March 07, 2010
Prabir Purkayastha

THE Congress-led UPA government has placed the Nuclear Liability Bill as one of 36 legislations it wants the parliament to pass this session. This is one more chapter in the sorry saga of the India US Nuclear Deal. The key part of the the proposed Bill is to absolve all US equipment suppliers of any liability. Without this, the US equipment suppliers will not supply any equipment and the US government has held up all action on the India US Nuclear Deal. Though the French and Russian equipment suppliers have not asked for any such liability legislation, the Manmohan Singh government has buckled under US pressure and is now willing to provide the US suppliers with this comfort.

The prime minister in his various speeches to the parliament had stated that the India US Nuclear Deal ensures lifting of ban on all dual use technology and has an up-front consent for reprocessing of spent fuel. The truth, as is apparent now, is quite different. In an interview  to Newsweek, on November 16, 2009, prime minister Manmohan Singh now says, “My sincere hope is that we can persuade the US administration to be more liberal when it comes to transfer of dual-use technologies to us. Now that we are strategic partners these restrictions make no sense...So, that is my number one concern.”

Fuel reprocessing is another critical issue, as otherwise, India could land in the old Tarapur mess of running from pillar to post for fuel for its reactors, while storing the spent fuel in costly holding ponds for decades. Dr Singh told parliament in 2007 that an "important yardstick has been met by the permanent consent for India to reprocess." The Left had held that the 123 Agreement does not constitute any approval to fuel reprocessing and the US will need to give formal approval for any such measure. The US side has now made clear that they have no intention of giving any permanent right to reprocess. During the PM's visit last year, it was announced that the consent to reprocess is a matter of a few weeks. It has yet to materialise!

INDIAN SUBSIDY FOR US REACTORS

It now appears that all this is linked to India passing a Nuclear Liability Act. For the US side, Condi Rice, Bush's Secretary of State, had made their interests in the Nuclear Deal clear – the US wants to kick-start its moribund nuclear industry by selling nuclear reactors to India. India is on record wanting to buy 10,000 MW of nuclear reactors from the US suppliers. The US nuclear industry wants the billions of dollars in profits from Indian sales, but does not want any risks: good old risk-free capitalism, US style. This is the genesis of the nuclear liability bill – a hefty subsidy from Indian tax payers for the US to be able to market its reactors.

The full details of the Nuclear Liability Regime is not yet available in the public domain.  The key elements is limiting all liability to about $450 million dollars, the operators liability to be restricted to only Rs 500 crore and no legal liability for the supplier. It can be a contractual arrangement between the operator and the supplier, but not in liability law. The difference between the $450 million limit and the Rs 500 crore limits is the Indian State's liability; through this legislation, India is also proposing to limit its liability as well.

All this is in direct contradiction to the current law of the land. The Supreme Court in its judgement on the Oleum leak case from Sri Ram Food and Fertilisers in 1987 had made clear that the industry operating hazardous plants had absolute liability including that for environmental damage. The current Bill seeks to reverse this. An upper limit of $450 million makes no sense when we know a nuclear accident can cause billions of dollars in damages. Even the Bhopal case showed that $470 million for the gas victims was totally inadequate. By keeping all liability – including that of the Indian State -- capped at $450 million, India will subsidise the nuclear industry at the cost of the Indian people.

ASPECTS OF LIABILITY

The Rs 500 crore limit for operators is well within their insurance cover. By keeping the operators liability so low, Indian government is playing with the safety of the nuclear  plants.

The Indian government is also claiming that the $450 million cap comes from the Vienna Convention on Civil Liability for Nuclear Damage. The Vienna Convention defines the minimum amount of limit of the operator’s liability-- it provides a floor and not a ceiling. It also allows countries to operate their own liability regimes. For example, Germany, Japan and Finland all have unlimited liability, the same as current Indian law. The US has a liability cap of $ 10.2 billion through its Price Anderson Act.

The Convention on Supplementary Compensation defines additional amounts to be provided through contributions by States Parties on the basis of installed nuclear capacity and UN rate of assessment.

