07.31.13
In May, a German member of the European parliament, Dagmar Roth-Behrendt, proposed a centralized authority to regulate and approve high-risk medical devices before they are sold on the European Union (EU) market. Roth-Behrendt asserted the European Union’s system—despite being known for being less bureaucratic than the U.S. system—was not rigorous enough, and therefore was posing a risk to patients.
One of the major factors that pushed Roth-Behrendt and her supporters to propose an overhaul of the European system of medical device approvals was the scandal that broke out in late 2011 over faulty breast implants. The French firm Poly Implant Prothèses (PIP) allegedly used cheap, industrial silicone not intended for medical use in its products for 10 years. Many of the breast implants were prone to rupture, causing dangerous leaks of silicone in women’s bodies. In France, of the 30,000 women who had PIP implants, almost half have had them removed and about 4,000 reported their implants rupturing. More than 5,000 women now are seeking compensation for harm dependent on the findings of the criminal trial of PIP’s founder and four senior executives.
When Roth-Behrendt first proposed a new system with suggestions such as a pre-market approval procedure for high-risk devices and the establishment of a committee for the authorization of medical devices within the European Medicines Agency to oversee the process, where patients would be represented, she met criticism. Naysayers were worried that this type of overhaul would cost the European Union its advantage over the United States. It typically takes devices considerably less time to reach the market in the European Union.
Serge Bernasconi, chief executive of Eucomed, the European medical technology industry association, said the industry agrees with doctors and patient organizations who say that changes are needed to improve the management of the current European system and keep pace with new medical technologies. He said, however, that the proposal by the Roth-Behrendt is not the right way forward.
“Europe has long been known as a world leader in providing its citizens with timely access to safe technology thanks to the effective decentralized approval system,” Bernasconi said. “We need to address the weaknesses of this system to make it even safer for patients without delaying access to safe, life-saving medical devices and without stifling innovation.”
He added that a case of criminal fraud like the PIP breast implant should never be allowed to happen again, but a centralized pre-marketing authorization system like the one proposed by Roth-Behrendt would not have prevented PIP.
“The suggestion that this system will allow approval within nine months is extremely optimistic. There are three points in the process which allow for potentially severe delays including a ‘clock-stop’ clause which can delay the approval process indefinitely. We need to keep what works and fix what needs to be improved instead of radically changing the system,” the chief executive said.
While the European Consumers’ Organisation supports Roth-Behrendt’s proposal for a centralized pre-market authorization system, the European Patients’ Forum is questioning whether such a change is needed, though it applauded the German parliament rapporteur for introducing more patient involvement earlier in the process.
Angelo Auricchio, M.D., a member of the European Society of Cardiology and president of the European Heart Rhythm Association, expressed vehement disapproval of what some clinicians and industry experts, including him, see as a move towards the approval methods of the U.S. Food and Drug Administration.
“I do accept that there have been issues in the past and there continue to be issues, but these issues can be solved,” Auricchio said. “Europe has to have a much different way of regulating things compared to what the United States has.”
The German parliament’s Environment, Public Health and Food Safety committee is scheduled to vote on Roth-Behrendt’s’s draft report later this year.
One of the major factors that pushed Roth-Behrendt and her supporters to propose an overhaul of the European system of medical device approvals was the scandal that broke out in late 2011 over faulty breast implants. The French firm Poly Implant Prothèses (PIP) allegedly used cheap, industrial silicone not intended for medical use in its products for 10 years. Many of the breast implants were prone to rupture, causing dangerous leaks of silicone in women’s bodies. In France, of the 30,000 women who had PIP implants, almost half have had them removed and about 4,000 reported their implants rupturing. More than 5,000 women now are seeking compensation for harm dependent on the findings of the criminal trial of PIP’s founder and four senior executives.
When Roth-Behrendt first proposed a new system with suggestions such as a pre-market approval procedure for high-risk devices and the establishment of a committee for the authorization of medical devices within the European Medicines Agency to oversee the process, where patients would be represented, she met criticism. Naysayers were worried that this type of overhaul would cost the European Union its advantage over the United States. It typically takes devices considerably less time to reach the market in the European Union.
Serge Bernasconi, chief executive of Eucomed, the European medical technology industry association, said the industry agrees with doctors and patient organizations who say that changes are needed to improve the management of the current European system and keep pace with new medical technologies. He said, however, that the proposal by the Roth-Behrendt is not the right way forward.
“Europe has long been known as a world leader in providing its citizens with timely access to safe technology thanks to the effective decentralized approval system,” Bernasconi said. “We need to address the weaknesses of this system to make it even safer for patients without delaying access to safe, life-saving medical devices and without stifling innovation.”
He added that a case of criminal fraud like the PIP breast implant should never be allowed to happen again, but a centralized pre-marketing authorization system like the one proposed by Roth-Behrendt would not have prevented PIP.
“The suggestion that this system will allow approval within nine months is extremely optimistic. There are three points in the process which allow for potentially severe delays including a ‘clock-stop’ clause which can delay the approval process indefinitely. We need to keep what works and fix what needs to be improved instead of radically changing the system,” the chief executive said.
While the European Consumers’ Organisation supports Roth-Behrendt’s proposal for a centralized pre-market authorization system, the European Patients’ Forum is questioning whether such a change is needed, though it applauded the German parliament rapporteur for introducing more patient involvement earlier in the process.
Angelo Auricchio, M.D., a member of the European Society of Cardiology and president of the European Heart Rhythm Association, expressed vehement disapproval of what some clinicians and industry experts, including him, see as a move towards the approval methods of the U.S. Food and Drug Administration.
“I do accept that there have been issues in the past and there continue to be issues, but these issues can be solved,” Auricchio said. “Europe has to have a much different way of regulating things compared to what the United States has.”
The German parliament’s Environment, Public Health and Food Safety committee is scheduled to vote on Roth-Behrendt’s’s draft report later this year.