Documenti di Didattica
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Author(s): S SRINIVASAN
Source: Economic and Political Weekly, Vol. 46, No. 24 (JUNE 11-17, 2011), pp. 43-50
Published by: Economic and Political Weekly
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expenditure on medicines garding healthcare which are interests of the poor that the relatively
Theregaining
areincreasing
a fewcurrency:
articles
good of faith re well-off, and the middle class are given
in India accounts for 50% to
quality healthcare should be accessible, access to publicly provisioned healthcare,
80% of treatment costs, affordable,
India's and available to all in need as this would in the long run ensure quality
pharmaceutical success has
and the poorest person should get the care. The real rich can look elsewhere if
medicines at all levels of public indeed so in comparison with most devel and state governments around Rs 30,000
oping economies with the possible excep crore per year if medicines are given free
healthcare and offers suggestions
tion of China. India's pharma success - to all from the primary to tertiary levels,
on how this can be done.
currently selling Rs one trillion worth of subject to various assumptions. A recent
active pharmaceutical ingredients (apis) study by Gupta et al3 estimates the cost to
and formulations annually - has given it be Rs 33,546 crore. We give the details of
the title of "pharmacy of the world".1 This our estimate in Annexure 1 (p 50).
success is attributed, among other reasons Four aspects must be looked at to en
to India's process-patent-only-regime for sure that the system does not work at
medicines post the Patents Act, 1970. cross purposes:
The irony, and the tragedy, of course is • Restrict the list of medicines available
that this success has not translated into
in this country to essential medicines. The
current National List of Essential Medi
availability or affordability of medicines
for all.2 What can be done to provide cines (nlem 2003) and who's Model List
Some of the arguments in this paper were (2010) have around 350 medicines. This
medicines in all our public facilities espe
presented at a meeting of the High Level can be increased to 500 to include medi
cially to the poor? The response of policy
Expert Group of the Planning Commission in makers is akin to the discourse in the issue cines for rare conditions and unnecessary
December 2010 and elsewhere. Comments
from Anant Phadke and T Srikrishna and fixed dose combinations and drugs of
of right to food and subsidised food for the
constant education from lawyers Leena poor. They have come up with targeted doubtful or no value can be removed.
Menghaney and Kajal Bharadwaj on schemes which suffer from disagreement • Price regulation of all these medicines.
intellectual property issues are gratefully over who should be targeted, what should be • A national vaccine policy to regulate the
acknowledged.
the extent of free care, which pre-existing entry of new vaccines as also in the Ex
S Srinivasan (sahajbrc@gmail.com) is with disease conditions should be exempted and panded Programme on Immunisation (epi).
LOCOST, Vadodara and with the All-India
how to deal with the potential hazard of the • Proactive use of Trade Related Aspects
Drug Action Network and Medico Friend Circle.
system being exploited by healthcare seekers of Intellectual Property Rights (trips)
Economic & Political WEEKLY HTTT] JUNE 11, 2011 VOL XLVI NO 24 43
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INSIGHT
list (edl) with 21 fast moving drugs accountAlbendazole tab IP 400 mg 10 tablets 11.00 250.00 4.62
ing for 80% of its procurement budget. It Alprazolam tab IP 0.5 mg 10 tablets 1.40 14.00 0.45
also had 322 "specialty" drugs - out of Arteether2 ml Inj 1 injection 9.39 99.00 9.71 for80mg per vial
which 10 drugs accounted for 85.6% of theAmylodipine tab 5 mg 10tablets 2.50 22.00 0.42 for 10 tabs of 2.5 mg
lOtablets 1.20 35.00 0.50
budget and one - Temozolamide Caps - for Cetrizine 10 mg
52.00 370.00 8.77 for 250 mg injection
52%. The tnmsc system services all levelsCeftazidime 1000 mg 1 injection
lOtablets 18.10 170.00 2.30 for 10tabsof10mg
of care. The patient does not have to payAtorvastatin tab 20 mg
Diclofenac tab IP SO mg lOtablets 2.20 25.00 0.63
for these drugs7 which are available only
Diazepam tab IP 5 mg lOtablets 1.90 29.40 0.47
through the government health system.