There are two important aspects of liability that are in the Vienna conventions. One is “strict liability”. This means that the nuclear plant operator is liable for any nuclear event originating from his plant. There is no need to prove negligence, wilful act, etc. The other is that channelled liability – all liability is channelled to the operator and all other parties including suppliers, contractors, etc., bear no liability.

The Price Anderson Act in the US was the first to introduce these conditions. The major reason for introducing the Price Anderson Act was the refusal of the insurance companies to insure the private operators in the United States. A study had shown that a nuclear accident could lead to damages up to 10 billion dollars. The insurance companies needed a cap on their liability in order to provide insurance. The suppliers – GE, Westinghouse, Bechtel, others – had also demanded that they should not be held liable for any such accident.  Other Acts that have similar provisions are in Canada and UK.

However, dozens of countries that operate nuclear power plants have not ratified these conventions nor have passed similar legislation. The Russians and the US have been locked in a dispute precisely because of nuclear suppliers' liability. The US is insisting that the Russians should sign the Convention on Supplementary Compensation, which protects the nuclear suppliers even from wilful damage. The Russians have till now refused to do so. Most countries also have not passed a Bill similar to what India is proposing to do. Those that have, the limits are much higher than the comparable Indian limits.

WHY THIS PROTECTION

Omer F Brown, the key spokesperson for the US nuclear industry, articulated the US position on the need for nuclear liability in India. “Currently, India does not have a nuclear liability law covering its facilities. Therefore, concerns over nuclear liability would be a major impediment to any nuclear trade with India ..Most US nuclear suppliers would not be willing to work in India without nuclear liability protection.”

At an international symposium hosted by the Uranium Institute in 1999 the same lawyer Omer  Brown had made clear why the private nuclear industry, as distinct from the State-run nuclear industry, needs protection from liability laws. “It is important to reiterate the fundamental factor that underlies the concerns of privately owned contractors and suppliers: Private - as distinguished from State-owned - companies have a fundamental obligation to protect the assets of their shareholders ..Private companies are exposed to tort and other liabilities to the full extent of their assets. The greater the assets of a private company, the greater its liability concerns are.”

The record is quite clear. It is the need for protecting the US private nuclear players that is the driver for the proposed Nuclear Liability Bill. This is the subsidy that the Indian State is proposing to pay to the US nuclear industry: all risks, ours, all profits, yours.

Even with this subsidy, the cost of imported reactors from the US is way above that of indigenous reactors – the prices are 3-4 times that of Indian reactors.  But that is a different story. The issue today is that even at this high prices, it is the Indian people who will be at risk. What is on offer is a huge implicit subsidy to the US nuclear industry. This is the crux of the Nuclear Liability Bill on the anvil.

February 28, 2010
Amit Sengupta


FIVE years ago the Indian Patent Act was amended to provide for patenting of medicines. Thanks to the efforts of Left Parties in parliament, supported by several movements and groups in the “access to medicines” campaign, the Indian Law incorporated several public health safeguards. While not perfect, the Indian Law is one of the best in terms of its attempt to restrict the monopoly power of patents over access to medicines.

MNCs in the pharmaceutical sector have been very unhappy with portions of the Indian Law and have tried to undermine it in different ways. Concurrently, patients groups and civil society groups have tried to use opportunities available in the Indian Patent Act to safeguard the rights and interests of patients. It is important that we take a view of the emerging legal battles that are now being fought in relation to the Patents Act.

It is important because the continued manufacture of essential medicines by Indian companies is not just a matter of interest for Indian domestic consumers. India is a key supplier of life saving drugs to many parts of the developing world. 92 per cent of patients on antiretrovirals (for treating HIV-AIDS) in low- and middle-income countries use generic drugs, mostly manufactured in India. 67 per cent of medicines exports from India go to developing countries. Further, approximately 50 per cent of the essential medicines that UNICEF distributes in developing countries come from India.

PATENTABILITY AND PRE GRANT OPPOSITIONS

A prime target of pharmaceutical MNCs has been the provision in the Indian Act that does not allow “ever greening” that is it does not allow perpetual patent monopolies by companies who make minor modifications in existing medicines and seek to extend the patent period beyond the 20 years provided for in the TRIPS agreement. The Indian Act restricts the scope for the granting of Patents on frivolous claims by clarifying in Section 3(d) of the Act that, “the mere discovery of a new form of a know substance which does not result in the enhancement of the known efficacy” is not patentable. It is further explained that: “Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.

