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August 20th, 2015:

The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines

Jing Luo, MD1; Aaron S. Kesselheim, MD, JD, MPH1

1Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
JAMA. Published online August 20, 2015. doi:10.1001/jama.2015.10872

After a difficult legislative battle, President Obama signed into law Trade Promotion Authority on June 29, 2015. The legislation allows for an up-or-down vote with no amendments in Congress for international trade agreements such as the Trans-Pacific Partnership (TPP) Agreement. The TPP Agreement includes 12 Asia-Pacific countries (United States, Canada, Mexico, Peru, Chile, Japan, Vietnam, Malaysia, Singapore, Brunei, Australia, and New Zealand) with a collective trading power amounting to 40% of the global gross domestic product. The TPP Agreement is still being negotiated; recently, in a meeting of trade ministers in Maui, Hawaii, negotiators failed to finalize the text of the Agreement due in large part to disagreement regarding intellectual property protections for pharmaceutical products.1

Intellectual property rights, including patents, are central to the business model of brand-name pharmaceutical manufacturers. Manufacturers can charge high prices during patent-protected periods without fear of competition, earning profits that are intended to provide incentives for investment in drug innovation. However, low-income patients frequently lack access to expensive drugs, and excessive spending on pharmaceuticals can strain government budgets, leading to reductions in other health services. In addition to addressing barriers to trade, the TPP will affect the pharmaceutical market in member countries due to its intellectual property provisions.
It is critical to ensure that patents protect only innovative pharmaceutical products and for governments to balance grants of market exclusivity with other competing interests, such as the widespread availability and affordability of certain drugs. In the United States, for example, patents are supposed to be issued only to novel products that are an innovative step beyond what already exists, and patents along with a variety of regulatory and other exclusivities permit conventional drugs to receive an average time of about 13 years of market exclusivity before competing generic versions are approved.2

The 1994 Trade Related Aspects of Intellectual Property (TRIPS) Agreement, which countries must agree to as a criterion for membership into the World Trade Organization, standardized basic intellectual property protections for pharmaceutical products around the world. Before TRIPS many lower-income countries had chosen not to grant patents for pharmaceutical products, emphasizing low-cost access over contributing to incentivizing innovation; however, the TRIPS Agreement required all signatory countries to change their policies and grant pharmaceutical patents.

In the years since, countries have implemented this requirement in different ways. Indian law, for example, required new forms of existing drugs to show significant improvements in efficacy before they can be granted a patent. This controversial provision was recently upheld in an Indian Supreme Court decision related to a new formulation of imatinib (Gleevec), a tyrosine-kinase inhibitor used to treat chronic myelogenous leukemia.3 In that decision, the Indian Supreme Court stated that the beta crystalline form of imatinib was not patentable in part because it was too similar to an older formulation discovered prior to India’s enforcement of patents for pharmaceutical products under TRIPS.

The TPP may end such flexible approaches to granting patents and add a number of new requirements related to intellectual property in addition to the TRIPS measures. Even though the exact details of the TPP are not known, negotiating drafts have been leaked, with the most recent intellectual property chapter dating from May 11, 2015.4 This chapter includes 8 sections covering a wide range of topics including patents, trademarks, copyright, industrial designs, and geographical indications.

In the case of pharmaceuticals, the text of the draft seeks to bring international intellectual property law into closer alignment with current US standards regarding the scope of what may be patented. For example, US negotiators favor allowing patents to cover inventions in all fields of technology (including inventions derived from plants and microorganisms), despite legal systems in other countries that include a more limited scope of patentable subject matter.

The TPP also could allow new uses of a known product to be granted additional monopoly protection. This may reduce TPP countries’ abilities to create patent laws that seek, as India’s does, to ensure that only truly innovative and clinically important pharmaceutical products are patentable. Seeking patents for the new methods of using existing drugs is a common tactic that pharmaceutical manufacturers in the United States use to delay the generic competition. For example, Eli Lilly sued Canada for $500 million dollars over its decision to invalidate 2 pharmaceutical use patents: the use of olanzapine (Zyprexa) in schizophrenia and atomoxetine (Strattera) in attention-deficit/hyperactivity disorder.5 Both drugs were previously patented in Canada for other uses, and a generic manufacturer (Novopharm) successfully challenged the validity of these patents by showing that there was insufficient evidence to support the claims at the time of filing. In the case of olanzapine, Lilly attempted to secure additional monopoly protection by restating the claims from an earlier patent while simultaneously failing to demonstrate substantial advantage over other antipsychotics for this new use, which is the current standard required under Canadian law. Under the TPP, a multinational pharmaceutical company could use the investor-state dispute settlement mechanism to challenge domestic laws like the one in Canada, which are intended to promote timely availability of generic drugs.6

The TPP also contains provisions that could make it more difficult to successfully challenge patents after they have been issued by shifting the burden of proof onto the challengers. This would ensure that potential generic market entrants must expend substantial resources to clear the numerous interrelated patents that innovator companies obtain on their products, increasing the cost and time of generic entry. The TPP draft could also impose substantial civil and criminal penalties on potential generic manufacturers found to have infringed patents, increasing the business risk for these companies. Moreover, language requiring the seizure and destruction of in-transit goods for “confusingly similar” products may expand the geographic scope of the TPP to affect countries not part of the direct agreement, such as India or Brazil, which may find it more complicated to ship generic medicines that are legal under their patent regimes through TPP member states.