Amikacin 500 mg 1 injection 6.95 70.00 6.78
In the Chittorgarh district and Nagaur *For similar strengths and pack sizes unless indicated otherwise, accessed 29 April 2011.
district models, the drugs are available atSource: Prices in Columns (3) and (4) from Samit Sharma's presentation, July 2009, and websites cited, op cit. Source for TNMSC
prices: http://www.tnmsc.eom/tnmsc/new/html/pdf/drug.pdfandhttp://www.tnmsc.com/tnmsc/new/html/pdf/spldrug.pdf
the district hospital levels at the retail level
as well through a series of retail shops run Table 2: Comparison of Chittorgarh Procurement Prices and Printed MRP
Drug Manufacturing Name Given by Company Ingredient Name of Rate at Which Drug Is Rate at Which Drug Is Sold
by the government cooperative set up for Company (Brand Name) Medicine (Generic Name) Purchased bythe Chemist to the Customer
(Printed MRP)
the purpose. The above poverty line (apl) (Stockist Price) One Injection
44 june ii, 2oii vol xlvi no 24 EH353 Economic & Political weekly
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INSIGHT
esting phenomenon: local predators arebut by a third party, i e, the doctor. Therefore, if prescribers and producers join hands and take advantage of a
patients' helplessness, only the State can stop them.
viewed as saints abroad.
Economic & Political weekly 0353 june 11, 2011 vol xlvi no 24 45
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INSIGHT
22,282 4,485
cisely what happened with the vaccine
Nozolamide 250 mg (5 capsules) Dr Reddys Sun
Pemetrexed 500 mg (vial) 73,660 Eli Lilly 11,990 Glenmark commitments made by private vaccine
Exemestane25 mg (30 tablets) 4,315 Pfizer 1,290 Natco manufacturers after the infamous closure of
Source: "NPPA Study Finds Huge Gap in Cancer Drug Prices", Joe C Mathew in Business Standard, New Delhi, 31 October 2010. the vaccine public sector units (psus) by the
46 june li, 2011 vol xlvi no 24 0353 Economic & Political weekly
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INSIGHT
Imovax polio Inactivated Poliomelitis vaccine 365 280 85 30.4 up by actually manufacturing the drugs so
Tripacel Component pertusis, Diphtheria and tetanus toxoids 1,211 762 449 58.9 licensed. Also, there are at least a couple of
Okavax Varicella vaccine 1,468 986 482 48.9 drugs for which a cl initiated by the gov
Avaxim80 Hepatitis A vaccine 952 665 287 43.2 ernment would be of use to the hiv patient
TetractHib Diphtheria, Tetanus, pertusis, Haemophilus community at large - for instance, Ralte
influenzae b conjugate vaccine 504 305 199 65.2
gravir, Etravirine, Rilpivirine, Maraviroc -
ActHib Haemophilus influenzae b conjugate vaccine 426 251 175 69.7
all useful in the new types of resistant
Source: Lodha, Rakesh and Anurag Bhargava (2010): "Financial incentives and the Prescription of Newer Vaccines by Doctors in
India", Indian Journal ofMedical Ethics, January-March, VII: 1. strains of hiv. To that one can add pegylated
Economic & Political weekly 0353 june 11, 2011 vol xlvi no 24 47
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NOTIFICATION
Applications are invited for the following Post Graduates Programmes in the School of Internatio
Politics, Mahatma Gandhi University.
Admission is based on the marks of qualifying examination, entrance test and interview.
The last date for receiving the applications in the office is 21 June, 2011. Application form and other de
be downloaded from the university website www.mquniversity.ac.in.www.sirpmgu.in
48 june li, 2011 vol xlvi no 24 B353 Economic & Political weekly
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INSIGHT
(Vadodara/Bilaspur: LOCOST/JSS), also available Richard R Nelson, Bhaven N Sampat and Arvids A
pharma self-sufficiency of India or for the Ziedonis (2001): "The Growth of Patenting and
online at: http://www.scribd.com/my_document_
many countries counting on India as the
collections/2879052 and http://www.scribd. Licensing by US Universities: An Assessment of
com/my_ document_ collections/ 2474529 the Effects of the Bayh-Dole Act of 1980", Research
pharmacy of the world. The sooner the
io The Sandhu Committee Report of 2004, the Policy, 30: 99-119
government takes measures to stem the easy 18 See for immunisation coverage figures for 2008:
earlier Drug Price Control Review Committee
http://www.searo.who.int/vaccine/LinkFiles/
Report of 1999, and a Task Force appointed by the
pickings that home grown drug companies
PMO EPl2oo8/Indiao8.pdf, accessed 29 April 2011.
in 2005 and chaired by Pronab Sen from the
have become, the more hopeful we canPlanning
be 19 Y Madhavi et al (2010): "Evidence-based National
Commission, the Commission on Macr
oeconomics and Health 2004, etc, - all have en Vaccine Policy", Indian J Med Res, May, 131: 617-28.
