Two Years’ Later – Now or never: on the edge of polio eradication

On 27 March 2014, the World Health Organization certified that the entire South East Asia Region was Polio free. This was a huge milestone, meaning that four out of the six WHO regions are now formally Polio free, and that every country within the region (Bangladesh, Bhutan, Democratic People’s Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka,  Thailand and Timor-Leste) are Polio free.

We are so close to the end of Polio, however new threats loom, with reemergence of the disease in Syria as a result of internal violent conflict. Children are those devastated by Polio. Below is piece published in May 2012, two years ago, and now, more than ever, we should work to finish this momentous task.

The piece below was originally published on ABC’s The Drum.

At some point in recent history, Australians forgot about the iron lung; the full-body metal chamber, changing air pressure so that polio sufferers could simply breathe in, and out.

We forgot about the Australian children who were left paralysed or whose legs were permanently deformed.

At some point, we lost our deep, dark fear of polio. Forgetting, thankfully, was perhaps as a result of an incredible medical advancement; when Australian Dr Percival Bazeley CBE, working with Dr Jonas Salk, developed, and then pioneered the Australian delivery of the Salk polio vaccine.

This remarkable moment in medical science is at the centre of events this week at the 65th World Health Assembly of the United Nations World Health Organization; the world’s highest-level health policy forum. Ministers of Health, national delegations, and leading international health experts and advocates converge on Geneva, Switzerland to meet and discuss the world’s most pressing health issues, such as pandemic influenza.

On Friday, Geneva time, I watched the World Health Assembly, composed of 194 countries, declare polio a global health emergency and that vaccinating children across the world is an immediate international health priority.

Although we have come incredibly close to the complete global eradication of polio, a sudden escalation of cases has demonstrated the vital importance of consistent, community-wide vaccination. According to the World Health Organization, we are facing a “now or never” moment to permanently eradicate polio globally.

Vaccination is the solution. Since the introduction of a coordinated global vaccination effort 20 years ago, led by the World Health Organization and Rotary International, the number of polio cases worldwide has dropped 99 per cent. No longer are millions of lives around the world lost to polio, and no longer are nearly 1,000 children permanently paralysed every day.

For doctors, scientists and health human rights experts the possibility of global polio eradication is both exciting and inspiring. For those living in endemic polio areas, and for the 200,000 children who are predicted to otherwise be crippled by polio, this is simply life.

The dangers of failure to vaccinate are too great; not only for individuals, but for communities, and as has been seen in this case, the entire globe. Consistent vaccination is absolutely essential. Contrary to the cries of anti-vaccination lobby groups, failure to vaccinate is not only scientifically and medically unfounded selfishness, but dangerous. Laurie Garrett, Senior Fellow for Global Health at the Council of Foreign Relations, has not only expressed that “[w]e’re so close on polio eradication that it hurts”, but that the rise of anti-vaccination movements are causing the “export” of vaccine-preventable diseases, including polio, to developing countries where ready access vaccinations is sparse.

As a result, in addressing its international legal and moral responsibilities in this global health emergency, it is essential that Australia takes steps to continue to ensure that parents are provided with education on the medical and scientific facts of vaccination. Maintaining and ensuring consistent, community-wide vaccination, even here in Australia, is the only way global eradication of polio will become a reality; ensuring the health and human rights of millions around the world.

Ban Ki-moon, Secretary General of the United Nations, last week warned that:

“Wild viruses and wildfires have two things in common. If neglected, they can spread out of control. If handled properly, they can be stamped out for good. Today, the flame of polio is near extinction – but sparks in three countries threaten to ignite a global blaze. Now is the moment to act.”

Now is the world’s moment to act. Now is every Australian parent’s moment to ensure that their child is vaccinated against polio, and that the iron lung is relegated back to its rightful place in museum exhibits of the remarkable achievements of medical science.

Alexandra Phelan is an Australian international health and human rights lawyer, presently based in Geneva, Switzerland. View her full profile here.

Malaria on Manus Island: a threat to human rights

This post was originally published on ABC’s The Drum.

International health and human rights lawyer Alexandra Phelan argues that by exposing asylum seekers to the risk of malaria on Manus Island, the Government could be violating human rights conventions.