In addition to forcing TPP member states to adopt patent laws that closely align with that of the United States, the TPP could also require member states to adopt the US Food and Drug Administration’s approach to preventing generic manufacturers from reaching the market for a minimum of 5 to 7 years after the approval of a new small-molecule drug, 3 years for new indications, and 12 years after approval of a new biologic drug.7 Nine TPP countries provide no guaranteed exclusivity periods for safety and efficacy data associated with biologic drugs because the complex manufacturing processes required to create these medicines naturally makes for fewer follow-on biologic competitors and fewer cost reductions arising from that competition. Notably, in the United States, the Federal Trade Commission similarly recommended no guaranteed exclusivity periods for biologics, and the Obama administration has repeatedly proposed to reduce the period of biologic exclusivity from 12 to 7 years for these same reasons. The TPP may reduce the flexibility of US policymakers to change the period of guaranteed biologic data exclusivity in the future, maintaining high biologic drug prices.

Thus, in its current form, the TPP could lower the bar for the patenting of pharmaceutical innovations and make it substantially more difficult for generic manufacturers to enter the market in TPP member countries. In addition, legal generic products could become seized during international transit. The overall effect of the TPP could be to extend the effective patent life of drugs and to decrease the availability of generic drugs or biosimilar medicines available to patients around the world.

Some economists have suggested that the intellectual property chapter of the TPP should be abandoned, because it could result in higher drug prices for patients.8 By contrast, industry representatives suggest that strong intellectual property protections are necessary for costly research and development, although this assertion has been disputed.9

It is likely that a balance between these competing objectives has not been struck by the TPP agreement in its most current form. The recent breakdown in negotiations suggest that some countries are taking a hard-liner on pharmaceutical-related provisions, so there remains hope that an agreement could be negotiated. If the United States continues down the path exposed in the leaked draft and expects other TPP countries to accept new standards for pharmaceutical intellectual property protections, it should also allow concessions that would encourage low-cost and high-quality generic drugs competition once market exclusivity ends. For example, data exclusivity for medicines should not be redundant or geographically transportable, meaning that if a 5-year exclusivity period has already expired in the United States, no additional exclusivity would be granted by regulatory authorities in other TPP member countries. In addition, meaningful technology transfer could be incorporated to promote local pharmaceutical manufacturing capacity. An innovative financing instrument, such as a nominal levy on top of existing tariffs for nonpharmaceutical trade (eg, goods and services), could also be created to help less-wealthy, signatory countries procure medicines that will inevitably be made more expensive by the agreement.

Cancer Council fights big tobacco on school survey data

Bridget Brennan

ELEANOR HALL: Health advocates say the tobacco industry is plumbing new depths with a devious move that could put children at risk.

British American Tobacco is using Freedom of Information laws to get its hands on data about children’s attitudes to smoking.

The corporation is denying it will use the information to market cigarettes to teenagers.

Authorities in New South Wales have already handed over their data.

But in Victoria, the Cancer Council is furiously trying to block the request.

As Bridget Brennan reports.

BRIDGET BRENNAN: British American Tobacco wants the results of surveys asking children what they think about cigarettes and smoking.

That’s handy information for big tobacco, which is fighting plans by countries including Norway and France to follow Australia’s lead and introduce plain packaging.

University of Sydney public health professor Simon Chapman says it’s a desperate grab.

SIMON CHAPMAN: This is a fight to the death.

The tobacco industry is desperate to get its hand on this sort of information for two reasons: it’s wanting to do all it can to try and discredit plain packaging, which is cascading all around the world now.

Some 10 to 12 nations have either decided they’re going to do it or have announced that they’re most likely going to do it. And so they’re just trying to get hold of anything that they can sift through to try and spin that it’s not working.

BRIDGET BRENNAN: In Victoria, the Cancer Council won’t give up the children’s survey data without a fight.

It’s trying to block the freedom of information application in the state’s civil and administrative tribunal.

The Cancer Council’s director is Todd Harper.

TODD HARPER: What the surveys include is information on age, gender, indigenous status, type of school, postcode, et cetera. So it’s information that in aggregate, could potentially identify people, which is why we want to make sure that it’s protected.

I’m also very cognisant of the fact that I can’t imagine any Australian parent would give permission for the tobacco industry to interview their children about those issues. And so if that’s the case, I really can’t see any reason why we would go against those wishes and hand over such sensitive data to the tobacco industry.

BRIDGET BRENNAN: But in New South Wales, that sensitive data has already been handed to British American Tobacco.

The Cancer Institute New South Wales says it was compelled to provide the survey data under New South Wales law.

University of Tasmania Associate Professor Rick Snell, a freedom of information expert, says that could set a precedent for the Victorian case.

RICK SNELL: They could make the application. Whether the application would be successful or not is a whole different matter. So the fact that that’s being release in New South Wales increases the likelihood of some or all of that information being released.

