By Katherine O’Shea – Interhealth Co-Chair
There are many things that restrict the access of affordable and effective medicines for millions of people the world over. One of the most dangerous and concerning is the TPP.
Yes, this is a piece of paper. Ok, pieces of paper. Ok, a >70,000 page document, which would be pretty terrifying if physically thrown at you.
The Trans-Pacific Partnership Agreement (TPP) represents a significant redrawing of the pharmaceutical patent maps, and ultimately if it is signed off as it currently stands, it will radically undermine both global access to medicines and the governments’ capacities to regulate their internal laws and policies related to health.
Negotiations of this aggressive behemoth of a Trade Agreement are being conducted behind closed doors by 12 countries including Australia the US, and are planned to conclude in October this year. The text is not even shared with opposition governments within negotiating countries, and versions of the text are only available to the public if leaked on the Internet. (They are, go read them – grazie Wikileaks).
So, what does a trade agreement have to do with medicines? Big scary answer = everything.
It has morphed from its original 4-country incarnation in 2005, and of the 26 chapters of text an underwhelming minority of clauses now directly address trade, while much of the text purportedly now concerns Intellectual Property clauses.
The issues are that the proposed TPP will mean that generic medicines, if they can be produced at all, will become a whole lot more expensive and take potentially decades to reach the market. Clearly, this is not a good idea for anyone, and it renders medicines prohibitively expensive for hundreds of millions of people.
Already, the majority of the world’s disease burden is shouldered by the World’s poorest, who are also the least able to afford expensive medication. And so, if the TPP is the biggest threat to A2EM right now, the second biggest threat is the US’ negotiating stance. The US stance actively impedes timely access to medicines and restricts further tightening of patent laws within countries’ own national law.
Gravely concerning is the proposition to lengthen the duration of patent life-spans up to 8 years and allow the potential for ever-greening of existing drugs, further prohibiting generic brands’ market access. Currently, under a bilateral FTA with the US (AUSTFA) patents are held in Australia for 5 years before a generic company can manufacture that same active compound, and biologics are not viewed separately and have the same life-span limit. There is a similar limit in most countries.
Once patents expire, generic companies are able to register the drug and produce it at a fraction of the cost – this is HOW most sick people in the world are able to live. This is how NGOs can afford to provide emergency medication, antibiotics and anaesthetics. This is why Polio is nearing eradication and why children grow up healthy.
Most concerning, however, are the provisions for data exclusivity periods, which will cause a dramatic rise in the cost of generic medicines.
The restriction of data use by tightening Intellectual Property rights over research and clinical trail data conducted by pharmaceutical companies, would mean that generic companies WOULD NOT be able to use this same information as they currently do to register their drugs with licensing and safety boards. This effectively removes the thing that makes generic brands cheap; it forces them to undertake research and development, which is costly, and in essence alters the foundation of the machinations of generic companies. At the time of writing, Round 19 of negotiations are underway and the US is calling for 12 years of data exclusivity for biologics. THIS IS BAD SH*T, BAD.
Further to this, ISDS clauses allow multinational companies to bring law-suits against countries which they (that is THE COMPANY) believe have harmed their investments through their laws, policies and decisions. What is this lunacy you say? Well, dear reader, it is fo’ realz.
ISDS clauses (Investor State Dispute Settlement) imbedded in the TPP make Nations vulnerable to litigation from companies via pre-existing agreements, which effectively allows a company to sue a Government. These clauses would give a multinational company the power to contend a country’s laws, and if they win, force an over-rule or even a re-write depending on the outcome of an international arbitration tribunal.
Of relevance to Australia is the potential for large scale IP cases to be brought against the Government by tobacco companies regarding the plain packing laws. As this first country to legislate plain packing, this has important ramifications for other countries considering following Australia’s public health lead on this. New Zealand is set to be the second country to bring in plain packaging and faces similar threats in their efforts to address the higher burden of smoking related disease.
From an Australian perspective, we are not protected from any of the bad, bad karma that will see majority world nations set back years in their development, protection of public health standards, and ability to address health needs of their populations. If the TPP is adopted, Australia’s PBS costs will blow out as drugs stay under patent for longer cheaper drugs are delayed in their registration and entry into the market. NZ’s Pharmac is in as similar a precarious situation and ultimately, the more money spent on the same amount of drugs, is less money available for equally essential public services.
The TPP will reshape the way the world accesses (or more pertinently, doesn’t access) healthcare, and should be on the tip of everyone’s lips and at the front of our minds.
Do not think that you can’t do anything about this. Armchair Advocacy has been putting this issue squarely in the face of millions; your tweet does matter.
The most important part of this – NEGOTIATIONS HAVE NOT FINISHED.
Anything you do RIGHT NOW can and will help make health a right everyone can realise.
WHAT TO DO NOW
- TWEET something relevant – #TPP #A2EM @MSF_access. Make ‘icanhasmedicines?’ a viral blog.
- READ what MSF, AMSA, AGH, UAEM and ASH are doing and join them.
- WRITE to your local paper, on a blog, in a journal, anywhere and encourage others to take an interest.
- MAKE A SUBMISSION to the Australian negotiators – contact [email protected] for the lead IP negotiator’s contact details. (They WANT public feedback and appreciate your views. Do it.)
- TALK to someone about it – understanding trade negotiations and FTAs can be a daunting task, but realistically, you don’t need to be an expert, you just need to have enough understanding to speak up and speak out. My little bro is a total pro at this now after I schooled him on this today.
- BE BOLD – Trade agreements aren’t sexy, but they are important. Moreover, while it looks like pure economics and international politics, these are the things which govern basic requirements for health; universal Access to Essential Medicines, a fair and affordable PBS, the right to govern our own approach to tobacco smoking prevention. These things are threatened and impacted on by potential decisions in the TPP; take a stand and do something about it.
Image: ‘Medication’ by Gatis Gribusts available at http://www.flickr.com/photos/7346479@N07/5223834995 under a Creative Commons Attribution 2.0. Full terms at http://creativecommons.org/licenses/by-nc-sa/2.0/