mbc 2 final assignment

7/31/2019 Mbc 2 Final Assignment

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IMPLICATIONS OF NAITIONAL HEALTH RESEARCH

POLICY IN INDIA

GROUP 9

2011HE009

2011HE0252011HE029

2011HE037

2011HO035

2011HO036

2011HO037

2011HO038

2011HO039

2011HO040

SCHOOL OF HEALTH SHYSTEM STUDIES

TATA INSTITUTE OF SOCIAL SCIENCES

DEONAR MUMBAI

2011


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INDEX

SERIAL

NUMBER

TOPICS PAGE

NUMBER

1. INTRODUCTION 3-7

2. POLICY IN BRIEF 8-9

3. DISEASE BURDEN 10

4. HEALTH WORKFORCE AND FINANCE 11

5. CAPACITY AND INFRASTRUCTURE

DEVELOPMENT

12-13

6. PARTNERSHIPS 14-17

7. ETHICS 18-19


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INTRODUCTION

Health research policy is an important component of the process for reaching the goal

of Health for All expressed in the Alma Ata Declaration. Today, 33 years after the

Declaration, the goal is best expressed in terms of health systems can provide

universal access to comprehensive healthcare as well as action on social determinants

of health to reduce the burden of disease and promote good health.

History Of Indian Health Research-

Indian Health Research Fund Association

In 1911 The Indian Health Research Fund Association was set up by Indian

government as a agency for sponsoring and coordinating medical research in India.This is redesigned as a Indian Council Of Medical Research in 1949.

Indian Council Of Medical Research

This was set up with expanded scope of functions which includes not only for

planning and promoting medical research in country but also for development of

skilled health professionals and health related infrastructure. The ICMR is funded by

the Govt. Of India through the Ministry OF Health AND Family Welfare. The

research is promoted by ICMR establishing centres for advanced research in various

research areas in selected departments of medical colleges and universities. Many

institutes engaged in research are funded and leaded by ICMR.

After independence many institutes are set up for the research in medical fields

National Institute of Nutrition-1969

National Institute for Research in Reproductive Health (NIRRH) 1970

The Malaria Research Centre was established in 1977.

Tuberculosis Research Centre (TRC) in 1978.

The National Institute of Cholera and Enteric Diseases (NICED)1979

Institute of Pathology in 1980.

The Institute of Immunohaematology (IIH) 1982

Vector Control Research Centre (VCRC) 1975

The National AIDS Research Institute was established in 1992

The National Health Policy 1983

In India National Health Research Policy formulated in 1983 in response to Alma Ata

declaration to achieve "Health for All by 2000" emphasing on provision of


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comprehensive primary health care services. This policy includes nutrition, drinking

water supply, active involvement and participation of voluntary organizations,

provision of essential drugs and vaccines, medical health research aimed at the

common health problems of people. Through 73rdand 74th Constitutional

Amendment Acts (1992) PRI and Municipal bodies are also assigned 29 activities

which are directly or indirectly linked with health.

The national Health Policy 2002

NHP1983 was revised in 2002 to achieve acceptable standards of good health yp to

2015.This policy addressed the inadequacies and minimal expenditure on health

research.

Department of Health research 2007

After long run in 2007 Govt.of India created Department of Health Research within

the Ministry of Health and Family Welfare. After reviewing the situation Committee

of Experts drafted National Health Research Policy.

Health Research Policy 2011

In April 2011 Govt.of India has formalised National Health Research Policy. The

policy has recommended creation of National Health Research Management Forum

with representation of all the stockholders including private sector and academia.

Definition of a national health research policy.

The people, institutions, and activities whose primary

purpose is to generate high quality knowledge that

can be used to promote, restore, and or maintain

the health status of populations of the nation. It can include the

mechanisms adopted to encourage the utilization

of research policy.

Need of national health research policy.


