Problems in the pharma sector must be tackled right at the source. Pharma multinational corporations must instill confidence about the veracity of their cost figures — whether low or high According to a recent study published in the Journal of the American Medical Association (JAMA), it costs a company just $648 million on an average in research and development to bring a cancer drug to the market — a small fraction of the $2.7 billion, the pharmaceutical industry claims, is the average cost of drug discovery. The report further shows that within about four years of approval (no drug is allowed to be marketed without taking prior registration from national regulator under relevant jurisdiction), revenue from sale of the drugs studied was, on an average, nine-fold...
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Category: Technology & Innovations
Are pharma MNCs fleecing patients?
According to a recent study published in the Journal of the American Medical Association [JAMA], it costs a company just $648 million on an average in research and development [R&D] to bring a cancer drug to the market — a small fraction of the $2.7 billion the pharmaceutical industry claims is the average cost of drug discovery. It further shows that within about four years of approval [no drug is allowed to be marketed without taking prior authorization/registration from national regulator under the relevant jurisdiction], revenue from the sale of the drugs studied was on average nine-fold higher than the R&D spending. Even accounting for what the money would have earned if invested in the market, the returns are seven times the costs. The...
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‘Branded generics’, where patients are fleeced
The 2017 Trade Policy Agenda unveiled by the Trump administration on March 2, 2017 pushed for a stricter regime for intellectual property rights (IPRs) and patents. While agreeing that India’s reforms on IPR are encouraging, it said “India’s new National Intellectual Property Rights Policy [NIPRP] should protect US innovations”. India’s defence is based primarily on the flexibilities available to the developing countries under WTO agreement on Trips [trade-related intellectual property rights] to ensure availability of drugs to patients [majority of them are poor] at ‘affordable’ prices. If the concern for the poor is so overwhelming, then the government must ensure that on ground zero, patients should get medicines at prices they can afford. Are they really getting? The manufacturers of...
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‘Branded Generics’ – an Indian innovation to fleece patients
During recent meetings of Modi with Trump, a sore point from the US side was its concern over alleged unsatisfactory record of India in regard protection of intellectual property rights [IPRs] in the area of patent, copyright, trademark and data protection etc. Earlier, the 2017 Trade Policy Agenda unveiled by Trump administration on March 2, 2017 pushed for a stricter regime for IPRs and patents. While, agreeing that India’s reforms on IPR are encouraging, it said “India’s new National Intellectual Property Rights Policy [NIPRP] should protect US innovations”. India’s defense is based primarily on the flexibilities available to developing countries under WTO agreement on TRIPs [trade related intellectual property rights] to ensure availability of drugs to patients [majority of them...
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Pharma woes – remedy worse than disease
Prime Minister Narendra Modi has exhorted doctors to prescribe medicines using their generic names only and hinted that the government will enact a comprehensive legislation. There is nothing new about this pronouncement even as the need for giving a push to use of generic medicines and drugs has been in the air for close to five decades ever since the Patent Act [1970] was passed by the parliament. Last year, the Medical Council of India [MCI] which is expected to keep a watch on doctors had amended the relevant rule ‘mandating doctors to prescribe using the generic name to ensure a rational prescription and use of drugs.’ Modi’s proclamation catapults the issue to the centre-stage. Already, the union ministry of...
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IPR concerns – India should shed its intransigence
The 2017 Trade Policy Agenda unveiled by Trump administration on March 2 pushes for a stricter regime for intellectual property rights and patents. While, agreeing that India’s reforms on IPR are encouraging, the document says “India’s new National Intellectual Property Rights Policy [NIPRP] should protect US innovations”. Specifically, US concerns are articulated in recent observations of Patrick Kilbride, Executive Director (International IP) of US Chamber of Commerce’s Global Intellectual Property Centre (GIPC). He has lamented that IP-intensive American firms continue to face severe challenges in the Indian market concerning Section 3[d] of the Indian Patents Act and compulsory licensing [CL]. The GIPC, in its annual IPR report, has ranked India in the bottom three for having a weak IPR and...
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Can India survive Trump bombshell?
The election of Republican Party candidate Donald Trump as the next President of the US has sent shock waves across the world. All along, America has been a strong protagonist of free flow of international trade and investment in goods and services. If Trump acts on his electoral pronouncements, this will tantamount to a reversal of the existing US policy stance. It will herald an era of “protectionism”. So what are the major areas of concern for India? President-elect Donald Trump wants American companies to operate from within the US and achieve this aim by imposing an import tariff of 35% on those who set up manufacturing facilities in other countries. Such a high tariff will seriously impact India where...
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Government cap on GM tech royalty hurt the farmer; here’s how
The ministry’s decisions reflect a mindset that views MMBL as an exploitative monopoly. This perception is flawed and out of sync with ground realities Under CSPCO, the ministry fixed the price of cottonseed sales at an ‘uniform’ level and the maximum trait-fee payable to the technology-provider (TP). Given GM Bt cotton accounts for 98% total cottonseeds used in India, the decision was directed primarily at this segment. On July 6, 2016, Mahyco-Monsanto Biotech India (MMBL) withdrew its application for environment clearances for commercial cultivation of cottonseeds carrying its Bollgard II Roundup Ready Flex (B-II-RRF) technology, which uses genes that not only kill pests but also imparts resistance to the herbicide, Roundup. MMBL has attributed its decision to the “uncertainty in...
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Agri ministry defies govt
While the intent of the government is to give a big push to commercialisation of GM crops, the agriculture ministry is against it. In December 2015, the Union Agriculture Ministry had issued a Cotton Seed Price Control Order under which it fixed the price of cotton seed sales all over the country at a uniform level and max trait fee (royalty) payable to the technology provider (TP). Given that the genetically modified (GM) Bt cotton accounts for 98% total cotton seeds used in India, the decision was directed primarily at this segment. The ministry also ordered a probe by the Competition Commission of India (CCI) – in to alleged ‘monopolistic’ practices by the Mahyco Monsanto Biotech (India) Private Limited (MMBL)...
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GM technology under siege
On May 18, 2016, the agriculture ministry issued an order that makes it mandatory for the GM [genetically modified] technology provider to license the technology to any seed company that approaches it. If the former does not give the license in 30 days, it is ‘deemed to have been given’ and the latter can use. At the same time, the order also makes it mandatory for the seed company to pay the trait license fee or royalty to the technology provider. Further, it caps the maximum royalty at 10% of the maximum retail price [MRP] for the first 5 years to be reduced by 10% from 6th year. It prescribes a 10-year life for every GM trait which implies that...
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