The European Affairs Consulting Group
The Transatlantic Trade and Investment Partnership, for short TTIP, has provoked considerable discussion of both its merits and drawbacks. Although rarely mentioned in the public arena, the medical devices sector deserves closer attention. The sector is significant, with the US constituting the world’s largest market and a current trade deficit of 1.9 $ bn on the part of the EU. With a common context of ageing populations medical devices, encompassing everything from elastic bandages to pacemakers, will most likely grow in importance on both sides of the Atlantic.
With the 9th round of negotiations ahead this month, it is time to take stock and take a closer look at the medical devices sector in TTIP, considering what has been achieved thus far.
Road to market – current process
Currently producers have to go through different market authorisation regimes that require different forms, audits and reviews. The process is decentralised in the EU with 66 different Notified Bodies (accredited by the member states) undertaking the testing that ultimately leads to a CE certificate. In the US there is only one body, the Food and Drugs Administration, which is in charge of testing and provides the FDA “Approved” and FDA “510 k” certificates. Even though slightly different in execution both systems provide for different strictness of testing depending on associated risks.
Aims of negotiations
As a sector that has seen tariffs lifted in recent decades, regulatory cooperation is the foremost aim in the negotiations. The rationale can be summarised as the following:
Double testing and registration leads to higher costs for industry and delays for consumers.
The aims in the negotiations are several: establish compatible identification and tracking systems for medical devices based on the Unique Device Identification (UDI) scheme, achieve mutual recognition of Quality Management System audits, harmonise application forms for the separate application processes and jointly develop future regulation in areas that are not yet regulated.
The aims of closer cooperation are to be achieved within the framework of the International Medical Devices Regulatory Forum (IMDRF). This is a forum for future discussions on regulation of the medical device sector. It includes the EU and the US as well as Australia, Brazil, Canada, China and Japan.
Like most sectors in the negotiations consumers’ and corporations’ interests meet and potentially conflict.
Consumer advocacy groups are at least in parts positive in their outlook, with a hope for `upward harmonisation´ of EU regulation to US level and a quicker authorisation process. There are nevertheless still other reservations, such as a loss of transparency due to extended commercial confidentiality.
The industry has showed strong support for the potential of medical devices within the TTIP negotiations. The potential benefits for them lie in the areas of industry growth, improved patient access and safeguarding the lead of American and European businesses in the world.
State of negotiations
Medical devices have featured in most negotiation rounds so far. The matter that seems to have received some increased attention is that of Quality Management Systems. Especially the participation of the EU as an observer on the Medical Devices Single Audit Program (MDSAP) seems to have been a matter of discussion. This is an initiative on the basis of the already mentioned IMDRF, which aims to develop a single audit programme for medical devices that satisfies the requirements of the different national QMS audits. So far this only includes regulators from Australia, Brazil, Canada, the US and most recently Japan. Medical devices would most likely also feature within the scope of the Regulatory Cooperation Council (RCC).
For more information:
Markedly ahead of schedule, by at least a month, an EU position paper on medical devices in the TTIP negotiations has been published. It as well as all other publicly available documents released by the European Commission’s DG TRADE can be found here
For the view of consumer organisation BEUC click here
A statement by the medical devices industry on the TTIP negotiations can be found here