IP and Health Law

'A Human Rights Approach to Intellectual Property and Access to Medicines' (Global Health Justice Partnership Policy Paper 1, 2013) [PDF] by Hannah Brennan, Rebecca Distler, Miriam Hinman and Alix Rogers notes that

In this paper, we address whether and how human rights norms and frameworks can be used to improve access to medicines (A2M) by reducing the barriers that intellectual property (IP) laws create to such access. We evaluate the feasibility and usefulness of four human rights- based strategies that our contacts in the A2M community suggested might be particularly productive: (1) the use of human rights arguments in domestic court cases that deal with intellectual property laws, (2) the articulation of norms in the United Nations (UN) human rights system, (3) the use of human rights arguments and frameworks to secure greater pharmaceutical corporate accountability, and (4) the use of health-related rights to build multilateral and regional alliances that can more effectively oppose free trade agreements (FTAs) with TRIPS-plus provisions (TRIPS being Trade-Related Aspects of Intellectual Property Rights). We offer insights and specific short- and long-term action steps for each strategy, including recommendations for further research. 

We also offer this brief executive summary of each of the four sections that follow. 

In the first section, we address how, in the past few years, domestic courts have displayed a growing willingness to use human rights laws to reinterpret and even strike down IP laws that impede access to medications. For example, a court in India concluded that it could not issue injunctions in patent cases where the result would be a substantial increase in the price of medicines, relying in part on the right to life in the Indian constitution. A court in Kenya struck down an “anti-counterfeiting” law as a violation of the right to health in the Kenyan constitution. And a court in Colombia concluded that local health rights required it to enforce price control requirements (if not issue a compulsory license, as activists argued). If the logic of these cases were successfully extended to other countries and other areas of doctrine, domestic human rights protections could serve as a powerful fulcrum to help dislodge harmful intellectual property laws. Judicial articulation of the relationship between the right to health and intellectual property law might also legitimize broader political actions that prioritize the right to health over intellectual property protection. Although such court cases have not always succeeded, and gains have been incremental thus far, this strategy appears to be gaining momentum. We recommend that activists prioritize the pursuit of human rights arguments in IP-related court cases at the national level. We consider this to be the most promising of the four approaches we have considered, with the greatest likelihood of providing real results for access in the near future.

The second section considers how a number of international human rights treaties contain rights that bear on access to medicines. A variety of UN human rights bodies have already begun to develop law at the intersection of health-related rights and IP. An important general comment, for example, makes it clear that access to medicines is a component of the right to health. Human rights bodies have also recognized that TRIPS can negatively impact access and have urged states to utilize TRIPS flexibilities and avoid TRIPS-plus provisions in FTAs. But existing articulations of these obligations remain somewhat underspecified and are often couched in terms that leave much discretion to states. At least one recent human rights document, however, suggests that states “must” use TRIPS flexibilities, at least in certain circumstances. There is potential to build upon this work, to enunciate more specific obligations, and to stimulate more focused reviews of state practice. However, processes for achieving these results within the UN system are challenging. Pursuing a system-wide strategy that incorporates all of the political and expert bodies would require tremendous resources with uncertain rewards. We recommend that A2M activists assess and pursue selected human rights mechanisms that are likely to be the most feasible and productive, especially as applied in specific, strategic moments and country contexts. This may be particularly valuable to help support and disseminate successes at the national level. 

The third section engages with the question of corporate accountability. Pharmaceutical corporations have traditionally rejected the notion that they have obligations under the right to health, in part because the international human rights system has not historically considered corporate actors to be directly governed by human rights law. Recent developments, including the emergence of the Working Group on Business & Human Rights, may give A2M activists new tools for campaigns against companies. Some, however, have concerns about the limits of the norms that are being developed in this process, which tend to be modest, for example focusing on transparency. In campaigns, however, human rights language continues to be an important moral resource for targeting corporate conduct. We recommend further discussion by activists of the benefits and limits of formal human rights work on corporate liability, and that “informal” human rights language be invoked in campaigning to help concretize norms on pharmaceutical companies’ moral and legal obligations. 