BRIDGET BRENNAN: British American Tobacco declined The World Today’s request for an interview.

In a statement, a spokeswoman says the company is trying to engage in a debate about plain packaging.

BRITISH AMERICAN TOBACCO STATEMENT (voiceover): This isn’t about children, this is about plain packaging.

It is illegal to sell tobacco to children and tobacco advertising has been banned for decades. Children are not, and will never be, our audience and we have always made this clear.

BRIDGET BRENNAN: But, plain packaging advocate Professor Simon Chapman says tobacco companies see children as imperative to their survival.

SIMON CHAPMAN: When you go to work every day in a tobacco company, you know, you’re taking, you know, your salary and your key performance indicators are that you want to sell more tobacco.

And if the tobacco industry does not sell more tobacco to young people, that industry will starve itself of new customers. I mean, that’s very obvious and that’s why they’re doing this.

ELEANOR HALL: That’s University of Sydney professor of public health Simon Chapman ending that report from Bridget Brennan.

Irish Cancer Society not Convinced with PHE Findings, calls for more research on electronic cigarettes

While health experts in Britain are already sold on electronic cigarettes as a way for people to give up smoking, the Irish Cancer Society is not quite convinced. Although new research recently released by Public Health England made the claim that electronic cigarettes are 20 times less dangerous than tobacco and could spell the end for smoking, the cancer society calls for more research on the long term effects of electronic cigarettes before it can fully endorse the product. They have stated that the move to suggest electronic cigarettes as a new way to quit is rather fast and they will review the subject as more evidence is presented. Until then, the society recommends traditional methods to people who want to quit smoking such as nicotine patches and chewing gums.

Even if the study released by PHE is welcome news in Britain, it is not enjoying similar status in other places as they are banned in Hong Kong, Brazil, the United Arab Emirates, and Panama. They are also currently banned in work places, trains, hospitals, some shopping centers, and in Dublin Bus in Ireland. Vape Business Ireland, a business alliance encouraging debate on electronic cigarettes in Ireland, is hoping that the Irish Department of Health will enact a new legislation next year after considering the findings from PHE.

If you’re not already terrified about the potential human cost of TTIP, these examples will do it

Ruby Stockham

In one of the most famous cases of TTIP-like nightmares, tobacco ‘giant’ Philip Morris sued Uruguay for its anti-smoking campaign

Unfortunately, the Transatlantic Trade and Investment Partnership (TTIP) is not very interesting. Part of the reason that the super secretive trade deal has been able to dodge scrutiny so nimbly is that the nuance of the legislation hardly makes for great headlines. Crucially, TTIP doesn’t have a face.

But it will do. If the deal goes through, there will be no shortage of human stories about the harm it has caused.

Take, for example, the farmers who will see their income fall by 0.5 per cent (the EU’s own estimate) if the partnership is implemented. TTIP’s deregulatory approach will lower EU food and environmental safety standards to bring them in line with those of the US. This will lead to an increase in factory farming that will harm both the environment and the livelihoods of farmers in the UK and across Europe.

And what about the animals themselves? The US has far fewer regulations on farm animal welfare than the EU does. It uses, for example, barren battery cages for hens, too small for a single animal to spread its wings in and yet employed to house three or four. You don’t have to be an animal lover to see that a deal which brings Europe down to this level is absolutely regressive.

For farmers, this is that ‘race to the bottom’ so beloved of the Conservatives – they’ll have to choose between lowering their standards of welfare, and trying to stay upright in a sea of aggressive corporate competition.

Then there’s the NHS. There is still a great deal of uncertainty around what TTIP will mean for the NHS, and the negotiators have a great aptitude for keeping the details murky.

The EU says that it will negotiate an exemption from the deal for publicly funded health services, and UK MEPs have scrambled to echo this. But what constitutes a ‘health’ service? What about those parts of the NHS that are not directly related to patient care like catering, IT or administrative services? Outsourcing these to private providers would still push up costs overall; perhaps more importantly, these privatised services would prioritise the rights of the corporations who own them over the patient in their care.

For a complete picture of the suffering this changed NHS would cause in the UK, consider alongside it the power TTIP would give corporations like tobacco companies to sue governments for health campaigns detrimental to their profits. In the most famous case, scary-sounding tobacco ‘giant’ Philip Morris sued Uruguay for its anti-smoking campaign. This is nothing short of a public health catastrophe.

And it’s not just Europe that will be affected by this deal. A lot depends on the wording of the final draft (currently due 2016) but in essence it would make it hard for non-TTIP countries to export processed goods. It could mean that a country like the Ivory Coast, which is the world’s largest cocoa producer, would only be able to export cocoa beans in their raw form. The country would begin to lose customers at the very moment international trade is helping to industrialise it.

This Saturday, thousands of campaigners will be taking part in a country-wide day of action, handing out leaflets and informing the public about this deal which will have such huge repercussions for this generation and the next. You can find out about what’s going on in your area here.

There’s no denying that TTIP is kind of boring, and the reading matter is dry as dust. But it’s important that we fight to know what’s happening as this deal murmurs on behind closed doors, because it is in the interests of some very powerful people to ensure that we do not.