of realising dreams of universal accessdorsed
to price regulation of drugs. 20 There is another recent draft at the behest of the
healthcare. One can only hope for a iishift
Recommendations/observations of the Committee, government that is doing the rounds and that
Para 10 in "Availability and Price Management of negates this sound principle, inter alia.
in the mindsets of those in power to effect
Drugs and Pharmaceuticals". Seventh Report,
21 Sarojini N B, Sandhya Srinivasan, Madhavi Y,
the change. Those without access to medi
Standing Committee on Chemicals and Fertilisers, Srinivasan S and Anjali Shenoi (2010): "The HPV
2005-06, Fourteenth Lok Sabha, Lok Sabha Secre Vaccine: Science, Ethics and Regulation", Eco
cines in India and elsewhere expect it as a New Delhi, September 2005.
tariat, nomic & Political Weekly, 27 November, XLV: 48.
12 The draft policy had several other recommenda
matter of human right and entitlement. 22 Personal Communication from industry observer
tions but it was quietly shelved because of opposi and researcher Gayatri Saberwal, 29 April 2011.
tion from India's pharma industry on the price The citations in the quote refer to the following:
NOTES regulation aspects. "Profitless Prosperity". The Economist. 379, 63 (22
i For some reasons not analysed sufficiently, India
13 "On Issues Relating to Availability of Generic, April 2006); Allison, M "Avastin's Commercial
dominates the formulations market internation Generic-Branded and Branded Medicines, Their March Suffers Setback", Nature Biotechnol, 28,
Formulation and Therapeutic Efficacy and Effec 879-80 (2010); and Shaffer, C "Pfizer Explores Rare
ally and China dominates the API market.
tiveness" (Presented to the Rajya Sabha on 4 Au Disease Path". Nature Biotechnol, 28,881-82 (2010).
2 See Sakthivel Selvaraj and Anup K Karan (2009):
gust 2010) (Laid on the table of the Lok Sabha on
23 The Draft Biotechnology Regulatory Authority of
"Deepening Health Insecurity in India: Evidence
4 August 2010). India Bill 2009 also has the by now infamous
from National Sample Surveys since 1980s", Eco
14 Ruth R Faden and Kalipso Chalkidou (2011): clause, Section 63, that proposes imprisonment
nomic & Political Weekly, 3 October, XLIV: 40.
"Determining the Value of Drugs - The Evolving and fine for anyone who "without evidence or
3 Narendra Gupta (2010-11): "What It Costs to Pro
British Experience", N Engl J Med, 7 April, 364 scientific record misleads the public about safety
vide Medicines to All Sick Persons in India", MFC
(14). As the authors point out, "Contrary to some of GM crops". No soft-pedalling of the law here.
Bulletin, August-January, Issue 342-43.
reports, NICE has no authority to restrict access - Space and Atomic Energy - presumably one can
4 Can be curtailed possibly by spelling out reim British law mandates only that the NHS provide 'mislead' and get away to some extent.
bursable costs of each test and diagnostic proce funding to cover recommended drugs. Nor 24
is Figures courtesy Anurag Bhargava, 2008.
dure - assuming we are talking of a universal NICE responsible for setting drug prices. In the 10
access system that will specify reimbursable costs 25 Section 84 - CLs initiated by generic companies who
to 15% of cases in which it recommends against
to private practitioners. can apply when (a) the reasonable requirements
providing access to a drug because of poor cost
5 See www.tnmsc.com for latest procurement of the public with respect to the patented inven
effectiveness or clinical effectiveness, stakehold
tion have not been satisfied or (b) it is not availa
prices of TNMSC, accessed 29 April 2011. Also, ers regularly exercise their right to appeal the de
S Srinivasan (1999): "How Many Aspirins to the ble to the public at a reasonably affordable price
cision and are sometimes successful. (Roughly
and (c) the patent is not being worked. The grant
Rupee? Runaway Drug Prices", Economic & Politi 30% of the NICE recommendations are appealed,
cal Weekly, 27 February-5 March.
of CLs to competitors such as generic companies
and roughly 10% of the appeals result in substan
can be an effective measure to make patented
6 See: Low Cost (Generic) Medicines Initiative, tial changes to the recommendations.)" Thanks to
drugs affordable and available. However, the pro
Chittorgarh, at http://chittorgarh.nic.in/Generic_ Sunita Sheel for pointing out this report.
visions impose a three-year waiting period from
new/ generic.htm. and http://nagaur.nic.in/ 15 For a spirited summary of the arguments against
the date of the grant of the patent before a generic
GMP.htm, viewed 29 April 2011. Also, S Srinivas high R&D costs, see Donald W Light and Rebecca company can make an application for a CL.
an (2009): "Too Good To Be True But True: Retail Warburton (2011): "Demythologising the High
Sale of Generic Drugs at Low Prices by the Gov Section 92 - Notification by central government
Costs of Pharmaceutical Research", BioSocieties,
ernment in Chittorgarh District", Health Action, in the official gazette that a CL needs to be issued
6:34-50.
