Members. The adoption of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1994 ushered in a new and unprecedented era of global intellectual property norms and created a new standard of intellectual property protection and enforcement. However, negotiators included safeguards, or ‘flexibilities,’ within the TRIPS Agreement that could be used by signatories to tailor national intellectual property regimes so that countries could fulfil their human rights and public health obligations (for instance, laws and regulations regarding competition, government procurement and medicines). The proliferation of free trade agreements containing expansive patent and test data protections on health technologies, which exceed the minimum standards for intellectual property protection required by the TRIPS Agreement (so-called ‘TRIPS- plus’ provisions), may impede access to health technologies. Also, an uneven application of health and trade policy within and among states can create tensions that fuel policy incoherence.

Intellectual property laws and access to health technologies

Public health-sensitive intellectual property rules and mechanisms can help address the misalignment between profit-driven innovation models and public health priorities. Voluntary licences, entered into between right holders and third parties to facilitate the market entry of more affordable health technologies, have helped to lower treatment costs in many countries. TRIPS flexibilities – for example, the freedom to determine patentability criteria and further define concepts such as “novelty,” “inventive step” and “industrial applicability” – can ensure that patents are only awarded for genuine innovation. Similarly, the ability to determine the terms upon which compulsory licences are issued allows governments to fulfil their human rights obligations by securing the availability and affordability of health technologies. Many governments have not used the flexibilities available under the TRIPS Agreement for various reasons ranging from capacity constraints to undue political and economic pressure from states and corporations, both express and implied. Political and economic pressure placed on governments to forgo the use of TRIPS flexibilities violates the integrity and legitimacy of the system of legal rights and duties created by the TRIPS Agreement, as reaffirmed by the Doha Declaration. This pressure undermines the efforts of states to meet their human rights and public health obligations. The use of TRIPS flexibilities may also be impeded by the proliferation of bilateral and regional free trade agreements containing TRIPS-plus provisions. The policies of public funders of health technology R&D can also play an important role in enhancing health technology innovation and access. The United States, for instance, holds a central position in health technology innovation. The country’s R&D and access policies influence other actors, including private and public sector donors and foundations, and have an impact on access to the fruits of technology worldwide. The introduction of the 1980 Bayh-Dole Act in the United States significantly changed academic research by allowing universities and public research institutions to patent the results of federally-funded research and license private enterprises to develop them. However, limiting access to academic discoveries can obstruct follow-on innovation and force taxpayers to pay twice for the benefits of publicly-funded research. Strong, enforceable policies on data sharing and data access should be a condition of public grants. Public funding agencies should strongly encourage patenting and licensing practices that benefit public health, including the use of non-exclusive licences, the donation of intellectual property rights, participation in public sector patent pools and other mechanisms that maximize innovation while promoting access. Open models of innovation can also lower entry hurdles and accelerate the pace of development of health technologies, including those needed to combat emerging infectious diseases.

New incentives for research and development of health technologies

Market-driven R&D has been credited by some for producing a number of important health technologies that have improved health outcomes significantly worldwide. However, significant gaps in health technology innovation and access persist. Under the prevailing model, the biomedical industry, with the help of intellectual property and data protections, in addition to benefiting from public funding for research, recoups the costs of its R&D and marketing through high product prices protected by patent monopolies and data and market exclusivities. As a result, new technologies are rarely developed for health conditions which cannot deliver high returns, such as bacterial infections that only require antibiotics. Rare diseases that a ect comparatively small proportions of the population have not traditionally attracted investments although this is changing.

Various efforts are being undertaken by governments, philanthropic organizations, international entities, civil society groups and the private sector to resolve the incoherence between market-driven approaches and public health needs. However, such e orts tend to be fragmented, disparate and insufficient to deal with priority health needs on a sustainable, long-term basis. A much greater e ort must be directed to supplementing the existing market-driven system by investing in new mechanisms that delink the costs of R&D from the end prices of health technologies.

Identification of global health priorities is necessary to efficiently distribute scarce health resources, to substantially improve the health status of populations and to enhance global preparedness for future health crises. The current patchwork of public, private and philanthropic funding cannot sufficiently and sustainably improve access to health technologies. Greater and more sustainable financial commitments are needed from both the public and private sectors and should be coordinated to achieve maximum utility and effect.

Governance, accountability and transparency

Good governance, strong and concrete accountability mechanisms and greater transparency are decisive enablers of the 2030 Agenda. An important factor behind the incoherence between human rights, trade, intellectual property and public health lies in the diverse accountability mechanisms and transparency levels of these different, but overlapping spheres. Trade- and intellectual property-related accountability mechanisms are typically regulated by the WTO Dispute Settlement Understanding and dispute settlement provisions found in free trade and investment agreements. In contrast, human rights and public health accountability mechanisms are characterized by varying and often limited degrees of precision, legal weight and enforceability.

Transparency is necessary to hold governments, the private sector and other stakeholders accountable for the impact of their actions on access to health technologies. However, accurate and comprehensive information on the costs of R&D, marketing, production and distribution, as well as the end prices of health technologies, can be difficult to aggregate. Existing public databases of health technology prices managed by international organizations and civil society groups, while laudable, tend to be limited in scope and accuracy, in part because of discounts, mark-ups, taxes and regional pricing differences. The absence of transparency in clinical trial data and a lack of coordination within national drug regulatory authorities can contribute to delays in the registration of new health technologies. Procurement decisions and generic manufacturing are often delayed by the absence of clear, accurate and up-to-date information on existing and expired patents. Moreover, trade and investment agreements containing TRIPS-plus provisions are often negotiated in secret. This lack of transparency makes it difficult to hold governments and other stakeholders accountable for the impact of their policies and actions on innovation and access to health technologies. The incoherencies between the right to health, trade, intellectual property and public health objectives can only be resolved using robust and effective accountability frameworks that hold all stakeholders responsible for the impact of their decisions and actions on innovation and access to health technologies.

The Panel's recommendations, in summary, are

Intellectual property laws and access to health technologies

World Trade Organization (WTO) Members should commit themselves, at the highest political levels, to respect the letter and the spirit of the Doha Declaration on TRIPS and Public Health, refraining from any action that will limit their implementation and use in order to promote access to health technologies. More specifically: TRIPS flexibilities and TRIPS-plus provisions World Trade Organization (WTO) Members must make full use of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities as confirmed by the Doha Declaration to promote access to health technologies when necessary.

WTO Members should make full use of the policy space available in Article 27 of the TRIPS Agreement by adopting and applying rigorous definitions of invention and patentability that are in the best interests of the public health of the country and its inhabitants. This includes amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred.

The United Nations Conference on Trade and Development (UNCTAD), the United Nations Development Programme (UNDP), the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO) should cooperate with one another and with other relevant bodies with the requisite expertise to support governments to apply public health-sensitive patentability criteria.

