Malaysia is facing a growing healthcare affordability crisis. Rising out-of-pocket (OOP) expenditure, coupled with the increasing prevalence of non-communicable diseases (NCDs) such as cancer, diabetes, and cardiovascular diseases, is placing a significant financial strain on consumers. The proposed Patent Linkage Guidelines risk delaying access to affordable generic medicines, thereby worsening medicine affordability and consumer welfare.

WHY THIS MATTERS TO CONSUMERS

Medicine prices in Malaysia have consistently increased over time, with no clear evidence of price reductions. At the same time, capacity constraints in public healthcare are pushing more consumers toward higher-cost private care. As a result, many households especially those in the B40 and M40 groups are facing significant out-of-pocket expenses. Additionally, the lack of timely availability of generic alternatives means that high prices persist longer, limiting access to necessary treatment. Higher prices lead to delayed or skipped treatment, as many consumers are unable to afford the medicines they need. This, in turn, contributes to financial hardship, especially for lower- and middle-income households. Ultimately, these challenges result in poorer health outcomes due to lack of timely and adequate care.

EVIDENCE: IMPACT OF GENERIC MEDICINES

Evidence shows that generic competition significantly reduces medicine costs. For example, the price of Combivir for HIV treatment dropped by about 81% after generic versions entered the market. Similarly, Nilotinib for cancer costs between RM55 and RM70 per tablet in Malaysia, while a generic version in India is priced at around RM3 per tablet representing more than an 18-fold difference. In the case of Lopinavir/Ritonavir, generic versions are also substantially cheaper than the original branded products. These examples clearly demonstrate that timely entry of generic medicines is critical to improving affordability.

KEY RISKS OF THE PROPOSED GUIDELINES

The proposed guidelines pose several key risks to consumers. Firstly, they may delay access to affordable medicines due to regulatory barriers such as notification periods and automatic suspension, which in turn slow the entry of generic medicines into the market. Secondly, they are likely to increase medicine prices by extending monopolies through patent linkage and reducing competition within the pharmaceutical sector. In addition, the guidelines may promote patent evergreening, where secondary patents such as those for new formulations or dosage forms are used to prolong exclusivity despite offering limited or no additional therapeutic benefit to consumers. Finally, these measures could undermine government efforts to regulate medicine prices, as existing Ministry of Health initiatives on price transparency already face resistance, including a court injunction by a group of general practitioners, and patent linkage would further weaken efforts to control rising medicine costs.

WHO IS MOST AFFECTED

Those most affected include B40 and M40 households, who are particularly vulnerable to rising healthcare costs. Elderly individuals and patients with chronic illnesses are also heavily impacted due to their ongoing need for medication and treatment. In addition, consumers without comprehensive insurance coverage face greater financial strain when accessing healthcare services. Rural populations, who often have limited access to public healthcare facilities, are likewise disproportionately affected.

POLICY RECOMMENDATIONS

The government should first withdraw the proposed guidelines, as they exceed Malaysia’s obligations under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) and risk harming consumers. It is also important to safeguard generic competition by ensuring the timely entry of generic medicines and preserving TRIPS flexibilities, such as the Bolar provision. In addition, price regulation should be strengthened by implementing greater transparency in medicine pricing, regulating excessive pricing in the private healthcare sector, and enhancing enforcement mechanisms. Finally, a more consumer-centric approach should be adopted by including civil society and consumer groups in policymaking, assessing the impact on out-of-pocket expenditure, and aligning policies with Universal Health Coverage goals. At a time of rising healthcare costs and disease burden, Malaysia cannot afford policies that delay access to affordable medicines. Patent linkage risks increasing prices, limiting access, and worsening financial hardship for consumers.

PROF EMERITUS DATUK DR MARIMUTHU NADASON

President