When the Australian officials head to Port Moresby this week to discuss the reopening of the Manus Island detention centre, their risk of contracting malaria on a short-term visit to Port Moresby (according to the Government’s own Smart Traveller website) is relatively low.

However, if the officials make their way to Manus Island, located north of Papua New Guinea to inspect the detention centre site, their health professionals would likely advise that they take prophylactic antimalarial drugs.

Given this visit is part of a government-related mission, the cost of these antimalarials would most likely, and rightly so, be covered by tax-payer funding.

Malaria is contracted by the bite of a mosquito infected with one of the five species of Plasmodium parasite. The parasite travels to your liver, where it multiplies and then ruptures liver cells, spreading to your red blood cells and then throughout your body. This process causes fever, shivering, headache, and vomiting. In the case of Plasmodium falciparum (the cause of 90 per cent of Papua New Guinea malaria cases), if not treated within 24 hours, the infection proceeds to severe malaria resulting in coma and death, especially in young children and pregnant women. In malaria endemic areas, local populations may develop partial immunity, meaning that individuals who have not grown up in the endemic area are at greatest risk.

There is currently no vaccine for malaria – prevention is through the use of antimalarials, which require important medical consideration of each patient’s age, weight, pregnancy status, underlying illnesses, the risk of side-effects and the increasing prevalence of the parasite’s antimalarial resistance.

Papua New Guinea is a malaria endemic country; in the World Health Organization’s (WHO)2011 World Malaria Report, the WHO concluded that 94 per cent of Papua New Guinea’s population is at high risk of malaria infection, with the remaining 6 per cent of the population at low risk. No person in Papua New Guinea is deemed by the WHO to be risk-free of malaria. In 2010, there were 1.4 million suspected malaria cases in Papua New Guinea, out of a total population of 6.9 million. In 2010, there were 616 reported deaths attributed to malaria, six times more than any other country in the Western Pacific Region.

Papua New Guinea is clearly the highest risk country in the entire Western Pacific Region for malaria. But to make matters worse, the WHO categorises Manus Island, where the Government proposes to send asylum seekers, as having the highest numbers of probable and confirmed malaria cases in all of Papua New Guinea.

The Manus Island detention centre was initially established in 2001 under the Howard government’s Pacific Solution policy. In February 2002, an outbreak of malaria affected at least 15 asylum seekers detained at Manus Island, a claim denied by then-minister Philip Ruddock, but supported by local doctors on Manus Island.

In response to the outbreak, the Royal Australasian College of Physicians (RACP) called for asylum seekers detained at Manus Island to be immediately removed. Then-president of the RACP, Richard Larkins, said that:

“[G]iven the medical evidence about the prevalence of malaria, in particular the chloroquine [an anti-malarial] resistant strains, on Manus Island, the responsible course of action is to immediately evacuate the detention centre. This is the only truly effective way people at risk can be protected, especially pregnant women and children, but also any others with low immunity.”

The Manus Island detention centre was closed in mid-2004, after asylum was granted to Aladdin Sisalem, who had been the sole detainee at the centre for the previous 10 months.

If plans to re-establish Manus Island are followed through, Australia will most definitely risk violating a number of the asylum seekers’ human rights and protections under international law, in particular, the asylum seekers’ right to health under article 12 of the International Covenant on Economic, Social and Cultural Rights, and possibly, their right to life.

The right to health provides that everyone has the right to a standard of living adequate for the health and wellbeing of themselves and their family. It imposes obligations on countries to take steps to prevent, treat and control disease. The principle of non-regression prevents countries from “going-backwards” in the realisation of the right to health. It is also arguable that by sending individuals to a country where their health is knowingly at risk so substantially as to risk their lives, the protections of their right to life under the International Covenant on Civil and Political Rights could be engaged.

These rights are universal, regardless of an individual’s status under a piece of Australian legislation. Even more so, due to their circumstances, asylum seekers are especially vulnerable and at risk of having their rights violated. Sending asylum seekers offshore to Manus Island where malaria is endemic, and present in its most deadly strain (Plasmodium falciparum), risks violation of the asylum seekers’ rights and contravention of Australia’s obligations under international law.

