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WHO resolution - Action taken etc.
to: ip-health@cptech.org, pharm-policy@cptech.org,
e-drug@usa.healthnet.org
subj: WHO Resolution - Action taken
no/dt: H.4/1998.5.6
from: cutscal@cal.vsnl.net.in
Dear Sir/Madam,
Greetings from CUTS!
I have the pleasure to introduce myself, Rajat Chaudhuri, as the
Coordinator of Consumer Unity and Trust Society (CUTS), Calcutta,
India.
Consumer Unity & Trust Society (CUTS) is a leading social action
group in India, and an active member of Consumers International
(CI), working at the grassroot, national, regional and
international levels by pursuing social justice and economic
equity within and across borders.
Presently our Calcutta office is working on health and related
areas of TRIPS (Agreement on Trade Related Aspects of
Intellectual Property rights) and Pharmaceuticals etc.
This mail is with reference to the new WHO resolution appended
below (a list of appendices is provided at the end of this
letter) that is to be tabled at its regular Assembly to be held
in May. The new resolution makes some important points in
relation to the TRIPS agreement and its probable implications for
the health sector.
The new WHO resolution urges Member states primarily to ensure
that "public health rather than commercial interests have primacy
in health policies and to review their options under the
Agreement on Trade related Aspects of Intellectual Property
Rights (TRIPS) to safeguard access to essential drugs."
In this context it may be noted that India which is a signatory
to the TRIPS agreement needs to change its patent laws (Indian
Patent Act, 1970) by 31st December, 1999, to bring it in line
with the international laws on patenting of pharmaceutical
products. Being a developing nation India has been given a grace
period of ten years for technologies previously unprotected in
its market. During this interim period of ten years all patent
applications will be put in a `black box'. However pharmaceutical
corporations can apply for an `exclusive marketing right (EMR)
for their products for five years only even before India has
phased into the new patent protection system. In the
pharmaceuticals sector India presently allows process patents
only.
The implications of the above and related rules are:
* the introduction of product patents may imply significant
social costs due to the higher prices charged for medicaments;
* the access to local firms of protected technology will become
more difficult because of the enforcement of the patent-holder's
bargaining position through investments in R&D; and
* there is the possibility that the most dynamic segments of
the pharmaceutical market, where the prospects of growth are
highest, will be excluded from domestic firms.
Side by side with the above some facts revealed by a recent study
by Consumers International are poignant in this respect:
A critical analysis of the retail prices of 22 dosage forms of
common essential drugs in over 30 countries around the world
revealed -
* The average retail price of 18 out of 20 dosage forms are very
much higher in developing countries of South and Central America
than in developed countries
* Many consumers in developing countries with low per capita GDP
are paying much higher retail prices than some consumers in the
affluent and developed countries.
The situation being such it can be well imagined what will be the
consequences when transnational pharmaceutical giants get most of
the patent rights for pharmaceutical products.
It is expected that the United States will seek to exclude point
no. 2 from the WHO resolution.
The WHO resolution among other things also urges member nations
to promote rational use of drugs through independent up-to-date
and comparative drug information. It further requests the
Director-General of the WHO to continue the development and
dissemination of information on rational prescribing.
In this context we can mention an India-wide prescription audit
study done by our organisation in 1995 which brought to light
alarming facts like:
* Propensity to prescribe drugs carrying brand names when
generic names were also available.
* Affinity to prescribe drugs manufactured by MNCs.
* Tendency to prescribe comapratively costlier and higher
generations of medicines.
* Rampant polypharmacy
* A large number of unnecessary prescriptions
* A large number of incomplete prescriptions
* A large number of irrational, semi-rational and alarming
prescriptions
Studies done by others have come to similar conclusions.
Our organisation is seeking funds for launching a nation-wide
advocacy campaign with various state governments and other
decision-making bodies to install a standing prescription audit
in various states of the country and to get a list of safe
essential drugs adopted by the governments.
We take this opportunity to ask all readers to help us in getting
funds to implement this project which in the long run would
translate to improved health for the people of one of the world's
most populous countries. Please find appended below (a list of
appendices is provided at the end of this letter) an executive
summary of this project.
