IT’S IPL MESS ALL OVER! COULD YOU HEAR THEM SPEAKING OF THE DPCO?

It has swept over the thinking horizon. A mercurial, controversial but a glamorous cricketer, a high-octane, high-decibel but low-sportsmanship spirit form of the gentleman’s game, a manifestation of the perennial human greed again and a hyperactive Indian media in an over-competitive market – the last week has been a potboiler with minute-by-minute coverage of what we know as ‘the Indian Premier League Spot Fixing scandal’, that the efficient-but-reckless-but-insensitive Delhi Police, by chance, came to know and pursued and dug more. The revelations are still a work-in-progress.

That is good. Cricket ‘was’ like a religion in India. Millions would sleep and get-up remembering and analysing the last seen game. Even now, if it is an India-Pakistan game, the whole nation still comes to a standstill.

But, the sorry state of affairs is, we cannot write now something like this – ‘cricket has been like a religion in India’ –that we used to read and write so frequently in the past!

And the major factor behind it is the credibility crisis that began to erode with the match-fixing scandals the first big casualties which were the likes of Mohammad Azaharuddin, seen as one of India’s most successful captains. Since then, cricket-fixing (betting) has taken away the sheen from the game. Cricket is now no more a game of flow of emotions. Rather, it has become a form of calculated, commoditized entertainment to be purchased, much like an IPL tournament.

Nothing wrong in that! Existence of the human mind needs entertainment but why to get swept away in the wave. Except that we are slipping in the quagmire of the misplaced priorities!

The IPL spot-fixing story has pushed everything else to the periphery as if nothing else is moving in this country of over a billion. In all this business of market sentimentalism and priority-shopping, a very important development was left almost untouched, very comfortably.

The development has the potential to change the lives of the millions, millions of the Indians who cannot afford the healthcare due to exorbitantly high prices of medicines.

The development is a must for a developing country like India which has the world’s second largest population.

The development is a must for a country like India where the majority of the population is quality-illiterate, where school dropout rate is a national shame, where education and healthcare, though necessary, are seen as additional burden-heads on the monthly household budget.

The government on May 16 cleared the long pending Drug Price Control Order 2013 (DPCO) under the National Pharmaceutical Pricing Policy 2012 to bring 348 essential medicines and 652 formulations under a controlled-pricing mechanism.

The DPCO that is to come into force in July is expected to bring down the cost of the essential medicines by 20-25 per cent and in some case, like the anti-cancer drugs, by 80 per cent.

27 therapeutic areas that are to be covered under it include cardiac, pain killers, anti-allergic, gastro-intestinal, anti-diabetic, anti-cancer, anti-leprosy, anti-tuberculosis and anti-hypertensive medicines.

The DPCO has the mechanism to keep the prices in check with only annual price-revision allowed and that too, has to be a market-based revision unlike the cost-based one that is in practice now. Another good aspect is the prices of the imported drugs, too, would come under this pricing-control regulation.

Now, this is a significant social empowerment milestone. Increased access to the essential medicines for millions means improved health of the nation. It is a good beginning and it is needed to be talked, discussed and spread if we intend to build further on it.

Increasingly, we have seen the governments come easily under the pressure of the industrial lobbies and we have all the reasons to think that this watchdog too, would be vulnerable to manipulations. We need to develop a vigilant voice to keep a check on it and that needs a healthy tradition of debate over it.

Non-governmental organizations and various social groups have been fighting for the controlled-pricing mechanism to regulate prices of the essential and life-saving drugs and this is indeed a significant victory. But there are many other necessary requirements on the agenda. There have been debates on introducing and promoting generic versions of the costly medicines to meet the healthcare demands of the majority of the Indians and that has to be implemented on priority.

The DPCO notification could well have been an opportunity to extend such debates from the environs of the social groups to the larger public sphere to make the ‘populations’ a direct stakeholder in the process.

But the speakers of the public interest didn’t see a glamour-quotient here and such an issue of social vitality was conveniently buried under the debris of the IPL mess.

When would we understand to prioritize? Why do we need some Aamir Khan to push us to act on the matters of social relevance?

©/IPR: Santosh Chaubey – https://santoshchaubey.wordpress.com/

GLIVEC PATENT APPEAL OF NOVARTIS REJECTED: A GLOBAL REPRIEVE

It was a big concern and came as a big relief.

It was about social concerns Vs commercial interests and in a world where over a billion people live in absolute poverty ($1.25 a day) while another billion plus people do not have a comfortable living (between $1.25 to $2 a day), it was a needed reprieve.

It was a court battle in an Indian court that the whole world was watching, from governments, to corporations, to activists, to people, calculating the aftermath of the outcome from their perspectives.

And the way Novartis reacted on Supreme Court of India rejecting its Glivec (www.glivec.com) patent appeal tells us about the scale of the stakes. Reportedly, the Swiss pharma major has said that it would be more cautious about investing in India in future.