The fourth section notes that activists already utilize human rights arguments to oppose TRIPS-plus provisions in FTAs. Human rights arguments could be additionally employed at all political levels by activists to generate political will and foster solidarity for the formation of multilateral alliances. Heightened negotiating power resulting from south-south alliances framed around human rights could provide developing countries with the opportunity and strength to oppose TRIPS-plus FTA provisions and stem the proliferation of IP norms that threaten access to medicines. Human rights arguments may provide a useful set of norms to help ensure that resulting alliances remain committed to protecting the right to health. We recommend that activists continue to invoke human rights as a political tool to encourage south-south alliances, particularly informal ones, and to help generate leverage against regressive FTAs. 

Finally, the paper concludes with several appendices that we hope will be of use to activists working on these issues. Appendix A gathers the most important recent domestic court cases in the area and describes their key holdings. Appendix B collects and describes the most important international human rights documents and standards relevant to IP and A2M. Appendix C offers clarification on the evolution of principles of corporate obligations to respect human rights.

Boundaries

In Bonang Darius Magaming v The Queen [2013] HCA 40 the Australian High Court, by majority, upheld the validity of the Migration Act 1958 (Cth) s 233C(1), which prescribed a mandatory minimum term of imprisonment for people smuggling, specifically the offence of facilitating the bringing or coming to Australia of a group of at least five non-citizens with no lawful right to come to Australia.

The High Court held that the provision was not beyond the legislative power of the Commonwealth Parliament and did not confer judicial power on prosecuting authorities.

Magaming was one of four crew members on a boat carrying 52 passengers intercepted near Ashmore Reef on 6 September 2010. The passengers were not Australian citizens; none had a lawful right to enter Australia. Magaming was charged with one count of facilitating the bringing or coming to Australia of a group of at least five unlawful non-citizens contrary to s 233C(1) of the Act.

The offence under s 233C(1) of the Act was an aggravated form of the people smuggling offence created by s 233A(1) of the Act, which prohibited facilitating the bringing or coming to Australia of an unlawful non-citizen.  Section 233C(1) of the Act carried a mandatory minimum sentence of five years' imprisonment with a minimum non-parole period of three years, in contrast to s 233A(1) which carried no mandatory minimum term of imprisonment.

Magaming was sentenced to the mandatory minimum term of five years' imprisonment with a non-parole period of three years, after pleading guilty in the District Court of New South Wales. He sought leave to appeal to the Court of Criminal Appeal of the Supreme Court of New South Wales, alleging that the provision prescribing the mandatory minimum term of imprisonment was invalid. The Court of Criminal Appeal granted leave to appeal but dismissed the appeal, concluding that the relevant provision was valid.

Magaming the appealed to the High Court by special leave. He contended that in circumstances where prosecuting authorities could choose between charging an offence that carried a mandatory minimum sentence and charging another offence that carried no mandatory sentence, the prosecuting authorities impermissibly exercised judicial power. He also contended that the provision of the Act prescribing the mandatory minimum sentence was incompatible with the institutional integrity of the courts and that it required a court to impose a sentence that was arbitrary.

The High Court this week dismissed the appeal. Although prosecuting authorities had a choice as to which offence to charge, that did not involve an exercise of judicial power or confer on prosecuting authorities an ability to determine the punishment to be imposed for the same conduct. Imposition of a mandatory minimum sentence was not inconsistent with institutional integrity and did not involve the imposition of an arbitrary sentence.

Doh

'The Impact of Mobile Phone Usage on Student Learning' by Jeffrey H. Kuznekoff & Scott Titsworth in (2013) 62(3) Communication Education 233 reveals that - whodathunkit - texting in class by students might just have some impact on their learning. The authors comment -

in this study, we examined the impact of mobile phone usage, during class lecture, on student learning. Participants in three different study groups (control, low-distraction, and high-distraction) watched a video lecture, took notes on that lecture, and took two learning assessments after watching the lecture. Students who were not using their mobile phones wrote down 62% more information in their notes, took more detailed notes, were able to recall more detailed information from the lecture, and scored a full letter grade and a half higher on a multiple choice test than those students who were actively using their mobile phones. Theoretical and pedagogical implications are discussed.