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The chairman of national health research policy will be the Minister of Health

and Family Welfare, and co-chairman will be the Minister of Science and

Technology, the State Health Ministers would be its vice-chairpersons and the

Secretary, Department of Health Research, its member-secretary. All Union

Secretaries of various departments of Science and Technology will be the

members as also the Directorate-General of Health Services and some health

experts.

Goals of National Health Research Policy

1)To establish Guidelines For Health Research in India-In India health research was

going on in very scattered manner and there many issues regarding ethics, funding,

planning, implementation of health research. To solve this issues and for research in

comprehensive manner certain guidelines are required.

2)Adequate Allocation of Funds-Only 3%of total health budget is allotted for health

research purpose in 11th five year plan.NHP 2002 proposed 2% of total budget on

health by 2010 but it was below 0.4%during 2007-10. This amount is so much less

and more funding is required for health research as it is important to improve

efficiency and effective programme implementation and planning.

3)To translate research into action-Research which has been done is essential to be

implemented as lot research o research has been done on various health issues but

never comes in action. Also recommendation of many committees put forwarded

much later.

4)Contribution to global health research-As research done in many health issues

related to planning, implementation, vaccination, sanitation can be studied and

accepted by many countries and so contributes to global health.

5) To better understand the causes of disease and the determinants and factors

contributing to both good and ill health, including the immediate, biomedical factors

and the larger social and environmental determinants of disease.


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6) To develop drugs, vaccines, diagnostics, prosthetics and other technologies for

preventing disease, promoting good health and for curative, palliative and

rehabilitative care.

7) To contribute to developing health programmes and health system that use

resources efficiently, are effective in reducing the disease burden and relieving

suffering, and allow greater autonomy to communities, families and individuals in

decision making on health.

What a national health research policy should do :-

1) The institutional framework required for developing basic medical research

capacity such that it would bring us in par with the best in the world.

2) The institutional framework for health system and health programmes

development.

3) The institutional framework and organisational process that must be put in

place to enable evidence-based decision making in public health.


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Let us now discuss the national health research policy in brief.

Objectives of national health research policy:

1. To identify the priorities of health research so that its results are translated by

policy makers into action.

2. Foster inter-sectoral coordination in health research collaborating the

government, private sectors at all levels along with networking between

academia and research institutes.

3. Focus on the vulnerable and the disadvantaged sections of the society thereby

increasing equity.

4. Development of strategies for assessing the cost-effectiveness of health

research and its impact on health systems.

5. Capacity building for health research in terms of human resources and

research infrastructure.

In order to implement the above mentioned objectives the policy has proposed the

creation of a new architecture in form of national health research system (NHRS)

which will be managed by a national health research management forum (NHRMF).

Goals of NHRS:

1. To generate and communicate knowledge that helps to form the nationalhealth plan and guides its implementation, and thus contributes, directly or

indirectly, to equitable health development in the country.

2. To adapt and apply knowledge generated elsewhere to national healthdevelopment.

3. To contribute to the global knowledge base on issues relevant to the country

NHRS would be based on principles of equity, self-reliance, inter-sectorality,

partnerships, originality and accountability. It aims to develop a research culture

promoting all the stakeholders involved in research ultimately trying to maximise

returns on investments in research. The following considerations would be focussed

on while strategising plans:

Setting priorities which are in line with current and emerging issuesconcerning health in India.

Inter-sectoral linkages between health, environment, ecology, social,behavioural sciences, population, agriculture, economics

Fostering participation of private sector in pharmaceutical industry,biomedical technology industry, educational institutions, hospitals, researchinstitutions and NGOs.

Linkages with the international agencies so as to facilitate technology transfer,capacity building and access to diseased populations.

Ensuring ethical research

Ensuring targeted financing- It will ensure allocation of atleast 2% of the totalfunds allocated to health along with mobilising international funds.

Monitoring and evaluating the existing research systems and their practices.

As mentioned earlier, NHRMF will be responsible for executing the goals ofNHRS. So, the functions of NHRMF will be as follows:


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To advise on national health research policies and evolve action plansfor their implementation.

