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.

Cadrage et mise à l'agenda du projet de privatisation d'une partie du parc national du Mont-Orford

Mémoire numérisé par la Division de la gestion de documents et des archives de l'Université de Montréal

La incidencia del sistema de patentes estadounidense en la política de salud pública sudafricana 2000- 2012

El interés de este estudio de caso es explicar la incidencia del sistema de patentes estadounidense en la política de salud pública sudafricana del 2000 al 2012. Teniendo en cuenta los altos costos que este sistema impone en los precios de los medicamentos especialmente para tratar el VIH/SIDA y la malaria dos de los males que más aquejan a la población sudafricana. Se pretende explicar y establecer los cambios que ha implementado el gobierno sudafricano en su política de salud pública a través de la creación de una incipiente industria farmacéutica genérica que alivia en parte esta situación, pero que resulta insuficiente debido a su primordial interés de mantener relaciones cordiales con Estados Unidos antes que experimentar cualquier represalia como sucedió en India y Brasil.

Gender and schooling : still making the difference?

This chapter analyses contemporary political responses to the perceived academic success of girls as compared with boys, and the motivations behind what they call the 'what about the boys?' lobby. It argues that the growth of this influential lobby group is emblematic of a feminist backlash in western societies. By exposing some of the theoretical problems with the construction of difference upon which the 'boys in education' case is based, the author constructs an alternative relational approach which urges that the school curriculum should encourage all students to deconstruct gender, and particularly the ways in which hegemonic masculinity is formed and shaped in our society

Welfare Lobby Groups responding to Globalisation: A Comparison of the Australian Council of Social Service (ACOSS) and the UK Child Poverty Action Group (CPAG)

The past decade has witnessed a period of intense economic globalisation. The growing significance of international trade, investment, production and financial flows appears to be curtailing the autonomy of individual nation states. In particular, globalisation appears to be encouraging, if not demanding, a decline in social spending and standards. However, many authors believe that this thesis ignores the continued impact of national political and ideological pressures and lobby groups on policy outcomes. In particular, it has been argued that national welfare consumer and provider groups remain influential defenders of the welfare state. For example, US aged care groups are considered to be particularly effective defenders of social security pensions. According to this argument, governments engaged in welfare retrenchment may experience considerable electoral backlash (Pierson 1996; Mishra 1999). Yet, it is also noted that governments can take action to reduce the impact of such groups by reducing their funding, and their access to policy-making and consultation processes. These actions are then justified on the basis of removing potential obstacles to economic competitiveness (Pierson 1994; Melville 1999).

‘Live your liberation, don’t lobby for it’ : Australian queer student activists’ perspectives of same-sex marriage

One topic covered in Australian queer university student print media is the legalisation of same-sex marriage. The legalisation of same-sex marriage is currently generating much debate in Western queer communities. Same-sex marriage is legalised in some countries such as, Canada, Spain, the Netherlands and Belgium. It has been outlawed in Australia and most states in the US. Campaigns continue to reverse these restrictions. Other countries, such as the UK and New Zealand allow same-sex civil unions, providing couples with the rights afforded to married couples. There is a range of research documenting queer communities’ attitudes towards this issue (for example Lannutti 2005; Clarke, Burgoyne and Burns 2006; Yep, Lovaas and Elia 2003; Wolfson 1993; Egan and Sherrill 2005). These studies document broad community views as well as those of community sub-sections. For example, Yip (2004) looks at the views of gay and lesbian Christians on same-sex marriage and Lahey and Alderson (2004) document the experiences of same-sex couples who have gotten married or who are waiting to get married. Philosophical analyses consider the legalisation of same-sex marriage in relation to, for example, liberalism, equal rights, liberation, queer theory, citizenship, history, activism, religious discourse and feminism (Ferguson 2007; Jordan 2005; Josephson 2005; Lipton 2006; Sullivan and Chauncey 2005; Riggs 2007). This paper explores Australian queer university student activist media’s representation of same-sex marriage, and the debates surrounding its legalisation. It examines a selection of queer student media from four metropolitan Australian universities, and the 2003 and 2004 editions of national queer student publication, Querelle. This paper uses discourse analysis of queer student activists’ media representations of marriage to investigate this issue in one specific context – metropolitan Australian universities. This paper thus contributes to the history of queer activism, documenting what one group of young people say about the legalisation of same-sex marriage, and furthers research on queer perspectives of marriage and same-sex relationships.

'Live your liberation - don't lobby for it' : Australian queer student activists' perspectives of same-sex marriage

One topic covered in Australian queer university student print media is the legalization of same-sex marriage. The legalization of same-sex marriage is currently generating much debate in Western queer communities. This paper explores Australian queer university student activists’ media representation of same-sex marriage, and the debates surrounding its legalization. It uses discourse analysis to examine a selection of queer student media from four metropolitan Australian universities, and the 2003 and 2004 editions of the national queer student publication Querelle. This paper thus contributes to the history of queer activism, documenting what one group of young people say about the legalization of same-sex marriage, and furthers research on queer perspectives of marriage and same-sex relationships.