Chapter 9

What is to be done?
Thirty years ago, medicines policy was a technical discourse mainly among UN agencies, ministries
of health, and international experts. However, the growing AIDS pandemic has galvanized
discussions about access to treatment. The United Nations, donors, recipient governments, and
suppliers are being pressured by a growing global network of public interest NGOs and civil society
groups that need medicines and are not able to get them. New bodies, such as the GFATM, have been
founded to provide financing for national programs to tackle three of the major diseases of poverty.
Existing organizations, both public and private, have become increasingly engaged in finding new
ways to increase access to medicines. But more needs to be done, and it will require new thinking and
new approaches.

In the last decade, most developing countries have undertaken measures to improve access to
medicines, with varying degrees of success. Even where there have been setbacks, the experience
gained strongly indicates that progress is possible. Where both the initiatives and the results have
been monitored, lessons emerge that can be adapted to local conditions and applied elsewhere. A key
finding is the need to involve the community in developing health system policies and programming.

1
- UN Millennium Project. 2005. Prescription for Healthy Development: Increasing Access to Medicines

There are 2 analogies I want to leave you with to illustrate the unreasonableness of CDER's standard
of evidence as applied to safety, both pre- and post-approval. If the weather-man says there is an 80%
chance of rain, most people would bring an umbrella. Using CDER's standard, you wouldn't bring an
umbrella until there was a 95% or greater chance of rain. The second analogy is more graphic, but I
think it brings home the point more clearly. Imagine for a moment that you have a pistol with a barrel
having 100 chambers. Now, randomly place 95 bullets into those chambers. The gun represents a
drug and the bullets represent a serious safety problem. Using CDER's standard, only when you have
95 bullets or more in the gun will you agree that the gun is loaded and a safety problem exists. Let's
remove 5 bullets at random. We now have 90 bullets distributed across 100 chambers. Because there is
only a 90% chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is
not loaded and that the drug is safe.

- Dr David J. Graham, MD, MPH, testimony before US Senate Committee, November 18, 2004

In this book we have surveyed, within the limits of space, factors that have and will impinge on drug
availability in India. The situation is quite dismal in terms of availability of medicines for the poor and in
terms of access to health care, and there are enormous concerns of safety and rationality of the drugs
available in India.

In the coming years, issues of access to drugs, highlighted by lack of access to drugs for TB, malaria, HIV/
AIDS and a host of communicable and non-communicable diseases, are likely to gain prominence. Closely
related issues are regulation of drug pricing and drug patent issues on newly emerging drugs for diseases of

356 ALayPerson'sGuide
public health importance. An area of concern would be the mindless enlargement of a vaccine-for-every-
disease policy rather than looking at the root causes of ill-health: typified by "let us have diarrhoea vaccine if
we cannot provide clean drinking water". Therapeutic and populist fashions seem to dictate health policies
2
than evidence-based risk/benefit analysis.

The other worry is the lack of safeguards in clinical trials even as India becomes a destination for contract
research and clinical trial outsourcing.

Indeed a situation of poverty and chaos amidst booming pharma scrips and international hosannas.
3
What then needs to be done? A minimum wish list would include:

Recognise
l access to medicines and health as a human rights
issue. I’M
HUNGRY!!

Incorporate
l explicitly gender concerns in pharma policy STOP
4 TALKING
making and marketing of drugs. POLITICS!

Restricting
l drugs available in India to essential drugs as per
th
the Government's own NLEM (2003) or the 14 Model List
5
of Essential Medicines (March 2005) of the WHO.

A comprehensive
l Rational Drug Policy that includes no
unnecessary formulation presentations in terms of syrups,
capsules and injections; a vaccine policy strictly guided by
science of public health and prioritization of use of public
money; a limited list of over-the-counter drugs to be
available.

Promotion
l of drugs under only generic names with strict regulation of promotional activities of drug
companies; strict guidelines of sponsorship, if at all, of medical symposia and other scientific meetings.

Mandatory disclosure of
l funding and potential conflicts of interests in all clinical trials, medical research
and publications as also by policy makers and members in various government committees related to
pharmaceuticals and health.

A limit on cross-practice; compulsory continuing medical education of

l doctors; improvement in medical
education as well as medical education fee regulation; a systematic policy of research on non-allopathic
drugs as well as a pricing and marketing policy for non-allopathic drugs.

Weeding out all irrational and harmful medicines.

l

Price Control on all essential drugs marketed in India.

l

Introduction of
l Essential Drug Lists and Standard Treatment Guidelines, especially in health facilities of
the governments at the Centre and State followed by legal changes to enable production and marketing of
only essential drugs in India (that is in both private and public sectors).