How ever greening impacts on medicines access can be seen from the example of some commonly used anti HIV-AIDS medicines. An important first line drug for treating AIDS patients, Zidovudine, was invented in the 1960s for the treatment of cancer, and its use in HIV was promoted decades later. Though many countries allowed it to be patented when its use in AIDS patients became known, the Indian law does not allow its patenting. Another essential medicine for AIDS medicines was patented in 1994 and hence cannot be patented under Indian law. However the syrup form of the medicine was again patented in 2001, but again the Indian law does not allow the patent. A formulation combining Lamivudine and Zidovudine is commonly used to treat AIDS patients. The two component medicines were patented before 1995 but the combination form was patented in 1997, but the Indian law does not recognise this patent.

Indian civil society organisations have made use of such useful provisions of the Indian Act to file pre-grant oppositions (and a few post-grant) in a number of cases, and by actually winning some of these cases. The battle however has been difficult and needs to be put in a certain perspective. Of over 10,000 patent applications on medicines; patients groups have opposed 15, though these constitute some of the main threats to access. The process of opposing patents is difficult, time consuming and requires substantial financial and human resources. What is particularly disturbing is that such opposition to frivolous patents have been done as a private initiative, without any help from the government, even though it is a valuable contribution to the safeguarding of public health.

LEGAL CHALLENGES TO THE INDIAN ACT BY MNCS

There have been several other legal battles related to the Indian Act. Unfortunately the government has been very timid in opposing such challenges, and often patient groups have taken the lead in defending the Indian law. Two such challenges to the Indian law are important as they could have far reaching consequences.

Patent Linkage

The German Multinational company, Bayer, had been granted a patent for its drug, Sorafenib tosylate (marketed as Nexavar by the company), in India a while back. The drug is used for the treatment of renal cell carcinoma (a type of cancer of the kidneys) and for treating advanced cases of hepatocellular carcinoma (a form of liver cancer). Meanwhile, an India company, Cipla, applied for approval for registration of a generic version of the drug. Bayer, responded by suing the Indian government in the Delhi High Court, on the ground that if Cipla’s request is granted, its patent right would be affected.  The Delhi High Court rejected Bayer’s appeal, but Bayer appealed against the judgment to a division bench of the Court. This appeal by Bayer has also been rejected.

The case filed by Bayer in India has several implications and we are likely to see other challenges of this kind soon. The most important implication is that it seeks to link the patent status of a drug with the procedures related to the drug’s marketing approval. Across the globe, such linkage is the exception rather than the rule. That is so because the body responsible for granting (or rejecting) patent applications is distinct from the one that grants approval for marketing. Patent applications are decided by Patent offices which have a certain kind of expertise which helps them to decide whether a patent application should be granted. On the other hand, drug regulatory agencies, have expertise in checking the safety and efficacy of a medicine. To ask the latter to do the job of the patent office is incorrect because it does not have the expertise to decide on patent related issues. That is why the functions of the two are kept separate. Further, patent rights are private rights and infringements of these cannot be fought on behalf of the companies by government institutions – i.e. the Government’s Drug Regulatory body cannot be asked to act as a “patent police” to safeguard private interests.

Here it must be understood that the mere grant of marketing approval does not mean that the drug would be marketed. Both the TRIPS agreement and the Indian law allow medicines to be legally registered (i.e. obtain approval from the drug regulatory agency) even when the drug is under patent protection. It is allowed so that the generic version of the medicine can be made immediately available as soon as the patent term of a medicine expires or as soon as a compulsory license is issued to the generic company even while the patent of the innovator company is still valid. It also covers for situations where the medicine is used for research purposes.

