Question Time (Commission) 
President
The next item is Question Time (B7-0009/2011).
The following questions are addressed to the Commission.

Subject: Marketing ban on the drug 'Médiator'
Can the Commission explain why a decision was not taken in 1998 to ban the marketing of pharmaceuticals containing benfluorex? Should the Commission not have been alerted, and not for the first time, by the bans imposed by the authorities in Spain and Italy? Why, ultimately, did the Commission not act until as late as June 2010, when it finally took a clear decision on the marketing of that molecule?
Will the Commission ask the European Medicines Agency to conduct a full retrospective investigation into the ways in which this drug was used over twenty years?
John Dalli
Member of the Commission. - Allow me to address each of the four component questions in turn.
The first question was: can the Commission explain why a decision was not taken in 1998 to ban the marketing of pharmaceuticals containing benfluorex? The answer: benfluorex was discussed in 1998 in the Committee for Proprietary Medicinal Products, now called the Committee for Medical Products for Human Use, of the European Medicines Agency, and subsequently in the Pharmacovigilance Working Party.
The committee considered that benfluorex should not be included in the scope of an ongoing evaluation procedure at European level, concerning certain anorectic agents due to a different mode of action. However, it was agreed that the committee's pharmacovigilance working party would investigate if there was a safety issue with this compound. In March 1999, the pharmacovigilance working party concluded that there were no major benefit-risk concerns for medicinal products containing benfluorex. Further discussion in the working party did not lead to changes in this conclusion.
The second question: should the Commission not have been alerted and not first by the bans imposed by the authorities in Spain and Italy? The answer: Italy and Spain did not revoke the marketing authorisation for benfluorex. In fact, the first time that a Member State effectively took measures to revoke the national marketing authorisation for Mediator was in 2009, when France suspended its national marketing authorisation.
In Spain, it was the marketing authorisation holder, Servier, that withdrew the marketing authorisation in 2003. Similarly, it was Servier itself that did not request the renewal of the marketing authorisation in 2003 in Italy.
The product remained authorised in France, Portugal, Luxembourg and Greece. Benfluorex was discussed within the pharmacovigilance working party, acting in its role as a forum for Member States to exchange pharmacovigilance data among themselves.
I would like to clarify that monitoring of pharmacovigilance data and the subsequent decision making on national authorisations for medicinal products is the primary responsibility of Member States. Commission intervention in these cases is exceptional and limited to concrete situations foreseen in the legislation.
The Commission can launch a Europe-wide evaluation by the European Medicines Agency in two cases: firstly, when Member States adopt divergent national decisions concerning a marketing authorisation and, secondly, before any decision is reached on the granting, variation, suspension or revocation of a marketing authorisation that appears necessary, in particular, when taking account of pharmacovigilance information in cases where it considers that the interests of the Community are involved.
In this case, no action was triggered at EU level in the light of the conclusions of the pharmacovigilance working party and the fact that no divergent decisions were taken at the time by the Member States in response to the discussions in the working party.
The third question was: why did the Commission not act until as late as June 2010 when it finally took a clear decision on the marketing of that molecule? The answer: it was only in 2009 that a Member State, namely France, suspended the marketing authorisation of Mediator. Under the new provisions in place since 2004, this automatically triggered a review of the product's benefit-risk balance, which led to the adoption of a Commission decision requiring all Member States to revoke any national authorisations for benfluorex containing medicinal products.
In this context, it is important to stress that the new pharmacovigilance legislation adopted on 15 December 2010 introduced additional provisions to ensure signal detection by the European Medicines Agency of safety issues for nationally-authorised products and creates new procedures at EU level to assess safety signals for such products, leading to harmonised actions by the Member States.
The fourth and last question was: will the Commission ask the European Medicines Agency to conduct a full retrospective investigation into the ways in which this drug was used over 20 years? The answer: to date, the Commission has not asked the European Medicines Agency to conduct a full retrospective investigation into the ways in which this medicinal product was used over 20 years. The figures and the documentation referred to in the French report clearly indicate that by far the highest use of this medicinal product was in France.