September, also in MFC Bulletin, October 2009 16 There is a vast burgeoning literature on pharma for public non-commercial use, national emergency
January 2010.
or extreme urgency. After the notification, the
innovation and desirable policies in a post-2005,
patent controller can grant a compulsory license
7 Maulin R Chokshi (2008): "TN Drug Procurement product patent world, especially on how to use to a generic company so that the drug is made
Model", WHO-SEARO. TRIPS flexibilities, how to get around patenting available to the public at an affordable price.
8 For medicine price mechanisms in other countries, by prize funds, patent pools, etc. The degree of
Section 92A - CL to generic company when another
see Chapter III of the Report of the Drug Price Control their belief in the sanctity of the TRIPS/WTO sys
country wants to import drugs. This provision is
Review Committee, Dept of Chemicals and Petro tem varies and mostly not stated upfront. Never
important, as Indian generic manufacturers play
chemicals, New Delhi, October 1999. For a more theless, see for instance, Joseph E Stiglitz and Ar
a key role in supplying medicines to developing
recent review of these, see: Sengupta, Amit, Reji jun Jayadev (2010): "Medicine for Tomorrow:
countries with insufficient manufacturing capacity.
K Joseph, Shilpa Modi and Nirmalya Syam (2008): Some Alternative Proposals to Promote Socially
"Economic Constraints to Access to Essential Section 100 - Government use licence, which will
Beneficial Research and Development in Pharma
Medicines in India", Centre for Technology and ceuticals", Journal of Generic Medicines, 7 July: apply in situations where the government needs
Development and Society for Economic and So 217-26; and the readable chapter 8 on "A Policy to manufacture, procure, distribute and sell the
cial Studies in Collaboration with WHO SEARO. A Agenda for IP, Access and Innovation" in T Hoen, patented drug on a non-commercial basis.
more recent news item (2011) at "Germany Caps Ellen F M (2009): The Global Politics of Pharma 26 "Two domestic drug makers", according to a re
Drug Prices", Nature Biotechnology, February, 29 (2). ceutical Monopoly Power: Drug Patents, Access, In port in the Business Standard, 3 May 2011 (http://
novation and the Application of the WTO Doha www.business-standard.com/india/news/domestic
For other views, see Gregson, Nigel, Keiron Spar
rowhawk, Josephine Mauskopf and John Paul Declaration on TRIPS and Public Health (Nether -drug-makers-set-to-invoke-compulsory-licensin
(2005):- "A Guide to Drug Discovery: Pricing lands: AMB). And the more legally researched g-route-by-june/434161/), "Cipla and Natco, are
Medicines: Theory and Practice, Challenges and tract by Spennemann, Christoph and Jerome H known to have already written such requests to
Opportunities", Nature Reviews Drug Discovery, Reichman (2011): Using Intellectual Property global pharmaceutical MNCs for such a contract
4 February: 121-30. For a review of the use of evi Rights to Stimulate Pharmaceutical Production in to manufacture an AIDS drug and a cancer drug,
dence in the market approval process, reimburse Developing Countries: A Reference Guide (New respectively. Natco's request for permission to
ment, and price control mechanisms for medicines York, Geneva: UNCTAD, United Nations). To touch manufacture a generic version of cancer drug Sor
and medical devices in Thailand, South Korea, base with Indian reality, see Sudip Chaudhuri, afenib has been rejected by Bayer. Cipla is await
and Taiwan, see Jirawattanapisal, Thidaporn, Chan Park and K M Gopakumar (2010): Five Years ing a response from Merck on AIDS drug Raltgravir.
