The extent that Term Extensions, (SPCs), are creating a barrier to access to pharmaceuticals

Abstract

This research critically assesses the development of Term Extensions, its impact and practicalities on generic market entry and with a focus on the European Supplementary Protection Certificates, the extent and effect on access to cheaper medication in terms of cost and availability. From a positivist theoretical perspective, using doctrinal research and secondary use of published data from the European Union, (EU), Canada and International bodies, this research provides in-depth illustration of the impact of term extensions on access. Patent Term Extensions, PTEs, appear to be at the forefront of the EU battle-ground between pharmaceutical originators and generic companies. Policy making for pharmaceuticals requires considerations on availability and price. For developing countries, it appears impossible to form policy without promoting generic medicines, which is proving to be an effective health care remedy to access and availability. A 20-year maximum patent term is generally recognised by originators to be insufficient with claims that it is inadequate to provide incentives for research into new active substances as the term is significantly reduced by delays surrounding securing regulatory approval enabling a product to be placed on the market. The EU’s response was the institution of SPCs which have been officially administered since the 1980’s but numerous complaints have been made on its efficacy and fit for purpose. The findings in this research suggests that term extensions provide significant barriers to entry for generic medications, continued operations within the EU market will have extended effects on cost and availability and most significantly, has acted as a legal transplant on the Canadian system, which previously did not recognise extensions. Additionally, this research demonstrates that the actual workings of the system suggests that the cost implications represent one dimension of impact and that other legal ramifications are at play that affect overall access matters, which are explored. Conclusions are drawn based on legislative review and re-analysis/interpretation of published data which facilitates suppositions on means of optimising existing legal structures and dissects practical solutions for addressing access and public health obligations under International Law, especially for countries with little or no manufacturing capabilities.