Jakarta, 26 January 2024

In response to the pandemic, every country and region is placing greater importance on preparedness, including by building vaccine development and production capacity. Efforts to provide protection for Indonesia’s large population make vaccines an important product in the health system and national resilience. The availability of sustainable and public health-based vaccine development and manufacture needs to be supported by a good ecosystem. These efforts must be carried out through a policy and regulatory framework that is oriented towards aspects of safety, quality and efficacy for public health.

In line with these efforts, the Ministry of Health together with the Duke-NUS Center of Regulatory Excellence (CoRE) collaborated with the Health Sector Group of the Asian Development Bank (ADB) to hold a meeting with domestic vaccine industry stakeholders to discuss vaccine regulations in Indonesia. Since 2023, Duke-NUS CoRE has collaborated with ADB to implement the ADB Vaccine Regulation Project with the aim of strengthening systems and analyzing the regulatory landscape in the Asia Pacific region, especially in developing countries such as Indonesia regarding handling pandemics/public health emergencies and treatment for other infectious diseases which also encourage access to innovative products, attract investment in production, and improve public health surveillance systems. The main purpose of this collaboration is to enable access to safe, efficacious and quality products through a range of scientific and regulatory activities deployed across the entire product life cycle. Countries covered in this collaborative project include Bangladesh, India, Indonesia, Korea and Singapore.

As a first step, Duke-NUS CoRE-ADB conveyed the aspects that will be analyzed in this project, including perspectives on the role of regulations on the vaccine ecosystem, national governance, regulatory capacity building, regulation of the vaccine life cycle, regional and global perspectives, as well as a roadmap for regulatory system strengthening. Also present in the event the Executive Director of the Center of Regulatory Excellence Duke-NUS Medical School, Professor John CW Lim and the Director of the Human and Social Development Office Sector Group Asian Development Bank Dr. Patrick L. Osewe to address remarks in the meeting.

Minister of Health Budi G. Sadikin appreciated and welcomed the collaboration between Duke-NUS CoRE and ADB. Minister of Health Budi conveyed the importance of strengthening the regulatory system in the Asia Pacific region, and hoped that this collaboration could have a positive impact in building a vaccine development ecosystem in the Asia Pacific, especially in Indonesia.

“We realize that the regulatory system plays an important role in providing faster services to the public. Reviewing, licensing, controlling and supervising pharmaceuticals and vaccines is a major challenge for national governance, in this case the national regulatory authority which is currently under government supervision faced with an increasing number of new products, complex quality problems and new technical problems arising from the rapid development of the pharmaceutical industry and advances in science. There is a need to strengthen national policies and regulatory authorities that are recognized worldwide,” said Minister Budi.

Furthermore, Director General for Pharmaceutical and Medical Devices L. Rizka Andalusia explained that the availability of sustainable vaccine production needs to be supported by a good ecosystem so that national vaccine independence and resilience can be achieved.

“The Economist states there are 5 (five) pillars that form the basis of a vaccine development ecosystem to achieve vaccine resilience, namely Research and Development; Manufacturing; Procurement, Pricing and Finance; Distribution, Logistic and Supply Chain Management, and User Acceptance and Uptake. All of this should be supported by robust and agile regulatory action”, said Director General Rizka.

In line with the intention to realize health resilience in the field of vaccines, the Ministry of Health launched the Vaccine Collaborating Center (VOLARE) initiative which aims to strengthen national and global collaboration to achieve vaccine independence and resilience and increase access to quality health products for the community. This initiative combines the potential and existing innovation ecosystem, involving the participation of various stakeholders to work more synergistically.

The VOLARE initiative launched by the Indonesian Minister of Health aims to master the latest vaccine technology, development capacity of national program vaccine and vaccine for pandemic response with 4 scopes, including:

1. Training hub or teaching factory: Facilitation, Technical assistance, Capacity building
2. Networking: Research and development laboratories/networks, Business Matching and partnerships, Business Matching Workshops, Financing Collaboration, Resource Sharing
3. Regulatory: Vaccine regulatory framework recommendations based on best practices
4. Bank Data

“I hope that this initiative can help us increase the research, production and delivery capacity of vaccines in Indonesia, which will bring more preparedness in handling the next pandemic, and have a significant impact on a better health system in Indonesia,” concluded the Minister.