These multilateral organizations should strengthen the capacity of patent examiners at both national and regional levels to apply rigorous public health-sensitive standards of patentability taking into account public health needs.

Governments should adopt and implement legislation that facilitates the issuance of compulsory licenses. Such legislation must be designed to effectuate quick, fair, predictable and implementable compulsory licenses for legitimate public health needs, and particularly with regards to essential medicines. The use of compulsory licensing must be based on the provisions found in the Doha Declaration and the grounds for the issuance of compulsory licenses left to the discretion of governments. WTO Members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license. WTO Members should, as necessary, adopt a waiver and permanent revision of the TRIPS Agreement to enable this reform.

Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities. Instances of undue political and commercial pressure should be reported to by the WTO Secretariat during the Trade Policy Review of Members. WTO Members must register complaints against undue political and economic pressure which includes taking punitive measures against o ending WTO Members.

Governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the right to health. As a first step, they must undertake public health impact assessments. These impact assessments should verify that the increased trade and economic benefits are not endangering or impeding the human rights and public health obligations of the nation and its people before entering into commitments. Such assessments should inform negotiations, be conducted transparently and made publicly available.

Publicly-funded research

Public funders of research must require that knowledge generated from such research be made freely and widely available through publication in peer-reviewed literature and seek broad, online public access to such research.

Universities and research institutions that receive public funding must prioritize public health objectives over financial returns in their patenting and licensing practices. Such practices may include publication, non-exclusive licensing, donations of intellectual property and participation in public sector patent pools, among others. Sufficient incentives must be in place in these practices to make it attractive for developers to underwrite the cost of bringing a product to market at affordable prices that ensure broad availability.

Universities and research institutions that receive public funding should adopt policies and approaches that catalyse innovation and create flexible models of collaboration that advance biomedical research and generate knowledge for the benefit of the public.

New incentives for research and development of health technologies

It is imperative that governments increase their current levels of investment in health technology innovation to address unmet needs. Stakeholders, including governments, the biomedical industry, institutional funders of healthcare and civil society, should test and implement new and additional models for financing and rewarding public health research and development (R&D), such as the transaction taxes and other innovative financing mechanisms.

Building on current discussions at the WHO, the United Nations Secretary-General should initiate a process for governments to negotiate global agreements on the coordination, financing and development of health technologies. This includes negotiations for a binding R&D Convention that delinks the costs of research and development from end prices to promote access to good health for all. The Convention should focus on public health needs, including but not limited to, innovation for neglected tropical diseases and antimicrobial resistance and must complement existing mechanisms.

As a preparatory step, governments should form a Working Group to begin negotiating a Code of Principles for Biomedical R&D. The principles would apply to public R&D funds and should also be adopted by private and philanthropic funders, product development partnerships, universities, the biomedical industry and other stakeholders. Governments should report annually on their progress in negotiating and implementing a Code of Principles as a preparatory step to negotiating the Convention in the United Nations General Assembly.

Governance, accountability and transparency

Governments

Governments must review the situation of access to health technologies in their countries in light of human rights principles and States’ obligations to fulfil them, with assistance from the Office of the United Nations High Commissioner for Human Rights (OHCHR) and other relevant United Nations entities. The results of these assessments should be made publicly available. Civil society should be financially supported to submit their own shadow reports on innovation and access to health technologies. Such national reviews should be repeated at regular intervals.

Governments should strengthen national level policy and institutional coherence between trade and intellectual property, the right to health and public health objectives by establishing national inter-ministerial bodies to coordinate laws, policies and practices that may impact on health technology innovation and access. Appropriate member/s of the national executive who can manage competing priorities, mandates and interests should convene such bodies. The deliberations and decisions of such groups should operate with a maximum of transparency. Civil society should be financially supported to participate and submit their shadow reports on innovation and access to health technologies.

Multilateral organizations

The United Nations Secretary-General should establish an independent review body tasked with assessing progress on health technology innovation and access. Challenges and progress on innovation and access to health technologies under the ambit of the 2030 Agenda, as well as progress made in implementing the recommendations of this High-Level Panel, should be monitored by this body. Membership should comprise of governments, representatives from United Nations and multilateral organizations, civil society, academia and the private sector. The United Nations Secretary-General should establish an inter-agency taskforce on health technology innovation and access. This taskforce, operating for the duration of the SDGs, should work toward increasing coherence among United Nations entities and relevant multilateral organizations like the WTO. The taskforce, charged with overseeing the implementation of the High-Level Panel’s recommendations should be coordinated by the United Nations Development Group and report annually to the United Nations Secretary- General on progress made in enhancing United Nations system-wide coherence on innovation and access to health technologies.

The United Nations General Assembly should convene a Special Session, no later than 2018, on health technology innovation and access to agree on strategies and an accountability framework that will accelerate efforts towards promoting innovation and ensuring access as set out in the 2030 Agenda. Civil society should be financially supported to participate and submit their reports on innovation and access to health technologies at this Special Session.

Private sector companies

Biomedical private sector companies involved in health technology innovation and access should report, as part of their annual reporting cycle, on actions they have taken that promote access to health technologies.

Private sector companies should have a publicly available policy on their contribution to improving access to health technologies setting out general and specific objectives, timeframes, reporting procedures and lines of accountability and a governance system that includes direct board-level responsibility and accountability on improving access to health technologies.

R&D, production, pricing and distribution of health technologies

Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to: (1) the costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and (2) any public funding received in the development of the health technology, including tax credits, subsidies and grants.

Building on the Global Price Reporting Mechanism (GPRM), V3P and others, WHO should establish and maintain an accessible international database of prices of patented and generic medicines and biosimilars in the private and public sectors of all countries where they are registered.

Clinical trials

Governments should require that the unidentified data on all completed and discontinued clinical trials be made publicly available in an easily searchable public register established and operated by existing mechanisms such as the WHO Clinical Trials Registry Platform, clinical trials.gov or in peer reviewed publications, regardless of whether their results are positive, negative, neutral or inconclusive.

Junk Publishing and Pseudolegalism

A small moment of cheer for scholars disquieted by email from junk publishers, with news last month that the US Federal Trade Commission  charged OMICS Group, Inc. (along with two affiliated companies and executive Srinubabu Gedela) with deceiving academics and researchers about the nature of its publications and hiding publication fees ranging from hundreds to thousands of dollars.

The FTC’s complaint alleges that the OMICS group - publisher of what the FTC characterises as "hundreds of purported online academic journals" - claim that

their journals follow rigorous peer-review practices and have editorial boards made up of prominent academics. In reality, many articles are published with little to no peer review and numerous individuals represented to be editors have not agreed to be affiliated with the journals.

