Jakarta, 20 September 2023.

The Directorate of Pharmaceuticals and Medical Devices held a Public Hearing on the Draft Derivative Regulation of Health Law No. 17 of 2023 in series. On the 2nd day of the Public Hearing agenda, the topic of Pharmaceutical and Medical Device Resilience was discussed.

This hybrid activity invited stakeholders from various sectors, including BPOM, BRIN, Ministries/Institutions, LKPP, BPJS Kesehatan, Pharmaceutical and Medical Device Industries, Professional Associations and Organizations, Universities, Academics, Health Offices and Expert Practitioners.

Secretary of the Directorate General of Pharmaceuticals and Medical Devices, Dita Novianti at the opening said that Law Number 17 of 2023 must be followed by derivative regulations in stages, one of which is a Government Regulation. In its preparation, public participation was carried out to accommodate input from all stakeholders or from all interested parties.

"I hope that offline and online can submit input directly or through the prepared links, namely the healthy participation web or social media," said Dita.

Director of Pharmaceutical and Medical Device Resilience, Roy Himawan through his presentation said that this arrangement was motivated by the conditions faced together both before the pandemic and during the pandemic. 

"We have the potential and opportunity to move forward and now we are making leapfrog changes and ensuring that everything is done responsibly. Some of the points that we experienced as experiences before and during the pandemic where we were dependent on imports, limited in the provision of innovative drugs and hindered by the production of the latest products in the country, are a concern to bring health to a more resilient condition," said Himawan.

Himawan further said that in Law Number 17 of 2023 there is a separate chapter on Pharmaceuticals, Medical Devices and Health Supplies, where the draft RPP section 4 regulates the Acceleration of Development and Resilience of the Pharmaceutical Supplies and Medical Devices Industry which is the mandate of Health Law Article 330, and section 5 regarding System Standards, Management of Pharmaceutical Supplies, Medical Devices, and Other Health Supplies in Emergency Conditions, Disasters, Outbreaks, or Outbreaks which is the mandate of Health Law Article 333.

The first pillar of achieving Pharmaceutical and Medical Device Resilience, namely Accelerating the Development and Resilience of the Pharmaceutical and Medical Device Industry, aims to build national health independence and progress. Efforts are made through increasing research and development of pharmaceutical preparations and medical devices and strengthening the governance of the supply chain of pharmaceutical preparations and integrated medical devices.

Meanwhile, the second pillar of System Standards, Management of Pharmaceutical Supplies, Medical Devices, and Other Health Supplies in Emergency Conditions, Disasters, Outbreaks, or Outbreaks aims to maintain the availability of pharmaceutical preparations, medical devices, and other health supplies that are safe, efficacious/beneficial, and of high quality. The efforts made are realized through source mapping and meeting needs. 

"It is time for us to develop a national minimum stock of a particular commodity or product for disaster preparedness," said Himawan. One of the forum participants, Engko Sosialine, said "Agree with the elaborated National Committee, it should be reduced to the Presidential Regulation so that Komnas has considerable authority in supervising the acceleration of the development and resilience of the domestic pharmaceutical industry. Komnas does not only involve K / L elements, but involves private elements such as the Pharmaceutical GP, and others," said Engko.