Turing and the Trans-Pacific Partnership: Intellectual Property, Public Health, and Access to Essential Medicines

A recent controversy in the United States over drug pricing by Turing Pharmaceuticals AG has raised larger issues in respect of intellectual property, access to medicines, and the Trans-Pacific Partnership (TPP). In August 2015, Turing Pharmaceuticals AG – a private biopharmaceutical company with offices in New York, the United States, and Zug, Switzerland - acquired the exclusive marketing rights to Daraprim in the United States from Impax Laboratories Incorporated. Martin Shkreli, Turing’s Founder and Chief Executive Officer, maintained: “The acquisition of Daraprim and our toxoplasmosis research program are significant steps along Turing’s path of bringing novel medications to patients with serious disorders, some of whom often go undiagnosed and untreated.” He emphasised: “We intend to invest in the development of new drug candidates that we hope will yield an even better clinical profile, and also plan to launch an educational effort to help raise awareness and improve diagnosis for patients with toxoplasmosis.” In September 2015, there was much public controversy over the decision of Martin Shkreli to raise the price of a 62 year old drug, Daraprim, from $US13.50 to $US750 a pill. The drug is particularly useful in respect to the treatment and prevention of malaria, and in the treatment of infections in individuals with HIV/AIDS. Daraprim is listed on the World Health Organization’s (WHO) List of Essential Medicines. In the face of much criticism, Martin Shkreli has said that he will reduce the price of Daraprim. He observed: “We've agreed to lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit, but a very small profit.” He maintained: “We think these changes will be welcomed.” However, he has been vague and ambiguous about the nature of the commitment. Notably, the lobby group, Pharmaceutical Research and Manufacturers of America (PhARMA), disassociated itself from the claims of Turing Pharmaceuticals. The group said: “PhRMA members have a long history of drug discovery and innovation that has led to increased longevity and improved lives for millions of patients.” The group noted: “Turing Pharmaceutical is not a member of PhRMA and we do not embrace either their recent actions or the conduct of their CEO.” The biotechnology peak body Biotechnology Industry Organization also sought to distance itself from Turing Pharmaceuticals. A hot topic: United States political debate about access to affordable medicines This controversy over Daraprim is unusual – given the age of drug concerned. Daraprim is not subject to patent protection. Nonetheless, there remains a monopoly in respect of the marketplace. Drug pricing is not an isolated problem. There have been many concerns about drug pricing – particularly in respect of essential medicines for HIV/AIDS, tuberculosis, and malaria. This recent controversy is part of a larger debate about access to affordable medicines. The dispute raises larger issues about healthcare, consumer rights, competition policy, and trade. The Daraprim controversy has provided impetus for law reform in the US. US Presidential Candidate Hillary Clinton commented: “Price gouging like this in this specialty drug market is outrageous.” In response to her comments, the Nasdaq Biotechnology Index fell sharply. Hillary Clinton has announced a prescription drug reform plan to protect consumers and promote innovation – while putting an end to profiteering. On her campaign site, she has emphasised that “affordable healthcare is a basic human right.” Her rival progressive candidate, Bernie Sanders, was also concerned about the price hike. He wrote a letter to Martin Shkreli, complaining about the price increase for the drug Daraprim. Sanders said: “The enormous, overnight price increase for Daraprim is just the latest in a long list of skyrocketing price increases for certain critical medications.” He has pushed for reforms to intellectual property to make medicines affordable. The TPP and intellectual property The Daraprim controversy and political debate raises further issues about the design of the TPP. The dispute highlights the dangers of extending the rights of pharmaceutical drug companies under intellectual property, investor-state dispute settlement, and drug administration. Recently, the civil society group Knowledge Ecology International published a leaked draft of the Intellectual Property Chapter of the TPP. Knowledge Ecology International Director, James Love, was concerned the text revealed that the US “continues to be the most aggressive supporter of expanded intellectual property rights for drug companies.” He was concerned that “the proposals contained in the TPP will harm consumers and in some cases block innovation.” James Love feared: “In countless ways, the Obama Administration has sought to expand and extend drug monopolies and raise drug prices.” He maintained: “The astonishing collection of proposals pandering to big drug companies make more difficult the task of ensuring access to drugs for the treatment of cancer and other diseases and conditions.” Love called for a different approach to intellectual property and trade: “Rather than focusing on more intellectual property rights for drug companies, and a death-inducing spiral of higher prices and access barriers, the trade agreement could seek new norms to expand the funding of medical research and development (R&D) as a public good, an area where the US has an admirable track record, such as the public funding of research at the National Institutes of Health (NIH) and other federal agencies.” In addition, there has been much concern about the Investment Chapter of the TPP. The investor-state dispute settlement regime would enable foreign investors to challenge government policy making, which affected their investments. In the context of healthcare, there is a worry that pharmaceutical drug companies will deploy their investor rights to challenge public health measures – such as, for instance, initiatives to curb drug pricing and profiteering. Such concerns are not merely theoretical. Eli Lilly has brought an investor action against the Canadian Government over the rejection of its drug patents under the investor-state dispute settlement regime of the North American Free Trade Agreement (NAFTA). The Health Annex to the TPP also raises worries that pharmaceutical drug companies will able to object to regulatory procedures in respect of healthcare. It is disappointing that the TPP – in the leaks that we have seen – has only limited recognition of the importance of access to essential medicines. There is a need to ensure that there are proper safeguards to provide access to essential medicines – particularly in respect of HIV/AIDs, malaria, and tuberculosis. Moreover, there must be protection against drug profiteering and price gouging in any trade agreement. There should be strong measures against the abuse of intellectual property rights. The dispute over Turing Pharmaceuticals AG and Daraprim is an important cautionary warning in respect of some of the dangers present in the secret negotiations in respect of the TPP. There is a need to preserve consumer rights, competition policy, and public health in trade negotiations over an agreement covering the Pacific Rim.

