Brussels, 22/10/2013 (Agence Europe) - On Tuesday 22 October, the European Parliament voted in favour of stricter monitoring and certification procedures to ensure full compliance and traceability of medical devices. MEPs also tightened up information and ethical requirements for diagnostic medical devices used for in vitro testing. Meeting up for their plenary meeting in Strasbourg, the European Parliament adopted the report by Dagmar Roth-Behrendt (S&D, Germany) on medical devices by 569 in favour, 79 against and 44 abstentions. It also adopted the report by Peter Liese (EPP, Germany) on in vitro medical devices by 525 in favour, 21 against, with 132 abstentions. Peter Liese said that this is a good day for European patients. The rapporteur also explained that they needed to find a balanced solution guaranteeing patient safety and respect for the industry's need to be competitive and innovative. The MEP expects criticism from the industry but said that they needed a balanced solution and industry should be able to work with it. Roth-Behrendt did not hide her disappointment that a system advocating preliminary authorisation being introduced before high risk products could be marketed, had not received the support she expected and she criticised the divergences in the EPP group. She asserted that “this system would have given a stronger role to the European agency for public health, the European Medicines Agency (EMA), which would have made sense.” She added that she was going to guide the trilogue towards something reasonable, saying that today we are witnessing something that is unreasonable.
The legislative proposals adopted by the European Parliament aimed to rectify inconsistencies in the interpretation of current rules. They also aim to provide more public health protection, improve the transparency of information provided to patients and strengthen traceability rules, without creating additional costs for innovative small companies. Roth-Behrendt emphasised that, “We talk about products which are supposed to help patients in their suffering, in their illness. We should assist doctors in making sure they are using the best possible products when they want to assist their patients”. The amendments adopted by the Parliament should help enhance access to clinical data for health professionals and patients, so that they are better informed about the products used. MEPs would also like patients who have implants to be given a registered “implant card”, which includes essential data so that they are aware if anything has happened with similar products. Although the bodies in charge of assessing the safety of medical devices often use subcontractors, MEPs would like them to have a permanent team of qualified experts in the future. A new group of EMA appointed bodies would also assess devices that are considered high risk, such as those used for implants in the human body. MEPs would also like to strengthen safety when single-use devices are reused on other patients (catheters or tweezers, for example). According to MEPs, people or institutions that want to reuse a single-use device should ensure the traceability of the device in question and assume responsibility for the retreatment action undertaken. With regard to the report by Peter Liese, MEPs strengthened safety rules for diagnostic devices used such as those used for pregnancy, diabetes, HIV or DNA tests. The Parliament called for an ethics committee to be set up and provisions introduced for the informed consent of patients and genetic counselling.
The EPP and conservatives from the ECR did not agree to Roth-Behrendt's proposal in favour of a centralised marketing authority and said that if this were set up it would have a negative impact on the competitiveness and innovation of companies. Michèle Rivasi (Greens, France) regretted this. She said that the compromise the Parliament had finally obtained on at-risk devices and greater monitoring of their work by the authorities really is the minimum we can accept. Similarly to Roth-Behrendt, she regretted the intensive lobbying from industry, which had succeeded in ensuring that the Parliament reduces the control mechanisms initially planned. Nonetheless, the Greens welcomed a ban on carcinogenic, mutagenic and repro-toxic substances in cosmetics and that toys had been expanded to include medical devices.
The rapporteurs managed to get the Parliament to agree to a negotiating brief with the Council for reaching a common position on the subject. The Parliament criticised the delay that had built up at the Council in its work in this connection and the fact that the Council had still not reached a position. Rapporteur Liese is hoping that negotiations could begin before the end of the year so as not to compromise adoption of the texts before the end of the current legislature. (IL/transl.fl)