Showing posts with label Supreme Court. Show all posts
Showing posts with label Supreme Court. Show all posts

Tuesday, October 17, 2017

Diwali Ban — Unwarranted Judicial Activism?

The Hindus of Delhi will not celebrate Diwali this year, at least not with the usual fervour associated with the festival of lights and crackers, thanks to an ill-conceived judgement by the Supreme Court. 

The ban was ordered on November 11, 2016 in response to a petition filed by three children stating that bursting of crackers on a single night – that is on the Diwali night – increased the suspended particulate matter in the air threefold and that “residents and children [were] feeling breathless and vulnerable to asthmatic attacks” in the air following the bursting of crackers on Diwali. Obviously agreeing with the petitioners, the Supreme Court “observed that the direct and immediate cause of the spike in air pollution during this time is because of burning ofcrackers for Deepavali.

In trying to understand the Hon’ble Court’s judgement it is necessary to understand

1.  Whether there is a causal relationship between bursting of crackers on a single night – that is on the Diwali night – and increase in particulate matter in the air

2. Whether there is a causal relationship between increase in particulate matter in the air and respiratory diseases as is being made out to be

In order to answer our first question, let us turn to Inside Story -China's pollution dilemma originally published on the Al Jazeera website on December 23, 2015. It features a panel discussion on the problem of air pollution in China. A report by Adrian Brown preceded the panel discussion moderated by Kamahl Santamaria. The panelists were Einar Tangen, (Political and economic affairs analyst advising the Chinese government), Steve Tsang (Senior fellow at the China Policy Institute at the University of Nottingham, UK) and Tamara Savelyeva (Professor at the Hong Kong Institute of Education). 

Here is the gist of the panel discussion:

Air pollution contributes to 17% of all deaths in China; 90% of cities failed to meet national air quality standards. Air pollution accounted for 1.6 million deaths in a single year. This means 4400 people die every day. The levels of air pollution are seven times the maximum exposure recommended by the World Health Organisation (WHO).

The government is forced to close schools, colleges and factories in order to protect people from pollution on the days on which there is a spike in the particulate matter in the air. 

In the words of Einar Tangen, “China polluted its way to success!” The major contributing factors of the air pollution were the coal and steel industries. Attempts to transit from coal as the energy producer have been on but it is a difficult trade-off in view of the highly labour-intensive nature of the industry. The economic costs of air pollution are already telling on the economy. The nation can be said to have reached its threshold limit.

[By the by the YouTube video is worth watching to understand how panel discussions are conducted on international television. There is no screaming; no talking over each other and the presenter let everyone talk!]

By no stretch of imagination could one ascribe the problem of air pollution in China to firecrackers or Diwali. The problem therefore should lie elsewhere. Here is a snapshot of a news report published in 2015 in Mail Today, according to which there are 110,000 smoke emitting cottage industries in Delhi. 


What causes pollution then? An IIT study report of 2013-14 published in Bloomberg identified industry, vehicular pollution, power plants and cottage industries as the main pollutants.

Now to the second question: several medical experts have appeared in television debates (as they did last year too), to testify that increased air pollution due to bursting of crackers on the one night of Diwali indeed causes respiratory diseases. As experts they are entitled to their individual opinions on the subject. As experts in a scientific discipline, they would also agree that voicing opinions in public fora without adequate studies is not exactly a scientific way of voicing opinions. For here is an excerpt from a scientific study on the subject which appeared in Lung Indiaa specialist magazine on the subject of lung diseases (with a formidable line-up of editors) intended not for laymen but for medical specialists in the subject:

An extensive Medline search revealed that a strong evidence of the impact of fireworks on respiratory health is lacking in susceptible as well as healthy individuals with no formal studies on COPD or asthma, other than a few case reports in the latter 

Here are a few noteworthy excerpts from the article which definitely warrant serious scrutiny, especially in view of, not conclusive proof but scientificspeculation” about a few hours on one night of fireworks causing serious health problems:

Fireworks and asthma Few investigators have identified the association between asthma and exposure to fireworks.

Fireworks and COPD We could not find any publications identifying an association between COPD and firework exposure.

An association between repeated exposure to firework emissions and respiratory symptoms has not been definitely identified.

One can argue that typical exposure to such pollutants is limited, as assessed by Singh et al., ranging from a few hours to a few days, depending on the duration of the firework festival, thus probably only causing minimal exposure. Also, fireworks are often let off following sunset when most people would go indoors to sleep after seeing the show, hence limiting exposure time to the ambient air pollutants.

