10 March 2017

Geographical Indications

'From Geography to History: Geographical Indications and the Reputational Link' by Dev Saif Gangjee in I Calboli and WL Ng-Loy (eds), Geographical Indications at the Crossroads of Trade, Development, and Culture in the Asia-Pacific (Cambridge University Press, 2017) comments
 For well over a century, the notion of a distinctive link between regional products and their places of origin has been articulated in the language of terroir. This type of causal relationship – where the physical geography factors within a region leave their distinctive traces upon the end product – is reflected in the definition of a geographical indication (GI) found in Article 22.1 of TRIPS. However this chapter focuses on the underdeveloped, yet increasingly utilised possibility of a link between product and place resting on a ‘reputation… that is essentially attributable to its geographic origin’.
As GI subject matter expands beyond wines, spirits and agricultural products to encompass confectionaries, charcuterie, cheese and crafts, a deterministic ‘physical geography’ explanation loses traction. This chapter proposes that historical evidence can complement that of geography, allowing us to more meaningfully answer the question of when a product’s reputation can be said to be essentially attributable to its geographical origin.
His 'Genericide: The Death of a Geographical Indication?' in Gangjee (ed) Research Handbook on Intellectual Property and Geographical Indications (Edward Elgar, 2016) 508 provides
a legal framework for deciding when a geographical indication (GI) has crossed over the line into generic usage, as the common name for a type of product (such as cheddar cheese). Genericide is a process and one that is highly controversial. While Art 24.6 of TRIPS has emerged as the international reference point, it is remarkably underdeveloped. The question of whether a designation has become the ‘common name’ for a type of product requires an empirically informed answer. However, when setting out the test for genericide, there are opportunities for normative inflections to be introduced.
Section 2 sets out the history of this controversial area and the commercial stakes which influence legal determinations. Section 3 identifies the four main structural issues to be addressed (which regime to opt for; who bears the burden of proof; what is the threshold or tipping point for genericide; and how the factors should interact). Section 4 proceeds to analyse the categories of evidence, drawing on comparative experiences with such categories in operation. Here the perception of the target audience (consumers or the general public, as informed by trade and expert opinion) must be gauged against the contextual backdrop of market conditions, legislative or bureaucratic classifications of the term and the actions of the rights holder. Section 5 concludes with a review of the options for preventing generic use in sui generis GI regimes, while also suggesting the avenues for reviving terms that were formerly GIs but have been declared generic. The comparative analysis is offered as a practical resource for decision makers, while also serving as a reminder that the overarching enquiry should remain focused on the public perception of the term, as opposed to the competing commercial interests at stake.
'Geographical Indications in Africa: Opportunities, Experiences and Challenges' by Michael Blakeney in (2016) 38(5) European Intelletual Property Review 290 comments
This article examines the opportunities and reasons for protecting, managing and promoting geographical origins, and the concrete experiences in protecting and using geographical indications in Africa, taking examples from selected African countries as well as highlighting the challenges that Africans have and will face in using such a tool. It discusses the findings of benchmarking studies commissioned by the World Intellectual Property Organization of agricultural products sourced from Burundi, Gambia, Uganda, Sudan and Tanzania, and reviews experiences in protecting and using origin indications in Africa and the challenges in protecting, managing and promoting geographical indications on the continent.

09 March 2017

Veterans' Privacy

The Turnbull Government will seek 'independent scrutiny' of new powers - proposed under the Veterans’ Affairs Legislation Amendment (Digital Readiness and Other Measures) Bill 2016 (Cth) - to unilaterally disclose personal information about veterans in 'correcting' what are deemed to be deliberately misleading statements.

That disregard for privacy, at odds with the Prime Minister's 2012 Alfred Deakin Lecture, is consistent with recent disclosure of personal information about people who deal with Centrelink, the subject of much comment about that agency's defective identification of supposed overpayments to a range of social service recipients.

Centrelink - and the Human Services  Minister, who has now been referred to the Australia Federal Police - appears  to have taken over the view that it is appropriate, legal and necessary to publicly disclose personal information of recipients who have claimed they have not been overpaid. The Department of Human Services states
You have a right to have your personal information kept private. The department is bound by strict confidentiality and secrecy provisions in social security, families, health, child support and disability services law.
The Human Services disclosure serves to chill what might be regarded as a legitimate expression of concern by citizens, particularly given the apparent scale of problems with the agency and its cavalier approach to addressing systemic failures.

