Advisory Committee on Health Research Bangkok, Thailand
11-13 October 2011 /
SEA/ACHR/32/2.1
8 September 2011Agenda Item 2.1
Report of Implementation of the Recommendations of the
Thirty First Session of WHO SEA-ACHR
The Thirty-first Session of the WHO South-East Asia Advisory Committee on Health Research (SEA-ACHR) was held in Kathmandu, Nepal on 21-23 July, 2009. The 31st Session ACHR was attended by 13 ACHR Members, 12 special invitees, 16 WHO secretariat and 3 resource persons.
The Thirty-first Session of the WHO SEA-ACHR made the following recommendations:
1. Recommendations pertaining to the follow up actions on the recommendation of the thirtieth session of the SEA-ACHR
2. Recommendations pertaining to the area of avian influenza research
3. Recommendations pertaining to the area of promotion of research and development in areas of drugs and vaccines
4. Recommendations pertaining to research management in countries
5. Recommendations pertaining to research management in WHO/SEARO
6. Recommendations pertaining to review of global work of WHO on health research
7. Recommendation pertaining to UNDP/World Bank/UNICEF/WHO Special Programme for Research and Training in Tropical Diseases
8. Recommendation pertaining to UNDP/UNFPA/WHO/Wolrd Bank/Special Funding of Research Development and Research Training in Human Reproduction
9. Recommendations pertaining to research priorities in communicable diseases
10. Recommendations pertaining to research priorities in non-communicable diseases
11. Recommendations pertaining to review of the Regional Strategy on Health Research
12. The overall recommendations
Follow up meetings:
WHO SEARO has organized three major meetings to discuss follow up of the 31st Session of the SEA ACHR. The first meeting was conducted on 29 July 2009. There were 8 major follow up actions taken after the meeting:
1. Consolidating the recommendations
2. Writing of proceeding and full report of the meeting
3. Formulation of regional and country strategy for research for health
4. Establishment of ACHR Subcommittee on Vaccine and Drug Development to build capacity in South East Asia for public private partnership.
5. Review of the Regional Policy on Vaccine for South East Asia.
6. Review of the last five ACHR meetings and recommendations whether recommendations have been implemented and were possible to be implemented. Only the recommendations that could be implemented should be considered.
7. Assess the quality of research conducted during 2008-2009 in order to ensure the quality of research proposals and reports as well as research capacity.
8. Strengthening research capacity in Bhutan, Maldives and Timor-Leste through countries visits for needs assessment.
The second meeting was conducted on 18 September 2009 with three outputs:
(3) Establishment of the Sub-committee of SEA-ACHR on Vaccine and Drugs Development, including its rationale, term of reference, composition of the sub-committee, modus operandi.
(4) Immediate actions to be taken to strengthen research capacity in Bhutan, Maldives and Timor-Leste, including:
a. The framework for country visits
b. Establishment of three teams to visit Bhutan, Maldives and Timor-Leste.
(5) Guidance on the development of regional strategy on research for health for South East Asia at the regional and country office.
The third follow up meeting on implementation of the 31st SEA-ACHR was held on 11 May 2010. There were 3 agenda of the third follow up meeting:
1. To review the consultants reports on assessing country health research activities for further capacity building in Bhutan, Maldives and Timor-Leste
2. To update the actions taken on the recommendation of 31st SEA-ACHR focusing on research priorities of communicable and non-communicable diseases
3. To review and discuss on the report of quality of research implemented in 2008-2009 funded by WHO in SEAR countries.
Strategic follow-up actions taken
During the past two years, among 12 broad recommendations, WHO SEARO has selected relevant and implementable six key strategic areas. Actions taken in the six key areas will be reported and discussed in different session. The six strategic recommendations are:
1. Development of regional strategy for research for health
2. Establishment of ACHR Subcommittee on Vaccine and Drug Development
3. Review of the Regional policy on research aspect of immunization
4. Review of the last five ACHR meetings (26th – 30th Sessions) and recommendations.
5. Assess the quality of research supported by WHO SEARO and Country Offices implemented in 2008-2009.
6. Strengthening research capacity in Bhutan, Maldives and Timor-Leste through countries visits.
Most of the rest of the recommendations need continuous follow up actions. An overview of the some activities undertaken related to each recommendation implemented in different countries and at regional level is given below.
