Santiago, June 18, 2026 — Thera Health Policy & Access was invited to participate in the Fourth Adjunct meeting convened by Chile’s Undersecretariat of International Economic Relations (SUBREI), contributing to a high-level technical discussion on the ongoing negotiations of the Comprehensive Economic Partnership Agreement (CEPA) between Chile and India, with a particular focus on the pharmaceutical sector.

The session brought together key public and private stakeholders, including representatives from industry associations and regulatory authorities. Participating organizations included the Industrial Association of Pharmaceutical Laboratories (ASILFA), the Chilean Association of Clinical Laboratories (CANALAB), and the Cámara de la Industria Farmacéutica (CIF), alongside Felipe Lopeandía, Bilateral Director at SUBREI and Chief Negotiator for the CEPA process.

The meeting served as a platform for a structured and candid exchange of views on the potential implications of the agreement, particularly in relation to regulatory integrity, market dynamics, and long-term public health safeguards.

Strategic Concerns within the Pharmaceutical Sector

Participants expressed a broad-based concern regarding the potential systemic implications of CEPA on the architecture of Chile’s current trade agreements, particularly in terms of regulatory coherence and competitive neutrality. Stakeholders highlighted the risk of asymmetries between market operators, which could emerge as a result of differentiated treatment across jurisdictions. There was also heightened sensitivity around potential regulatory relaxation, with participants underscoring the importance of preserving the autonomy and rigor of Chile’s health regulatory framework.

Ensuring Quality, Safety, and Fair Competition

A central theme of the discussion focused on the prospective entry and expansion of India’s pharmaceutical industry into the Chilean market. While acknowledging India’s role as a major global pharmaceutical producer, participants emphasized that this integration must not come at the expense of established standards of quality, safety, and efficacy. Concerns were raised regarding differences in regulatory oversight, noting that India’s regulatory authority is often perceived as having lower levels of inspection and enforcement compared to Chile, the European Union, and the United States. In this context, stakeholders stressed the importance of robust safeguards to prevent any dilution of regulatory standards, ensuring that all products entering the Chilean market comply with the country’s established benchmarks.

Government Position:

Preserving Regulatory Sovereignty In response, representatives from SUBREI reiterated that the government is actively engaging with industry stakeholders throughout the negotiation process, with the objective of ensuring that Chile’s regulatory framework remains fully preserved. Authorities emphasized that any eventual agreement will respect Chile’s sovereign capacity to regulate in the public interest, safeguarding high standards of quality and safety, and preventing the entry of products that do not meet national requirements.

Thera’s Contribution

Thera Health Policy & Access participated in the session within the framework of its broader commitment to evidence-based health policy and responsible market development. While maintaining a constructive and observant role during the discussion, Thera’s engagement is guided by a set of core principles that inform its approach to trade and regulatory processes. Thera supports the strengthening of resilient and diversified pharmaceutical supply chains, recognizing their critical role in ensuring continuity of access and enhancing health system preparedness. Likewise, we advocates for fair and transparent competition, grounded in the application of equivalent regulatory and quality standards across all market participants. In this context, Thera underscores the centrality of quality-assured medicines as a foundational element of any health system, and views the deepening of international trade relationships as an opportunity to reinforce—rather than weaken—these standards. Furthermore, Thera promotes regulatory convergence and progressive harmonization, aligned with internationally recognized best practices, as a key enabler of sustainable competition. Such alignment is considered essential to support innovation, improve system efficiency, and ultimately generate tangible benefits for healthcare systems and patients alike.