In considering the permissibility of the Centrelink disclosure under the Privacy Act 1988 (Cth) it is worth noting L v Commonwealth Agency [2010] PrivCmrA 14. The Privacy Commissioner there noted that a complainant made adverse comments in the media and on a blog about a Commonwealth agency's handling of an application, resulting in the agency receiving several media enquiries. The agency then disclosed the complainant’s personal information, with the complainant consequently alleging the agency improperly disclosed personal information to a journalist.

The Commissioner stated that
 IPP 11 prohibits agencies from disclosing personal information to anyone other than the individual concerned, unless an exception applies.
The exception at IPP 11.1(a) permits disclosure where the individual concerned is reasonably likely to have been aware, or made aware under Principle 2, that information of that kind is usually passed to that person, body or agency.
Outcome: The Commissioner investigated this matter under section 40(1) of the Privacy Act. The Commissioner’s Plain English Guidelines to Information Privacy Principles 8-11 provide examples of when an individual may be considered to be reasonably likely to be aware that information may be disclosed under IPP 11.1(a).
The Guidelines state: a person who complains publicly about an agency in relation to their circumstances (for example, to the media) is considered to be reasonably likely to be aware that the agency may respond publicly – and in a way that reveals personal information relevant to the issues they have raised.
The Commissioner took into account that the complainant had complained publicly about the agency’s handling of their application. The information provided by the agency was confined to responding to the issues raised publicly by the complainant.
The Commissioner considered that the complainant was reasonably likely to have been aware that the agency may respond, in the way it did, to the issues raised. Therefore, the Commissioner took a preliminary view that IPP 11.1(a) permitted that disclosure.
The complainant withdrew and the matter was closed.