1. Follow up actions on the recommendation of the thirtieth session of SEA-ACHR
(1) WHO SEARO has reminded country offices to work closely with Member Countries in developing WHO biennial work-plans, including work plan to support research and research capacity strengthening activities.
(2) WHO has worked with SEA Network of Medical Council Network and medical councils at the national level in further strengthening the institutional mechanisms for improving ethical standards including research, particularly through developing and disseminating learning modules for teaching medical ethics in undergraduate medical education. Several WHO Country Offices have been supporting Ethical Review Committees in implementing ethical review to research involving human subjects.
(3) Advocacies on Ethical Review Boards (ERB) have been done by WHO staffs in countries in their respective technical areas. SEA Network of Medical Council has developed and disseminated modules for teaching medical student on ethics.
2. Avian influenza research
(1). There has been no systematic review of surveillance for avian influenza in the region by WHO. The only country which continues to be severely affected in the region is Indonesia and surveillance for AI is an ongoing issue under periodic scrutiny. Influenza surveillance, including for AI, but in the context of the pandemic was formally reviewed by a joint WHO / MoPH team in Thailand 5-9 October 2009.
(2). A system already exists through the WHO Global Influenza Surveillance and Response System (GISRS- new name for GISN): there are eight National Influenza Centres (NICs), one regional influenza reference laboratory and one global H5 reference lab in SEAR. There is a network of National Influenza Centres in SEAR and WPR and annual meeting is organized to share influenza information since 2007. Regional meeting of National Influenza Centres (NIC) with emphasis on determination of drug resistance in influenza virus was held in Bangkok in August 2010. Influenza Pandemic related meeting in SEA Region was held in Cochin, Kerala (India) in February 2010 which was jointly organized by SEARO and CDC Atlanta. The objectives of the meeting were to review surveillance efforts and progress in the region as well as to discuss challenges and to share and document lessons learned from the current H1N1 influenza pandemic.
(3) WHO collaborates closely with FAO and OIE and there are regular ‘tripartite’ meetings under the ‘One Health’ banner – and this is precisely the kind of approach we advocate for and support in SEAR Member States. WHO SEARO held a regional meeting to discuss a ”Public Health Research Agenda for Influenza” in August 2010, which included consideration of all the technical areas mentioned above.
(4) An informal consultation was held in New Delhi from 29-30 October 2009 to assess regional pandemic influenza vaccine production capacity and discuss possibility of public private partnership.
3. Promotion of research and development in areas of drugs and vaccine.
(1) Map of centres of research and development of drugs and vaccine of countries in the region has been developed.
(2) Clinical trials conducted in the countries of the Region has been identified and reviewed.
(3) Harmonization of drug regulation in the South East Asia Region has been initiated.
At the 14th International Conference of Drug Regulatory Authorities (ICDRA) 30 November – 3 December 2010 in Singapore, a lunchtime meeting for drug regulators from the SEA Region was organized by RA-EDM. Regulators from all participating countries (except India and Myanmar who were absent) attended. In the meeting member states mentioned that they would like SEARO to facilitate more regional meetings and training programmes for them.
In addition, mention was made of the advantages of the ASEAN pharmaceutical working group as a useful forum for the concerned countries (Thailand, Indonesia, and Myanmar) to collaborate and help each other. Since 1999 in ASEAN a process of harmonization with regard to drug registration has been on-going with the lesser developed countries with weaker Drug Regulatory Authorities (DRAs) relying on the more developed countries with stronger DRAs.
There are already existing mechanisms within SAARC to collaborate and even fund joint activities on health. There is no technical professional in the SAARC secretariat but they have a Technical Committee on Health and Population which represented by health officials from all SAARC countries. There is also a SAARC development Fund (SDF) which may be used for harmonization of drug regulation.
(4) Promoting rational use of medicine and containing antimicrobial resistance
WHO SEARO updated the WHO database on use of medicine in primary care in developing and transitional countries with survey up to including in 2009. This data provides evidence of trends in irrational use of medicines remain serious in the Region.
