APEC Fora.  From the outset, other APEC forums that will be involved in the planning and implementation of activities included in this proposal will initially include the APEC HWG, the APEC Harmonization Center, and the Anti-Corruption Task Force. APEC HWG has fully endorsed this proposal as being important to ensuring the health and welfare of patient populations throughout APEC by working toward access to medical products that are known to be of high quality, safe and efficacious. Thus, throughout implementation of this project, the HWG will be consulted to provide relevant experts on matters related to proper dispensing and use of medical products throughout APEC markets. Similarly, the APEC Harmonization Center will be actively involved by serving as the Secretariat to the Oversight Committee appointed by the RHSC for project implementation. Moreover, the APEC Harmonization Center will coordinate all meetings necessary to facilitate project implementation. Finally, the Anti-Corruption Task Force will be drawn upon to provide expertise in the development of a Single Point of Contact System to enable quick public awareness and reporting of suspect and non-conforming products throughout the APEC region.

Non APEC Fora.  The World Health Organization (WHO) will be involved in planning and implementation of the project due to both the project’s public health focus and its global implications. Other non-APEC stakeholders include the European Medicines Agency, international Pharmacopeia, and other international organizations including private sector, non-profit organizations, as appropriate. Government and industry representatives from a limited number of non-APEC economies will be invited to serve as expert speakers and participants in the Oversight Committee. APEC participants will benefit from non-APEC participation since non-APEC economies are a significant part of the global medical product supply chain. In turn, the World Health Organization and all other non-APEC participants will be able to leverage the work product derived from this project by incorporating it into their work streams to further assist in maintaining the security of medical products moving in international commerce.

Previous Work. The activities proposed under this proposal supports previous APEC LSIF activities related to the quality, safety and efficacy of medical products, including APEC projects covering counterfeit medicines, quality in manufacturing (specifically, Quality-by-Design), and multi-regional clinical trials.    

Importantly, this project is governed by the Regulatory Harmonization Steering Committee, whose overarching operating principle, as described in the Strategic Framework, is to take account of and not duplicate the work of initiatives within APEC and other organizations.  It is for this reason that key international organizations have been invited to participate in this global exercise.

APEC’s Comparative Advantage.  As a multi-lateral organization, APEC is distinct from other multi-lateral venues as it applies to this project. First, many APEC economies are involved in a number of otherwise unlinked activities related to regulatory convergence (e.g., the Pan-American Network for Regulatory Harmonization, the ASEAN Pharmaceutical Product Working Group, and the Asian Health Working Party. For these economies, APEC therefore serves as a common denominator that facilitates the exchange of sound, science and risk-based practices that can be shared among all APEC economies, as well as non-APEC economies. Second, although every single country and economy in the world is affected to some extent by the movement in international commerce of SSFFC products, APEC also encompasses the South East Asian region that the World Health Organization has determined to be one of the most susceptible to international movement of such non-conforming products. In addition, there is a wealth of subject matter experts in the region. Hence, the increased risk to patients and corresponding additional costs to health systems caused by the international movement of SSFFC medical products are well understood.