My attempt here is to examine the role of pharmacist in healthcare budgets. Whose budgets we are trying to influence? I suppose, these are nations and agencies expenditure on healthcare. This is a complex subject and requires an analysis at a macro level. 1) How the management of healthcare budgets has impacted the relationship between the patient and the pharmacists. 2) In the current socio-economic situation in view of pharmacy practice at a greatly higher level of recognition in the developed countries, what is the scenario in the developing countries. 3) In spite of the discrepancies which exists, is it possible to create evidence of some good work in the developing countries.

To begin with let me focus on the current healthcare scenario and then, move on to India specific situation by citing examples of interrelationship between the patient and the pharmacist. Later, I will focus on a few important emerging activities in healthcare budgets, which must engage pharmacists' attention, so that they are able to offer pharmaceutical services in the mainstream national health programmes.

Health system and healthcare system
As per WHO's World Health Report 2000, "health system" includes all activities whose primary purpose is to promote, restore or maintain health. Formal health services include professional delivery, use of medication, home care of sick, health promotion, disease prevention and health education. The "healthcare system" on the other hand, refers to provision of and investment in health services. These are preventive, curative and palliative interventions directed to individuals or populations. No doubt, these activities have offered a platform for building an interface between the patient and the pharmacist.

Types of national health systems
While there is no clear-cut demarcation, broadly there are four types of national health systems of the world countries classified by economic levels and health system policies. The health system policies in terms of market intervention are: 1. Entrepreneurial and permissive, 2. Welfare oriented, 3. Universal and comprehensive, and 4. Socialist and centrally planned. Economic classification of the countries in term of GNP per capita is: Affluent and industrialized; Developing and transitional; Very poor; and Resource rich. In developing and transitional countries, Thailand offers a good example of entrepreneurial and permissive; Malaysia of welfare orientation; and Israel of universal and comprehensive health system. Among very poor countries India/Myanmar have welfare orientation, Sri Lanka has universal and comprehensive and China has socialist and centrally planned health systems.

National health programmes
Among the national health programmes, contents of intervention include: DOTS treatment for TB; Prevention, information and safe blood supply for HIV/AIDS; Vaccines for immunization; Early assessment, prompt treatment and preventive measures for malaria; and Tax, information, NRT and legal action for tobacco control.

World population and pharmaceutical expenditure
In terms of world population and pharmaceutical expenditure, there has been a wide disparity. While 15% of the world population in North America, Europe, Japan and Australia spends almost 80% of global expenditure on pharmaceuticals, 85% of the population in the rest of the world spends only about 20%. It is true that drugs constitute just one component of total healthcare interventions. Of over 1 trillion US$ spent on health care worldwide, only 10% goes towards the costs of drugs every year. However, it has been established that while the component of drugs in total health care in terms of involvement and expenditure is only 10-12% in the developed economies, the figure for the transitional economies ranges from 15-30% depending on the nature of the disease segment, capacity of the country to access and make drugs available to the public, the ratio of medical and para-medical personnel to the patient population and to a much lesser extent on the costs of treatment. It has been reported that in certain developing countries, the expenditure on drugs as part of the total health care costs is as high as 25-66%.

Wealth on health
Not only the level of public spending on health is low in the developing countries, these countries also rank lower in human development. For example, In India, public spending on health is a mere 0.9% of GDP and India ranks 127th in the Human Development Report 2004. China spends 2% of GDP on health and ranks 94th. In contrast, Germany, France and USA invest 6-8% of public spending on health. In India, private spending on healthcare is about four times of the public spending.
France, Germany and USA spend 10-14% of their total GDP on health. Developing countries spend as low as about 4% in Sri Lanka and Bangladesh and maximum of about 8% in Brazil of their total GDP on health.

Health system financing 2001
On the health system-financing front, a large proportion is out of pocket of the per capita total expenditure of health.

In Egypt, per capita expenditure on health is US$ 46 and the out of pocket expenditure as % of private expenditure on health is almost 92%. It is also over 90% in China, India, Ghana and Indonesia. The per capita expenditure on health in China and India are as low as US$ 49 and 24.

