consultation on a draft global action plan to address ... · inclusion of rational use of...

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Dear Sir/Madam,

We are pleased to submit the input of Third World Network for the WHO's AMR Consultation. We are

in the process of compiling the references to good practices, which we will provide as soon as possible.

With best wishes,

Third World Network

Consultation on a draft Global action plan to address antimicrobial resistance

The questionnaire is divided into four sections. The questions are broadly framed and intended to

give you the opportunity to enter into some depth and explain your organization's viewpoint. While

only questions marked with * are mandatory, we would appreciate answers to as many as possible.

Where a choice of answer needs to be selected please highlight your answer.

Before answering the questions, please refer to our list of supporting documents.

http://www.who.int/drugresistance/amr-consultation/en/index.html

About you

1. Name of individual respondent*

(deleted)

2. Email address* (preference for official email addresses)

(deleted)

3. Are you authorised to represent your organization or interest group?*

Yes

4. Organization Name*

Third World Network

5. Address of the organization*

131 Macalister Road, 10400 Penang, Malaysia

6. Organization website (if available)

http://www.twn.my

7. Country*

Malaysia

http://www.who.int/drugresistance/amr-consultation/en/index.html

http://www.twn.my/

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8. Type of Organization*

• Government department, ministry or agency

• Development or aid agency, foundation, trust or other funding authority

• International developmental organization

• Civil society

• Other non-governmental organization (NGO)

• Other (please specify)

9. Main sector of interest

• Human health

• Animal health

• Finance/economics

• Agriculture or food

• Environment

• Communication, education and community

• Other (please specify)Research and Innovation

10. Would you like to be added to our mailing list to receive updates on the development of the

global action plan?* Yes

General questions

1. From the perspective of your organization, what are the most important areas of concern

in AMR?

i. Curbing overuse/excessive use while securing access for people in need especially in developing countries

-Emergence of anti microbial resistance to major communicable diseases, with an existing weak public health system

Need for public awareness that antibiotics are different than other drugs like antacids & implications of irrational use of antibiotics are serious for the individual & for society/community

Recognizing that public health investment is necessary in developing countries and strengthening public health systems remains a priority

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Prevention of infection through ensuring safe drinking water, prevention of malnutrition

Recognizing the fact that different languages are spoken in different parts of the world and different languages, different dialects and different scripts can be found in the same country therefore there is a need for demystification of medical technical information into consumer friendly information that is understandable to promote behavioural change and better communication

Working with Women‘s Health, gender sensitive communication related to reproductive health, rational antibiotic use in health problems they face, e.g. puerperal sepsis (infection during childbirth), septic abortion, sexually transmitted diseases

Similarly prioritizing child health, childhood infections and acute respiratory Infections, diarrheal diseases which are the biggest killers of children in developing countries, working towards strengthening public health systems

Promotion of Standard Treatment Guidelines to working towards Access to Essential Antibiotics in Paediatric Dosages

Effective regulation and control of antibiotics to ensure that existing and new antibiotics are accessible (available and affordable) to all those in need in all countries, especially developing countries. Antibiotic treatments and diagnostics should be considered global public goods. Regulations must encompass distribution, marketing and sale of antibiotics for humans and animals use; and prescribing practices of health care providers

Promotion of national policies on rational use of antibiotics Securing access for people in need irrespective of the ability to pay (Involvement with

the issue of Pricing of Essential Antibiotics) Ensuring appropriate and effective antibiotic stewardship programmes in all health care

settings Information and public education campaigns/programmes involving multi-sector

collaboration for consumers, animal farm operators and better (re)training of health professionals

Strengthening health systems and surveillance capabilities: regular data collection on hospital and community acquired infections for effective action and infection control, with assurances of public disclosure to all stakeholders (civil society, medical professionals and governments)

Promotion of national systems for the monitoring of antibiotic use and antibiotic resistance in humans and animals to enable effective action

Development and availability of affordable rapid diagnostic tools and techniques to identify and specify type of infection thereby preventing irrational use of antibiotics.

