Over past couple of months, the investigation led by the Indonesian police into the distribution of fake vaccines for children been thrust into the media spotlight. Most disturbingly of all, the police eventually announced that the distribution of fake vaccines dates back all the way to 2003 and involves hospitals, health centers (puskesmas) and other important medical facilities. Data from the Food and Drugs Supervisory Agency (Badan Pengawas Obat dan Makanan – “BPOM”) shows that a total of 37 health facilities across nine areas [i.e. Jakarta, Banten, West Java, Central Java, Yogyakarta, East Java, Medan (North Sumatra), Padang (West Sumatra) and Aceh] have been affected by the scandal and have taken receipt of vaccines from unofficial sources.[1]The current state of play is that the ongoing investigation has revealed that at least 12 types of vaccine are commonly counterfeited, specifically Engerix B, Pediacel, Euvax B, Tripacel, Tyberculin PPDRT, Penta-Bio, Tetanus vaccines, Measles vaccines, Hepatitis B vaccines, Polio bOPV vaccines, BCG vaccines and Harvix vaccines.
 
The production of vaccines, from the time of their manufacture until they are eventually distributed to the general public, is generally considered to be a lengthy process, and currently there are no definite answers regarding which part of the distribution chain is responsible for the introduction of the illegal fake vaccines. What is certain however is that this scandal has caused nationwide concern and has brought widespread condemnation, and people are starting to blame the government as well as the BPOM for a lack of supervision and control. This week’s Indonesian Law Digest (ILD) will be looking at issues specifically relating to the legitimate distribution and certification of vaccines according to Indonesia’s various laws and regulations. Our analysis will confine itself to the following topics: