Trans-Pacific Partnership (TPP) Countries: Comparative Trade and Economic Analysis

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The TPP biologics provisions, if interpreted as guaranteeing 8 years of market exclusivity, would also be likely to create additional costs for the national pharmaceutical coverage programmes of both Australia and New Zealand, possibly amounting to hundreds of millions of dollars per annum see Gleeson et al. While the costs for the national drug programmes of these countries can be relatively easily estimated, the cost to society as a whole is likely to be much higher for the developing country parties.

Based on the available evidence, the TRIPS-Plus provisions in the TPP IP chapter, newly implemented mainly by developing countries, would delay the market entry of generics and biosimilars and increase costs for individuals and governments. While developed countries may arguably be able to absorb most of these additional costs, the impact would be felt most in the countries which are already least able to provide affordable access to medicines for their populations.

There is no way of knowing whether the putative economic benefits of TPP participation would in fact outweigh the increased costs to the health care system and to individuals, and it seems unlikely that any economic benefits that countries do accrue would be used to offset increased costs for medicines. Econometric studies have predicted small aggregate economic benefits for most TPP countries. The models on which these projections are based assume full employment and invariant income distribution.

A study by Capaldo and Izurieta using a different model, which allowed for changes in employment and income distribution, found smaller benefits for most countries and negative income growth for the United States and Japan. A review of seven studies estimating the economic impact of the TPP Ciuriak, concluded that those studies which were based more closely on the final TPP text make smaller estimates of impact.

Ravenhill points out that the models for these studies do not account for the costs associated with IP protection, which could well outweigh the estimated economic benefits, at least for some countries. Furthermore, implementing the obligations of the TPP would involve significant administrative costs and strain the scarce resources and capacity of governments. As Walls et al. Administering complex arrangements such as patent term extensions absorbs time and money that would be better spent providing health services, particularly in countries with health budgets that are already under pressure.

If the TPP pharmaceutical IP provisions are adopted in a revived TPP or any subsequent agreement, the greatest costs are likely to be borne by developing countries that accede in the future. To a certain extent, the existing participating countries were able to soften the effects of the TPP IP provisions by proposing language that accommodated their existing policy settings and by at least in the early stages presenting a united front against the US proposals. Developing countries seeking later accession would have neither of these opportunities and may also have more difficulty negotiating transition periods in the context of bilateral negotiations which would not attract the same level of public attention as the original TPP negotiations did.

In addition, if faced with challenges over rules in the TPP, developing countries may not have the human resources to effectively defend their positions. Why did the developing countries accept such a poor deal in the TPP? The ultimate acquiescence of the developing countries to the pharmaceutical industry agenda in the TPP can be seen as the continuation of a historical trajectory that began well before TRIPS and has continued since Jawara and Kwa, The answer to this question also lies partly in the wider context for the initiation of the TPP negotiations: Such imbalances in negotiating power are even more pronounced in bilateral and regional trade agreements where developing countries often have to make large concessions to obtain access to developed country markets Ravenhill, Splintering of the earlier unanimous opposition to the US IP proposals can be traced through successive drafts of the IP chapter and appeared to accelerate towards the end of the negotiations.

The transition periods for developing countries, for example, seem to have been negotiated bilaterally Public Citizen, The conditions for democratic bargaining as described by Drahos all relevant interests are represented, all parties have full information about the consequences of decisions and no one party is dominant were eroded in the context of aggressive negotiating strategies. There is no evidence that stronger IP rights in developing countries incentivize pharmaceutical companies to invest in developing treatments for diseases that are endemic in these countries: These provisions could be expected to delay access to affordable generic and biosimilar medicines for their populations, as well as create a significant impact on scarce infrastructure and resources that could be better invested in more productive activity.

In contrast, the developed countries albeit with a few exceptions, most notably New Zealand have largely managed to negotiate provisions that accommodate their existing policy settings. These differential impacts on regulatory regimes will exacerbate existing inequities in health and access to medicines. Developing countries would be well advised to carefully weigh the consequences of accepting these outcomes, particularly given the dubious economic benefits offered by the TPP World Bank Group, To date, there has been no officially commissioned or recognized health impact assessment of the TPP undertaken; such an assessment would provide better evidence on which to make decisions about the way forward.

If the TPP IP chapter is adopted in its current form, it will be important for developing countries to plan carefully for implementation to ensure that they mitigate the effects as much as possible. This effort will need to include attention to the distribution of economic benefits across the population and across sectors. This approach needs a re-think, given the dismal outcomes for developing countries in the TPP — outcomes which could affect a much wider array of countries, including those which accede later and those participating in subsequent trade agreements which take the TPP as a model or template.

She has published over 20 peer-reviewed articles and book chapters examining the impact of international trade agreements on health systems, public health policy and access to medicines. In addition, he has worked in the emergency department at the University Health Network also in Toronto for 29 years.

