Advantages of Using an Independent DMAH
Under the PAL, and Act on Securing Quality Efficacy and Safety of Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD Act) that was implemented since November 25, 2014, only one DMAH may be assigned for a medical product. Given this, there are several considerations that a foreign medical products firm must entertain in choosing a DMAH. There are several advantages in selecting an independent DMAH, and these are described below.
An independent DMAH provides for flexibility in dealing with distributors. In the past, the importer-distributor was in the driver’s seat, and the overseas manufacturer, although nominally the product’s registration owner, was at the mercy of the Japanese importer-distributor for all matters relating to the product in Japan. With the PAL amendment, overseas medical product producers are able to add or change distributors, and are no longer closely tied to a single importer-distributor as before. Moreover, having an independent DMAH allows for multiple importer-distributors of an overseas firm’s medical products (for example, for geographic market segregation), something that was virtually impossible before.
By delegating regulatory-compliance duties to an independent DMAH, overseas medical product companies avoid encumbering negotiation and selection of Japanese distributors with these matters, and frees the discussion to focus on business matters during development of the distribution agreement, including sales performance and transfer pricing. Cost transparency of fees for DMAH services also is furthered in having an independent DMAH, such as Cobridge, separate from the distributor.
Of interest to innovators and manufacturers of generic products alike is the fact that having a DMAH such as Cobridge, which can also handle preparation of Japanese dossiers and management of the product-registration process, itself, allows for better protection of an overseas medical products firm’s intellectual property. It is often of interest to tap into a domestic medical products company’s established distribution channels in order to maximize the potential for successful marketing of the overseas exporter’s products in Japan. But Japanese importer-distributors with the best distribution networks are often product-developers and manufacturers, themselves, and potential competitors. The health ministry requires the firm that is responsible for regulatory-compliance matters to maintain information on the product that is often of a sensitive nature, for example, the product-registration dossier. That is, in many cases, the importer-distributors are technically capable of product-development and manufacture, and the overseas medical products firm is reluctant to divulge to them the kinds of confidential information that the PMD Act requires the DMAH to hold. An independent DMAH that does not undertake product development or manufacture, such as Cobridge, works best from the overseas firm’s perspective.