How the generic and biosimilar medicines industry could take advantage of trade opportunities

Abstract

International trade policy initiatives, including trade negotiations and regulatory dialogues, have a rather significant impact on the industry. This is particularly the case for the pharmaceutical sector, which is a highly regulated sector. Non-tariff barriers (NTBs) to trade have a negative effect on generic and biosimilar medicine exporters as they often create an advantage for local companies. To aim at their removal, several actions can be taken by governments both at bilateral level or with the World Trade Organization in the context of its dispute resolution procedures. NTBs can also be addressed in the context of trade agreements or bilateral and plurilateral regulatory dialogues. Regulatory cooperation in trade agreements can produce very positive results for patients, industry and regulators, as the Transatlantic Trade and Investment Partnership Agreement (TTIP) demonstrate.