Prohibitions on the advertising and promotion of antibiotics by pharmaceutical companies.

ii. Addressing overuse/excessive use in food and agriculture

Restricting and limiting antibiotics for treating animals only where there is genuine

therapeutic need, based on antibiotic treatment guidelines Prohibition of the use of antibiotics as growth promoters Prohibition of the use of antibiotics for prophylaxis Addressing and prohibiting farm practices such as overcrowding, unhygienic conditions,

inappropriate diets, and early weaning requiring routine antibiotic administration. Encourage good farming practices and best practices in disease control e.g. appropriate housing design for animals, good disinfection procedures, isolation of sick animals, use of vaccines and disease eradication programmes

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Prohibition/Severe restrictions on the use of critically important antibiotics for humans in animals except in specific circumstances to prevent serious suffering or to save lives

Ban the use of antibiotics in animal feed in countries where this practice prevails and until a ban is in place develop guidelines for veterinarians to reduce the overuse/misuse of antibiotics in animal feeds and discourage non-therapeutic use

Introduction or enforcement of laws on the use of antibiotics in animals i.e. approval of veterinary drugs and restrictions on their use; promote animal health; strengthen hygiene in the food chain

Provide education and training for livestock farmers on responsible use of antibiotics Consumer campaigns for antibiotic-free foods including exposure and boycotts of

corporations that produce food with routine use of antibiotics.

iii. Developing an effective innovation system for new antibiotics, diagnostics and other tools that supports health, access and rational use

Promotion of public health priority needs driven diagnostic tools for early detection of infections e.g. Tuberculosis and also to detect TB drug resistance in persons not responding to anti-TB treatment

Early diagnostic tests for Malaria, and tests which can differentiate between Plasmodium Falciparum from Plasmodium Vivax as their rational treatments are different, similarly for Typhoid, ParaTyphoid , HIV etc . Diagnostic tests which are accessible, affordable and accurate

Early finding of emergence of resistance & communication of rational management under those circumstance

Promotion of needs-driven research and development models for new antibiotics with significant public health value and affordability (based on the principle of de-linkage).

Affordable rapid diagnostic tools to reduce inappropriate use and aid surveillance, including vaccines.

Access to complete trial data and information on safety, efficacy and resistance profiles of antibiotics and diagnostics.

Safeguarding of standards of clinical trials for new antibiotics. Drug regulatory agencies must not approve antibiotics based on clinical trials with small sample sizes and surrogate endpoints.

No burdensome intellectual property measures for the development of antibiotics that reduce access to affordable antibiotics.

2. Is your organization currently involved in work related to AMR? Y__ N __

If Yes, How?

i. Research and publication: Data gathering, monitoring and research on the use of

antibiotics and antibiotic resistance in developing countries especially in Asia Pacific

and Latin America with detailed studies starting in Malaysia and China. Public

dissemination of information on the issue through published articles in Third World

Resurgence, a monthly publication of the Third World Network with global distribution;

media outreach as well as through distribution with network partners, such as Health

Action International Asia Pacific, a well established network of health professionals,

academia and health and developmental groups working to promote rational health and

drug policies in the Asia Pacific region.

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ii. Lobbying and advocacy: At national level, started with the Ministry of Health Malaysia

through dialogue, and written memoranda/submissions on antibiotic use and antibiotic

resistance in food animals and human use in Malaysia, as well as collaboration for joint

future activities, including workshops and trainings on rational use of antibiotics. Also

with advocacy in India on the areas listed in (i) above where TWN’s representative is a

member of several government committees that are relevant to the AMR work.

iii. Networking: Founding member and collaborator of Antibiotics Resistance Coalition

(ARC), a global coalition of civil society, academia, intergovernmental and research

organizations working to address antibiotic resistance issues that was launched in April

2014.

Questions about the draft global action plan outline document

Before the WHA resolution was adopted, two WHO AMR Strategic Technical Advisory Group (STAG)

meetings were held in anticipation, which included members plus a large number of representatives

from other organizations. These meetings identified key issues, concerns and led to the

development of a draft outline.

As this consultation progresses and stakeholder meetings are held, the secretariat will harvest and

incorporate the input into the draft global action plan.

1. How would you rate your understanding of WHO’s intention in the development of a global

action plan to address AMR?

Very good_*_ Good__ Fair__ Poor__

Additional comments

2. From the perspective of your organization, are the major issues relating to AMR outlined

in the draft global action plan? Y_*_ N __

If No, what additional issues need to be addressed?

The role that the pharmaceutical industry has played, and continues to play, in

promoting overuse and misuse of antibiotics in human medicine, industrial food animal

production and the food-processing sectors, through decades of unrestrained

distribution, promotion and marketing practices.

Inadequate regulation and control of the sale and use of antibiotics in animals and

humans including financial incentives for prescribers and dispensers has been a major

factor leading to this crisis.

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All promotional activities aimed at health personnel, particularly doctors, in hospitals

must be subject to some form of regulation. Drug industry incentives to doctors to

increase antibiotic prescriptions must cease with immediate effect.

