TPP draft reveals surgical strike on public health

This post originally appeared on East Asia Forum.

Authors: Alexandra Phelan, Georgetown University, and Matthew Rimmer, ANU

On 13 November, WikiLeaks released a secret draft text of the Intellectual Property Chapter of the Trans-Pacific Partnership (TPP). The text reveals substantive proposals for expanded protection in respect of copyrightpatenttrade mark andtrade secrets law, and intellectual property enforcement.(L-R) Japan's Prime Minister Shinzo Abe, New Zealand's Minister of Trade Tim Groser, New Zealand's Prime Minister John Key, US Secretary of State John Kerry and US Trade Representative Michael Froman are seen at the start of the Trans-Pacific Partnership (TPP) summit on the sidelines of the Asia-Pacific Economic Cooperation (APEC) Summit in Nusa Dua, Bali, Indonesia, 08 October 2013. (Photo: AAP)Across this, there is much cause for concern. In particular, the IP Chapter poses worrying challenges for patient care, access to medicines, and public health across the Pacific Rim. As WikiLeaks Editor-in-Chief Julian Assange warned, ‘[i]f you’re ill now or might one day be ill, the TPP has you in its crosshairs’.

With the drafting notes intact in the leaked TPP draft, the text reveals a fierce battle amongst the Pacific Rim nations over patent law, public health, and the objectives and the principles behind the TPP’s IP Chapter.

New Zealand, Canada, Singapore, Chile, Malaysia and Vietnam have proposed that the agreement should ‘support each Party’s right to protect public health, including by facilitating timely access to affordable medicines’. As an additional clause, New Zealand, Canada, Singapore, Chile and Malaysia have proposed the agreement should recognise that countries can ‘adopt measures necessary to protect public health and nutrition’.

The US and Japan opposed such recognition of the importance of public health in the agreement’s objectives, with Peru, Brunei Darussalam and Mexico withdrawing their names from the proposal to include public health in the TPP objectives. In contrast, Australia has reserved its position on the scope of the objectives — a disappointing stance given that Australian leaders have publicly emphasised the importance of public health measures, such as access to medicines and the plain packaging of tobacco products.

The TPP contains a raft of measures designed to boost the position of patent holders in the fields of pharmaceutical drugs, medicine and biotechnology.

The US has proposed a broad approach to patent law — demanding that plants, animals and medical procedures be subject to patent protection by Pacific Rim members. This could result, particularly for medical procedures, in greater patent litigation against doctors, surgeons and medical professionals.

In addition, the US has argued for extensions of the patent term in respect of pharmaceutical drugs, including extensionswhere there have been regulatory delays — something which could result in skyrocketing healthcare prices. A review of pharmaceutical drug patents in Australia, for example, found that patent term extensions were exceedingly expensive in Australia.

There has also been concern about the problem of patent ‘ever greening’ — that the TPP will impose low patent standards ‘likely to lead to a proliferation of secondary patents being granted … preventing fair competition for long periods’. This would be an undesirable outcome, creating excessive opportunities for the extension of monopoly protections.

The US also argues for patent-registration linkages to marketing regimes. There has been significant debate over theprotection of undisclosed data for regulatory purposes. The UShas proposed 12 years for data exclusivity for biological medical products, though the text on this proposal was, unfortunately, not amongst the leaked material. The US has also controversially pushed for the cross-border seizure of infringing IP in transit. In light of past controversies with the seizure of Indian generic drugs, it is possible that such text could result in the interdiction of medicines in transit.

Given what is at stake, the TPP is a matter of life and death: it will affect access to life-saving medicines, drugs and treatments in developed and developing countries across the Pacific.

It is also very questionable whether the TPP’s IP Chapter fully embodies international understandings about the need for flexible public health measures, as reflected in the WTO through the Doha Declaration on the TRIPS Agreement and Public Health 2001 and the Decision of the General Council of 30 August 2003.

The US and its allies have proposed measures that would raise prices and reduce competition. This includes the Obama administration’s revocation of a 2007 agreement between the Bush administration and the Democrat-controlled Congress to give developing countries more flexible access to medicines through IP laws. In addition, the US has sought to limit the use of compulsory licensing, which would provide access to patented inventions in respect of medicines.

A group of five countries — Canada, Chile, Malaysia, New Zealand and Singapore — have put forward a counter-proposal to the US demands on medicines. Krista Cox of Knowledge Ecology International observed that the counter-proposal ‘preserves TRIPS flexibilities, and specifically takes into account important factors including the public interest, levels of development, and the potential for abuse of intellectual property rights by the right holders’.

Australia has been passive in the debate over access to medicines. Earlier this year, the Coalition party, then in opposition, opposed a bill that would have provided for the export of essential medicines to developing countries. It will be interesting to see what stance the now in-office Coalition government will take in the TPP on IP and drug pricing.

