// March 31, 2016

A Multi-Sectorial Approach to Ensuring Medical Product Quality & Supply Chain Integrity

By: Victor Pribluda, Manager, Promoting the Quality of Medicines–Latin America Programs and Lukas Roth, Program Manager, USP Global Health Impact Programs

The globalized medical marketplace has provided great opportunity—offering communities around the world improved access to quality medicines and healthcare. Conversely and concomitantly, the international movement of spurious, substandard, falsified, falsely-labelled and counterfeit (SSFFC) medical products has also grown. According to the Pharmaceutical Security Institute, there were more than 2,000 incidents of pharmaceutical crime in 2014, involving diversion, theft, and counterfeiting of medical products in more than 100 countries, primarily in Asia.

To help keep citizens healthy and ensure trade in legitimate products is not disrupted by the threat of SSFFCs, the 21 member economies of the Asia-Pacific Economic Cooperation (APEC) have developed the Healthy Asia Pacific 2020 initiative. Two APEC teams are leading this effort: the Health Working Group and the Life Sciences Innovation Forum (LSIF). The U.S. Pharmacopeial Convention (USP) has been fortunate to participate in the LSIF through our Global Public Health Division.

Developing a Plan for Sustainable Medical Product Quality and Supply Chain Security

The LSIF, established by APEC in 2002, is a tripartite forum of representatives from government, industry and academia. The forum provides a venue to actively discuss policies and promote an environment that fosters the growth of life-sciences innovation and the importance of public health in the Asia-Pacific region. Such innovation is critical because ensuring people’s health is vital for a country’s sustainable growth and socio-economic development.

As part of the Healthy Asia Pacific 2020 initiative, the LSIF identified several priority work areas integral to ensuring the efficacy, safety and quality of medical products. One of these is seeking to protect APEC economies against SSFFCs through the assurance of medical product quality and supply chain security. Under this priority work area, the LSIF created 10 Work Groups, each tasked with conducting a gap assessment and developing a suite of resources (i.e., guidance documents, toolkits, training materials, etc.) specific to their focus area. These resources, in turn, can be readily implemented by governments and other stakeholders in APEC economies initially, and ultimately at a global level.

 The LSIF Work Groups include Manufacturing Practices, Distribution Practices, Import and Export Practices, Internet Sales, Product Security, Clinical and Retail Pharmacy Practices, Detection Technologies, Single Point-of-Contact, Track and Trace, and Surveillance.  An added strength of the overall project, these groups comprise multiple stakeholders who play leading roles in helping to assure medical product quality around the world, namely regulators, industry and other organizations operating at an international level (such as USP).

Collaborating on Clinical and Retail Pharmacy Practice and Detection Technologies

In February 2016, we attended the LSIF Training Program on Global Medical Product Integrity and Supply Chain Security in Lima, Peru. At the Lima meetings, the various Work Groups reported on their progress. On behalf of USP, we have participated in two groups: the Clinical and Retail Pharmacies Practice Work Group and the Detection Technologies Work Group.

The Clinical and Pharmacies Work Group has been identifying gaps and best practices to ensure the quality of medical products dispensed at clinical and retail pharmacies. This is a critical component as clinics and pharmacies often are the primary dispensing points to patients in the supply chain, and the last stage in which it is possible to exert regulatory control of products patients will use. The group’s toolkit, which is almost complete, will include best practices identified in selected countries and the requirements (training, technology, countries resources) for their implementation. In addition, the group has identified opportunities for collaboration with other LSIF Work Groups.

The Detection Technologies Work Group has been assessing current practices and providing recommendations for identifying SSFFCs and, more generally, assuring the quality of medicines throughout the supply chain. As part of this effort, they have been developing recommendations for effectively using surveillance and screening technologies and identifying best practices for working with industry stakeholders to authenticate suspect medical products. The group is also determining how to use detection technologies at country borders; how regulators, industry, law enforcement and customs can coordinate efforts; and how APEC economies can work together and share information on the applicability of various technologies and the findings garnered from the use of those technologies.

Progressing towards Increased Patient Access to High-quality Medical Products

The initiative was approved in January 2013 for a five-year implementation period. Each group has been working in accordance with a multi-stage process: gap analysis, toolkit development, training, and incorporation and application of best practices and recommendations by stakeholders. At the Peru meetings, it was evident that significant progress has been made, with several groups nearing completion of their toolkits, training programs and other deliverables. Completion of all LSIF Work Group activities and deliverables is expected by 2017.

Overall, this LSIF project aims to help regulators, industry and other stakeholders in APEC economies prevent, promptly detect and respond to the presence of SSFFC medical products in the national, regional and global supply chains that service their populations. The roadmap and resources developed by this project will enable countries to identify gaps or limitations in their quality systems and best practices that will lead to effective, efficient and germane improvements. Implementation of these practices will support regional economic integration by driving regulatory convergence in critical areas, with the intended result being expanded trade of, and increased patient access to, high quality, safe and effective medical products throughout the Asia-Pacific region and beyond.

To learn more about APEC and the LSIF, visit www.apec.org