APEC member economies are moving ahead with a joint multi-year initiative to improve the integrity of medical product manufacturing and security of distribution chains across borders to combat fraud in the world’s largest consumer market.
Discussions between senior administrative authority officials, technical experts and industry representatives over the last week in Qingdao opened the door to greater alignment of policies safeguarding pharmaceuticals, medical devices and biomedical goods in regional and global supply chain networks, which they agreed is critical to the protection of public health.
“There is considerable variation in medical product manufacturing, distribution, and import-export practice requirements, not to mention differences in the oversight of things like internet pharmacies which are proliferating,” said Dr Ryan MacFarlane, Co-Chair of the APEC Life Sciences Innovation Forum. “Regulatory gaps, in and across economies, create opportunities for bad actors to interject unregulated products into the marketplace.”
“Our priority is to improve access to safe medicines,” Dr MacFarlane explained. “The only way for us to ensure medical product quality and safety and that international shipments flow in a robust, secure way is through the establishment of a seamless regulatory environment based on global standards and the type of far-reaching policy coordination we are pursuing now.”
APEC economies are working towards regulatory convergence for medical products by 2020, as agreed to by APEC Trade Ministers who will meet this weekend in Qingdao. The focus is on stocktaking existing regulatory approaches and the use of public-private partnerships to drive the formulation and implementation of regulatory best practices. This is supported by capacity building training in areas like surveillance and monitoring of the movement of products not meeting established requirements.
“Keeping a lid on medical products that don’t meet required specifications, that are misbranded, adulterated or are counterfeit is a challenge for us all,” said Mark Paxton, a compliance expert from the US Food and Drug Administration’s office of Drug Security, Integrity and Recalls who heads the initiative’s oversight committee. “What we’re asking each other is, “what are the holes and what do we need to do to fill them to increase assurance levels about product quality, safety and efficacy?””
“We are sitting down with regulated stakeholders in the medical products and the logistic sectors to work out solutions that are based on international best practices and make sure that they are informed enough to meet them,” Paxton added. “At the same time, we’re trying to keep compliance costs in check by encouraging the adoption of global data standards to avoid undermining product innovation and increasing prices for consumers.”
Private sector representatives underscored the importance of maintaining the right regulatory balance and offered views on advancing this process.
“The goal is to have economies adopt common global data standards for medical products moving through the supply chain,” said Kate Clemans a senior trade director with Crowell & Moring International.
“If you have a little tweak in your product verification requirements, suddenly you’re out 30 per cent in terms of compliance costs,” noted Clemans who is an advisor to the APEC Life Sciences Innovation Forum Co-chairs. “These numbers can get very big, very fast. Regulatory harmonization is a route to reducing the cost of compliance for companies in the sector, which ultimately boosts trade, economic growth and patient welfare,” she concluded.
Regulatory authorities will provide an update on the progress of their implementation work and identify next steps during an APEC High Level Meeting on Health and the Economy in Beijing in August.
For greater insight into the APEC Life Sciences Innovation Forum and its agenda, click here.
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