In developing countries there are limited employer-based health care insurance systems or subsidized government-based health care programmes and the available schemes only cover smaller segment of society.

Generics
The global increase in cost of health care has become an enormous issue and one that is set to continue as a consequence of ageing population, for example, the current average world life expectancy of 66 years is forecast to rise to 76 years by 2050. We are seeing a global expansion of generics in pharmaceutical sector. Specifically in the USA, since 2001, branded prescriptions have declined while generics have grown. Furthermore all projections forecast this trend to continue so that generics will represent over 50% of all new prescriptions dispensed. In India, within the domestic pharmaceutical sector there are approximately 9,000 companies and about 130 branded generics or generics may exist for any one molecule. A definite competitive edge, which many in Europe and North America associate with Indian Pharmaceutical companies, is the cost of manufacture. Such is the penetration that India now has the highest number of FDA approved plants outside USA and FDA may soon open an office in Delhi so that inspectors can walk into Indian approved plants freely as they do in USA. Furthermore, one-third of all drug master filings with FDA come out of Indian facilities.

In light of these competitive advantages and its experience in generics, our pharmacists need to be trained in biopharmaceutical aspects of generics in the pharmaceutical sector.

Price comparison
Price comparison on medicine prices in developing countries reveal interesting trend. Drug prices in India are one of the lowest in the world. Prices of Indian drugs are sometimes 40-50 times cheaper than in many developing countries.

As per the SEARPharm Forum's Report on medicine prices in SEA countries, not only among SEA countries themselves but also even within these countries prices vary considerably between branded generics and generics formulations.

India has for the past several years tried to implement price control on drugs. The very first drug price control order implemented in the country had followed the principle of keeping all essential drugs under the category 1 with a mark up of 40% over the ex-factory cost of production. The consequence of that stipulation was that it resulted in shortage of essential drugs since the manufacturers found it unattractive to produce them. This situation however will change with the advent of the product patent regime when the monopoly offered by the patent system will lead to high drug prices for patented products, even when they are in the essential drug category.

The situation has become further complicated by "gaps" in therapeutic, health literacy, equity and access in health care services.

The therapeutic gap has lead to growing resistance, which is affecting prevalent infectious diseases.

1. In 81 countries patients are reported to be resistant to chloroquin,
2. There is up to 40% primary multi drug resistance in TB, and
3. Up to 55% penicillin resistance in ARI and bacterial meningitis.

Although 45-90% of adult women are illiterate in some countries, yet by 2020 India is expected to have an excess of 47 million, many of whom will speak English and will be well educated.

Health literacy gap
Due to health literacy gap, basic information is lacking in many countries while information expands in others.

1. Among the middle and lower income countries, available information is often underutilized.
2. Only 1 out of 2 drugs are available with sufficient information for safe and effective use.
3. Only 1 out of 4 of drug packs in Asia contain inserts.
4. In India, the problem of cutting alu-foil strip to dispense lesser number of units is a constant nightmare to retail pharmacy outlets.

The pharmacist is forced to strip cutting, because the doctor does not prescribes the dose as per strip size or gives a start-up dose of few samples of the tablets/capsules, and tells the patient to buy the remaining requirement from the retail pharmacy outlet. Due to poor affordability, patients do not have enough money to buy the whole strip/dose, or in some emergency situations or when trying out the medicine prescribed by the doctor for the first time.

Equity gap
Differences in pharmacy care, drug costs and safety nets have created a cumulative problem of equity gap.

At times there is only 1 properly educated and trained pharmacist for a population of 10,000 against 1 for 2000-3000 people in developed countries. In India, even while the pharmacist population ratio compares favorably with that in developed nations (1:2000-3000), knowledge and expertise acquired by pharmacists after a two-year diploma education is pathetically low. Even in some Asian countries, like Thailand and Philippines, a degree education and periodic CEP are necessary to practice pharmacy. This is further aggravated because there is no professional obligation or statutory requirement to observe continuing education as a condition for renewal of registration periodically.