President
I would just like to make it clear how I will deal with the supplementary questions this evening. I will take all the supplementaries together - remember that you have 30 seconds for the supplementary - and then I will ask the Commissioners to answer all the supplementaries en masse.
Gilles Pargneaux
(FR) Madam President, I would like to raise one more point in the light of the comments made and the responses given by Commissioner Dalli, whom I would like to thank for the clarifications provided. As you pointed out, Commissioner, in 2003 and 2005, it was Servier which asked for the product to be withdrawn from sale in these two countries. You also said that in 1998 and 1999, the working party chose neither to authorise nor propose the withdrawal of this product. Yet we know that the medicinal product was withdrawn in the United States in 1997.
Therefore, surely it is clear - and here is the nub of the matter - that in a market as large as the European Union, which encompasses 500 million European citizens, we need more vigilance? In particular, we need additional alerts that will trigger Europe-wide action, with clear competences for the European Commission and the European Medicines Agency. In this way, we will be able to avoid a repeat of the situations that have occurred in some Member States, such as the French case that was cited.
Marc Tarabella
(FR) Madam President, Commissioner, let us extend the terms of this debate, because the Mediator product is simply the visible tip of the iceberg and raises a range of other questions.
For example, how is it that a medicinal product that is considered to be potentially harmful, even fatal, and that has been withdrawn from the market in some Member States, can continue to circulate freely within the European Union?
Should we not give serious thought to the role and the effectiveness of the European Medicines Agency, if its findings are not binding for Member States?
John Dalli
Member of the Commission. - In effect, the procedures that were in force at the time of the historic events that I recounted in my answer were as I stated: there was a clear separation between Member States and the European authority - a separation that is still, in fact, in force and jealously guarded by Member States. In effect, that is why, over time, we feel that we should be strengthening our pharmacovigilance processes and procedures.
I must say that, in 2004, a step forward was taken on revising the pharmacovigilance procedures and processes that we already have, and also in the last pharmacovigilance agreement. We now have a lot of 'stoppers' and it is now also possible for other action to be taken at European level, too, to ensure that anything that is withdrawn from any market is notified and action can be taken upon it. This was not the case before.
So this is the situation today. I have instructed my services to conduct a stress test now, including on the new pharmacovigilance processes and procedures put in place after our last agreement. They are taking Médiator as a case study to see whether something like Médiator could still happen with the latest pharmacovigilance processes. We will make sure that if we do find any vacuums, bottlenecks or spaces where action will not be taken in these cases, we will come back to you and try to correct the situation.
Subject: Sale of iPad subscriptions by Apple
iPad producer Apple is demanding that newspaper and magazine publishers offer their readers their products (casual sales as well as subscriptions) exclusively via Apple's iTunes online store, so that it retains control of the sale conditions. This means that iPad users can no longer order any newspaper or magazine for iPad via the website of the publishers concerned.
Does the Commission regard this action as compatible with EU law and such principles as interoperability and an open Internet?
Could this be a case of abuse of a dominant position and therefore infringement of Articles 101 and 102 of the Treaty on the Functioning of the European Union?
What action will the Commission be taking in this connection?
Andris Piebalgs
Member of the Commission. - Apple announced today that it will offer digital subscriptions to newspapers and magazines on iPad devices exclusively through applications (Apps) sold via its online store. Publishers will still be able to offer online subscriptions through their websites, or by other means, but they will no longer be able to process the subscription via an App on an iPhone using Apple as an intermediary.
Whether Apple's behaviour constitutes a violation of the EU competition rules depends on a range of factual, legal and economic elements. It requires, inter alia, that Apple holds a dominant position in the relevant market. The boundaries of such relevant markets are not clear, as the sector is still relatively new and evolving and as there are also several comparable platforms and devices that provide similar functionalities, some of which are supported by online application stores as the consumer demand for electronic and/or print magazines is unclear and evolving.
Once the market has been properly identified, the question of dominance would have to be assessed. Dominance has been defined by the European Court of Justice as a position of economic strength enjoyed by an undertaking which enables it to hinder the maintenance of effective competition on the relevant market by allowing it to behave to an appreciable extent independently of its competitors and customers and ultimately, of consumers.
