kfajdsl/voxpopuli huggingface dataset:
measures should also be put in place to enhance the reporting of incidents by healthcare professionals and patients. patients' awareness should also be improved through for example implant cards providing appropriate information.
in order to provide a rapid answer to european patients' concerns i have identified and shared with the european parliament a number of actions to be taken immediately together with the member states on the basis of the current legislation.
for months before the pip case the commission was reviewing the medical devices directive because we found that it needed quite a number of improvements.
and has provided the flexibility needed for the high number of medical devices and the short life cycle of these products.
this includes tightening market controls in order to provide a better guarantee of the safety of medical technology especially high risk devices.
the advantage of doing so will be twofold.
first it will ensure an equal level of assessment by notified bodies in particular with regard to clinical evidence.
information will be given to national authorities with regard to negative outcomes of such audits.
this is why the commission foresees a pre market scrutiny mechanism to be put in place for high risk devices and other devices where necessary but on a case by case basis.
for the longer term the revised medical device legislation that the commission has been preparing independently of the pip case as i said will also take on board the experiences of this affair.
this is where i believe that the transparency of the market should be enhanced by giving all interested parties the right information not only as mrs mcavan has said about costs and benefits but also about the duration durability
and we want a stronger role to be given to competent authorities both in pre and post market phases.
a number of improvements were already foreseen to reinforce the system. these improvements will contribute to avoiding cases like the pip implant case.
this mechanism has the advantage that scarce resources and expertise are used to ensure efficient and proportionate pre market control and reinforced vigilance and market surveillance.
following the pip case the commission performed a stress test' of the medical device legislation in order to identify additional possible shortcomings of the regulatory framework and address them in the context of the upcoming revision. as a result of the stress test additional measures will be included in the commission proposal.
we all agree that patient health comes first and foremost in our policy deliberations.
this is exactly what we are doing too when we insist that we must continue to have a flexible system that delivers innovation as fast as possible to our patients because that is also a function of patient health.
when we talk about authorisation what we are saying here is let us continue to keep the flexibility that we have in europe; let us enforce and make sure that whoever is involved in the process is competent to do so;
let us make the competent authorities in the member states more involved in what is happening in their own countries within this process and then let us have a europe wide expert group that will ensure the consistency all across europe of a standard level of authorisation.
the pip case is not about authorisation.
the pip case has nothing to do with authorisation.
we do not need to wait two years until this legislative process that we will be launching very soon is finished.
transparency not only in the information that is given to everybody who might be deciding on making any type of procedure but transparency also in the vigilance aspect so that all incidents that happen within the medical devices sector have to be reported back.
the problem of the pip fraud was not authorisation.
as stated by the council last december turkey's contribution to the eu will only be fully effective in the context of an actual negotiation process that makes progress.
the resolution on turkey and its endorsement in the plenary is indeed a forceful political and strategic message. i also believe that in contacts with fellow parliamentarians from the turkish parliament this house will be able to make an important and much appreciated contribution to enhancing understanding of the eu the values that we share and the way we work.
we will also act in support of the commission's positive agenda.
i would like to recall that the council has regretted statements by turkey threatening to freeze relations with the eu presidency during the second half of this year.
much of the work on this key reform is of direct relevance for the enlargement negotiations with turkey.
as noted both in your resolution and in the council conclusions of december some very important issues have to be addressed.
it has to take place in a broad and inclusive way and in a spirit of constructiveness and compromise.
the process is an opportunity to address a number of important issues.
i would especially like to highlight freedom of expression.
as far as the reforms in turkey are concerned i will begin with a few words about constitutional reform.
however if the opportunity for progress in negotiations arises the danish presidency stands ready to seize it.
to promote political and economic reform in turkey and to strengthen the relationship between the eu and turkey.
turkey is more to europe than a candidate country.
as such it has a privileged relationship with a number of crucial actors in the region.
it is also an essential strategic ally playing a key regional role.
turkey is also an important and growing economic player.
the motion for a resolution highlights a number of significant issues and concerns and comes at an important point in eu turkey relations.
only in this way can we contribute to containing and overcoming tensions in our neighbouring regions. the eu turkey relationship is a close one and goes back several decades.
it also demonstrates the power of the enlargement process to give impetus to political and economic reform in turkey.
