Medical Device Link.

Originally Published EMDM May/June 2004

Industry News

EUCOMED director general Maurice Wagner has been named vice chair of the Global Harmonization Task Force.

Should the Global Harmonization Task Force (GHTF) be renamed the Global Convergence Task Force? Perhaps not, but convergence is clearly the new mot d’ordre in official circles. The term came to the fore at the GHTF’s sixth steering committee meeting in San Francisco last November. The European Union, which officially took over the three-year rotating chairmanship of the GHTF from Japan at the end of January, seems to be speaking the same language. EMDM asked the newly appointed GHTF vice chair Maurice Wagner, director general of EUCOMED, what’s in a word?

“Harmonization is sort of a loaded term,” says Wagner. “The construction of the single market has been based on the harmonization of existing legislation. It’s a process that leads to binding pieces of legislation,” he explains. “By accepting harmonization, the GHTF may be seen by some as deviating from existing processes to create new pieces of legislation.” Convergence, suggests Wagner, has a more pragmatic resonance. “And guess what? If the work is done in a proper manner, if the discussions lead to sensible conclusions, then there isn’t a great deal of difference between convergence and harmonization.”

Formed in 1992 as a global platform to promote regulatory harmonization and international trade, the GHTF’s mission has not, in fact, deviated. Under the current chairmanship of Cornelis Brekelmans of the European Commission DG Enterprise, its objective remains the establishment of balanced and predictable regulatory frameworks. To further that goal, Europe will propose tackling a set of issues under the theme of enhancing patient safety. Design for patient safety, the use of software in medical devices, and human tissue–based products are among the priority items that will be addressed during the next three years, according to Wagner.

“Medical device software is a relatively new area,” says Wagner, “and we need to act on it.” Human tissue products are also an area of concern. “Some act like pharmaceuticals, others act like medical devices, and many of them are neither one nor the other,” he notes. Appropriate regulatory regimens will need to be drafted, stresses Wagner. They may take the form of regulations as opposed to directives.

“Regulations are directly applicable in all member states. They enter into force as soon as they are adopted.” Industry would favour this approach, says Wagner, over a directive that must be transposed by each member state, thereby creating an opportunity for national variances. Although the GHTF has not yet formally committed to this agenda—those decisions will be made at the next steering committee meeting in June—it reflects the views of many EU regulators, notes Wagner.

The past three years are deemed by Wagner to have been a time of significant progress for the GHTF. “I think I reflect the view of the Europeans, who are very grateful for what has been accomplished under the Japanese presidency. Specifically, I was struck by the constructive spirit at the November meeting,” says Wagner. The reason it went as smoothly as it did, he adds, had a lot to do with the preparatory work done by the Japanese delegation and the open-mindedness of the attendees. “That showed me the importance that the various participants attach to the process. To me, it was very encouraging. That said,” adds Wagner, “there are a number of challenges to tackle during the next three years. In a way, the more you do, the more there is left to do.”

Copyright ©2004 European Medical Device Manufacturer