Critical Analyses, Musings and General Observations on Malaysian and International Health Law. All views are mine unless expressly stated otherwise.



Wednesday, 7 October 2015

The Illusion of a ‘Golden Balance’: Access to Medicines and the TPP

by Fifa Rahman and Fran Quigley

In an account of life in Malaysian Borneo in the 1930s, the author Agnes Newton Keith detailed a card game played in Sandakan involving a card box placed at the entrance to a married woman’s house. The game dictated the protocol to meet newcomers to the area. These rules proved to be a conundrum. The author elaborated: ‘Sometimes newcomers do not understand about this game, or play it with a different set of rules in the outer world from which they come. This creates an impasse in social relations, for not until the first round of cards can people meet in person. The impasse continues until someone quietly hands the newcomer a printed slip containing the laws of the Medes, the Persians, and the Game of Cards.’

More than 80 years later, in July 2013, hundreds of negotiatiors and maybe 40 civil society actors descended upon the city of Kota Kinabalu in Malaysian Borneo for another game of a similarly confounding temperament. This time, the game involved disagreements on intellectual property and state-owned enterprises and technical barriers to trade creating geopolitical and social impasses between nations. This game, the 18th round of negotiations of the Trans-Pacific Partnership Agreement (hereinafter TPP), did not happen in the environment described in the above book, out in the open, obscured only, perhaps, by the glistening fronds of palm trees. The TPP negotiations had been – and continue to be – negotiated in secret, and Kota Kinabalu was no different. Held at the lavish Sutera Harbour Resort, negotiators from 11 countries convened daily discussing terms of this agreement, which negotiators say will be the ‘gold standard’ for generations to come, poring over pages of pages of documentation of provisions that had very little to do with traditional trade matters.

A token day was reserved for civil society engagement, during which a series of 7-minute presentations to negotiators were permitted, followed by a briefing from Chief Negotiators, after which civil society and other stakeholders were permitted questions. Locked out of the negotiations, frustrated civil society representatives asked about international litigation on tobacco control, food labelling requirements, restrictions on capital controls, state sovereignty to regulate in favour of health, and last but not least, the eternally controversial issue of stronger intellectual property provisions and access to generic medicines.

Reacting to civil society questions on access to medicines, U.S. Chief Negotiator Barbara Weisel stated:
We are looking for the golden balance on IP. We are thinking about a system that promotes generics. Balanced against that is the next generation of drugs. We all share an interest in making sure we find that balance. So we'll take that time. We have to all come to an agreement that satisfies all parties. And it is not an issue of patients versus companies, it is not.

The ‘golden balance’ in access to medicines in trade is rooted in the idea that stronger intellectual property is needed to promote innovation of future drugs, i.e. that if these IP provisions were not given, there would be no incentive for pharmaceutical companies to research new drugs. So in the TPP, the proposals seek extensive monopolies beyond the current 20-year patent period under WTO rules, including patents for minor modifications of medications, regardless of whether the modification improves therapeutic efficacy. It should be emphasised that this idea of a ‘golden balance’ was precipitated in the name of innovation. This emphasis is important because there is no evidence that stronger intellectual property has encouraged innovation of new drugs.

Cynthia Ho, Professor of Intellectual Property Law at Loyola described in her 2015 article the ‘innovation crisis’ affecting pharmaceutical companies, referring to the European Commission Director-General’s 2009 Pharmaceutical Sector Inquiry that found that pharmaceutical companies increasingly patent drugs that are ‘merely minor variations’ of existing drugs. India is another example – their flexible IP system has come under attack recently for being too weak, but this argument does not hold water. Medécins Sans Frontières’ Chase Perfect describes this, well, perfectly: ‘India’s current intellectual property model is under attack not because it has failed, but because it has succeeded.’ India’s system enables access to generic medications, while ensuring that real innovation occurs, not merely minor variations of old drugs.

The failures of unrestrained patent monopoly systems to develop new and needed drugs, especially compared to the success of systems like India, reveal the false premise in the narrative that stronger IP protection is needed for drug innovation.  Thereon, how do we expect to achieve a ‘golden balance’ if the base of that balance is fundamentally flawed?

Neither can we achieve a golden balance where there is radically unbalanced participation by civil society in these negotiations. Flynn et al. (2013) posit that if the intention is to find balance, the ‘interests of those excluded from the formal process must be amplified’, and that the process ‘is, in short, an incredibly unbalanced proposal emanating from an extraordinarily imbalanced process.’

To illustrate further, Ottersen et al. (2014) in the Lancet talk about ‘transnational activities that involve actors with different interests and degrees of power’ and how these global political determinants of health inequity are the result of 5 dysfunctions of global governance systems.  One of these dysfunctions is the democratic deficit i.e. lack of participation of civil society actors and marginalised groups in these processes. That is the very same democratic deficit which TPP negotiators tried to remedy via a one hour Chief Negotiator briefing on one day of an eleven day negotiation round.

Not surprisingly, given who has access to the process and who is locked out, the leaks of the IP chapter of the TPP show, as described by Rohit Malpani, Director of Policy for Doctors without Borders, “There’s very little distance between what Pharma wants and what the U.S. is demanding.”

This debate on the existence of a golden balance is exhausting. It’s exhausting not because there isn’t one to be found. There should be one to be found because the rights of right holders who create medicines that are truly new and involve an inventive step and have industrial application are legitimate.

Whether the patent system is the best system to reward them is an equally exhausting debate meant for another day. It is exhausting because these global political determinants are protecting the rights of companies that are not really innovating, on a premise that is structurally unsound. To protect this premise they are shutting out civil society voices, the voices that can help dysfunctional global governance systems and ensure that occurrences of health inequity are mitigated. It is exhausting because it is lucidly clear that the negotiations are pro-pharma, and that the golden balance is not what the U.S. Chief Negotiator is looking for, at least not as part of her professional mandate. So at the end of this article we are back to this discombobulated game, the TPP, played back then on the island of Borneo, continuing to create impasses throughout the world in lobbies and meeting rooms of luxury hotels, until that time when it’s simply is too late and the TPP has been signed.

*Fifa Rahman is Policy Manager at the Malaysian AIDS Council and has attended 4 rounds of the TPP negotiations as a stakeholder; and Fran Quigley is Clinical Professor of Law, Health and Human Rights Clinic at the Indiana University Robert H McKinney School of Law and has written extensively on the TPP and medicine prices.

*This post was written prior to the conclusion of the negotiations in Atlanta on 5 October 2015. For my comments regarding the conclusion and impact on Malaysian access to medicines, see this link: http://www.bfm.my/fifa-rahman-the-trans-pacific-partnership-and-medicine-in-malaysia.html 

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