According to a story from Financial Review, the US is not the only place in the world where lobbying is a central component of political activity. So far, lawmakers in Europe have introduced new proposals to update safety regulations for a diverse array of implanted medical devices in recent years, only to have industry lobbyists mislead them into curtailing their efforts.
Safety Should be Priority
These safety regulations medical implants, like defibrillators, stents, breast implants, and pacemakers. Rare disease patients often rely in medical devices to keep themselves alive. Many public health experts and rare patient advocates say that the EU is in dire need of updated safety rules for these devices as well as many others. Although most patients are able to successfully benefit from these devices without any serious issues, the EU has also seen major stories pop-up from time to time with failing medical devices as the central focus. These failures can and do lead to fatal results.
Innovation, the Buzzword of Deceivers
Medical devices have been getting approved at a steady and quickening clip in recent years in the US, but many companies can turn to the EU in order to get new medical devices approved even more quickly, as the EU has very light regulations when it comes to these devices. Device companies and lobbyists around the world have hailed the EU rules as the cutting edge world standard of innovation, an all too common trope from dishonest actors who aim to sweep aside necessary regulations and protections for the people who may actually have to rely on these devices to stay alive.
This is the unfortunate result of an economic system that treats medicine as another for-profit playpen that the unscrupulous can exploit in order to make a quick buck. Many countries across the world approve medical devices quite readily if they are cleared in the EU, despite the minimal standards.
Lucky to be Alive
Winery manager Jürgen Thoma of Freiburg, Germany is an example of a patient in need that the lobbyists and device manufacturers have more or less labeled as disposable. He received an all metal replacement hip designed by a US company. In the EU, the device was approved without any clinical testing; the company simply argued that it was similar enough to already approved devices, and that was enough. After fragments of metal from the device caused him pain and a bone infection, he was able to win a paltry €25,000 in damages for his trouble.
Mr. Thoma was fortunate to survive, much less receive any compensation. Many incidents of devices failures go unreported, although new regulations in some countries have been improving this trend. The EU has finally passed a new regulation law that will go into effect in 2020, but industry meddling has ensured that the legislation has far less potency than it would have otherwise.
