Better to Best: Thoughts on Global Health Care Systems

Why I’m even more skeptical about a Novartis exec joining the Gates Foundation

Posted in Health Rights, Human Rights, PharmFree by reshmagar on October 19, 2011

From MSF India – still unclear as to why a executive coming from a company that is trying very hard to deny access to an affordable version of a key life-saving leukemia drug is joining the Gates Foundation, an organization that prides itself in providing inexpensive vaccines and other drugs to developing countries worldwide.


Médecins Sans Frontières briefing note, 4 October 2011

Swiss pharmaceutical company Novartis issued a press statement last week in
response to the growing concerns regarding its latest legal challenge
against the Indian government. Ahead of the next hearing of the case in the
Indian Supreme Court set for 17 October 2011, Médecins Sans Frontières
addresses the issues Novartis raised in its statement.

BACKGROUND: The Supreme Court case is the final act in a legal battle over
the patentability of the salt form of the anti-cancer drug imatinib and
section 3(d) of the Indian patent law that stretches back over five years.
In 2006, the Indian patents office ruled that Novartis did not deserve a
patent for imatinib mesylate, a salt form of a life-saving cancer drug, on
the grounds that the application claimed a new form of a drug too old to be
patentable in India (see notes below). The company then embarked on a series
of lawsuits against the Indian government including the one that is
currently pending before the Supreme Court. In this case Novartis is
challenging a part of India’s patent law – Section 3(d) – which read with
other provisions of the patent law and the Madras High Court decision says
that a new form of a known medicine can only be patented if it is not
obvious and shows significantly improved therapeutic efficacy over the known

*What Novartis says: “price doesn’t affect access to medicines”.*

In its statement, Novartis writes “Acknowledging innovation by granting a
patent is unrelated to the access to medicines issue. Improving access to
medicines is a matter of making medicines available.”

This is not the entire truth. MSF has found, during its field experience in
working in many developing countries, that granting a patent has had a
direct bearing on access to affordable essential medicines. Granting a
patent on a medicine provides the patent holder with a monopoly on that
medicine, which in turn allows the company to charge a high price in the
absence of any generic competition. In fact, improving access to medicines
is a matter of not simply making the medicine available but also making it
affordable for patients and governments to buy. This is well documented.
When AIDS treatment first became available in the late 1990s, the price of
first line patented AIDS medicines was – even after discounts – US$10,439
per patient per year. Millions died in developing countries, particularly in
Africa, as prices were too high. Generic competition brought prices down
making treatment possible. In MSF’s experience, patents on medicines are a
key barrier to making medicines affordable, as it prevents access to those
who cannot afford it.

*What Novartis says: “this case will in no way impact access to medicines
to poor countries”. *

This is not true. If Novartis succeeds in weakening the interpretation of
section 3(d) for the purpose of obtaining a patent on imatinib mesylate, the
Indian Patent Office would have to apply the same standards of intellectual
property protection as wealthier countries like the US, granting far more
patents than required under international trade rules or envisioned by
India’s lawmakers.

It is not only about this particular medicine. The interpretation of the
clause has a direct bearing on the examination of patent applications
claiming salt forms, pediatric formulations and other improved formulations
of AIDS drugs, the generic versions of which are currently used by MSF in
its medical projects. This case would set a precedent in this regard.

This could lead to generic competition on many essential drugs ending
entirely and prices for these in both India and developing countries
increasing. This would have a devastating impact on not only people MSF
treats, but also on people the world over who rely on affordable medicines
manufactured in India. MSF buys 80% of the ARVs it uses to treat 170,000
people for HIV across the developing world from Indian generic
manufacturers, and donors rely on Indian sources in similar proportions.

It is crucial to preserve the public health safeguards of Indian patent law
– particularly Section 3(d). The future of generic production is largely
dependant upon the outcome this case.

Imatinib mesylate is a crucial anti-cancer drug sold by Novartis in India
for Rs.120,000 (US$ 2,400) per patient per month. Indian generic companies
sell generic versions for Rs. 8 – 10,000 ($160 – 200) per patient per month.