To develop 5 yr projection of plans for health research To review the output annually and prepare the plan for next biennium. To review research activities and suggest strategies to overcome the

problems. To suggest mechanisms to nurture scientific environment and develop

human resources for health research.

A strategy has been proposed in the policy for the assessment of the health research

system and it is based on the following criteria:

Robustness Competence and effectiveness Credibility and accountability Cost effectiveness Ability to generate research funding

Research governance and management


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DISEASE BURDEN


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In order to achieve equity in healthcare, there should be a fair and equitable

deployment of available resources for the benefit of the whole population. Two

important resources i.e the health workforce and financial resources will be discussed

in details:

Health workforce:

Health workforce is a critical ingredient for building of an effective and responsive

health service system. The responsibility of delivering health services falls primarily

on health workers, making them central to the health systems capacity to deliver

health services.

The health sector in India faces several challenges in human resources for health.

At one hand, despite the vast institutional network and diverse human resources, that

includes physicians, AYUSH practitioners, dentists, nurses, rehab specialists, nurses,

public health workers, policy makers, public health educators, pharmacists, health

managers; health system in India suffers from problems such as shortages of staff,

imbalances, maldistribution, poor work environment, high staff turnover, loss ofpersonnel to urban areas and overseas.

On the other hand, information on the size, composition and distribution of health

workforce is sparse and fragmented and the research is limited.

Thus need of the hour for the health service system is to get the right number of

service providers with the right skills to the right place at the right time.

While various attempts are underway by multitude of stakeholders to address these

issues, it is recognised that there is a need to strengthen evidence for informed policy

decisions, making and monitoring of the progress in the area human resources in the

health sector, so as to support the health system. The nature of initiatives undertaken

include:- provision of technical support for control of studies and documentation,

development of guidelines , organising workshops and conducting trainings.

Thus, building an accurate and reliable database that provides information about key

aspects of human resources in health, such as different type of health workers and

their general locations, number of doctors and nurses that are registered, number of

health professionals who emigrate, and student capacity in public and private

institutions. Research can play a very significant role in achieving this.

The National health research policy which emphasizes on prioritisation, better co-

ordination and effective utilisation of resources, will complement calls for increased

health system research and evaluation by providing concrete and specific suggestions

as to where new and existing research resources can best be utilised.

Also, no adequate data is available to reveal the total number of health researchers inIndia. The National health research policy promotes guided development of human

resources for health research, fostering the research culture and defining a clear

research career structure and productivity related incentives which will thus help India

attain and retain a critical mass of researchers in various disciplines affecting health.


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CAPACITY AND INFRASTRUCTURE DEVELOPMENT

One of the far reaching and long term implications of the national heathresearch policy would be the creation of a national health research

development forum. The NHRMF will be given the special function of research capacity

development which basically covers the fundamental areas of the creation of

an integrated national health information system , health research financing

and increasing the capacity for human resources and infrastructure dedicated

to health research

Health information system

Definition of health information - any quantifiable and non-quantifiableinformation that can be used by health decision-makers and clinicians to better

understand disease processes and health care issues, and to prevent, diagnoseor treat health problems

Definition of health information system - inter-related component parts foracquiring and analysing data and providing information (management

information, health statistics, health literature) for the management of a health

programme or system and for monitoring health activities.

The NHRP would seek to improve the quality and timeliness of health relatedinformation and statistics, review of health information systems and the

development of a health repository which seeks to compile and make available

information and evidence from India on various health and related issues.

Information from various sectors would be integrated into the healthinformation system hence providing a comprehensive view of the burden of

disease and conditions in the country and understanding which sub-

populations are most affected (inter sectoral linkages)

Linkages with other international research efforts and WHO and other UNagencies would require to be encouraged in order to access global research

Human resource development

Efforts would be required in order to increase the number of skilledresearchers employed by research institutes. This can be done by giving

financial incentives to skilled personnel. Facilities in existing research institutes would require be updating and

modernising in order to achieve global credibility and reliability.