Please also find appended below (a list of appendices is
provided at the end of this letter)a letter which we have sent to
our Health, Commerce and Industry ministries as also the Indian
ambassador to the United Nations asking them to support the new
WHO resolution and take appropriate policy measures in
concurrence with its contents.
We feel that the US opposition to point no 2. of the WHO
resolution needs to be countered with cogent logic and facts.
The appended mail which we have sent to our governement will give
you an outline of our stand and the future work we would like to
do in the area of health. (In this context please also find
appended below an executive summary of a health related advocay
project that we have designed. We will feel obliged if you can
guide us to funders who may be interested in financing this
project)
With regards
Rajat Chaudhuri <Coordinator>
Consumer Unity & Trust Society (CUTS),
3-B Camac Street, Calcutta 700016.
Ph: 91.33.29 7391/2786
Fax: 91.33.29 7665/249 6231
Email: <CUTSCAL@CAL.VSNL.NET.IN>
Website: http://www.cuts.org
(KINDLY ALWAYS QUOTE THE REFERENCE NUMBER/DATE IN YOUR RESPONSE)
APPENDICES: 1) MAIL SENT BY OUR ORGANISATION TO THE INDIAN GOVERNMENT
2) THE NEW WHO RESOLUTION
3) EXECUTIVE SUMMARY OF THE HEALTH ADVOCAY PROJECT
[][][][][][][][] COPY OF LETTER TO GOVERNMENT [][][][][][][][][][][][]
To: Mr Dilip Sinha, India's Ambassador to the United Nations
Secretary, Ministry of Health and Family Welfare
Secretary, Ministry of Commerce
Secretary, Ministry of Industry
Dear Sir,
Greetings from CUTS!
You may be aware that the World Health Organisation (WHO) is
going to hold its regular Assembly in May of this year and among
other things consider a new resolution. The new WHO resolution
(appended below) is also available on the WHO web page at
http://www.who.ch/gb/pdfangl/angr24.pdf
The new WHO resolution urges Member states primarily to ensure
that "public health rather than commercial interests have primacy
in health policies and to review their options under the
Agreement on Trade related Aspects of Intellectual Property
Rights (TRIPS) to safeguard access to essential drugs."
In this context it may be noted that India which is a signatory
to the TRIPS agreement needs to change its patent laws (Indian
Patent Act, 1970) by 31st December, 1999, to bring it in line
with the international laws on patenting of pharmaceutical
products. Being a developing nation India has been given a grace
period of ten years for technologies previously unprotected in
its market. During this interim period of ten years all patent
applications will be put in a `black box'. However pharmaceutical
corporations can apply for an `exclusive marketing right (EMR)
for their products for five years only even before India has
phased into the new patent protection system. In the
pharmaceuticals sector India presently allows process patents
only.
The implications of the above and related rules are:
* the introduction of product patents may imply significant
social costs due to the higher prices charged for medicaments;
* the access to local firms of protected technology will become
more difficult because of the enforcement of the patent-holder's
bargaining position through investments in R&D; and
* there is the possibility that the most dynamic segments of
the pharmaceutical market, where the prospects of growth are
highest, will be excluded from domestic firms.
Side by side with the above some facts revealed by a recent study
by Consumers International are poignant in this respect:
A critical analysis of the retail prices of 22 dosage forms of
common essential drugs in over 30 countries around the world
revealed -
* The average retail price of 18 out of 20 dosage forms are very
much higher in developing countries of South and Central America
than in developed countries
* Many consumers in developing countries with low per capita GDP
are paying much higher retail prices than some consumers in the
affluent and developed countries.
The situation being such it can be well imagined what will be the
consequences when transnational pharmaceutical giants get most of
the patent rights for pharmaceutical products.
It is expected that the United States will seek to exclude point
no. 2 from the WHO resolution. You would appreciate very much
the implications of such an exclusion. Moreover we would request
your good offices to coordinate and brainstorm on the delicate
areas of the TRIPS agreement so that our options remain open and
the health of the nation is not left at the mercy of mindless
profit-seekers. In this context we would request you to strongly
support the WHO resolution and especially point no 2.