There are only two ethical options left for the Australian Government. The first option is to invest Australian tax payers’ money in improving the facilities on Manus Island, providing mosquito nets, and supplying universal medical prophylaxis and healthcare with informed consent to detainees (which may be impossible with pregnant women, children and those most vulnerable to malaria). The second option is to immediately abandon any plans the Government has to send asylum seekers to Manus Island.

When Australian Government officials on Manus Island this week take their medically-assessed and freely consented to antimalarials, don their long shirts and pants, spray their insect repellent, and don’t have to worry about closing their mosquito nets securely around their hotel beds thanks to the air-con, perhaps they can take a moment to consider whether it would be conscionable for the Australian Government to expose persons in its custody and care to the conditions on Manus Island.

Alexandra Phelan is an Australian international health and human rights lawyer, and was involved in writing a book chapter on a human rights based approach to malaria at the World Health Organization, to be released later this year. View her full profile here.

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).

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.

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.

A Taste of Their Own Medicine: Appealing Texas to the US Supreme Court

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Used under creative commons licence, copyright to image held by Mark Fischer on flickr @ http://www.flickr.com/photos/fischerfotos/7432028860/

Sometimes, the consequences of a law on individuals can be too abstract. The implications may be set before a court by lawyers, but when a decision is made that affects not only a woman’s rights but also the tangible, physical sense of control over her own body, its consequences are immediate.

On Friday, more than forty women were turned away from previously scheduled abortions at Whole Women’s Health clinics in Texas, and more than one hundred women have had their appointments cancelled at a Planned Parenthood clinic in Austin. Only a few days earlier, a Federal Court Judge had struck down parts of a Texas Law that required physicians performing abortions to conform to strict admission privileges requirements as unconstitutional.  On Halloween however, the Fifth Circuit Court of Appeal agreed to hear an appeal by Texas at a later date, while also putting the Federal Court Judge’s decision on hold. As a result, come Friday morning, the admission privileges requirement (even though deemed unconstitutional by a Federal Court Judge) came into effect, denying Texas women in areas unable to conform to the strict requirements their reproductive rights, and putting their health and safety at risk.

While the full appeal is yet to be heard, and the current stay of the decision only temporary until then, there is a risk that the Court of Appeal, may permanently uphold the constitutionality of the Texan abortion law reforms.

In a proactive response, the women’s health providers who filed the original suit have lodged an emergency application with the US Supreme Court to reinstate the Federal Court’s decision to strike down the Texan laws. In effect, they’ve given the Texas Attorney-General a taste of his own medicine.

According to the Center for Reproductive Rights, the Supreme Court has given Texas until next Monday (11 November) to respond to the appeal. Until then, the law will remain in place. Here’s hoping that even in granting a temporary decision, the Supreme Court recognises that the mere risk of violating Texan women’s constitutionally protected rights, as well as the risk to their health and access to essential services, far outweigh Texas’ clearly political position on this matter.

Halloween descends: Texas abortion law reinstated temporarily

In a fitting All Hallows’ Eve turn of events, the Texas Attorney-General’s emergency motion to reinstate the controversial abortion law following Monday’s District Court decision has been granted. Feel like banging your head against a table? Here’s the link to the decision, or alternatively read on.

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© Alexandra Phelan (2013)

Last night, the United States Fifth Circuit District Court of Appeal pressed pause on Justice Yeakel’s decision that requiring physicians performing abortions to have admission privileges placed undue burden on women seeking abortions, and was unconstitutional. As a result of granting the emergency motion and staying the District Court’s decision, the Texas law at the centre of these legal debates has come into effect. Like a temporary injunction, the Court of Appeal will hear the appeal in full at a later date, and come to a permanent decision on the law.  If you’re legally minded, how the Court of Appeal came to its decision is discussed in more detail below. Regardless of the outcome of that decision, it is likely that, in the words of Texas Attorney-General Greg Abbott (a leading Republican candidate for governor and the proponent of the law) “this case is going all the way to the United States Supreme Court”.

According to the Planned Parenthood Federation of America, one-third of Texas health centres providing abortions will be forced to cease providing them today. Planned Parenthood, who has 13 clinics in Texas, has already been forced to stop providing abortions at four of its clinics today, as they have been unable to find physicians satisfying the law’s required admission privileges.

