Concept Foundation
&
MTP Registration Advocacy
Thailand
Presented by
Wanapa Naravage, Ph.D.
Program Manager, Concept Foundation
11th March 2012
ICMA and WoW Meeting
Concept Foundation

An international not-for-profit organization working in
the field of reproductive health.

Established by the WHO/HRP, World Bank, UNFPA in
1988 to help increasing access to health-improving
medicines and technologies.

Concept Foundation’s goal to:
“Provide access to products for reproductive
health of assured quality to the public sector of
lower and middle income countries at the lowest
possible price.”
2
Conditions of agreement between WHO and
Concept Foundation
Under its collaborative agreement with WHO, agreed to:

Price – Co-packaged product with preferential price to public sector, making
it affordable to many more women.

Quality - Manufactured in USFDA/EMEA compliant facility, meeting
international current Good Manufacturing Practice (cGMP).

Regulatory issues – Misoprostol used “off-label”, regulatory agencies
welcome formal registration of misoprostol for use in medical abortion;
clinical part of registration dossier based on WHO clinical trials.

Ease of use – co-packaged product easier for both provider and woman.
3
Background
4
Situation of Abortion (1)

To terminate pregnancy
 Law restriction
 Regulation under medical council is ambiguous,
therefore doctors are reluctant to carry out abortion
 Attitude of providers
 Social stigma
 Limited safe abortion services

To continue pregnancy
 Lacking or inadequate support health service systems
 Social stigma
5
Abortion Laws and Regulations (2)

Criminal code 305 (1) (2), 276, 277, 282, 283, 284 and
Medical council regulation 2005 - medical doctors
can perform abortion legally in order to:





Save a woman’s life and preserve physical health
Preserve mental health
Rape
Women under 15 years of age
Baby malformation
6
Situation of Unsafe Abortion (3)

Surgical technologies
 Dilatation and Curettage (D & C) by sharp curettage
 Manual Vacuum Aspiration (MVA)

Medical abortion
 Mifepristone (not legally available in Thailand)
 Misoprostol (available for gastric ulcer, only doctors in
hospitals can administer)
 Easily purchased from internet and black market
7
Situation of Unsafe Abortion (4)

In Thailand, 200,000* abortions per year are quoted but no hard
data is available.

A study carried out in 1999 demonstrated that 28.8%** of the
13,090 induced abortion cases resulted in serious complications i.e.
uterine perforation, infection and death.

Cost per visit for treatment of complication was 90 US$. In case of
severe complication, it would cost around 700 US$ per case**.

84% of young people age between 13-22 experienced unplanned
pregnancy, of which 53% had induced abortions***.
Ref: * Boonlert Lieoprapai, Population and Social Research Institute, Mahidol University
(Bangkok post 15 March, 1978)
**Suwanna Warakamin and Nongluk Boonthai. Situation of induced abortion Thailand, 2000.
*** Nartruedee Dendoung, 2010.
8
Develop of an Advocacy Strategies
Step 1: Face –to-face meeting with the
stakeholders (GO, NGO and WHO)
 Step 2: Form an advocacy group (working
group)
 Step 3: Select theme for advocacy
 Step 4: Assess the situation
 Step 5: Develop the model
 Step 6: Scale up

9
Four Key Principles for all Steps

Systems thinking – bringing inter-relationships and the
bigger picture into view.

A focus on sustainability.

Understanding the determinants of the pilot model
program and scaling-up success and use of this
understanding to shape the scaling-up strategy.

Maintaining a focus on human rights, participation,
gender equity, equitable access to quality of care, and
ownership.
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Theme: “Making MTP Available, Accessible,
Affordable Products of Assured Quality ”
By
Working Group & SC
Department of Health, MoPH
Siriraj Medical School
Ramathibodi Medical School
Chulalongkorn Medical School
MCH Hospital
WHO/Thailand
PATH/Thailand (Choices Network)
Concept Foundation
SC
RTCOG, Medical Council, Medical Association
11
Planning Pilot Program:
Conceptual Framework of Strategic Approach (2)
MTP
Making Available, Accessible,
Affordable Products of Assured
Quality
Pilot MTP
models
university hos
• MCH hos
Choices
Network (58)
Resource
Team (WG)
• prevention
• options counseling
• advocate for early
seeking help
• refer cases
Lessons Learnt
Scaling-up
12
Planning Pilot Program:
Conceptual Framework of Strategic Approach (1)
Making MTP Available, Accessible, Affordable Products of
Assured Quality
Phase I
Strategic Assessment
& Advocacy
2010-2011
Resource Team
Phase II
Phase III
Testing
Interventions
Scaling up &
Expansion
2011-2012
2012-onward
Process of product registration
External Environment
understanding norms, values, laws & regulations and help or health seeking patterns of the UP women
13
source: Adapted from R. Simmons. ExpandNet and WHO, Presented at DoH, MoPH, Thailand, 17 Jan 2011
Phase I:
Strategic Assessment & Advocacy
Objectives

Assess opportunities and constraints in the political,
policy and health sectors structure

Assess capacity levels of supportive health systems,
health care facilities and health care personnel

Advocate policy and decision makers on evidence
based on MTP
14
Phase I:
Strategic Assessment & Advocacy

Generation of a working group (resource team) and
steering committee i.e. OB & Gyn experts from Siriraj,
Chula, Rama, RTCOG, Medical Association, Medical
Council, trainers/educators, decision makers from DoH,
representatives of WHO, PATH and Concept
Foundation.