Inclusion of rational use of antibiotics & concerns related to AMR, including strategies to

address it in medical education

Questions on the ‘Building blocks’ described in the draft outline.

You will notice, the global action plan has been constructed around “building blocks” in recognition

that different countries will have different starting points. In this situation, countries can choose

building blocks to concentrate upon. Each building block specified has been identified as a key area

where specific attention, planning and work are needed to achieve progress in addressing AMR.

Through questions in this section, we would like to hear your opinions on these building blocks in

more detail.

I. Building block-1: Increasing awareness and understanding about AMR and of the actions

and changes needed

a) What do you consider to be the main issues under this priority?

Ensuring responsible & rational use of antibiotics

Ensuring restriction, prevention of trivialization in use of Potent Antibiotics, earlier

called second line or third line antibiotics.

Overcoming the following: lack of understanding and access to information on the

magnitude (emergence and spread), seriousness and consequences of the problem

across all sectors; public misunderstanding about the difference between infectious &

non-infectious medical problems; and an ill-informed fear of bacteria in general

Overcoming the entrenched belief that antibiotics are necessary as growth promoters

and prophylaxis for farm animals and preventing the inappropriate/excessive/overuse

in food animals and overprescribing by health professionals

Understanding the following: difference between antibiotic & antacid, difference

between friendly & pathogenic microbes; the conditions which increase vulnerability of

infection & emergence of AMR; the difference between bacterial and viral infections

Promoting the understanding of the critical importance of using antibiotics

appropriately and only when necessary.

b) What are the main actions that need to be done -- and who are the main

actors/stakeholders who need to take action -- to go beyond the status quo?

Civil society, health professionals, academia and government must engage in raising

broad-based public awareness and efforts to support behaviour change among people,

grounded in creativity, popular education, art, social movements and reformed school

(including medical/dental/pharmacy) curricula.

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Interventions and retraining of animal farm operators and veterinarians on appropriate

and rational use of antibiotics in (farm) animals with bans/prohibitions as part of the

strategy

Interventions and better (re)training of health professionals aimed at changing existing

prescription behaviors through non-commercial and evidence-based programs.

Creation of standard treatment guidelines that should inform antibiotic administration

in pharmacies, hospitals, health centers and any health care provider authorized to

provide antibiotics.

Health Policy Makers & Drug Regulatory Authorities to have clear antibiotics use

guidelines regarding restriction on over-the-counter sales, prescription of potent

antibiotics, etc. For e.g. there is Schedule H1 as Part of the Antibiotics Policy in India

whereby special antibiotics are only to be provided by a specialist etc. This brings up

the issue of the need for adequate number of trained, skilled experienced doctors,

nurses, pharmacists to ensure rational use of antibiotics, prevent hospital infections,

emergence of drug resistance etc.

Action against pharmaceutical companies promoting antibiotic use unethically to

doctors for making unnecessary, irrational prescriptions.

Conducting of prescription audits of select significant infections , where resistance has

emerged & of specific antibiotics against which resistance has emerged.

National Antibiotic Stewardship Programs, involving optimal antibiotic drug regimens

and appropriate duration of therapy and route of administration, as well as future

effectiveness.

c) What steps have already been taken to address this priority? (please provide references where possible)

WHO’s Theme for World Health Day 2011 “Use antibiotics rationally” translated into action nationally through information dissemination at community level on compliance, dangers of self-medication and appropriate and rational use of antibiotics.

Civil society engagements by ReACt partners for community based education programmes in South East Asian countries as well as in Ecuador, on rational and appropriate use of antibiotics

Information materials/resources on antibiotic resistance, appropriate and rational use of antibiotics for human and farm animals

In India a new National Health Policy is being worked on, National List of Essential Medicines 2014 is being undertaken, revising the last NLEM 2014. Effort to identify & get irrational Fixed Dose Combinations of Antibiotics withdrawn as they have also contributed to the AMR problem as have the irrational use of antibiotics themselves.

d) What are concrete and measurable indicators of progress for this priority? (Including, for example, global and national goals to be achieved within 2, 5 and 10 years) The following is an indicative list only:

Increase in the number of medical/dentistry/pharmacy schools with curricula that incorporate, integrate and prioritize rational use of antibiotics, good sanitation and hygiene practices including proper hand washing techniques and discusses and offers treatment options and non-drug alternatives.