As all this suggests, the TPP’s draft IP Chapter confirms many of the concerns put forward by public health advocates prior to its release. The TPP is a surgical strike against public health. The text demands that signatory parties amend their laws in a manner that risks the health of their citizens and is ethically questionable. Médecins Sans Frontières has warned: ‘The leak of the secret text confirms that the US government continues to steamroll its trading partners in the face of steadfast opposition over terms that will severely restrict access to affordable medicines for millions of people’.

Obama may struggle, though, to obtain support for the TPP from the US Congress. Indeed, 151 House Democrats and 25 House Republicans have already signalled their opposition to granting Obama a fast-track authority for the TPP. And, on the 27 November, after much criticism at the Salt Lake City talks,the USTR announced that it will put forward new revised proposals on intellectual property and access to medicines in the TPP. It remains to be seen whether such proposals will remain unpalatable to the other Pacific Rim nations.

Alexandra Phelan is an international health and human rights lawyer and doctoral candidate specialising in global health law at Georgetown University, Washington DC.

Dr Matthew Rimmer is an Australian Research Council Future Fellow, an Associate Professor at the ANU College of Law, and an Associate Director of the Australian Centre for Intellectual Property in Agriculture (ACIPA).

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Pacific Rim Treaty threatens public health: patent law and medical procedures

This post originally appeared on Edward Elgar Publishing’s Elgar Blog.

by Alexandra Phelan and Matthew Rimmer


Doctors, surgeons, and physicians around the Pacific Rim should be concerned by the proposals revealed by WikiLeaks in the Trans-Pacific Partnership (TPP).

One of the most controversial features of the TPP is the proposal to provide for patent protection in respect of medical procedures. As Public Citizenobserved, ‘Health providers, including surgeons, could be liable for the methods they use to treat patients.’ The civil society group noted: ‘Essentially, except for when a surgeon uses her bare hands, surgical methods would be patentable under the U.S. proposal.’

The TPP takes a broad approach to patents and medicine; lacks appropriate safeguards; and fails to address larger questions about equity, development, and human rights.

Such a measure could result in greater litigation against medical professionals; barriers to access to medical procedures for patients; and skyrocketing health costs.

 

1.         Medical Procedures

Under the TRIPS Agreement 1994 in the WTO, governments are allowed to refuse to grant patents that cover diagnostic, therapeutic and surgical methods for the treatment of humans or animals. This allowance under international trade law recognises that patents over medical treatment methods are an unjustifiable limitation on the freedom of physicians to treat their patients to the best of their abilities and are a risk to human health. If a patent exists over a surgical method, a physician has a choice (assuming they are even aware a patent exists over the surgical method): respect the patent and risk the health of their patient, or violate the patent and risk being sued for infringement. This is not a decision that physicians, particularly in emergency situations, should be required to make, and is an unjustifiable risk to health and undermines medical ethics.

It is no surprise then that the World Medical Association (WMA) has taken a strong position against patenting of surgical methods. In its position statement on the patenting of medical procedures, the WMA states that the patenting of medical procedures poses serious risks to the effective practice of medicine, and is unethical and contrary to the values of the medical profession.

From the draft text, the US has been the standard bearer of limiting public health exemptions to the intellectual property provisions of the TPP. In particular, it is particularly disturbing that the US Trade Representative is pushing for an expansion of patentable subject matter, at the same time as the Supreme Court of the United States has been seeking to delimit the boundaries of patentable subject matter.

In a case in 2006, Justice Breyer of the Supreme Court of the United Statesemphasized the need to clarify the boundaries of patentable subject matter. He observed: ‘To fail to do so threatens to leave the medical profession subject to the restrictions imposed by this individual patent and others of its kind.’ Justice Breyer stressed: ‘Those restrictions may inhibit doctors from using their best medical judgment; they may force doctors to spend unnecessary time and energy to enter into license agreements; they may divert resources from the medical task of health care to the legal task of searching patent files for similar simple correlations; they may raise the cost of healthcare while inhibiting its effective delivery.’ Justice Breyer noted that guidance on the limits of patentable subject ‘would permit those in the medical profession better to understand the nature of their legal obligations’ and ‘would help Congress determine whether legislation is needed.’ Subsequently, in a trilogy of cases – Bilski KapposMayo v Prometheus; and AMP Myriad Genetics – the judges of the Supreme Court of the United States have expressed reservations about an overly broad approach to patentable subject matter.

Australia is a somewhat unique negotiator in the TPP with respect to surgical patents. Out of the eleven TPP negotiating parties, Australia is the only country that has expressly deemed surgical procedures as patentable subject matter under its domestic law. However, even in Australia, in 2009 the Royal Australasian College of Surgeons released a position paper on the patenting of medical procedures, concluding that it was opposed to the patenting of medical procedures on ethical, practical, economic and scientific grounds, while recalling the core ethical duty of the medical profession that the health of patients is their first consideration.

