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.

What just happened in Texas?

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(c) Alexandra Phelan, 2014

Today has seen a new blow to Texan women’s reproductive health rights. A quick background of events for those not familiar:

  • House Bill 2: a Texas law that changes the definition of fetal viability to 20 weeks (drastically cutting back the time period of a woman’s right to seen an abortion: Roe v Wade set viability at ~28 weeks). In addition, House Bill 2 requires that a physician conducting abortions have admission rights to a hospital less than 30 miles away and blocks off-label use of two drugs, limiting women’s access to medication abortions to 49 days after the last menstrual period, rather than 63 days. These latter two provisions are the “Litigated Provisions”.

Timeline

  • June 2013: House Bill 2 passes the Texas House, and upon it being brought before the Senate, Senator Wendy Davis partakes in a marathon filibuster, defeating the Bill.
  • July 2013: Republican efforts don’t stop there, and a special session is held to pass House Bill 2 through the Senate. Governor Rick Perry signs it into law, to take effect 29 October 2013.
  • September 2013: Women’s health organizations (including Planned Parenthood) file a suit in the Federal Court to block the Litigated Provisions of House Bill 2 that violate women’s health rights.
  • 28 October 2013: Federal Court Judge Lee Yeakel strikes down the Litigated Provisions on the grounds that they were unconstitutional, placing an undue burden on women’s access to abortion. Discussion on this case can be found here.
  • 29 October 2013: Texas seeks an emergency temporary injunction from the Fifth Circuit Court of Appeal to block Judge Yeakel’s decision, and asks for a full appeal to be held in January.
  • 31 October 2013: Fifth Circuit Court of Appeal allows in part Texas’ emergency injunction, putting on hold Judge Yeakel’s permanent injunction, allowing the Litigated Provisions to come into effect with one exception: medical abortions allowable for women 50-63 days from their last menstrual period, where, due to a physical abnormality or preexisting condition, a surgical abortion is not a safe option. The Fifth Circuit agrees to hear the full appeal in January 2014. Nearly 20 clinics are forced to close around the State, as they are unable to meet the physician admissions requirements. More on this decision here.
  • 4 November 2013: Women’s health organizations file an emergency application to the US Supreme Court, seeking that Judge Yeakel’s injunction be reinstated until the full appeal is held. More here.
  • 19 November 2013: The US Supreme Court splits on idealogical grounds, refusing to grant the emergency application 5-4. The Texan laws stay in effect pending the Fifth Circuit Appeal.
  • 6 January 2014: Arguments presented to Fifth Circuit Court of Appeal.

And then flash forward to today, 28 March 2014, the Fifth Circuit Court of Appeal has handed down its ruling, reversing all of Judge Yeakel’s decision.

Given the geography of Texas, thousands of Texas women will now have virtually no access to safe and legal abortion services, and in the words of the American Medical Associations and the American College of Obstetricians and Gynecologists, upholding a law that “jeopardizes women’s health in Texas” that does “nothing to protect the health of women”.

This is an incredibly disappointing decision, with the three-judge panel giving Texas the complete go-ahead to violate fundamental human rights by severely restricting women’s health rights. The result of this decision means that both of the Litigated Provisions (requiring physicians to have admission privileges and limitations on medication abortions) come into effect on a permanent basis.

Just how permanent this is remains to be seen: there is still an option to appeal the decision to the US Supreme Court. However, given the 5-4 ideological split seen in the unsuccessful November 2013 appeal, it is not clear whether such an option would result in a decision that protects the fundamental liberties and rights of Texan women to health services.

However one would hope that the Supreme Court, as the United States’ bastion of protecting the liberties and freedoms guaranteed to Americans, when vested with the express jurisdiction to decide on the constitutionality of House Bill 2 (rather than simply on whether the requirements for an injunction have been met) would fulfill this role, not simply reinforcing the personal ideologies of the justices.

Reflections from the US environment: Zoe’s Law

Yesterday, the NSW lower house passed the Crimes Amendment (Zoe’s Law) Bill (No. 2) 2013 to amend the Crimes Act 1900 (NSW).  This version of Zoe’s Law establishes a separate offence for actions that cause serious harm to or the destruction of a foetus. There are a wide range of legitimate criticisms of Zoe’s Law that need examination before becoming law, as the Bill will still need to pass the NSW upper house early next year.

The history of Zoe’s Law actually provides a little insight into where the criticisms of this piece of legislation stem from. When looking for the original text of the Bill, I came across three different Bills before the NSW parliament this year purporting to be a “Zoe’s Law”.