The WHO resolution among other things also urges member nations
to promote rational use of drugs through independent up-to-date
and comparative drug information. It further requests the
Director-General of the WHO to continue the development and
dissemination of information on rational prescribing.
These are some of the other areas which needs your support. In
this context we can mention a nation-wide prescription audit
study done by our organisation in 1995 which brought to light
alarming facts like:
* Propensity to prescribe drugs carrying brand names when
generic names were also available.
* Affinity to prescribe drugs manufactured by MNCs.
* Tendency to prescribe comapratively costlier and higher
generations of medicines.
* Rampant polypharmacy
* A large number of unnecessary prescriptions
* A large number of incomplete prescriptions
* A large number of irrational, semi-rational and alarming
prescriptions
Studies done by others have come to similar conclusions. (In
this context it can be mentioned that our organisation is
seeking funds for launching a nation-wide advocacy campaign with
various state governments and other decision-making bodies to
install a standing prescription audit in various states of
the country and to get a list of safe essential drugs
adopted by the governments.)
In view of these and the new WHO resolution we again request you
to take a stand supporting the points of the resolution which you
may think would be beneficial for our country. Especially the
items dealing with TRIPS, rational use of drugs, rational
prescribing, we feel, need to be supported with all our
collective might.
It is expected that such support which you might provide to this
WHO resolution and the possible changes in government policy that
you may influence in the process, will go a long way in
promoting consumer benefits and health of the nation.
With regards
Rajat Chaudhuri <Coordinator>
Consumer Unity & Trust Society (CUTS),
3-B Camac Street, Calcutta 700016.
Ph: 91.33.29 7391/2786
Fax: 91.33.29 7665/249 6231
Email: <CUTSCAL@CAL.VSNL.NET.IN>
Website: http://www.cuts.org
(KINDLY ALWAYS QUOTE THE REFERENCE NUMBER/DATE IN YOUR RESPONSE)
[][][][][][][] END OF LETTER [][][][][][][][][][][][][][][][][]
THE NEW WHO RESOLUTION TO BE CONSIDERED IN ITS REGULAR ASSEMBLY
TO BE HELD IN MAY.
101st Session EBl0l.R24
Agenda item 9 27 January 1998
Revised drug strategy
The Executive Board
>RECOMMENDS to the Fifty-first World Health Assembly the adoption
of the following resolution:
>
> The Fifty-first World Health Assembly,
>
>Recalling resolutions WHA39.27, WHA41.16, WHA43.20, WHA45.27, WHA47.12,
>WHA47.13, WHA47.16, WHA47.17, and WHA49.14;
>
> Having considered the report of the Director-General on the revised
>drug strategy;
>
>Noting the activities of WHO to further the implementation of the
>revised drug strategy, in particular through support to the development
>and implementation of national drug policies; the strategy to review and
>assess the effectiveness of the WHO Ethical Criteria for Medicinal Drug
>Promotion; the flow of market information; guidelines for drug
>donations; and model drug information;
>
>Recognizing with satisfaction the progress made, and approving WHO's
>comprehensive response to current and new challenges in the
>pharmaceutical sector;
>
>Commending the strong leadership shown by WHO in promoting the essential
>drugs concept and national drug policies, which are contributing to the
>rational use of resources in the pharmaceutical sector and to improved
>health care;
>
>Noting with satisfaction that a number of Member States have adopted
>guidelines for drug donations that were based on the interagency
>guidelines issued by WHO, but concerned that inappropriate drug
>donations, such as donations of expired, mislabelled, in essential
>products, continue to be common;
>
>Concerned about the situation in which one third of the world's
>population has no guaranteed access to essential drugs, in which new
>world trade agreements may have a negative impact on local manufacturing
>capacity and the access to and prices of pharmaceuticals in developing
>countries, and in which poor quality pharmaceutical raw materials and
>finished products continue to move in international trade;
>
>Concerned also that drugs continue to be irrationally used by
>prescribers, dispensers and the general public, and because unethical
>promotion in developed and developing countries and a lack of access to
>independent, scientifically validated drug information contribute to