In a positive turn however, the District Court of Appeal did not grant the emergency motion staying Judge Yeakel’s decision on ensuring that pregnant women who would not be suitable for surgical abortion can still access medication abortions up to 63 days from her last menstrual period. That being said, the fact that the District Court of Appeal describes these women as “mothers” demonstrates the unfortunate perspective from which the court approached this decision.

To stay or not to stay? How the Court of Appeal came to its decision

The emergency motion lodged by Texas requested that the Fifth District Court of Appeal stay the District Court’s Monday decision as if it had not been made, therefore allowing the Texas law to come into effect on 1 November 2013.

As is the case with temporary injunctions pending a full trial, a decision on a “stay pending appeal” is based on a series of tests to determine whether the stay should be temporarily granted, with a permanent decision coming at a later date. As a result, none of the actual facts of the case, “the merits”, are decided upon.

The Fifth District Court of Appeal considered four factors in its decision:

  1. Whether Texas made a strong showing that it was likely to succeed on the merits (i.e. is it likely to win at the later trial);
  2. Whether Texas will be irreparably injured if a stay is not granted;
  3. Whether issuance of the stay will substantially injure the other parties interested in the proceeding; and
  4. Where the public interest lies.

As you can see in the latter three points, in a case like this, compared to a purely commercial situation, it’s pretty difficult for the merits of the case to not be assessed to some degree. Unfortunately, as a woman’s health and human rights advocate, it’s hard not to read the Court of Appeal’s ruling as being essentially a decision on the merits, including the statement that “the district court’s finding … is not supported by the evidence, and in any event, “a legislative choice is not subject to courtroom fact-finding and may be based on rational speculation unsupported by evidence or empirical data”. That is, legislators are completely entitled to make laws that are not based on any evidence, even if they justify the laws as being based on rational speculation. If you think that sounds a bit oxymoronic, you’d be right. Perhaps its the scientist in me, or the public health policy advocate, but when it comes to making decisions about women’s health, actual medical or other scientific evidence is critical in rationalising legislative restrictions. From a legal standpoint however, the sovereignty of the legislature is a well established element of democratic representation, and here, the Court of Appeal has made it clear that the decisions of the Texas legislature, even if based on evidence found by a court to be wanting, reigns supreme.

Fundamentally (see what I did there?), Texas pushed the argument that the laws these laws were crafted “to protect the health and safety of Texas women”. How delightfully paternalistic. While abortions may require extra protections to ensure they are carried out in a safe manner, that is due to their history as illegal and hidden procedures, carried out in unsanitary and unsafe conditions. It is the illegality of abortion that has caused these extra protections. In contemporary society, with legalised and widely available services for women’s reproductive health, abortion may be treated as any other medical procedure. As a result, the scrutiny of physicians performing abortions should be no more and no less than any other surgery or drug administration. It is the fact that abortions are singled out in these laws that demonstrates that they are discriminatory against women and in violation of their constitutionally protected reproductive rights.

The District Court of Appeal’s finding that the the State does have a case to make on the merits seems  superficial. However, such conclusions are often the case with temporary measures by courts, with full analysis of the merits taking place at a later date. The problem however, is the injury experienced by women in Texas per element three the four stage test set out by the Court above. How the Court came to the conclusion that having to travel 240 km (150 miles) to obtain an abortion is not an undue burden is beyond me. When the Court proposes that women drive (or bus, or train, or bicycle, or walk) to Corpus Christi, 160 miles away from Rio Grande City, I can completely understand why women cross the border to Mexico. If Texas legislators truly cared about women’s health and safety, they would ensure that all Texan women, regardless of race or whether they live in rural or urban areas, have access to abortions. It is quite clear that none of these laws are about women’s health, and the Court of Appeal’s failure to see through this, and failure to adequately weigh the detriment to Texas women in its decision to stay, is disappointing.

Worth watching

Check out Amy Hagstrom Miller on the Rachel Maddow show last night talking about the ruling.

Oklahoma! Questions Answered – SCOTUS Repro Rights Case Case Can Proceed

Oklahoma Capitol Seal (2013) by mrlaugh on flickr at: www.flickr.com/photos/mrlaugh/9529159402/

Used under creative commons licence, copyright to image held by mrlaugh on flickr @ http://www.flickr.com/photos/mrlaugh/9529159402/

It’s been a busy week in the US for the law and women’s reproductive rights. Following yesterday’s Federal Court decision in Texas, this morning the Oklahoma Supreme Court has issued its answers to questions submitted to it from the US Supreme Court.