Wow

In modern classrooms, instructors face many challenges as they compete for students’ attention among a variety of communication stimuli. Rapid growth of mobile computing, including smart phones and tablets, presents a double-edged problem: along with previously unimaginable access to information come previously unfore- seen distractions. Of wide concern to many instructors is the potential distraction caused by students using their mobile devices to text, play games, check Facebook, tweet, or engage in other activities available to them in a rapidly evolving digital terrain. That concern has potential merit; recent statistics from the Pew Foundation show that the median number of daily texts for older teens rose from 60 in 2009 to 100 in 2011 (Lenhart, 2012). Moreover, 64% of teens who own cell phones have texted during class, even in schools where cell phones are technically banned (Lenhart, Ling, Campbell, & Purcell, 2010). Those texts potentially come at the expense of learning, as texting during class reduces students’ ability to self-regulate and give sustained attention to classroom tasks (Wei, Wang, & Klausner, 2012). Cell phones, and the broader array of digital mobile devices, pose unique communication challenges for both users and those with whom they interact. Some critics argue that texting and other digital communication behavior potentially diminish key social skills like effective listening. As one commentator noted, ‘‘We think of phones as a communication tool, but the truth is they may be just the opposite’’ (Skenazy, 2009, np). Other views suggest that people are adapting to new communication norms in an increasingly digital world, learning to quickly attend to, process, and respond to multiple and sometimes simultaneous messages (Davidson, 2011). Given the many possible ways that digital communication tools will continue to influence practices of teaching and learning (Schuck & Aubusson, 2010), instructional communication scholars should enact programmatic research to understand how these tools impact classroom communication and subsequent learning outcomes. 

The present study builds on past research by examining whether texting or posting to a social network site has negative impacts on students’ note-taking behaviors and subsequent performance on exams. Participants took part in simulated classroom conditions where they watched a recorded lecture, took notes over the lecture, and were then tested over lecture content. There were three conditions in the study: a control group and two experimental groups. The control group simply watched the lecture, took notes on the lecture, and answered exam questions over lecture content. The other two groups engaged in the same activities as the control group, but also took part in simulated texting/Facebook interactions during the lecture; one group had a low frequency of texts/posts, and another had a high frequency. By using simulated text messages and Facebook posts, the objective of the study was to determine what effects, if any, these distractions had on student learning.

Disability and the CRPD

''Striking for the Guardians and Protectors of the Mind': The Convention on the Rights of Persons with Mental Disabilities and the Future of Guardianship Law' by Michael Perlin in (2013) Penn State Law Review comments that

 In many nations, entry of a guardianship order became the “civil death” of the person affected. It has been accurately characterized as “civil death” characterization because a person subjected to the measure is not only fully stripped of their legal capacity in all matters related to their finance and property, but is also deprived of, or severely restricted in, many other fundamental rights, [including] the right to vote, the right to consent or refuse medical treatment (including forced psychiatric treatment), freedom of association and the right to marry and have a family. 

Guardianship is also frequently entered. In Hungary, for example, there are approximately 80,000 people under guardianship, and approximately 40,000 of these people are under guardianship without active legal capacity. An estimated 300,000 people in Russia alone are currently under guardianship, all stripped of their personhood and of their legal rights. 

The United Nations’ ratification of the Convention on the Rights of Persons with Disabilities (CRPD) radically changes the scope of international human rights law as it applies to all persons with disabilities, and in no area is this more significant than in the area of mental disability law. And there is no question that the CRPD speaks to the issue of guardianship. 

The question is this: What impact, if any, will the CRPD and other international human rights documents have on guardianship practice around the world? This question is of great importance, given the common usage of this status and the lack of procedural safeguards that attend the application of this status in many nations. Although there is some recent scholarship dealing with this issue, it has not been the focus of nearly enough attention in the four years since the CRPD’s ratification. I hope this article causes both scholars and advocates to take this issue more seriously in the future. 

