Ex-post Evaluation

1. Outline of the Project

Country:

Indonesia

Project title:

The Fundamental Technology Transfer Project for Production of Live Attenuated Measles and Poliomyelitis Vaccines

Issue/Sector:

Cooperation Scheme:

Project-type Technical Cooperation

Division in Charge:

Medical Cooperation Department

Total Cost:

Period of Cooperation

(R/D): June 1989
September 1989 – August 1994

(Extension):
September 1994 – August 1996

Partner Country’s Implementing Organization:

Ministry of Health, PT. Bio Farma

Supporting Organization in Japan:

Research Foundation for Microbial Diseases of Osaka University, Japan Polio Research Institute

Related Cooperation:

Grant Aid: “Project for the Construction of the Facilities for Live Attenuated Oral Poliomyelitis and Measles Vaccine Production”, “Project for the Improvement of the Equipment for Live Attenuated Oral Poliomyelitis and Measles Vaccine”

1-1 Background of the Project

In keeping with the Expanded Program on Immunization (EPI) of the World Health Organization (WHO), the government of Indonesia raised the reduction of infant mortality rate and the mortality rate of children less than five years as the most important goal of the health sector as its fourth five-year plan. Recognizing the importance of preventing polio and measles, one of the main causes of infant and child mortality, the plan aimed to raise the vaccination rate for measles and poliomyelitis to 65%. However, Indonesia relied on foreign imports for both of these vaccines, and could not guarantee the supply to be available when needed. Additionally, the government expected the increase in costs involved in importing vaccines in the future, so they decided to manufacture the vaccines within an integrated domestic system. The government requested the Japanese government for Grant Aid cooperation and project-type technical cooperation for PT. Bio Farma (hereafter, “Bio Farma”).

1-2 Project Overview

In order to build up an independent supply system for the measles and poliomyelitis vaccines, the Project transferred technologies of basic manufacturing.

(1) Overall Goal
To enable Indonesia to manufacture all the measles and poliomyelitis vaccines it needs and to supply appropriate amounts to Indonesia when needed.

(2) Project Purpose
To develop fundamental capacity for the production and quality control of live attenuated measles and poliomyelitis vaccine in Indonesia through technology transfer to PT. Bio Farma.

(3) Outputs
1) Basic manufacturing technology is transferred.
2) Quality control technology is transferred.
3) Independent laboratory technology is transferred.

(4) Inputs

2. Evaluation Team

Members of Evaluation Team

Toni Mulya, PT. MISPRAPACIFIC CONSULINDO INTERNATIONAL

Period of Evaluation

January 29, 2003 – March 14, 2003

Type of Evaluation:

Ex-post Evaluation by Overseas Offices

3. Results of Evaluation

3-1 Summary of Evaluation Results

(1) Impact
Bio Farma is Indonesia’s only vaccine manufacturer, and the Project enabled the company to supply the full amount of vaccines needed for the government’s preventative vaccination program. As a result, the Indonesian government was able to implement an appropriate vaccination program at the right times for infants and children under five years old, based on the WHO’s EPI. The polio vaccination rate for infants under one year of age increased from 88.5% in 1995 to 90.3% in 1999, according to data from the Ministry of Health (43. 1% and 46. 1%, according to data from Susenas). The measles vaccination rate increased from 82.0% in 1995 to 88.3% in 1999 (59.1% and 67.6%, according to data from Susenas).

Bio Farma passed the WHO quality evaluation conducted in 1995 and 1999, and in 2000 met the criteria for Good Manufacturing Procedure (GMP) and the International Organization for Standardization (ISO). This demonstrated that Bio Farma’s quality meets international standards, and the company was able to begin exporting vaccines. Through UNICEF, in 1998 Bio Farma exported 4 million doses (one does/person) of poliomyelitis vaccine and 1. 2 million doses of measles vaccine to various countries in Asia. From 1999, Bio Farma expanded its export of both vaccines to Central South America and Africa as well as Asia.

Bio Farma is recognized as a training institute in the WHO’s Global Training Network, and accepts 8-12 trainees every year, sent regularly by WHO and UNICEF from all over Asia to receive third-country training from Bio Farma. One of those programs provided training on quality assurance for poliomyelitis and measles vaccine in the Global Training Network in 1999. It trained 11 trainees from eight countries under the sponsorship of Indonesia’s Ministry of Health, JICA and WHO.