These questions form part of a case that has been appealed to the US Supreme Court from Oklahoma’s top court, Cline et al v Oklahoma Coalition for Reproductive Justice. The US Supreme Court paused hearing the proceedings until its questions had been answered by the Oklahoma Supreme Court.

In 2011, Oklahoma passed a law banning the off-label use of misoprostol (Cytotec), mifepristone (RU-486) and methotrexate, for the termination of a woman’s pregnancy (a more detailed description of off-label use of RU-486 is available in a previous post). The law did not ban off-label use of these drugs in other circumstances, reflecting that the purpose of the laws was to target abortion specifically and therefore denying women specifically the right to medical advances and scientific evidence in their medical care. This law was challenged by the Oklahoma Coalition for Reproductive Justice on the grounds that the law was in violation of the rights of women to equal protection of the laws, privacy, bodily integrity and freedom of speech as protected under the Oklahoma Constitution.

Prior to the law, Oklahoma did not differentiate between medication and surgical abortions. Similar to the case in Texas yesterday, the law required doctors to use the drugs only in accordance with the protocol set out by the US Food and Drug Administration. For a number of reasons, such protocols are not necessarily the most safe and effective uses of a medication, leading doctors to examine medical literature and scientific evidence for the best use of the medications, “off-label use”. Doing so is not illegal and is common practice in the United States allowing for best medical practice in the face of scientific advances. An example of such advances is medication abortions, which can be performed earlier in pregnancy than surgical abortions, is less invasive and more private. There are also a number of medical reasons why a medication abortion would be more advantageous than a surgical abortion for certain women.

According to the Plaintiffs’ petition to the Oklahoma County District Court in 2011, approximately 2/3 of patients having a first-trimester abortion choose medication abortions. Such abortions would have been banned under the effect of the Oklahoma law.

Events leading to Supreme Court

In December 2011, the Oklahoma County District Court issued a preliminary injunction preventing the enforcement of this new law. In May 2012, this was converted into a permanent injunction, recognising the rights to bodily integrity and the right to terminate a pregnancy as protected under the Oklahoma Constitution.  The Oklahoma Commissioner of health, Terry Cline, and others, appealed the decision to the Oklahoma Supreme Court. In December 2012, the Court upheld the District Court’s decision, finding that the law was unconstitutional. In March of this year, the Oklahoma Attorney General filed a petition for certiorari with the US Supreme Court, seeking judicial review of the Oklahoma Supreme Court’s ruling.

The US Supreme Court allowed the petition, meaning that it would hear the case and conduct a judicial review of the Oklahoma Court’s ruling, however before doing so, required that two questions of law must be answered by the Oklahoma Supreme Court.

Question 1: Does the law prohibit the use of misoprostol to induce abortions, including its use in conjunction with RU486 according to an FDA protocol?

That is, are the methods of use set out by the FDA the real issue here, or is it clearly a way of banning abortions regardless of FDA approvals.

Question 2: Does the law prohibit the use of methotrexate to treat ectopic pregnancies?

That is, when a woman has a pregnancy where the embryo implants outside of the womb, which is in most cases not viable and dangerous to the mother, are doctors prohibited from using methotrexate terminate the growth of the developing embryo.

The Oklahoma Supreme Court answered both questions with a resounding yes. Answering these questions was a matter of statutory interpretation, and therefore legal rather than factual questions. For law students, the Oklahoma Supreme Court’s responses provide an interesting example of how a court proceeds with statutory interpretation, but that’s an examination for another day. The Court concluded that the law “effectively bans all medication abortions”, and made a very clear statement on the poor attempt by the legislature in Oklahoma to supersede their political beliefs over the training and experience of medical professionals, stating that:

“[t]he role of the physician is to heal the sick and the injured, and physicians are required to undergo rigorous training to develop the required knowledge and experience to perform that role well”.

Citing their original finding, the Court reiterated that the law’s restrictions on the use of these drugs when used for abortion is

“so completely at odds with the standard that governs the practice of medicine that it can serve no purpose other than to prevent women from obtaining abortions and to publish and discriminate against those who do”.

