kfajdsl/voxpopuli huggingface dataset:
we must ensure a high level of health and safety protection for eu citizens using these products and must adapt the eu legislation to the significant technological and scientific progress in this sector over the last twenty years.
while focusing on consumer safety i would also acknowledge the importance of innovation and these proposals do exactly that.
indeed in the wake of the breast implant and metalonmetal hip scandals of two thousand and twelve it is now more important than ever that patient confidence be restored.
i firmly believe that support for these proposals is warranted. with the introduction of more systematic post market checks as well as stricter monitoring and traceability measures these proposals create a framework whereby errors are more easily identifiable allowing for more targeted and efficient responses and minimising any negative fallout.
so i think you have got the balance right and i will be very happy to vote for this tomorrow.
i am often one of the first to say that additional regulation can be burdensome however when it comes to the realm of public health especially when lives are in jeopardy and the safety of our healthcare system is questioned tighter oversight and control mechanisms are vital.
throughout our work on this legislation we had in mind that we needed stronger rules to improve device safety and protect patients without stifling the innovation that is a key feature of the industry in europe.
this will strengthen requirements for medical devices and require high risk devices to undergo additional pre market assessment.
it is clear that member states will have to cooperate and share information and the new eu wide database eudamed will help them do that.
once again thank you to everyone who has helped us to get to this stage and again in particular to all of our staff and the group staff who have worked their socks off on this.
unfortunately we cannot go back in time and prevent past scandals from happening but with this legislation we can make them much less likely in the future.
i hope we have strong support in the vote tomorrow because at the end of the day this is about the safety of patients across the eu and nothing can be more important than that.
we have a responsibility to make sure that patients can have confidence in the medical devices industry and i firmly believe that this is what the agreement we will be voting for this week will do.
stricter rules on post market surveillance will also ensure a faster response if there is a problem with a device and a new id system will improve traceability.
i believe the agreement that we have reached strikes the right balance.
patients rightly expect that if a device has been placed on the market then it must be safe.
thank you all for making this happen. we have set the conditions for europeans to receive the safest and most reliable healthcare and for the eu to remain at the forefront of innovation in the field.
however let me also add that the adoption of these two comprehensive texts represents only the beginning of a long and challenging process.
we now need to make sure that the new system is effectively put on the ground and delivers the expected added value to all stakeholders.
the commission will continue to consider this dossier as an utmost priority.
i am really glad also to see such a large attendance by the public in the galleries today because this field we are speaking about and discussing is diverse competitive and highly innovative.
it is an area of great promise sometimes spectacular promise but it can also be an area of a number of pitfalls. devices are routinely implanted in our bodies.
they replace limbs bones tissues and sometimes entire organs but medical and diagnostic devices when well designed well made and properly used can improve our quality of life and can save lives. if not they can threaten and impair it. as the directlyelected representatives of our citizens it is our mission to make sure that patients in the eu can access safe
effective and highquality medical devices and diagnostics and that they have timely access to medical technologies that will really help them.
we are living in a digital era where we need to be proactive and anticipate innovation. our regulatory framework needs to be prepared for the type of technology that will come our way.
it needs to help foster innovation and the development of lifesaving and lifeenhancing equipment.
my thanks to the commission and the council and i would also like to thank the luxembourg and in particular dutch presidencies for their determination to get the council agreement that we have today. we have put in place strong clear rules for the whole lifecycle of devices from design and manufacture through clinical testing and authorisation to vigilance and market surveillance giving manufacturers legal certainty about what they have to do.
protecting patients is at the heart of this legislation.
we all remember the scandals of the past.
i have heard from women whose lives have been turned upside down after having a pelvic mesh implant women who are now living in constant pain.
i have heard from women who are still not sure which breast implants they have had and whether they need to be worried about their future health.
it just is not right that people have not got sufficient information about devices that have been used in their medical procedures.
so in future all devices will be traceable with a unique device identification number and patients will receive an implant card with this number so we will all know which device has been implanted in which patient.
if there is a problem with the device patients deserve to be compensated so it is clear that manufacturers must have sufficient financial coverage to deal with their potential liability.
we know that in the case of metalonmetal hips there was little clarity for patients as to whether the problems were caused by the device or by the medical professionals treating them.