The Commissioner's current guidelines appear to be broader. In relation to APP 6 () they state
6.20 The ‘reasonably expects’ test [regarding permissible disclosure] is an objective one that has regard to what a reasonable person, who is properly informed, would expect in the circumstances. This is a question of fact in each individual case. It is the responsibility of the APP entity to be able to justify its conduct.
6.21 An APP entity should consider whether an individual would reasonably expect it to use or disclose for a secondary purpose only some of the personal information it holds about the individual, rather than all of the personal information it holds. The entity should only use or disclose the minimum amount of personal information sufficient for the secondary purpose. ...
6.22 Examples of where an individual may reasonably expect their personal information to be used or disclosed for a secondary purpose include where:
  • the individual makes adverse comments in the media about the way an APP entity has treated them. In these circumstances, it may be reasonable to expect that the entity may respond publicly to these comments in a way that reveals personal information specifically relevant to the issues that the individual has raised.
In response to the Centrelink controversy the  Australian Information and Privacy Commissioner stated last month
I am aware of the media reports concerning this issue. My office is making inquiries with the Department of Human Services. 
Government agencies are entrusted with a significant amount of personal information. This information must be handled in accordance with the Australian Privacy Principles. 
An agency may only disclose an individual’s personal information in a limited range of circumstances.
The Explanatory Memo for the Veterans Bill states
In certain limited circumstances it may be appropriate for the Secretary of the Department of Veterans’ Affairs to disclose information about a person that was obtained by a delegate performing their duties under the MRCA [Military Rehabilitation and Compensation Act 2004], DRCA [Safety, Rehabilitation and Compensation (Defence-related Claims) Act 1988] and the VEA [Veterans’ Entitlements Act 1986].
Examples of the circumstances in which it might be appropriate for the Secretary to disclose information about a case or class of cases include where there is a threat to life, health or welfare, for the enforcement of laws, in relation to proceeds of crime orders, mistakes of fact, research and statistical analysis, APS code of conduct investigations, misinformation in the community and provider inappropriate practices.
The Privacy Act 1988 legitimately limits the circumstances surrounding the handling and disclosure of a person’s personal information, as set out in the Australian Privacy Principles. The purpose of the public interest disclosure provisions is to put beyond doubt that the Secretary may, in accordance with items 1, 7 and 10, release information about a case or class of cases.
The information sharing provisions, and related consequential amendments, are necessary because, with the creation of a stand-alone version of the SRCA with application to Defence Force members, the ability of the MRCC to share claims information about current serving members with either the Secretary of the Department of Defence or the Chief of the Defence Force is more limited than it is under the MRCA . These amendments will align information sharing under the DRCA with arrangements under the MRCA. ...
Public interest disclosures
The public interest disclosure provisions are modelled on paragraph 208(1)(a) of the Social Security Administration Act 1999 and would enable the Secretary to disclose information about a particular case or class of cases where the Secretary certifies that it is necessary in the public interest to do so. In deciding whether to make a public interest disclosure, the Secretary must follow rules set by the Minister and there are limits about disclosing personal information, which could result in the Secretary committing an offence.
Examples of the circumstances in which it might be appropriate for the Secretary to disclose information about a case or class of cases include where there is a threat to life, health or welfare, for the enforcement of laws, in relation to proceeds of crime orders, mistakes of fact, research and statistical analysis, APS code of conduct investigations, misinformation in the community and provider inappropriate practices.
It is expected that the “class of cases” disclosure would be particularly relevant for research and statistical analysis purposes.
Because this is a new power, five safeguards have been incorporated to ensure that it is exercised appropriately. They are described in further detail below but, briefly, they are: ·
  • the Secretary must act in accordance with rules that the Minister makes about how the power is to be exercised ( s ubitem (2) of items 1, 7 and 10 ) 
  • the Minister cannot delegate his or her power to make rules about how the power is to be exercised ( item 11 ) 
  • the Secretary cannot delegate the public interest disclosure power ( item 12 ) 
before disclosing personal information about a person, the Secretary must notify the person in writing about his or her intention to disclose the information, give the person a reasonable opportunity to make written comments on the proposed disclosure of the information and consider any written comments made by the person ( subitem (6) of items 1, 7 and 10 ), and
  • unless the Secretary complies with the above requirements before disclosing personal information, he or she will commit an offence, punishable by a fine of 60 penalty units (approximately $10,800) ( subitem (7) of items 1, 7 and 10. )
In addition to the above safeguards, the Department (on behalf of the MRCC and the Repatriation Commission) manages clients’ personal information in compliance with the Privacy Act 1988 , and the Department can be required to pay compensation for breaches of the Privacy Act 1988.
In addition, departmental staff may face sanctions under the Australian Public Service Code of Conduct if they handle a client’s personal information in an unauthorised manner.
Some citizens are more equal than others. In response to criticism of the Bill the Veterans' Affairs Minister  has now announced that he had listened to concerns from the veteran community and would accordingly ask the Australian Government Solicitor to provide an independent privacy impact assessment.

That assessment will be in addition to one already undertaken by his Department, with both PIAs being released to the public before the rules about disclosure under the statute are tabled in Parliament. Release of the PIAs will form part of what the Minister characterises as "part of the continuing comprehensive consultation process".

The Bill went though the House with with bipartisan support. The ALP veterans' affairs spokesperson  has now referred to  "serious concerns" and foreshadowed action to disallow the new arrangements.

