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Patent protections

AFP reports that the Indian drug manufacturer Cipla will drastically reduce the price of three important cancer drugs — each of them under patent to one of the big western pharmaceutical firms.  With Cipla’s new pricing scheme, the drugs will be purchasable for about 25% of the price charged by the patent holders, Bayer, AstraZeneca, and Schering.

As the Wall Street Journal reports, the break point came when the Indian patent office required Bayer to grant a license to an Indian manufacturing firm (not Cipla, actually) for its liver/kidney cancer medication Nexavar.

The head of the European Federation of Pharmaceutical Industries and Associations said that the companies would prefer to make drugs affordable through so-called tiered pricing schemes, wherein the price of a drug varies from country to country in regard to local cost of living.

In a 2009 article in Global Health magazine, Andrew Jack notes that some big pharmaceutical companies have lowered their prices to try to compete in the huge Indian market, including selling the diabetes drug Januvia (Merck) for one-fifth its US price.  GSK, Jack notes, even has different prices in different parts of India.

Tiered pricing or patent busting — a big problem remains unresolved:  even when prices are lowered to $100 per dose, many people can’t afford them.  Last year, an article in The Economist showed results of surveys by Abhijit Banerjee and Esther Duflo:  over 90% of respondents in rural India (and about 80% of Pakistanis, 70% of Bengladeshis, etc.) live on $2 a day or less.  For such households, the cost of a single dose of cancer medication — even at the Cipla price — is equivalent to weeks worth of food.

A Reuters article today describes the problem of access to cancer medications for India’s poor.  Even though India has allowed local manufacturers to make a cancer drug that is elsewhere patented by Bayer, and might allow the same to happen with Novartis’s Gleevec, many Indians are too poor to afford even the generic medications.

With around 40 percent of the population living below the poverty line, healthcare is an upper-middle-class luxury in much of India where spending in private clinics is four times the amount of that in government hospitals. The poorest would-be patients literally beg for treatment on the outside of a chronically underfunded and overstretched health system.

If compulsory licensing still leaves millions of people untreated, what else should be done?

A briefing paper issued by Doctors Without Borders (Médecins sans Frontières) takes issue with Novartis’s response to the contention that the company should not be granted a patent on the leukemia drug Gleevec in India.

Basically, the humanitarian organization disagrees with Novartis’s claim that there’s no connection between patent protection and drug cost/availability.  They explain their own experience, for instance with patent protection on AIDS meds:

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.

And, whereas Novartis argues that it should be able to have a monopoly on Gleevec in India because 40 other countries have recognized its patent, MSF says

Although the World Trade Organization’s (WTO’s) … TRIPS Agreement obliges all WTO members, including India, to grant patents on medicines, nothing obliges developing countries to replicate the patent systems of wealthy countries.

The Gleevec suit will be decided by an Indian court at the end of March.  Meanwhile, there’s a new development in a related case:  This week, India used compulsory licensing to grant the right to make a different cancer drug, sorafenib tosylate (used for kidney and liver cancers), breaking Bayer’s monopoly.

The director of MSF’s Access campaign said

When drug companies are price gouging and limiting availability, there is a consequence: the Patent Office can and will end monopoly powers to ensure access to important medicines. If this precedent is applied to other drugs and expanded to include exports, it would have a direct impact on affordability of medicines used by MSF and give a real boost to accessing the drugs that are critically needed in countries where we work

 

 

Today’s New York Times offers a long article on the case before India’s Supreme Court regarding licensing of off-patent versions of the leukemia drug imatinib.  Currently Novartis sells this under patent as Gleevec.  The article mentions the potential implication for availability not only of this effective cancer medication, but also for AIDS medications worldwide.  For the pro-patent case, the website IP Watch gives extensive coverage to the industry contentions and intellectual property aspects.

Two drugs used to treat leukemia have been found to prevent the Ebola virus from replicating itself in someone’s body. The rare virus currently has no vaccine, treatment, or cure, and causes those who are infected to bleed to death 90% of the time. Ebola virus is most commonly associated with strains present in Africa, as well in the Western Pacific but with less severity. It can be contracted through direct contact of blood, secretions, organs, or bodily fluids of someone who is already infected.

The two drugs in question are imatinib and nolitinib, more commonly known as Gleevec and Tasigna respectively. However, what good is this if they are not even as affordable in countries that are comparatively more well-off like Korea as we saw in the Dying for Drugs documentary? Prices for one 100mg pill can range from $20-$30, and at least 50% of the population in Sub-Saharan Africa receive less than $1 per day. This happens to be the region in which the Ebola virus is most prevalent.

Is it Novartis’ obligation under UN declaration to provide these drugs that would otherwise be completely inaccessible and unaffordable to those with the virus? Will it be more effective to manufacture the drugs under compulsory licensing or to distribute them in some other way? Compulsory licensing is used in extreme national emergencies, but the virus in itself calls for emergency medical assistance at all times due to the rate in which the body becomes infected.

The significance of all of this is that while rare, the virus is extremely deadly and highly contagious. It is also important to recognize that animals can also become infected and whether the subject is dead or alive does not matter. More testing is underway, but this is just some food for thought if researchers find that theses drugs are ultimately effective. After all this would be quite a breakthrough in the fight against the Ebola virus, as there is no treatment, but what good is it if it cannot be put to use where it is needed most?

The economics of supply and demand have allowed drug companies to reap exorbitant profit from the market, but what are the effects when the supply does not meet the demand? The United States is currently wheeling from a shortage of two drugs used to combat cancer, this shortage has prompted the FDA to seek drugs from foreign markets, such as India. The two drugs are Doxil and methotrexate, which is known by the trade names Rheumatrex and Trexall. Pharmaceutical companies have a market interest in providing their products to consumers. After the introduction of a product, should companies be mandated to ensure a consistent supply chain? As patients/consumers what assurance do we have that life saving drugs will be available if we need them? In some way I can see situations such as this manifesting a loosening of international trade agreements. If India did not have a readily available supply of a drug similar to Doxil this would have undoubtedly affected the lives of a larger number of people. The intellectual property rights of drug developers are protected through trade agreements, what is the impact of these protections in critical shortage situations? The loosening of patent restrictions may improve the health of consumers by ensuring access to needed drugs, while keeping costs lower.

Worldwide protests are underway as trade talks between India and the European Union come closer to finalizing a free-trade agreement (FTA). Both sides argue that it will provide greater access to better medicines that treat HIV, AIDS, cancer and the like. However, humanitarian groups such as Médecins Sans Frontières (MSF)is calling for international protests against the FTA because as India is the “pharmacy of the developing world,” this agreement would make generic drugs less available to developing countries. Currently, India frequently ignores patents, and the FTA promises “cheaper access to European goods & markets” in exchange for India’s compliance with intellectual property rights of pharmaceuticals. Another provision also makes it easier for  the companies that violate IP rights to be sued and any drugs that are shipped off, will be stopped at ports of entry.

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Protesters of the India-E.U. pact in New Delhi carry a capsule-balloon to signify the importance of generic pharmaceuticals and stress rejection of the pact

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