when there is reason to believe a device has caused harm to a patient information on that device must be made available to the patient and their doctor.
to ensure patient safety in the future we must make sure devices are safe before they reach the market.
all devices will undergo a thorough clinical evaluation before marketing and parliament insisted that there should be additional scrutiny for the highestrisk devices.
things such as implants insulin pumps and pacemakers will be referred to an expert panel for additional assessment.
wherever possible manufacturers will have to substitute materials that are carcinogenic mutagenic or toxic to reproduction and justify where this is not possible.
notified bodies will still have responsibility for awarding a ce mark but it is clear that these have to be up to the job.
notified bodies will also have greater powers to carry out unannounced inspections and must inspect samples of all devices regularly.
any problem should be picked up early and action taken straight away.
while it is vital that we ensure devices are safe before they are placed on the market it is also essential that they are carefully monitored afterwards.
the new law will significantly strengthen requirements for post market surveillance including introducing periodic safety update reports similar to those that are now produced for medicines.
finally on reprocessing of singleuse devices this was one of the most difficult issues to get agreement on.
for the member states it is a very sensitive issue.
therefore reprocessing will only be allowed if it is permitted under national law.
those member states that want to ban it can do so.
for those that allow it there are eu wide standards that must be complied with including reprocessors assuming all the obligations of the manufacturers.
colleagues it has taken a long time and a lot of work to get to this point so i hope you will support the final agreement as one which gives patients much more protection while ensuring continued innovation.
i am relieved and happy to be here.
and commissioner thanks go to your colleagues as well and to the council because this was not just technical; it was political.
i am also glad that the chamber is full with visitors because what we are talking about today will affect each and every one of us now and in the future.
also commissioner thank you for acknowledging the importance of this industry in terms of both jobs and its output. this industry makes our lives better and extends our lives and for that we should be grateful.
yes we are talking about when things go wrong and that spurs us to do more things and to do them better.
we should acknowledge that the industry is a very good industry that europe should be proud of.
what we are doing today is making it more certain for that industry to continue so that when we get slightly older and may need things that are improved upon we may live better and longer lives.
what i think is most important is that we implement and that the member states who have signed up to this and the commission who are with us on this journey realise that this parliament will keep a watching brief and will make sure that resources are put in place so that we do put action on the words.
i think it is very important that we say this openly because on the technical side they were incredible both our group staff and our individual staff.
if i may say so i very carelessly lost two staff members during the course of this regulation and both to the medical devices industry because they are excellent workers on behalf of citizens mark taylor and sinead duggan who i know is watching this debate.
i think that is the good thing about what we have done.
we will make our industry more certain.
we will make safer the lives of citizens and we can grow jobs and grow our economy.
mr president the role of medical devices in the uk as well as in europe is of exceptional importance and the medical devices sector plays a fundamental role in the diagnosis prevention monitoring and treatment of diseases.
i share the concern about this issue with the rapporteur and the european commission and recognise that disgraceful things have happened in the past where women having breast augmentation procedures were given poly implant prostheses pips containing industrial silicone.
although i agree with the objectives of this report which aims to influence the manufacturers at the site of production as well as to increase transparency in instances where patients have had an adverse reaction to a medical device and are searching for information i believe however that member states are best placed to act in this field.
so go with the tide take back control over trade policy so that you can determine trade policies that reflect your constituents in your country first and foremost because we are sent here as public servants.
there is another way that you can change this you can take back control.
it seems that the solution to all of the problems in the european union is more money more money more money not a change of policy not a change of direction.
the european globalisation adjustment fund well there is a euphemism if ever i heard one.
god forbid you guys actually ditch the single currency which is causing misery to southern europe and creeping its way upwards.
you may see increased gdp numbers but in my country productivity may be up but people's wages have been compressed because of the seemlessly unlimited supply of cheap labour coming from complete free movement and open borders.
there is a democratic revolution taking place with referendums becoming the issue of the day across every single eu member state and they will happen.
it has been the policies of deindustrialisation and unfettered free trade which in the main have created the need for the egf.
in many countries such as my own ireland there has been a severe underspend of egf funds and it does not become apparent until the end of the term when the monies are handed back. this is unfair to workers as they are the ones that suffer when the funding is not put to the best use.