The report of the Senate Standing Committee on Foreign Affairs and Trade inquiry into the Bill features the following -
2.45 The department acknowledged community concerns regarding the proposed power to correct misinformation but asserted that it is important to correct misconceptions about the department's services. It argued that misinformation about the department's services can cause clients unnecessary concern and potentially dissuade veterans from accessing the services they require. It pointed out that following the Parliamentary Joint Committee on Human Rights inquiry into the Social Security (Public Interest Certificate Guidelines) (DSS) Determination 2015, the committee concluded that 'public interest certificate determinations are likely to be compatible with the right to privacy'.
2.46 During the hearing, the Privacy Commissioner noted that the protection of an individual's privacy through the protection of personal information is not an absolute right but must be balanced with the broader interests of the community and allow government agencies to carry out their activities:
Our approach in that context is generally to advise agencies to ensure that any changes that authorise a disclosure of personal information by invoking an exception in the Privacy Act are reasonable, necessary and proportionate to the expected benefits.
2.47 The department's submission argued that the bill contains adequate safeguards which control how the public interest disclosure power will be exercised. In addition to the bill's specific safeguards, it pointed out that the Privacy Act and the Australian Public Service Code of Conduct provide additional protections. It argued that client information is handled in compliance with both the Privacy Act and the Code of Conduct and that staff may face sanctions and the department fined penalties if a client's information is mishandled. Persons concerned about disclosures also have the option to lodge a complaint with the Privacy Commissioner or apply for judicial review under the Administrative Decisions (Judicial Review) Act 1977.
2.48 With regards to the Minister's rules on the exercise of the Secretary's power, the department advised that the final rules were not able to be provided to the committee within the inquiry's timeframe but that Parliament will have an opportunity to consider them once they are drafted as a disallowable instrument. However, during the committee's hearing, DVA indicated that it could provide a draft copy of the rules to the committee to consider in camera.
2.49 During the hearing, the Privacy Commissioner suggested that the department consult with the Commonwealth Ombudsman and the Office of the Australian Information Commissioner on the content of the Minister’s rules before they are finalised and introduced in the Parliament:
... my office, should the bill proceed as it currently is, would like the opportunity to be consulted on the draft rules to be made by the minister under the public interest disclosure provision. Those draft rules will go to many of the areas where the privacy principles currently apply, and if the bill proceeds and then the APP 6 does not apply to those disclosures then I think we could provide some useful guidance in tightening up those particular rules.

08 March 2017

Medical Identity Crime

The ABC reports that Shyam Acharya, whose current whereabouts are unknown, 'is facing a $30,000 fine after allegedly masquerading as a doctor at New South Wales hospitals for more than a decade'. NSW Health has defended the Department's recruitment practices.

Acharya  is accused of stealing an Indian doctor's identity while in India, later moving to Australia where he posed as a medical practitioner and became a citizen. He allegedly used fraudulent documents to gain registration with the Medical Council of New South Wales in 2003, working at several hospitals under the name Sarang Chitale until 2014.

The Australian Health Practitioner Regulation Agency has laid charges for a breach of the Health Practitioner Regulation National Law, with a maximum penalty of $30,000. Not a major deterrent and not providing for imprisonment. The impersonation is a ground for cancellation of Acharya's citizenship, although medical identity incidents noted elsewhere in this blog and in my doctoral dissertation might lead us to suspect the offender will reappear in another jurisdiction as a medical practitioner.

NSW Health executive Karen Crawshaw said no complaints were received by the Medical Council of NSW or the Health Care Complaints Commission.
"The root cause of this was false identity to get into the country in the first place.
The documentation that got him registered was in fact legitimate documentation of a doctor.
We now require written references and contact directly referees of doctors seeking employment.
The ABC reports that
Crawshaw had defended the department's recruitment practices and said the blame does not rest with the state. 
Health Minister Hazzard said the situation was shocking - no surprises there - and that he would raise it at a national level.
It is quite disturbing that a foreign national could get through our border protection with a false passport and ID based on an Indian citizen who had trained as a doctor.
I will raise it at this month's COAG Health Minister's meeting to see whether the checks and balances are in place at a national level so that this can't occur again.
In November last year AHPRA that on behalf of the Psychology Board of Australia it successfully prosecuted social worker Sermin Baycan for claiming to be a psychologist.
Ms Baycan pleaded guilty in the Melbourne Magistrates’ Court after AHPRA brought charges against her for using the title ‘psychologist’ and holding out as being a registered health practitioner under sections 113 and 116 of the National Law.
Ms Baycan has never held registration as a psychologist, however, it was alleged that she purported to use the title ‘psychologist’ at two medical clinics in Victoria between May 2015 and June 2015 by accepting referrals under mental health plans.
Ms Baycan pleaded guilty to 14 charges and was ordered to pay a fine of $12,000 and costs of $20,200 to AHPRA, with no conviction recorded.
Psychology Board of Australia Chair, Professor Brin Grenyer welcomed the Court’s decision.
‘This judgement is a case in point. It is unacceptable for anyone who does not hold registration as a psychologist to claim to be a psychologist and worse still see patients when they are not qualified to do so. If you are not an appropriately qualified psychologist and registered with the Board, then you cannot present yourself to be a psychologist. No matter what other qualifications you hold, there is no excuse.’
AHPRA noted that
The National Law protects the public by making sure anyone who uses the title ‘psychologist’ is registered, qualified and trained to do so.
‘When the public access psychological services they are often vulnerable and rely on their registered practitioner to provide them with the best care possible. The actions of Ms Baycan were not only against the law, but did an injustice to the patients, who believed they were seeing a qualified psychologist,’ said Prof. Grenyer. ...
All registered health practitioners appear on the online Register of Practitioners, which is a searchable list that is accessible on the AHPRA website. If a person does not appear on the register, they are not registered to practise in a regulated health profession in Australia. Title protection is an important way the National Law helps to protect the public. Only registered health practitioners who are suitably trained and qualified are able to use protected titles. Psychologists and other practitioners from other regulated health professions have to register annually with their National Board and declare that they meet current national standards.