(2) Sustainability
By the time the Project had finished, Bio Farma was able to produce the annual 7.5 million doses of measles vaccines needed for the approximately 5 million newborns in Indonesia. The year after the Project finished (1995) the company was able to produce the 20 million doses (three vaccinations needed per person) of poliomyelitis vaccine needed in Indonesia. At the time of this evaluation, Indonesia had a completely self-sufficient system, able to produce 35 million doses of measles vaccine and 140 million doses of poliomyelitis vaccine.

At Bio Farma, the counterparts carried out a secondary technical transfer for those staff members and new hires that had not been part of the previous technology transfer. As a result of these independent efforts, Bio Farma has sustained a technical level at which they are able to manufacture specific pathogen free (SPF) eggs and concentrated solution; perform quality control tests and SPF monitoring in its manufacturing of measles vaccines; and raise monkeys under asepsis in its manufacturing of poliomyelitis vaccine. Quality management is used in all experiments, including local procurement of experiment materials, ensuring that Bio Farma provides vaccines that meet the WHO manufacturing standards. Bio Farma follows the Standard Operating Practices (SOPs) in vaccine manufacturing and quality management, and keeps work records (worksheets) and these practices are revised as circumstances dictate.

The inspection and manufacturing equipment provided in the Grant Aid cooperation meet the GMP, and Bio Farma has an in-house system for managing and maintaining the equipment. The budget allocated is adequate. Accordingly, all the equipments are maintained and managed properly from the preparation to the manufacturing process, and are operated efficiently. It takes 3-6 months to obtain spare parts for the foreign equipment due to complex and bureaucratic customs procedures.

To strengthen management, in 1997 Bio Farma became an independently operating biological product company, shifting from its previous status of a public company. The number of employees increased from 104 when the Project finished, to 643 by the time the evaluation was conducted. Bio Farma has a tie-up with a Danish pharmaceutical company, a pharmaceutical management service company in Pakistan and a pharmaceutical company in the Philippines. Its activities are broad ranging and serve to maintain and expand its export channels. Domestic sales were about 62 billion Rp. in 1995, but increased to about 362 billion Rp. in 2000, while export revenues increased from 1 billion Rp. in 1998 to 128 billion Rp. in 2000.

Lastly, Bio Farma’s annual budget for recurring expenses and development expenses are both allocated by the Indonesian government. A report prepared by the government’s auditors shows that there were no problems with the cash flow, its enterprises and other business.

3-2 Factors that Promoted the Realization of Effects

(1) Factors Concerning the Planning
N/A

(2) Factors Concerning the Implementation Process
1) The fact that counterparts learned the basic technology for integrated production from the raw material for the virus vaccine to the final product in the first stage of the product, and that passing the WHO evaluations gave the counterparts confidence and a source of pride, helped the project goals to be achieved.
2) Third-country training is implemented every year, contributing to neighboring countries while also enabling continued technical follow-ups through experts dispatched as teachers, thus helping to ensure the maintenance of the internal technology level.

3-3 Factors that Impeded the Realization of Effects

(1) Factors Concerning the Planning
N/A

(2) Factors Concerning the Implementation Process
N/A

3-4 Conclusion

The Project had a significant impact. Before the Project was implemented, Indonesia had to rely on vaccine manufacturers in developed countries for its supply of poliomyelitis and measles vaccines, but as of this evaluation, Indonesia had a completely self-sufficient supply system and was also able to export vaccines to other countries in Asia, Africa and South America through UNICEF. As a result, Indonesia is now able to contribute to other countries’ efforts to combat infectious diseases. Bio Farma passed WHO’s quality evaluation and met GMP and ISO standards, and sustainability in organizational skills is high.

3-5 Recommendations

The facilities and equipments are operated without problems, but since the equipments are about ten years old now, Bio Farma will need to develop a counter plan in case the equipments break down and halt manufacturing, as well as a plan to update the equipments.

3-6 Lessons Learned

N/A

3-7 Follow-up Situation

N/A