but this fund is often used to compensate for the damaging effects of policies that have stemmed from the european commission.
not only have these policies caused job losses but their fallout has undermined workers' rights and caused irreparable social damage. within the report i agree with the call for greater government transparency and the reference to a mid term review at member state level so that member states can assess the progress of the egf in their countries and identify issues early that might need intervention.
i also welcome the reference to creating stronger working conditions and working relationships with the community and voluntary sector as they are the ones that are best placed to assess particularly the needs of neets and to raise the awareness of egf opportunities with them.
my personal view is that anticipating is always better than repairing the damage.
today as you know the preparation of trade agreements includes a social impact assessment.
today the european globalisation fund cannot be used to anticipate the consequences of global trade;
a trade agreement must of course generate overall a positive outcome for both partners but within the globally positive deal it is not excluded that certain sectors of our economies could suffer.
because this a new facet to the egf we have not had time yet to assess its impact but we need to ensure that measures targeting neets are tailored towards their needs and in that context i thank my colleague lynn boylan whose amendment on ensuring community participation will i believe improve the participation of neets.
the core point is that the egf does not replace the responsibilities of companies;
many colleagues spoke of the need to anticipate and manage change and i think we need to broaden our thinking to see if earlier action or pre emptive action could be more effective.
i reject this assertion as in all cases member states guarantee that the dismissing enterprises have complied with all their legal obligations.
and i agree with colleagues who say that workers in smes have not had the same access as workers in larger companies.
four two where in exceptional circumstances there can be applications from small labour markets.
some colleagues suggested that employers are using the egf as a means of evading their legislative responsibilities.
we might wish that those legal obligations were more extensive but that is a separate issue.
commissioner you started by agreeing that the egf cannot be used as an intervention tool in job losses in the case of trade deals and that was re echoed by many colleagues particularly maria reina who quite rightly challenged commissioner malmstrm for suggesting at some point previously that a small eur one hundred and fifty million per annum fund could deal with the negative fall out from proposed trade deals.
it is a solidarity mechanism from the eu and employers do not benefit. i was really pleased to hear the commissioner say that the commission going to come forward with a proposal to extend the derogation on neets.
i think that gives us a sense that we can help to shape it in a positive way.
we need to take a different approach to neets and to redundant workers.
and how we can spend that money in a more efficient way;
what partnership models will deliver better outcomes for redundant workers who have lost their jobs due to globalisation; how we can organise the process so that it responds in a more timely way to the needs of workers;
the member states need to make publicly available all relevant information in regard to egf cases and they need to set quantitive reintegration objectives so that we can measure the success.
we also propose that member states need to achieve synergies between egf and esi funds.
and of course crucially how we can help ensure personalised well coordinated measures that are tailored to the individual needs of the redundant workers.
finally the most important point is that the egf must guarantee eu added value for redundant workers and taxpayers. then we can strongly call for its continuation and expansion.
funding has been cut from five hundred million to one hundred and fifty million budget implementation is only fifty five but improving.
the re employment rate is around fifty and as member states become more used to the fund their applications are more timely.
but there are still negatives member states don't use the egf often enough and crucially do not often use the derogation.
in that way we do two things we express our solidarity with them at a difficult time and secondly we assist them in the transition to sustainable employment. so what makes the egf different to the esf?
how can we ensure we have relevant data that allows us to assess the outcomes from the funds without placing undue requirements on member states;
how we can ensure better value for money for both the workers and for eu taxpayers;
so it is important to design the egf in such a way that it can respond to their needs.
we emphasize that esi funds can act as follow up measures in egf areas of support by stimulating investment and overall job creation.
in this report we look to see how we can help to make it more effective;
there is a concentration of applications in the manufacturing automotive construction and aviation sectors.
well timelines have improved considerably due to efforts by all actors the commission member states parliament etc. the self employed are now included. neets can benefit from egf support in numbers equal to the numbers of targeted beneficiaries. the egf is now part of the shared fund management system and i commend the commission on this.
co funding has been increased to sixty more member states are using egf and spending under personalised measures has been lowered
to. twenty four the inclusion of neets as eligible beneficiaries of globalisation fund support in the current egf regulation by way of derogation helps to counterbalance this tendency and is an expression of solidarity with young unemployed persons in regions with high unemployment levels.
