National Drug Resilience within the Legal Framework: An Analysis of Regulation and Implementation of Law Number 17 of 2023

  • Raymond R. Tjandrawinata Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia
  • Ina Heliany IBLAM University, Jakarta, Indonesia
Keywords: National Drug Resilience, Pharmaceutical Regulation, Health Law, Legal Regulation, Policy Implementation.

Abstract

National drug resilience is a fundamental pillar for achieving health independence and sovereignty in Indonesia. Strengthening this resilience has become a strategic mandate outlined in Law No. 17 of 2023 on Health, emphasizing the critical role of producing pharmaceuticals, vaccines, medical devices, and natural-based medicines to support the national healthcare system. This article examines the regulatory aspects, implementation, and challenges of realizing national drug resilience through a normative juridical approach. The integration of progressive legal theory, utilitarianism, and the welfare state model is the primary analytical framework for evaluating policy effectiveness. This approach is reinforced by a human rights perspective, particularly the right to health as enshrined in Article 28H of the 1945 Constitution and international frameworks such as ICESCR. The findings highlight that synergy among adaptive legal policies, strengthening biodiversity-based research and innovation, and supporting local industries are key to reducing dependence on imported materials and enhancing global competitiveness. This article contributes to local legal literature by integrating legal theory with human rights frameworks in the context of pharmaceutical policy while offering practical recommendations for supporting sustainable drug resilience policies. It provides a theoretical and strategic foundation for bolstering the national healthcare system through an inclusive and progressive legal approach.

References

Algorri, M., Abernathy, M. J., Cauchon, N. S., Christian, T. R., Frankenfeld Lamm, C., & Moore, C. M. V. (2022). Re-envisioning pharmaceutical manufacturing: Increasing agility for global patient access. Journal of Pharmaceutical Sciences, 111(3), 593–607.

Badan POM. (2023). Laporan tahunan Badan Pengawas Obat dan Makanan 2023. Jakarta: Badan Pengawas Obat dan Makanan.

Cane, P., & Kritzer, H. M. (Eds.). (2010). Chapter 38: Qualitative approaches to empirical legal research. In Oxford Handbook of Empirical Legal Research (pp. 927–950). Oxford University Press.

Fakrulloh, Z. A., & Lubna. (2023). Legal review of hospital responsibility for medical actions carried out by doctors. Jurnal Indonesia Sosial Sains, 4(12), 1237-1247.

Gamalliel, N., & Fuady, A. (2024). Indonesia's new health law: Lessons for democratic health governance and legislation. The Lancet Regional Health-Southeast Asia, 23, Article 100390.

Gough, I. (1978). Theories of the welfare state: A critique. International Journal of Health Services, 8(1), 27–40.

Government of India, Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals. (2023, December 5). Potential of phytopharmaceutical products in the country: Rajya Sabha starred question No. 27.

Guennif, S., & Ramani, S. V. (2010). Catching up in pharmaceuticals: A comparative study of India and Brazil. HAL Open Science.

Herlindah, H., & Darmawan, Y. (2022). Development legal theory and progressive legal theory: A review in Indonesia’s contemporary legal reform. Peradaban Journal of Law and Society, 1(1), 14–27.

Hermawan, E., Hadiyati, N. A., Adiarso, A., Setiyadi, E. D., Zunuraen, S., Hidayat, D., Wahyudi, A., & Ru’yi, H. A. (2023). Challenges and policy supports in Indonesian pharmaceutical raw materials industry. Indonesian Journal of Health Administration (Jurnal Administrasi Kesehatan Indonesia), 11(2), 196–211.

Huda, N., Adha, I. A. F., & Ashfina, S. R. S. (2020). The role of research and development expenditure on GDP growth: Selected cases of ASEAN 5 plus 4 Asia major countries. INDEF Working Paper No. 5/2020.

Huda, N., Pawennei, I., Ratri, A., & Taylor, V. L. (2020). Making Indonesia’s research and development better: Stakeholder ideas and international best practices. Bappenas and Knowledge Sector Initiative (KSI).

Ivus, O., Jose, M., & Sharma, R. (2021). R&D tax credit and innovation: Evidence from private firms in India. Research Policy, 50(1), 104128.

