Pharmaceutical companies advocate for prompt approval of approximately 1,000 new drug treatments
Bangladesh is facing a critical deadline as it approaches its graduation from the Least Developed Country (LDC) category in November 2026. The transition will bring about significant changes, particularly in terms of drug regulation and patent compliance, due to the implementation of the World Trade Organisation's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.
The registration of over 1,000 new medicines, currently pending with the Directorate General of Drug Administration (DGDA), is urgently needed to avoid potential financial implications within the next three and a half months. Failure to register these drugs could result in high royalty payments and expensive patent procedures, as unregistered drugs will be subject to patent protection and royalty costs post-graduation.
The TRIPS agreement, which will take full effect after November 2025, will require compliance with global patent rules, potentially increasing costs for medicine imports and domestic pharmaceutical production. This shift could raise healthcare costs and impact affordability, as Bangladesh is expected to lose the TRIPS waiver that currently allows certain flexibilities, including easier access to generic medicines.
The Active Pharmaceutical Ingredient (API) Industrial Park in Bangladesh, launched in 2007, has yet to fully take off due to gas shortages and infrastructure limitations. Despite policy amendments and several companies setting up factories, only four out of 27 companies allocated plots have started operations in the last 15 years. Some companies are considering consolidating unused plots to initiate joint ventures, a move that could potentially boost the park's development.
However, the biggest issue in the API Industrial Park is the absence of gas supply. Companies allocated plots in 2017 have been exploring technological partnerships with countries like India and China, but Chinese experts found the plot sizes too small and the park lacking critical facilities.
A views exchange meeting, jointly organised by the Bangladesh Association of Pharmaceutical Industries (BAPI) and the Bangladesh Health Reporters Forum, highlighted the urgency of the situation. Speakers at the meeting included Md Zakir Hossain, M Mosaddek Hossain, Kaiser Kabir, Major (Retd) Mohammad Mostafizur Rahman, and Muhammad Halimuzzaman.
Kabir, the CEO and MD of Renata, urged that if Bangladesh's LDC graduation cannot be postponed, the government should at least seek a three- to four-year transition period similar to other countries. He stated that Bangladesh shows little interest in negotiations to defer its LDC transition, unlike Cambodia and Senegal. Bapi is calling for the registration of all pending drugs before November 2025 to prevent patent-related complications and cost increases.
If Bangladesh manages to register these medicines before its LDC graduation, it could mitigate the financial burden and ensure continued access to affordable medicines. The government's preparation for a smooth transition is crucial to navigate the emerging challenges and safeguard the healthcare sector.
- The science community in Bangladesh should collaborate with the government to expedite the registration of the over 1,000 pending medicines, as the TRIPS agreement implementation in 2025 could drastically increase costs for medicine imports and production, potentially impacting health-and-wellness and general-news.
- The government's deliberation on a possible three- to four-year transition period, as suggested by Kabir, could be beneficial for the business sector, allowing more time for the pharmaceutical industry to adjust to the new patent rules and avoid sudden financial implications.
- Facing these critical changes in policy-and-legislation and politics, the Bangladesh Association of Pharmaceutical Industries (BAPI) is advocating for the registration of all pending drugs and is urging the government to actively engage in negotiations for a deferred LDC transition, similar to Cambodia and Senegal, to ensure continued affordability and accessibility in the health-and-wellness sector.
