1. What is the current legal landscape for Life Sciences Law in your jurisdiction?

Colombia’s life sciences sector operates under a dual reality: technically sophisticated regulations on one side, and deep structural fragility (financial, political, and institutional) on the other. Pharmaceutical companies, medical device manufacturers, healthcare providers, and investors must simultaneously navigate a modernising regulatory framework and an increasingly interventionist government approach to intellectual property.

The current government has pursued deep health system reforms, most of which have not been approved by Congress, generating sustained uncertainty throughout the sector. The government’s attempt to eliminate health service providers (EPS) and centralise resource allocation under a new national entity represents perhaps the most disruptive of these initiatives and, though suspended in Congress, continues to difficult long-term planning.

The sector is caught between the health authority’s (INVIMA) efforts to modernise the regulatory environment through risk-based prioritisation and an ambitious digital transformation programme, and the government’s escalating use of compulsory licensing as a cost-containment tool.

On the modernisation front, the INVIMA has recently adopted the Common Technical Document (CTD) format for biological medicines and is advancing guidelines on Risk Management Plans (RMP), immunogenicity, stability, and biosimilar comparability. For medical devices and in vitro diagnostic reagents, a semantic coding standard became mandatory in early 2026, reflecting the authority’s commitment to aligning with international best practices.

On the IP front, the Ministry of Health issued Resolution No. 453 on 16 March 2026, declaring reasons of public interest to compulsory licensing three of Gilead’s hepatitis C patents (covering Sofosbuvir + Velpatasvir and Sofosbuvir + Velpatasvir + Voxilaprevir). This resolution was made on the grounds of a rise in new hepatitis C diagnoses and the fiscal burden of purchasing branded treatments. The Ministry has now referred the matter to the Superintendence of Industry and Commerce (SIC), which is responsible for establishing the specific terms of any licence, including the royalty rate payable to Gilead by generic manufacturers.

This action overrides a 2021 recommendation of the Interinstitutional Technical Committee (ITC), which in 2021 had unanimously concluded that no public interest grounds existed when there was no unmet demand. It also follows Colombia’s first-ever compulsory licence, issued in April 2024 for the HIV drug dolutegravir, and signals a consolidating pattern of IP override for cost-containment purposes.

The political landscape adds further uncertainty. The 2026 presidential election (with a first round on 31 May 2026 and a potential runoff on 21 June) will be determinative for the health sector. A left-wing continuation would likely bring expanded compulsory licensing, deeper state intervention in procurement, and the continued marginalisation of private health providers. A centre-right outcome would likely restore investor confidence and return the country to a more predictable regulatory model. Either way, the incoming administration will be forced to confront the healthcare system’s unsustainable finances.

Finally, civil society groups, in partnership with organisations such as Ifarma, are taking an increasingly active role in challenging pharmaceutical patents they consider lack inventive step. Also, between 2022 and 2025, patent rejection rates in the pharmaceutical and biotechnology sectors increased, reflecting both a tougher examination environment and a shift in the political dynamics surrounding IP.

2. What three essential pieces of advice would you give to clients involved in Life Sciences?

Navigating Colombia’s life sciences sector today requires clients to accept instability and fragility. Our advice centres on three priorities:

• Prepare for the post-election landscape. The presidential election is the most consequential near-term variable for the sector. Clients should test their business models against two distinct scenarios. Under a left-wing continuation, the environment is likely to include aggressive use of compulsory licensing (as already demonstrated with dolutegravir and the Gilead hepatitis C patents), expanded centralised public procurement, strengthened price controls, and a diminished role for private health providers. Under a centre-right administration, the outlook shifts toward a more predictable regulatory environment and a potential restoration of investor confidence, though structural healthcare finance pressures will remain regardless of ideology. Contingency planning should encompass supply chain options, pricing strategies, and adaptable market access models for each scenario.
• Reinforce IP portfolios. Compulsory licensing and the rise of civil society patent challenges signal that intellectual property is under active and sustained scrutiny. Patent applications must be drafted with exceptional rigour to withstand potential oppositions and hostile examination environments. A robust defensive strategy includes securing patent protection early, maintaining meticulous records supporting inventive step, monitoring generic pipeline activity, and actively enforcing rights. In parallel, companies should consider pricing schemes that demonstrate genuine access commitments, as this materially reduces the likelihood of facing compulsory licensing.
• Legal compliance and data protection. Enforcement of personal data protection obligations (particularly for sensitive health data) has intensified significantly, carrying financial and reputational risks. Clients that go beyond minimum legal requirements and build data protection cultures will not only mitigate regulatory exposure but will also stand out. Compliance is increasingly a prerequisite for operating in Colombia’s public health ecosystem.

