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Inspired to find a cure for diseases, spurred not mainly by the lure of money but by the responsibility to alleviate suffering
- Biji T. Kurien, Jobin T. Kurien, Mustang High School, Mustang, OK 73064, USA (22 December 2006)
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THE WORLD - WILL THE TREATMENT DIFFER BETWEEN DEVELOPED AND DEVELOPING PART OF THE WORLD
- Visahan Y Sabaratnam (24 December 2006)
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Do we really need any new drugs?
- William H Konarzewski (28 December 2006)
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The Swedish Pirate Party agrees
- Christian Engström (31 December 2006)
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Scooge and IP rights - Scrooge may not cause all the evils of the world
- Matthew Wicks (3 January 2007)
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Intellectual Property: Feudalism Redefined
- Lynn Howard Ehrle (4 January 2007)
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Re: THE WORLD - WILL THE TREATMENT DIFFER BETWEEN DEVELOPED AND DEVELOPING PART OF THE WORLD
- Maureen A Orlando (12 February 2007)
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Call for a Health Impact Fund
- Leila Chirayath (7 January 2008)
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Intellectual Property Right, Drug prices control and rational use of drugs in West Bengal: India-an urgent need
- Professor Pranab Kumar Bhattacharya, Bhattacharya Rupak; Bhattacharya Ritwik; Bhattacharya Upasana; Chakraborty Anindya; Dasgupta Jayanta; Sarkar Ruchirendra (2 February 2008)
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In defence of an improved Patenting system
- Paul G Fairhurst (15 December 2008)
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Biji T. Kurien, Senior Research Scientist Oklahoma Medical Research Foundation, Oklahoma City, OK 73104, USA, Jobin T. Kurien, Mustang High School, Mustang, OK 73064, USA
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For those of us who have not yet been inspired to find a cure for any of the myriad of debilitating diseases, this article (1) by Nobel laureate Dr. Joseph E Stiglitz could be a wake up call. Not for the money aspect mainly, but to alleviate suffering. Money and fame is just a follow-up, and maybe an incentive to work harder. This article could also encourage governments/philanthropic foundations to float prize funds, along the model of the Nobel Prize and the comparatively smaller Laskar Awards. Dr. Bruce Charlton, Editor-in-Chief of “Medical Hypothesis” espoused a similar thought in a recent editorial (2) and points to late Dr. David Horrobin (the founder of “Medical Hypothesis”) for putting forward a similar idea in 1986, saying that large cash prizes should be used as an incentive to find cures (3). In this connection it is worth mentioning that Prize4Life (4), a nonprofit organization announced its $1 Million Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's Disease/ Motorneuron Disease) ALS/MND Biomarker Challenge on November 6, 2006. An award of $1 million is to be presented to researchers who discover a biomarker for ALS. Five $15,000 prizes are also proposed to be given for the best ALS biomarker proposals due by March 2007. A step in the right direction has already been initiated. References 1) Stiglitz JE. Scrooge and intellectual property rights. BMJ 2006;333:1279-1280. 2) Charlton BG. Mega-prizes in medicine: Big cash awards may stimulate useful and rapid therapeutic innovation. Medical Hypotheses 68; 2007;1-3. 3) Horrobin DF. Glittering prizes for research support, Nature 324;1986: 221. 4) http://www.prize4life.org/ Competing interests: None declared |
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Visahan Y Sabaratnam, consultant surgeon Sri Lanka
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Knowledge is not free- sensible argument. But if you take a journal like BMJ, it does not pay for the authors. The author gets the funding through other means. It carries advertisements as well. Hence a journal similar to BMJ should be given free access on the net - as in the past. If free access is not given, a new trend will develop with which the east will go seperate. Competing interests: None declared |
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William H Konarzewski, Consultant Anaesthetist Colchester General Hospital, CO4 5JL
