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EU and Medical Agencies must issue Emergency Use Authorization for coronavirus med tech

EU and Medical Agencies must issue Emergency Use Authorization for coronavirus med tech

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This petition has been created by Bullitt D. and may not represent the views of the Avaaz community.
Bullitt D.
started this petition to
EU, EU Parliament, CEN/ ELEC, ISO, Thierry Breton, health ministries of individual states
The EC has already asked the CEN and CENELEC to make standards for protective medical equipment available for free. Why not PAPRs and ventilators?  (This list: https://www.cencenelec.eu/News/Press_Releases/Pages/PR-2020-003.aspx does not include medical devices.) Government are awarding contracts to large manufacturers who have no experience with medical devices. Before this emergency, it had been small to medium businesses that filled the niche. Now indepedent developers are kept from 'trade secrets'-- which are actually necessary standards and regulations-- by inaccessibility and a pay wall. 

Health care systems in the EU are well beyond capacity. Hospitals need to increase capacity with emergency technology like low cost PAPR and open source ventilators NOW. Patients have no time to wait for the long process of CE approval. Yet, independent developers are unable to make devices to meet specified quality because standards and electronics safety testing are not accessible.

The FDA has already promulgated Emergency Use Authorization enforcement policy to fast track ventilators being manufactured.
https://www.fda.gov/media/136318/download
The UK government has promulgated specs for Rapidly Manufactured Ventilator Systems:
https://www.gov.uk/government/publications/coronavirus-covid-19-ventilator-supply-specification/rapidly-manufactured-ventilator-system-specification
and made ISO and UK standards free to the public:
https://www.bsigroup.com/en-GB/topics/novel-coronavirus-covid-19/ventilators/

In contrast, individual EU member states have not made guidelines accessible and CEN and CENELEC continue to require developers to buy the standards . Testing facilities are closed due to the lockdown and in. Developers cannot even conduct testing at their own cost. The EU can support people living in its member states by adapting the application of CE and testing requirements, it has not. By not doing so, t he EU is favoring large business and institutions over people.

The EU's lethargic reaction is failing all European member communities, slowing down the return to everyday activities. The people of the EU have the talent and capacity to produce domestic solutions. Many are ready for non-commercial production. But they cannot meet standards because of the imposed inaccessibility.


The EU has the ability to encourage immediate medical device production by promulgating a policy similar to the EMA's early access compassionate use scheme for medications, adapting the expanded access scheme to medical devices and expedite the approval process. Interestingly, it is doing the opposite. The EU Parliament has the duty to facilitate electrical compliance testing and adapt application of CE and other compliance laws in the face of the emergency.
 
The health ministries of EU member states have the obligation to respond to demands in their hospitals as well as in-home self care . They also have the power to call for help from their populations as the US and UK did, by making standards and testing accessible. They are not. A change in the EU policy will surely prompt member state governments to clear obstacles for developers, just as some non-EU countries have already done.
Promises of funding long term research is lip service, it does not answer IMMEDIATE needs. Innovation means practical applications, it is not a buzzword nor mere appearance. Clear the red tape now.

(A version of this petition directed at the EU Parliament was submitted via its web portal on the 3rd of April; also presented to Mr. Breton on 5th of April.)




--Updates--

15 April -   registered as petition #0403/2020 by the European Parliament secretary general















Posted (Updated )