According to the FTC’s complaint, OMICS does not tell researchers that they must pay significant publishing fees until after it has accepted an article for publication, and often will not allow researchers to withdraw their articles from submission, thereby making the research ineligible for publication in another journal. Academic ethics standards generally forbid researchers from submitting the same research to more than one journal.

“The defendants in this case used false promises to convince researchers to submit articles presenting work that may have taken months or years to complete, and then held that work hostage over undisclosed publication fees ranging into the thousands of dollars,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “It is vital that we stop scammers who seek to take advantage of the changing landscape of academic publishing.”

Among the deceptive statements OMICS made to researchers, according to the complaint, were descriptions of its journals as having a high “impact factor,” a term that describes approximately how frequently articles in a particular journal are cited in other research. Thomson Reuters’ proprietary measure of journals’ impact factors is the widely accepted standard, but OMICS allegedly calculated its own impact scores and did not clearly disclose that fact to consumers.

The defendants also tell researchers that their journals are indexed by federal research databases, including the National Institutes of Health’s PubMed and MEDLINE services, when in fact that is not true, according to the complaint.

In addition to misrepresentations related to their journal publishing services, the FTC’s complaint alleges that the defendants regularly deceive consumers while promoting academic conferences they organize. The defendants allegedly include the names of prominent researchers as participants and presenters at the conferences, which charge registration fees that can cost more than $1,000, when in fact many of those researchers often did not agree to participate in the events.

The FTC’s complaint charges the defendants, OMICS Group Inc., iMedPub LLC, Conference Series LLC, and Srinubabu Gedela, with multiple violations of the FTC Act’s prohibition on deceptive acts or practices.

There's another perspective in Ennis v Credit Union Australia [2016] FCCA 1705. 

Jarrett J states 

The respondent suggests that the applicant has pursued these proceedings by seeking to engage an argument which has found some favour with persons who are seeking to avoid payment of their debts, around the world really, but principally in the United States, Canada and Australia. The argument is described in the material as an “Organised Pseudolegal Commercial Argument” and there are, as the respondents submissions point out, a number of hallmarks to that type of approach which are present in the current case. 

The relevant approach has been described in other cases – and I do not intend in these reasons to go through chapter and verse what that argument entails other than to say that it has been the subject of scholarly explanation in a decision from Canada called Meads v Meads (2012) ABQB 571. The argument and the approach is flawed and cannot succeed for the reasons explained in Mead v Mead. 

In this application, although Ms Ennis disavows any knowledge of the “Organised Pseudolegal Commercial Argument” she does, nonetheless, seek to rely on a case which tends to suggest that she is, in fact, relying on the “Organised Pseudolegal Commercial Argument”. 

The case concerned is a decision from a United States court in Minnesota. That decision, First National Bank of Montgomery v. Jerome Daly, Dec. 9, 1968 (Justice Court, Credit River Township, Scott County, Minnesota), also known as the Credit River Case was a case where a Justice of the Peace in a court in Minnesota determined that the U.S. Federal Reserve Act was unconstitutional and void; determined that the U.S. National Banking Act was unconstitutional and void and declared a mortgage acquired by the First National Bank of Montgomery, Minnesota in the regular course of its business, along with the foreclosure and a sheriff's sale to be void. The respondent, who was being pursued by his bank for recovery of land that was used as security for a loan, was successful in avoiding having to repay the debt and by the decision was able to keep his land. 

In her materials Ms Ennis suggests that that case is somehow important here; she suggests that the decision has survived an appeal because an appeal was made out of time and dismissed and that the decision should bind me. But none of that is correct. The decision has no importance here for a number of reasons. First, it is a decision of a very minor court in the United States given in 1968. It has no precedent value here. It is not even part of the same court system. Secondly, the decision in that court was “voided” in 1969 by a subsequent decision of the Minnesota Supreme Court: see Zurn v Northwestern National Bank 284 Minn. 573, 170 N.W.2d 600 (1969). 

The same thing happened in another case also involving Mr Daley, as it turns out, Daly v Savage State Bank 285 Minn. 503, 171 N.W.2d 218 (1969). Sadly for Mr Daly, who was a lawyer, following those decisions he was disbarred as a direct result of the arguments in those cases: In re Jerome Daly 291 Minn. 488, 189 N.W.2d 176 (1971). 

There has also been an erudite discussion of these types of matters in a case called Tuttle v. Chase Home Finance, LLC et al., U.S. District Court for the District of Utah, Oct. 26, 2008, case no. 2:08-CV-574-DB. 

So enough said about the “Organised Pseudolegal Commercial Argument” and the cases upon which it might be founded. ...

Corporate Criminal Identity

'When and How Corporations Became Persons under the Criminal Law, and Why It Matters Now' by W. Robert Thomas (University of Michigan Law School) comments

The Supreme Court concluded in 1909 that a corporation, like an individual, can be held criminally responsible for its misconduct. Yet even now, corporate-criminal liability has yet to overcome the same skeptical argument it faced then — and, for that matter, for centuries prior. The skeptic’s challenge appears as simple as it is persistent: Lacking a mind distinct and independent from its constitutive stakeholders, a corporation cannot produce the sorts of intentional attitudes needed to satisfy the law’s mens rea component. In other words, a corporation is straightforwardly incapable of satisfying one of criminal law’s most basic requirements. Accordingly, to the skeptic the very idea of corporate-criminal liability is, and always has been, pure nonsense.

Though it presents as a simple, common-sense challenge to a corporation’s ability to intend — criminally or otherwise — unpacking the skeptic’s critique quickly implicates profound considerations regarding the nature of personhood and proper methods of attribution. Animating the dispute between skeptics and proponents of corporate-criminal liability is a disagreement over how to evaluate personhood, and further how one’s conception of personhood licenses attributions of actions, attitudes, and ultimately responsibility to the entity in question. This brand of disagreement is nothing new: These themes recur throughout Western thought and extend far beyond corporate law, from Plato’s Phaedo to Boethius and Bartolus of Sassoferato, from Thomas Hobbes to John Locke. Given the intellectual lineage behind what is otherwise an ordinary policy disagreement, perhaps it should not be terribly surprising that skepticism about corporate-criminal liability was never put to rest.

I don’t expect that we can break this conceptual stalemate all at once, if at all, to solve the challenge facing corporate crime. More to the point, we don’t need to. As it turns out, in taking up this very dispute at the turn of the 20th century, courts and legislature sided with the proponents of corporate crime in a way that the skeptic cannot, or at least should not want to, unwind. The proponents of corporate-criminal liability did not just win the policy fight; they did so in a way that rendered the skeptic’s position incompatible with broader theoretical commitments that are now instrumental to the modern corporation.