Has formally and informally met with the Thai FDA
senior management team regarding MTP registration

Identified a local pharmaceutical distributor submitting of
the MTP product dossier for registration.
15
Phase I:
Strategic Assessment & Advocacy

Abortion and MTP remain sensitive issues. Therefore,
the project organized meetings with stakeholders
nationwide and Choice Network Members to consult on
making MTP available and accessible in Thailand. Also,
evidence based on MTP from multi nation experiences
had been presented in the meetings.

Develop an innovative project based on each health
facility setting and system.
16
MTP Registration:
Concerns and Needs from the
Thai FDA

Study needs to demonstrate measures to
assure that:

the product is distributed to the hospital and
prescribed by medical doctors

prescription MTP for the cases based on the law and
regulations

Collaboration from medical society to control the drug
in order to use based on the registration purpose as
17
an dedicated product for early MTP
Phase II:
Testing Intervention
Project Goal and Objectives

The goal is to prepare for the provision of quality and
accessible Medical Termination of Pregnancy (MTP)

The objectives:
 To develop a service delivery model for MTP
 To develop a strategy for scaling up the accessibility
and availability of MTP based on the findings
18
What is a supportive health
system?

Drugs for medical abortion can be provided by trained medical
doctors but, in the few cases of incomplete abortion, there is need for
access to referral services.

The health systems must ensure access to a provider trained in the
use of manual vacuum aspiration (MVA) and to blood transfusion
services.

The health system must be prepared to provide training of all levels
of health care providers and values clarification with providers.

Abortion remains a sensitive issue in our country and there is a
continuing need for advocacy with providers as well as the broader
society.
19
Phase II:
Testing Intervention (1)

Selection of health facilities to perform MTP

Adaptation of international MTP training curricula to the
needs of the Thai health service system

Adaptation of values clarification and options
counseling materials to the needs of the Thai health
service system

Training of health care providers at the selected study
sites in the provision of MTP services including values
clarification and options counseling.
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Phase II:
Testing Intervention (2)

After training, sites will be provided with combination
packages of Mifepristone and Misoprostol.

Development of a service protocol for MTP using
international guidelines

Development and testing of IEC materials for
providers and women

Development of a record-keeping system that can be
used for the study and provide insights for recordkeeping in routine service delivery
21
Phase II:
Testing Intervention (3)

Collection of data on service provision and outcomes
of the treatment including adverse events

Provision of MTP using practical guidelines

Interviewing of providers and women who have used
MTP on their opinion of MTP service

Assessment of how provision of MTP affects services
and costs
22
Phase II:
Testing Intervention (4)

Reporting of the outcomes of MTP including rates of
complete and incomplete termination of pregnancies,
failures and any complications

Review of the experience of MTP provision in a
participatory process with key stakeholders, for the
development of a strategy to make MTP more widely
availably and accessible in Thailand

Organization of a dissemination workshop

Preparation of scientific papers on the results
23
Phase II:
Testing Intervention
The Regimen for MTP to be used

The regimen for MTP used in the study consists of:
 1 tablet of 200 mg mifepristone taken orally
followed 24 hours later by;
 4 tablets of 200 μg misoprostol each (800 µg) is
administered vaginally (or sublingually).
 This protocol is based on the recommended MTP
regimen by WHO and the UK Royal College of
Obstetricians and Gynaecologists:
 This regimen can be used until 63 days of pregnancy
and has shown the highest efficacy of all clinically
proven regimens
 Follow up 14 days after the first visit
24
Medabon®
25
The Need for Information
PATH, Ipas and Concept have produced materials
for health care providers and programme managers who are
working to introduce Medabon®. They are also intended to
reach policy makers and the media and include:







Medical Abortion & Medabon®: Key Talking Points
Medabon®: Frequently Asked Questions (FAQ)
Medabon®: What You Need to Know (sample patient brochure)
Medabon®: Medical & Service Delivery Guidelines
Medabon®: Background for Providers of Emergency Care
Medabon®: A Framework for Introduction
Medical Abortion: Selected References
Can be downloaded from www.medabon.info
26
Phase III:
Scaling up & Expansion
Participatory Development of Scaling – up Strategy and
Dissemination



At the end of pilot project the Department of Health, steering
committee, the principal investigators and members of WHO,
PATH and Concept Foundation will develop a strategy for
expanding the availability and accessibility of MTP within
Thailand.
Strategy development will be based on review of findings and
study experience
Study results will be disseminated through a variety of
appropriate channels within Thailand e.g. a dissemination
workshop and scientific papers.
27
Conclusion
MTP: Key Information/Messages

Decision makers and regulatory authority:




Safety
Efficacy
Acceptability
Service providers and users:




Regimen
Timing
Route
Expected side effects
‘This option and will be prescribed under
existing law and regulation’
28
Conclusion
MTP: Advocacy Strategies

Face – to – face meeting with the decision makers and regulatory
authority

Set up working group by involvement of the relevant government
sectors, academic and NGO

Organize meeting regularly with the WG to ensure effective
collaboration and trouble shooting

Seminar/workshop for sharing solid evidence based model program

Avoid using of mass media campaign to prevent attack by the
opponents
29
Visit www.conceptfoundation.org
and www.medabon.info
30