First, in Part I, I will examine why guardianship is considered “civil death” in much of the world, with special focuses on practices in nations in Central and Eastern Europe. As part of this examination, I will consider why designating a psychiatric institution as a patient’s guardian is a conflict of interest per se and terribly wrong. Then, in Part II, I will briefly survey domestic law, with special focus on distinctions that are drawn between guardianships of the person and of property, and between limited and plenary guardianships. After that, in Part III, I will look more carefully at the CRPD, the relevant literature about that Convention’s possible impact on the application of guardianship laws, and the meager caselaw that has emerged, with specific focus on the question as to how the CRPD potentially can reshape guardianship law internationally. 

Next, in Part IV, I will raise some “red flags” that must be confronted in this inquiry. Such issues include the need for some mechanism to insure the appointment of counsel to persons facing guardianship; the need for a mechanism to insure that, in those cases in which guardianship is inevitably necessary, “personal” guardians will be appointed instead of institutional ones; the need for domestic courts — in all parts of the world — to take these issues seriously when they are litigated on a case-by-case basis; and the inevitable problems that will arise when our attention is drawn to Asia and the Pacific region, where there is no regional court or commission at which litigants can seek enforcement of the CRPD. Finally, in Part V, I will consider the impact of the school of therapeutic jurisprudence on the questions at hand. I will conclude by looking again at the CRPD as a potentially emancipatory means of restructuring guardianship law around the world, but if, and only if, the variables discussed immediately above can be resolved.

Tasmanian Marriage Regime

The Tasmania Law Reform Institute research paper [PDF] The Legal Issues Relating to Same-Sex Marriage considers issues regarding a state-based same-sex marriage scheme. It complements the George Williams paper highlighted here.

The authors note that the objective

is not to draw conclusions or to provide recommendations; it is simply to provide a comprehensive guide to both sides of the debate, to allow the reader to appreciate more fully the legal arguments in relation to same-sex marriage. 

They go on to comment that

 Same-sex marriage is a topical issue in Australian politics and in society more generally at both a state and Commonwealth level. In 2012, an unsuccessful attempt was made to pass a Tasmanian same-sex marriage law. Other Australian states are also in the process of debating same-sex marriage laws. State-based initiatives raise legal questions about the capacity of the states to legislate for same-sex marriage, and the consequences which may follow if such laws are enacted. The legal questions emerged as major concerns for Tasmanian parliamentarians during the 2012 Same-Sex Marriage Bill debate. This paper aims to address these concerns. ...   

The issues and concerns raised by the Tasmanian Legislative Councillors in response to the Same-Sex Marriage Bill provide the starting point for this paper. Among the concerns voiced were:

• That marriage is a topic that should be dealt with by the Commonwealth Parliament. Some members suggested that a national referendum is the only way to measure public opinion properly and to determine whether a change to existing laws should be made. 

• That the Tasmanian Same-Sex Marriage Bill, if passed, would be unconstitutional. Advice from academics, practitioners and the Solicitor General could not provide a definitive prediction of whether the Tasmanian Bill would be valid. 

• The likelihood of the Tasmanian Same-Sex Marriage Bill, if passed, being challenged in the High Court. Uncertainty about the parties who would have standing to make such a challenge was also a concern. 

• The costs of defending a challenge in the High Court. Members quoted figures between $50,000 and $1.2 million as the potential cost. The uncertainty of the cost, coupled with the uncertainty of success in a High Court challenge was a significant factor in many of the dissenting members’ speeches. 

• That same-sex marriages entered into in Tasmania would not be recognised as valid marriages in other states or under Commonwealth laws. 

• That a same-sex marriage law would not achieve true legal equality for same-sex couples. 

The paper deals with a succession of questions regarding  state-based same-sex marriage, initially by offering explanatory context and then by providing a detailed assessment of competing arguments.