Potential institutes should be identified where research labs can be put up andthese institutes would be provided with incentives in order to make research an

appealing and profitable aspect.

Increased participation by the private sector , pharmaceutical industry ,biotechnology and biomedical technology oriented industries , private

educational institutions , hospitals and nursing homes etc. would be fostered

Health research financing


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In 1990 the commission on health research and development introduced theconcept of Essential National Health Research and proposed that at least 2 %

of national health expenditure should be invested in ENHR.

In keeping with this recommendation the national health research systemwould try to ensure that the allocation of funds towards health research is at

Least 2% that of the total expenditure on health although this too would quitea meagre amount.

International funds would also be mobilised in keeping wit the priorities.Research organizations should be able to organize funding through their

credibility from international funding agencies.

The government should be able to provide tax and other incentives for theprivate sector setting aside research funds


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PARTNERSHIPS

Public Private PartnershipsThe NHRP has envisaged public private partnerships to promote research inthe field of Health and medical sciences. The government is keen in providing

financial assistance to private partners to promote research which willprimarily be Translational and operational.

Why PPP in research is required??Post 1990s saw a number of trends which led to the emergence of PPPsin health research. Developing world is facing a problem of poverty andrising disease burden as a result of which the research cost to thepharmaceutical companies leading to the development of the new drugshas risen to a great extent. This led them to divert from the commerciallyrisky and unattractive projects. On the other hand the pandemic of HIVand increasing disease burden has led the government and other publicagencies to realise that the research and development in the field ofpharmaceutical and other health related field is only possible by fundingthe private partners so that they are not demoralised to undertakeresearch projects in India.Under this objectives two types of PPPs are being considered

1. Product development PPP2. Access PPP

By now two of such initiatives has been materialised which are1. The Uttaranchal Mobile Hospital and Research Center (UMHRC), which a

three way partnership among the Technology Information, Forecasting andAssessment Council (TIFAC), the Government of Uttaranchal and the Birla

Institute of Scientific Research (BISR).2. The Department of AYUSH envisages accreditation of organizations with the

MoHFW for research so that it could gain the benefit of financial assistanceunder the scheme of Extra mural research on ISM&H. Under thisarrangement the R&D organizations recognized by the Ministry of Scienceand Technology, one Government or semi-Government or autonomous R &D Institution under the government of India or state government or UnionTerritory; and one private R&D institutions registered under any State/CentralAct will act as a Research Organization.

According to the national health research policy 2% of the total health budgetwill be allotted to the health research sector. Since the health budget of India

is already a meagre, 2% of this amount is just peanuts which will not sufficethe requirement for research. Therefore it is important for the government tofind an alternative to the problem of financing and promotion through PPPs.Also PPPs will motivate the private sector to enter the field of health researchand contribute to the health care structure of the nation which was beingpreviously harnessed by the foreign countries for growth and strengthening oftheir health care infrastructure and facilities.

National and international partnerships

Health research policy has highlighted the need of collaboration between the

national and international agencies to undertake health research. This type ofcollaboration will help the national agencies harness the benefit of


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advancement in technology and knowledge of the international partners thusbenefiting the national interests. They can better address the requirements ofthe country in the field of health research like research in the field ofsanitation, drug development, drinking water, disease control and eradication,ETC.