work on the actual content of this agenda is still at an early stage but we are following and supporting developments with great interest.
this is a task that we can only realise with the support and cooperation of the member states the commission and not least this parliament.
the eu position on this has not changed and in the absence of progress in the full non discriminatory implementation of the protocol the eu will maintain its measures from two thousand and six which will continue to affect overall progress in the negotiations.
we can all see that the accession negotiations are not advancing as quickly as we would like.
the rotating presidency is a fundamental institutional feature of the eu provided for in the eu treaty and must be fully respected a position which i know is also included in your resolution. in conclusion the aim of the presidency is to do our utmost to facilitate progress in the enlargement negotiations
we very much welcome initial steps towards ensuring this.
preparing a new constitution is now well under way.
we have witnessed a large number of cases brought against writers and journalists and although there have been some positive developments such as the recent liberation from prison of four journalists the high number of cases against writers and journalists raises serious concerns which need to be addressed.
while constitutional reform is important further progress by turkey in other areas is required.
however further progress is needed on issues such as fundamental rights and freedoms.
we must not lose sight of turkey's and the eu's mutual interest in deepening our relations in spite of the challenges encountered in the formal accession talks. it is clear that the positive agenda should be a complement to the negotiations and not a substitute for them.
we will do our utmost to facilitate progress but needless to say this will require additional significant efforts from the turkish side.
we also continue to expect turkey to make progress towards normalising its relations with the republic of cyprus without further delay.
mr president has mr howitt ever considered the impact on his constituents of giving ninety million turkish citizens including an oppressed kurdish minority of approximately fifteen million the absolute right to live work and settle in the united kingdom which will be the consequence of admitting turkey as a member of the european union?
turkish friends say to me when we make concessions we never get anything in return' or when we offer to make concessions we never get anything offered in return'.
on. why should this house be split on this process?
the european union should continue to encourage the reform process in turkey.
i have not heard it and i am afraid i will not hear it in the future.
and the road map as put forward by the united nation's secretary general and implemented by special representative alexander downer.
i also hope that this house is not going to split on the issue that the best way to achieve this the best way to help turkey to strengthen democracy is actually the accession process. does anyone in this house believe that building a big wall between us and turkey
i hope that the energy which i have sensed in your discussion will be turned towards supporting the two leaders who will be meeting tomorrow addressing the core issues and allowing downer to recommend to the secretary general to go for the finalisation of the process and not to leave it
now coming to particularities but important ones as regards a paragraph in the resolution on civil military relations i would like to agree that the formulation of the sentence on the integrity of the armed forces could be improved in order to clarify more precisely what is
i will not miss any opportunity.
because interestingly enough in this debate i have not heard one single idea how to do it better and more efficiently to the benefit of the turkish people.
the honourable member knows a few things about losing elections.
it supports the reforms but also says that there are still reforms that need to be carried out especially on freedom of speech and press freedom.
turkey's economy is growing and turkey is becoming a regional and global power.
the positive agenda is important to keep supporting the reforms but if we want real changes we must support the opening of chapters twenty three and.
twenty four the report we will vote on tomorrow is important because it recognises these issues and it gives support to the positive agenda.
we are concerned about the wide margin of appreciation allowed by the anti terror law; we are concerned about the arrested journalists and those working under the threat of being arrested.
such a move would not be about power and pride and prejudice but about the people about greeks and turks christian and muslims who could
strongly supports the report and i agree that it is possible to be positive but it is impossible to be
the accession process is an important incentive for change and reform in turkey as it is for other enlargement countries as well.
if there is a genuine desire to reunite the island of cyprus then the turkish cypriots need to feel they are actually welcome and respected in the island that they share.
by all means call for reductions in turkish troop numbers in the north of cyprus and for agreement to the additional protocol but match this with opening trade through the ports and airports in northern cyprus.
is it sending a really positive message to turkey?
for my part i have always been supportive of turkish aspirations towards the european union and i am particularly appreciative of turkey's role as a key ally over the years.
this is unrealistic it is unjust and it prevents progress.
we make demands of turkey but we should reciprocate with movement in turkey's direction.
there are constant demands for turkey to make unilateral concessions and in return she gets nothing.
of course there are many aspects of the report which we might have liked to see worded in a rather different way and i appreciate that there are strong feelings on the subject of turkey on all sides of the house.