*What Novartis says: “Section 3(d) – as it relates to evergreening – is not
applicable at all to Glivec”. *

Novartis is seeking a patent in India on the salt form of imatinib (Glivec).
Claiming a patent on a salt form of an existing drug is a common and
well-known form of evergreening by pharmaceutical companies to extend the
patent life – and monopoly – of their drugs. And companies do this routinely
to prevent generic competition. An example of this is the AIDS drug
abacavir. Although the abacavir molecule was first developed and patented in
the 1980s, pharmaceutical company GSK applied for a patent in 1997 on
abacavir sulphate (salt form) in developing countries, with the intention of
obtaining a patent monopoly until 2017. Where the patent was granted this
has blocked access to affordable generic forms of abacavir in many
developing countries.

*What Novartis says: “Glivec has been granted a patent in nearly 40
countries and India should also follow suit”*.

This is a mistaken interpretation of international intellectual property
rules. Although the TRIPS Agreement obliges all members of the World Trade
Organization to grant patents on medicines, nothing obliges developing
countries like India to replicate patent systems of wealthy countries. An
important flexibility in this respect is the right of WTO Member States like
India to define the patentability criteria in accordance with their
particular national priorities. This is precisely what India did when it
amended its Patents Act in 2005. At the time of implementing TRIPS, India
felt that many countries were granting a large number of patents on new uses
and new forms of known medicines, which was becoming a key reason for
creating longer patent barriers and high prices in developing countries. So
along with patent protection for new innovative medicines, Indian lawmakers
introduced a specific provision, section 3(d), in its patent law that
excludes from patentability new uses and new forms of known medicines. The
system India has is not perfect, but it does prevent drug companies from
getting unjustified 20 year monopolies every time they come up with a new
use or a new form of a known medicine.

*What Novartis says: “medicines can be made available through access
safeguards in international agreements and, in the case of essential and
life-saving medicines, special pricing arrangements in developing
countries”. *

While this is correct – countries have the legal flexibility to issue
compulsory licences to generic producers on patented drugs where it hinders
access to essential medicines – measures like tiered pricing in our
experience are not the most effective way to make medicines affordable.

Novartis also seems to imply that countries can only act once patents are
granted. However, a lesser known key TRIPS flexibility is the right of a
country to take steps before a patent is granted to ensure that patent
applications on routine and obvious improvements of medicines are not
granted so that they do not disrupt supply of affordable generic medicines
to patients. India has chosen to adopt this safeguard with the introduction
of Section 3(d) in its patent law, while allowing patents to be granted on
new medicines from 2005.

*Notes for the editor: *
The basic molecule imatinib was first patented (US 5521184) in 1993. India
signed the WTO TRIPS agreement in 1995 and opened up filing of product
patent applications in India. In 1998, Novartis filed an application
1602/MAS/1998 on the mesylate salt of Imatinib. This case relates to the
1998 application.

Pharm Stuff. In ze news.

Posted in Human Rights, PharmFree by reshmagar on July 26, 2011

Read this:

The Bin Laden vaccine: Yes, vaccinations are a CIA plot | The Economist.

Then, read this:

KENYA: People Dying Because of Lack of Anaesthetics

And this:

Companies Shut Down HIV Drug Discount Programmes In Middle-Income Countries, Where Prices Can Be Over Ten Times Higher

Finally, read this:

Pfizer Breaks Psychological Need To Always Seek FDA’s Approval
(Thanks Alissa!)

And because the above stuff is mostly depressing, you should listen to this to cheer you up. It’s cheering me up from studying for my shelf! YAY!

What does secession mean for Southern Sudan?

Posted in Human Rights by reshmagar on January 10, 2011

Yesterday, the people of Southern Sudan voted on independence referendum to create a brand new country in the world. So far, so good.

(courtesy of Long lines formed Sunday at polling places in Juba, in southern Sudan, for a referendum on independence. The voting, which will continue through the week, was reported to be going smoothly.

To read more about this historic event, go here: In Southern Sudan, a Jubilant Vote on Secession

But what does this all mean? I came across this great Q&A with Jonathan Temin, senior program officer on Sudan at the U.S. Institute of Peace from PBS Newshour.