The authors indicate that

Many of the issues involved in this debate rely on complex legal principles. In writing this paper, attempts have been made to simplify the material as much as possible, while still retaining the integrity of the legal arguments. ... The 2012 Same-Sex Marriage Bill will be considered in some detail. However, this paper is intended to have a broader application than the analysis of the 2012 iteration, as any future bills on this topic may encounter new and different challenges. Discussion of the 2012 Bill is therefore intended to highlight the legal hurdles it faced and suggest ways in which these difficulties might be avoided in future versions. The issues which will be covered in Part 2 are as follows: 

1. What are the differences in the way marriage and same-sex relationships are currently recognised? 

2. Does the Commonwealth government have the power to make laws for same-sex marriage? 

3. Can Tasmania legislate for same-sex marriage? 

4. What would be the consequences if a Tasmanian same-sex marriage law came into force but was later invalidated? 

5. Which jurisdiction would deal with the breakdown of a same-sex marriage? 

6. Could same-sex marriages be recognised or dissolved outside of Tasmania? 

7. Would a same-sex marriage law encourage or lead to the sanctioning of polygamous marriages? 

8. If a law has the potential to be challenged in court, should it be passed? 

9. Who would have standing to bring an action to challenge a Tasmanian same-sex marriage law in the High Court? 

10. What would it cost Tasmania if its same-sex marriage laws were challenged in the High Court? 

11. Have same-sex marriage laws been enacted in overseas jurisdictions?

... As has been noted throughout the paper, the answers to some of the questions raised will be unknown until they are determined by the High Court. Some aspects of this debate raise relatively new issues which have not previously been considered. Consequently, it is difficult to even predict how the High Court might approach these issues. 

In closing, it can be noted that a state-by-state same-sex marriage scheme would not be an unusual legislative development. Until 1960, marriage was regulated by the states, with each state having its own slightly different legislation. It was not until the Commonwealth recognised a need for national uniformity that the Marriage Act came into existence. Similarly, Deeds of Relationship (or the equivalent) are regulated at a state level and are now available in Tasmania, Victoria, New South Wales, the Australian Capital Territory and Queensland. Commonwealth recognition of these relationships has been achieved through s 4AA of the Family Law Act, which lists formal registration of a relationship as an indicator of the existence of a de facto relationship for Commonwealth purposes. 

The recognition of same-sex marriage in other countries illustrates the wide range of ways in which the topic can be approached and regulated. Many common-law countries with systems similar to Australia now recognise same- sex marriage using a variety of different legislative mechanisms. Indeed, during the writing of this paper, there has been a significant increase in the number of jurisdictions which now recognise same-sex marriage, which indicates the rapid pace at which change and acceptance is occurring. Of course, marriage equality legislation remains in its infancy, and it is inevitable that new issues and challenges will arise. How these are dealt with remains to be seen.

Oyston Damages

Another bullying benchmark, with final orders in the Oyston dispute.

In Oyston v St Patrick's College (No 3) [2013] NSWCA 324 the New South Wales Supreme Court of Appeal has made final orders awarding damages in the sum of $ 162,207.34 to Jasmine Oyston, who was subjected to bullying and harassment by other students of St. Patrick's College in Campbelltown.

The final order reflected an increase in the amount awarded for non-economic loss and interest as agreed by the parties.

In Oyston v St Patrick's College (No 2) [2013] NSWCA 310 the Court considered Oyston v St Patrick's College [2013] NSWCA 135, which followed Oyston v St Patrick's College [2011] NSWSC 269 and Oyston v St Patrick's College [2011] NSWSC 826. The judgment in NSWCA 135 - noted here - found that the College's breach of duty of care to the Oyston was the institution's failure, particularly during 2004 when she was in Year 9, to take reasonable steps to bring to an end her bullying by other students.