Now that the the Oklahoma Supreme Court has responded to the US Supreme Court’s questions, it is likely to proceed to be set for argument and decided in the current US Supreme Court Term. According to SCOTUS blog, there is a possibility that the US Supreme Court will seek formal responses to the Oklahoma Supreme Court’s answers from the plaintiffs and respondents.

Couple this case with yesterday’s Texas case (and the announcement that it will be appealed to the US Court of Appeals in the Fifth Circuit) and we have a positive track of the judiciary upholding women’s reproductive rights that we can only hope will be affirmed by these higher courts.

Good but not Great: Parts of Texas Abortion Law Declared Unconstitutional

Texas Legislature 2013

Used under creative commons licence, copyright to image held by sparkleplen_t on flickr @ http://www.flickr.com/photos/98759094@N00/9195467920/

Update 2 30 Oct 2013 @11.25am: The 5th Circuit Court of Appeal did not grant Texas’s emergency motion to block Judge Yeakel’s decision. As a result, Judge Yeakel’s permanent injunction preventing the new abortion laws discussed below from coming into effect remains in effect, allowing clinics to stay open and doctors to administer medical abortions in certain cases.

Update 29 Oct 2013 @1.52pm: Overnight, Texas asked for an emergency order from the 5th Circuit Court of Appeal to block Judge Yeakel’s decision. The struck out provisions would have otherwise gone into effect today. Texas has asked the Court of Appeal to decide on an emergency temporary injunction today, and hear the full appeal in January.

Less than 2 hours ago, a Federal Court Judge in Texas struck down two key parts of the Texas Abortion Law amended by “House Bill 2” on the grounds that they placed undue burden on women seeking an abortion. The law is the same one made famous by Democrat Senator Wendy Davis’ marathon filibuster efforts when House Bill 2 was brought before the Texas Senate in June this year.  House Bill 2 was later signed into law by Governor Rick Perry after passing both the Texas House and Senate in a special session, however women’s health organisations, including Planned Parenthood, launched an appeal to the law seeking that it be declared unconstitutional by the court. House Bill 2 is scheduled to take effect on 29 October 2013.

The lay of the land

In Texas, a woman has a right to terminate her pregnancy before it is viable. A law will be unconstitutional if it imposes an undue burden on a woman’s decision to abort a fetus before it is viable. An undue burden includes any legislation that has the purpose or the effect of placing a substantial obstacle in the path of a woman seeking an abortion for a nonviable fetus. Where a fetus is viable, legislation may be made restricting the right to an abortion, except where an abortion is necessary for the preservation of the life or health of the mother. In the seminal (or perhaps ovarial?) case on this issue, Roe v Wade, fetal viability “is usually placed at about seven months (28 weeks) but may occur earlier, even at 24 weeks”. Part of House Bill 2 changed the definition of fetal viability to 20 weeks, drastically cutting back the time period of a Texan woman’s right to an abortion for a nonviable fetus.

This change to the definition of fetal viability was not the central point of the court’s decision – rather, two other parts of House Bill 2 were challenged on the grounds that they were unconstitutional.

Judge Lee Yeakel of the Federal Court for the Western District of Texas (see a primer on US District Courts here) held that two parts of House Bill 2 were unconstitutional, as they placed undue burden on women seeking an abortion of a nonviable fetus.

In summary, Judge Yeakel held that:

  • the requirement that doctors performing abortions have admission privileges was without a rational basis and placed a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus; and
  • the restrictions on medical abortions place a similar obstacle in cases where a physician finds such an abortion necessary.

The findings of the Court on these two points are discussed in further detail below.

Admission privileges requirement

Admission privileges are the ability of a doctor to admit a patient to a particular hospital for medical treatment. Typically, a doctor will have admission privileges where they are on a hospital’s medical staff, however admission privileges may also be given to external doctors to admit patients to a hospital.

House Bill 2 required that a physician performing an abortion must have admission privileges at a hospital with obstetric or gynaecological health care services less than 30 miles away from where the abortion is performed. If a physician performs an abortion contrary to these requirements, they are liable for a Class A misdemeanour, punishable by a fine up to $4,000. As a result, doctors working in an abortion clinic in a rural area or any area more than 30 miles from a gynaecological hospital where they have admission privileges would be criminally liable under the House Bill 2.