Q&A: South Sudan’s Independence Vote

Residents of southern Sudan vote Sunday in a long-awaited referendum on whether to split from the north and form their own country. Analysts expect the oil-rich south will choose independence in the Jan. 9 referendum, which lasts a week, possibly triggering clashes between militias tied to both governments.

Jonathan Temin, senior program officer on Sudan at the U.S. Institute of Peace who travels regularly to the region, provides insight on the historic vote:

When will we know the results?

JONATHAN TEMIN: Vote counting is expected to take several weeks, so results will not be immediate. Current estimates are that results will be finalized in the first half of February. So some patience will be required as the counting process plays out — the authorities will be careful to stick to the provisions for vote counting and appeals in the legislation that govern the referendum.

Would the split occur immediately?

TEMIN: No, if there is a vote for secession it will occur at the conclusion of the Comprehensive Peace Agreement, which will be July 9, 2011, six months after the referendum. So patience will also be required in waiting for that date. The fact that there will be six months between the referendum and possible secession is not widely understood in many of the more remote parts of southern Sudan. But those six months will be important to the ongoing negotiations between northern and southern authorities on outstanding post-referendum issues, such as future revenue sharing, division of Sudan’s debt, and citizenship rights.

What changes would southern secession bring to people’s daily lives?

TEMIN: Significant changes may not be immediate. Many people in southern Sudan have high expectations that secession will quickly bring significant dividends, but this is not likely to happen. The Government of Southern Sudan remains nascent and in need of substantial capacity building; its ability to bring much-needed services to its constituents, especially in rural areas, is minimal.

Of the services (food, health, education, etc.) that are available in southern Sudan, many are delivered by nongovernmental organizations and United Nations agencies. Managing expectations in the post-referendum period will be essential, because if citizens maintain high expectations, and the Government of Southern Sudan continues to struggle to deliver services, the discontent created can be dangerous.

Will we see mass movements of people either to the north or south?

TEMIN: It is possible; the most likely movements are of southerners living in northern Sudan moving back to southern Sudan. Estimates vary widely, but many people agree that there are approximately 1.5 million to 2 million southerners living in northern Sudan, many of them in and around Khartoum.

Already a significant number of southerners living in the north — possibly up to 100,000 — have returned to the south in recent months. There are concerns that southerners living in the north may be targeted for violent attacks or deprived of some of their rights if there is a vote for southern secession. This is why ongoing negotiations on post-referendum citizenship rights are so important — those negotiations will define what rights and status (dual nationality, permanent resident status, etc.) will be enjoyed by southerners living in the north and northerners living in the south. The safety and security of northerners living in the south is important as well, but there are significantly fewer of them than southerners living in the north.

Would the split have any impact on Darfur?

TEMIN: This is an important question that doesn’t get enough attention, especially given recent accusations by the north that the south is supporting Darfur rebels. There has been periodic cooperation between southern authorities and Darfur rebels over the years (fighting through proxies is a common practice throughout Sudan).

But if the south secedes peacefully I expect it will limit support for northern opposition groups and turn inwards, focusing on internal challenges (and when President [Omar] al-Bashir visited Juba on Tuesday the southern leader, Salva Kiir, publicly promised that the south would not support any armed northern opposition).

The Darfur rebel movements are likely in a holding pattern, waiting to see what happens in the referendum process and whether it is peaceful or violent. If there is violence, they may see an opportunity to try to force the northern army to fight on two fronts, something it is not eager to do.

You’ve been there in the lead-up to the vote. In your view, what are the chances that violence or even civil war will break out?

TEMIN: I am cautiously optimistic that the referendum process will proceed relatively smoothly and peacefully — and this is a change from my expectations six months ago, when I thought there was a significant likelihood of a southern unilateral declaration of independence and substantial violence.

Preparations for the vote have been impressive and recently the international community, including the U.S., has done a good job sending a unified message that the referendum should happen on time and the results should be respected.

There likely will be some local violence around the referendum process, as Sudan can be a violent place, but what will be essential is not allowing that local violence to escalate and become politicized. Ultimately, it is up to the leaders in northern and southern Sudan to ensure that doesn’t happen.