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Management of hospital waste especially in places where untreated hospital waste is coming from hospitals dealing with patients with AMR, & in places where sewage lines & drinking water pipe lines are laid together

On going joint inter-sector and multi-sector public information/education programs/campaigns to raise awareness about antibiotic use and antibiotic resistance.

Progressive bans on the use of antibiotics as growth promoters in farm animals Progressive bans on the use of critically important antibiotics for human use, in farm

animals Withdrawal of irrational Antibiotics Fixed dose combinations.

II. Building block-2: Identifying the most important approaches for preventing development

of infections and the steps needed to move beyond guidance to more effective implementation of

such approaches


Access to adequate safe drinking water as water borne diseases constitute a significant

percentage of infectious diseases (access to drinking water as well as for personal

hygiene)

Poor infection control practices (inadequate hygiene and hand washing techniques) and

sanitation in health care settings

Addressing rampant childhood malnutrition, which increases vulnerability to infection

perpetuating the downward spiral of the vicious circle of malnutrition-infection-

malnutrition

Strengthening of public health systems with adequately trained and skilled health

personnel

Lack of effective vaccines (defects in the cold chain, inappropriate use)

Lack of adherence to Standard Operating Procedures to contain and control outbreaks of

infection.

Poor surgical site infection control practices

Poor infection prevention in animal husbandry/farming (e.g. farm practices such as

overcrowding, unhygienic conditions, inappropriate diets, and early weaning requiring

routine antibiotic administration.)

b) What are the main actions that needs to be done -- and who are the main


Retraining of health care providers on effective hygiene and hand washing techniques; prevention of surgical site infection and sexually transmitted diseases

Ensuring high standards of cleanliness/sanitation in health care/hospital environments through refresher courses for janitorial/support staff

Promoting use of effective, rational and epidemiologically relevant, safe vaccines at affordable costs to countries and including them in their national immunization programs or in their markets

Encouraging good farming practices and best practices in disease control e.g. appropriate housing design for animals, good disinfection procedures, isolation of sick animals, use of vaccines and disease eradication programmes.

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c) What significant work has already been done to address this? (please provide references

where possible)

Efforts towards ensuring access & affordability of Essential Antibiotics and Rational Antibiotics

Policy

(more to be provided)

d) What are concrete and measurable indicators of progress for this priority? (Including, for example, global and national goals to be achieved within 2, 5 and 10 years)

Reduction in mortality rates due to AMR Reduction in prevalence of resistant microorganisms

(More to be provided) III. Building block-3: Optimizing the use of existing antimicrobials for human and animal

health and in agriculture


Inadequate/poor prescription and dispensing practices resulting in irrational use of antimicrobials

Strengthening and enforcement of medicines regulations in all sectors (compliance/ adherence)

b) What are the main actions that needs to be done -- and who are the main actors/stakeholders who need to take action -- to go beyond the status quo?

Instituting the use of standardized Antibiotic Treatment Guidelines in all care settings including veterinary practice

Antibiotic stewardship programmes to control/optimize use of existing antimicrobials Progressive bans on the use of antibiotics as growth promoters in farm animals Inclusion of Rational Use of Antibiotics principles and the concept of Essential Drugs,

standard treatment Guidelines, Medical Ethics, Emergence of Anti microbial Resistance as a Public Health challenge in Medical Education

c) What steps have already been taken to address this priority? (please provide references

where possible)

Denmark has been an example in the reduction of antibiotics as growth promoters in

pig farms

An EU-wide ban on the use of antibiotics as growth promoters in animal feed entered

into effect on January 1, 2006

d) What are concrete and measurable indicators of progress for this priority? (Including, for

example, global and national goals to be achieved within 2, 5 and 10 years)

Some examples:

Inclusion of Rational Use of antibiotics & AMR in Medical Education text books & medical

education

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Regulatory Action for pharmaceutical companies for unethical promotion of irrational use

of Potent Antibiotics for Profit

By 2024 ban routine use of antibiotics as growth promoters globally

By 2024 ban the provision of incentives by pharmaceutical companies for pharmacists,

doctors and veterinarians for selling antibiotics

IV. Building block-4: Identifying and closing critical gaps in knowledge needed to address AMR


Inadequate/out dated health information systems impacting on quality of data collection on AMR.