The one that passed yesterday, as you can see above, is the (No. 2), and was sponsored by Chris Spence MP, a Liberal Party MP. There are some interesting facts about Spence in his Wikipedia entry and its references. Before joining the Liberal Party, Spence was a member of One Nation and president of the One Nation Youth Wing, standing twice as a One Nation candidate in elections. Since joining the Liberal Party, Spence has said that his involvement in One Nation was a mistake. As an interesting aside, Spence was also the electoral officer of “Liberal powerbroker” Chris Hartcher, who provided the paperwork for and witnessed the statutory declarations against Belinda Neal and John Della Bosca in the “Iguanagate” scandal. What brings Spence to the party on this mater however is that he is the local MP for Brodie Donegan, a woman who lost her 32-week old foetus after being hit by a driver under the influence of drugs.

Before the law that passed the lower house existed, here were two previous versions of “Zoe’s Law”, sponsored not by Chris Spence, but by Fred Nile MP. Yes, that Fred Nile – aka Reverend Fred Nile of the Christian Democratic Party – a very vocal advocate against gay marriage and homosexuality. The Christian Democratic Party policy platform includes strong opposition to abortion and believes that it should be banned, and that abstinence only sex-education is the only acceptable form of sex-ed in schools. Fred Nile’s version was developed with no consultation or consent from Brodie Donegan.

In the previous Fred Nile version of “Zoe’s Law” available (the “No.1”), the language of the Bill is telling. The object of that Bill was to “establish a separate offence for conduct causing serious harm to or the destruction of a child in utero”. The use of the term “child” here, that is, “a young human being”, rather than “foetus”, immediately denotes a state of personhood. Using this term makes the only difference of a child before birth and after birth is its location, not its viability or its capacity to survive outside the mother’s uterus. As a result, the term “in utero” is required to designate the particular location of the “child”. As a contrast, “foetus” however denotes reliance on the mother’s body for life, it does not possess its own personhood and information about its location is superfluous.

While the latest version of “Zoe’s Law” changes the term “child” to “foetus”, however (and this is a big however), it clearly states that:

an unborn child is taken to be a living person despite any rule of law to the contrary

An unborn child is defined as the foetus of a pregnant woman that is at least “20 weeks’ gestation” or, where gestational age cannot be determined, has a body mass of least 400 grams.  This immediately creates personhood in law for a foetus that has a gestational age of 20 weeks or more. Why this figure? Why 20 weeks?

It’s no coincidence that 20 weeks is also the point at which some of the most extreme anti-abortion laws put forward by Republican Party politicians over the last three years in the US come into effect. This is one measure used by the GOP Tea Party to skirt around the Constitutionally protected right of US women to an abortion before “viability”. Viability means the ability for a foetus to exist on its own outside of the uterus PROVIDED that substantial medical assistance is provided. To put this into context, actual viability is typically deemed to be about 28 weeks (or seven months) without substantial intervention, and this was the definition of viability accepted by the US Supreme Court in Row v Wade.

At 20 weeks, chance of viability is considered to be 0%. If a baby is born before 22 weeks, resuscitation generally does not occur due to major disability. When I completed my Bachelor of Biomedical Science a couple of years ago, contemporary medical science stipulated 24 weeks as the absolute minimum of survival of a baby born, however this was survival with significant disabilities and substantial medical intervention. To put it simply, the foetus’ organ development is just not advanced enough for survival before these dates. Even slightly premature babies suffer health difficulties. I was born premature at around 8 months and spent my first days in an incubator, and have chronic asthma (the only one in my family) correlated with preterm birth.

incubator pic

Me in an incubator (c) lexsanitas

So, when Zoe’s Law defines an unborn child at 20 weeks, I find it scary. I find it scary for women’s rights to access reproductive health services, such as abortions, and I find it scary when I think about attempts to redefine viability by politicians rather than experts, such as neonatal physicians and doctors.

Now, Zoe’s Law Mk II, does include the following provision:

This section does not apply to or in relation to: (a) anything done in the course of a medical procedure or medical treatment, or (b) anything done by, or with the consent of, the pregnant woman concerned.

On its face, this provision is comforting. It reiterates the notion that Zoe’s Law is intended to give some sort of acknowledgement of the loss of a potential baby as a result of an attack (deliberate, reckless or negligent, such as with dangerous driving) to a pregnant woman. I remember when I was studying criminal law, and I felt torn by the notion that a pregnant woman who loses her baby as a result of an attack, in particular, for example domestic violence against the mother, has no additional criminal recourse against the attacker beyond a criminal assault charge and other crimes specifically against the mother. I get this. I can completely understand Brodie Donegan’s perspective, when she called for this legislation to be introduced. I think Brodie Donegan makes a compelling argument as to the validity of this law. And I get it. I know that I agree with the desire to have one’s loss recognised. I just don’t think that this is the way to do it.