Going Gadamerian

'Sources in the Meta-Theory of International Law: Hermeneutical Conversations' by Alexandra Kemmerer in Samantha Besson and Jean D’Aspremont (eds) The Oxford Handbook on the Sources of International Law (Oxford University Press, 2017) comments 
A meta-theoretical approach to sources opens reflexive spaces, situates theories in time and space, and allows for a contextual interpretation of sources. In this paper, drawing on the hermeneutic philosophy of Hans-Georg Gadamer and the writings of his most perceptive readers in international law, I develop a concept of reflexive situatedness prompting a constructive contextualization of sources and their interpreters in our ‘normative pluriverse’ (D’Aspremont). Following the traces of international law’s current ‘turn to interpretation’ and a reading of international law as a ‘hermeneutical enterprise’, my assessment of the limits and potentials of Gadamerian philosophical hermeneutics prepares the ground for an analysis of the writings of international lawyers who have developed theories of international legal interpretation inspired by his work — and, in particular, for a closer look at the writings of Outi Korhonen, linking her concept of situationality to an emphasis on context(s) that engages with the rhetorical dimension of Gadamer’s work. Gadamer’s conversational hermeneutics opens new perspectives for a contextual theory and praxis of international legal interpretation that brings together various disciplinary perspectives and cultural experiences, and thereby allows for a more nuanced and dynamic understanding of sources and their interpreters within their respective interpretative communities.

