WHO estimates that currently one third of the world's population lacks access to essential drugs and that over 50 per cent of people in poor countries in Africa and Asia do not have access to even the most basic essential drugs. According to WHO, access to essential medicines and vaccines depends on four critical elements:
(1) rational selection and use;
(2) sustainable financing;
(3) reliable supply systems; and
(4) affordable prices.
Drug prices are likely to be influenced by some of the WTO agreements. For example, WTO negotiations led to the elimination or reduction of import duties on drugs, vaccines and other medical supplies in member countries. This would help in lowering prices in the importing countries. However, TRIPS Agreement will establish monopolies, which would lead to an increase in drug prices due to more stringent patent protection. It will also effect the role of the domestic pharmaceutical enterprises in making available drugs at competitive prices.
Since the inception of GATT more than 50 years ago, Article XX of GATT guaranteed members the right to take measures to restrict imports and export of products when those measures are necessary to protect the health of humans, animals and plants. TRIPS does not contain any exception for health purposes per se, but it does allow measures necessary to protect public health and nutrition, provided they are consistent with other TRIPS provisions (Article 8 - Principles).
Doha Declaration on the TRIPS Agreement and Public Health also aims at the concern expressed about the possible implication of the TRIPS agreement for access to drugs. It does so in a number of ways, such as that 'TRIPS agreement does not and should not prevent members to protect public health and confirms the right of members to use in full the provisions of TRIPS Agreement for this purpose'.
Thus it is now for the member countries to ensure that their patent laws are framed in such a manner that the objectives of health - care are not hampered in any way. Health scenario and health policies parameters of the four countries have been specifically analysed to focus that framing of patent laws is an important exercise to achieve health care objectives and goals.
Rising health care investments in India
The major cause of concern in the health area in India is the evergrowing population which now exceeds 1,000 million. India thus ranks 2nd in global population after China. The average growth rate of population declined from 2.14 % in the 80s to 1.93 per cent in the 90s. The census of 2001 estimated the population of India at 1,027 million - 531 million male and 496 million females. India's GDP was US$ 464.6 billion during 2000 and its per capita income during the same year was US$ 459.
HIV/AIDS has emerged as one of the most serious public health problems in the country. In mid-2001 the total number of HIV cases was 3.97 million. A multi-sectoral approach has been adopted to tackle this problem. HIV/AIDS is also accompanied by social stigma, which leads to other social and psychological problems. Because of this reason, detection of such cases and timely treatment becomes rather difficult. To overcome this problems, creating community awareness is being emphasized. In the sphere of leprosy elimination of leprosy an intensive media campaign was launched. The prevalence rate declined from 57 per cent per 10,000 population in 1981 to 3.74 cases per 10,000 population in March 2001. The objective is to reach elimination at national level by 2004. As regards activities under the revised national tuberculosis control programme the population converge increased from 120 million to more that 440 million in 2001 with the help of a World Bank assisted project. The government has a plan to expand coverage to 700 million population.
In the above context, the government initiatives in the public health sector have recorded noteworthy successes. Smallpox and Guinea-Worm disease have been eradiated from the country. Polio is on the verge of being eradicated. Leprosy, kala-azar and filariasis can be expected to be eliminated in the foreseeable future. There has been a substantial drop in the total fertility rate and infant mortality rate.
The main objective of the health policy announced by the government in 2002 is to achieve an acceptable standard of good health for the people. The approach would be to increase access to decentralized public health system by establishing new infrastructure in deficient areas, and by upgrading the existing infrastructure. Overriding importance has been given to ensure a more equitable access to health services across the social and geographical expanse of the country.
Emphasis will be given to increasing the aggregate public health investment through a substantially increased contribution by the central government. It is expected that this initiative will strengthen the capacity of the public health administration at the state level to render effective service delivery.
The contribution of the private sector in providing health services would be significantly enhanced, particularly for the population group which can afford to pay.
The population of Indonesia was 204 million according to the 2000 census making it the fourth most populous country, after the Republic of China, India and United States. The population growth rate was 1.35 per cent annually during the period 1990-2000 compared to 1.97 per cent annually during the 1980s. The GDP of Indonesia in 2000 stood at US$ 152.2 billion and the per capita income was US$ 738.
For the period 2000-2005, the projection of life expectancy indicates an increase up to 68.2 (approximate). The infant mortality rate showed a consistent decline starting from 71 during 1990 to 51 during 1995 and finally to 41.4 during 1997 per thousand live births. The child mortality rate also declined from 111 to 81 per thousand under the age group of 5 during the period 1986-1993. The maternal mortality rate declined from 540 per 100,000 live births during 1986 to 390 during 1994. The crude death rate also declined from 7.9 per 1000 population during the period 1985-1990 to 7.1 during 1990-1995.
The Strategic Plan for Health Development 2001-2004, aims to elaborate the relevant laws to identify intervention programme strategies reflecting conformity, commitment, cooperation, coordination and integration amongst the internal and external elements to achieve the goals of health development.
Indonesia faces problems of infectious and parasite diseases. Malaria is endemic with the annual incidence fluctuating from 20 per cent in 1995 to 16.1 per cent in 1997 and finally to 21.6 per cent in 1998. Dengue haemorrhage fever (DHF), was reported for the first time in 1968, the number of cases increasing sharply thereafter.
As regards HIV/AIDS, reported for the first time in 1987, the number of positive cases rapidly increased during the period 1991 to 2000. The number of HIV/AIDS cases increased from 24/23 in 1991 to 438/1,083 during 2000. The distribution of AIDS cases by age group indicate a relatively high proportion among young adults aged 20-29. T
Strategic Plan for Health Development 2001 -2004
To tackle the health problems the government evolved a strategic plan for health development during 2001-2004. The paradigm of health management which used to be very centralistic has completely changed now following the issuance of Laws - No. 22 and 25 of 1999. In practice, both laws have withdrawn the major exclusive authority of the central government in formulating health and other social policies. The local governments have now been given the authority to develop a health policy that is more responsive to the specific needs of their population.