There is limited literature describing the physical characteristics of firework particles themselves including size distribution, number concentrations, modal characteristics as well as particle density

Following a thorough review of the literature available, further studies are necessary to consolidate current evidence and speculation. (Emphasis added.)

Is everyone, the “children”, the activists and the Supreme Court oblivious of the elephant in the room and barking the wrong tree?

Or is there any other ulterior motive for the “activists” which the Hon’ble Supreme Court, to give it the benefit of doubt, did not sense? 

Thursday, April 04, 2013

Novartis Vs. The People Of India

Ivan Illich opened his seminal work 
Limits to Medicine’ with the observation that ‘The growth of the medical establishment is a major threat to health. A large part of Illich’s work dealt with iatrogenic (meaning physician-induced) diseases. But to Illich, the ‘medical establishment’, includes the pharmaceutical industry also.

The recent Supreme Court verdict in the Novartisimatinib (Glivec) patent case has generated a lot of heat and uninformed debate in the media. Novartis challenged the order of the Intellectual Property Appellate Board (IPAB), for rejecting a patent for its ‘old wine in a new bottle’, first in the Madras High Court and then in the Supreme Court. Novartis filed world-wide patents for its active molecule imatinib in 1993. In India, the company filed patent in 2003 for imatinib mesylate a beta crystalline form of the active ingredient, under the ‘mailbox provision’.

NOVARTIS Vs. PEOPLE OF INDIA

Novartis’ application for a patent for its beta crystalline form was rejected by the IPAB in 2006 on the ground that the company’s original patent application covered all forms of imatinib. The Madras High Court decreed that IPAB’s rejection of the application under Sec. 3 (d) of the Indian Patents Act as amended in 2005 did not violate Article 14 of the Indian constitution. This is now upheld by the Supreme Court.

The Indian Patents Act of 1970 did not recognize product patents but only process patents. However India agreed to consider patent applications filed from January 1 1995 for granting product patents pending amendment of its laws in line with the requirements of the WTO. The process was known as the ‘mailbox’ provision. Eventually India amended its patents law in 1999, to grant product patents with effect from January 1, 2005. A patent is an intellectual property which has a life of 20 years from the date of filing and which gives its holder exclusive marketing rights. The actual period of exclusive marketing depends on the company’s ability to develop the product for commercialization.

R&D COSTS

In the pharmaceutical industry, Research and Development (R & D) is of course an expensive and risky process. A company begins with thousands of molecules and narrows down its search to a few (less than a dozen) for further experimentation. After initial animal experimentation to establish efficacy, safety and toxicity a candidate drug (known in the industry as New Chemical Entity or NCE) is selected for human clinical trials. A patent application is generally filed at this stage and approval sought for commencing human clinical trials. These are conducted in four phases before it is submitted for marketing approval by the regulators. It is called filing a New Drug Application (NDA). The process takes quite a few years. This means, although a patent is granted for 20 years a company gets to exclusively market it for the residual period after conducting clinical trials and obtaining marketing approval. Even after a drug is approved for marketing it is still tested in a process called, Post Marketing Surveillance (PMS) every year to find out if any hitherto unnoticed side effects come to light. The company has an obligation to market a product only to be used in conditions for which it is approved. However a physician may use it in other conditions if he finds it suitable. This is known as off-label usage.

There are varying estimates about the cost of research and development of drugs. Several years ago an article in the Readers’ Digest put it at between $100 million and $200 million. Recent estimates vary from $500 million to $1 to $2 billion depending on the therapeutic category and method of calculation used, such as inclusion of capitalization and opportunity costs. This does not mean that the entire amount is spent by a company. There is public funding and tax write-offs on R & D spending, which is a not unlikely incentive for bolstering the figures.

Pharmaceutical companies quite naturally argue that they have to make profits out of successful candidate drugs because they have to incur huge expenditure on R & D, which is a long drawn and uncertain process. This is the reason they claim, new drugs cost so much.

