GBMA supports the negotiation of international trade agreements aimed at fostering trade in generic and biosimilar medicines.
The competitiveness of the generic and biosimilar medicines industry is threatened by regulatory divergences with respect to country requirements for the approval and marketing of generic and biosimilar medicines, and excessive standards for intellectual property rights (IPR) protection. Specific instances of IPR abuse/misuse, as well as pricing and reimbursement policies are also areas of concern.
The removal of such barriers will reduce costs for the development of generic and biosimilar medicines, and ensure that such products can be traded freely and enter markets without delay.
To this end, GBMA support the IGBA set of trade principles that should systematically inform trade negotiations. These principles concern four key priority areas:
- Fostering regulatory convergence of the requirements for the approval of generic and biosimilar medicines, and recognition of compliance inspections through the establishment of frameworks providing for regulatory cooperation;
- Ensuring that the regulation of IPRs in trade agreements does not lead to excessive IP standards that delay access to generic and biosimilar products;
- Establishing an appropriate framework of pro-competitive provisions to prevent IPR abuse/misuse, and;
- Establishing an appropriate framework for incentivising generic and biosimilar medicines’ market access.
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