The Australian Nonprofit Sector Legal Almanac 2015

Collected summaries of court cases involving nonprofit organisations, from Australia and overseas, during 2015, along with updates of legislative changes in all Australian jurisdictions. Significant Australian cases included several disputes with State Revenue Authorities about exemption from payroll taxes.

STREAM Journal, Vol. 5, No. 1, pp 1-18. January-March 2006

CONTENTS: Policy development as a theme and policy briefs as a genre, by Graham Haylor and William Savage. Decriminalizing Cambodian family-scale fishers through a livelihoods approach to law reform, by Nao Thuok and Chun Sopha. Longer pond leases in Orissa, by Reshmee Guha and Rubu Mukherjee. One-stop aqua shop: a “one-window delivery” service center for aqua-farmers and fishers, by S.D. Tripathi, Rubu Mukherjee and Kuddus Ansary. Fisheries and aquaculture policy formulation process in Pakistan, by Muhammad Junaid Wattoo and Dr. Muhammad Hayat. Improving the international marine ornamental fish trade to sustain and improve the livelihoods of poor people involved in the trade, by Aniza Suspita, Michael J. Phillips and Samliok Ndobe.

The Mixed Fortunes of Irish Unions: Living with the Paradoxes of Social Partnership

We assess the fortunes of Irish unions since 1980 and, in particular, focus on the period of national social partnership since 1987. We argue that, structurally, unions have been weakened by a sharp decline in union density levels. In addition, labor law reform has not been as permissive as unions desired. However, on the other hand, we highlight that union membership in Ireland has never been higher and unions exert a strong influence over many areas of government policy. In conclusion, we argue that continuing with social partnership is the most viable option for Irish unions, though significant gains in union power are unlikely to happen.

Conference Reflections. Some Practice and Practical Implications of Banning the Physical Punishment of Children through Legislation.

This brief paper represents the reflections of a participant at the recent conference ‘The Physical Punishment of Children’ organised jointly by Child Care in Practice and The Office of Law Reform. The participant’s reflections are related to his roles both as a Family Therapist and as a Guardian Ad Litem. The writer largely accepts the academic and moral arguments in respect of making the physical punishment of children a legal offence, so eloquently put by the main speakers. He wishes, however, to draw out some of the practical and practice implications which need to be considered alongside the implementation of such legislative change.

