The ins and outs of regulatory reform in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare systems?
There are number of proposals of laws and regulations that may affect the pharmaceutical and medical devices industry in Indonesia, including:
Bill on Drugs and Food Supervision Law
The Bill has been submitted by the Indonesian government to the House of Representatives for deliberation. Once approved, the law will serve as an umbrella for regulations on supervision of foods and drugs, which covers a whole range of aspects in the foods and drugs industry, including: production; distribution; export and import; promotion and advertising; laboratory testing, recalls and disposal; liabilities; and criminal sanction.
Draft Regulation on E-Pharmacies
BPOM has published draft Regulation on the Supervision of Online Circulation of Drugs. The draft stipulates requirements for pharmacies in conducting sales of drugs through online platforms. The enactment of this regulation will provide certainty to the growing number of e-pharmacies.
Deregulation of Foreign Ownership Restriction in Pharma Industry
The government in the end of 2018 announced, as a part of its economic policy, that it would fully open certain business that are currently restricted for foreign investment, including pharma manufacturing activity. Currently, foreign ownership in pharma manufacturing activity is restricted to a maximum of 85%, while traditional drug manufacturing is fully closed for foreign investment. Based on the current precedent, a Presidential Regulation is required to amend the list of businesses that are restricted for foreign investment.
2. When they are likely to come into force?
It is not clear and difficult to predict on when the new law and regulations will come into effect.
The bill on Drugs and Food Supervision Law has been deliberated between the government and the House of Representatives since 2016 and there has been no indication on when the House will approve the bill. The House’s approval is required to enact the law.