This Article offers two contributions to the debate over corporate-criminal liability: one conceptual, and one practical. First, the same argument embraced by today’s skeptics was tried but rejected in the late 1800s, when the practice of holding corporations responsible first developed. Courts previously receptive to the skeptic’s reasoning abandoned the view — and more importantly, the relationship between personhood and attribution underwriting it — as increasingly untenable amidst a changing economic environment in which commercial corporations transformed from tiny, narrowly constrained, quasi-state entities to sprawling, sophisticated, dominant participants in the national marketplace. Meanwhile, the gradual embrace of corporate liability, both in tort and crime, is intimately connected to the simultaneous demotion of corporate law as a regulatory tool. The turn towards corporate-criminal liability thus reflects a broader abandonment both of a long-dominant conception of personhood and of an approach to corporate regulation rendered ineffective by the development of what has become the basis for our modern corporate law. In a slogan, corporations today are persons under the criminal law not because they have always been eligible, but rather because they became eligible.

Second, a clear theoretical understanding of how and why courts first held corporations criminally responsible has profound consequences for how and why we continue to hold them responsible today. Most directly, recognizing the conditions under which corporations became persons for the purposes of criminal law removes from contemporary debates one complaint with modern practice, and does so without having to resolve some deep metaphysical truth about the ultimate nature of personhood. Today’s skeptic of corporate capacities presupposes an outdated premise about how capacities should be attributed to a person, the abandonment of which is pivotal to creating and maintaining modern corporate law and today’s commercial corporation. Taking seriously the skeptic’s position, on this discovery, threatens to undermine the conceptual foundation integral to a regulatory framework making commercial corporations what they are today. In addition, taking seriously courts’ actual reasoning in holding corporations criminally responsible unearths both a method and rationale for continuing to do so, which is rooted in a constellation of fairness considerations towards individuals that, although mostly lost to history, nevertheless applies more strongly today than ever before. Commitment to this qualified anti-discrimination norm applies at least as powerfully today as it did a century ago: Far from being a once-excusably incoherent, now-superfluous practice, corporate-criminal liability has as much reason to exist today as it did upon inception.

Governance

The Australian National Audit Office report on Offshore Processing Centres in Nauru and Papua New Guinea: Procurement of Garrison Support and Welfare Services offers a damning assessment of governance regarding Australia's offshore detention centres.

The report notes

The objective of the audit was to assess whether the Department of Immigration and Border Protection (DIBP) had appropriately managed the procurement of garrison support and welfare services at offshore processing centres in Nauru and Papua New Guinea (Manus Island); and whether the processes adopted met the requirements of the Commonwealth Procurement Rules (CPRs) including consideration and achievement of value for money.

 The ANAO states

Background

1. In 2012 the Australian Government established offshore processing centres1 in the Republic of Nauru (Nauru) and Papua New Guinea (PNG) with the agreement of the Nauruan and PNG Governments. Under the agreements, the Australian Government was to bear all costs associated with the construction and operation of the centres. Transfers of asylum seekers to Nauru commenced on 14 September 2012 and to PNG on Manus Island on 21 November 2012.

2. To underpin operations at the centres, the Department of Immigration and Border Protection (DIBP or the department) entered into contracts for the delivery of garrison support and/or welfare services with a number of providers. Garrison support includes security, cleaning and catering services. Welfare services include individualised care to maintain health and wellbeing such as recreational and educational activities.

3. The department has undertaken a series of procurements relating to the garrison support and welfare services functions. The department applied limited tender procurement methods to acquire the services initially in 2012 and then again in late 2013. In 2015–2016, the department conducted an open tender procurement process for the services (for a single contract across both islands).

4. In October 2015, Transfield6 became the sole provider of all garrison support and welfare services to asylum seekers at the offshore processing centres in Nauru and on Manus Island. In February 2016 these arrangements were extended through to 28 February 2017 and in August 2016 the contract with Transfield was further extended until 31 October 2017. The contracts for garrison support and welfare services are set out in Table 1.1. The total combined contract value as at the end of March 2016, as reported on AusTender, was $3 045 million.

5. The Australian Government is a significant purchaser of goods and services and has in place resource management legislation and related policies that establish a framework for Government procurement and contracting. The Commonwealth Procurement Rules (CPRs) establish procurement principles that apply to all Australian Government procurement processes. The CPRs combine both Australia’s international obligations and good practice, and enable Government entities to design processes that are robust, transparent and instil confidence in the Australian Government’s procurement activities. The CPRs are issued under the Public Governance, Performance and Accountability Act 2013 (PGPA Act) and articulate the requirements for officials performing duties in relation to procurement.

Audit objective, scope and criteria

6. The objective of the audit was to assess whether the Department of Immigration and Border Protection (DIBP) had appropriately managed the procurement of garrison support and welfare services at offshore processing centres in Nauru and Papua New Guinea (Manus Island); and whether the processes adopted met the requirements of the Commonwealth Procurement Rules (CPRs) including consideration and achievement of value for money.

7. The audit examined procurements conducted since 2012, when the arrangements were first put into place, through to the open tender process which commenced in 2015. The ANAO reviewed DIBP and service provider records; and interviewed relevant DIBP officials (past and present) and stakeholders including service providers, tenderers and Government officials from Nauru and Papua New Guinea. The audit team also visited Manus Island and Nauru during August and September 2015. Due to shortcomings in DIBP’s record keeping system, DIBP was not able to provide the ANAO with assurance that it provided all departmental records relevant to the audit.

Conclusion

8. The Department of Immigration and Border Protection’s (DIBP) management of procurement activity for garrison support and welfare services at the offshore processing centres in Nauru and Papua New Guinea (Manus Island) has fallen well short of effective procurement practice. This audit has identified serious and persistent deficiencies in the three phases of procurement activity undertaken since 2012 to: establish the centres; consolidate contracts; and achieve savings through an open tender process.

9. Of most concern is the department’s management of processes for contract consolidation and the open tender. The Australian Government intended that these procurement processes would rein in the growing expense associated with managing the centres. In both cases, the approach adopted by the department did not facilitate such an outcome. The department used approaches which reduced competitive pressure and significantly increased the price of the services without Government authority to do so. The open tender process was cancelled by the department on 29 July 2016 and consequently had no outcome.

10. The conduct and outcomes of the tender processes reviewed highlight procurement skill and capability gaps amongst departmental personnel at all levels. Procurement is core business for Commonwealth entities and the deficiencies have resulted in higher than necessary expense for taxpayers and significant reputational risks for the Australian Government and DIBP. The audit’s two recommendations are intended to address: the significant skill and capability gaps identified amongst personnel at all levels in the department, including within the central procurement and budget units; and persistent shortcomings in the planning and conduct of the procurements, including in relation to record keeping, consistency and fairness in the treatment of suppliers, and the assessment of value for money.

Supporting findings

Establishing the offshore processing centres in 2012

11. For each of the procurements involved in this establishment phase, the department adopted limited tender arrangements. The department relied on the conditions for limited tender in the Commonwealth Procurement Rules, relating to urgent and unforeseen circumstances. Given the circumstances which existed—the department was expected to establish operations for the offshore processing centres in Nauru and on Manus Island immediately—the use of limited tender was justified. However, there was limited specification of the type of services to be delivered, and no estimation of the expected value of individual procurements, as required by the Commonwealth Procurement Rules.

12. The department was unable to demonstrate the achievement of value for money in three of the four procurement processes. In engaging Transfield the department set aside an earlier approach to Serco.  The department did not require Transfield to provide a proposal specifying services to be delivered and a price. As a result it was very difficult for the department to demonstrate that it had conducted a robust value for money assessment which considered the financial and non-financial benefits of the proposal. Transfield was instead assessed on its ability to respond in a short timeframe. The Salvation Army was also assessed as providing value for money on the basis of availability, without any specification of the services to be delivered or price. The department could not make available any records of how Save the Children was assessed as providing value for money. G4S was engaged following a limited tender procurement that involved a request for expressions of interest from five potential suppliers. This approach introduced competition in an otherwise limited tender procurement.

13. Contracts with service providers took between 16 and 43 weeks to negotiate, and the department relied on letters of intent or heads of agreement pending contract signature. Service requirements and prices were not settled until contracts were entered into. The approach adopted by the department introduced additional risk for the Commonwealth.

14. The department was not able to provide the ANAO with evidence that it implemented mechanisms to manage probity risk. The ANAO’s review, based on available evidence, of the conduct of these initial procurements indicates that suppliers were not always treated fairly or equally. In particular, Serco’s proposal was set aside without an opportunity to negotiate. The available records indicate that the department did not seek probity advice on this proposed course of action or document its decision-making. There are no available records of specific conflict of interest declarations having been made by departmental officers responsible for the initial procurements.

15. The department’s central procurement unit had limited effective oversight of the initial limited tender procurements. Available records indicate that program areas with responsibility for conducting the initial procurements obtained the necessary approvals to conduct limited tender procurements from the Chief Financial Officer, but not prior to commencing the procurement process as required by DIBP’s financial delegations. Consolidation of contracts in Nauru and on Manus Island in 2013–14

16. The department again relied on paragraph 10.3(b) of the CPRs16 to conduct a limited tender, on the basis of urgent and unforeseen circumstances, to engage Transfield in Nauru and on Manus Island as part of a contract consolidation process. At the time, consolidation was considered an interim measure pending an open tender process in 2014. The available record does not indicate that urgent or unforeseen circumstances existed but suggests that the department first selected the provider and then commenced a process to determine the exact nature, scope and price of the services to be delivered. The department decided not to continue with the existing provider (G4S), but did not clearly document its reasons. Advice prepared by the department’s Central Procurement Unit was not consistent with the CPRs and the Department of Finance (Finance) guidance on key issues. In seeking advice from Finance, the Unit made written statements implying underperformance by service providers which was not supported by the evidence. The department subsequently referenced Finance’s support in briefings for its Minister.

17. DIBP’s approach to engaging Transfield through limited tender procurement removed competition from the outset. The services to be provided and related costs were not agreed with Transfield prior to G4S and The Salvation Army being advised that they would exit from service delivery on Manus Island. The proposed costs submitted by Transfield were higher than the department had anticipated and exceeded those charged by G4S and The Salvation Army for service provision on Manus Island.

18. Ministers expected the consolidation of contracts to achieve innovation and savings. Savings were not realised and the basis which the department relied upon to demonstrate savings was unreliable. In particular: The department applied a benchmark model to demonstrate the achievement of value for money. Overall the benchmark was adjusted above historical costs to account for changes to the department’s service requirements and contractual approach, upwards to $372 million, to accommodate a number of service enhancements. The Government had directed the department to reduce per-head costs. The department had no authority to increase the funding value of the contract above historic costs. Separate benchmarks were developed for Nauru and Manus Island, but the department determined ‘value for money’ and claimed savings (against the benchmarks) on a combined basis. This allowed the department to demonstrate ‘savings’ by offsetting higher costs for Manus Island against lower costs for Nauru. While Transfield’s bid for Nauru was lower than historical costs, the bid for Manus Island exceeded historical costs by between $200 million and $300 million.

19. While the department based the negotiated contract price on a high capacity scenario, there was a steady drop off in new asylum seeker arrivals from a high of 1 647 in August 2013 to zero in March 2014. On this basis it was increasingly unlikely that the high capacity levels would eventuate. The resulting contract was volume driven, with significant economies of scale expected at high capacity levels. This contract exposed the Commonwealth to the risk of locking-in a high price for services delivered at lower capacity levels.

20. There is no available record of specific conflict of interest declarations having been made by departmental officers who were responsible for the procurement. There is also no available documentation to indicate whether the department performed due diligence checks on the successful tenderer (Transfield) or its subcontractors as part of the contract consolidation.

21. The Prime Minister had requested that per head costs be lower as a result of retendering the contracts, but the department did not calculate a per person cost. Finance advised the ANAO that under the consolidated contract, the per person per annum cost of holding a person in the offshore processing centres in Nauru and on Manus Island, was estimated at $573 111, at the time of the Mid-Year Economic and Fiscal Outlook 2015-16.18 Prior to consolidation Finance estimated the cost at $201 000.

Open Tender Process from 2014 to 2016

22. While aspects of the department’s open tender planning addressed the requirements of the CPRs, insufficient consideration was given to: The use of benchmarking to determine overall value for money. The department’s approach involved comparing only the preferred tenderer’s negotiated final costs with a benchmark, and was incompatible with the CPRs. The CPRs require each eligible  tenderer’s financial and nonfinancial benefit to be compared on a like for like basis with other eligible tenders. The scope of services set out in the statement of requirement. In particular, whether the department had policy authority to expand the services or increase the value of the contract beyond the contracts which were in place. The value of expanded services was estimated by an external adviser (KPMG) at between $594 million to $835 million above historical costs. The Government had not provided policy authority to expand the services or increase the funding value of the contract to accommodate service enhancements or adjustments.

23. The department’s tender evaluation processes were not sufficiently robust to meet a range of applicable CPR requirements. In particular: the department was unable to demonstrate that the original tender documents lodged through AusTender were used by evaluation team members for the tender evaluation; individual assessor records were incomplete and there were missing documents in relation to various aspects of the process; using compact disks rather than TRIM20 files did not provide sufficient control over the security of the tender documentation and the commercial material contained within those documents; and there were significant unquantified pricing risks related to most of the tender bids, which the department did not clarify prior to selecting a preferred tenderer and forming an opinion on value for money of the preferred and reserve tenderers.

24. The assessment of value for money focused on provider claims and referee reports and did not take into account the department’s own contract management experience with suppliers.

25. The department determined to only enter into negotiations with the preferred tenderer (Transfield). During the course of negotiations the department amended its requirements and accepted enhancements and adjustments to services which flowed through to a $1.1 billion increase in Transfield’s overall price. The department did not seek clarification or repricing from any other tenderers and instead set out to determine value for money by comparing the negotiated price with a benchmark. The benchmark was the cost of services provided in Nauru and on Manus Island, which had been procured via a non-competitive limited tender process in 2013–14. The approach adopted was not consistent with an open tender which requires that eligible tender bids are compared on a like for like basis. 26. The delegate had determined to finalise the procurement process and sign the contract. There are no available records to demonstrate that the delegate: considered if sufficient funds were available to enter into the commitment; considered if additional policy authority was required to accommodate the service enhancements negotiated; or questioned the increased cost of the bid.

27. A steering committee and independent probity adviser were key oversight mechanisms for the open tender process. Both were consulted after the negotiation team had reached agreement on a final negotiated outcome with Transfield and prior to the anticipated contract signing. The probity adviser identified that the department’s negotiation report appeared to include substantial modifications to the statement of requirement from that released to the market and that Transfield appeared to have been permitted to make material changes to its original tender, including significant overall price increases. The probity adviser considered that these developments raised significant probity and process risks, including the risk that the department was not in a position to determine whether the changes continued to represent best overall value for money compared with other tenderers.

28. After considering this advice the steering committee decided it was unable to determine whether the final negotiated outcome with Transfield demonstrated best value for money. The effective operation of these oversight mechanisms contributed to the department initiating an amended tender process. The Minister was advised of the amended tender process prior to it commencing, and that approvals for funding would need to be reassessed. The amended process only involved the preferred and reserve tenderers and was in effect a limited tender process. On 29 July 2016, in the course of this audit, the department cancelled the initial and amended request for tender. DIBP extended its contract with Transfield until 31 October 2017 and the department advised the ANAO on 29 August 2016 that it was conducting market testing to determine its next steps.

Recommendations

29. Procurement is core business for Commonwealth entities and deficiencies in capability, process and advice can result in higher than necessary expense for taxpayers and significant reputational risks for the Australian Government and responsible entities. The audit recommendations are intended to address significant weaknesses in the Department of Immigration and Border Protection’s (DIBP) administration of procurement.

Recommendation No. 1 Paragraph 4.64 That the Department of Immigration and Border Protection address, as a priority: through training and staff selection—the significant procurement skill and capability gaps identified in this audit amongst personnel at all levels, including: the central procurement unit; budget unit; program area staff; and delegates; through guidance, training and staff selection—an approach to ensuring that officials have appropriate seniority and experience to undertake key procurement roles, such as chief negotiators and delegates, and effectively manage procurement risk; and through guidance, training and a strategic approach to records management—persistent shortcomings in record keeping for procurement activities.

Department of Immigration and Border Protection response: Agreed

Recommendation No. 2 Paragraph 4.65 That the Department of Immigration and Border Protection take practical steps to ensure adherence to the requirements of the resource management framework when undertaking procurements, including: the obligation to manage all aspects of a procurement process in accordance with the Commonwealth Procurement Rules; compliance with Government approved scope and contract value; in respect to open tender processes, adopting a value for money assessment which compares tenderers against other bids; the application of documented eligibility criteria in line with the Request for Tender and consistent with the Commonwealth Procurement Rules, with any modifications advised to all potential suppliers; the need for ethical conduct throughout the procurement to ensure consistent and fair treatment of suppliers; the need to recognise and manage actual, potential and perceived conflicts of interest; and the maintenance of clear and complete records of all tender bids, key actions, decisions, conflict of interest and SES disclosure declarations.

Department of Immigration and Border Protection response: Agreed

DTC

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

The myDNA genetic test has been available to purchase through Chemmart pharmacies since November 2015. It is sold for $149 and is not covered by Medicare or private health insurance rebates. It is supplied by myDNA Life Australia Pty Ltd (MDLA).

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

The ACCC states

A person’s genetic profile is just one of a wide range of factors that may be considered by a medical practitioner in determining the type and dose of drug that is suitable for an individual.

“Consumers place a high level of trust in pharmacists and the information they provide. They’re entitled to expect that products and services in pharmacies are promoted in a way that is clear and accurate, and explains both the benefits and limitations of those products or services,” ACCC Commissioner Sarah Court said.

“This is a reminder to pharmacies to avoid making statements about products in advertising and promotional materials that are overly broad or which do not contain sufficient qualification, and consequently have the potential to mislead consumers.”

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

Animal Welfare in Victoria

The Victorian Government yesterday released its draft animal welfare action plan Improving the Welfare of Animals in Victoria with feedback due by 11 October.

Lizzie Blandthorn MP has been appointed as the state's Ambassador for Animal Welfare.

The Ambassador is

to lead the conversation – collaborating with the community, animal industries and welfare groups. Whether the focus is on pets, animals bred to produce food, or animals in the wild, we all have a role to play in ensuring the welfare of animals. 

The draft plan has been developed with the assistance of the expert Animal Welfare Advisory Committee, a group of animal industry and welfare specialists with a broad range of experience and knowledge. 

Meaningful animal welfare reform requires a collective approach by government, animal industries and the community that underlines a shared responsibility. 

The Government is seeking feedback from interested individuals, industry bodies and community groups on the draft plan's key priorities of a modern legal framework, education and effective enforcement.

The draft plan identifies "three key priority areas to improve animal welfare in Victoria" -.

• Action Area 1: To develop new, contemporary laws for animal welfare in consultation with Victorian stakeholders and the community. 
• Action Area 2: Collaborative approaches underpin knowledge, commitment and investment in animal welfare. 
• Action Area 3: Compliance and enforcement is efficient and effective.

The draft states

Our main animal welfare act – the Prevention of Cruelty to Animals Act 1986 (POCTAA) – has been in place for 30 years. It has a reactive approach that focuses on preventing cruelty to animals. In addition, a number of other laws interact with the POCTAA, creating a complex regulatory environment for animal industries and custodians. It is time to review and refresh our legislation and ensure we have laws in place that are contemporary and meet modern international practice. Specifically, we must move beyond cruelty to a proactive approach to animal welfare, by including provisions (such as a duty of care) that provide for an acceptable quality of life for all animals and underpin sound animal welfare practices. 

Contemporary animal welfare laws will provide for clear and timely action to address animal welfare issues. They will also reflect changes in community, animal industries and market attitudes and expectations; advances in research, science and technology; and the whole of society’s responsibility towards animals, domestic or wild. They will be flexible and robust enough to move with innovation and expectations.