But the SC decision is not about India only. It is for the billions across the countries who cannot afford healthcare cost.

According to a report*, in 2008, 54 per cent of the new cancer cases were from African and Asian countries while the region accounted for 61 per cent of the cancer deaths. It is just a natural corollary when such reports point out that the less developed regions account for greater number of new cases and deaths because majority there cannot afford the treatment available.

A report** on HIV/AIDS prevalence says, in 2010, around 30 million of the 34 million adults and children living with HIV/AIDS were from African, Asian and Latin American countries. Sub-Saharan Africa alone accounted for almost 23 million cases. Naturally, these regions have world’s poorest countries with no or very poor health infrastructure.

The predominating stand on healthcare in context of these concerns has to be socially oriented. Here, the social concerns have to prevail over the commercial interests when there are billions not able to afford the treatment costs resulting in death of millions annually.

The SC’s Glivec decision has to be seen in this context only.

In case of life threatening diseases like Cancer or HIV/AIDS, the cost of the diagnosis as well as of the medicine is out of reach of almost of the population segments living in the poor countries.

Pharma giants claim they develop such medicines after pumping billions of dollars in R&D. Many of such medicines, known as blockbuster drugs (generating revenue of a billion dollar or more a year) are priced astronomically high in order to recover the costs.

Initially justified, soon the break-even point and the ethical business of profit-making give way to a monopolized profiteering exploiting the legal tools like the exclusivity patent or the extended patent once the exclusivity patent expires. In some cases, it is genuine. In most of the cases, it is intended to manipulate, a practice known as ‘evergreening’ where the manufacturer goes for the minimum possible modification in the drug so as to meet the patent extension criteria.

In the Glivec case, the SC didn’t find Novartis’ claim of further changes in Glivec innovative enough to grant it patent.

Novartis markets the drug Imatinib under trade names Glivec and Gleevec (US). Some other trade names for the drug are Glivic and Milatus.

Glivec is an anticancer blockbuster drug generating billions of dollars of revenue annually. Developed in 90s and hailed as ‘magic bullet’ in cancer treatment by the TIME magazine in 2001, Gleevec had a worldwide sale of $3.9 billion in 2009. Though it is not sure if the figure is for overall Imatinib sale but it tells Novartis has reaped enough of the profit from this blockbuster molecule alone.

And when it’s such an important medicine (some say it is miraculous in effects on some forms of Leukemia), it is to be seen and regulated that it reaches as far as possible, to the cancer patients who cannot afford it.

The ways out are to make the medicines available free as happened in case of Tuberculosis or to make the treatment available at affordable cost. Now, the profiteering Big Pharma cannot be expected to play such a role.

Tuberculosis was successfully routed out after the multi-drug therapy was made available free of cost at a mass level. HIV/AIDS spread has seen some significant control after the affordable antiretroviral treatment has been made available in poorer countries where maximum number of the affected live.

At a time, when governments and global bodies like the UN are finding it hard to fund free shipments of the antiretroviral medicines due to slowdown in the global economy, the generics have come as a big reprieve saving millions of lives. Cancer has no such provisions like the antiretroviral treatment on a worldwide scale and availability of the generic medicines is the most important ray of hope for the cancer patients who cannot afford the costly medicines of the big pharma companies.

So, the cost-barrier has to be brought down, either by making free shipments available or allowing other pharma companies to make the same medicines (generics) at fraction of prices, so that it can reach to the maximum number of the affected people.

And why not given the sensitivity of the price points involved. If we take the Indian examples where the country’s apex court has rejected the patent appeal of blockbuster drugs, it becomes clear.

Before Glivec, the SC had rejected Bayer’s patent appeal for its anti-cancer drug Nexavar that brought down the price, from Rs. 2,80,000 for Nexavar to Rs. 8,000 a month for its generic version. In case of Glivec, the cost of the generic version is around Rs. 10,000 a month while Glivec costs Rs. 1,20,000.

Given the high number of cases in low income segments, generics are the effective way to make the treatment available to a larger section of the global population.

The Glivec decision by the Supreme Court of India has once again given an opportunity to reiterate it. Even if the ruling comes as a short-lived reprieve as some analytical reports are pointing out as it would result reduced R&D and new medicines launches in India, it has to be appreciated for the fact that nothing is more important than saving human lives.

An analytical article in New York Times wrote on the development: “The ruling is a landmark in one of the most important economic battles of the 21st century, in which rich nations that increasingly rely on the creation of idea-based products like computer programs and medicines require poorer countries to pay for their ideas. But some countries – particularly India, Brazil and China – have begun to challenge the price they must pay, particularly when the ideas-based products are life-saving medicines that their people desperately need now.”

©/IPR: Santosh Chaubey – https://santoshchaubey.wordpress.com/

* http://www.cancerresearchuk.org/cancer-info/cancerstats/world/demographics/demographic-facts-for-the-world-population

** http://www.avert.org/worldstats.htm