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Editorials

Scrooge and intellectual property rights

BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.39048.428380.80 (Published 21 December 2006) Cite this as: BMJ 2006;333:1279

Intellectual Property Right, Drug prices control and rational use of drugs in West Bengal: India-an urgent need

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

Competing interests: No competing interests

02 February 2008
Professor Pranab Kumar Bhattacharya
Professor of Pathology, Incharge Histopathology, Bloood Bank&VCTTC, Cyogenetics, MD pathoogy Course,
Bhattacharya Rupak; Bhattacharya Ritwik; Bhattacharya Upasana; Chakraborty Anindya; Dasgupta Jayanta; Sarkar Ruchirendra
Institute of Post Graduate Medical Education & Research(IPGME&R) 244a AJC Bose Road,Kol-20,W.B,India