Kaur, A., & Chaturvedi, R. (2015). Compulsory licensing of drugs and pharmaceuticals: Issues and dilemma. Journal of Intellectual Property Rights, 20, 279–287.

Lubis, R. F., Siregar, R. S., Siregar, A. F., & Mujahiddin, S. S. (2023). The industrialization of medicinal plants in Indonesia. African Journal of Food, Agriculture, Nutrition and Development, 23(5), 23285-23304.

Mahendradhata, Y., Andayani, N. L. P. E. P., & Marthias, T. (2021). COVID-19 health system response monitor: Republic of Indonesia. WHO World Health Organization Regional Office for South-East Asia.

Marseille, E., & Kahn, J. G. (2019). Utilitarianism and the ethical foundations of cost-effectiveness analysis in resource allocation for global health. Philosophy, Ethics, and Humanities in Medicine, 14(5).

Muis, L. S., Jened, R., Barizah, N., & Tjwan, G. C. (2023). State responsibility for access and availability of patented drugs for public health. Yuridika, 38(2), 219–242.

Parmaksiz, K., Bal, R., van de Bovenkamp, H., & et al. (2023). From promise to practice: A guide to developing pooled procurement mechanisms for medicines and vaccines. Journal of Pharmaceutical Policy and Practice, 16, 73.

Perehudoff, K., Mara, K., & 't Hoen, E. (2021). What is the evidence on legal measures to improve the transparency of markets for medicines, vaccines and other health products (World Health Assembly resolution WHA72.8)? Health Evidence Network synthesis report 73. World Health Organization.

Permata Bank. (2024, June). Monthly industry report: Pharmaceutical industry. Retrieved from: https://www.permatabank.com/sites/default/files/2024-08/Monthly%20Industry%20Report%20-%20Pharmaceutical%20Industry%20-%20Jun%202024.pdf.

Pradana, Y., & Arijanto, A. (2024). Implementation of strategic human resource management in improving the quality of education. Indonesian Journal of Business Analytics, 4(2), 483–502.

Rahardjo, S. (2002). Polisi Sipil dalam Perubahan Sosial di Indonesia. Kompas.

Rina, R. (2020, April 27). Harga Bahan Baku Obat Melonjak 30% di Tengah Pandemi Corona. CNBC Indonesia.

Riyanto, B. (2020). National Law Development in the New Normal Era. Indonesian Law Journal, 13(2), 87–107.

Singh, K., Nainwal, N., & Chitme, H. R. (2024). A review on recent advancements in pharmaceutical technology transfer of tablets from an Indian perspective. Annales Pharmaceutiques Françaises. Advance online publication. https://doi.org/10.1016/j.pharma.2024.07.003.

Suroso, J. T., Durahman, D., & Budi, I. (2024). The simplification of licensing procedure in job creation law: The effectiveness to attract foreign investors. Cogent Social Sciences, 10(1), 2414509.

The Prakarsa (2020). Towards sustainable tax policies in ASEAN: A case for progressive taxation. Retrieved from: https://repository.theprakarsa.org/media/publications/314887-towards-sustainable-tax-policies-in-asea-83d96a80.pdf.

Tijaja, J., & Faisal, M. (2014). Industrial policy in Indonesia: A global value chain perspective (ADB Economics Working Paper Series No. 411). Asian Development Bank.

Tjandrawinata, R. R. (2020). Konsep Obat Modern Asli Indonesia (OMAI) dalam penggunaannya di fasilitas kesehatan formal: Working paper Mei 2020. https://doi.org/10.6084/m9.figshare.12367331

Widowati, I. G. A. R., & Zamroni, M. (2023). Indonesia facing challenges of pharmaceutical care implementation in community pharmacies: A legal perspective. Jurnal Hukum Prasada, 10(2), 69–79.

World Health Organization. (2010). Monitoring the building blocks of health systems: A handbook of indicators and their measurement strategies. World Health Organization.

Published
2024-12-16
How to Cite
Tjandrawinata, R. R., & Heliany, I. (2024). National Drug Resilience within the Legal Framework: An Analysis of Regulation and Implementation of Law Number 17 of 2023. International Journal of Science and Society, 6(4), 378-394. https://doi.org/10.54783/ijsoc.v6i4.1339