they will cover the current derogation giving access to egf cofunding also to neets in certain egf applications.
the report is very useful to us. indeed despite several improvements introduced in the regulation for the two thousand and fourteen two thousand and twenty period and subsequently reflected in the functioning of the fund there is still a margin for additional fine tuning. the egf is an emergency instrument with its own role.
i welcome your appreciation for the commission's efforts to develop standardised procedures for the egf applications and management using the functionalities of the electronic data exchange system sfc. since three august two thousand and sixteen the reporting module for egf cases is also available in sfc and i am confident that the expectations regarding reporting improvement will be fulfilled once sfc becomes fully operational for egf cases.
i would like to recall that the commission has promoted regular peer reviews across national exchanges or partnering in order to exchange good practices and implementing experience since the start of the fund.
some member states apply this almost exclusively using the intervention criteria of article.
i am happy to announce that the commission just yesterday tabled a proposal for the extension of this derogation as part of the midterm review of the multiannual financial framework.
we expect the first results of the ongoing egf mid term evaluation for the two thousand and fourteen two thousand and twenty period by the end of this year.
the commission shares your view that the egf should continue to provide assistance to neets who live in regions eligible under the youth employment initiative after december two thousand and seventeen the date of expiry of the derogation.
i agree with the vast majority of what you have said but obviously as somebody who has been a trade union member for many years my interests are with the workers.
reluctantly i accept it because we need anything that we can get particularly in ireland and i am sure in many other member states to help those workers get back into employment.
however i agree with you we need to change the direction of the eu to deal with multinational corporations and their shocking treatment of workers.
this time more than ever in addition to positive priorities we should examine what is not performing.
this is not surprising.
we should be looking not just for actions which involve money but strengthening of the single market.
where we are looking for monies we should be thinking about where we can be generating savings from elsewhere in the budget as we are looking to do in parliament and in the other institutions.
i think that unlike the other guidelines which we have discussed over many others years in this house it is focused and it does not get into a whole lot of different details which are obviously to come later in the budget procedure.
we take the line that if you want more money then you can take it from savings elsewhere.
the attempt to justify an increase in the budget on the basis that the europe two thousand and twenty strategy will take us out of the crisis lacks all credibility when we look back at the complete failure of the lisbon strategy.
on behalf of british taxpayers i call on david cameron to demand not a freeze but a significant reduction of the budget for.
the threat and it is a threat that limiting the level of the european union budget will have a detrimental effect on european solidarity and the pace of economic development in the member states is both facile and displays an overwhelming ignorance of the impact of the crisis upon european citizens.
now there is a need for action for decisions and for restored confidence in public finances.
they are defending the same policies that led to the deficits and the crisis of greece spain and portugal and other countries.
and finally working towards a robust and permanent crisis resolution mechanism for euro area member states in fiscal distress.
i am personally fully committed to helping you in the process in every possible
introducing a european semester' to strengthen ex ante integrated economic policy coordination;
in spite of the crisis education budgets announced for two thousand and ten have remained constant or increased in many member states.
while a number of delegations have expressed support for the commission proposal within the social protection committee some insist on including a labour market dimension in the eu target
let us not forget that we also intervene in this area through the structural funds.
we should bear in mind that some governments had already planned and in some cases executed general cuts in public budgets before the onset of the crisis.
the third question concerns the differences between two commission papers on the one hand the communication on public finances in the emu two thousand and six of june two thousand and six and on the other hand the two thousand and eight emu ten report.
to facilitate this work the employment committee indicators group has produced two alternative technical approaches that show what each member state would need to do to ensure the eu meets the seventy five target in terms of employment levels.
and the number of jobless households.
the commission will continue to watch this issue carefully.
last week's communication on reinforcing economic policy coordination focuses on making the pact more rigorous with regard to both its preventive and corrective arm.
if there are discrepancies between the eu target and the sum of the national targets we intend to continue the discussion with the member states to see how national or eu level action could bring the eu closer to the targets.
on governance i wish to reassure you that we set great store by your role in the new strategy and by your input.
boosting economic recovery investing in europe's youth and building tomorrow's infrastructure are the priorities of the two thousand and eleven draft budget that the commission recently adopted.