MARKET RISKS

However pharmaceutical companies are aware there is an element of uncertainty in the business. For, even if a company is able to come up with a successful candidate drug, there is no guarantee that a rival company with a competing product might not upstage it. As an illustration, see the case of the first anti-ulcer drug cimetidine. It was introduced by the British multinational, Smith Kline & French (SK&F) in the mid-seventies when the only cure for peptic ulcers was surgery. The drug was indeed a boon for patients as it reduced the necessity for surgery in about 90% of cases. The drug marketed by SK&F as Tagamet entered the Guinness Book of World Records for maximum number of prescriptions received in a year. A few years later another British multinational Glaxo came up with an updated version of the drug ranitidine which it marketed as Zantac. It too entered the Guinness Book of World Records in the year of its introduction, and Tagamet lost 50% of its market share. As a result, many heads rolled in SK&F and its Chairman had to resign. The two companies merged in the mid-nineties to become what is now known as GlaxoSmithKline (GSK). (In its process of mergers and acquisitions, GSK has also absorbed several other companies like Allen & HanburysBeecham and Burrows Wellcome.)

The success of the first two molecules, in the class of drugs called H2 receptor antagonists, made other companies board the bandwagon and many variations of cimetidine were launched. These include famotidine, loxitidine, nizatidine and roxatidine. Of these molecular variations only ranitidine and famotidine could achieve significant commercial success, while the others remained small players. For the treatment of peptic ulcer, another class of more powerful drugs known as proton-pump inhibitors emerged with members like omeprazole, esomeprazole, lansoprazole, pantoprazole and rabiprazole, a few years later.

Wouldn’t it be unfair for a company marketing, for instance, roxatidine to claim the same pricing privilege as SK&F which has laid the groundwork for finding a drug for peptic ulcer? On the flip side could SK&F claim that, as there was every possibility of its market monopoly being upstaged, it should be permitted to recover its costs at the earliest? In view of this should the company be allowed to price a tablet of cimetidine at say, $100?

R&D – WESTERN BIAS

It would be unfair to see the Indian Supreme Court verdict as a triumph of left-liberal altruism against Western capitalism for several reasons. Firstly, US courts too held that derivatives of known substances are not eligible for patent protection under the ‘doctrine of inherent anticipation’. Also in the US a patentee cannot claim rights for more than one substance with identical claims, under the ‘doctrine of double patenting’. The third principle governing US jurisprudence in relation to intellectual property rights is the ‘patent misuse doctrine’, which prevents pharmaceutical companies from extending their patent rights by obtaining multiple patents covering essentially the same invention. In her extensively researched paper, ‘Trials And TRIPS-ulations: Indian Patent Law And Novartis AG v. Union Of India, (Berkeley Technology Law Journal, Vol: 23. Mar 21, 2008. 281-313), Lynda L. Lee opined that the stand of the Indian courts ‘indicates that the objective of India’s Section 3 (d) is not a radical departure from international practices to regulate the patenting of derivatives and new uses.’ It must be noted that the article was based on the Madras High Court judgment and written much before the final verdict of the Supreme Court.

The reaction of Novartis to the Supreme Court judgement appeared a bit peevish. In a press statement, the company’s Vice Chairman warned that it will discourage R&D spending by multinational companies in India. This is a bit surprising as multinational companies may have been using India as low cost hub for manufacturing and conducting clinical trials but never seem to be bothered about diseases specific to India. For a long time the healthcare fraternity has been complaining that multinational companies focus on diseases prevalent in the western world for researching remedies. For example, we have not seen new drugs introduced to combat malaria and tuberculosis which are endemic to countries like India, in years. The incidence of both the diseases is seeing a resurgence of virulent, intractable forms. Today tuberculosis resistant to multiple drugs – multidrug resistant TB or MDRTB is quite prevalent. On the other hand new drugs for antiplatelet medications atherosclerosis, cancer, diabetes and hypertension and related diseases are introduced by the dozen, every year.

R&D – ALTRUISM OR BUSINESS STRATEGY? THALIDOMIDE TO GATIFLOXACIN

Multinational companies which have been assuming moral high ground for their altruistic R&D efforts ‘to ameliorate pain and suffering of humanity’ have also been guilty of destroying the lives of millions of people for short term gains.

The introduction and withdrawal of thalidomide is a classic example. In the 1950s, Distillers & Co (the makers of Johnnie Walker whisky) purchased Grunenthal, a small German pharmaceutical company. Grunenthal developed a tranquiliser named thalidomide which was then believed to be so safe it could be prescribed to pregnant women to relieve them of morning sickness. It was introduced in several countries in Europe and freely prescribed for pregnant women. In the early sixties a causal link was established between the use of thalidomide and delivery of malformed babies. This property of a drug which causes foetal abnormalities known as teratogenicity, was unknown till then. By 1961 an estimated 10000 to 20000 thalidomide babies were born and the drug was withdrawn. 