Introducing this law is incredibly risky to women’s rights. I know that these provisions attempt to cover all bases and protect women’s reproductive rights. But it puts criminalising the destruction of or injury to a foetus on the table; making amendments a pen stroke closer than a law that isn’t there at all. Such amendments could include changing the definition of viability, removing the protections for medical treatments, or, as may be possible, extrapolating the creation of personhood in this law to other criminal laws against women.

Creating foetal personhood is not the answer to this horrible situation experienced by Brodie Donegan and other women. It is medically and scientifically faulty law. Legal personhood should not be extended to a baby in utero. A feotus in utero is not capable of surviving on its own, and furthermore, exists solely within the pregnant woman’s body, covered by her legal personhood. Birth is the point of separation – where the baby is no longer a foetus, no longer a part of the mother’s body, but becomes a separate individual. Defining personhood before birth completely obfuscates and ignores the existence of a woman’s body between the baby and any third party.

By giving the foetus legal personhood, you are also giving the foetus rights against its mother. With the pregnant woman’s consent one of the pivotal “safeguards” in this law, the right of that person to give consent, can then be challenged. The autonomy of the pregnant woman becomes second to the personhood of the foetus.

That is why I disagree with this law. Any legal challenges brought on behalf of a foetus’ legal personhood risks a woman having to continue a pregnancy beyond the point at which she no longer can access reproductive services over her own body and violates her bodily integrity.

As an alternative solution, I agree with Hannah Robert’s proposal: a law that is focused on criminalising a violation of a pregnant woman’s right to continue with a pregnancy against her will. Such a law focuses on the mother, and the right of the mother to bodily autonomy. It attempts to criminalise any person that deliberately, recklessly or negligently violates a woman’s right to reproductive autonomy, to keeping her pregnancy, and having a child. This is the sort of right that is engaged in arguments against China’s previous one-child-policy, or a government attempt to control a woman’s reproductive rights and violate a woman’s bodily autonomy, such as forced abortions.

This is a more ethical construction, focused on the woman – an individual human being with existing legal rights –  and a more ethical example of how the law clumsily tries to give people resolution of their loss. The law can only do so much in this respect, which makes ethics the most important guidance in this process.

From a medical, scientific and ethical perspective, protecting the reproductive autonomy of a pregnant woman – not constructing personhood for a foetus – is the best answer.

Game Changer: Women’s Health Protection Act

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Senator Blumenthal speaking at the announcement of the Women’s Health Protection Act Used under Creative Commons licence. (c) Senate Democrats at http://flic.kr/p/hwcW9Y

“A republican legislature in any state almost, as soon as they get elected to run the state legislature, they start going on offense with a whole variety of ways of trying to restrict choice, or trying to ban abortion. You don’t see the same thing in reverse; which is to say, when Democrats take over a State, they’re not out there leading on this issue.”

Chris Hayes on msnbc. View full video here.

As the past few weeks in the various courts across the United States have shown, the current term of GOP run State legislatures have been pushing hard to curb women’s reproductive rights. Perhaps emboldened by the backing of the Tea Party movement, legislatures like Texas and Oklahoma have passed laws attempting to get around a woman’s Constitutional right to abortion when it comes to medical treatment as espoused by Roe v Wade. These attempts have included redefining the point at which a fetus is deemed to be viable on its own outside the womb (sometimes described as “personhood”), thus triggering what the US Supreme Court deemed a justifiable limit on the right to privacy when balanced with the state’s legitimate interest in the woman’s health and prenatal life once it is viable. This “legitimate interest in a woman’s health” has guided the rhetoric behind much of the recent law-making by Republican State legislatures, such as in Texas and Oklahoma, where laws allegedly intended to “protect women’s health” and enable them to make “informed choices” have resulted in unjustifiable limitations of women’s reproductive rights by placing an undue burden on women seeking abortions.

But the game has now changed. In addition to the judicial actions launched by tireless organizations like the Center for Reproductive Rights and Planned Parenthood to protect women’s rights, Democrats are no long only reacting to proposed laws but are going on the offensive with the Women’s Health Protection Act.

