Free-trade provisions will damage access to medicines
Impact studies warn that TRIPS-Plus provisions can lead to higher prices and reduced access to medicines, say Nusaraporn Kessomboon and colleagues.
The non-technical term TRIPS‐Plus refers to provisions for the protection of intellectual property rights that go beyond the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).
They include extending the life of a patent beyond the minimum requirement imposed by TRIPS; limiting government permission to reproduce a patented product or to reprocess without the patent owner's consent ('compulsory licensing') in ways not required by TRIPS; and limiting exceptions that facilitate the prompt introduction of generic drugs into the market. 
Impact studies based on the Free Trade Agreements (FTAs) between Thailand and the United States, and between the European Union and Andean nations, have shown how TRIPS-Plus provisions can affect access to medicines — and have identified concerns that other developing countries should be aware of before FTA negotiations are completed.
Bilateral FTAs that have already been signed, are currently being negotiated or on hold — including the Thai–US, EU–Andean, EU–ASEAN (Association of Southeast Asian Nations) and EU–Indian FTAs — may require TRIPS-Plus provisions.
Provisions common to these proposed agreements include extension of the patent term; supplementary protection certificates that offer an extension of a patent; and data exclusivity, which allows drug manufacturers to protect the technical data that prove the efficacy and safety of their products.
For example, Article 4 of the Thai–US FTA obliges Thailand's drug regulatory authority to notify the patent holder and inform the patentee when there is any attempt to register a generic drug. And Article 7 allows manufacturers to extend the patent term of a drug to offset unreasonable delays in either granting the patent or approving it for marketing.
Article 17.3 of the proposed EU–Indian FTA makes provisions for supplementary protection certificates, and Article 18 protects data submitted to obtain a marketing authorisation for pharmaceutical products (data exclusivity).
The text of the EU–ASEAN proposed FTA also includes provisions for supplementary protection certificates (Article 9.3) and data exclusivity (Article 10).
But what do these proposals mean for people in developing countries negotiating FTAs?
Impact studies of the Thai–US FTA  and the EU–Andean FTA  estimated that the intellectual property proposals pose serious threats to drug expenditure and access to medicines.
Both studies were based on the 'Guide to Estimating the Impact on Access to Medicines due to Changes in Intellectual Property Rights', a working draft produced jointly by the WHO and the Pan American Health Organization.
The study of the Thai–US FTA assessed the collective impact of provisions included in the proposed agreement on access to medicines in Thailand, based on the text of the sixth round of Thai–US FTA negotiations on intellectual property rights.
These provisions included a 10-year patent extension as compensation for delays in regulatory approval or granting of a patent, and a 10-year delay in generic versions entering the market due to data exclusivity.
The modelling studies show that by 2027 the TRIPS-Plus provisions would raise the price of all medicines by 67%. National pharmaceutical expenditures would increase by more than US$23 billion, and Thailand's pharmaceutical industry could lose US$9 billion.
The Andean impact study predicted that the introduction of two measures in Peru — data exclusivity and supplementary protection certificates — would increase the number of active pharmaceutical ingredients protected by 11%, which in turn would decrease consumption and raise prices by 26%.
The provisions would also lead to an increase of US$459 million in Peru's total pharmaceutical expenditure by 2025, assuming current consumption levels.
It is difficult to exaggerate the potential health impacts associated with access to medicines in countries that implement TRIPS-Plus provisions in FTAs. Some countries that put them in place after complying with US FTAs have already reported worrying consequences.
For example, according to Oxfam , the price of medicine in Jordan has increased by up to 800% since the FTA was implemented in 2001. More than 25% of the Ministry of Health's budget is now spent on medicines. And the provision on data exclusivity has delayed the introduction of cheaper generics for 79% of medicines, even though there are no patents on them.
Impact studies that forecast similar trends can help policymakers in developing countries balance the benefits of trade with the negative effects on access to medicines and public health.
Negotiations for the Thai–US FTA are currently on hold, and the EU–Indian FTA talks are ongoing. Policymakers in both Thailand and India should seize this opportunity to argue against damaging provisions.
For example, after intense negotiations for the EU–Andean agreement, the EU has agreed to substantially lower its demands on data exclusivity and supplementary protection certificates.
Advisory groups that include academics, nongovernmental organisations and experts in intellectual property and public health must develop negotiation strategies that maximise the flexibility offered by TRIPS, create awareness of the impacts of TRIPS-Plus provisions in developing countries, and mitigate their impact.
Nusaraporn Kessomboon is assistant professor at the Faculty of Pharmaceutical Sciences, Khon Kaen University, Thailand. Jiraporn Limpananont is associate professor at the Faculty of Pharmaceutical Sciences, Chulalongkorn University,Thailand. Kannikar Kijtiwatchakul is coordinator of the health consumer protection programme at Chulalongkom University, Thailand.
 World Health Organization. WHO Policy Perspectives on Medicines – Globalization, TRIPS and access to pharmaceuticals. No. 3, March 2001. www.who.int/entity/hiv/amds/regulations1.pdf(accessed 02/05/2011).
 Kessomboon, N., Limpananont, J., Kulsomboon, V., Maleewong, U., Eksaengsri, A. & Paothong, P. Impact on Access to Medicines from TRIPS-PLUS: A Case Study of Thai-US FTA. Southeast Asian J. Trop. Med. Publ. Health 41, 667–677 (2010).
 IFARMA. Impact of the EU-Andean Trade Agreements on Access to Medicines in Peru. http://www.haiweb.org/11112009/11Nov2009ReportIFARMAImpactStudyPeru(EN).pdf [484kB] (accessed 30/04/2011).
 Oxfam. All Cost No Benefit : How TRIPS-plus intellectual property rules in the US-Jordan FTA affect access to medicines. Oxfam Briefing Paper, March 2007.