Beyond Financialisation? Transformative Strategies for More Sustainable Financial Markets in the European Union

The global financial crisis has led many regulators and lawmakers to a rethinking about current versus optimum financial market structures and activities that include a variety and even radical ideas about delevaraging and downsizing finance. This paper focuses on the flaws and shortcomings of regulatory reforms of finance and on the necessity of and scope for more radical transformative strategies. With 'crisis economics' back, the most developed countries, including the EU member states, are still on the edge of disaster and confronted with systemic risk. Changes in financial regulation adopted in the aftermath of the financial meltdown have not been radical enough to transform the overall system of finance-driven capitalism towards a more sustainable system with a more embedded finance. The paper discusses financialisation in order to understand the development trends in finance over the past decades and examines various theories to describe the typical trends and patterns in financial regulation. By focusing on a limited number of regulatory reforms in the European Union, the limitations of current reforms and the need for additional transformative strategies necessary to overcome the finance-driven accumulation regime are explored. Finally, the regulatory space for such transformative strategies and for taming finance in times of crisis, austerity, and increased public protest potential is analysed.

An international comparison of legal frameworks for supported and substitute decision-making in mental health services

There have been important recent developments in law, research, policy and practice relating to supporting people with decision-making impairments, in particular when a person’s wishes and preferences are unclear or inaccessible. A driver in this respect is the United Nations Convention on the Rights of Persons with Disabilities (CRPD); the implications of the CRPD for policy and professional practices are currently debated. This article reviews and compares four legal frameworks for supported and substitute decision-making for people whose decision-making ability is impaired. In particular, it explores how these frameworks may apply to people with mental health problems. The four jurisdictions are: Ontario, Canada; Victoria, Australia; England and Wales, United Kingdom (UK); and Northern Ireland, UK. Comparisons and contrasts are made in the key areas of: the legal framework for supported and substitute decision-making; the criteria for intervention; the assessment process; the safeguards; and issues in practice. Thus Ontario has developed a relatively comprehensive, progressive and influential legal framework over the past thirty years but there remain concerns about the standardisation of decision-making ability assessments and how the laws work together. In Australia, the Victorian Law Reform Commission (2012) has recommended that the six different types of substitute decision-making under the three laws in that jurisdiction, need to be simplified, and integrated into a spectrum that includes supported decision-making. In England and Wales the Mental Capacity Act 2005 has a complex interface with mental health law. In Northern Ireland it is proposed to introduce a new Mental Capacity (Health, Welfare and Finance) Bill that will provide a unified structure for all substitute decision-making. The discussion will consider the key strengths and limitations of the approaches in each jurisdiction and identify possible ways that further progress can be made in law, policy and practice.

The United Kingdom, the United Nations Human Rights Council and the first cycle of the Universal Periodic Review

The introduction of the Universal Periodic Review (UPR) mechanism as an innovative component of the new Human Rights Council in 2006 has suffered little academic scrutiny. This is partly because it holds as its objective an improvement in human rights situations on the ground, a goal that is difficult to test amongst so many possible causal factors attributable to law reform and policy change, and partly due to the fact that the mechanism has only completed one full cycle of review. This article seeks to remedy this absence of analysis by examining the experience of the United Kingdom during its first review. In doing so, the article first considers the conception of the UPR, before progressing to examine the procedure and recommendations made to the UK by its peers. Finally, the article considers the five year review of the UPR which occurred as a subset of the Human Rights Council Review in 2011 and the resulting changes to the process modalities.

De la réforme et de l'harmonisation du droit des sûretés dans un contexte de mondialisation de l'économie : vers un retour au paradigme de l'uniformisation du droit?