i have to say that the assumption of the eu presidency by the republic of cyprus in the second half of this year would present a great opportunity for progress if there was real courage.
obviously the real test will come with the first discussions on the substance.
these conclusions list a large number of political reforms already underway or planned for the near future by the turkish government.
we have also agreed to work on bringing the relevant turkish legislation closer into line with the eu acquis.
only a mature domestic political debate with full respect for dissenting voices will ensure that these reforms deliver the democratic standards and practices the citizens of turkey expect.
turning now briefly to some recent developments in turkey which are also reflected in the resolution i have welcomed the overall consensus on the need for a new constitution which emerged after the general elections last june.
the commission services will use kick off meetings to update the turkish authorities on all developments regarding the acquis.
it. if this right is not defended democracy inevitably withers.
work continues also in other areas of the positive agenda.
we will report in the two thousand and twelve progress reports on developments in trials and in investigations of alleged criminal networks as we have done over the past years and as expressly requested in your resolution.
we hope that his package will address the outstanding core concern as regards freedom of expression and the right to a fair trial. these issues are rightly highlighted as persistent concerns in the resolution you intend to adopt later.
the commission and turkey have agreed to work on eight chapters including the chapters on company law on the information society and the media on the judiciary and fundamental rights and on justice freedom and security.
this debate and your resolution come at an important time for european union turkey relations and the draft resolution underlines a number of issues of great importance for the commission. last friday the high representative and vice president of the commission cathy ashton and i met ministers
once again i realised that we have much more in common at strategic level than there are differences. we discussed our ever closer foreign policy dialogue and progress related to the political criteria and agreed in particular to work concretely and constructively to make the positive agenda a reality.
let me emphasise once again that this agenda exists to complement and not to replace the accession process. the positive agenda means renewed efforts in a number of key areas including support for political reforms in turkey such as the alignment with our acquis
the positive agenda is there to provide a realistic and feasible way of injecting new life into eu turkey relations in general and into the accession process in particular and i wish to thank you for your support as expressed in the resolution we are discussing today.
i am happy to tell you that since the member states endorsed the positive agenda last december we have made very good progress in putting it into practice.
we hope that our cooperation with turkey on these issues notably as part of the positive agenda will bring badly needed improvements in legislation and practice.
i would like to single out the intention to table a fourth judicial reform package which envisages further reforms in the area of freedom of expression and the media.
as regards energy for instance turkey and the commission have agreed to set up a joint working group which will develop a road map by may to identify concrete actions for intensified cooperation.
working groups will be set up for each chapter in may june.
in a mature democracy dissenting voices are not ridiculed or pushed into self censorship but valued for their contribution to the democratic fabric of society.
the specific work launched by the turkish parliament to bring this process forward including constructive collaboration between the four main political parties has started.
does he agree that it is the duty of the presidency of the council to project the values and principles of the european union and to complete that process of integration
the rigid role which women play in turkish society means lower participation by women in the workplace politics and civil society.
worse still attacks against women are commonplace and the authorities are too lenient on the perpetrators of gender based violence.
more women's shelters are needed in order to protect the vulnerable.
turkey must work harder to eradicate the practice of honour killings with dozens of turkish women murdered each year.
i call on the commission to put women's rights at the forefront of negotiations with turkey.
madam president as my good friend and colleague knows full well i am not overly enthusiastic about many aspects of the european union in particular political integration.
but the fact is that turkey does have an aspiration towards joining the european union and i think turkey's strategic position is a very important one.
i have always said that if we send negative signals to turkey we should not be surprised if she starts heading off in a rather different direction.
we have to very careful about that.
but we need to meet turkey's aspirations and what she wishes is accession to the european union.
mr president turkey's prime minister erdogan has described un sanctions against iran as and i quote a mistake'. since march last year turkey iran iraq and syria have issued tourist visas valid for those four countries together. turkey of course has a customs union with the eu
but it also has a customs union with the five turkic speaking countries of central asia.
the inconvenient truth is that turkey is a regional power of the middle east and this is because of the actuality.
turkey is an asian country moreover one that does not tolerate meaningful dissent.
turkey should not even be considered for membership of the european union and it certainly should not be receiving almost one billion euros a year in pre accession funding.