I too would like to be “cautiously optimistic” and hope that through this referendum there may be a start of a decline in violence and death in the region. It’s uncertain to me though what will occur with prized resources such as oil being primarily in the South. It is certain though that the country born out of this vote will be one of the poorest nations in the world – how will the new government of Southern Sudan fare in tending to its citizens? All eyes around the globe should be trained on the nation and be ready for whatever is to come.

President Obama offers another optimistic view on the vote: In Sudan, an Election and a Beginning

And another.

Posted in Human Rights by reshmagar on December 31, 2010

I couldn’t really sleep last night. I’m not sure why. I know I was really, really wanting pancakes to the point of imagining them with various toppings doing the sugarplum fairy dance. I even tried to read some of the most boring books I had with me (thanks, Med school) but nothing worked so I instead decided to catch up reading the news. Amidst all the articles about the best things of 2010, I found this and it sunk my spirits a bit:

Sudan recalls its team from Doha but says it’s still committed to peace in Darfur

December 30, 2010 (DOHA) — Sudan’s negotiating team will leave the Qatari capital but that does not means the government’s withdrawal from the peace process, said presidential adviser Ghazi Salah Al-Deen in Doha on Thursday.

The move comes after an ultimatum given by President Omer Hassan Al-Bashir in Nyala, South Darfur Wednesday. He also said his army would fight rebel groups in the region stressing dialogue should take place inside Darfur with those who want development.

and then there was another…

Peace Hovers in Sudan, but Most Soldiers Stay Armed

The peace negotiations included agreements on representation in government, the sharing of wealth and a huge reduction in troops on both sides, by 180,000 soldiers in all. Many treaties had collapsed before, and there were moments when this one seemed doomed as well, but it has managed to endure — nearly all the way to its climax, a vote on Jan. 9 on independence for the south.

With little more than a week to go until the vote, ballots have been printed, voters registered and campaign rallies held. A countdown clock is posted in the capital, Juba, and foreign officials are flying in for the occasion.

But a major component is lagging: virtually none of the soldiers have put down their weapons and fully rejoined civilian life.

and there were some that were just surprising. This epitomizes the phrase “the lesser of two evils”.

Omar al-Bashir is no bogeyman

Bashing Omar al-Bashir is a popular pastime in progressive circles, not least in the conscience-flaunting milieus favoured by actor George Clooney and other celebrity campaigners. Sudan’s president, demonised by the UN over Darfur, pre-judged by the international criminal court’s chief prosecutor and ostracised by western governments, makes an easy target. America always needs bogeymen and Bashir fits the bill: big, bothersome, bad-tempered, black, Arab and Muslim.

But as Sudan moves towards a 9 January referendum in which southerners are expected to vote overwhelmingly for secession from Khartoum, Bashir-bashers have fallen on lean times. Confounding his critics’ predictions, Bashir has not purposefully obstructed the ballot, not fatally impeded voter registration, and not indulged in intimidation of southerners – an assessment shared by the UN and Britain. Bashir, so far, is behaving reasonably well. This is particularly impressive given the North (as the Khartoum-led portion of Sudan may soon be known) stands to lose 25% of its territory, substantial oil revenues and 20% of its population when the South secedes. Any leader might feel nervous in such a scenario. And Bashir, less the great dictator of western imagining and more the chief oligarch of the cut-throat National Congress party, is vulnerable. He has no inevitable hold on power.

I suppose since he’s cooperating we can set aside the fact that he sanctioned the deaths of millions. No biggie. Shake hands with the devil much?

A small setback but on a positive note, the Sudanese government did still make a public pledge to peace. Plus, there’s still time for you, my wonderful reader, to make a New Year’s Resolution that you are guaranteed to fulfill within 2 minutes.

Go to SudanNow’s website and follow the steps to take action to tell President Obama that the United States needs to be a prominent member in creating real peace in Sudan.

Here are things I liked from 2010 (or in other words, the past week):

Jillian Ross

A more recent bit of odd news, a 23-year-old South Carolina man was struck by a car after apparently yelling "go" and darting across traffic. He was in stable condition as of Monday night. Authorities said he had been discussing the game (Frogger) with friends prior to the incident.

And because my back-up plan to becoming a doctor is to become a culinary master, check out heavens on plates: Party Food Recipe Inspiration for New Year’s

Happy happy happy New Year everyone! See you again in 2011.