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My congratulations to Joseph Stiglitz on well written, provocative editorial. At the risk of sounding reactionary, I would like to go one step further and propose that we abolish the development of all new drugs on the grounds that they are extremely expensive and take money out of the health service. The health of the nation (and indeed of the world) would be better served, I believe, if we concentrated on treating patients effectively with the agents that we already have at our disposal than by the constant development of new drugs. Whilst costly new drugs may benefit some patients, I strongly suspect that they also deprive other patients of effective, but less spectacular, treatments by eating into limited health budgets. In other words, to paraphrase George Bernard Shaw, new drugs rob Peter to pay Paul, and therefore get the wholehearted support of Paul. The alternative proposal would be that the costs of new drugs are regulated in such a way that they have a zero impact on health budgets and a proven net benefit on the health of the nation. This proposal is probably unworkable because it requires a degree of altruism on the part of those who produce our drugs. But if we continue with the present system, in which people are paying thousands of dollars for medications which cost only a few dollars to produce, I suspect our collective health services will find themselves bankrupt within a decade or two. How do we meet the challenge? Competing interests: None declared |
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Christian Engström, Vice chairman, The Pirate Party (Sweden) Stockholm
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This proposal is entirely in line with what the Swedish political party Piratpartiet (The Pirate Party) is suggesting as a way of funding pharmaceutical research without having to rely on the patent system. [1]
The Pirate Party was formed on January 1, 2006, and nine months later got 0.6% of the votes in Sweden's September 2006 national elections. The party's political platform consists of three issues only: respect for personal privacy, reform of copyright legislation, and the gradual abolishment of the patent system, including pharmaceutical patents [2]. Pharmaceutical patents are not only highly immoral, by depriving people in third world countries access to life saving drugs that they would have been able to afford, had it not been for the patents. They also make drugs unnecessarily expensive for the developed world. If a system like the one Dr. Stiglitz is proposing was adopted for all pharmaceutical research, it has a great potential for saving money, in addition to saving lives. The standard argument for granting patent monopolies and allowing the pharma companies to charge whatever they want for the patented drugs, is that they spend the excess revenues on research for new drugs. But this is not true. As an example, we can look at the annual reports for Novartis [3], Pfizer [4], or AstraZeneca [5]. They all spend around 15% of their revenues on research. The number is typical for the industry. The other 85% go to other things, according to their own figures. More than half their revenues are spent on marketing and profits. Particularly from a European perspective, sustaining this system simply does not make sense. In Europe, over 80% of the pharmaceutical companies' revenues come from the public sector, thanks to various systems for universal medical coverage [6]. In other words, it is already the public sector that pays for most of the research that goes on within the pharmaceutical companies. But as can be seen from the annual reports, at least half the money spent neither goes towards research nor the actual manufacturing of the drugs. If the governments of Europe would instead take 20% of what they currently spend on drugs, and allocate that money directly to pharmaceutical research, there would be more money than today for the research. If the results are made freely available, generic drug manufacturers would be able to produce modern drugs without spending any money on research themselves. And as experience shows, this would radically lower the prices. A conservative estimate would be that we could cut the pharmaceutical bill in half, while still giving more money than today to research. And as a free "bonus", we could give the developing world unfettered access to the knowledge that would save lives, just as Dr. Stiglitz proposes. Exactly how to administer the public sector research money under such a system, is of course something that needs to be discussed. A medical prize fund is one method, but it need not be the only one. Direct funding of research done at universities and similar institutions might also be a method, as well as allowing private research companies to make tenders for specific research projects. Considering the substantial amount of money that would be available for research under a scheme like this, a combination of all of these methods (and others as well) may turn out to be the best solution. But the important thing right now is to open up a global discussion about the effects of pharmaceutical patents, and the alternatives. Today's system is not only grossly immoral, it is also expensive and wasteful. What arguments are there for keeping the pharmaceutical patents, and rejecting the cost savings and other benefits possible if we choose a different approach?