why do these two facts if they are facts justify political union with turkey?
i would have to say that the whole question of the impact of turkey on the european union is not one of the major factors as to why we should be supporting european union accession by turkey.
it is true that the european union would inevitably be very different with a country like turkey as a member.
but as i say i hope that by the time that comes about the european union will be very different to what it is today.
what we need is a european union of overlapping circles of engagement where if there are those that want to push forward with intense integration by all means let them.
so i hope it will be a very different european union when turkey joins and that turkey will help that process.
mr president today we call for a renewed boost in eu turkish relations and to open the negotiation chapters on the most essential issues now the chapters on fundamental freedoms justice and the rule of law.
our emphasis on these key issues prompts the turkish authorities the government first and foremost to ensure the rule of law is upheld. while we are open to cooperation in relation to the middle east and on mutual security challenges we strongly condemn the abuse of anti terrorism laws.
it is essential for turkey its role in nato and its relations with the eu that both process and outcomes of these trials are fairly conducted and that suspects get a due process.
the same goes for the high number of journalists imprisoned as many colleagues have mentioned.
the climate of fear and mistrust in institutions in turkey is undermining its potential to be a leader in a changing world and we urge the turkish government to take its responsibilities.
voluntary agreements and standardisation have failed to deliver significant progress in terms of deployment and use of such systems.
mr president i suppose one could say that one would want to be pretty stupid to oppose intelligent proposals. certainly the intelligent transport systems cannot be opposed they are to be welcomed.
all the emphasis seems to be on speed and obviously that is a major contributory factor.
there are already four zero dead as a result of this. the eu must do everything now in its power to help stabilise this fragile country and help bring the perpetrators of these terrorist atrocities to justice.
the principle of innocent until proven guilty' cannot be replaced by the destruction of entire villages where suspected members may live.
threats to journalists for reporting as well as censorship should be prevented condemned and avoided.
two thousand and eleven the role of the media deserves our special attention.
the international criminal court is investigating whether boko haram has committed crimes against humanity.
if nigeria develops democratically and successfully into a rule based society it could be an example for the region an example in the good sense.
the legal path should prevail as it sets the state apart from those who act outside of the law more clearly and more justly.
we need to focus on nigeria which has a lot of great opportunities in terms of resources and human capital.
the eu as nigeria's largest financial donor should forcefully urge the government to work within the law.
it is not acceptable for journalists to be kept out of large areas because there is a state of emergency.
while it may seem like a good idea for the government to shut down mobile services to prevent militants and terrorists from communicating this also restricts the digital freedoms of many ordinary nigerians.
we have made a clear statement expressing our concerns following the adoption by the national assembly of the so called same sex marriage bill.
we cannot approve of nigeria's response which has become increasingly brutal and indiscriminate.
securitisations would be standardised to make them easy to identify and understand.
there is a broad consensus among regulators supervisors and companies that this would benefit the european economy.
by rebuilding issuance back to the pre crisis levels we could generate an additional eur one hundred and fifteen billion of yearly funding for households and companies. after two years of discussions i am happy to say that the final result is both balanced and ambitious.
it will help restore an important funding channel for the eu economy while learning from the mistakes of the past.
the qualifying securitisations would be simple. for example only comparable loans can be brought together in one product and the repackaging of other securitisations would generally not be allowed.
we have ensured that those who are responsible for originating securitisation products take full responsibility for the products' place in the marketplace.
during our negotiations on this regulation we tried to find the right balance between the lessons learned from the financial crisis and having a framework which ensured that we did not stifle the potential of the securitisation market.
we have enhanced the transparency of securitisation markets notably through the establishment of data repositories which will enable competent authorities to have a full overview of the products in the market.
we have agreed to have a sensible level of skin in the game with the risk retention rate for banks of.
they will not be able to shift responsibility to empty shelves such as specialpurpose vehicles.
i believe that carefully monitored highquality securitisation can serve to benefit business across europe. in the eu as a whole we are too reliant on loans and other forms of funding from banks. capital markets give businesses a new avenue for funding for their activities. the diversification of funding is important to help deliver more growth for the european economy.
i do welcome the fact that it makes financial instruments safer and more transparent and that there will be greater standardisation. this is a real step forward and it ensures that an important source of capital can support smes in the european economy.