His book Private Profits vs Public Policy: From Ruth was chief medical officer in the Australian Therapeutic Goods Administration, and in preceding roles directed the pharmaceutical policy unit in the Australian Department of Health and served as a clinical and policy advisor to the national formulary committee. She was awarded a Harkness Fellowship in Health Policy in A literature-based submission is one which relies solely, or predominantly, on bibliographic data i.

The exclusivity period for biologics in the United States comprises 4 years of data exclusivity plus 8 additional years of market exclusivity, as specified in the Biologics Price Competition and Innovation Act of BPCIA. See Budget Paper No.

Declaration of conflicting interests: The authors have no other conflicts of interest to declare. Joel Lexchin, York University, Canada. National Center for Biotechnology Information , U. Published online Oct Author information Copyright and License information Disclaimer. This article has been cited by other articles in PMC. Abstract The final text of the Trans Pacific Partnership Agreement TPP , agreed between the 12 negotiating countries in , included a suite of intellectual property provisions intended to expand and extend pharmaceutical company exclusivities on medicines.

Access to medicines, developing countries, intellectual property, pharmaceuticals, Trans Pacific Partnership Agreement.

Trans-Pacific Partnership (TPP) Countries: Comparative Trade and Economic Analysis

As the negotiations wound up in October , MSF concluded that Although the text has improved over the initial demands, the TPP will still go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies. For each of these provisions, we examined the following: Which of the TPP parties may need to implement legislative changes if the TPP were to come into force in the form agreed among the 12 participating nations in ;.

Whether a transition period would apply for particular countries, and if so, the length of the transition period;. The likely effect of the provision on access to affordable medicines, based on a review of existing evidence in the literature regarding IP stringency. TPP IP provisions with implications for access to medicines Despite resistance by the majority of TPP countries to the US pharmaceutical industry agenda throughout the negotiations, many provisions remained in the final text of the IP chapter Trans Pacific Partnership, which extend or expand exclusivities on medicines and can be expected to affect affordable access, including the following: Patent term extensions, to compensate for delays in granting patents Article Exclusivity on undisclosed test data small-molecule drugs — at least 5 years for new pharmaceutical products plus either 3 years for new indications, formulations or methods of administration or 5 years for combination products containing a chemical entity that has not previously been approved Article Exclusivity on undisclosed test data biologics , provided through one of the two options: Patent linkage provisions, that is, preventing regulatory agencies from granting marketing approval for generic drugs when patent holders claim potential patent infringement Article Open in a separate window.

Andean Community Decision No. Along with the requirement to provide secondary patenting is a footnote which establishes a lower threshold for inventiveness than is currently generally accepted: TPP Chapter 18, Footnote 30 Secondary patenting is widely acknowledged to have a significant effect on the length of pharmaceutical monopolies and on the entry of generic medicines to the market Gleeson et al. Exclusivity of undisclosed test data biologics TPP Article Patent linkage Article Conclusion There is no evidence that stronger IP rights in developing countries incentivize pharmaceutical companies to invest in developing treatments for diseases that are endemic in these countries: Footnotes Declaration of conflicting interests: The cost of trade-based intellectual property.

Journal of Generic Medicines 9: Amin T, Kesselheim AS. A case study of how patents on two HIV drugs could be extended for decades. PLoS Medicine 13 3: Baldwin R, Thornton P. Centre for Economic Policy Research. Business Wire , 4 October Available at: VhKIh8tViko accessed 2 August Northwestern Journal of Technology and Intellectual Property 8: Capaldo J, Izurieta A. Unemployment, inequality and other risks of the Trans-Pacific Partnership Agreement.

Understanding the Alternative Estimates. Ciuriak Consulting Inc; Available at: Journal of World Intellectual Property 5: Liverpool Law Review Gleeson D, Lopert R. The Conversation , 6 August Available at: Potential Consequences for Australia. The Medical Journal of Australia Hern A, Rushe D.

Trans-Pacific Partnership (TPP) :: Studies and Research Archives

The Guardian , 14 November Available at: Jawara F, Kwa A. Heavy-handed tactics in TPPA talks aim to isolate dissenters. Kilic B, Maybarduk P. Comparative analysis of the U. Kyle M, McGahan A. The Review of Economics and Statistics Is it everything we feared for health?

Studies and Research

International Journal of Health Policy and Management 5: Impact of the trade agreement between Europe and Canada on the costs of prescription drugs. Epub ahead of print 6 May Lexchin JR, Gleeson D. International Journal of Health Services Lopert R, Gleeson D. Luo J, Kesselheim AS. Stuff , 21 May Available at: Oxfam International All costs, no benefits: Currents International Trade Law Journal Frontiers of Economics and Globalisation. Public Citizen TPP transition periods: Bad rules coming soon in a TPP country near you. Review of International Political Economy New Political Economy 22 5: A health impact assessment of the Trans-Pacific Partnership.

Critical Public Health Health Law Journal 9: Asia Pacific Journal of Public Health 28 8: Trans Pacific Partnership Intellectual property rights chapter draft, 10 February. United Nations World economic situation and prospects US Government Fiscal year budget of the U.

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