Trade secrets protection and vaccines: Role of medicine regulatory agencies

COVID-19 Vaccine Vial Prop - mRNA. Creative Commons

by K M Gopakumar, Chetali Rao and Sangeeta Shashikant.

The TRIPS Waiver proposal for dealing with COVID-19 covers trade secrets, and this Briefing Paper discusses the rationale for including this category of intellectual property in the scope.

“The current pandemic situation demands rapid diversification of manufacturing and scale-up of .supply of vaccines. Under the current regulatory framework, the demand for safety and efficacy data, especially Phase III trial data, delays the entry of follow-on vaccines. In this context, lifting trade secrets protection and allowing the sharing of regulatory dossiers containing safety and efficacy data as well as information about the manufacturing process, especially with other regulatory agencies and potential manufacturers, can accelerate the production and approval of follow-on non-originator vaccines. Further, funding agencies which possess some of this information also can disclose it to potential manufacturers if a waiver is in place.

The sharing of regulatory information can also prevent regulatory delays. …

The IP regime attempts to strike a balance between IP protection and public interest. Unfortunately, there is little articulation of flexibilities surrounding trade secrets protection in the context of protecting public health. This urgently necessitates the waiver of such protection in the context of COVID-19 medical products.

Last but not least, the current situation is also a wake-up call to design and incorporate various public interest flexibilities, including public health safeguards, in the context of trade secrets protection. All forms of IP protection are subject to exceptions and limitations, and trade secrets protection and enforcement should not be an exception to this rule. Countries can and should explore avenues for creating exceptions to trade secret/confidential information protections that would require disclosure of such information and even sharing of cell lines sufficient to allow alternative producers to manufacture essentially identical products via essentially identical processes.”

The full paper is available here.

- Third World Network