Sri Lanka makes breakthroughs in measles, leprosy control
The mid-year population of Sri Lanka in 2000 was estimated at 19.4 million. The population growth rate since 1981 has been approximately 1.7 per cent. The GDP in 2000 was US$ 16.3 billion with a per capita income of US$ 882. In 2000 the economy expanded strongly due to revival of economic activity that commenced in 1999 and recorded a real growth rate of 6 per cent which was significantly above the 4.3 per cent rate of growth in 1999.
According to the Annual Health Bulletin 2000, life expectancy at birth increased from 70 years in 1981 to 73 years in 1996. The crude birth rate declined significantly from 28.2 in 1981 to 20.7 in 1991 per thousand population.
The network of health facilities has been of a satisfactory level. As of December 2000, there were 558 medical institutions with inpatient facilities and 404 central dispensaries compared to 556 and 383 respectively in 1999. The number of hospital beds increased from 55,195 in 1999 to 57,027 during 2000. The National Hospital of Sri Lanka located in Colombo, is the largest hospital in the island. In 2000 it had 2,881 beds. This hospital provides for a number of specialities and sub-specialties.
Cases of deaths from notifiable diseases are received from government medical institutions. In 2000, 83 cases of Japanese encephalitis were reported from medical institutions. Immunization programmes for children were carried out in almost all provinces. During 2000, 3,343 cases of dengue fever and dengue haemorrhagic fever were reported from government institutions. Measles is an important childhood disease. Five years after introduction of the measles vaccine in 1990, the overall immunization coverage had increased to 80 per cent. Over the years, the coverage gradually increased and in 2000 it reached 100 per cent. Malaria continues to be a major public health problem. Leprosy continued to decline inspite of a slight increase in the case detection rate. This indicates that leprosy transmission is still not completely interrupted.
Thailand had a population of 61 million in 1997. The GDP stood at US$ 152.2 billion in 2000 and the per capita income was US$2,018. Thailand is a developing country with a market-oriented health system.
Health Sector Development Plans
The Thai Food and Drug Administration staff total 492 of which 25 are administrators, 285 comprise pharmacists, nutritionists and food technologists and 43 are professionals. By 2006, FDA has the following vision:
"...the FDA will be the principal organization of Thailand that the population can trust in its mandate about consumer health protection - Towards scientific based and proper technology; this will ensure the safety of health products and empower consumers' behaviour."
The Ministry of Public Health is concerned with the operational framework of the Public Health Development Plan in accordance with 'the Ninth National Economic and Social Development plan for the period 2002-2006'. In fact, the strategic planning process of the Ministry of Public Health has been classified into two levels:
- The Ninth National Health Development Plan
- Plan 9 of Ministry of Public Health
The intent of both plans is to reflect in an organized and systematic way, the purpose, goals, strategies, actions, accomplishments, environment and challenges with the aim of making choices about allocating resources and aligning their constituents towards a desired future.
The 1997 Constitution of the Kingdom of Thailand and other legislative measures, political reforms as well as public sector administrative system reforms have had a significant impact on the health of population. Presently, there is an increase in noncommunicable diseases and the socio-economic-related diseases, such as suicides, homicides, violence and drug abuse. The Ninth National Economic and Social Development Plan places emphasis on holistic development based on the people-centered development approach together with the royal initiative of His Majesty the King on the "Philosophy of sufficient economy".
The objectives of strategic plans are:
(1) To foster proactive health that centres on health promotion, and life safety in terms of food safety and security, occupational health and safety, consumer protection and disease control.
(2) To establish a security net that protects population health from economic and social impacts as well as developing and establishing a safety net for equal access to quality health services, especially for the poor and the deprived.
(3) To strengthen the capacity of individuals, families, communities and society in caring for and promoting their health, creating learning and participatory approaches and strengthen health system administration.
(4) To promote innovative mechanisms and measures for health development through research and development by integrating international knowledge and Thai folk wisdom for health self-reliance.
To achieve the above objectives the following targets have been laid down in respect of quality of life upgrading:
(1) Maintaining an equilibrium of demographic structure
(2) Availability of social security system for the Thai people at every stage of life.
(3) The proportion of the indigent shall not exceed 12 per cent of the total population in 2006.
(4) Infant mortality rate shall not exceed 15 per 1,000 live births.
(5) Maternal mortality ratio shall not exceed 18 per 100,000 live births.
(6) Life expectancy at birth; Female: from 74.9 to 77 years; Male: from 69.9 to 72 years
(7) No polio cases
(8) Prevalence rate of HIV/AIDS infections in
- Male military recruits shall not exceed 1 per cent
- Fertile females shall not exceed 1 per cent
(9) Morbidity rate of tuberculosis: contaminated phase (positive sputum smear) shall not exceed 60 per 100,000 population
(10) Morbidity rate of malaria nationwide shall be less than 1 per 1,000 population.
The health goals of all the four countries are laudable. Since the financial resources are limited, it is vital that there are least impediments in easy access to drugs at affordable prices to the general public. Impediments from the patent system need to be understood and the maximum flexibility available utilized in national legislation.
Click here to view Information showing the selected health and socio-economic indicators of Thailand during 1997
- (Extracted from Review of Patent Legislation of India, Indonesia, Sri Lanka and Thailand -- Measures to Safeguard Public Health, WHO Sept 2004)