TPP parties Brunei Darussalam, Chile, Japan, Malaysia, Mexico, Peru, Singapore and Vietnam all expressly exclude surgical procedures from patentability. Canada andNew Zealand have case law that rejects surgical procedures from patentability. It is therefore no surprise that the parties seeking an express permission to exclude surgical patents from patentability under the TPP are New Zealand, Canada, Singapore, Chile and Malaysia.

2.         Safeguards

In United States law, special defences were created for doctors after controversy over medical patents in the 1990s.

In the case of Pallin v. Singer (1995) 36 USPQ (2d) 1050, an eye surgeon, Dr Singer, was sued for patent infringement by Dr Pallin. Dr Singer was outraged by the litigation. He told The New York Times: ‘For a surgeon to claim a freely exchanged method as his own property is wrong.’ Dr Singer was able to challenge the validity of the patent by pointing to prior art. The case received wide attention. The President of the American Medical Association, Robert McAfee, observed that patent litigation over medical procedures posed a threat to the altruism of the Hippocratic Oath to freely share information amongst medical practitioners: ‘The history, excellence, and tradition of medicine has been that whenever a new procedure occurs and is proven effective, it is imperative to share that knowledge with the world at the earliest moment.

In response to the controversy, the 104th United States Congress passed A Bill to Limit the Issuance of Patents on Medical Procedures in 1995. Section 287 (c)(3)(1) provides: ‘With respect to a medical practitioner’s performance of a medical activity that constitutes an infringement… shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.’ The Physician’s Immunity State has been criticised for being a flawed, compromised, and limited response to the problem of patents on medical procedures. In his book,Owning the Future, Seth Shulman observed that ‘the law does little to address similar problems arising in biomedical research, a far more lucrative branch of the medical field than Jack Singer inhabits, and one in which the most important players are more likely to be large corporations than individual practitioners’.

The TPP does not even recognise such limited protections in terms of the proposed model on surgical procedures. Public Citizen commented: ‘While U.S. law immunizes certain care providers from infringement liability, the U.S. TPP proposal fails to include these safeguards, risking yet more serious consequences for TPP negotiating countries.’

3.         Access to Health-Care

From a global health perspective, surgical patents result in inequitable access to medical treatment between developed and developing countries, preventing doctors from utilising the most recent and clinically appropriate technologies to treat their patients.

Developed countries tend to possess the resources and funding to research and develop new medical treatments and surgical techniques, whether formally or on an ad hoc basis. It is for this reason that international trade law includes both public health and surgical method exclusions to intellectual property regimes. Even in a country with a strong public health system like Australia, a patient without such resources, or in an emergency situation, will be denied access to the patented surgical method, to the detriment of their health.

With an ageing population in need of surgical interventions to relieve pain and provide mobility, elderly citizens – particularly those on pensions or limited income –  are at risk of being denied access to medical advances in surgical techniques.

The draft text of the TPP demonstrates the push to remove these public health exclusions, to the detriment of developing countries. As has been seen with the pharmaceutical industry, countries like India and Brazil have drastically stripped back intellectual property protections with the aim of increasing access to essential medicines. The TPP risks sitting on the opposite extreme: protecting economic and innovation arguments at the expense of public health in the majority of the TPP negotiating parties, including Chile, Mexico, Brunei Darussalam, Vietnam, Malaysia and Peru.

Conclusion

The TPP should alarm doctors, physicians, surgeons, nurses, hospitals, and medical students, who, if the proposed provisions come into effect, risk being sued for using medical treatments in the best interests of their patients’ health. Fundamentally, the draft text is inequitable and forces medical professionals into a corner where they risk making unethical decisions. No government should be supporting such a measure. Australia should support not only its medical professionals, but all Australians who would face the rising costs of medical treatments should the proposed expansion make it into a final text.  The countries of the Pacific Rim should immediately act to remove the provisions expanding patentability to medical treatment methods from the draft TPP text. Doctors should not be put in harm’s way by the TPP.

Krista Cox from Knowledge Ecology International on the Trans-Pacific Partnership and Medical Procedures:

 

Alexandra Phelan is an international health and human rights lawyer and doctoral candidate specialising in global health law at Georgetown University in Washington DC.

Matthew Rimmer is an Australian Research Council Future Fellow, an Associate Professor at the ANU College of Law, and an Associate Director of the Australian Centre for Intellectual Property in Agriculture. He has authored and edited a number of books with Edward Elgar Publishing, including Digital Copyright and the Consumer Revolution: Hands off my iPodIntellectual Property and Biotechnology: Biological InventionsIntellectual Property and Climate Change: Inventing Clean Technologies and Intellectual Property and Emerging Technologies: The New Biology.