07 March 2017


'Best interests: The ‘best’ way for courts to decide if young children should act as bone marrow donors?' by Shih-Ning Then in (2017) Medical Law International 1–40 comments
Young children who are called upon to donate regenerative tissue – most commonly bone marrow – to save the life of a sick relative are in a unique position. The harvest of tissue from them is non-therapeutic and carries the risk of physical and psychological harm. However, paediatric donation is relatively common medical practice around the world. Where some doubt exists over the legality of allowing a child to donate, courts can be asked to authorize the procedure and in doing so will apply the ‘best interests’ test in making their decision. How are a young child’s rights recognized in such a situation? This article considers whether the best interests test is the ‘best’ test to be applied by courts when cases of potential child donors come before it. The approach of courts in three jurisdictions is analysed, and problems in the application of the test in this context are discussed. While the continued use of the test by courts is supported, the way the test has been used by courts is critiqued and recommendations made to better respect the rights of the potential donor child.
Children who act as regenerative tissue donors – providing bone marrow or periph- eral blood stem cells (PBSCs) – can potentially save the life of another. The great good that can come about through their participation is at the cost of donor children undergoing physically invasive and unnecessary medical procedures. The non- therapeutic element of their involvement raises legal and ethical issues related to appropriate decision-making on behalf of children by parents, clinicians and courts and child donors’ vulnerability in being exposed to physical and potentially psychological harm.
This article focuses on the appropriateness of the legal best interests test applied by courts from three jurisdictions – Australia, England and the United States – in applications for young children (i.e. children who are not ‘Gillick competent’) to be used as a tissue donor for the benefit of another. While it is acknowledged that applications before the courts are rare – with parental consent and/or legislative conditions being relied upon in the vast majority of circumstances – it is argued that these cases remain important. Increasingly, the medical and wider community has acknowledged that donor children have not been given sufficient attention; to date, their individual rights have not been the focus in the context of the sick recipient’s situation. These rare cases are therefore important for two reasons: firstly, the cases that come before the courts will be those that are most ‘controversial’ – there may be disagreement between parties, questions as to whether legislation can be satisfied or other uncertainties – as such they will be looked to as guidance by others when faced with similar situations. Secondly, today with an increasing focus on children’s rights – including rights to participation and increasing respect for children in the clinical domain – this impacts on how donor children are viewed. How courts treat them and how decisions about them should be made is therefore important. Since the wide adoption of the United Nations Convention on the Rights of the Child (the ‘Convention’), the way children have been viewed within society has changed in most Western societies. While the United States is not a party to the Convention, the discussions in this article of children’s rights to have their ‘best interests’ used as a guiding principle and their right to participate in decisions affecting them are not irrelevant to that jurisdiction.
Generally, in the Western world, children are no longer solely viewed as recipients in a traditional welfare-based model. Instead there is increasing acceptance of the need for child-centred approaches that recognize their rights – as identified under Article 12 of the Convention – to be involved in decisions affecting them. Such an approach is more cognisant of a child’s individual interests as separate from their parents’ interests or the interests of others. These rights extend to young, non-Gillick competent children. The Committee on the Rights of the Child has stated that, ‘[c]hildren, including young children, should be included in decision-making processes, in a manner consistent with their evolving capacities’. This is highly relevant in this context where a decision about whether a child should undertake a non-therapeutic procedure for the benefit of another is being made.
Internationally, the best interests test is recognized in Article 3 of the Convention as the appropriate standard to govern decision-making on behalf of children. Despite this, the standard has been much maligned, both generally and in this context. Difficulties arise in applying it where no physical benefit for the donor child exists and some physical harm is suffered.
While there are arguably many rights under the Convention that might be applied in the child donor situation – that is, the right of the child to physical integrity and dignity, to protection from harm, to have family relationships protected and so on – the focus of this article is on the child’s right to participate in court decisions (Article 12) and the appropriateness of the best interest standard (Article 3).


'From Nagoya to Rio and Back, a Detour Through Brussels. The Protection of Traditional Knowledge and Genetic Resources in the EU' (Faculty of Law, Stockholm University Research Paper No. 4 by Frantzeska Papadopoulou comments
The most important contribution for the international regulation and protection of traditional knowledge and genetic resources (TKGR) was made in Rio in 1992 by means of the Convention on Biological Diversity (CBD). The objective of the CBD was to remedy the market failure noted in cases such as that of the Hoodia cactus, the maca plant and the ayahuasca vine. This market failure depends on the fact that the countries where TKGR is found, the countries where traditional knowledge is developed are not the ones to reap the benefits of their application and use in research and commercial products. While the CBD constitutes the first international attempt to bring a certain institutional balance in the CBD market, it had to overcome a very important barrier, namely that of the strong and at the time of its entry into force, still growing stronger, Intellectual Property Rights (IPRs) regime. The need to relate to the Intellectual Property (IP) system and to the extent possible, use it in order to achieve the Convention’s objectives has considerably influenced the final text of the CBD, as well as its implementation. It is also the existence of the IP system that has formed the subsequent international negotiations and the way contracting states (and non-contracting for that matter), have positioned themselves in the post-CBD negotiations.