Moreover this type of collaboration will help in the transfer of technology in thefields of genomics, life sciences and biotechnology and will further improvethe scenario of research in these fields.On these lines there has been collaboration between India and EuropeanUnion under the INDIA-EUROPEAN UNION SCIENCE & TECHNOLOGYCOOPERATION OPPORTUNITIES. Under which an emphasis has beengiven on the research in Genomics, life sciences and biotechnology which willhelp in the improvement in knowledge and will lead to the further progress inthe unexplored fields of research by the exchange of knowledge.These types of collaborations will enable India to harness the capability ofresearch institutes established by the government agencies to the full capacity

which were not able to take up and proceed in research due to the lack oftechnology and knowledge and whatever was being done was proved to beirrelevant to the present context. It will help the indigenous researchers toparticipate to full capacity and help the country to retain the researchers whowere earlier migrating to the foreign countries to undertake research.This will also enable India to collaborate with the countries who have thesame health issues and proceed the research in its own interest rather thanbeing guided and dictated by the international agencies to undertake researchwhich according to them is considered more important than the issuespertaining in the country for e.g. under the influence of WHO and otherinternational agencies a large amount of research is being directed to AIDSwhile there is low prevalence of AIDS in the country as compared to otherdiseases consisting of communicable diseases like Malaria, TB and waterborne diseases and non communicable disease like Diabetes, cardiovasculardiseases and Cancer.It will also help India to strengthen its knowledge management system byavoiding the duplication of the research work being undertaken by differentagencies in country and the world and also by well documentation of theresearch being undertaken by publishing the same in the internationaljournals of research.

3) Educational and Research Institutes

Health research policy has emphasized on the inclusion and promotion ofresearch in the medical and other health related educational institutes. Thereis a notion of mandating research in the curriculum as criteria for graduation inthe medical colleges.By now only nine (9) out of about three hundred medical colleges areparticipating in the active research. This is a serious setback to the field ofhealth research since the graduating students are not involved in researchand are just following the knowledge given to them in the colleges instead ofanalyzing and contributing to solve problems in field of health.


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Moreover a curriculum fostering a curative approach to the health problemshas overshadowed career approach of the students who pursue it as alucrative career.Health policy also stresses the need of providing appropriate incentives to theresearchers since by now research appears to be a non lucrative and non

productive career to the students. Moreover the collaboration and support tothe educational institutes especially medical colleges will help in building theknowledge base of research and will avoid duplication of the research workbeing undertaken by various institutes.Also the collaboration with the private institutes and industries undertakingresearch in the field of health should be emphasized since these institutes hasthe initiatives of research. These institutes lack financial assistance and alsoburdened by various legal and other sanctions by different departments of thegovernment which are considered by the government agencies to be nonaligned to research. This will help the industries to take up research and thuscan contribute to the real time problems being faced by the country.

Basic, Clinical and Applied Research.Health research policy advocates translational research so that the researchin the Basic sciences can be translated in clinical or applied science andutilized in the public health.This type of translational research will result in actual product developmentwhich can be utilized for many health related issues. Thus an expertise in thefield in addition to basic sciences and epidemiology would be required toconvert the research into a meaningful and usable process/product.More stress should be given on the related fields of health like physiologybiochemistry, pharmacology, microbiology, molecular sciences and cellularsciences, to undertake fundamental research which can be converted touseful knowledge and also lead to the development of a critical mass ofscientist which could utilise the modern technology to health research.The national policies for health can also be framed in a better and moresensible way utilizing the research in the basic sciences so that it addressesnot only the problems related to health but also the possible solutions to thesame.

Intersectorality of health research

Policy advocates the inter-sectoral collaborations between various other fieldsto harness the resources of areas like social sciences, economics andtraditional medicine.Health research does not only mean the research in the field of modernmedicine which has been the major area where most of the research isconcentrated. In a diverse country like India where there are different culturesand economic status of people in different regions the research should alsoconcentrate on the social acceptability of the results and should result in theproducts which are economically viable and acceptable.India has various traditional systems of medicine which lack acceptance in theinternational world due to the absence of documentation and research

accountability. As these can contribute to solve many health related problemsof the country the research should be undertaken in these fields so that the


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results can be documented and published to enable them to be accepted bythe world.


