By Daniele Dionisio

 

The ominous prospects on health bound up with TPP negotiations are alarming at a time when trade agreements and governments’ choices, largely by the US and the European Union, are turning IP agendas into policies which protect monopolistic interests  at the expense of unbiased access to care and  lifesaving treatments in resource-limited settings.

 

The Trans-Pacific Partnership, or TPP, talks began in March 2010, promoted by the United States (US) to deepening free trade in the Pacific realm. Shrouded in unprecedented level of secrecy, the talks aim to address global trade issues including piracy and counterfeiting, while raising standards by taking into account the implications for the multilateral trade system and the different economic levels and needs of participating countries. These currently include Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, US and Vietnam.

A plan for medicines, known as Trade Enhancing Access to Medicines, or TEAM, was introduced by US negotiators at the eighth round of TPP talks in Chicago on September 9-15, 2011. While the US administration did not disclose the plan’s contents, a US white paper released on September 12 outlined its aims to accelerate access to medicines, get rid of tariffs on medicines and medical devices, and step up legal certainty for manufacturers of generic medicines. The paper also urged TPP parties to reaffirm their commitment to the Doha Declaration on the TRIPS Agreement and Public Health.

The TEAM plan incurred, however, harsh opposition by many public interest groups and non-governmental organizations, also in the light of a leaked draft which led Médecins Sans Frontières to allege that the TPP chapter on intellectual property (IP) would encompass TRIPS-plus measures including:

• Making it easier to patent new forms of old medicines that offer no added therapeutic

efficacy for patients (“evergreening”).

• Restricting “pre-grant opposition,” which allows a patent to be challenged before it is

being granted.

• Enforcing intellectual property beyond what TRIPS requires, allowing customs officials

to impound shipments of drugs on mere suspicion of IP infringement, including “in

transit” products that are legal in origin and destination countries.

• Expanding data exclusivity beyond World Trade Organization (WTO)’s request for data protection against unfair commercial use only.

• Extending patent lengths beyond 20-year TRIPS requirements.

• Preventing drug regulatory authorities from approving new drugs if they may infringe

existing patents.

 

And India raised concerns that the TEAM approach would delay access to affordable generic medicines.

Regrettably,  while on 12 November 2011 TPP negotiators agreed to reinforce and develop existing WTO’s TRIPS rights and obligations, no shared solutions to the issues above were achieved over  the subsequent years of strictly “closed doors” negotiations, in the face of growing controversy in many TPP nations about demanded trade-offs relevant to  medicine prices and the overall health impact of  IP chapter terms.

Relevantly, US Congress members have been severely limited in their access to treaty-related documents, while as reported“…Content industries and pharmaceutical industries sit on the IP advisory committee…..smaller innovators, generics companies, and public interest groups do not…”

As such, it is good news that the whole draft of IP chapter  from the 26-30 August 2013 round of TPP negotiations in Brunei  was leaked and made available by Wikileaks on 13 November 2013.

While showing  that at least the August draft was hugely prone to big industry interests, the leak has confirmed that all concerns above were definitely to the point. As such, enforcement , which makes up the widest  section of IP chapter, not only re-presents but even exacerbates, mainly per US requests (including much blamed penalties relevant to third party accountability), the provisions from the shelved ACTA treaty.

As an effect of  mounting resonance bound up with the leaked draft, some lip-service has been flaunted as a corrective to the “riding roughshod” bullying policy over TPP negotiators the US still pursued throughout the 19-24 November 2013  TPP round in Salt Lake City.

Relevantly, an 27 November 2013 statement by the US Trade Representative  gave little openings limited to data protection length of biologic medicines and patent pre-grant opposition procedures.

However, as reported, “…Required patents for new uses, required granting of patents on medicines even in the absence of improved therapeutic effects, data/regulatory monopolies on clinical trial data (data exclusivity), mandatory patents on virtually all medical, surgical, and diagnostic procedures, enhanced damages for patent infringement, mandatory injunctions, and stronger border measures will all be mandatory the minute the TPP is signed. Even more ominously, IP will remain in the investment chapter, meaning that drug companies will immediately be able to sue TPP members if the companies’ expectations of IP-based profits are thwarted by fully lawful legislative, regulatory, or judicial decisions…”

Inherently, the  impending threat of an investor state system enforcement as regards access to medicines cannot be underestimated . In this regard, many forms of government regulations, including price cuts of medicines, could be argued not to conflict with the TRIPS agreement, yet to make pointless or erode the expectations of the patent owners.

Relevant risk sectors also include tariffs on medicines, as would be the case should a country that has agreed to reduce tariffs on an imported product later subsidize home manufacturing of the same medicine. A complaint against this country under an investor state system would be allowed to re-establish the conditions of competition in the original transaction.

Additionally, the sectors relevant to packaging and labelling requirements, and to IP protection enforcement measures, may also result as risk target areas, since they might affect the patent holders’ access to the market of medicines.

Under these circumstances, should an investor-state system be enforced in TPP, it would make it easier for a claim to be lodged against a member for nullifying or eroding benefits by applying IP protection rules or packaging and labelling models that, despite full alignment with TRIPS requirements, are deemed to be insufficiently stringent or fraudulent.

These prospects appear ominously alarming at a time when trade agreements and governments’ choices, largely by the US and the European Union, are turning IP agendas into policies which protect monopolistic interests  at the expense of unbiased access to care and  lifesaving treatments in resource-limited settings. So, it was not by chance that on 27 November 2013, after inclusion in the just-concluded Canada-EU Trade Agreement , European Union Trade Commissioner  defended the inclusion of an investor-state dispute settlement provision also in the Transatlantic Trade and Investment Partnership (TTIP).

Not to mention fear that terms including an “investor-state mechanism”   could be approved inside an  EU-India deal on track to conclusion.  This would mean a threat to India as a provider of lifeline medicines to the poor’s world.

The concern is even greater now that a 12 June 2013 EU custom regulation has incurred criticism of allowing illicit seizing of in-transit goods (including legal generic medicines) “over a simple suspicion of IP infringement without checking beforehand whether these goods are headed to the European territory or just in transit” and without “clear and convincing evidence of a substantial risk of diversion”. These terms would hamper TRIPS flexibility grants and run against EU commitments regarding access to treatments without restrictions.

On these grounds, what are the expectations now that trade ministers are gathering from  7 to 10 December at  an TPP meeting in Singapore that the US eagerly wishes to be the “end game” of negotiations?  Claims that a “deal” could finally be announced are hardly credible with the load of unresolved issues still on the table. And, unless there is an infusion of standing power by TPP participating countries against US pressure,  the US will certainly force through its position to consolidate monopoly control by large companies hence undermining access to  health and lifesaving medicines for millions of people in resource-constrained settings.

 

 

 

Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is reference advisor for “Medicines for the Developing Countries” for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). Starting February 2012, Dionisio is Head of the research project Geopolitics, Public Health and Access to Medicines (GESPAM). He may be reached at d.dionisio(at)tiscali.it

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