Civil society groups in Indonesia have raised concerns over proposed amendments to the Patent Law, which they argue serve the interests of pharmaceutical companies at the expense of public health in Indonesia. The Make Medicines Affordable campaign, represented by the Indonesia AIDS Coalition (IAC), along with Indonesia for Global Justice (IGJ) and the Coalition for Affordable Medicines (Koalisi Obat Murah – KOM), have strongly criticized the Patent Bill that has undergone deliberations in the House of Representatives and was approved in a Plenary Meeting on September 30, 2024 — just one day before the transition to new legislative members on October 1, 2024. The bill introduces amendments to the Indonesian Patent Act (Law 13/2016), which civil society groups fear could undermine public health, especially for those in need of life-saving treatments.

The concern arises from provisions within the Patent Bill — particularly Article 4(f), Article 19(1), and Article 93 — that could lead to the extension of pharma companies’ patent monopolies and the weakening of the Government of Indonesia’s mechanisms to ensure prompt access to essential medicines. The patent law amendment, which covers 48 articles, has the potential to open the door for patent evergreening, according to Aditya Wardhana, IAC’s Executive Director. 

Opening the door for evergreening

Evergreening is a common strategy used by pharmaceutical companies to extend the life of patents by applying for secondary patents over different aspects of known medicine or over minor modifications of an old drug. Through this tactic, pharmaceutical companies can extend their patents, thereby continuing to profit from medicines or vaccines while preventing the manufacture of generic versions. 

“Article 4, point f, [in the Patent Bill] initially excluded the new use of an existing drug or new forms of known compounds without a significant increase in efficacy from being considered inventions …but in the new Patent Bill, this practice is permitted,” said Wardhana. 

The bill also introduces what are known as method patents through Article 19 (1), which is not known in the TRIPS Agreement and Indonesia isn’t obliged to implement.

Agung Prakoso, Program Coordinator for Health Issues at IGJ, said that the amendment serves the monopolistic interests of pharmaceutical companies and “represents a step backward …obstructing public access to medicines.” He urged that the provisions in Article 4, point f, be restored to their original form in Law 13/ 2016 concerning patents. 

Prakoso further stated that the government, notably the Directorate General of Intellectual Property (DGIP) of the Ministry of Law and Human Rights, should not focus on increasing the number of patents, karena hal itu bukan merupakan tanggung jawab dari DGIP dan justru kerap kali didorong oleh kepentingan bisnis yang dapat merugikan pasien.  

Prakoso further emphasized that the government, particularly the Directorate General of Intellectual Property (DGIP) under the Ministry of Law and Human Rights, should not prioritize increasing the number of patents, as that is not the responsibility of the DGIP and is often driven by business interests that could potentially harm patients.

Compulsory licensing for pharmaceuticals

Indonesian civil society groups further state that the bill also weakens mechanisms that the government can use to ensure public access to medicines. The bill removes Article 93, which concerns compulsory licensing for pharmaceutical products. Compulsory licensing serves as a safeguard against monopolistic practices by pharmaceutical companies. 

Civil society groups note numerous instances where pharmaceutical companies register patents simply to block others, including local manufacturers, from utilizing the technology, while at the same time failing to use these patents locally. For example, in some instances, pharmaceutical companies may not introduce the relevant medicine in the country at all, which then makes the drug completely inaccessible to people who need it. 

Aditya Wardhana, Executive Director of IAC, explained how patent blocking is a harmful practice. “If a pharma company engages in blocking, local producers can apply for a compulsory license on the patent. The compulsory license can also be used as a bargaining chip by the government, as patent-holding companies often grant voluntary licenses to prevent the issuance of a compulsory license,” he said. 

Patent bill likely to impose financial burden 

Civil society groups state that the Patent Bill will impose financial burdens on the government as monopolies on drugs intensify, affecting the healthcare budget. 

According to Agung Prakoso, Program Coordinator for Health Issues at IGJ, the strong vested interest by pharmaceutical companies in the patent bill amendments will lead to “an economic burden for the public and the government, which will have to bear the cost of expensive medicines in the national health insurance and/or national HIV and TB program.” 

Civil society groups have previously successfully advocated for increased access to essential medicines, which has provided significant cost savings to the government. For example, IAC’s success in pushing for generic competition led to lowering the price of HIV medication Tenofovir Lamivudine Efavirenz (TLE), by 48% from 2016 to 2020. This continues to save the Indonesian government US $8 million annually, while increasing the number of PLHIVs accessing the medication. 

The way forward

IAC launched a petition expressing the organization’s concern regarding the amendments proposed to the Indonesian Patent Act of 2016. The petition states the bill amendments will extend patent monopolies and further restrict access to affordable medicines, including newer, life-saving treatments, which may exacerbate Indonesia’s current public health challenges, such as its exceptionally high rate of tuberculosis. Indonesia is included in all three of the WHO’s lists of high-burden countries for TB, HIV-associated TB, and drug-resistant TB. The petition was signed by global civil society organizations, who backed Indonesian groups in decrying the proposed bill amendments. 

“The discussion of this Patent Bill has not only been conducted in a closed manner but also rushed, without meaningful participation from civil society groups. As a result, the Bill prioritizes the business interests of patent holders while neglecting patients’ rights,” said Prakoso. 

The signees request that the government reconsider the proposed changes and engage in a transparent, inclusive consultation process with all relevant stakeholders, especially affected communities, civil society organizations, relevant ministries, and public health experts.

Click here to read press releases by the Indonesia AIDS Coalition (IAC).