Lack of surveillance and laboratory capacity on antibiotic use and resistance. Need for more research and development of new antimicrobials and rapid diagnostic

tools; and on interventions to prevent resistance and the spread of AMR. Early identification and efficient communication about emergence of AMR in outbreaks

of infectious diseases and provision of alternatives and recommendations by health authorities. For example: the Shigella outbreak, resistant to most commonly used antibiotics and recommended ones, which spread along trains & road routes from East India. Health personnel were not told about the emergence of multiple resistance & which ones were the recommended alternative to deal with the outbreak.

b) What are the main actions that need to be done -- and who are the main actors/stakeholders who need to take action -- to go beyond the status quo?

Strengthening national health information systems including surveillance capacities nationally, regionally and globally.

Incentivizing research and development of new antimicrobials and diagnostics and ensuring that these remain affordable.

Actors must primarily be public sector health providers and institutions and where non-state actors participate this needs to be within a clear public interest framework with no conflict of interests.


where possible)

c) What are concrete and measurable indicators of progress for this priority? (Including, for example, global and national goals to be achieved within 2, 5 and 10 years)

Annual national reports on rates of AMR Setting up or linking up with sources of unbiased information, e.g. Essential Antibiotics,

Rational Antibiotics , existing Irrational Antibiotics Fixed Dose Combinations, Antibiotics with possibility of Cross resistance , major safety concerns in Pregnancy and lactation period , children , elderly etc.

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V. Building block-5: Developing an innovative and sustainable approach to develop and

distribute critical products and technologies needed to address AMR


Need for public leadership regarding innovation that should look beyond antibiotics.

Need to provide new avenues of treatment

More diagnostics equipment that is affordable and easily accessible for developing

countries to improve their diagnostic capabilities

Increase the availability of and affordable access to epidemiologically relevant, effective,

safe vaccines in order to reduce infections

Increase public leadership towards new, needs-driven research and development

models based on the principle of de-linkage: divorcing price from research and

development costs as well as from sales volumes.

Access to the building blocks of knowledge

Rejection of additional/burdensome intellectual property measures

b) What are the main actions that need to be done -- and who are the main


Public funding is essential, and benefits of these investments should accrue to the public.

Incentives should target new antibiotics with novel mechanisms of action or with

significant public health value.

Need for public leadership to establish pooled efforts and support open research. These might include enriching compound libraries with potential new drug candidates, providing specimen banks to aid developers of new diagnostics, building clinical trial networks to ease recruitment of patients, sharing pre-clinical and clinical data, and publishing findings in open access journals. Rejecting additional intellectual property measures that compromise patient access.

Recognizing and understanding the important role of other Systems of Medicines which

have been treating infections for centuries.


where possible)

d) What are concrete and measurable indicators of progress for this priority? (Including, for

example, global and national goals to be achieved within 2, 5 and 10 years)

VI. Building block-6: Assessing the long term economic, developmental and social costs and

implications of AMR as a basis for sustainable investment and action


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Economic impact of the increasing use of last generation antibiotics for public health

systems

Economic impact of longer hospitalizations and hospital acquire infections

Economic & Social impact of loss of lives of livelihood providers & also loss of home

builder & child carer i.e. mother of the family (impact on Neonatal & child mortality,

with loss of mother is known, yet it needs to be recognized and emphasised).

Economic costs however continue to be underestimated. Conditions which increase

vulnerability of women to Infections, Sepsis, HIV, Malaria & emergence of AMR need to

be addressed .

b) What are the main actions that needs to be done -- and who are the main


- Governments, health officials and the general public need to be involved and to be aware of the

long term impact that not taking action will bring to the public health system/services.


where possible)

d) What are concrete and measurable indicators of progress for this priority? (Including,

for example, global and national goals to be achieved within 2, 5 and 10 years)

Need for Epidemiological, Health, Social & Economic Impact studies

Concluding questions

2. What contribution would your organization be able to make in implementing the global action plan?

Public education and awareness programmes/campaigns on AMR and rational use of antibiotics in all sectors

Lobbying and advocacy with policy makers in developing countries on strengthening regulations/measures on use, marketing and promotion of antibiotics for animal and human, through written submissions/memoranda/consultations.

Promoting Rational Health &Policy , Rational Drug Policy ,Rational Antibiotic Policies Monitoring and advocating for policies to address use in animal husbandry, aquaculture

and humans. Information dissemination through regular publications including written articles for

public consumption through the internet and in print form.

3. Additional input that you feel would be facilitate development of the GAP.

Industry commitment to ethical marketing and sale of antibiotics Industry commitment to research and development of new antimicrobials and

diagnostics that are affordable and available.

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These cannot be left to voluntarism but requires appropriate regulation, compliance mechanisms and penalties for non-compliance.

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