3. What are the greatest threats and opportunities in Life Sciences Law in the next 12 months?

The next twelve months will be mostly defined by the outcome of the presidential election. A left-wing victory would likely accelerate compulsory licensing and deepen state-led management of the health system. A centre-right outcome would signal a move toward stabilisation and renewed private-sector engagement. Both scenarios carry significant implications for market access, pricing, and IP strategy.

However, Colombia’s healthcare system is in critical financial condition. For pharmaceutical and medical device companies, this translates into delayed payments, disrupted distribution channels, and growing pressure on reimbursement terms. The risk of further systemic disruption is real and should be considered into commercial planning.

On the IP front, the March 2026 declaration of public interest for three Gilead hepatitis C patents represents a decisive shift in Colombia’s IP policy. This action overrode the ITC’s 2021 unanimous recommendation that no public interest grounds exists when access is not compromised. This second compulsory licence in two years suggests that Colombia may be establishing a recurring pattern of IP override for cost-containment purposes.

Nevertheless, the environment also presents genuine opportunities:

• Colombia’s pharmaceutical market continues to grow, driven by expanding coverage, an ageing population, and rising demand for complex therapies. Companies positioned to supply high-quality generic versions of treatments subject to compulsory licensing, or to operate efficiently within a cost-sensitive public health system, can capture meaningful market share.
• The government has activated significant investment plans to rebuild national capacity in vaccine, pharmaceutical, and biotechnology production. This creates partnership opportunities for foreign companies willing to establish local manufacturing or research operations. Colombia’s recognition by PAHO/WHO as a Level 4 regulatory authority facilitates sanitary registration homologation and lowers barriers to exporting medicines produced in Colombia to other Latin American markets. Local production capacity opens doors to preferential public procurement and regional export opportunities. Products registered in Colombia can benefit from homologation pathways in other Latin American markets, reducing the cost and complexity of regional expansion.
•  As enforcement of data protection obligations intensifies, companies that invest in robust health data governance programmes can distinguish themselves in an increasingly scrutinised market. Demonstrating compliance leadership builds trust with patients, providers, and regulators.

4. How do you ensure high client satisfaction levels are maintained by your practice?

In Colombia’s life sciences sector, clients need advisors able to anticipate the political and regulatory twists (e.g., compulsory licensing, election outcomes), integrating health law and IP expertise to navigate regulatory complexity.

Our practice is built on real-time intelligence. When the Ministry of Health issued the compulsory license declaration for hepatitis C in March 2026, we provided immediate client alerts mapping the implications for specific portfolios. Responsiveness is core for client’s satisfaction.

We understand that the greatest source of client anxiety is the collision between cost-containment pressures (compulsory licensing, price controls) and the need to have strong exclusivity rights through IP. Our response is pre-emptive patent landscaping to identify vulnerable assets before threats materialize.

We also help clients to execute under uncertainty. That means advising on renegotiation of contracts with health authorities, structuring value-based agreements with public payers, and preparing amicus briefs and technical submissions when civil society groups file patentability challenges against life sciences patents.

High satisfaction comes from combining legal rigour with pragmatism in the specific context of Colombia’s fast-moving regulatory environment.

5. What technological advancements are reshaping Life Sciences Law and how can clients benefit from them?

Beyond the political and regulatory turbulence, Colombia’s life sciences sector is experiencing a meaningful digital and regulatory transformation. Technological modernisation is emerging as a source of stability.

The INVIMA has moved decisively toward a fully digital regulatory ecosystem. Since mid-2025, the authority has operated under a pro-competitive model based on risk prioritisation, digital-first submissions, and progressive implementation. For clients, the most effective strategy is to structure all submission dossiers to align with INVIMA’s digital-first framework. It is recommended that companies proactively classify their products, adopt CTD format for pharmaceuticals, and make use of the InvimAgil. This may reduce time to market and provide real competitive advantages.

Health sector modernisation extends beyond INVIMA’s initiatives. The Interoperability of Electronic Health Records (IHCE in Spanish) is a strategy of the Ministry of Health that integrate each patient’s clinical data into a single, secure system, seeking to ensure continuity of care and strengthens security and confidentiality of information. The emerging regulatory framework for Software as a Medical Device (SaMD), and the developing governance structures around artificial intelligence in health create a more predictable, data-driven environment for life sciences companies.