In essence

a) The College, through Mrs Ibbett (the Year 9 Coordinator responsible for investigating any reports of bullying) recognised that bullying could affect the well-being of a student and could occasion a depressive condition in an adolescent girl already suffering from anxiety, as was Oyston to Mrs Ibbett's knowledge; 

b) The College was well aware that bullying was taking place and of the impact of bullying upon individual students, which it had recognised by putting in place an anti-bullying policy which required action to be taken in response to any complaints about bullying; 

c) Not only were complaints of bullying to be investigated, but a specific procedure was laid down in the policy depending upon whether the bullying by a particular perpetrator was the first, second or third incident of such conduct by that student; 

d) Particularly during 2004, the appellant was regularly, if not relentlessly, bullied, in particular by JP and LM; 

e) The College was aware that the appellant claimed that she was being bullied at least from 6 February 2004. The evidence disclosed a number of particular incidents of bullying during 2004, particularly in April, May, November and December, all of which put the College on notice that bullying of the appellant was continuing; 

f) The College was obligated in performing its duty of care towards Oyston to take reasonable steps to ensure that she was protected from bullying, including taking reasonable steps to ascertain the identity of the perpetrators and to take such action as was reasonable to prevent repetition by those persons of such conduct. In particular, Mrs Ibbett was well aware that bullying was a serious ongoing problem in the school, to eradicate which it was necessary to take such active steps as the College's policy contemplated; 

g) The College was aware from February 2004 that the Oyston was vulnerable, that she suffered from anxiety and panic attacks and, therefore, that she was likely to be susceptible to psychological harm if bullied; 

h) The steps taken by Mrs Ibbett during 2004 did not provide a reasonable response to the not insignificant risk of harm to students such as Oyston if bullying of them continued. It was insufficient for the College merely to request teachers to keep an eye out for bullying once a complaint of bullying had been received. Once such a complaint was received it required investigation and, if substantiated, action against the perpetrator. In this context, the evidence established that Oyston was regularly bullied by JP and LM and, to a lesser extent, by AM. However, no reasonable steps were taken by Mrs Ibbett to investigate Oyston's allegations of bullying by those students and to act on them if she was satisfied that they were justified; 

i) Accordingly, the primary judge's conclusion that Oyston was subject to ongoing bullying in 2004, that the College was aware that this was so, and that it failed to take reasonable steps to bring that conduct to an end, was amply justified by the evidence.

National Breakups

Who gets the family cat, the fridge, the mortgage and the unwanted wedding presents when a relationship breaks up? Disassembling nations is more interesting, particularly if there isn't bloodshed.

'Legal Issues Surrounding the Referendum on Independence for Scotland' by Stephen Tierney in (2013) 3 European Constitutional Law Review comments that

On 18 September 2014 a referendum will be held in Scotland. It will pose the following question to the people: "Should Scotland be an independent country?". If a majority of voters say "Yes" to this proposition, Scotland will withdraw from the United Kingdom (UK), ending a union formed in 1707 and offering an unclear future for one of Europe’s oldest nation states. The significance of this process for other European States and for the European Union (EU) project itself is also considerable. Never before has part of an EU Member State broken away while simultaneously seeking to remain a member of the EU as a new State. Important questions arise. The UK is an important member; would its influence within the EU diminish with the loss of an important part of its territory and territorial waters? Will Scottish independence offer encouragement to other highly mobilized sub-state nationalist movements in Belgium and Spain for example, while providing a precedent for access to international and European institutions for secessionist territories? 

These questions are political in nature and rather than attempt to answer them directly, this paper will address the legal context which must condition how such questions are addressed. We will look first at the domestic constitutional situation in the United Kingdom. It is notable that an intergovernmental agreement has been reached by the UK and Scottish Governments setting out a framework for the process rules which will govern the referendum. This is itself remarkable. The UK Government has entered consensually, if somewhat reluctantly, into a process which could lead to the break-up of the State, a level of acquiescence which is itself unprecedented in the EU context. We will consider the key elements of the referendum process which are being set out in detailed legislation by the Scottish Parliament, assessing the prospects for a fair constitutional referendum. Secondly, we will turn to the possible implications of a majority Yes vote for Scotland and the United Kingdom under international law. Would Scottish independence be characterized by the international community as a case of secession or as bringing about the dissolution of the UK? What challenges would Scotland face in seeking recognition as a new State and in succeeding to the UK’s international obligations? And, most crucially, how would an independent Scotland come to take up membership of international institutions, in particular the United Nations and the EU?