But even then they should be approached with caution, given emerging evidence of the extreme risks of becoming party to the provisions in modern PTAs. At the time of negotiation, it is often difficult to know the real costs and benefits of PTAs for public health because of the indeterminacy of the principles they establish or because of difficulties predicting the effects of specific rules in dynamically changing markets.
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During the s and s tobacco multinationals became advocates of stronger trademark protection. Both individually and as part of business organizations such as the International AntiCounterfeiting Organization, companies such as Philip Morris pushed an international trademark agenda. Briefly, stronger trademark protection became a key issue for a number of globalized industry sectors in the s, leading a coalition of US, European Union and Japanese multinationals to draft text for an IP agreement [ 21 ].
This is precisely the point. Trade negotiators did not understand them and most likely made little attempt to do so. Where business interests do have a disproportionate influence on the PTA text, states could easily leave the negotiating table having delivered private gains to industry actors while increasing costs to the public in the form of, for example, higher prices to medicines. The risk management problem in regard to the negotiation of PTAs is exacerbated for developing countries by an inequality of bargaining power. PTAs involving the US, for example, are by far the most comprehensive in terms of their coverage of goods and services and their inclusion of WTO-plus provisions with greater public health risk [ 22 ].
Studies of PTAs between large developed countries and small developing countries find a weak reciprocity; the small country gives up a lot to gain a little [ 23 ]. Importantly, the developing country in these cases takes on developed country regulatory standards without having the capacity of the developed country to manage the risks of those standards [ 24 ]. An example of this relates to food safety standards.
Most developing countries lack the scientific capacity needed to evaluate the public health costs and benefits of these food standards or to play an influential role in the technical meetings that produce them [ 25 - 27 ]. Not only do countries need the administrative regulatory capacity to effectively negotiate PTAs, if they do decide to become signatories, they also need to increase their capacities in regard to PTA implementation and on-going management. The earlier examples of corporations suing the Australian and Canadian governments highlight the need for administrative capacity to defend public interests against globally coordinated litigation strategies backed by multinationals, law firms and lobbyists [ 11 , 28 , 29 ].
On-going management of PTAs poses a huge administrative burden to governments. Kesselheim et al. The US Attorney General has noted the difficulty of enforcing limits on pharmaceutical industry behaviour in managing the risks of monopoly extension, despite the considerable resources available to the US government [ 11 ]. If states do not find ways to increase their administrative regulatory capacities in regard to the negotiation, implementation and on-going management of PTAs, these PTAs will potentially drive greater health inequities [ 10 , 34 ].
But how might countries, and particularly small and poor countries, improve their capacity to manage the risks of PTAs? The scale of the problem is daunting, however we offer the following suggestions. First, states have to recognize that PTAs carry social risks and costs, and that administrative regulatory capacity is needed for their risk management, including their negotiation, and later, assuming a country does choose to become a signatory, implementation and on-going management. Second, states should not confuse this risk management task with compliance and acquiescing to donor aid objectives.
The EU, for example, has been active in Southeast Asia helping countries establish patent offices. However, the grant of patents by these offices overwhelmingly benefits EU companies in sectors such as pharmaceuticals. It may be prudent to develop a node of excellence first in regard to the negotiation of PTAs, however, and this relates to point five, if such expertise can be appropriately shared perhaps regionally, a different regulatory target may be more appropriate.
A fourth and related point is that creating these nodes of excellence might be easier and indeed more justifiable by learning from the regulatory experience of other countries and encouraging the dissemination of best practice. But it is also the case that developing countries such as Brazil, China and India have begun to realize the problems of trade agreements containing IP chapters and have started to address these through regulation.
For example, Brazil has devised an approach in which the National Sanitary Surveillance Agency ANVISA is involved in the examination and grant of pharmaceutical patents rather than having all regulatory power over the grant of pharmaceutical patents centred in the Brazilian patent office [ 39 ]. This model of more disperse regulatory power grants some influence to a public health perspective rather than simply paying it lip service.
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It also provides a safeguard against regulatory capture when a regulatory agency tasked with acting in the public interest instead advances the commercial or special concerns of interest groups that dominate the industry of sector it is charged with regulating of a patent office. Fifth, developing countries specifically should be looking to intensify collaboration and networking amongst themselves.
Hoekman et al. US models of private enforcement of public regulation depend on an entrepreneurial adversarial legal culture that is not found in most developing countries. South-South regulatory learning and diffusion — and indeed, coordinated action — is just as important as North-South learning in this context. Entering into PTAs should be approached cautiously, and with the capacity to negotiate effectively. However for those states that do decide to proceed, it is important to have the capacity to manage the risks they pose to public health through regulation.
Thus, the negotiation, implementation and on-going management of PTAs all require considerable administrative regulatory capacity — a significant administrative burden on governments. States must recognize the importance of this risk-management task; distinguish it from regulatory compliance; and focus on regulatory learning and building nodes of excellence in regulation.
Developing countries especially will benefit from networking to overcome capacity deficits and look to South-South collaborations in the process of regulatory learning. The authors would like to thank the anonymous reviewers for thier helpful suggestions. Competing interests. The first author drafted the manuscript. All authors contributed to revisions of the manuscript and critical content. All authors read and approved the final manuscript. Helen L Walls, Email: ku. Richard D Smith, Email: ku.
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Peter Drahos, Email: ua. National Center for Biotechnology Information , U. Journal List Global Health v. Global Health. Published online Mar Author information Article notes Copyright and License information Disclaimer. Corresponding author. Received Dec 1; Accepted Mar 5. This article has been cited by other articles in PMC. Abstract Modern trade negotiations have delivered a plethora of bilateral and regional preferential trade agreements PTAs , which involve considerable risk to public health, thus placing demands on governments to strengthen administrative regulatory capacities in regard to the negotiation, implementation and on-going management of PTAs.
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Keywords: Trade policy, Trade agreements, Regulatory capacity, Health inequities. Main text Trade agreements can lead to substantial benefits, including economic growth, lower cost and wider access to goods through trade barrier reductions, and reduced risk of military conflict between countries where their economies are more entwined [ 1 ]. Implementation and on-going management of PTAs Not only do countries need the administrative regulatory capacity to effectively negotiate PTAs, if they do decide to become signatories, they also need to increase their capacities in regard to PTA implementation and on-going management.
States need to find ways to increase administrative regulatory capacity If states do not find ways to increase their administrative regulatory capacities in regard to the negotiation, implementation and on-going management of PTAs, these PTAs will potentially drive greater health inequities [ 10 , 34 ]. Conclusion Entering into PTAs should be approached cautiously, and with the capacity to negotiate effectively.
Footnotes Competing interests The authors declare that they have no competing interests. References 1. Douglas A. Free Trade Under Fire.
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Pharmaceutical industry behaviour and the Trans Pacific Partnership Agreement. The Trans Pacific Partnership Agreement: Exacerbation of inequality for patients with serious mental illness. Aust N Z J Psychiatry. Health Policy. Bhardwaj K, Oh C. You have clicked on a link to a page that is not part of the beta version of the new worldbank. Will you take two minutes to complete a brief survey that will help us to improve our website? Thank you for agreeing to provide feedback on the new version of worldbank. Thank you for participating in this survey! Your feedback is very helpful to us as we work to improve the site functionality on worldbank.
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