Originally Published EMDM May/June 2005
A NOTE FROM THE EDITOR
What the World Needs Now. . .
You may have noticed that this issue marks the 15th anniversary of EMDM. We haven’t exactly been subtle about it. Nor should we be.
The past 15 years have been a time of momentous change for the European community and the device industry. Think back: in 1990, a patchwork of national laws regulated the development and marketing of medical technology. There was no single currency. Cross-border trade was fraught with obstacles. The advent of new-approach directives, open borders, and the euro has radically altered this landscape. EMDM has been a witness to and, in its own small way, an advocate of this transformation.
In the first issue of International Medical Device and Diagnostic Industry, which was rechristened European Medical Device Manufacturer in 1994, Jean-Marie Vlassembrouck, then director of EC governmental affairs with Baxter in Brussels, wrote about challenges facing the device industry. He began his article with the following paragraph:
“Politicians, industrialists, consumers, and union representatives agree that the European single market will be a reality tomorrow. The events in Eastern Europe will speed up the political integration of the European Economic Community . . . Euro-pessimism is history.”
Vlassembrouck’s comments were prescient . . . with one exception:
Euro-pessimism is alive and well. It thrives in the United Kingdom, of course, and flares up occasionally on the continent. In a surprising turn of events, the malaise seems to have migrated to France.
As I write this column, the French are preparing to cast votes in a referendum on the European Constitution. Opinion polls suggest that les nons will carry the day. Depending on whom you believe, the repercussions could range from a momentary setback to a dismantling of the European Union as we know it.
In a televised debate with French students, Jacques Chirac fielded questions and tried to explain why a yes vote mattered. From what I could tell, many in the audience weren’t buying it. Chirac grew increasingly frustrated as question after question revolved around national issues that had no relevance to the constitution. Chirac and his questioners were talking at cross purposes.
I bring up this dialectical disconnect because of something Dario Pirovano, EUCOMED’s regulatory affairs director, writes in his article on the history of the medical device directives (see page 56). Like the European Union, Europe’s regulatory system for medical devices has been a remarkable success story. And yet, Pirovano feels the need to go on the defensive. He has good reason to do so.
An Italian legislator critical of the medical device directives is quoted by Pirovano as saying that medical equipment is covered only by the CE mark, “which applies also to toys.” This makes for a good sound bite on the evening news, but it is devoid of meaning. Meanwhile, some legislative busybodies are calling for more-rigorous scrutiny of medical devices by applying concepts used to regulate drugs. It’s an absurd proposition to those of us who know the industry. But let’s face it: it takes talent to explain precisely why it’s absurd to the general public that has just gorged itself on the latest tabloid exposé on “Medical Devices that Kill.”
We’ve come a long way, and I invite you to turn to the 15th Anniversary Section starting on page 55 for a refresher course. But we must also guard against complacency. The device industry must find more effective ways to communicate its achievements to the world at large. And French voters should find a more productive way to channel discontent with their government than by rocking the foundations of the European Union.
Copyright ©2005 European Medical Device Manufacturer
