The Global Medical Technology Alliance (GMTA) member associations represent companies that produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our represented companies produce nearly 85 percent of the health care technology purchased and utilized annually around the world. Our companies range from the largest to the smallest innovators and bring medical technology to patients around the world in every setting.
In June of 2008 the World Health Organization (WHO) launched a prequalification program applicable to all diagnostics proposed for procurement by UN agencies, and began accepting applications for designated high priority categories limited to HIV, malaria, and hepatitis diagnostics . CD4 enumeration technologies have recently been added to the list. Prequalification is a multi-step process that involves 1) submission of a product summary application for initial consideration, 2) with acceptance of application form, manufacturer signs letter of agreement and pays program fee, 3) manufacturer submits detailed product dossier for review, 3) upon approval of dossier, WHO conducts manufacturing site inspection, 4) laboratory evaluation of diagnostic is performed by WHO Collaborating Center, 5) if manufacturer satisfies WHO requirements then product is eligible for inclusion in UN procurement tenders, 6) when product is purchased, manufacturer agrees to participation in WHO post market surveillance program.
Communications from WHO indicate that the organization recognizes global differences in national and regional regulatory processes but makes no distinction between products that have undergone rigorous review procedures by a mature regulatory authority and those with less or no regulatory review. Examples of rigorous regulatory processes would include those of the US, EU, and Japan. WHO indicates that diagnostic "certification from a stringent regulatory authority" may speed up the process but does not replace it, because "conditions in countries with stringent regulations are different from resource-limited settings". The rationale for laboratory evaluation of diagnostics is so that WHO laboratories and WHO Collaborating Centers assess technical performance based on the "suitability of the product for testing services in resource-limited settings." WHO inspection of manufacturing sites is explained as necessary to "assess the adequacy and effectiveness of manufacturer's quality management system and the correct implementation of documented procedures", with the inspection "based on internationally recognized standards".
The WHO website shows over 100 applications received to date. Based on the website information, none of these products have progressed beyond the initial dossier review stage and no products have been prequalified. Several applications have been rejected because the products do not fit current high priority targets as defined by WHO.
The GMTA strongly supports WHO's mission to increase access to affordable diagnostics of assured quality in underserved regions of the world. We share WHO's concern for the quality and suitability of diagnostic products intended for use in those regions of the world, and we recognize the need for a product and quality system review of manufacturers not already subject to appropriate regulation. For manufacturers and products already subject to review and acceptance by mature regulatory systems and authorities, however, much of the WHO pre-qualification process is duplicative and may add significant delays to the procurement of these diagnostics. This duplication and delay undermines WHO's important mission to increase timely access to much needed quality diagnostics in underserved regions of the world.
A two tiered approach to diagnostics prequalification that would streamline access to these types of diagnostic medical devices, while ensuring that products not already subject to stringent regulation undergo the full WHO prequalification process, represents the best approach to fully address the needs of underserved regions. This approach would provide a platform for manufacturers to work with WHO to assure product quality and strengthen regional regulatory processes while maximizing availability of quality diagnostics in a timely and cost effective manner. This approach would also allow WHO to better allocate the organization's resources by focusing more effectively on those manufacturers and products that would most benefit from interaction with WHO under the full prequalification program. Undertaken in collaboration with the Medical Technology industry, this approach would address the critical points identified by WHO:
This approach would ensure a consistent and rigorous regulatory standard for manufacturers while allowing WHO resources to focus on review of products not already covered by stringent regulatory review.
Post market surveillance requirements for diagnostics registered under stringent regulatory systems include detailed adverse event reporting to one or more appropriate agencies, including a reputable European Notified Body, US FDA or Japan's MHLW. Adverse event reporting for product marketed in new regions would also be required, and periodic summaries could be submitted by manufacturers to WHO.
The GMTA strongly supports the mission of WHO to increase access to affordable diagnostics of assured quality in underserved regions of the world.
The current WHO diagnostic prequalification program, however, creates unnecessary additional regulatory hurdles for manufacturers who already comply with product registration and Quality System requirements under stringent regulatory authorities such as those in the US, EU, or Japan. For companies that routinely and reliably manufacture diagnostics already meeting stringent regulatory requirements, the program adds significant delay and potentially undermines WHO's important mission to increase access to much needed diagnostics in underserved regions of the world.
We echo WHO's longstanding concern for the quality and suitability of diagnostic products intended for use in critical regions of the world, and we recognize the potential need for a product and quality system review of manufacturers not already subject to appropriate regulation. We urge WHO to adopt a two-tiered approach similar to that outlined in this paper as the best means of addressing the organization's concerns over regulatory, quality, and manufacturing standards to be met by diagnostic products procured through its programs. This important step provides a means for WHO to improve regulatory requirements for all products while opening the way for timely access to high quality diagnostics. This also allows better utilization of both industry and WHO resources to specifically address the unique requirements of products for use in underserved regions of the world.