Deborah Cohen: Despite recent scandals, implantable devices will not have to undergo clinical studies, leaked European draft legislation reveals

Deborah Cohen

Metal on metal hips; breast implants; cardiac devices—the list of European device regulatory failures goes on. And it may be set to continue, if current EU proposals to “reform” device regulation go ahead.

To try to alleviate consumer concerns two years ago, the European Commission—responsible for developing the legislation about how medical devices are regulated—decided to revisit their guidance.  They are due to issue a proposal in June.

A letter sent to the European Commission by the European Consumer Organisation (BEUC) in January this year urged policy makers, in light of a litany of device failures, to put patient safety first. They asked the European authorities to ensure that implants should have a “form of marketing authorisation similar to that foreseen for medicines.”

A subsequent letter sent to Sabine Lecrenier, the lawyer who is drafting the updated proposals, by BEUC on 19 March says that: “The breast and the hip implants cases clearly showed that the current rules are not adequate and that the whole system needs to be reviewed. These recent scandals undermined consumers’ confidence in medical devices.”

However, such concerns seem set to fall by the wayside. Draft EU proposals seen by the BMJ suggest that European officials don’t intend to change the current system much. Under current medical device legislation, manufacturers of high risk medical devices—such as hip prostheses, breast implants, and pacemakers—do not have to undergo clinical studies or trials before they are used in thousands of patients. It is the lack of clinical studies that has been a source of surprise and consternation in light of the high profile scandals.

Nevertheless, bureaucrats in the European directorate for public health—called DG SANCO—have little appetite to introduce higher hurdles for manufacturers. In the US, many new high risk devices have to undergo thorough clinical studies before their regulator, the Food and Drugs Administration, allows them on to the general medical market.

Europe wants to protect its medical technology market and not lose competitive advantage to the US. Currently, Europe is a hotbed for medical innovation as companies have far easier access to the market—which has led some doctors to describe patients here as guinea pigs and industry to applaud the streamlined regulation.

France is one such country calling for more premarket clinical studies. In response to the PIP breast implant scandal, the French health authorities have recommended that clinical studies should be performed before the medical device is approved for sale.

But some within the Commission have dismissed this as political electioneering said to garner votes in forthcoming elections. Even though it is the public health division of the European Commission that is responsible for reworking the legislation, it remains unconvinced about the need to perform studies to demonstrate safety and efficacy—even for implantable devices that have a direct impact on health outcomes.

Sources have told the BMJ that to recommend more premarket studies, the EC says there needs to be compelling scientific evidence that this is necessary and cost effective.

Discussions about the future of device regulation in the EU have focused primarily on enhancing the innovativeness and competitiveness of the medical devices industry.

At a high-level conference in March 2011, EU Health and Consumer Commissioner John Dalli, and Hungary’s Minister of State for Health Miklós Szócska, called for “improvements in the innovation process so that, safe, life-saving, and life-enhancing medical equipment can be brought to Europe’s patients and consumers as quickly as possible.”

Sources say that one argument that is determining the direction of travel is economic growth—industry says that by demanding more rigorous testing this will restrict market entry and limit jobs. It’s not clear how this argument bears out.

But also standing in the way of substantive reform are representatives from Italy and European powerhouse Germany—home to a thriving medical technology industry.

Health professionals have also expressed concern about how fragmented the system currently is, with little or no transparency.

More than 70 private organisations—”notified bodies”—currently check the device meets certain criteria and gives it a certificate allowing it to display a CE Mark. Once it has this stamp, the device can be used in patients all over Europe. Regulators in member states make sure these bodies are up to their job. But patients and doctors are unable to see the scientific basis on how an implant has entered the market.

This will not change. There will be no overarching body responsible for assessing the efficacy and safety of devices or for post-marketing studies like there is for drugs—the European Medicines Agency or the US Food and Drugs Administration. The furthest the commission is willing to go is to have a small European Expert Group on Medical Devices to offer advice that will sit within the European Commission itself or the  EMA.

National regulatory authorities, such as the MHRA, will be given more control over the notified bodies. They will check that the bodies have the in house expertise to assess medical devices and they make available the information for evaluation—to the national regulators at least. There is a push for more cooperation between the notified bodies and clarity over the criteria used to make assessment.

Post-marketing surveillance has also been left up to the companies. The directive related to implants depends largely on self policing by manufacturers once their products are approved for sale. Patients and health professionals can report problems directly to the national regulator, such as the MHRA, if problems occur. The PIP and hip prosthesis scandals have highlighted that this system has failed to protect patients.

In 2010, there were only 728 reports made to the national regulators across Europe— even though it has subsequently come to light that many devices have caused problems. There were 286 from Germany, 1 from Portugal, 2 from Finland, 7 from Italy, 141 from the UK, and 59 from France. And under the current system, it’s not clear what devices these were referring to.

The draft legislation says that there should be more post-marketing surveillance—but has fallen short of recommending large post-approval studies as happens with drugs. The European Commission just want a more joined-up approach to collecting adverse reactions on a central database. Whether the public will have access to this remains to be seen—increasing transparency has not been a central theme.

Deborah Cohen is investigations editor, BMJ