The Women’s Helath Protection Act (WHPA) was presented to the US Congress last Wednesday, 13 November, by Senators Richard Blumenthal (D-Conn), Tammy Baldwin (D-WI), and Representatives Judy Chu (D-CA), Marcia Fudge (D-OH) and Lois Frankel (D-FL).

The WHPA Bill aims to “protect a woman’s right to determine whether and when to bear child or end a pregnancy by limiting restrictions on the provision of abortion services”. Pivotally, the WHPA recognizes that:

Access to safe, legal abortion services is essential to women’s health and central to women’s ability to participate equally in the economic and social life of the United States.

This is an incredibly powerful statement: a piece of legislation that recognizes that not only is access to abortion services a matter of individual liberty and self-determination, but is fundamental to achieving women’s economic and social equality. This is so powerful, and reminiscent of then Secretary of State Hillary Clinton’s clear and resolute response to questions regarding reproductive healh services in foreign aid.

The core provisions of the WHPA act to prevent any legislation that attempts to bypass the women’s Constitutionally protected right to access an abortion through the imposition of burdensome administrative or regulatory requirements. These bypass laws have become increasingly common, such as recent cases highlighted on this site, such as in Texas and Oklahoma.

The WHPA sets out some examples of the kinds of requirements that would be unlawful:

  • Where a doctor is required to perform a test or particular procedure only in abortions, but not other comparative medical procedures;
  • Where an abortion provider is restricted from prescribing drugs based on good-faith medical d judgment;
  • Where an abortion provider’s ability to provide abortion services via telemedicine;
  • Any unique accreditations, resources, arrangements with hospitals, that is not imposed on medically comparable facilities;
  • Where a woman is required to make medically unnecessary appointments, either to the abortion provider or any other entity (such as a counsellor or religious advisor).

It is important to note that this is not an exclusive list, and any requirement imposed by a law that restricts women’s access to abortion services, in a manner not comparable with similar medical procedures, will also be deemed unlawful.

From a lawyer’s perspective, the WHPA also sets out burdens of proof in a manner that shifts the burden onto the government imposing the restriction. As a result, this attempts to address the risks that we’ve seen in Texas where the government was able to make a prima facie case that the requirements imposed in women were likely to be for their health, thus satisfying the burden of proof for the granting of a temporary injunction. Under the proposed law, a government would have to show that the measures “significantly” improve women’s health to successfully shift the presumption, with the burden requiring “clear and convincing evidence”. This is a higher evidentiary standard than on the balance of probabilities or preponderance of evidence.

There is a lot of great stuff in the WHPA; it is an act that takes into account all of the lessons learnt in the recent few years, and anticipates weaseling by anti-women’s rights legislatures. If this Bill passes, it will be historic, and put to rest the pain and angst suffered by women around the US facing uncertainty over their ability to access Constitutionally protected rights.

Key legal documents

Text of the WHPA Bill can be found here.

Doubling Down: Supreme Court refuses to hear Oklahoma’s anti-abortion arguments for transvaginal ultrasounds

Doonesbury 3-14

Part of Trudeau’s 2012 comic series on the transvaginal ultrasound legislation in Texas (but equally applicable in the context of this Oklahoma case) – Universal Uclick (c) 2012 G.B. Trudeau

For the second time in as many weeks, the US Supreme Court has rejected Oklahoma’s request that the court review an Oklahoma Supreme Court’s decision invalidating anti-abortion laws.

This time, the law in question required women to undergo a “narrated ultrasound” before being allowed to proceed with an abortion. The original law (the “Oklahoma Ultrasound Act”, or HB 2780) patronisingly determined that

“[i]n order for the woman to make an informed decision, at least one (1) hour prior to a woman having any part of an abortion performed or induced… the physician [performing the abortion] shall

1. Perform an obstetric ultrasound on the pregnant woman, using either a vaginal transducer or an abdominal transducer, whichever would display the embryo or fetus more clearly;

2. Provide a simultaneous explanation of what the ultrasound is depicting;

3. Display the ultrasound images so that the pregnant woman may view them;

4. Provide a medical description of the ultrasound images, which shall include the dimensions of the embryo or fetus, the presence of cardiac activity, if present and viewable, and the presence of external members and internal organs, if present and viewable”