The thalidomide story should have warned the managements of pharmaceutical companies to be extra careful in vetting and promoting their products. Alas no, drugs with serious adverse effects have been introduced by pharmaceutical companies with unceasing regularity. Here are a few examples, some of which may not be as lethal as thalidomide. Analgin (like penicillin) is known to cause anaphylactic reactions so severe that a single tablet could kill a patient. Anti-inflammatory drugs like oxyphenbutazone and phenylbutazone have been known to cause blood disorders. Later arthritis drugs like celecoxib and rofecoxib were found to cause acute termporary visual impairmant. However all these drugs were marketed by multinationals in India for a long time after they were banned in their home countries. The newer pain-relieving drug, nimesulide has been banned in several European countries but is still marketed in India (not by multinationals; by Indian pharmaceutical companies). Terfenedine, introduced as an advanced, non-sedating anti-allergic had to be withdrawn a few years later as it was found to cause heart-problems. The latest in the series of drugs to be withdrawn was the antibiotic gatifloxacin, which was found to cause cardiac problems. Illich mentioned in his book that the American innovator of chloramphenicol (trade name Chloromycetin) marketed the drug for simple conditions like acne. Originally introduced for treating typhoid, the drug is known to cause bone-marrow depression. (The human body produces red-blood cells in the bone-marrow.)

PRICING DRUGS

An argument that was vociferously voiced in the television debates relates to pricing; especially that pharmaceutical companies which spend millions (billions?) should be allowed the freedom to price their products. And any regulation would be a disincentive for them to introduce newer products. This argument lacks substance because the pricing of drugs is not uniform even in the western world. For example the prices of drugs in Canada are far lower than the corresponding prices of drugs in neighbouring USA. In some cases the Canadian prices are about half of their American counterparts.

The marketing of anti-retroviral drugs (used to treat AIDS) in South Africa offers an object lesson for those who blindly take sides with the advocates of free-pricing. Indian companies like Cipla and Hetero Drugs offered to sell a combination of anti-retroviral drugs at $350 for a year’s course. Four multinational companies challenged them in the South African Supreme Court, on the ground that these companies were infringing their patent rights. They were selling the drugs at $10000 for a year’s course. They had to withdraw their suit following worldwide revulsion. For, more than a third of world’s AIDS population lives in Sub-Saharan Africa.

In the television debates, medical doctors representing Novartis claimed that the company has a scheme for providing the medicine free of cost to ‘below poverty line’ patients. This is not entirely true because the company stopped providing imatinib free after two Indian companies were permitted to introduce low cost alternatives in 2006. (See the research paper cited above.) Even if the company has been providing the medicine free to BPL patients, how does one define a BPL patient? Certainly a household with an income of 50000 per month cannot be considered BPL? If the household has a patient who requires imatinib, can it expend 1,20,000 a month? Besides, many cancers require multiple regimens of treatment, which include chemotherapy (drugs), radiation and surgery. The latter two are even more expensive than the cost of medicines.

TAILPIECE: By the by, the promotional or marketing budgets of pharmaceutical companies exceed their R&D budgets by a long chalk.   

Saturday, March 23, 2013

Have political ploys made the law an ass?


Is the law an ass?’ asks a character in Charles Dickens’ famous novel, Oliver Twist. Several incidences over the last few days make ordinary folk wonder whether the law is really an ass?

ITALIAN MARINES CASE The first of these concerns the Italian marines’ case, which raises several questions. Why had the Indian Supreme Court exhibited unseemly generosity in permitting the Italian marines – undergoing trial for first degree murder - to return home first to celebrate Christmas and then to vote in an election?

The Italian marines were undoubtedly undergoing trial for first degree murder as they shot to kill. Their claim that they thought that a pirate ship was closing in and they shot in self-defence does not wash. For, as trained naval officers, could they not distinguish between a pirate ship and a fishing boat? Were the naval officers so scared of a small fishing boat, that they thought that it was closing in to hijack their vessel? If so why did they not fire warning shots to dissuade the boat even assuming that it was closing in, which appears far-fetched?

Could an Indian citizen undergoing trial for first degree murder expect the same treatment from the Indian courts? Had an Indian Court ever permitted a prisoner, undergoing trial for first degree murder, to go home to celebrate Diwali? It would never have occurred to an ordinary citizen in judicial custody, undergoing trial for first degree murder to even pray for such leave. Therefore an ordinary citizen should not be faulted if he wonders why, even for the Indian Supreme Court Italian citizens are more equal than Indian citizens’. On many occasions in the last thirty years, the Indian establishment has demonstrated that for it, Italian citizens are indeed more equal than Indian citizens. The reason for the establishment to bend backwards being the Italian connection of India’s ruling party is quite obvious. But does it matter to the Supreme Court, the highest judicial body and the last arbiter for the ordinary citizen without any clout?

