Trends & Perspectives

Published: January 25, 2012
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Industry associations discuss mutually important issues

By: Richard Park

Last October, the European Diagnostic Manufacturers Association (EDMA; Brussels) hosted the European IVD Forum 2011. The primary purpose of the forum was to facilitate discussions among high-level stakeholders on the challenges faced by healthcare systems. To this end, the forum was attended by members of the IVD industry, key policymakers from European and national institutions, and representatives from patient and professional healthcare groups.
According to EDMA officials, the key global policy issues discussed at the forum were the following: the convergence of legislation at a global level and the importance of intra-association cooperation in achieving solutions to common global challenges; the importance of health technology assessment; and the crucial role of IVDs in active and healthy aging.
As an offshoot of the forum, representatives of six IVD associations from around the world held a meeting to discuss a number of mutually important global policy issues. Officials from AdvaMedDx (United States), IVD Australia, the Camara Brasileira de Diagnostico Laboratorial (Brazil), EDMA, the Japan Association of Clinical Reagents Industries, and the Japan Analytical Instruments Manufacturers exchanged views on the ongoing policy debates in their respective regions and engaged in forward-looking discussions. The meeting built on the longstanding relationships among the international partners and aimed to form the basis for even greater cooperation in the future in order to find solutions to common global challenges and ensure the place of IVDs at the forefront of twenty-first-century healthcare.
“We have come together to further strengthen the ties between our organizations and to enhance the effectiveness of the sector by contributing to policies that will advance public health through the development and use of innovative diagnostics all around the globe,” said Dr. Jurgen Schulze, EDMA’s president. He further pointed out that “this relationship will take our coordination, collaboration, and alignment of information and policies on mutually important issues to a new level.”
As priority issues, the delegates identified the need to raise awareness of the value of IVD testing, facilitate the timely access of patients to good diagnostic testing, and cooperate with regulators and policymakers on issues such as companion diagnostics, clinical evidence for IVDs, and the convergence of regulatory requirements around the world.
Andy Fish, executive director at AdvaMedDx, attended the meeting and said that a good part of the time the associations spent together was taken up providing briefings on key policy issues, the status of those issues, what was going on with regulators, and how the IVD industry was engaged with regulators and policymakers in each of their respective marketplaces.
“Clearly one of the key takeaways from that discussion is that we are all facing essentially the same issues,” said Fish. “And that is the need for regulatory reform to ensure faster and timely patient access to new tests and technologies as well as the need for reimbursement reform to more fully recognize the full value of diagnostics. Beyond those core policy areas, we also continue to underscore our mutual recognition that it is incumbent on all of us as industry representatives to continue our work around educating policymakers and other stakeholders about the technologies and the value of the technologies that we all employ, and to continue to expand those efforts to support our overall advocacy work.”
Fish also said that AdvaMedDx and its sister IVD associations continue to recognize that not all policymakers are as versed in diagnostics as they should be.
“We all have individually and increasingly collectively taken on this task of educating policymakers about how IVDs contribute to all major healthcare systems, both for individual patients and to healthcare as a whole,” said Fish. “So we recognize that in order to maximize our value as advocates for this industry, we need to make sure that the policymakers we’re talking to are as educated as possible about our products. We’ve all taken that on individually, and increasingly we’re sharing ideas and good practices for doing that.”
In addition, Fish said what all of the IVD associations have identified was that they each have their own individual plans for continued advocacy work, resting in part on a robust public affairs outreach.
“I can speak more specifically to both EDMA and AdvaMedDx having well formed plans for continued engagement with a number of stakeholders as we look ahead to the coming year, which would include both increasing engagement with patient advocacy organizations as well as direct briefings for policymakers,” said Fish. “So we didn’t so much identify additional activities for all of us to engage in as a group of associations but rather identified that we’re all working on the same kinds of activities within our own spheres. What we did agree to was to continue to share the kinds of information that we’re all developing to support our overall public affairs and advocacy work. For example, continued health economics studies that may come out of one region or another, case examples of particular technologies and the impact that they’re having on healthcare, and so forth.”
Information about AdvaMedDx can be accessed at Information about EDMA can be accessed at
 -Richard Park


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