Data Protection

'Big Data, Open Data, Privacy Regulations, Intellectual Property and Competition Law in an Internet of Things World' (Faculty of Law, University of Stockholm Research Paper No. 1) by Bjorn Lundqvist comments
The interface between the legal systems triggered by the creation, distribution and consumption of Data is difficult to grasp, and this paper therefore tries to dissect this interface by following information, i.e. ‘the data’ from its sources, to users and re-users and ultimately to its consumers in an ‘Internet of Things’, or Industrial Internet, setting. The paper starts with the attempt to identify what legal systems are applicable this process, with special focus on when competition law may be useful for accessing data. The paper conclude that general competition law may not be readily available for accessing generic (personal or non-personal) Data, except for the situation where the Data set is indispensable to access an industry or a relevant market; while sector specific regulations seem to emerge as a tool for accessing Data held by competitors and third parties. However, the main issue under general competition law in the Data industry, at its current stage of development, is to create a levelled playing field by trying to facilitate the implementation of Internet of Things.
'The EU data protection reform and the challenges of big data: remaining uncertainties and ways forward' by Maria Eduarda Gonçalves in (2017) Information and Communications Technology Law comments
As the first broad reform of the EU data protection legislation is being achieved, and notwithstanding EU institutions’ confident discourse, scepticism remains about the reform’s ability to safeguard the fundamental right to data protection in the face of evolving data processing techniques underlying so-called big data. Yet, one might wonder whether the cause for this difficulty should be ascribed mainly to technological progresses that the law finds it hard to deal with or rather to the policy choices embedded in the legal reform itself. Indeed, a new data protection enforcement model is being adopted, which relies heavily on risk assessment and management by the data controllers themselves. Likewise, data protection authorities see their supervisory role significantly weakened. These developments and the underlying rationality are discussed. Given the limitations of the risk-based approach as currently devised, we suggest that it be reappraised in consideration of risk regulatory experiences in other domains. 
'Legal Implications of Data Mining: Assessing the European Union's Data Protection Principles in Light of the United States Government's National Intelligence Data Mining Practices' (Faculty of Law, Stockholm University Research Paper No. 5) by Liane Colonna comments
The world has changed dramatically in recent decades. Private documents are no longer stored in basement cabinets within identifiable locations but rather they are housed in unknown data centers around the word. International communication has become easier, cheaper and more prevalent than ever before because of ongoing advances in information communication technologies. More and more of people’s lives are lived online where the details of their private existences – where they travel, what they eat, who they communicate with most frequently, what they read and write, how much they exercise, how much they sleep, what government services they utilize and so on – can be tracked with relative ease. Because of the structure of the Internet, not only do these data travel through a variety of different countries en route to their final destination but they may also be accessed from places very distant from where the communication was initially generated.

06 March 2017


The Grattan Institute report Cutting a better drug deal comments
Australians pay too much for prescription drugs. Patients and taxpay- ers continue to pay much higher prices for medicines listed on the Pharmaceutical Benefits Scheme (PBS) than they should. This report identifies savings of over $500 million a year if the government pursues a better drug deal. With a mounting budget repair task, and the need to find money to fund new and better drugs, the government should grab this low-hanging fruit.
The government should reform two components of the PBS pricing pol- icy. The first is ‘price disclosure’, a policy introduced in 2007 in a bid to cut costs of ‘generic drugs’ that are no longer covered by a patent. It has not gone far enough or fast enough. The second is the ‘therapeutic group premium’ policy, which was introduced in 1998 in a bid to stop the government wasting money on over-priced drugs that are chemically different but have the same outcomes for patients as cheaper drugs. The policy is now full of loopholes and no longer works. The Grattan Institute has previously published three reports that tackled these issues and identified savings: Australia’s bad drug deal (March 2013), Poor pricing progress (December 2013) and Premium policy? (June 2015). This report updates the savings estimates. There is some good news, but mainly bad news.
The good news is that price disclosure has been working, albeit slowly. Our March 2013 report identified more than $1 billion in savings that could be made each year, based on retail prices, with a better policy. In terms of wholesale prices – the approach used in this report – that is more than $600 million in savings each year. Price disclosure has forced prices down over the past few years, and we now estimate there are about $93 million in savings still to be made from reform. However, Australian drug prices remain unacceptably high, at 3.7 times higher than the best international prices.
Price disclosure should be supplemented by a new and more effec- tive policy of benchmarking Australian prices to the best prices paid by comparable countries. Australia could have saved over $1.2 billion over the past four years had international benchmarking been in operation. The bad news is that Australia’s therapeutic group premium policy is weak and getter weaker. Our June 2015 report identified $320 million in savings that could be made each year if this policy were applied consistently across seven groups of commonly used drugs in Australia. In this report we update the analysis, to find that strengthening the policy as well as extending Australia’s relatively small list of therapeutic groups from seven to 18 would together save more than $445 million a year.
These pricing reforms should be complemented by introducing more competition to retail pharmacies, which would both save patients more and provide better access to quality health care.