Examining the growing structural gap between TRIPS’ public-health objectives and the contemporary political economy of pharmaceuticals, Tanya Verma in her entry for the SpicyIP-jhana Blogpost Writing Competition, argues that tariff regimes and expanding trade-secret protections together create a “double bind” that constrains the Global South’s ability to both import and manufacture medicines. Tanya is a fifth year student at Dr. Ram Manohar Lohiya National Law University, Lucknow.
Tariff-Secrecy Double Bind: How Global Trade Rules Undermine Pharmaceutical Access In The Global South
By Tanya Verma
Understanding that global trade liberalisation would facilitate technological transfer and ensure stable, fair markets for essential goods, developing nations agreed to strict enforcement of IP norms when TRIPs was concluded during the Uruguay Round. The Doha Declaration reaffirmed this understanding and made it clear that IP laws cannot obstruct access to medications. After more than two decades since the inception of the WTO, global supply chains have become more brittle, technology transfer is still very limited, and growing protectionism in the Global North has increased obstacles for ensuring access to essential medicines. Resultingly, a stringent framework of trade-secret protections and regulatory data exclusivity has made it even more difficult for developing countries to build independent manufacturing capacity.
What’s left is a kind of structural difference between TRIPs’ original focus on public health and the political economy of pharmaceuticals today. While a number of factors affect pharmaceutical access in the Global South, this analysis focuses on two trends, as they are externally imposed and legally entrenched through trade instruments, thus isolating them from domestic policy correction. One, the imposition of tariffs raising the cost of “Active Pharmaceutical Ingredients” (APIs) and finished formulations; and second, a globally expanding exclusionary secrecy regime preventing diffusion of technical manufacturing know-how. When combined, these mechanisms create a modern “double bind” for the Global South, restricting its capacity to both import and produce. The examination is thus not of exhaustive causes, but of most determinative constraints. This piece proceeds by analysing the aforementioned structural impasse using three analytical lenses: first, taking into account current tariff policy trends; second, outlining the broad development of trade-secret jurisprudence; and third, investigating observable constraints of mandatory licensing.
Tariff Protectionism and Differential Impact on Pharmaceutical Access
Between 2018 and 2024, several economies in the Global North, most notably the United States, imposed multiple rounds of tariffs on medical equipment, pharmaceutical inputs, and precursor chemicals that came from China, the world’s biggest supplier of APIs. Despite being marketed as attempts to improve supply-chain resilience, these actions come with a substantial distributive impact. These increases either eliminate profitability or force a price increase in markets where generic drugs are sold on extremely thin margins. Effects spread swiftly. During tariff peaks, mid-tier manufacturers in Bangladesh, Kenya, and India reported 30-40% decreases in export margins for frequently tendered generics, akin to the African pool, which increased by 25-30% costs.
These results highlight a straightforward limitation: negative spill-over effects of tariff increases in the Global North have evident negative effects on the Global South. Increase in tariffs on pharmaceutical inputs by major importing countries leads to an increase in global prices of APIs and finished formulations in their supply chains, even in markets that are not directly affected by the tariff. To low-margin manufacturers and import-dependent health systems in developing countries, these price shocks are unbearable without a subsidy or fiscal buffer, leading to increased prices on medicines, slowed procurement, or decreased supply. Though the application of tariffs is officially made non-discriminatory, the actual impact is asymmetrical. Thus, abrupt changes in tariff policy deter any long-term industrial planning and government procurement strategies and make it even more dependent on the outside supply.
Trade Secrets and Withholding of Pharmaceutical Know-How
A strong secrecy regime governing pharmaceutical data and manufacturing know-how has been consolidated over the past 20 years in tandem with these tariff changes. Although Article 39.3 binds WTO Members not to disclose regulatory information to unfair commercial use, most bilateral and plurilateral trade agreements, such as Trans-Pacific Partnership (TPP) and multiple successors, have mandated a lengthy data exclusivity term in effect banning any reliance on undisclosed regulatory information of originators to seek approval of generic and biosimilar products. These commitments extend beyond TRIPS and put in place long-lasting non-patient entry barriers, and protection under investment treaties goes further to shield regulatory decisions to transparency.
Important aspects of production for complex biologics and many sophisticated small molecule products are shielded by layers of trade secrecy and regulatory data exclusivity rather than patents. Treaty practice has strengthened this system. Original TPP text prescribed extended data-exclusivity periods for biologics; although these provisions were moderated in Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), the underlying model shaped subsequent agreements such as the United States-Mexico-Canada Agreement (USMCA), which mandates ten years of biologics data protection. Simultaneously, regulators looking to reveal dossier material now face legal risks due to the inclusion of trade-secret protections in investment agreements. Even in situations where increased openness would be justified by public health considerations, concerns that increased regulatory transparency could lead to investor-state claims have resulted in more restrictive disclosure practices. Secrecy regime’s structural effects are now obvious. Compulsory licensing (CL) would not allow domestic production of many biologics or vaccines because essential tacit knowledge remained unavailable. Many manufacturing initiatives failed during the COVID-19 pandemic because validated industrial processes could not be reconstructed without the originator’s cooperation, but patents could be circumvented. Also, patent disclosure does not apply to fermentation pathways for biosimilars, continuous-flow synthesis methods for new cancer medications, or specialised excipient data for long-acting injectables. Essentially, formal legal entitlements granted by TRIPs do not translate into operational production capacity where secrecy controls essential technical parameters.
