Stricter monitoring, stronger certification bodies, better traceability: following several recent scandals like the PIP breast implant and the hip "metal on metal", health MEPs amended draft legislation in order to better protect patients on Wednesday. They also introduced stricter rules on informed consent and ethics in a separate law on in vitro diagnostic medical devices, used for example for HIV and DNA testing.
The legislative proposals aim to iron out inconsistencies in the interpretation of current rules, boost public health protection, remove obstacles faced by industry in the EU internal market, improve transparency of information to patients and strengthen traceability rules.
"We have achieved our main objective: patients will be better protected from defective products. We were able to enforce our goals and to be more ambitious than the Commission proposal. We really needed to put patient safety first and to bring transparency to an industry that is quite unregulated", said rapporteur Dagmar Roth-Behrendt (S&D, DE).
“We now hope that the improvements we have achieved will not be diluted later in the legislative process”, she added.
The committee’s amendments would boost public access to clinical data, create a new approach to labelling medical devices, and create a new advisory body of experts. Beefed-up conformity assessment bodies (called “notified bodies”) will provide closer scrutiny of manufacturers’ own product safety tests. The bodies must have a permanent team of in house experts who meet new requirements for minimum qualification requirements.
MEPs propose that special notified bodies are designated by the European Medicines Agency in order to assess a select number of devices that pose the highest risk. For certain high risk devices, a special case-by-case check will be conducted by a proposed new expert body - the Assessment Committee for Medical Devices.
In vitro diagnostic medical devices
In separate legislation aiming at reinforcing patient safety for in vitro diagnostic medical devices (such as for diabetes, HIV and DNA), the committee called for involvement of an ethics committee and introduced provisions on informed consent and genetic counselling.
"Europe has a duty to make sure that advice for genetic tests is provided. Unfortunately, not all EU countries rules currently protect patients. It is very important that DNA tests are carried out in a protected area, by trained staff, and that appropriate consultation takes place", said Peter Liese (EPP, DE), the MEP responsible for steering the legislation through parliament.
MEPs also set new conditions for the involvement of minors and incapacitated people in clinical studies and proposed new criteria regarding access to data collected in such studies.
Both draft laws are due to be put to a vote by the full House during the 21 to 24 October session in Strasbourg.