Having blundered twice, the Indian Supreme Court sought to make amends by taking a tough stance in restricting the movements of the Italian ambassador. This put the Indian establishment – especially with its Italian connection – in a quandary. After days of huffing and hawing about Italian perfidy (by the primary and proxy protagonists of the government), the External Affairs Minister grandiosely announced (not without a hint of self-congratulatory glee) that diplomacy succeeded in making the Italians see reason. His tall claims notwithstanding, there are several questions that require answers: 

Why did the Indian government sign a treaty with the Italian government in a hurry while the murder trial was under way? Was it not to benefit the two marines? Do sovereign nations sign bilateral treaties to solve instant crises? 

How would the Italian government have reacted if two Indian naval officers killed two Italian fishermen and were undergoing trial in an Italian court? Would it have been as generous as the Indian government?   

Did the Indian government make a clandestine deal with the Italians to satisfy the Supreme Court and bring back the marines? If this is not so, how could Salman Khurshid assert that the marines ‘will not be awarded death penalty as theirs is not a rarest of rare cases’? If it does not fall in the ‘rarest of the rare cases’ category are Indian fishermen routinely fired at and killed by foreign marines? 

Who should decide which case falls under the ‘rarest of the rare cases’ category or not? Is it the judiciary or the External Affairs Ministry?

The upshot of the deal - which the Minister denies was done - is, the marines will not be taken into judicial custody during the course of the trial; they will stay in their embassy; they will not be awarded death penalty as their case is not in the ‘rarest of rare cases’ category; and if awarded a prison sentence, they will serve it in their own country.

SANJAY DUTT CASE The second case is even more bizarre. It is about the sentence the Supreme Court awarded to Sanjay Dutt, famous film personality, son of a famous film personality and former Congress MP and bother of a sitting Congress MP. The four qualifiers deserve to be stressed to put the case in perspective. The 1993 Bombay blasts (in eleven locations) killed 257 people and severely injured 700 people. According to some sources, the number of injured was 1400.

[Sharad Pawar, Chief Minister of Maharashtra (at the time) later confessed that he deliberately misled people by adding Muslim dominated Masjid Bunder to the list blast locations to pacify communal tensions. See: To keep the peace, I misled people on 1993 blasts: Pawar. This secular balancing of terror has been going on since 1993. Pawar’s confession puts the pronouncements of P. Chidambaram, Sushil Kumar Shinde et al., Rahul Gandhi’s whispering to the American ambassador about Hindu Terror and the NIA ‘investigations’ in certain cases, all in perspective. To grab and retain power, secular politicians would go to any extent to appease the minorities, principally the Muslims. The invention of a phantom Hindu terror is part of the game.]  

The Supreme Court verdict in the case confirms the role of the ISI and several underworld dons. Sanjay Dutt’s role in the blasts has been known almost since the beginning. He had been known to confer with the dons, converse with them over phone and collect and store arms for the attack. His pedigree and the power of his political connections helped in almost getting him off the hook. 

If the CBI could be used to discipline wayward coalition partners to fall in line, it could also be used to save loyal allies. In Sanjay Dutt’s case the CBI did all it could to help him evade the long arm of law. It did not matter to India’s premier investigation agency that it was indeed obstructing the course of justice. It delayed investigation to help Sanjay Dutt destroy evidence, did not pursue leads, presented a weak case in the trial court and did not appeal against the trial court verdict. The CBI did not work for the people, who are its paymasters. It worked against them, and for an individual who declared a clandestine war on the people. Just as in the marines’ case, in Sanjay Dutt’s case too, it has been kinship with the high and mighty that carried the day.

One can understand the clamour of the film fraternity to obtain state pardon for Sanjay Dutt. It has been known for long that the same forces that supplied Sanjay Dutt with prohibited arms and ammunition to wage a war on the Indian state also control the film industry. But why would a retired judge of the Supreme Court and Chairman of the Press Council want to interfere with the administration of justice? That is the sad part.

The highest court in the country has delivered its verdict unambiguously pronouncing Dutt guilty. The Supreme Court has also been magnanimous in awarding the least possible sentence according to law. If in spite of this, as the Law Minister averred, an appeal for pardon is favourably considered, it would amount to subverting the justice system.