Assessing the potential impact of data exclusivity in India : a systems dynamic modelling approach

Abstract

Data exclusivity is a form of intellectual property protection where confidential data generated during clinical trials by drug originator pharmaceutical companies can be safeguarded. This data is the basis for getting drug approval from regulatory authorities. Data submitted to the authorities entails information about safety, efficacy of the drug, along with the process. Generic companies rely on access to this data to produce generic version of the drug. The benefit to the generic company is that it does not need to significantly invest in human clinical trials, costs of which run into billions of dollars over a period of 10-15 years.

To prevent the generic companies from access to this data, stringent forms of IP protection like data exclusivity are being used by nations where presence of drug originator companies is strong. Once the data exclusivity is enforceable as a legal provision, there is little that a generic company can do with respect to accessing the clinical trial data. Data exclusivity makes the clinical trial data confidential, hence restricting the access to it. This forms the foundation for a debate- whose rights should be protected. The intellectual property right of the originator company that pumps significant time and money into development of a new drug or the right to access to cheap generic drugs, especially in the developing and least developed nations.

India has gained prominence as the pharmacy of the world, owing to a strong presence of generic pharma producers. Hence, a strong push for data exclusivity in India can be debated. There will always be two sides operating in this space,with advocates of data exclusivity pivoted on protecting pharmaceutical companies' research and development investment, while opposers arguing about increase in drug costs, hindering access to affordable medicines.

Data exclusivity is hence a complex issue. Data exclusivities' benefits as mentioned by its proponents include encouragement of pharmaceutical innovation for development of new drugs and saving patients from drugs of bad or hazardous quality counterfeits. On the other hand, data exclusivity critics enumerate the cons associated with it. These include monopoly of the originator drug company, reduction of access to cheaper generic drugs, especially in the developing and underdeveloped countries and stifling of innovation by reduction of incentives to companies other than the originator companies for development of new drugs.

There are 40+ countries around the world that have enacted data exclusivity provisions. Many of these provisions have been pushed through bilateral free trade agreements (FTAs) signed between nations having strong presence of originator companies, chiefly the US, the EU and other nations. Data exclusivity and stronger protection of IPR have dedicated chapters in multilateral agreements like the Trans-Pacific Partnership (TPP) and Central America Free Trade Agreement. Some of these countries, like Jordan and Guatemala have experienced rapid increase in the cost to healthcare due to restrictions of marketing of generics. On the other hand, countries like Malaysia have evolved mechanisms like exclusivity waivers in their national laws, to maintain a balancing act between respecting the FTA and public health of its population. The study has provided jurisdictional analysis, based on a simple framework evolved by the author - GRI-Governance, Rationale and Impact.

Keywords- Data Exclusivity, FTAs, Originator companies, Generics, Jurisdictional Analysis