Challenge to Section 3d. of Indian patents Act by Novartis: The Gleevec Case

We have discussed in this column, earlier, the challenge mounted by Novartis on Section 3(d) of the Indian Act. To briefly recollect, the patent application for Novartis’ leukemia drug, Gleevec, was rejected by the Indian Patent office on the grounds that it was just a different form of a drug that had been patented way back in 1993. In 2006, Novartis challenged this order in the Chennai High Court and also challenged the legal validity of Section 3(d), based on which the company’s application had been rejected. The two-judge bench while dismissing the writ petition ruled that Section 3(d) was not in violation of the Indian Constitutional and also said that Indian courts cannot rule on whether its law violates an international treaty. However, Novartis continues to persist in its challenge to the Indian Act and has now filed for a fresh review in the Supreme Court.


ISSUES RELATED TO THE INDIAN PATENT OFFICE

In the changed situation since 2005, the India Patent Office has an important role in interpreting the Indian law. Responding to the needs of an enhanced role for the patent offices in India, several measures have been set in motion. These involve  steps to modernise the patent offices (patent offices are located in Delhi, Mumbai, Kolkata and Chennai) including digitalisation of patent related information (grants, applications, etc.) and online publication of patent journals with this information; creation of searchable databases of patent applications and grants; preparation of a patent manual for examiners; training of patent examiners; and capacity building of patent examiners and patent office modernisation.

The patent manual has remained a “draft manual” for almost three years. The patent office had invited comments about the draft, but since then there have been no forward movement. While a well drafted patent manual can be a useful tool for patent examiners given that they need to pass judgment on a large diversity of subject matter that might be out of the scope of their initial training, the present draft manual leaves a lot to be desired. A majority of case laws cited in the manual are from the US or EU, both regions with patent laws that differ from that in India and with distinctly different objectives. Further there are instances where the manual misinterprets the Indian Patent Act.

In an extensive programme to train patent examiners has been undertaken, over a 100 IP officials have been trained in the US (a majority of them being patent examiners). Further MOUs for capacity building have been signed, all with developed countries such as the US, EU, Netherlands, and France. These measures taken together create a situation in the patent office where the letter and spirit of the country’s patent act run contrary to the orientation provided to patent examiners, as patent acts in developed countries are designed to promote very different objectives from those in India.

Finally the patent office continues to be non-transparent in provision of information related to applications and grants. Details of patent specifications, patent examination reports, pre and post-grant opposition board decisions, etc. are not made available.

GOVERNMENT IS ABDICATING ITS ROLE

Clearly, pharmaceutical MNCs are starting to aggressively challenge the Indian law on patents. There are also other legal issues that require intervention by the government – such as procedures for patent oppositions, the transparency and capability of the patent office, etc. The government has chosen to take a back seat in this process and as a result there are serious concerns that it might thereby be providing tacit support to the undermining of its own law. This is not surprising given that the government is actually not in agreement withy its own law and was forced to move amendments to safeguard public health at the behest of Left parties, in 2005, as it depended on them for survival in government. It is imperative that continued pressure be maintained on the government to defend its own law, that is designed to serve the interests of the people.

11th February 2010

D. Raghunandan

It seems even a day cannot go by without some newspaper, magazine or TV channel carrying an expose about yet another blunder by the Intergovernmental Panel on Climate Change (IPCC). On the eve of the Copenhagen Conference, there was the so-called “climategate” scandal when hackers breaking into computers of the Climate Research Unit at UK’s University of East Anglia discovered e-mails and documents revealing attempts to suppress evidence going against the Unit’s conclusions. Then the story broke about an erroneous prediction in IPCC’s Fourth Assessment Report (IPCC/AR4) that Himalayan glaciers would disappear by 2035 due to global warming. A virulent campaign was conducted mostly in the British press not only against the IPCC but also against Chairman Rajendra Pachauri who was held responsible for the IPCC flaws and also accused of personal corruption especially by securing research funding for The Energy & Resources Institute (TERI) in Delhi (which also he heads) based on faulty findings in the IPCC Report.

Going by the media frenzy, one would think the IPCC had got it all wrong, on glaciers, extreme weather events, dwindling numbers of polar bears, what have you. IPCC’s Assessment Reports were seen as the gold standard of climate science and now uddenly, IPCC stands accused even of fudging the facts. Climate skeptics never had it so good. Two decade-old arguments have been reinvigorated: scientists are needlessly spreading panic, climate change may not actually be happening, and even if some of it is, how do we know it is not natural? 
There are clearly many levels of debate involved here. First, regarding the facts. Second, as regards procedures in reviewing research and arriving at conclusions. Third, as regards individual and institutional ethics in the IPCC, in TERI and in government. And fourth, perhaps as important as all the others especially in a broader context, the credibility of science itself.   

