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EU Policy Updates

Adoption of a strong Tobacco Products Directive in danger!

The European Parliament rescheduled the debate and the vote on the Tobacco Products Directive which should have taken place in September 2013. After several Members of the European Parliament (MEPs) complained that they did not have enough time to go through the report and German MEPs declared they had to focus on German national elections, the tobacco agenda was moved to the October session (check the statement of EU health campaigners here).

EFA, together with other health campaigners, is concerned that this delay is just another attempt of the tobacco industry to hamper the efforts of ENVI committee to protect health of European citizens and weaken the text of the Directive. Moreover, the adoption of the directive is now in a serious danger as the European Parliament’s elections are coming early next year and there might not be enough time to get the text approved.

This delay already significantly reduces the time for Parliament’s negotiations with the Council of the EU and puts the possibility of reaching an agreement before the Health Council on December 10 in danger.

EFA welcomed the position of the ENVI committee, the leading committee responsible for the dossier in the Parliament, which adopted a strong position on the Tobacco Products Directive in July 2013. Members of ENVI supported large pictorial warnings covering 75% of the package, ban on flavourings and slim cigarettes, and regulation of e-cigarettes as medicinal products.

EFA now keeps on advocating for the strongest directive possible. The vote is now scheduled for October 8 and we call on European policy makers to stand up to the interest of tobacco industry and vote for a strong Tobacco Products Directive. Any delay now might bring the whole legislative process to its very beginning and put lives and health of European citizens in danger.

More information on the directive here.

 

ENVI voted on medical devices

The vote on medical devices, another legislative dossier of major concern for EFA, has at first been postponed and in the end the ENVI leading committee has voted on the report of Mrs. Roth-Behrendt MEP on September 25.

The medical devices regulation is a very important piece of legislation as it affects millions of patients in Europe. For instance, medical oxygen containers, inhalers or adrenaline auto-injectors fall under the scope of this regulation and are essential for people with allergies and respiratory diseases (check EFA’s briefing on medical devices here).

The MEPs with their votes supported higher patients safety through more transparent information and better product traceability. A special system of pre-market approval for high risk medical devices has been introduced with the involvement of the European Medicines Agency. Ethics committees now have to approve clinical investigations and patients’ involvement has been strengthened. EFA is satisfied with the ENVI vote and we will continue advocating for patient’s safety ahead of the plenary vote scheduled for October.

We at EFA think that it is necessary to guarantee the safety and efficacy of such devices, and also empower patients to take active role in their own care which will enable them to manage their disease better. Delay in adoption of this text puts the effort to guarantee patients’ safety and ability to take informed decisions at risk.

First reading in the Parliament’s plenary will now take place on October 22. Similarly to the Tobacco Products Directive, a delay might the whole legislative process in danger as there might not be enough time to get the text approved in the Parliament and negotiate the position with the Council of the EU before the elections in May 2014.More information on the regulation here.

 

Clinical trials regulation will be voted on in March 2014

Regulation of clinical trials is another crucial piece of legislation awaiting a debate in the Parliament’s plenary. According to the preliminary schedule, even this discussion has been rescheduled and is now about to take place in March 2014.

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.

EFA is concerned that postponing the debate to the next spring means that the legislation will not be approved and patients’ safety thus not enhanced and guaranteed.

As regards transparency in clinical trials, through EPF, EFA has responded to the EMA public consultation on its draft policy on the publication and access to clinical-trial data. EFA welcomes EMA draft policy and believes that clinical trials data should be published to benefit research and public health, although the protection of personal data of patients involved should always come first.

More information here.

 

F-gases will be discussed in January 2014

The regulation of fluorinated greenhouse gases is awaiting its first reading in the plenary of the European Parliament in January next year. This piece of legislation is very important for EFA, as it might affect patients in need of hyfrofluorcarbons-based metered dose inhalers (HFC-based MDIs).

EFA monitors developments in this area closely and advocates for the best possible outcomes for people suffering from asthma, allergy and COPD together with IPCRG (International Primary Care Respiratory Group) and HOPE (European Hospital and Healthcare Federation).

More information here.

 

Seventh Environment Action Programme to be adopted in October

The plenary of the European Parliament will vote on Mr. Franco MEP report on the seventh environmental action programme in October. EFA welcomed the ENVI report as for the first time, the programme gives due weight to improving the quality of the indoor air. In addition, it sets the goal that by 2020 outdoor air quality has significantly improved, moving closer to WHO recommended levels and has the overall objective of protecting the health of most vulnerable groups in particular.

More information here.

 

Pollen monitoring in Europe

Pollen emissions are not man-made and hence cannot be reduced by Member States action. That was the Commission’s reply to a question on facilitating real-time pollen monitoring in the EU, asked by the Italian MEP Andrea Zanoni earlier this year.

While pollen might not be directly produced by humans, pollen emissions are very much affected by human activities. Therefore, EFA (the European Federation of Allergy and Airways Diseases Patients Associations), EAACI (the European Academy of Allergy and Clinical Immunology) and ERS (the European Respiratory Society) do not agree with this position. To put the record straight, EFA office prepared and sent out a press release – available here.  

The production of pollen is directly affected by air pollution resulting from human activity and by planting of unsuitable plants (birch trees, olive trees, oilseed rapes etc.) in immediate vicinity of people’s homes. Since various allergies triggered and aggravated by airborne allergenic pollen affect more than 24% adults and up to 40% children in Europe, it is high time for the European authorities to reconsider their position and step up to protect and inform allergic people in Europe.

EFA, EAACI and ERS believe that in an increasingly integrated Europe real-time pollen monitoring and dissemination of information on pollen levels have to be guaranteed and its funding secured. We call on the European Commission to step up and include monitoring of pollen levels in all EU Members States into the clean Air for Europe Programme, because it is a matter of great importance for European citizens and public health.

Download the Press release in PDF.

 

1 Comment

  • EU Policy Updates

    Oct 31, 2013

    [...] The main difference to the text adopted by the ENVI committee in September (last issue of the eZine informed you on this) is that now not all medical devices are considered as reusable by default. If [...]

EFA eZine Archive