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Tobacco Product Directive

On May 30 the ENVI Committee discussed amendments to the proposed Tobacco Product Directive, which is currently being discussed at the European Parliament. More than 1360 amendments were tabled and EFA is going to have a look at all of them and advocate for those which will help to put people off smoking and relieve the burden for patients already suffering from respiratory diseases. The proposal was also discussed at the Council working party meeting and at the European Economic and Social Committee (EESC) – the EESC Bureau eventually decided to postpone adoption of the opinion on the Directive to July plenary session. In May, the regulation of electronic cigarettes, tobacco control measures and plain packaging dominated the public debate regarding the TPD. For more information, check the special section devoted to the proposed Tobacco Product Directive in our May e-zine.  

Medical Devices Regulation

The ENVI Committee and the IMCO Committee of the European Parliament discussed amendments to the Medical Devices Regulation on May 29. MEPs proposed more than 900 amendments to the regulation, most of them focused on the pre-authorisation procedure of medical devices, definition of single use products, reprocessing and monitoring of notified bodies. Many different opinions arose. As the rapporteur responsible for the dossier Dagmar Roth-Behrendt (S&D) pointed out, it is going to be hard to find a compromise. EFA will continue monitoring this topic very closely to ensure that the perspectives of people with allergy and respiratory diseases are taken into consideration, while patients’ safety and involvement are enhanced and transparency strengthened. Watch the meeting on-line here.  

Clinical Trials Regulation

On May 29 the ENVI Committee of the European Parliament voted on report on the Clinical Trials Regulation prepared by rapporteur Glenis Willmott (S&D).The regulation focuses on patients’ safety and aims at enhancing transparency of trial results. EFA is supporting the European Patients Forum (EPF) position statement on this issue, emphasising the need to ensure that patients involvement is strengthened and their safety guaranteed. Watch the vote on-line here.