The pharmaceutical sector in the country has experienced significant expansion in the last forty years. With an impressive track record of meeting 98 percent of the local demand for medicines valued at over $3 billion and exporting to more than 150 countries, including highly regulated markets such as the UK, the US, and the EU, the industry has emerged as a strategically crucial sector.
This growth has been primarily supported by a crucial provision of the World Trade Organization (WTO) known as the TRIPS (Trade-Related Aspects of Intellectual Property Rights) waiver for least developed countries (LDCs). This waiver, set to expire upon Bangladesh’s graduation from LDC status in 2026, has enabled local pharmaceutical companies to legally manufacture and sell patented drugs without authorization. This has ensured affordable healthcare and promoted industrial development. However, the removal of this waiver will present a significant challenge, necessitating prompt and strategic actions from policymakers and industry stakeholders.
The most immediate impact of this change will be the inability to reverse-engineer newly patented drugs, limiting the production of generic versions of these medicines. This could lead to increased reliance on imports and higher treatment costs. Furthermore, medicines patented post-2005 may encounter legal restrictions, jeopardizing a portion of the existing product lineup. To remain competitive, especially in regulated markets, pharmaceutical companies will need to heavily invest in research and development (R&D) to innovate new drugs, biosimilars, or complex generics, which demand substantial capital. Failure to adapt and invest promptly may result in the industry losing its competitive edge both domestically and internationally.
India’s experience with TRIPS post-2005 provides valuable insights. India revised its patent legislation strategically in 2005, with Section 3(d) of the Patents Act playing a crucial role in preventing “evergreening” practices. This safeguarded the generic industry by ensuring that only truly innovative drugs received patents. India also utilized compulsory licensing to maintain access to essential medicines while pharmaceutical companies focused on significant R&D investments and advanced manufacturing, transitioning from generic producers to global players.
To navigate this crucial phase, Bangladesh must devise a comprehensive strategy. Initial steps should focus on policy and legal readiness. The government needs to proactively amend the Patent and Designs Act to integrate TRIPS-compliant flexibilities, including provisions for compulsory licensing for generic drug production in the public interest. Embracing Bolar-type provisions would allow generic firms to conduct research and secure regulatory approval before a patent expires, facilitating immediate market entry upon expiration.
Shifting from imitation to innovation is imperative. The government should foster a supportive environment through tax incentives for R&D, research grants, and public-private collaborations to establish advanced pharmaceutical research hubs. Bangladeshi companies must elevate their quality standards to meet EU-GMP and US-FDA benchmarks for global competitiveness, necessitating government support in technology transfer and facility upgrades.
Collaboration with neighboring nations and regional alliances will be key to sharing manufacturing capabilities, technology, and enhancing bargaining power with multinational corporations. Policymakers should devise targeted subsidies, reimbursement mechanisms, or negotiation strategies for costly patented drugs to safeguard public health budgets.
With strategic planning, forward-thinking policymaking, and collective efforts to enhance innovation capabilities, the pharmaceutical sector can transform this impending challenge into an opportunity for sustainable and value-driven growth. Bangladesh can uphold its healthcare achievements and secure a competitive stance in the global pharmaceutical arena.