[1] Piratpartiet: An Alternative to Pharmaceutical Patents [2] Piratpartiet: Introduction to Politics and Principles [3] Novartis: Financial Highlights 2004 [4] Pfizer: Financial Highlights 2005 [5] AstraZeneca: Financial Highlights 2005 [6] The Pharmaceutical Industry in Figures 2006 by EFPIA, The European Federation of Pharmaceutical Industries and Associations. Figure in page 37 of the pdf: Pharmaceutical Reimbursement Competing interests: None declared |
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Matthew Wicks, Patent attorney WC1X 8BT (London)
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One of the problems identified with the status quo of drug research by Joseph Stiglitz (BMJ 333, 1279-1280 (2006)) is that drug companies currently spend more money on advertising and marketing than on actual research. His solution to these problems is to replace the current system of patenting new drugs with a winner-takes-all medical prize fund. However, of all the criticisms that can be made of the patenting system, it is unfair to suggest that it contributes to the amount of money spent on advertising. A patent is a monopoly to a particular product. As such, a drug company is able to market its patented product on the basis of the product's unique clinical effects because no other product is exactly the same. In contrast, with a system based on a winner-takes-all medical prize fund model, product manufacturers will be in direct competition with other manufacturers making exactly the same product. As a result, more emphasis would have to be placed on marketing the product on the basis of a brand to differentiate the product from one manufacturer from another. This would not only cost more - brands are expensive to create and to advertise - but the advertising would be less worthy and less informative because it would have to focus on the brand of a product rather than the unique clinical effects of the product. A parallel should be made with the NHS on this point - now that the NHS is moving away a system where a local hospital has a 'monopoly' on providing health services in a particular area to a system where hospitals compete against one another for a patient's 'custom', hospitals are now allowed to start to advertise to attract patients. Moving away from a monopolistic system in this case means that more money will be spent on advertising. One of Stiglitz's other criticisms of the status quo is that it does not encourage research in areas that have less potential for commercial exploitation, for example in the development of drugs for diseases that mainly affect the developing world. In a European context, the EU has identified a problem with a similar cause: too little research is being carried out into the effects of drugs on children because of the lack of a commercial incentive. The EU's proposed solution to this problem is to actually extend the term for patent protection by six months if paediatric studies are carried out with the drug. Perhaps (and I am careful here to leave it at only 'perhaps') a similar solution could be used to stimulate research in other less commercially lucrative areas. Competing interests: I am (for my sins) a trainee patent attorney - although I used to be a research chemist |
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Lynn Howard Ehrle, Senior Biomedical Policy Analyst, Organic Consumers Association 8888 Mayflower Dr., Plymouth, MI 48170 USA
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Professor Stiglitz (23 Dec) observes, "the costs of restrictions[intellectual property rights and monopolies that limit the use of knowledge]can outweigh the benefits" but his editorial misses the mark in his prescription for reform. Medical research prizes will do little to bring drugs to market that will conquer diseases in developing countries. Not when their economies have already been decimated by policies promulgated by the Transnational Trinity(World Bank, World Trade Organization, & International Monetary Fund), operating under the WTO's mantra-- "least restrictive to trade." As for Big PhRMA's huge marketing outlays at the expense of research funding, they result from the misinterpretation of headnotes(with no legal standing)in an 1886 U.S. Supreme Court case resulting in a new legal concept- "corporate personhood"- giving free speech rights to all corporations and feuling the lobbying and advertising boom. Stiglitz refers to patenting of the human genome but does not discuss the legal and ethical ramifications. How is it that human life forms can be patented? This is a colossal gift to the biotechnology industry, one that most certainly will come back to haunt future generations, reminding me of a prescient statement by the eminent biochemist, Erwin Chargaff-- "What can be done must be done." We are now part of a feudal system headed by corporate masters whose employees dare not question decisions from headquarters, nor can they reveal the conflicts of interest that, in the medical field, are a very real threat to the public health and safety. These megamerged monsters, along with their willing surrogates in academia and government, have created a medical-industrial complex that has mutated into a two-headed monster-- corporatized medicine and the systematic commodification of human life. Competing interests: LHE is founder and chair of the International Science Oversight Board (pro bono), a Special Project of the Organic Consumers Association. |