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Ethics and Regulation

Ethics are norms for conduct that distinguish between acceptable and unacceptable

behavior. ( )

Ethical practices not only promote the aims of research but also promote values

essential for collaborative work amongst researchers. It makes researchers

accountable to the public thus building public support.Transparency means ensuring availability of information to measure the authorities'

performance and to guard against any possible wrong use of powers. It is the

obligation of the authorities to accept responsibility for their actions.

Current scenario of Ethics in research

o The Ethical Guidelines for Biomedical Research on Human Subjects, puttogether and published by the Central Ethics Committee on Human Research

(CECHR) of the Indian Council of Medical Research (ICMR) in the year 2000

also called as the (ICMR Code) enlists clear guidelines for biomedical

research. However, the ICMR Code does not provide guidelines or regulations

to be followed by other branches of research. For instance, the document does

not state any clear regulations for Medical Devices which has lead to a largenumber of second-hand medical devices floating in the Indian market.

o Excessive and unorganized bureaucratic control has made the procedures to be

followed for securing approvals by researchers from govt. bodies

painstakingly lengthy.

o The lack of quality governing committees in medical and health research has

failed to instill faith amongst researchers about the competence of the

bureaucrats examining and evaluating their research.

Urgent need to

o De-bureaucratize and streamline procedures, preferably create a one

window approach. Allow adequate flexibility to engage and retain the best

minds in the country for research.

o Adherence to strict ethical norms and regulations,

o Ensure greater transparency,

o Standardize methodology and international standards of research.

The National Health Research PolicyThe policy advises ethical research, Ethical Guidelines for Biomedical Research on

Human Subjects. (ICMR 2000), along with guidelines that are being developed by

The Dept. of Biotechnology for Human Genetics Research and the Animals Ethical

Guidelines of the GOI. The ICMR Code protects the dignity and safeguards the

welfare and rights of the participants.

The policy states the need for greater accountability and transparency. The

accountability criteria must include the translation of research to action as well asfinances. Continuous monitoring and evaluation through policies and procedures

would help maintain transparency. This would help develop a reliable and responsive

approach to support and funding in research.


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The policy advises the government to initiate steps to de- bureaucratize procedures in

order to foster a culture for research, if implemented it will reduce bureaucratic

hassles for researchers.

Issues the policy fails to address

The ICMR CodeThe policy recommends the adherence to the Ethical Guidelines for Biomedical

Research on Human Subjects by ICMR, a document which has to be updated to add

to its contemporary relevance.

The Ethical Review Procedures in the ICMR Code mandates all proposals for

research involving human subjects to be cleared by Institutional Ethics Committees

(IECs). These IECs are essentially, locally constituted individual ethics committees. A

Clinical Trial refused permission by an ethics committee at one trial site may be

submitted to another and approved.

Transparency and Accountability

Although the policy stresses on the need to increase transparency and accountability,however there is no mention of any specific guidelines for the same. V Raman Kutty(3)

recommends a continuous and active peer review process instead of greater

bureaucratic control in order to increase accountability.

De-bureaucratization of procedures

The policy document states the need to de-bureaucratize procedures in order to

promote a more congenial environment for research but once again fails to state any

specific guidelines or procedures. V Raman Kutty(3)

suggests research proposals must

be reviewed by competent researchers and within a specified time frame to avoid

delays.

Others

The Policy document fails to address the need for institutional mechanisms for quality

assurance in health.


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REFERENCES

1. ICMR bulletin may 2010

2. the hindu,,,,aarti dhar,,,3 apr 2011)

3. the ethic of medical review.

4. Ethical Guidelines for Biomedical Research on Human Subjects, ICMR, (2000)

5. Sundararaman, T.(2011) Comments on the National Health Research Policy. Indian

Journal of Medical Ethics ,90-92.

6. Kutty, V.R.(2011) The Draft National Health Research Policy. Indian Journal of

Medical Ethics, 93-94

7. Report of the National Commission on Macroeconomics and Health, Ministry of

Health and Family Welfare, Government of India, (2005)

mbc 2 final assignment

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