Outcomes 

1. Victoria’s laws enable a proactive approach to animal welfare, and the humane and ethical treatment of animals, both domestic and wild. 

2. Victoria’s regulatory system underpins positive animal welfare practices and in uences and enables improvements in animal welfare. 

3. Processes are in place to drive continuous improvement of Victoria’s laws that are evidence-based, strive for national consistency and respect community expectations. 

4. Animal welfare laws in Victoria are proportionate to risk and well understood and regarded by the community and animal industries.

Sheep and Goat ID Tags

Consultation is currently underway in Victoria regarding the state's new sheep and goat identification regime.

From 1 January 2017 all sheep and goats born in Victoria will require an electronic identification tag, linked to the National Livestock Identification System (NLIS), before being shipped to a saleyard, abattoir or another property.  From mid next year all Victorian saleyards, abattoirs and knackeries will be required to scan the electronic tags and upload the information to the NLIS database.

The Department's media release states

Minister for Agriculture Jaala Pulford today announced a four week consultation period on both the transition package and draft implementation standards to ensure the smooth introduction of the electronic identification system. 

Funding to support the transition will be provided based on feedback received and will focus on the phased adoption of electronic identification technology across the supply chain. Agriculture Victoria will take feedback on the draft standards and transition package to assist with the implementation. 

While the current national approach is a mob-based visual tag system, individual electronic tags offer greater traceability, productivity improvement and information for key international trading partners. 

Electronic identification tags have been mandatory in the cattle industry for over a decade. In addition to the traceability benefits during a disease outbreak or food safety emergency, the storage of individual animal data provides opportunities for producers to further improve their production systems. 

Agriculture Victoria currently retails the cheapest electronic NLIS tags in Australia thanks to a competitive tendering process and increased demand for the tags is likely to deliver even cheaper products to support producers adopting the technology.

The Department elsewhere notes

Victoria introduced pig tattoo branding requirements in December 1977, in conjunction with other States. Following consultation with industry, the Livestock Disease Control Act 1994 has requirements for the identification of pigs being consigned for sale or slaughter. 

The requirements are:

• All pigs being consigned for sale, or to an abattoir or knackery for slaughter, must be identified by either a tattoo brand or ear tag, depending on bodyweight, before they leave their property of origin. 

• Pigs less than 25 kg body weight must be tagged with an approved ear tag. This tag has the same numbers as the tattoo brand. It is not an option to tattoo pigs less than 25 kg body weight; they must be ear tagged. 

• Pigs over 25 kg body weight are required to be tattooed with the owner's tattoo brand. 

• Pigs that have been purchased earlier and are then sold must be tattooed with the current dispatching property tattoo brand. 

• All pigs must be accompanied by a current and valid PigPass National Vendor Declaration (NVD) when moving from a property to a saleyard or abattoir. Pigs also require a PigPass NVD when moving from property to property, except where the ownership of the pig(s) remains unchanged and the property of dispatch can be identified for the life of the pigs.

Updated Broadcast Privacy Guidelines

ACMA has released an update of its Privacy guidelines for broadcasters, which "provide an overview of how ACMA assesses complaints by listeners or viewers that allege breaches of the privacy provisions" in the broadcast codes developed by industry under the self-regulatory regime.

The September 2016 update reflects

•  amendments to codes of practice since 2011
• new case studies of key ACMA privacy investigation decisions over the past five years 
• references to personal information and
• clarification of  ACMA’s approach to consent, material in the public domain, and children’s privacy.

The Guidelines were introduced in 2005 with the expectation that they would "increase general awareness of privacy obligations under the codes of practice and assist broadcasters to better understand these obligations". They were last revised in December 2011, the first comprehensive review since introduction. The review considered ACMA’s investigations from 2005 to 2011, amendments to broadcasting codes of practice, developments in case law, and qualitative and quantitative community attitudinal research commissioned by ACMA.

The 2016 review elicited a mere seven submissions, from the ABC, ASTRA, CRA, Derek Wilding, Free TV, OAIC and SBS (ie 5 out of seven were from broadcasters).

The guidelines state

Introduction—balancing privacy and public interest

Privacy protections specific to broadcasting are set out in the various broadcasting codes of practice that are developed by industry and registered by (or, in the case of the national broadcasting codes, notified to) the ACMA.

These guidelines are intended to: > increase general awareness of the privacy obligations under the various broadcasting codes > assist broadcasters to better understand their privacy obligations under these codes.

The guidelines do not deal with unlawful, unethical or distasteful journalistic practices. Nor do they deal with federal or state privacy and privacy-related laws. They provide general guidance in relation to code privacy obligations and do not vary the terms of any particular broadcasting code of practice. Examples used in these guidelines are illustrative only.

Privacy is a matter of enduring relevance to the community.

While digital technologies and social media may be changing the ‘privacy environment’ and presenting challenges that legal experts have grappled with in recent times , the community continues to value privacy safeguards in broadcasting.

The various broadcasting codes of practice can be found on the ACMA website. Their privacy provisions reflect the balance that should be struck between the media’s role in informing the public and an individual’s expectation of privacy.

Some codes offer express privacy protections only in the context of news and current affairs broadcasts. Other codes offer privacy protections for all broadcast content. Some codes also provide that a complaint about privacy can only be made by the person (or a representative of the person) who considers their privacy was intruded upon.

The precise privacy obligations to which each broadcaster is subject will depend on the terms of the applicable code. The outcome of any investigation will depend on the facts and context of the particular broadcast. A potential breach of code privacy provisions may be investigated by the ACMA in the exercise of its discretion. This will generally occur when:

• a code privacy complaint has been made to a broadcaster in accordance with the applicable code 

• the broadcaster has not responded within 60 days or the complainant considers the broadcaster’s response inadequate 

• a complaint is then made to the ACMA.

The general principle

Generally, the codes protect against the broadcast without consent, of material that:

•  relates to a person’s personal or private affairs or private life —for example, by disclosing their personal information; or 

• invades a person’s privacy or intrudes into their private life—for example, by intruding upon their seclusion; unless it is in the public interest to broadcast the material.

Investigation steps

When investigating the alleged breach of a code privacy provision, the ACMA will consider the elements of a breach:

• Was a person identifiable from the broadcast material? 

• Did the broadcast material disclose personal information, or intrude upon the person’s seclusion in more than a fleeting way?

If the answer to both of the above questions is yes, then there is a potential breach of code privacy provisions. The ACMA will then consider:

• Was the person’s consent obtained—or that of a parent or guardian? 

• Was the broadcast material available in the public domain? 

• Was the invasion of privacy in, and proportionate to, the public interest?