CL: Evidence of Effectiveness and Structural Limits
Third, two distinct dimensions should be considered when determining the limits of mandatory licensing. In situations where manufacturing capacity already existed or where imports could be sourced from established producers, CLs have produced measurable improvements in public health. Thailand’s government-issued antiretroviral licenses from 2006-2007 reduced procurement costs and increased treatment coverage. Similarly, prices were lowered by more than 97% against originator prices post India’s 2012 sorafenib licence. CLs were successful in these situations. However, CLs are substantially less effective where tacit knowledge constitutes a primary barrier. A mandatory licence grants legal authorisation but not practical capability for biologics and more recent pharmaceutical classes. Essential inputs like cell lines, reference standards, , and verified bioprocess parameters are still unavailable to manufacturers. Resultingly, actual production timelines often span years, if at all, even in cases where CLs are legally granted. This dynamic explains why states are reluctant to deploy instruments for technologies other than small-molecule drugs. Meanwhile, technological complexity is not the only reason why mandatory licensing is not widely used. State behaviour is also influenced by political pressure, threats of retaliation, inability to develop regulatory capacity, and reliance on foreign investment. Thus, in situations where a working supply base already exists, the CL mechanism can produce price reductions but is unable to facilitate technological advancement. CLs are structurally unable to address the structural asymmetry that the Global South faces in an innovation system where trade secrets, not patents, increasingly determine competitive advantage.
TWAIL Perspective: Tariff Power and Knowledge Power as Modes of Structural Subordination
Through the TWAIL lens, the combined impact of tariffs and secrecy is revealed as a mechanism of structural subordination ingrained in the international political order. While knowledge regimes strengthen technological control within originator jurisdictions, tariffs shift the financial burden of global supply-chain adjustment onto import-dependent states. Together, these tools maintain a hierarchy in the world’s pharmaceutical production. This hierarchy is a product of carefully planned legal and economic architecture rather than an organic result of innovation cycles. The international system sustains dependency patterns typical of previous phases of economic globalisation by allowing trade-secret expansion without significant countervailing transparency obligations and by allowing tariff regimes that disproportionately burden low-margin producers. There is a growing gap between the original guarantees found in the Doha Declaration and TRIPs, and the current regulatory framework further demonstrates this change.
Towards a Viable Framework for Pharmaceutical Sovereignty
If the double bind is structural, the response must likewise be systemic. A practical framework, therefore, emerges from three evidence-based interventions.
First, it is administratively possible to achieve regulatory transparency. Clinical data demonstrates that graduated disclosure is feasible without compromising commercially sensitive information. Comparable programs could enable regulators, researchers, and manufacturers in the Global South to access critical stability data, comparability protocols, and reference standards required for the safe production of biosimilars on a global scale. Broader advantages of managed disclosure are demonstrated by early assessments of the EMA program, which show improvements in secondary analysis, a stronger position in pricing negotiations, and more stringent regulatory scrutiny.
Second pillar is of regional manufacturing hubs. Africa’s new networked bioproduction projects and the WHO’s mRNA Technology Transfer Program show that coordinated regional investment can convert shared repository support and technology training into scalable manufacturing capability. Even though Africa currently makes up a very small portion of the world’s vaccine production, feasibility studies show that unified regulatory strengthening and pooled capital investment can significantly increase that proportion within ten to fifteen years. Additionally, by facilitating collective bargaining for technology transfer, these hubs produce much greater negotiating leverage than dispersed national initiatives.
Treaty design is the last pillar. Exclusivity standards are neither fixed nor irreversible, as evidenced by the partial retrenchment of biologics data exclusivity in CPTPP after US withdrawal. Trade and investment agreements that include emergency disclosure provisions, proportionality protections for investor claims, and public-interest exceptions would allow states to promote transparency and public health regulation without experiencing the regulatory chill typically associated with investor-state dispute settlement. These clauses are already present in several treaty models; their methodical implementation would aid in the restoration of regulatory space. When taken as a whole, these components offer a workable way out of the tariff-secrecy bind.
Conclusion
The landscape of pharmaceutical access has drastically changed as a result of the convergence of tariff protectionism and increased secrecy protections. Higher import prices, decreased export competitiveness, and limited access to knowledge required for independent production are now issues facing the Global South. Therefore, the discrepancy between the Doha Declaration’s focus on public health and the current structure of the global trade regime is not coincidental; rather, it is a reflection of structural incentives that prioritise national industrial strategy over equitable access. Disparities in pharmaceutical capacity will widen even more if this trend continues. However, treaty-level protections, regionally coordinated manufacturing strategies, and transparent regulatory frameworks offer workable alternatives. The lack of political will to align international trade and IP regulations with commitments at the heart of TRIPs and the Doha Declaration is an obstacle here, not a lack of practical models.
