DRUGGING OF ASIA—PHARMACEUTICALS AND THE POOR

Item

Title: DRUGGING OF ASIA—PHARMACEUTICALS
AND THE POOR
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VOLUNTARY HEALTH ASSOCIATION OF INDIA
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GRAMS : "VOLHEALTH" New Delhi 110 016

DRUGGING OF ASIA—PHARMACEUTICALS
AND THE POOR
Workshop organized by IOCU, VHAI and ACHAN
Madras 6th—9th December 1 985
Summary of Workshop Conclusions on National Drug

Policy prepared by Dr. K. Balasubramaniam, Pharma

ceutical Advisor,

Caribbean Community Secretariat

The Heads of States or Governments of Non-aligned and other developing
countries had at two of their summit conferences recommended unanimously
that each developing country should formulate and implement an integrated
national drug policy in order to ensure access of the entire population to
essential drugs at reasonable cost.
At the request of the developing countries, the United Nations Action
Programme for Economic Cooperation among Non-aligned and other deve
loping countries (UN-APEC) convened a meeting of a group of experts on
Pharmaceuticals in July 1976 in Georgetown, Guyana. This Expert Group was
mandated to prepare an Action Programme on Pharmaceuticals and present
it to the Fifth Non-Aligned Summit Conference held in August 1976 in Colombo.
The Summit Conference endorsed the recommendations of the Expert Group
in Resolution No. 25 on pharmaceuticals. In this Resolution, the Heads gave
an outline of an integrated pharmaceutical policy and also requested the
relevant UN agencies to assist developing countries by examining in depth
the pharmaceutical sector in developing countries and preparing a detailed
drug policy and programme suitable for these countries. Accordingly in 1978,
four UN agencies—UN APEC, UNCTAD, UNIDO and WHO constituted a Joint
Task Force on Pharmaceuticals and fielded an inter-agency mission to several
countries in Asia, Africa and Latin America to study the pharmaceutical
sector in these countries. The Mission had discussion with relevant govern
ment officials involved in the public sector pharmaceutical supply system and
with the private pharmaceutical industry and reported its findings to the Joint
Task Force which then prepared a comprehensive report entitled, "Pharma
ceuticals for the Third World : Policy for Health, Trade and Production."
The conclusions and recommendations of their report contained a detailed
description of an integrated national drug policy This report was
submitted to the Sixth Non-aligned Summit Conference held in Havana in
September 1979. The Conference endorsed the conclusion and recommen
dations of the Task Force Redort in their Resolution No. 8 on Pharmaceuticals.

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From the foregoing it is clear that the developing countries have, at the
highest political level, underscored the imperative need for each developing
country to formulate and implement an integrated national drug policy to
ensure access of the entire population to essential drugs at reasonable cost.
The policy recommended by the Heads was based on a limited list of
essential drugs.

Of the countries represented at the Asian Seminar on Pharmaceuticals
Bangladesh alone had in 1982 formulated and implemented a rational drug
policy based on the guidelines recommended by the Non-aligned Summit
Conference. Within a period of three years the pharmaceutical supply system
in Bangladesh has improved tremendously. Essential drugs are increasingly
available to larger sections of the population at reduced costs. On the other
hand countries which had not formulated and implemented a national policy
based on essential drugs are paying very high prices for their lapse. For
example the Workshop was informed that in India. A child was going totally
blind every 13 minutes due to the unavailability of Vitamin ‘A’—a cheap and
essential drug. Some participants believed that it would be amounting to
criminal neglect if health authorities in other countries continued to delay the
formulation and implementation of a national drug policy based on essential
drugs, particularly when our Heads have on two occasions, given clear direc
tives to this effect. The participants therefore, appeal to the Prime Minister
of India, Mr. Rajiv Gandhi, as the Current Chairman of the Non-aligned
Movement to use his good offices to force health authorities of the member
countries of the Non-aligned Movement, particularly those in South Asia, to
formulate and implement national drug policies based on essential drugs
and suited to their needs without any further delay.
The workshop also took the opportunity to identify the major components
of a model drug policy suitable to countries in South Asia, using as guide
lines the directives given by Non-aligned Summit Conference, Countries in the
region may wish to use their model drug policy as a basis to formulate their
own national drug policies.
A MODEL NATIONAL DRUG POLICY

A national drug policy should be linked to the health needs of a country
and designed to ensure access of the entire population to essential drugs
at reasonable cost.

The supply of essential drugs involves the active participation of many
sectors including health, industry, trade, finance etc. It is, therefore, essen
tial that an intersectional drug committee with representatives from all
relevant sectors be established prior to the formulation of a national drug
policy. Failing to observe this vital point and formulating a drug policy

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without participation of all the relevant sectors would result in floundering
at midstream at some point in the implementation stage leading to an inter
ruption in the drug supply system. In formulating the national drug policy
care should be taken to avoid undue influence of the private drug industry,
particularly the multinationals.

