Test data protection in Colombia is a key issue for the pharmaceutical sector and for any laboratory seeking to introduce innovative molecules into the market. This legal mechanism, regulated primarily by Decree 2085 of 2002 and complemented by Decree 481 of 2004, aims to strike a delicate balance: incentivizing scientific research without sacrificing access to essential medicines.
What is test data?
When a laboratory develops a new molecule, it must submit to INVIMA (Colombia’s National Food and Drug Surveillance Institute) clinical and scientific studies proving the product’s safety and efficacy.
These data represent years of research and significant investment. The law protects them from competitors who might otherwise try to “free ride” on this information to obtain marketing approval faster and at lower cost.
Put simply: test data are the evidence that proves an innovative medicine is effective and safe.
When does protection apply?
According to Decree 2085 of 2002, exclusivity only arises when:
- INVIMA approves the commercialization of the new chemical entity.
- The resolution is final and enforceable.
Key elements of protection:
- Duration: 5 years of exclusivity, counted from final approval.
- Requirement: the laboratory must demonstrate considerable effort through costly and complex studies.
- Scope: during those 5 years, INVIMA cannot use this information to grant approvals to other laboratories.
The dilemma of Vital Non-Available Medicines (VNAMs)
VNAMs, regulated by Decree 481 of 2004, are medicines essential for public health that are not otherwise available in Colombia. INVIMA may authorize their exceptional importation even without marketing approval.
Here lies the tension:
- If a competitor imports a VNAM containing the new molecule before exclusivity is granted, it does not violate the protection.
- Even once exclusivity is in place, previously issued import authorizations remain valid, as they constitute acquired rights.
FAQs
Does protection start with the application to INVIMA?
No. It only begins once marketing approval is final.
Does exclusivity end if another company imports the product as a VNAM?
No. The VNAM mechanism does not cancel exclusivity, but it does limit its effects in cases of essential access.
Conclusion
Test data protection in Colombia recognizes the effort of innovative laboratories by granting exclusivity, while ensuring the population can still access essential medicines through the VNAM mechanism.
Our Experience
At Nieto Lawyers, we have advised both innovative laboratories and competitors in interpreting this regime, always seeking solutions that harmonize incentives for innovation with access to public health.
If your company faces challenges related to test data protection or the importation of VNAMs, contact us for strategic legal advice.
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