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Maureen A Orlando, Health Informatics UK
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In the age of open source coding, file sharing and their benefits thus far, sharing of knowledge fundamental to global healthcare should be encouraged; Else health inequalities will continue to rise. Surely there are other means of making money without hoarding knowledge. Competing interests: None declared |
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Leila Chirayath, US Director Incentives for Global Health
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This piece clearly articulates the need for alternative models that address pharmaceutical innovation for poor-world diseases. I helped found an organization with Professor Thomas Pogge, a political philosopher noted for his work on global justice, to develop such models. The organization, Incentives for Global Health, is working on a proposal for a Health Impact Fund that would reward innovators based on the overall impact of their products on the disease burden. In exchange, innovators would relinquish sales revenues for products registered under the scheme, encouraging them to license innovations to generics for competitive manufacture and lowering prices dramatically. Advance Market Commitments, the brainchild of Harvard economist Michael Kremer and a team at the Center for Global Development, address many of the same challenges and have resulted in a US$1.5bn commitment to develop a vaccine for Pneumococcal disease. The Health Impact Fund can be viewed as a "Comprehensive Advance Market Commitment," to use economist Aidan Hollis' term, in that it goes a few steps further than AMCs by rewarding innovators based on overall health impact, rather than on developing a specific product. For more information on the project, please visit www.incentivesforglobalhealth.org. Competing interests: None declared |
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Professor Pranab Kumar Bhattacharya, Professor of Pathology, Incharge Histopathology, Bloood Bank&VCTTC, Cyogenetics, MD pathoogy Course, Institute of Post Graduate Medical Education & Research(IPGME&R) 244a AJC Bose Road,Kol-20,W.B,India, Bhattacharya Rupak; Bhattacharya Ritwik; Bhattacharya Upasana; Chakraborty Anindya; Dasgupta Jayanta; Sarkar Ruchirendra
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Dear Editor We, have gone through the interesting editorial by Joseph E Stiglitz1, Nobel lauratee, Economics,2001 “Scrooge and intellectual property rights” published in BMJ1 where he described Intellectual property rights, specially Patent right, enables one person or a company to have exclusive control of the use of a particular piece of knowledge, thereby creating monopoly power of knowledge and as such developing countries like India has to pay a high price for drugs and the drug companies spend more money on advertising1 and marketing than on research, more on research on lifestyle drugs than on life saving drugs, and almost nothing on diseases that affect developing countries . E Stiglitz, proposed ‘A medical prize fund ‘ in every country provides an alternative1. Such a fund would give large rewards for diagnosis, cures or vaccines for diseases like malaria, TB, HIV &AIDS that affect millions of the poor countries, and the prizes could be funded by governments in advanced industrial countries1. We authors agree to his view. However there already exist several such rewards like X prizes of Washington DC; Jhon Hopkins Prize; Laskar awards6 Another Prize may be instituted like or equivalent to Nobel Prize in medicine particularly for research and drugs /vaccine design and development that effects poor people and made available in market at negligible cost Poverty is acknowledged to be the biggest risk factors for ill health not only in India but worldwide, as I personally realized in my medical carrier for last 34 years. The W. H.O estimates that today also about 1.5 billion people live in extreme poverty, without any decent shelter, clean drinking water, adequate sanitation, or one meal food.2 A total of $2.3 trillion (£1.1 trillion; 1.6 trillion) had been spent on development aid over past five decades, but still quite a large numbers of world population lives bellow poverty line specially in