WhatistobeDone? 357
Access to objective information on drug risks and hazards from the Drug Controller General of
l India.

Transparent
l Pooled procurement in all States as in Tamil Nadu and Delhi State Governments after
assessing rational, essential drug needs (which has resulted in procurement of drugs for the public health
facilities at a rate which is up to 2% of the prices in the retail market!).

Implementing
l the Mashelkar Committee recommendations without centralization and
bureaucratization.

Action on corruption at all levels of

l drug administration including in the drug industry.

No product patents on diseases of

l the national programme and more careful orchestration of the health
needs of India.

Increasing
l the ease of getting/issuing compulsory licensing of drugs of importance to the people of
India.
How about some
Transparent
l decision making in matters of cheap fruits from
across the border
patents, pre-grant opposition, royalty, data to pep you up?
exclusivity, etc., keeping in mind the
interests of the people of India.

Transparent access to information on clinical

l
trials with a clinical registry accessible in the
public domain.

Specific
l research on gender-related aspects
of medicines access and use by women and
Developed Countries Developing Countries
girls, and men and boys.
Trading up, July-Sep 2005
Universal
l Health Access and Health Insurance for every citizen of India by increasing the government's
per capita expenditure on health and recognising user fees as a deterrent to access to health and
6
medicines.

The need for consumer action cannot be over-emphasised in view of the aggressive and unethical marketing
practices employed by the pharmaceutical companies. Consumer awareness is an important pre-requisite for
consumer action. Consumers, individually or as a group, can play a key role in protecting themselves and
preventing unethical promotion of drugs, and unnecessary suffering caused by dangerous drugs or by
irrational use of drugs.

Prescribers in turn can facilitate patient compliance of drugs by doing several things. For an illustrative list,
see the box below.

Individual consumer action may be taken by:

Having
² basic knowledge of medicines and how they work.

Knowing
² which drugs are hazardous, banned or need to be avoided.

358 ALayPerson'sGuide
Avoiding
² taking drugs that are useless and/or irrational.
Asking
² your doctor to prescribe drugs by their generic names and avoiding OTC drugs whenever
possible.
Asking
² your doctor for more information on the drug you have been prescribed.
Avoiding
² tonics and other health restoratives; instead ensuring a balanced diet for the whole family.
Participating
² in activities of local consumer groups and drug action networks.
Critically
² evaluating advertisements for health products.
Reporting
² any unethical promotion of drugs to the local health or consumer group.

Aids to Improving Patient Adherence to Treatment

Patientleaflets
Patient leaflets reinforce the information given by the prescriber and pharmacist. The text should be in clear, common
language and in easily legible print.

If the patient cannot read, try pictorials. If they are not available, make pictorials or short descriptions for your own P-
drugs, and photocopy them.
Daycalendar
A day calendar indicates which drug should be taken at different times of the day. It can use words or pictorials: a low
sun on the left for morning, a high sun for midday, a sinking sun for the end of the day and a moon for the night.
Drugpassport
A small book or leaflet with an overview of the different drugs that the patient is using, including recommended
dosages.
Dosagebox
The dosage box is becoming popular in industrialised countries. It is especially helpful when many different drugs are
used at different times during the day. The box has compartments for the different times per day (usually four), spread
over seven days. It can then be refilled each week. If cost is a problem, the box can be made locally from cardboard. In
tropical countries a cool and clean place to store the box will be necessary.
Even if the patient aids described here do not exist in your country, with creativity you can often find your own
solutions. The important thing is to give your patients the information and tools they need to use drugs appropriately.

Source: Guide to Good Prescribing. WHO Action Programme on Essential Drugs, Geneva, 1995.

Group consumer action is more effective in bringing about necessary changes. It would require getting
together like-minded people who are genuinely concerned about these issues. Groups may be formal or
informal. Informal groups may be formed where people simply come together on single issues requiring
urgent steps for redressal. Formal groups may be formed with a proper structure as per the rules of a society
or a public trust.

Some of the activities groups can undertake are:

create awareness of
² health issues and disseminate information.
bring out regular publications to keep consumers aware.
²

WhatistobeDone? 359
organise and encourage people to participate in health activities.
²

identify publications essential for drug information.

²

ensure
² availability of preventive health amenities and services such as clean water, sanitation,
immunisation and healthy environment in your neighbourhood, and safe working conditions at work
place.
report all drug shortages to the Drug Controller of
² India.
participate in health and consumer campaigns.
²

write in local press and publicise issues of

² concern.