>such abuses,
>
>URGES Member States:
>
>(1) to reaffirm their commitment to develop, implement and monitor
>national drug policies to ensure equitable access to essential drugs;
>
>(2) to ensure that public health rather than commercial interests have
>primacy in pharmaceutical and health policies and to review their
>options under the Agreement on Trade Related Aspects of
>Intellectual Property Rights to safeguard access to essential drugs;
>
>(3) to establish and enforce regulations that ensure good uniform
>quality assurance standards for all pharmaceutical materials and
>products manufactured in, imported to, exported from, or in transit
>through their countries; :
>
>(4) to enact and enforce legislation or regulations in accordance with
>the principles of the WHO Ethical Criteria for Medicinal Drug Promotion,
>and to monitor drug promotion in collaboration with interested parties;
>
>(5) to develop or maintain national guidelines governing drug donations
>that are compatible with the interagency guidelines issued by WHO and to
>work with all interested parties to promote adherence to such
>guidelines;
>
>(6) to promote the rational use of drugs through the provision of
>independent, up-to-date and comparative drug information, and to
>integrate the rational use of drugs and information about commercial
>marketing strategies into training for health practitioners at all
>levels;
>
>(7) to promote and support consumer education on the rational use of
>drugs and its inclusion into school curricula;
>
>(8) to evaluate progress regularly, making use of indicators developed
>by WHO or other suitable mechanisms;
>
>(9) to continue their funding and material support for the revised drug
>strategy especially by the provision of extra budgetary resources to
>WHO;
>
>2. REQUESTS the Director-General:
>
>(1) to support Member States in their efforts to develop and implement
>policies and programmes that achieve the objectives of the revised drug
>strategy, including the development of tools, guidelines and
>methodologies for evaluation and monitoring;
>
>(2) to adopt a comprehensive strategy to implement the WHO Ethical
>Criteria for Medicinal Drug Promotion and to continue to review its
>effectiveness with all interested parties;
>
>(3) to extend the guidelines incorporated in the WHO Certification
>Scheme on the Quality of Pharmaceutical Products Moving in International
>Commerce to cover pharmaceutical starting
>materials; develop and disseminate uniform guidelines on the regulatory
>control, export, import and transit conditions of pharmaceutical
>products; and develop standards of practice for entities involved in
>international trade in pharmaceuticals and pharmaceutical raw materials;
>
>(4) to strengthen and expand the provision of independent information on
>market prices of raw materials of assured quality for production of
>essential drugs;
>
>(5) to continue the development and dissemination, also using electronic
>media such as the Internet, of independent information on pharmaceutical
>product safety and instances of counterfeit drugs or medicines, on drug
>selection and on rational prescribing;
>
>(6) to assist Member States to analyse the pharmaceutical and public
>health implications of agreements overseen by the World Trade
>Organization and to develop appropriate policies and regulatory
>measures;
>
>(7) to review and update the revised drug strategy to reflect current
>and continued challenges in the pharmaceutical sector and the principles
>articulated in the renewed health-for-all policy;
>
>(8) to report comprehensively to the Fifty-third World Health Assembly
>on progress achieved and problems encountered in the implementation and
>renewal of WHO's revised drug strategy, with
>recommendations for action.
=================================================================
[][][][][][][][][] EXECUTIVE SUMMARY OF HEALTH ADVOCACY
PROJECT [][][][][][][][][][][][][][][][][][][][][][][][][][][][]
CUTS Consumer Unity and Trust Society
3-B, Camac Street,
Calcutta 700 016
Ph: 91.33.29 7391/2786
Fx: 91.33.249 6231/29 7665
Email: cutscal@cal.vsnl.net.in
Website: http://www.cuts.org
STANDING PRESCRIPTION AUDIT AND A LIST OF SAFE ESSENTIAL DRUGS
Funding Proposal: EXECUTIVE SUMMARY
BACKGROUND
Consumer Unity & Trust Society (CUTS) is a leading social action
group in India, and an active member of Consumers International
(CI), working at the grassroot, national, regional and
international levels by pursuing social justice and economic
equity within and across borders.