Access gap
Financing, deliveries and such constraints have created access gap and limited access to essential drugs. 1/3rd of world's population lacks regular access and 320 million in Africa have less than 50%. With low affordability, the present estimates are that only 40% of the patients in India who need drugs have access to them.

When WHO published its first list of essential drugs in 1977, it identified 208 individual drugs, which together would provide safe and effective treatment for the majority of communicable diseases. This list was by no means considered applicable to its universal audience of all countries. Since then the patterns of diseases show wide variability between the various geographical regions, let alone countries. It has been revised several times in the last quarter of a century. The list published in 2002 contains 326 individual drugs. It is claimed that this list, which also includes 12 anti-retroviral drugs, offers effective treatments for the infectious and chronic diseases, which affect majority of the world population.

Global mortality and DALYs
In spite of all the advances in medical science, in absolute numbers there has not been any major reduction in mortality or morbidity in the world. The morbidity is usually best represented through the concept of Disease Adjusted Life Years lost or DALYs. Over the years WHO has given valuable data on morbidity and DALYs. Deadly diseases like HIV/AIDS, TB, and malaria have resulted in global mortality and disease adjusted life years lost. In terms of DALYs, HIV/AIDS ranks 3rd, malaria 8th and TB 10th. CVD ranks 7th in terms of DALYs, but 2nd in terms of mortality.

The global burden of infectious diseases expressed in DALYs and their analysis in a WHO-IFPMA roundtable showed that many diseases do not have appropriate drugs. The areas of greatest need for research and practice are malaria, TB, leishmaniasis and chagas disease.

Patient and pharmacists in healthcare
Over a period with diverse health systems in developing countries, patients and pharmacists have come to a unique relationship in healthcare practice. The situation implies that while healthcare systems and provision of healthcare to patients show a strong connection between patient and pharmacists, unfortunately, interface between patient and pharmacist has generally lacked pharmacist's professional role in national health programmes, health promotion and disease prevention and projecting pharmacists as human resource for health through relevant training and continuing education. Consequently, pharmacist's remuneration is mere and system for payment of value added services does not exist.

A major problem is the sale of drugs without prescription. Also, transportation and storage of drugs are one of the least reviewed components of the distribution chain. Drugs are neither transported nor stored at recommended conditions. Additionally, the present modes of transportation make pharmaceutical goods vulnerable to theft and also expose them to unscrupulous elements resulting in substandard and spurious drugs.

India has a typical situation where indigenous systems of medicines like Ayurveda, Homeopathy, Siddha and Unani also exist. These Indian Systems of Medicines (ISMs) have been neglected ever since the advent of the allopathic medicines. Of late, however, the trend has been to promote Ayurvedic and Homeopathic medicines, through direct-to-consumer (DTC), pharmacies and doctors also.

In Indonesia and Malaysia, traditional Chinese herbal specialist operates many drug shops. In some Latin American countries, the rare pharmacist may give drug injections to patients.

Patients and pharmacy/pharmacist interventions in healthcare
The 2nd ICIUM in 2004 reported a number of studies of pharmacy/pharmacist led interventions in healthcare in developing countries.

In Thailand, for monitoring of pulmonary TB, pharmaceutical care and refilling of DOTS medication by the pharmacists over other health workers improved clinical outcomes in DOTS treatment against those receiving normal treatment.

In Tanzania, malaria fact card project provided skills to pharmacists to contribute effectively in the prevention of malaria in both urban and rural areas and the results revealed greater understanding by the consumer of their medication, awareness and early treatment. Overjoyed by the success of the project, the Common Wealth Pharmaceutical Association has funded a study to involve pharmacists in Mumbai and Pune in a TB fact card project.

In India, a study, which was conducted in a large government hospital by the Delhi Society for the promotion of rational use of drugs, pharmacist counseling to hospital patients resulted in qualitative and quantitative improvements leading to correct use of drug, adherence, awareness of side effects and overall compliance.