If the answer to any of these is yes, then there may be no breach found. Identifiable person For the codes to be breached, a particular person must be identifiable from the broadcast. That person can be a private individual or a public figure. A person is identifiable if, from the broadcast (including audio or visual material), the person’s identity is apparent or can reasonably be ascertained. Pixelation of a person’s face will not necessarily be sufficient to de-identify that person—for example, where they are identifiable from other details in the broadcast.

For examples, refer to case studies 1, 2, 5, 7 and 8 in the Appendix.

Personal information

Personal information can include a person’s residential address or telephone number, facts about a person’s health, genetic or biometric information, information about personal relationships and domestic or family life, personal financial affairs, sexual activities, and sexual orientation or practices. It can also include information about a person’s racial or ethnic origin, political opinions, membership of a political association, religious beliefs or affiliations, philosophical beliefs, membership of a professional or trade association, membership of a trade union, criminal record and other sensitive personal matters.

This information need not be secret or confidential in order to be private.

Personal information will usually be factual in nature. However, it may include opinions based on facts or presented as if based on facts—for example, an opinion on a person’s sexuality, religion or health status, or an expert’s prognosis of a person’s health or welfare.

For examples, refer to case studies 2, 5 and 7 in the Appendix.

Seclusion

A person’s seclusion may be intruded upon where: > they would have a reasonable expectation that their activities would not be observed or overheard by others; and > a person of ordinary sensibilities would consider the broadcast of these activities to be highly offensive. Depending on the circumstances, this may include everyday activities and it will usually include sexual activities. The invasion should be more than fleeting. It is possible for this to occur in a public space.

For examples, refer to case studies 3, 8 and 11 in the Appendix.

Consent

If consent is obtained prior to the broadcast of private material, then the consenting person can have no expectation of privacy in relation to that material. When given,

consent should be voluntary, informed, specific, current and given by a person with legal capacity and an understanding of the use to which the material will be put.

Consent can be express, such as when obtained in writing. It can also be implied; for example, where a person is a willing participant in an interview. If the affected person’s consent to broadcast private material is obtained by deception, it is not true consent.

Consent to the broadcast of material that would invade privacy or intrude into a person’s private life may be withdrawn before it is first broadcast, if in all the circumstances it is reasonable to do so.

The use of material that has been surreptitiously obtained will be an indicator that the person has not (at least at the time the material was obtained) consented to the broadcast. Consent to the use of such material can be obtained after recording but before broadcast.

The absence of an objection will not automatically be taken to constitute consent.

Consent to an interview concerning an individual’s personal affairs or private life may not amount to consent to the use in a broadcast of additional personal information or of material intruding upon their seclusion—for example, material not disclosed in the interview that has been obtained without consent or for a different purpose.

For examples, refer to case studies 4, 5, 8 and 11 in the Appendix.

Material in the public domain

Using material that is already in the public domain will generally not be an invasion of privacy.

This may include the use of material obtained from online or social media sites where there are no access restrictions. However, the absence of access restrictions, while an important consideration, may not be determinative. Account will be taken of the nature of the material and the context in which it has been published.

The relevant content may be of a nature that indicates it has been put in the public domain without the affected person’s knowledge or consent—for example, material that is inherently offensive and appears to have been uploaded by someone other than the affected person.

Using material that has previously been disclosed by a person on a confidential basis, or to a limited or closed circle of recipients, may be an invasion of their privacy. Its private nature may be implied, even if there was no express request to keep it confidential.

For examples, refer to case studies 9 and 11 in the Appendix.

Children and people in vulnerable circumstances

Code privacy provisions apply to material used in a broadcast that concerns people in vulnerable circumstances, as well as children.

Vulnerable circumstances may be intrinsic (for example, where a person has a disability or difficulty communicating in English) or situational (for example, where a person is bereaved or has been involved in a distressing event).

The Commercial Television Industry Code of Practice 2015 expressly requires that special care be taken in the use of material concerning a child. ‘Child’ is defined in that code to mean a person under the age of 15.

Where broadcast material concerns both an adult and a child, code privacy obligations and public interest considerations may be assessed separately for the adult and the child.

Subject to the relevant code, a parent or guardian’s express consent should be obtained before using material that invades a child’s privacy. Parental consent alone will not always be sufficient for a broadcaster to comply with its code privacy obligations.

Even where consent is obtained, there may be circumstances where a person of ordinary sensibilities would consider the use of material that invades a child’s or vulnerable person’s privacy to be highly offensive.

In each case, careful account should be taken of the nature of the material proposed for use and the potential consequences of its use. Broadcasts concerning child welfare or protection may be in the public interest. Such material will require careful consideration of the justification for, and, as applicable, the extent of any intrusion into the private life of a child.

In reporting on public interest issues concerning the activities, actions or behaviour of another party, such as a child’s parents, the use of material disclosing the child’s personal information or intruding upon the child’s seclusion should be proportionate to the particular public interest issues raised in the broadcast.

For examples, refer to case studies 6, 7 and 9 in the Appendix.

Public figures

Public figures such as politicians, celebrities, prominent sports and business people and those in public office do not forfeit their right to privacy in their personal lives.

However, it is accepted that public figures will be open to a greater level of scrutiny of any matter that may affect the conduct of their public activities and duties. For an example, refer to Case study 8 in the Appendix.

Public interest

The broadcast of personal information or material that invades privacy, without consent, will not breach the codes if there is a clear and identifiable public interest in the material being broadcast. The public interest is assessed at the time of the broadcast.

Whether something is in the public interest will depend on all the circumstances, including whether a matter is capable of affecting the community at large so that the audience might be legitimately interested in or concerned about what is going on.

Public interest issues include:

• public health > national security 

• criminal activities 

• corruption 

• misleading the public 

• serious anti-social behaviour 

• politics 

• government and public administration 

• elections 

• the conduct of corporations, businesses, trade unions and religious organisations.

Not all matters that interest the public are in the public interest.

Any material that invades a person’s privacy in the public interest should directly or indirectly contribute to the public’s capacity to assess an issue of importance to the public, and its knowledge and understanding of the overall subject. The information disclosed should be proportionate and relevant to those issues, and not include peripheral facts or be excessively prolonged, detailed or salacious.

Whether an invasion of privacy or intrusion into a person’s private life is justified in the public interest will generally depend on the public interest matters raised in the broadcast.

In the case of public figures, the broadcast of material that invades the person’s privacy may be in the public interest if it raises or answers questions about any of the following:

• the person’s appointment to or resignation from public office 

• e person’s fitness for office 

• the person’s capacity to carry out his or her duties 

• conduct or behaviour that contradicts the person’s stated position on an issue.

However, disclosure is unlikely to be in the public interest if it is merely distasteful, socially damaging or embarrassing.

For examples, refer to case studies 1, 3, 6, 7, 8 and 11 in the Appendix.