In a four series workshop for training of young consumer leaders
organised by CUTS the Voluntary Consumer Action Network(V-CAN
i.e.We can!) was launched which adopted the vision statement:
"Affordable and sustainable health care for all", with the
mission: "Equipping activists to empower people to achieve their
right to health."
In a nationwide survey done in 1995 by V-CAN, data of about 2000
prescriptions from Rajasthan, West Bengal, Gujarat, Maharashtra,
Tamil Nadu and Andhra Pradesh were assessed and the data was
analysed using World Health Organisation's guidelines. The
analysis showed alarming trends of misprescription, irrational
prescription, unnecessary prescription of costlier drugs,
predeliction for brand names, incomplete prescriptions and other
such serious lacks.
THE PROPOSAL
The dismal scenario prevalent in this country as brought out by
the report of the prescription audit, coupled with a more
liberalised drug policy and reduced controls on pharmaceutical
industry necessiates follow up. Health being a state subject it
has been decided to pursue state level advocacy for having a
standing prescription audit. Under similar situations elsewhere
in the world standing prescription audits have shown good
results. It is also proposed to use advocacy to make the state
governments adopt a list of safe essential drugs.
GOALS
To undertake advocacy and communicate with the legislatures,
executive, judiciary and the medical profession for installing a
standing prescription audit system and get a list of safe
essential drugs adopted by state governments. The object is to
improve the quality of health delivery systems available to the
common man.
METHODOLOGY
1. VCAN will organise four advocacy workshops in four different
states. The aim will be to get standing prescription audits and
a list of essential drugs declared in these four states.
2. The advocacy workshops will involve representatives from the
legislatures, the executive, the judiciary, media persons and the
medical profession and representatives from civil society groups
(NGOs and other voluntary organisations). So both the decision
making strata and civil society-where opinion is built, will be
represented.
3. The workshops will discuss in detail the results of the
previous prescription audit done by VCAN and other such audits
done elsewhere in this country. Placing these results against the
broader perspective of the prevalent health scenario and
liberalised drug policy as also reduced controls on the
pharmaceutical industry the interactions will be tailored to
impress upon the decision makers the importance of the avowed
aims.
4. These workshops will review plans for further advocacy and
campaign, identify media strategies for national and zonal level
advocacy and campaigns. It is also proposed to publish a
quarterly newsletter highlighting various facets of health issues
in the country as well as editorialising upon the need for a
standing prescription audit, a list of safe essential drugs
declaration.
ANTICIPATED OUTCOME
The advocacy workshops and newsletter will serve to increase the
awareness of decision makers about the importance of improving
prescribing practices. Public opinion coupled with a sense of
belongingness and motivation that will be imbibed in decision
makers as well as the medical fraternity to lead to adoption of a
standing prescription audit and a list of essential drugs.
Publication of newsletter as well as transactional analysis
techniques(used in the advocacy workshops) will help to generate
increased awareness and responsibility on part of prescribers.
These would serve as self-regulatory devices and further help to
improve the quality of health delivery systems available in the
country.
FUNDS SOUGHT
Head Rs.
A. 4 Regional Workshops: 2,20,000
i) Travel
[ Average Rs.1,000 X 20 ] 20,000
ii) Boarding & Lodging
[ Rs.450 X 2 days X 20 ] 18,000
iii) Venue & Seminar kit 12,000
[hiring charges of hall,
P.A. system photocopier,
computer etc]
iv) Communication & Overheads 5,000
B. National Workshop: 1,80,000
i) Travel
[ Average Rs.5,000 X 20 ] 1,00,000
ii) Boarding & Lodging
[ Rs.750 X 3 days X 20 ] 45,000
iii) Venue & Seminar kit 28,000
[ hire of hall, P.A. system
photocopier, computer etc]
iv) Communication & Overheads 7,000
E. Newsletter
(Writing, printing, posting
& presentation etc)
[ 2000 copies x Rs.12.50 x 4] 1,00,000
----------
GRAND TOTAL Rs. 500,000
----------
( US $ 12,820
US $ 1.00= Rs 39)
Rupees five lac only
US dollar twelve thousand eight hundred and twenty only
===============
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