India, Bangladesh, Africa and it has been the subject of vigorous debate among development economists3. In India, specially in rural & sub urban West Bengal, even at early dawn of 21st century, diarrhea, GI disorders and respiratory diseases have an intimate but preventable link with poor living conditions, inadequate and contaminated water, dirty household, fuels, and unsafe food. Other risks include malnutrition, worm’s infestations, Malaria, Tuberculosis, Rapid rise of HIV, domestic accidents, road traffic injuries, job less, depression, suicide and exposure to Arsenic, lead, pesticides, and other poisons. Children& young are particularly vulnerable. By the term development of a state/country/or a local area, I {first author} always meant about providing food, a reasonable shelter, and health [related with price of diagnostics, technology, drug and IPR] to everybody on this planet in such a way that future generation can do the same, but never the big shopping malls, five stars hotel like health units/ cities, cinema halls,ionox, plenty flyovers, big mansions or looking interest of private business houses; private national & international drug houses & traders, what probably the economists thinks. Sustainable development is, of course, about climate change and rising sea levels. It is about the loss of biodiversity and spreading deserts. In India, there exist well- established statutory, administrative and judicial frameworks to safeguard intellectual property rights, whether they relate to patents, trademarks, copyright or industrial designs. The year 1999, India witnessed the passage of major legislation with regard to protection of intellectual property rights in harmony with international practices and in compliance with India's obligations under TRIPS of WTO. These include: The Patents (amendment) Act, 1999 passed by Indian Parliament on March 10, 1999 to amend the Patents Act of 1970[that accorded exclusive marketing rights for 5 years only]. The Patents (second amendment) Bill, 1999 further amended Patents Act, 1970 and made it TRIPS compliant for 20 years. It had been alleged that there was absence of effective patent protection in pharmaceutical sectors in India and Indian Pharmaceutical houses are highly expert in copying patented drugs/molecules. In India in terms of Section 5 of Patents Act, patents are presently restricted to methods or process of manufacture and not the substances/products i.e on the molecule. In terms of TRIPS agreement, India had time till January 1, 2005 to extend patent protection to this area. The ten year transition period available for providing product patents to pharmaceutical products is within WTO rules. On December 31, 1994 Concern had also been expressed over the compulsory licensing provision in Patents (Amendment) Act, 1999. As per provisions of Section 84 of Patents Act, 1970 and Clause 35 of Patents (Second Amendment) Bill, 1999, a compulsory license was granted in case the patented invention. This provision is intended to provide for necessary and adequate safeguard for the protection of public interest taking in to account the specific needs of a developing country like India. The Indian Patent laws are neutral in applications to domestic or foreign inventions. Any disqualification, compulsory licensing, and exclusion from patentability, are provided for only in the larger interest to provide therein necessary and adequate safeguards for the protection of public interest, national security, bio-diversity, traditional knowledge, etc. These provisions are within the sphere allowed under Article 27, 30 and 31 of TRIPS. But Patent application cost, patent attorney cost [ to write up patent application, for patent search and fighting patent for opposition after gaze ting] in India is too high[often approximate in Indian currency Rs2.5-5 Lacks] & preventing a scientist to move for patent application on individual basis for his /her invention. And as such he/she has to seek for a company or an institution to bear the cost of patent. Regarding the copy Right Protection, India has modern copyright protection laws. Major development in the area of copyright during 1999 was the amendment to the Copyright Act of 1957 to make it fully compatible with the provisions of the TRIPS Agreement. Called the Copyright (Amendment) Act, 1999, IPR Copy right, came into force on January 15, 2000. The Copyright Act in India is now in full conformity with the TRIPS obligations and both central/sate governments paid stress to the need for strict enforcement of the Copyright act and rules. IPR Copy Right act is less costly, by declaration in tangible media and probably beneficial for individual scientist if his/her research/ inventions are published under his/her own copy right [especially material & methods, data of research, design and discussion or conclusion of his research/invention]. However in majority