Texas argued that the admission privileges requirement was a necessary part of protecting the health of women, as a physician with admission privileges will be in a better position to ensure continuity of care at a hospital in the case of patient complications. In addition, Texas argued that this would also decrease the likelihood of medical errors in the patient transfer process from abortion provider to hospital. Texas failed to provide any evidence supporting a correlation between medical errors, patient transfers and a physician’s “admission privilege” status. The Court destroyed this position rather logically – pointing out that admission privileges have nothing to do with a patient when they turn up at a hospital for emergency care, and that by law a hospital cannot refuse to provide emergency care. In addition, there was no evidence that admission privileges affected a patients quality of care in an emergency room. As a result, the Court found that there was no rational basis of imposing this requirement, and as such a requirement would leave at least 24 counties in the Rio Grande Valley without an abortion provider who could satisfy it, women in those regions would face a substantial obstacle in accessing abortion services.  The outcome: the admission privileges requirement places an undue burden on Texan women seeking to exercise their Constitutional right to an abortion before fetal viability, and as a result, is unconstitutional and struck out.

Medication abortion

A medication abortion typically requires the administration of two drugs. The first, mifepristone, or RU-486, acts by preventing a fertilised egg from attaching, or an embryo from staying attached, to the uterine lining. Misoprostol acts to contract to uterus and expel the embryo and uterine contents. These drugs are an alternative to surgical abortions, or dilation and curettage.  The FDA has approved the use of these drugs to the first 49 days after a woman’s last menstrual period. The American College of Obstetricians and Gynecologists has endorsed the use of these drugs in a varied manner (“off-label”) and at lower doses, resulting in reduced doctor visits and side effects while also extending the period that RU-486 can safely be used up to 63 days after a woman’s last menstrual period.

House Bill 2 amended Texan safety laws to restrict the administration of these drugs to the FDA protocol, while allowing the off-label dosages. In Court, Texas conceded that the mixed FDA/off-label protocol required by the law was completely untested. The Plaintiffs argued that the FDA protocol required by House Bill 2 is not medically necessary and the off-label protocol, taken as a whole to include administration method and dosage, is the safest and most widely used use of RU-486. In addition, the FDA approach prevents medication abortions from 50 – 63 days, leaving women with only surgical options to abortion. The Court held that the differences between the off-label and FDA protocol may on their own be incidental, but as a totality, such as doctors visits plus side effects plus cost, but in totality may become an undue burden, however this was not satisfied in this situation. The Court also was not satisfied by the argument of a “preferred” option of medication versus surgical abortions, stating that “[i]ndividuals do not have a constitutional right to a preferred medical option, so long as a safe, medically accepted, and actual alternative exist”. For the Court, surgical abortions satisfy this.

However (and it’s a big however!) where a medication abortion is the only safe and medically sound option for women with particular physical abnormalities or preexisting conditions, House Bill 2 places a substantial obstacle in the path of such women seeking an abortion. Even though the Attorney-General of Texas stated that they wouldn’t prosecute a doctor performing such an abortion, “a promise not to prosecute from the Attorney General is not binding”.

As a result, the Court held that the medication abortion provisions of House Bill 2 placed an undue burden on those women for whom surgical abortion is, in the medical opinion of their physician, a significant health risk during a pregnancy from 50 to 63 days after their last menstrual period.

Conclusions

The findings of the Court and Judge Yeakel are generally good outcomes. As a result of this decision, 1/3 of Texas abortion clinics that would otherwise have likely had to close will not, and safe, medication abortions are available for women whose health would otherwise be put at risk by a surgical abortion.

Unfortunately, the 20 week viability definition still remains on foot. In addition, women must fall within a very specific category to have access to medication abortions after 49 weeks, which are safe, effective and more private than surgical options.

In the words of Nancy Northup from the Centre for Reproductive Rights, “[p]oliticians, not doctors, pushed for both of these unconstitutional restrictions – despite the best medical standards for women’s health care”.

The Texas Attorney General is expected to file an appeal of Judge Yeakel’s order to the 5th Circuit Court of Appeal.

Regardless of whether that occurs, there is more work to do in Texas: access to safe abortion options are a reproductive right, and an essential element of access to essential healthcare for women.