The following would be the major components of a model national
drug policy :
Drug Needs : National lists of essential drugs selected on the basis of
the health needs of a country should be established. Evidence from some
developing countries and the reports of the WHO Expert Committee on
Essential Drugs indicate clearly that a limited number of essential drugs of
about 250-300 would be sufficient to meet the major needs of the people.
Drug Names : International Non-Proprietory names (generic names)
should be used whenever possible.

Quality Assurance : Appropriate steps should be taken to assure the
quality of all marketed drugs. The success of a generic drug policy is
critically dependent on assuring the quality of drugs.

Objective Information on Drugs and Therapeutics: Health Authorities

should provide objective information to health persons.
Drug Legislation : A country should enact appropriate legislation
covering registration, control of drug information including therapeutic
indication, mention of adverse reactions, contra-indication, drug interaction
price regulation and post market survey.

Price controls or monitoring should be introduced at the import, whole
sale and retail levels.
Any introduction, amendment, alteration, variation, deletion of any drug
legislation or releated laws shall be made available to all organization,
association and individuals.
Procurement : At present drug imports are fragmented not only bet
ween the public and private sectors but also within each of these sectors.
Foreign exchange savings could be effected by pooling these purchases by
means of a centralised buying agency, some of the countries in the region
have a centralised buying agency for the purchase of the public sector
requirements but their bargaining power is limited since they do not have
the vital market intelligence.

Production : All countries in the region have already established drug
manufacturing units. In the majority of the countries, local production is
dominated by the private sector. The commercial practices of the private

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sector with emphasis on creating a demand and generating profits are counter
productive to the large scale production of socially useful essential drugs.
A national drug policy based on essential drugs cannot be implemented with
the uncontrolled practices of the private sector. Countries in the region
should therefore give a leading role to the public sector and to socially
conscious manufacturers like GK Pharmaceuticals of Bangaladesh.
Transfer of Technology : The uncontrolled transfer of pharmaceutical
technology into the countries of ths region has resulted in the manufacture
of a large number of non-essential expensive drugs. Production facilities
brought into the country at high costs are not being used for the manufacture
of essential drugs.

Priority technological needs of the country should be identified when the
decision to acquire technology has been made. Explore all possible sources
of technology and select the most suitable technology, if necessary with
assistance from relevant international agencies. The terms and conditions
of the technology transfer agreement should be carefully examined and all
restrictive clauses controlled and reduced. Priority should be given to
acquiring technology from another developing country.
Promotion : Drug promotion by the drug industry must be controlled
by the drug regulatory authority.

Patents : All countries in South Asia except India grant patent protec
tion to pharmaceutical products and processes. India grants protection to
processes only. Product patents enable the patent holder to gaida monopoly
of the market. The host country will be prevented by its own national patent
legislation from buying the same drug from a cheaper source.

The Non-aligned Summit Conference has recommended that pharma
ceutical products and processes should be excluded from patentability. If
process patents are granted, compulsory licensing should be used for ex
ploiting the patent locally. Other alternatives relate to shortening of the
duration of patents.
Regional Cooperation : Some of the components of the drug policy
would be difficult to implement at the national level by some of the smaller
countries of the region. These would include quality assurance, collecting
market intelligence and local production. Taking these constraints into
consideration, the Non-aligned Movement recommended the formation of
regional pharmaceutical centres by developing countries so that member
countries belonging to a regional centre could take joint action to implement
some of the components at a regional level.

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Several years of multinational negotiation would be required before a
South Asian Regional Pharmaceutical Centre could be established. However
Health authorities in the region could initiate some joint activities.

1. Market intelligence is totally lacking in the region. Countries could
exchange information on manufactures, price trends, quality of products
etc. among themselves.
2. Drug regulatory authorities in the region may wish to establish drug
quality norms and explore the possibilities of enacting uniform drug
legislations. This would enable the smaller countries in the region with their
drug registration and quality assurance,
3. Objective information on drugs and therapeutics is another compo
nent which could be provided regionally.

The crux of the matter still remains that the cheif responsibility
for the formulation of Rational Drug Policies lies with the
National Governments.
In the view of the availability of well defined WHO criteria for
such formulation - it is possible for Asian countries to have
such rational policies provided they have the political will to do so.

Pot more information on Rational Drug Policy contact

:

Co-ordinator, low Cost Drugs &

Rational Theraputics

VHAI

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COMMUNITY HEALTH CELL
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