When read like this, it is clear that the experience intended by Oklahoma was to be a traumatic one; an experience aimed at manipulating or shaming a woman out of making decisions about her own health and body. From a statutory interpretation perspective, the first clause is particularly interesting – making a decision between a standard ultrasound or transvaginal ultrasound (an ultrasound on a stick inserted up the vaginal canal to the cervix) is based on clarity of viewing the embryo or fetus. There is no space in the Act’s provisions for a physician to take into account the necessity of the procedure, nor in deciding which ultrasound to go for, the wellbeing, comfort or desires of the woman (probably even less so if you take a purposive, rather than purely constructional interpretation approach). As transvaginal ultrasounds tend to provide higher quality resolutions in early stage pregnancies, the result is clear: you want an abortion in Oklahoma, you’ll have to have a physician stick an ultrasound up your vagina, while they narrate to you a story of the gestating embryo or fetus. Now, there’s nothing inherently wrong with transvaginal ultrasounds – they are an incredibly useful tool in women’s reproductive health, including in the abortion setting. However, having a law dictate that a woman must go through with what is an invasive procedure under the patronising guise of enabling them to make an “informed choice” is a completely different matter, and warrants fierce opposition. This is even more so given that abortion and reproductive health procedures are constitutionally protected rights.

In December 2012, the Oklahoma Supreme Court upheld a lower court’s ruling that this patronising law was invalid as it violated women’s constitutional rights. The Oklahoma Supreme Court ruling is delightfully short, stating simply that the law is “facially unconstitutional”. In particular, the Oklahoma Supreme Court upheld the lower court’s finding that the law was in violation of:

  • Article V-59 of the Oklahoma Constitution, which fundamentally is about upholding the Rule of Law. This Article prohibits a legislature from creating a “special law”; that is, a law just for one particular subset of the population. Oklahoma therefore exceeded the powers given to it by the Constitution by passing a law that targeted only female patients, doctors and sonographers where women were seeking an abortion, not all patients, all doctors, and all sonographers in any medical situation.
  • Article V-46, which in a similar vein, provides that the legislature may not create a special law that grants a right to take a civil action (ie take a matter to court) only to a particular class of people. In this case, this related to the rights of a woman’s family, doctors, and the Attorney-General to seek an injunction against abortion providers who violate the law, and to seek damages from an abortion provider knowingly or recklessly violating the requirement to conduct a narrated ultrasound.

So after being struck down as unconstitutional by the Oklahoma District Court, then the Oklahoma Supreme Court, Oklahoma sought to appeal these decision at the US Supreme Court. Tuesday’s denial however means that the last door has closed on this law. With two decisions in the last two weeks, Oklahoma women can breathe a sigh of relief that these laws, putting women’s physical and mental health at risk, have been relegated back to the dark ages from which they came.

Key Legal Docs

US Supreme Court ruling

Here’s a link to the US Supreme Court’s refusal to hear the case by elegantly listing simply the case name under “Certiorari Denied” at the bottom of page 1.

State Supreme Court ruling

Here’s a link to the short and sweet Oklahoma Supreme Court ruling (Nova Health Systems v Pruitt 2012 OK 103 (292 P.3d 29)).

State District Court ruling

Here’s a link to the original Oklahoma District Court ruling (Nova Health Systems et al v Pruitt et al Case No. CV-2010-533) granting the permanent injunction (this was tricky to find!).

Improvidently Granted: Surprise Early Victory from US Supreme Court for Oklahoma Women’s Rights

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Used under creative commons licence, copyright to image held by Mark Fischer on flickr @ http://www.flickr.com/photos/fischerfotos/7526267232/

In a surprising early turn of events, the US Supreme Court has dismissed Oklahoma’s appeal against a December 2012 ruling by the Oklahoma Supreme Court which struck down a ban on medication abortions as unconstitutional.

As you may recall, on Tuesday, the Oklahoma Supreme Court responded to questions posed to it by the US Supreme Court, seeking clarification on its interpretation of the impact of the law on Oklahoma women. Following this, it was expected that the case would then proceed to securing a place on the SCOTUS hearing docket this or next term.

This afternoon however, SCOTUS has dismissed Oklahoma’s case, stating in one single, elegant line that

“[t]he writ of certiorari is dismissed as improvidently granted”.

This effectively means that following a reading of Oklahoma’s answers, the US Supreme Court has changed its mind on granting Oklahoma the right to appeal, stating that it should not have accepted the case. Oklahoma’s case is therefore dismissed, and the original Supreme Court of Oklahoma’s ruling that the 2011 Oklhamoma law banning off-label use of abortion drugs was unconstitutional is upheld.

Given the legal events of the last two weeks, this is a fantastic win for women’s reproductive health and protection of Oklahoma women’s constitutionally protected rights.

Today’s US Supreme Court ruling in full (all one line of it) can be found here.