Some all-India networks/groups/resource persons that can be consulted by consumer groups are the All-
India Drug Action Network (AIDAN); Bulletin of Drug & Health Information (BODHI) (email:
<bodhi_fha@dataone.in>; the Medico Friend Circle <www.mfcindia.org>; the Jan Swasthya Abhiyan
( J S A ) < h t t p : / / p h m - i n d i a . o r g > ; A f f o r d a b l e M e d i c i n e s & Tr e a t m e n t C a m p a i g n
<http://www.lawyerscollective.org/lc_hivaids/amtc>; and Indian Jour nal of Medical Ethics
<http://www.issuesinmedicalethics.org>; LOCOST, the publishers of this book <www.locostindia.org>.

R.K. Laxman in Times of India

Our traditional way of hiding is too old-fashioned for you, I suppose!

360 ALayPerson'sGuide
Endnotes
1
Report of the Task Force on HIV/AIDS, Malaria, TB, and Access to Essential Medicines, Working Group on Access to
Essential Medicines. Sterling, Va.: Earthcscan.
2
The Hepatitis-B vaccine and related scare-mongering is an example. See “Why we do not need to give Hepatitis
B vaccine for all newborns: Letter to Health Minister," mfc bulletin, 313-314, Oct 05 -Jan 06. See pp. 502-503 of this
book.
3
Some of the formulations are after Phadke, Anant. Drug Supply and Use: Towards a Rational Drug Policy in India.
New Delhi: Sage Publications, 1998.
4
The UN Millennium Project, 2005, report Prescription for Healthy Development: Increasing Access to Medicines. (Report
of the Task Force on HIV/AIDS, Malaria, TB, and Access to Essential Medicines, Working Group on Access to
Essential Medicines. Sterling, Va.: Earthcscan.) has this to say in its recommendations related to gender:
Nationally:
lEnsure women have access to accurate, gender-sensitive medicines information.
lInvolve women in medicines policymaking.
lPromote innovative and outcome-based research in the gendered aspects of medicines access and
use by women and girls and men and boys.
lCollect sex- and gender-disaggregated data on access and use, which, in combination with
adequate gender analysis, should inform policies, plans, and budgets.
lEnsure that women and girls have equal access to medicines.
lEnsure full and equitable access to sexual and reproductive health services and commodities.
lEnsure that national essential medicines lists contain the core medicines and devices for sexual and
reproductive health recommended by the UNFPA and WHO.
And internationally,
organise
² and encourage people to participate in health activities
identify publications essential for drug information
²

ensure
² availability of preventive health amenities and services such as clean water, sanitation, immunisation
and healthy environment in your neighbourhood, and safe working conditions at work place.
5
For the 14th WHO Model List of Essential Medicines (2005), see <http://www.who.int/>. For National
Essential Medicines List (NEML) 2003 see <http://www.expresspharmapulse.com/nedl.pdf >
6
“…It may be asked, whether India has the resources today to give health care insurance to everybody. The answer is
yes. We are already spending about 6% of our Gross Domestic Product (GDP) on health-care. But the state's share in
only 21% of this expenditure. This share is lower than that seen even in Bangladesh (33%) and Pakistan (53%). In most
developed capitalist countries, this share is 70 to 80% and even in the U.S. - the supposed heaven of private medical care,
the state's share in total health-expenditure is 44%. … the governments in Sri Lanka, Bangladesh, Pakistan … spend a
higher proportion for health-care than private health-expenditure, why can't the Indian government do this? The
people are already paying 4.5% of GDP in the private sector. If the government spends 5% of GDP on health-care by
almost quadruplicating its current health-expenses, then an additional special health-tax proportional to income, to
meet the extra needs for a Universal Health Insurance can be justified. Instead of paying directly to the often exploitative
private sector as is done today, people would be willing to pay a health-tax to the local government who could in turn pay

WhatistobeDone? 361
 the private practitioners as per negotiated, rational rate-structure. Thus without people having to pay more on
health-care than what they are paying today, India can provide for expenses for a Universal Health Insurance of up
to 9.5% of GDP. This much expense should suffice. Though higher in absolute terms, the health-expenditure in
Japan, Germany, Canada, France is in the range of 4.5 to 9.5% of the GDP. What is needed in India is intensive
public pressure on the Indian government to divert more resources towards health-care." (Phadke 1998, op.cit.,
chapter on "What Can be Done?")

362 ALayPerson'sGuide