THE DANGERS OF INCLUDING PATENT INFRINGEMENTS IN ACTA: SOME IMPLICATIONS FOR ACCESS TO MEDICINES
Summary
The report warns that the Anti-Counterfeiting Trade Agreement (ACTA) risks conflating 'counterfeit' medicines with patent infringements. This conflation could lead to the criminalization of legitimate patent disputes and the use of border seizures to block generic drugs produced under compulsory licenses or through parallel importing, ultimately hindering access to essential medicines. The author advocates for a clear distinction between therapeutically harmful counterfeits and IP-related disputes, suggesting that public health is best served by strengthening regulatory safety authorities rather than expanding IP enforcement.
Key insights
- The Anti-Counterfeiting Trade Agreement (ACTA) is a plurilateral agreement intended to create a "common standard for IP enforcement to combat global infringements of IP particularly in the context of counterfeiting and piracy", which may include criminal sanctions and ex officio authority for enforcement officers.
- There is a dangerous tendency among negotiating governments to equate "counterfeit" with "IP infringing", which may lead to the conflation of patent infringements with counterfeit medicines.
- Applying ACTA's enforcement regime to patents could restrict the use of critical public health safeguards, specifically compulsory licensing and parallel importing.
- The report argues that patent infringement during normal business development should remain a private civil matter rather than a crime; criminalization would create a "chilling effect" that discourages R&D and reduces competition in the pharmaceutical industry.
- Expanding border and precautionary measures to patent disputes could result in the seizure of therapeutically beneficial medicines, causing them to "languish in storage" during lengthy litigation and preventing them from reaching the market.
- The document highlights a discrepancy between the WHO definition of counterfeits, which focuses on "deliberately" and "fraudulently" mislabelled medicines, and newer standards sought by the EU and others that lower the standard of proof and expand the scope to any "false representation".
- The author suggests that the most effective way to address the public health risk of therapeutically harmful medicines is to strengthen regulatory regimes for testing and market removal, rather than focusing on patent enforcement.
Cite the original document
- APA
- Center for International Environmental Law (2008). THE DANGERS OF INCLUDING PATENT INFRINGEMENTS IN ACTA: SOME IMPLICATIONS FOR ACCESS TO MEDICINES. https://www.ciel.org/wp-content/uploads/2015/03/IP_Update_2Q08.pdf
- Chicago
- Center for International Environmental Law. THE DANGERS OF INCLUDING PATENT INFRINGEMENTS IN ACTA: SOME IMPLICATIONS FOR ACCESS TO MEDICINES. 2008. https://www.ciel.org/wp-content/uploads/2015/03/IP_Update_2Q08.pdf.
- Wikipedia
- {{cite report |author=Center for International Environmental Law |title=THE DANGERS OF INCLUDING PATENT INFRINGEMENTS IN ACTA: SOME IMPLICATIONS FOR ACCESS TO MEDICINES |date=2008 |url=https://www.ciel.org/wp-content/uploads/2015/03/IP_Update_2Q08.pdf |access-date=23 October 2026 |via=Climate Insights Directory}}
- BibTeX
- @techreport{centerforinternationalenvironmentallaw2008dangers, author = {{Center for International Environmental Law}}, title = {{THE DANGERS OF INCLUDING PATENT INFRINGEMENTS IN ACTA: SOME IMPLICATIONS FOR ACCESS TO MEDICINES}}, institution = {Center for International Environmental Law}, year = {2008}, url = {https://www.ciel.org/wp-content/uploads/2015/03/IP_Update_2Q08.pdf}, urldate = {2026-10-23}, note = {Indexed by Climate Insights Directory} }
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