Pritaporn Kingkaew, Tae-Jin Lee, Ming-Chin into the Product Patent Regime: India's Response The next step, following an unsuccessful attempt
Yang (2009): "Evidence-Based Decision-Making (New York: UNDP). to enter into a contract, will be to apply for a com
in Asia-Pacific with Rapidly Changing Healthcare17 See Sara Boettiger and Alan B Bennett (2006): pulsory licence....three cancer drugs - Nilotinib,
Systems: Thailand, South Korea, and Taiwan", 'Bayh-Dole: If We Knew Then What We Know exclusively marketed by Novartis under the brand
Value in Health, Vol 12, SUP3 [Note(s): S4-S11]. Now", Nature Biotechnology, 24: 320-23. Also see name Tasigna; Sunitinib, marketed by Pfizer as
Thanks to Szymon Jaroslawski for these papers. Bhaven N Sampat. The Bayh-Dole Model in Devel Sutent; and Bristol Myers Squibb's Dasatinib
9 We have discussed this at length in LOCOST (2006): oping Countries: Reflections on the Indian Bill on (brandname Sprycel) - are the other products
A LayPerson's Guide to Medicines: What Is in Them Publicly Funded Intellectual Property. UNCTAD eyed by domestic pharma companies for compul
and What Is Behind Them (Vadodara: LOCOST). ICTSD Project on Sustainable Development on sory licensing opportunities".
And also in LOCOST/JSS (2004): Impoverishing IPRs and Sustainable Development. Policy Brief See http://dipp.nic.in/ipr-feedback/CL-DraftDis
the Poor: Pharmaceuticals and Drug Pricing in India Number 5, October 2009. Also David C Mowery, cussion.doc, accessed 29 April 2011. The DIPP of
Economic & Political weekly [3353 june 11, 2011 vol xlvi no 24 49
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INSIGHT
the Government of India administers the Patents recollect that these are at tnmsc rates which are
health, the facilities are geographically acces
Act 1970, the Trade Mark Act 1999, Geographical
sible - which is of course not true generally. very low and are quoted at just above bare costs
Indications of Goods Act, 1999 and Designs Act,
of manufacture. If India's pharma industry sells
2000. It also coordinates issues relating to World (2) Population of Tamil Nadu and India: 7.2 crore
medicines at this rate and only these essential
Intellectual Property Organisation (WIPO) in and 121 crore (2011 provisional census figures).
consultation with other ministries. A departmental medicines at that, they probably will be in a
(3) Tamil Nadu government drug budget for
release of 11 April 2011 clarified, "As the existing
legal framework is comprehensive, government
medicines 2011-12: Rs 142.88 crore out of a to
spot of a bother with respect to sustainability
has decided that there is no need to issue additional and viability. We suggest that the Chittorgarh/
tal health budget of Rs 4,554 crore (Table 6).
guidelines for the issue of compulsory licences". There is a bias in tn government policies of lateNagaur figures, which are on the average 3-4
28 Internationally acclaimed by developing countries times the tnmsc price, are more realistic. Or like
towards tertiary care.
and positive groups as a life-saving measure that
prevents evergreening and frivolous patenting, a Table 6: Amount Budgeted for Supply of Medicines through TNMSC (2011-12)
clause that prevented the product patenting of at Account Head Amount Budgeted Source
least the following drugs after vigorous contesta 2011-12 (inCrore)
tion pre-grant, post-grant: lamivudine/zidovudine
Directorate of public health
(fixed-dose combination); tenofovir (intermediate,
3.00 http://www.tn.gov.in/tnbudget/demands/d1904.pdf
salt and pro-drug forms); darunavir polymorph; and preventive medicine
tenofovir disoproxil fumarate/emtricitabine (co Directorate of medical and rural health services 61.88 http://www.tn.gov.in/tnbudget/demands/d1902.pdf
formulation); imatinib crystalline form; pro-drug
Directorate of medical education 78.00 http://www.tn.gov.in/tnbudget/demands/d1903.pdf
of oseltamivir; crystalline adefovir dipivoxil;
crystalline adefovir dipivoxil; and valgancyclovir. Total 142.88
Annexure 1: Estimating Drug Requirements 2 year Diploma Course in Conflict Transformation &
of India under Universal Access to Health for All
Peacebuilding Program 2011-2012
Assumptions:
(l) We have used utilisation figures of the
The Diploma is open to undergraduate and graduate students,
Tamil Nadu government, from the Tamil Nadu
budget documents, and its procurement agency Armed forces personnel, Civil Servants, NGO Workers, Researchers,
the Tamil Nadu Medical Services Corpora Journalists and Grassroot practitioners.
tion (tnmsc). We do not define utilisation but
we use it here as some rough indicator of the The course is open to both men and women
percentage of total population of the state us
ing the services of the Tamil Nadu public health Application forms can be downloaded from :
system where "using" means attendance at www.lsr.edu.in
an outpatient department per year and/or in
patient services per year when otherwise the
person seeking treatment would have had the Last Date for the Submission of forms - 16th July 20
option to go to the private practitioner/private For Further Information contact: 011-45494949,26434459 & 0999904
sector. We also assume for all those who seek
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