Himalayan howler First prize for blunders must go to the statement about Himalayan glaciers in IPCC/AR4 that “the likelihood of them disappearing by 2035 or sooner is very high” (Working Group II or WG-II, Section 10.6.2). As admitted by IPCC after the controversy made headlines, this statement was based on “poorly substantiated estimates of rate of recession and date for the disappearance of Himalayan glaciers”. That is putting it mildly! The assessment is simply wrong and should never have been made, certainly given the evidence cited.

Dr.Murari Lal from India, one of the Coordinating Lead Authors of the AR4’s WG-II Chapter on Asia, and not himself a glaciologist, has since stated in an interview to London’s Daily Mail that the date was inserted in order to “impact policy-makers and politicians and encourage them to take some concrete action”. This excuse of good intention only make matters worse, for it confesses to an agenda-driven rather than fact-based scientific conclusion. That said, there are other angles to the story too.
The 2035 prediction is not carried anywhere else in the Report. In the Executive Summary to the whole AR4, a more careful statement on trends is made: “widespread mass losses from glaciers… are projected to accelerate throughout the 21st century, reducing… meltwater from major mountain ranges eg. Hindu-Kush, Himalaya, Andes.” It is well known that Himalayan glaciers are poorly studied, especially on the Indian side, and the authors of IPCC/AR4 do not seem to have placed too much stock on, nor based any major conclusions, on this statement. Indeed the 2035 date is nonsensical even by the unsubstantiated annual rate of recession given in the Report! But even those attacking the IPCC with the Himalayan glacier stick have not, and cannot, dispute the above more general opinion rightly defended by the IPCC as “robust, appropriate, and entirely consistent with the underlying science and the broader IPCC assessment.” It does not take a rocket scientist to figure out that rising temperatures will sooner or later result in melting of polar ice and of mountain snow caps and ice.    

The science is still correct In the case of other errors pointed out, the IPCC Report is even less at fault. The UK’s Sunday Times carried a tendentious story titled “IPCC Wrongly Linked Global Warming to Natural Disasters”. The story was splashed by several other media outlets including Indian newspapers. But the article was prompted by some social scientists casting doubts on a statement supposedly made in the IPCC Report on high economic costs of natural disasters, not on anybody questioning the linkage between climate change and extreme weather events! IPCC/AR4 in fact makes no definitive statement on economic costs beyond the indisputable observation that “extreme climate events… can cause significant loss of life and property damage in both developing and developed countries”. IPCC Reports are famous for their qualifying statements and predictions in probability rather than in absolute terms. Here too the Report states that some studies showed negative economy-wide costs while others did not, that there are many complex factors affecting costs appraisal of, say, near-term agricultural impact, and that “there is considerable uncertainty associated with assessment of economic impact of climate change”.

So let us be clear. Several issues have indeed been raised by the controversies over different statements in IPCC/AR4, but none of them contradict the core assessments that climate change is real and man-made, that global average temperatures are rising, that atmospheric concentrations of carbon dioxide and other greenhouse gases are increasing and that these will have serious consequences for humanity. On these there is wide scientific consensus. More than 17,000 published and peer-reviewed papers have been taken into account and more than 3000 scientists have been involved in writing AR4. No other scientific exercise hitherto has involved such extensive and inclusive work. The message of the IPCC is incontrovertible, the attempt here is to shoot the messenger.

It must be noted that from the very beginning of the climate debate, there has been a concerted effort to discredit the science and scientists backing the idea of anthropogenic climate change. Fossil-fuel based energy and automobile industry lobbies, the US and some other governments, right-wing think tanks and many others have been known to distort evidence, doctor reports, famously within the White House itself, and otherwise cast doubt on the growing evidence and consensus. Big tobacco did the same and produced many “scientific” studies “disproving” the link between smoking and high incidence of lung cancer. Not all climate skeptics or media reports fall into this category, of course, and several valid issues have no doubt been highlighted. But the increasingly shrill chorus of the current campaign against the IPCC and its core findings smack of orchestration.

