A NOTE FROM THE EDITOR
Mutual Recognition Disagreement
The globalization of the medical marketplace is a fait accompli. Companies have overcome a patchwork of conflicting regulatory systems to develop and produce devices for the world market. These regulations, however, have slowed the spread of new technology and driven up costs.
To deal with this problem, the European Commission in the early 1990s embarked on an ambitious project of global harmonization. By necessity a long-range plan, harmonization work has forged ahead within the Global Harmonization Task Force (GHTF), but it may be many years before a medical product is approved once and accepted everywhere. In the meantime, the European Union has negotiated a series of more-attainable mutual recognition agreements (MRAs) with foreign partners. In May, the European Union signed an MRA with the United States, bringing together the world's two largest medical device markets.
MRAs are not designed to harmonize regulatory systems, but to enable conformity assessment bodies within the exporting country to assess compliance with the regulatory system in a product's destination country. Nevertheless, optimists hoped the dialogue between US FDA and the European Union would lead, in time, to the commonsense realization that this protocol was simply an unnecessary detour on the road to harmonization. That epiphany has not happened and it may, in fact, never materialize, according to Ian Cutler, director of European regulatory affairs at Smith & Nephew plc (London).
The MRA with the United States is not delivering any of the anticipated dividends for European interests, Cutler told attendees at a recent conference on Medical Device Regulation in Europe. Not only are the potential trading benefits dubious, but reciprocal market access is far from certain, he said. Furthermore, rather than easing regulatory restrictions, MRAs seem to be having the opposite effect, according to Cutler. "There is a tendency for the basis of the MRAs to be compounded by all the complex features from each set of regulations," a phenomenon that he called the "ratchet effect."
MRAs and global harmonization are developing into two different concepts, Cutler posited. "MRAs are not providing equivalent market access, and global harmonization continues to be a distant vision." In this scenario, everyone loses. "Excessive regulation will stifle and retard medical device development, increase the costs of market entry, discourage investment, and ultimately deny patients potential benefits," Cutler said. Consequently, the initial enthusiasm for MRAs is waning among Europe's stakeholders, at the same time that some countries are launching regulatory schemes at odds with the harmonization concept. Cutler cited systems implemented recently by Taiwan and by MERCOSUR, the trading bloc that comprises Argentina, Brazil, Chile, Paraguay and Uruguay, as two examples.
Enthusiasm for MRAs has not entirely vanished from the Earth—ironically, it has found a new home in the United States, which historically has not been a driving force of the movement. US FDA recently assumed the chairmanship of GHTF, and some industry observers have warned that the agency may tilt harmonization still more in its favour.
These glum reports are not the death knell of harmonization, but rather a wake-up call. The game is not played out, and industry has a crucial role to play to ensure that "approved once, accepted everywhere" does not become the Esperanto of device regulation. Industry needs unencumbered market access, freedom from excessive and costly bureaucratic legislation, and a straightforward mechanism to establish equivalence between existing regulatory regimes, as Cutler summarized. That message needs to be conveyed with conviction to national authorities.
MRAs may not be the perfect tools to achieve these ends, but they are the best available so far.
Additional coverage of the conference on Medical Device Regulation in Europe, organized by the Association of British Health-Care Industries and IBC UK Conferences Ltd., appears in the Industry News section.