of scientific indexed journals in India, for publication of a research paper, copy right of authors must be transferred to editor/editorial board of journal [having joint responsibility to maintain copy right of an article] and journal houses profits huge out of authors articles published & disseminating knowledge, providing scope for others to implement the research in fields/in industries and thus infringing copy right in the name of fair use(Non open access journals).How ever open access journals importance are increasing today. Open access journals typically allows to retain copy right by the authors do peer review and have partially allows the readers (readers have access to only a fraction of relevant literature & potentially missing the vital part of the paper). It allows self archiving also. Such Open access journals are “The Lancet, BMJ, Nature, Science “ with high impact factor. Researcher may contribute to these journals Special cells for copyright enforcement have so far been set up in 23 States and Union Territories including West Bengal. States have also been advised to designate a nodal officer for copyright enforcement to facilitate easy interaction by copyright owners. As per data relating to copyright offenses available with the National Crime Records Bureau, number of copyright infringement cases registered has gone up from 479 in 1997 to 802 in 1998 in industries only. The number of persons arrested has increased from 794 in 1997 to 980 in 1998. The value of seizures has gone up from Rs.2.88 crore (28.8 million) in 1997 to Rs.7.48 corer (74.8 million) in 1998. These figures reflect how much Indian business houses infringes the copy right of authors as well the general improvement in enforcement of the copyright law4 For scientists/ laboratory bench workers, of university, institutes & private sectors mainly of developed world, and for developing world’s scientists, intellectual property rights [both Patent Right and Copy Right] are no doubt beneficial & good and the system may one day track off the business houses out of train& they wants5 Intellectual property Right systems must be strengthened.. But Intellectual property Right if not used carefully, introduces distortions that are detrimental to interests of developing countries like India, Bangladesh. Developed countries should pay more attention to reconciling their commercial self-interest with the need to reduce poverty in developing countries, which is in everyone's interest. To bring a new molecule as a drug it requires a cost of $ 170 million to $ 300 millions in the market and an expected time of 15-18 years are required. .Money is the most important factor no doubt. But the most important factors are finding a new molecule, purifying it, checking that they do what for they are designed to do, whether they work in clinical practice without causing unacceptable harm, to pass through clinical trials(phase-1 to phase-4) to look for animal tests, side effects, drug interactions and all these are done by academics or clinicians in any hospital/ university/ institutes by a group of team. The function of manufacturer are to provide money, produce the bulk production of raw drugs, sales and marketing and to gain profits. When concerned with drug Prices in India and in West Bengal state, in Indian markets two types of drugs are now available. These are non Essential drugs (NED) and Essential drugs(ED)5. ED as per WHO are basic indispensable and necessary for the health of Population and WHO urges that a country must identify numbers of drugs that reflect the pathology and therefore the priority need of the population. And these lists must be made of generic names proven to be effective safe and at lowest cost. The WHO expert committee on ED pointed out that majority of the diseases in India can be cured and treated by less than 400 drugs4. But in India total numbers of drugs is about 70,000 and we have more than 16,000 pharmaceutical companies than primary health center [6000]. These are non essential drugs mainly. NED are two types1) scientific drugs i.e., drugs having a place in reference/ standard text books of pharmacology/medicine but not included in the ED list on ground of either having better substitute or being needed only for uncommon diseases, 2) unscientific drugs- These drugs have no place or not included in any text books of pharmacology/ medicine and they are brain wave of business men in India. Majority of the drugs in our West Bengal state are Type 2 of NED. They are mostly tonics of various hues, vitamins, combinations health foods, cosmetics, auervadic, indigenous drugs, homeopathy drugs, hazardous drugs and massive numbers of irrational combinations. Thousands and thousands numbers of General Practitioners, Specialists, and physicians, surgeons Gynecologists are prescribing them and never prescribe in generic name of drugs. In government hospital