In the third part of the post on data exclusivity (see here for Part I and Part II), Arnav explores whether there are alternative ways to incentivise domestic pharmaceutical innovation and clinical trials without introducing a data exclusivity regime. In this post, he examines possible policy interventions and alternative models, including a compensatory liability framework, while also highlighting the need for meaningful public consultation before any such policy decisions are made. Arnav is a 5th-year law student from Rajiv Gandhi National University of Law, Punjab. He’s interested in Narratives and the Law.
[Part III] The Trial of Data Exclusivity
By Arnav Kaman
Phase III: Alternative Treatment
Not all proponents of the data exclusivity regime are bad faith actors. There are genuine concerns of how to increase domestic innovation and generate safety and efficacy data suited for Indian populations but the question asked at this point must be: Is data exclusivity the best or only model to address such problems? For me, it appears to be a classic case of trying to push a square peg into a round hole. Data exclusivity is thankfully not the only solution.
Outside of direct injection of money into public clinical trial facilities, the government should (and already has) provide for other incentives for innovation such as direct grants and prizes for rare diseases that disproportionately affect Indian populations. Considering how international regulatory bodies require trials conducted with good clinical practices and ethical review, increasing regulatory oversight and enforcement from CDSCO will only likely make the country more attractive for clinical trials when it comes to quality for early phase clinical trials. By focusing on quality first, India can become a proven area for early clinical trials
Beyond these policy measures to supplement the current system, there are alternative regimes such as the compensatory liability model touted by Prof. Basheer in his thesis. The model imagines protecting the investment of R&D made by innovator companies, not by patents or data exclusivity, but rather through a compensatory liability model whereby competitors could enter the market only after paying reasonable compensation to the originator. Rather than relying on market conditions that could take many years for a return, originator companies could gain a reliable fee from competitors. This model consisted of a cost sharing methodology wherein the costs of the drug development process from discovery, capital allocation and clinical trials would be submitted and made public to determine the compensation. Until these total costs and reasonable return would be accrued by the originator wherein this period of “exclusivity” would then end.
This model would require a degree of financial transparency as originators would submit the exact costs accrued for the clinical trial for formulation of the appropriate compensation. It would not only sufficiently incentivize trials, but also avoid the drastic impacts that a DE regime would have on the domestic industry. All it would require is a little bit of honesty and co-operation.
On a final note, I want to take a moment to point out that we, the public, essential stakeholders have only come to know of these recent rumblings of data exclusivity from third party sources such as news reports and LinkedIn posts. We know that closed-door meetings between the government and MNCs and pharma lobbies took place after last year’s CSDSCO notice but we remain in the dark about the exact directives planned. No statement has been tendered by the government declaring their newfound considerations nor has there been a public call for consultation specifically about the regime of data exclusivity, the date of approval, the period of time, etc. Public consultations only seem to take place after the decision has been made and we are called forth only to discuss how to cross the t’s and dot the i’s. The irony of all of this is that Public Consultations and Clinical Trials actually share the same common premise: Solutions that affect everyone must account for everyone. Before any decisions to introduce data exclusivity are made, we must be sufficiently consulted. Otherwise, we will all have bitter pills to swallow at the end of this road.
(The Author would like to thank Swaraj and Praharsh for their unlimited patience and deeply insightful contributions to the post, and Archi Chaturvedi for her valuable insights)