WHO SEARO continued to collaborate with HQ in collecting information on drug policy from Member states through questionnaire sent to MOHs. There were surveys in 2003, 2007 and again survey is underway in 2011. Some policies being monitored are: prescription audit in the last 2 years, national strategy to contain AMR, antibiotic non-availability in OTC, public education on antibiotics undertaken, DTCs in more than half of government hospitals, national drug information center for prescriber, obligatory continuing medical education for doctors, training for medical students on EML and STGs, national EML used in public sector procurement, national EML updated in the past 2 years, and national STGs updated in the last 2 years.
In the area of advocacy, the following publications were done:
· Three reviews on promoting rational use of medicine: The World Medicine Situation 2011: Rational use of medicine; Combating inappropriate use of medicines; and promoting rational use of antibiotics
· Two articles on methodological lessons learned on community surveillance of antibiotic use and antimicrobial resistance in resource constrained setting based on pilot projects conducted in India and South Africa first published by WHO in 2009.
· Five articles on various aspects of the essential medicine concept, medicine use in children and safety.
A number of educational programmes were supported:
· Bi-regional (SEAR/WPR) training on pharmacovigilence held in New Delhi in February 2011
· Regional training on promoting rational use of medicine in the community held by the IIHMR in Jaipur February 27 – march 10, 2011.
· Regional training programme on drug and therapeutic committee to be held by Delhi Society for Promoting Rational Use of Drugs in Delhi, November 2011.
The inter-country meeting on promoting rational use of medicines was held in SEARO 13-15 July 2010. The recommendations of the meeting included the following:
· Regional resolution on promoting rational use of medicines
· Countries to establish a dedicated, fully resources unit in the government to monitor medicine use and coordinate the implementation of national policy to promote rational use of medicine and that the unit be guided by a broad-based steering committee involving all stakeholders
· Countries to undertake a situational analysis to develop a road map for action
· WHO SEARO to support countries in the above endeavors.
In September 2011, 64th Regional Committee discussed a report by secretariat and adopted resolution SEAR/RC64/R5 on National Essential Drug Policy including the rational use of medicines.
(6) Pharmacovigilance
Phramacovigilance has been implemented in India, Sri Lanka, Indonesia, Maldives, Bhutan, Thailand, and Nepal.
The National Pharmacovigilance Programme in India started in 2004. This has been revamped last year as the Pharmacovigilance Programme of India by the Central Drug Standard Control Organization (CDSCO) under the aegis of Ministry of Health & Family Welfare, Government of India in collaboration with Indian Pharmacopeia Commission, Ghaziabad.
In Sri lanka the Department of Pharmacology, Faculty of Medicine, University of Colombo in collaboration with the Ministry of Health, undertakes monitoring of adverse drugs reactions (ADR) and providing drug information. In Indonesia, pharmacovigilance is carried out by the pharamcovigilance unit which is coordinated by the National Agency of Drug and Food Control (NA-DFC).
In Maldives, pharmacovigilance activities are conducted by the Medicine and Therapeutic Goods Division (MTG) of Maldives Food and Drug Authority (MFDA) in collaboration with Indira Gandhi Memorial Hospital (IGMH) and ADK private hospital. In Bhutan, the National Pharmacovigilance Centre is at the Pharmacy Department, Jigme Dorji Wangchuk National Referral Hospital (JDWNR) Hospital. Theis is coordinated by the Drug Regulatory Authority, Royal Government of Bhutan.
The Thailand ADR monitoring Centre was set up in 1983 as part of the Thai Food and Drug Administration. 18 centres were set up in 1992. In 1997 the activities were expanded to cover all health products. In 2010 the focused changed from hospital based to community based monitoring of all drug related problems. The National Centre is known as Health Product Vigilance Cntre which is under FDA. Reporting of adverse drug reactions (ADR) is a national program and all hospitals send reports of ADRs to this Centre.
The national pharmacovigilance centre in Nepal is at the Department of Drug Administration under the Ministry of Health and Population. The programme was started in 2004.
(7) Development of traditional medicine for the prevention and treatment of avian influenza
There is no specific study conducted on the use of traditional medicine for prevention and treatment of avian influenza. However, there are lessons learned from clinical research projects combining TCM with modern medicine for prevention, treatment and rehabilitation from SARS in China.
4. Research management in countries
In the last two years, WHO Country Offices have been working with Member countries and partners in:
(1) Strengthening institutional capacity to report and share good practice, by facilitating regional and global networks, and with the involvement of WHO collaborating centres;