practice, generic name is not used though there is circular for it. Generic name prescription is an exception than a rule, not only in West Bengal but all over India. Generic drugs are not also available in Indian market as drug companies are reluctant to market their drugs in generic names, because generic drugs are so cheap. Use of brand names helps companies to hike prices and to place other companies in unhealthy competition in market. To influence doctors various sales promotion techniques are adopted by drug manufacture through representatives to hood wink doctors[ like in literature/ leaflet they influence saying about “Potency of the drug better than existing one but not the efficacy, bioavailability, complete ADR of molecule”, providing gifts to doctors, sponsoring the scientific conferences, cocktails, bumper lucky draw, sponsoring air fare, hotel charges for family international tours, providing literature which contain either journal names/or authors name only. The volume no; page no. year, indexing no; often they suppress &often an article related to drug published in supplementary issues which often publishes other than scientific merit of the article and not considered for inclusion of the article for indexing for the same journal. Many banned drugs by FDA are in market and prescribed often due to inadequate knowledge of GPs. The practitioners in our country are little bothered about the prices of drugs they are prescribing to poor people of the state. The majority private doctor’s [98%] moral value, ethical value, in West Bengal and In India lost and monetary, status values by any means are important to them. They often prescribe costlier brand names drugs for a better commission, gifts from companies and as a mark of prestige5. Printing MRP is must from 1962& calculation are like following-: RP(Retail Price)= (MC+CC+PM+PC)x(1+MAPE/100)+ED Mc= Material cost, PM=Cost of Packing material, ED=Excise duty; CC=Conversion cost; PC=Cost of packing charges. The formula allows manufacture to make 100% profit for packing material, which is not manufactured by drug companies but bought from market. The current policy follows MAPE which means all cost incurred by a manufacture from the stage of ex factory cost to relating and includes trade margin for the manufacturer and it shall not exceed 100% for the indigenously manufactured schedule formulations. In case of imported formulations the landed cost form the basis for fixing its price along with such margin to cover selling and distribution expenses including interest and importer profit which shall not exceed 50% of landed cost5. The material cost or landed cost for the imported drugs intermediate/raw material/formulation. Higher the declared cost (real or imaginary) greater is the profit. Actually price difference of a same pharmaceutical ingredients varies between with a profit range of 300% to 500% and these price hikes are not for the Intellectual property Right (patent right) implementations in the country but for the evilness and lure of manufacturers, drug traders and providing scope by government who has less interest for drug price control for the name of industrialization & private industrial development. An example is as follows_: In 1974- 450 drugs, in 1979-347drugs in 1986-142 drugs and in 1994 only 76 drugs were brought under drug price control act-1995. In our opinion use of Generic version drugs in government hospitals, and in all private sector hospitals[through availability in market & implementation by government order for prescription generic drugs through Indian medical association amongst private sectors & GPs), stopping sales representatives to visit in hospital premises for promoting a molecule, stopping irrational prescribing of drugs, Prescription audit and application of Infection control committee in every hospitals can control drug price hikes’ Of course, developing countries should set their own agenda and develop laws that give them easier access to cut-price drugs and generic versions of drugs that are still patented. They should also aim to ensure that diagnostic and surgical methods are excluded from patents. Copied versions of innovative medicines are not the solution for countries that lack even the most basic of healthcare systems, including diagnostics. We authors respect the Intellectual property right,personal intellectual property& privacy (Patent Right and copy right) strengthening in our country. We think that implementation of strict copy right according to IPR copy right laws for the authors even to the published research articles in the indexed journals and lowering the cost for patent application & patent attorney charges will help many brilliant medicos to move for research in drugs needed for poor counties References 1)Joseph E Stiglitz “Scrooge intellectual property rights”BMJ 2006;333:1279-1280 (23 December), 2)WHO. Health and development: poverty and health. www.who.int/hdp/poverty/en/. 