Millennium development goals 1990-2015
Among the newer healthcare systems in the pipeline, Millennium development goals at global level offer tremendous opportunities as they represent commitments at a national level to fight ill health. The UN announced millennium development goals as part of the millennium declaration includes several vertical approaches for targeting specific disease conditions.

Some of the initiatives in the area for improving access to healthcare are 3 by 5 initiatives by WHO and UNAIDS, whereby 3 million HIV/AIDS patients will have access to retroviral and other drugs by 2005.

Roll back malaria (RBM) partnership programme launched by WHO, UNICEF, UNDP and the World Bank aims to halve the burden of disease by 2010.

Global alliance for vaccines and immunization (GAVI) created in 1998 for increasing children's access to vaccines. Partners in this programme include the Bill and Melinda Gates Foundation, UNICEF, World Bank and WHO.

All these programmes and other healthcare measures, such as, prevention and information in HIV/AIDS, safe blood, quality assurance of pharmaceuticals, anti microbial resistance monitoring, and rational and improved use of medicines require interventions by pharmacists.

WHO's commission on macroeconomics and health
WHO established the commission on macroeconomics and health in January 2000 under the chairmanship of Prof. Jeffrey Sachs. It's members consisted of several former ministers of various countries, the IMF, the WTO, UNDP, the Economic Commission on Africa and the OECD. The Commission had financial support from various donor agencies. The Commission advocates increased commitments by WHO and partnerships between the low and high-income countries and for poor to essential health services by 2015. WHO endorsed the report in 2002.

India's national commission on macroeconomics and health - 2003
India's national commission on macroeconomics and health was set up 2003 under the joint chairmanship of the MoF and MoH. Its primary objective is to make evidence based arguments for investing in health as an important instrument for economic development. While the national commission has a broad frame of reference, perhaps the most important ones are: Providing an essential health package addressing basic health needs and delivering the same efficiently in a cost effective and time bound manner by 2015; Improving access to quality essential medicines; Ensuring proper procurement, pricing, logistics, inventory control, quality and timely delivery to patients; Studying the impact of TRIPS agreement which will come into force from 2005; The aspects of access, cost of treatment; and Development of new drugs for diseases endemic to India.

A working group of experts is studying factors for providing an essential health benefit package and delivering the same efficiently. This is a very important development for the pharmacy profession in India, perhaps the most promising one as the working group is also charged with responsibilities for estimating availability of pharmacists and their training needs assessment and drug distribution in public and private sectors.

Conclusion
In conclusion, I would like to say that I have made an attempt to describe current and emerging healthcare budgets and systems, and provided a glimpse of the ways in which pharmacists can play role. These systems offer for pharmacist's opportunities for improving access to quality medicines by understanding various aspects of national health policies. Pharmacists need to ensure proper procurement, pricing, logistics, inventory control and timely distribution of medicines to the patient with pharmaceutical care both in public and private sectors. Going by the available data on registered pharmacists and pharmacy outlets there does not appear to be a shortage of pharmacists to run existing establishments. However, the academic and training programme should be up-graded to a higher standard in stepwise manner say by 2005, 2010 and 2015.

To facilitate upgradation efficiently, FIP's Board of Pharmacy Practices is offering an outreach project on the good pharmacy practices guidelines which should be pursued by Indian Pharmaceutical Congress Association. These and other FIP guidelines and policy statements provide excellent roadmap for building pharmacists' role in managing healthcare budgets.

In the SEARPharm Forum ExCo meeting held in Bangkok on 30 November 2004, it was decided that the FIP will conduct a three day training-for-trainer programme on how to implement GPPs in the developing countries. The programme will be conducted in March 2005 at Bangkok and is open to National Pharmaceutical Associations of SEA Region. I earnestly request that this should be seriously pursued by the members of IPCA and MoH in India. Implementation of GPP and up gradation of training and education of pharmacists will equip pharmacists in managing healthcare budgets which will further lead to better recognition in the society.

(The author is Immediate Past President, Indian Pharmaceutical Association & Professional Secretary, South East Asian FIP-WHO Forum of Pharmaceutical Associations.)