The “early working” or Bolar exception, allows competitors to import, manufacture and use a patented product for the purpose of seeking regulatory approval.

Developing countries and LDCs should incorporate both Bolar (early working) and research, experimental and educational exceptions in their patent laws and explore how additional limited exceptions could further promote access to medicines.

Thus, because the standards adopted in the Agreement are derived, in the main, from developed country contexts and notions, TRIPS considerably increased the burden shouldered by such countries in respect of enforcing IPRs, despite the fact that the agreement contains several provisions, such as articles 6 (non-discriminatory “parallel importation”), 7 (promoting technological innovation and transfer), 8.1 (protection of public health and nutrition as well as public interest), 8.2 (research exceptions/the “Bolar” provision), 30 (exceptions to patents), 31 (other use or “compulsory licensing”) and 40 (controlling anti-competitive practices), designed to allow countries to take measures shielding them from the adverse consequences of full IPR protection.