3)Dan J Ncayiyana combating poverty: the charade of development aid BMJ 2007;335:1272-1273 (22 December), 4)Embassy India “ Intellectual property Rights In India” F:\New Folder\IPR& cpoy right\Intellectual Property Rights in India, Embassy of India, Washington, DC.htm 5)Bhattacharya Pranab Kumar” Rational drug therapy- an urgent need in West Bengal” Bull RGKMC vol5, no3 2000 P29-32 and vol5, no1,2000 6)Biji T. Kurien “ Inspired to find a cure for diseases, spurred not mainly by the lure of money but by the responsibility to alleviate suffering” Rapid Response to Joseph E Stiglitz Scrooge and intellectual property rights BMJ 2006; 333: 1279-1280 Corresponding Author’s Address-: Professor Pranab Kr Bhattacharya; Professor Dept. of pathology, In charge of Histopathology Unit, in charge of Cytogenetics, Ex-In charge of 24 hours Ronald Ross Malaria clinic, Technical Supervisor In charge of Blood Bank, 3rd floor, Dept. Of Pathology;Institute of Post Graduate Medical Education& Research (IPGMER) ;244A AJC Bose Road, K0lkata-700020, India Email= profpkb@yahoo.co.in pranab@unipathos.com phone no- 91- 9231510435 Competing interests: None declared |
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Paul G Fairhurst, Partner IPV Consulting 04808 Leipzig Germany
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The suggestion that the current Patent system be replaced by an over simplified system of bounty offer in reward for "important" pharmaceutical (or any invention) is both fraught with naïve misconceptions about the patent “social contract” and poses more questions of implementation than it solves. To incentivise innovation which J E Stiglitz appears to support, The reward is offered to incentivise the research and development of valuable inventions for social good. One problem with a bounty is how to determine which innovation is significantly important to warrant reward and how to value such reward commensurate with the inventions social value. Surely an incentive needs to be perceived to warrant the often substantial investment demanded of innovation research. Another question is who determines this importance, selects the most worthy recipient and who shoulders the burden of paying this reward? His reference to “governments in advanced industrial countries” may well be translated into the “taxpayers of advanced industrial countries” Someone would need to define that august club and convince them of its merits and surely they would want a say as to the relative importance of the proposed innovation. Would they select a cure for an unknown tropical disease over their own topical threats? But the real question raised is; In what way does the proposed “reborn” scrooge differ from the existing patent system and if so in what way/s is it improved upon? Firstly a patent grant is a reward. The patent granting authority offers the grantee (the inventor) normative scarcity to an otherwise freely available idea. In this way it creates a commercial asset. If the innovation is of little value this scarcity may not even be worth the cost of registration. (Interestingly more than 90% of patents are withdrawn due to lack of commercial viability). If it is truly of value it may warrant considerable further investment to bring it to market. Thus the reward is driven by market demands and the reward commensurate with social wants. Yet the burden of payment of the reward is borne by the end user the one who actually needs and benefits from the innovation. Of course the writer would agree that an arbitrary term and somewhat “flexible scope of claim” may allow for disproportionate reward for social good but this arises out of the difficulty to define innovation (IP asset) values. However this value could be agreed upon between grantor and grantee subject to taxable declared revenues over the life of the grant. At a point where this payback is reached the grant could be withdrawn. Also the investment in so called orphan drugs where commercial viability is limited by a small number of sufferers would demand extended rather than limited patent protection to recoup the investment required. The point about underdeveloped countries having limited access to these innovations has been debated for decades and continues. As a result there are a number of measures including mandatory local licensing which allow for this disparity. Thus the patent system, though flawed and in real need of adjustment to more developed global conditions, offers all the benefits proposed by Stiglitz without the vague and arbitrary controls which would be impractical to enforce on any free commercial society. A reward commensurate with social value. Incentivised innovation and continued investment in worthy pharmaceutical research. Competing interests: None declared |
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