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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. - 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
public health importance. An area of concern would be the mindless enlargement of a vaccine-for-everydisease 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. What then needs to be done? A minimum wish list would include:
access to medicines and health as a human rights
STOP TALKING POLITICS!
explicitly gender concerns in pharma policy 4 making and marketing of drugs.
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.
l A comprehensive
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.
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.
l Mandatory disclosure of
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.
l A limit on cross-practice; compulsory continuing medical education of
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.
l Weeding out all irrational and harmful medicines. l Control on all essential drugs marketed in India. Price l Introduction of
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).
l Access to objective information on drug risks and hazards from the Drug Controller General of l Transparent
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!).
the Mashelkar Committee recommendations without centralization and bureaucratization. drug administration including in the drug industry.
l Action on corruption at all levels of lproduct patents on diseases of No
the national programme and more careful orchestration of the health
needs of India.
the ease of getting/issuing compulsory licensing of drugs of importance to the people of
How about some cheap fruits from across the border to pep you up?
decision making in matters of patents, pre-grant opposition, royalty, data exclusivity, etc., keeping in mind the interests of the people of India.
l Transparent access to information on clinical
trials with a clinical registry accessible in the public domain.
research on gender-related aspects of medicines access and use by women and girls, and men and boys.
Developing Countries Trading up, July-Sep 2005
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:
basic knowledge of medicines and how they work. which drugs are hazardous, banned or need to be avoided.
² Avoiding ² Asking
taking drugs that are useless and/or irrational.
your doctor to prescribe drugs by their generic names and avoiding OTC drugs whenever possible. your doctor for more information on the drug you have been prescribed. tonics and other health restoratives; instead ensuring a balanced diet for the whole family. in activities of local consumer groups and drug action networks. evaluating advertisements for health products. any unethical promotion of drugs to the local health or consumer group.
Aids to Improving Patient Adherence to Treatment
² Participating ² Critically
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 Pdrugs, 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:
² create awareness of
health issues and disseminate information.
² regular publications to keep consumers aware. bring out
² organise and encourage people to participate in health activities. ² identify publications essential for drug information. ² ensure
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. India.
² all drug shortages to the Drug Controller of report ² participate in health and consumer campaigns. ² in local press and publicise issues of write
Some all-India networks/groups/resource persons that can be consulted by consumer groups are the AllIndia Drug Action Network (AIDAN); Bulletin of Drug & Health Information (BODHI) (email: <email@example.com>; 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!
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. 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. Some of the formulations are after Phadke, Anant. Drug Supply and Use: Towards a Rational Drug Policy in India. New Delhi: Sage Publications, 1998. 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:
l Ensure women have access to accurate, gender-sensitive medicines information. l Involve
women in medicines policymaking.
innovative and outcome-based research in the gendered aspects of medicines access and use by women and girls and men and boys.
sex- and gender-disaggregated data on access and use, which, in combination with adequate gender analysis, should inform policies, plans, and budgets. that women and girls have equal access to medicines. full and equitable access to sexual and reproductive health services and commodities.
l Ensure l Ensure l Ensure
that national essential medicines lists contain the core medicines and devices for sexual and reproductive health recommended by the UNFPA and WHO.
and encourage people to participate in health activities
² publications essential for drug information identify ² ensure
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.
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 >
“…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
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?")
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