Further need for medical devices to be regulated?

What's in it for rare disease patients?

The European Commission has called for a Public Consultation on a Recast of all EU Medical Devices Directives. A medical device is an object which is useful for diagnostic or therapeutic purposes. Often overlooked by the health system, they can greatly contribute to the life expectancy and quality of life of patients. This is especially true for many rare disease patients for whom no therapeutic cure exists and for whom the, often life-long, use of specialised medical devices is the only way of alleviating their suffering. Medical devices can also play a crucial role when combined with a medicinal product, for example nebuliser devices for Cystic Fibrosis or implantable drug delivery pumps to alleviate chronic pain or deliver cancer chemotherapies.

There are currently several EC directives adopted through the '90s and early '00s, already in place, which aim at regulating the manufacturing and marketing of medical devices, including active implantable medical devices and in vitro diagnostic medical devices. However, the Commission is now seeking to simplify the system by consolidating these texts into one legal framework with the aim to reinforce patient safety issues.

Some stakeholders disagree not with the principle - most people would agree that patient safety needs to be ensured - but with the means. They are afraid that tampering with existing legislation, which has been recently revised, will complicate the rules and therefore increase the cost and notably delay the placing on the market of valuable medical devices.

Such is the view of EURORDIS who, already in a previous consultation on medical devices in 2005, welcomed the opportunity for patient representatives to join the debate but firmly rejected any attempt to over-regulate an industry, which has no record of patient safety problems and is of vital importance to rare disease patients.

“This recast is based on the not solid assumption that there is an issue of safety today in the EU for patients with medical devices. This is not our view. In 10 years we never had a rare disease patient safety issue reported to us,” says EURORDIS Chief Executive Officer Yann Le Cam. “On the contrary, the proposed new legislation, aimed at increasing safety, will require more clinical trials before authorisation, and a more thorough regulatory and scientific process for approval. This will result in a dramatic increase of cost for development and maintenance on the market, growing issues of pricing and reimbursement and increased delays of access. Overall, it will create issues of access to medical devices for rare disease patients, where there are none today. Therefore it will turn against the interest of patients.”

EURORDIS and the European Federation of Medical Technology Manufacturers and Suppliers (Eucomed) are also concerned that the proposed system would have a negative impact on the medical devices manufacturing sector because of increased registration costs and increased time to the market. “If the product is ready and is not getting to the market because of bureaucratic hurdles, this represents a big cost for all companies, especially small and medium enterprises (SMEs), which make up most of the sector,” argues Dario Pirovano, Director of Regulatory Affairs at Eucomed. “Moreover, there is no proof that making the system more cumbersome will make these products safer.”

Patient representatives, like EURORDIS, manufacturers' representatives, like Eucomed, and the medical community at large, agree that, unlike orphan drugs, the biggest bottleneck when producing medical devices is not lack of incentives for research and development, but rather the high cost of these devices and the uneven reimbursement thresholds applied by each Member State. 'If you think that some medical devices can cost some hundreds of euros and that many need to be constantly replaced, you understand that reimbursement is vital.' explains Dario Pirovano.

In order to lower the cost of medical devices and make them more accessible to patients, the United States has come up with a system that grants fee waivers for the registration of designated devices. Designated devices are granted a Humanitarian Medical Device (HMD) label. This U.S legislation has had a very limited impact and only a handful of devices would not have been developed without these incentives. However, the idea of a “label” is one that EURORDIS is keen to promote in Europe.

“The label of rare disease medical device would help alleviate the problem of accessibility by guiding on the reimbursement decisions. Involving patients actively in the reporting and monitoring of medical devices will serve to closely monitor the industry since patients will be the first to flag safety problems if they occur,' argues Flaminia Macchia, Director of Public Affairs at EURORDIS. 'The problems faced by users at present have more to do with lack of access due to reimbursements than with safety.'

For more information go to:
EURORDIS Contribution July 2008
EURORDIS Contribution June 2005
EU Directives on Medical Devices
 

This article was previously published in the November 2008 issue of our newsletter.

Author: Paloma Tejada
Photo credits: All photos © European Commission except RD patient © EURORDIS