La réforme et l’harmonisation du droit des sûretés mobilières sont à l’ordre du jour de plusieurs organisations internationales, car il est admis qu’un régime de sûretés efficient favorise l’accès au crédit à de faibles coûts. L’harmonisation de ce droit comporte deux volets. D’une part, dans l’Occident industrialisé, les efforts d’harmonisation vont de la réforme des droits internes à l’établissement de régimes spéciaux relativement à des biens spécifiques (principalement les biens mobiles de grande valeur, tels les aéronefs, le matériel ferroviaire roulant et les satellites, et les biens incorporels, comprenant les créances, valeurs mobilières, actifs financiers et titres intermédiés). Ces efforts d’harmonisation démontrent que d’un point de vue systémique, malgré quelques différences notables, les régimes nord-américains et européens sont fondés sur des principes similaires et atteignent des résultats comparables. En résulte l’émergence d’un ordre juridique transnational en droit des sûretés mobilières, fondé sur les principes de la primauté de l’individu et la reconnaissance du droit de propriété de l’individu dans ses biens, mis en œuvre grâce à l’État de droit. D’autre part, les institutions financières internationales encouragent l’établissement de régimes de sûretés dans les pays en voie de développement qui obéissent aux mêmes critères que ceux de l’Occident, en insistant sur les réformes institutionnelles et juridiques visant l’établissement d’une bonne gouvernance et l’État de droit. Cependant, une transposition des régimes occidentaux ne peut se faire sans heurts dans les pays en voie de développement, notamment pour des raisons socio-culturelles et politiques. Lorsque les principes de la primauté de l’individu, de la propriété individuelle et de l’État de droit ne sont pas reconnus dans un pays donné, la réforme et l’harmonisation du droit des sûretés s’en trouvent compromis. La démonstration de l’état d’avancement de la réforme et de l’harmonisation du droit des sûretés dans les pays occidentaux industrialisés est faite grâce à une comparaison du Uniform Commercial Code, du Code civil du Québec, des Personal Property Security Acts des provinces canadiennes de common law, des principes des droits français et anglais, de l’influence du droit communautaire sur les pays membres de l’Union Européenne. Sont analysés, aussi, dans cette optique, les principaux instruments de l’harmonisation du droit émanant des organisations internationales. Par ailleurs, deux études de cas relatifs à la réforme du crédit foncier en Égypte et à la réforme de l’urbanisme et de l’habitat en République démocratique du Congo, viennent étayer les difficultés que rencontrent les institutions internationales, telles la Banque mondiale et l’ACDI, dans le cadre de projets de réformes visant la bonne gouvernance et l’instauration d’un véritable État de droit, en partie à cause d’un pluralisme des ordres juridiques de ces pays.

La fonction de l'intervention des tiers en droit judiciaire privé québécois

Cette étude présente une caractérisation du mécanisme procédural de l'intervention des tiers en droit judiciaire privé québécois. Développée en trois volets, elle aborde successivement l'origine historique de l'intervention des tiers, qui révèle sa pérennité et sa longévité (première partie). Un modèle conceptuel de sa forme contemporaine selon lequel son bien-fondé repose sur sa légitimité et son utilité est proposé (deuxième partie). Enfin, une étude critique, dans une perspective sociologique et comparative, de la place de l'intervention des tiers dans les projets de réforme de la procédure civile, expose son incompatibilité avec les modes alternatifs de résolution des conflits et trouve, dans le pouvoir judiciaire de l'ordonner d'office présent la législation étrangère, une assurance contre l'iniquité à laquelle le droit québécois devrait souscrire (troisième partie).

Copyright issues on the protection of architectural works and designs

Architects and engineers depend on copyright law to protect their original works. Copyright protection is automatic once a tangible medium of expression in any form of an innovative material, conforming the Copyright Designs and Patents Act 1988, is created. In terms of architectural works, they are protected as literary works (design drawings and plans) and as artistic works (the building or model of the building). The case law on the concept of “originality” however discloses that it may be difficult for certain artistic works of architecture to achieve copyright protection. Although copyright law provides automatic protection to all original architectural plans, the limitation is that it only protects the expression of ideas but not the ideas themselves. The purpose of this research is to explore how effective the UK’s copyright law regime is for protecting the rights and interests of architects in their works. In addition, the United States system of copyright law will be analysed to determine whether it provides more effective protection for architects and engineers with regard to architectural works. The key objective in carrying out this comparison is to compare and contrast the extent to which the two systems protect the rights and interests of architects against copyright infringement. This comparative analysis concludes by considering the possibility of copyright law reform in the UK.

Embryonic stem cell research: the principal ethical issue-when does life begin?

Embryonic stem cell research is perhaps the most controversial ethical issue of the new century. This is not surprising. It promises unprecedented potential benefits to human health but arguably comes at the expense of violating the most fundamental moral virtue - the right to life. The debate has become increasingly emotive. The Catholic Church has labelled stem cell research as cannibalism.1 This has led perhaps the world's most famous moral philosopher, Peter Singer, to label the Church, which has over a billion followers, as irrelevant.2 The principal purpose of this paper is not to  discuss all of the relevant moral issues in the embryonic stem cell debate. Considerations of space do not permit this and in any event there are  numerous reports which catalogue the relevant issues.3 Rather we attempt  to identify the crux of the issues in the debate. In our view, the main issue is the point at which life commences. We offer some preliminary observations on this matter. This discussion appears in section four. In the next section, we provide a brief  overview of nature and potential benefits of stem cell  research. This is followed by a discussion of the current legal position. In the final section, we offer some concluding remarks including some  suggestions for law reform.