Deficient procedures However, none of this excuses the mistakes made in IPCC/AR4 which have resulted not so much from poor research but from inadequate review cross-checking procedures vital in so complex and multi-disciplinary a subject.

The peer review system, that is appraisal of research by other experts in the same or related fields, has long been the established best practice in science to assess the quality of research and its findings. Yet it also carries some inherent dangers, especially when not practiced scrupulously. The peer review system is often abused by hand-picking of reviewers with favourable views on the research subject or friendly relations with the scientist in question. Old boys’ networks, cronyism and mutual back-scratching have long plagued research, as academics and researchers in India know only too well!    With over 90,000 reviewers’ comments, and with multiple authors for different chapters, IPCC/AR4 may have built-in fairly good checks but obviously not foolproof ones. The glacier data cited was from just one scientist, and it is not known what other reviewers had to say about it then, but certainly afterwards many Indian and other glaciologists have raised serious questions.  But as Dr.Murari Lal observed, the mistake in the Report was made not by just one or a few scientists but went unnoticed by the many hundreds of authors and reviewers involved! IPCC peer review in future must go beyond a few selected reviewers, and procedures need to be evolved to enable the wider scientific community to also read and comment on IPCC Reports. Mistakes may still occur but not for want of doing everything possible to check them.

For his part, Environment Minister Jairam Ramesh went hammer and tongs against the IPCC blunder and lamented that Indian scientists had not done enough climate research and were too dependent on western information. True enough, even though the glaciologist cited here happened to be Indian! Then his Ministry went on to officially publish a clearly agenda-driven “counter” study on Himalayan Glaciers which was also not peer-reviewed and contained numerous unverified statements and internal contradictions, including an executive summary that differed with findings in the text! The Minister also conveniently forgot that, as per UN procedures, the IPCC Report had been reviewed and approved by the Indian government who too had overlooked the mistake! Everyone has an axe to grind, it seems. And now the Minister has decided to send a government minder to all IPCC Board Meetings, ostensibly to exercise oversight on the IPCC and Chairman Pachauri! Does science benefit from being sarkari?

Grey literature A more troublesome problem is the use, certainly in the glacier case, of what is known as “grey literature”, that is articles or other publications that have not been peer-reviewed.  The Report’s statement on Himalayan glaciers disappearing by 2035 is referenced to an article in a journal of the Worldwide Fund for Nature (WWF), wherein a further reference had been made to an earlier magazine interview given by the single glaciologist referred to above! Not a peer-reviewed publication, not a research-based conclusion, just an off-hand speculative comment highlighted in the publication of an NGO committed to pushing for climate action! WWF too has had to clarify that the statement on glaciers was speculative. Other prominent international environmental NGOs too have had to make similar admissions in the wake of the recent controversies.

In the modern era, rapid advances in science and technology are impacting a wide swathe of society in many ways. Increasing specialization as well as cloistering of research behind corporate or institutional walls has further heightened the distance between science and the people it affects, prompting suspicion and fear about both science and scientists. Indeed, issues relating to large dams, GM foods, environmental pollution and climate change are intrinsically societal issues and cannot be left only to experts to decide upon. Peoples science or public interest science has come up as a response to shutting out peoples voices from decision-making relating to S&T which is sought to be confined only to those with expertise in the subject. Numerous NGOs, popular movements and “civil society organizations” now rightly conduct independent studies on many S&T issues, publish material, pronounce opinions and campaign on them.

Surely the same caution, cross-check, peer reviews and verification that are demanded of the mainstream scientific community should also apply to such NGO studies, publications and campaigns based on them. This has most definitely not happened till now, and many sweeping statements and unverified pronouncements are made by various organizations on complex issues.

The recent controversies will have served a good purpose if the IPCC, as assured by them, build more robust systems and procedures for the Fifth Assessment Report to ensure that the well-enunciated Principles Governing IPCC Work, namely to thoroughly review the “quality and validity of each source” of information and conclusions, are adhered to. It is clear that most climate skeptics and critics of the IPCC have not, and do not, bother to do this. But will at least NGOs and popular movements do the same?