The Commission notes, in particular, that alternative application platforms exist and several companies have recently launched, or are expecting to launch in the near future, a number of devices similar in terms of functionality to the iPad. The Commission is following the developments regarding Apple's commercial policies and is in close contact with the national competition authorities.
Ivo Belet
(NL) Madam President, this afternoon, Apple indeed announced that it wants to offer a new model to its subscribers, but it is clear that it wants to take advantage of its market position, no matter whether it is in the dominant market position or not, in order to get its hands on customer information which is at the disposal of publishers. In the long term, this could be particularly detrimental to publishers in Europe, as well as to media pluralism.
I would therefore like to ask you whether you are prepared to act, regardless of whether or not this is a case of dominant position, and when you are going to take the initiative, if at all. In other words, could you explain what timescale you have in mind for this? Is the Commission taking the initiative going to be a question of weeks or a question of months?
Janusz Władysław Zemke
(PL) Madam President, Commissioner, I would like to thank you for your answer but, in my opinion, you failed to mention an issue of fundamental importance, namely, whether we are capable of imagining at all what portion of the European market could be dominated by Apple's new product. You responded in a rather general fashion, by stating that the matter was only being examined at present. However, I think that we should know whether there is, in fact, a real threat that Apple will become dominant on the European market.
Andris Piebalgs
Member of the Commission. - It remains to be seen whether Apple will become dominant in the market, because the market is evolving. We need to assess what the market is and what a dominant position means in this market. As far as market scale goes, at this stage, this is small, and it is premature to speak about any action by the Commission.
If there are lots of competitive proposals and an Apple approach does not constitute a dominant position, then there is no need for the Commission to take action. As I said, the Commission is monitoring the situation according to the rules of EU competition law, and if there is a need for steps to be taken, they will be taken independently when the moment is right, when we conclude that action needs to be taken. So rest assured that action will be taken, if necessary.
Subject: Protection of investments in the context of EU-Russia negotiations on the new partnership and cooperation agreement
Does the Commission raise issues relating to investment protection, especially in the energy sector, in its negotiations with the Russian Federation on the new partnership and cooperation agreement? Drawing on a number of cases when European energy companies were forced out of the Russian market without the possibility to seek impartial and fair local judicial protection, does the Commission intend to include an investor-to-state dispute settlement mechanism in the new partnership agreement or additional economic agreements with the Russian Federation?
What is the position of the Commission with regard to the Energy Charter Treaty (ECT)? Is the Commission still hopeful that the Russian Government might again sign the ECT and eventually ratify it? Or will similar provisions relating to the protection of investments in the energy sector be included in the new partnership agreement?
Andris Piebalgs
Member of the Commission. - Madam President, with a total stock of EUR 92 billion of foreign investment at the end of 2008, the European Union is by far the largest foreign investor in the Russian Federation.
With regard to the energy sector, it is the EU's firm intention to ensure that the key principles enshrined in the Energy Charter Treaty will also be part of the ongoing negotiations between the European Union and the Russian Federation on the new treaty. The relevant provisions should include investment protection for the energy sector and, in particular, a strong dispute settlement mechanism.
This approach would be without prejudice to the EU general assessment that the Energy Charter Treaty continues to be a valuable multilateral instrument to govern international energy relations. Its unique feature is that it sets legally binding rules on investment protection transit and that it contains provisions on dispute resolution in the energy sector.
The European Union considers that Russia's renewed engagement in the Energy Charter process, as expressed in the last EU-Russia Summit, is very important and it will follow a constructive and open approach in that regard. In this context, the EU welcomes the Russian interest in a legally binding energy framework, following its recent proposal for a draft convention on ensuring international energy security. The modernisation of the Energy Charter process would be the appropriate context for multilateral negotiations on this proposal.
Laima Liucija Andrikien
I have an additional question. In the European Parliament, we are currently working on the future European investment policy. When it comes to Russia, we often hear about the expansion of Russian companies in the European market, especially in the energy sector, but, at the same time, European investors face enormous difficulties when they want to invest in Russia, especially in sectors that Russia deems as strategic, such as the energy sector. So how is the Commission going to ensure that the principle of reciprocity in the investment relationship is upheld in the new partnership agreement?
Andris Piebalgs
Member of the Commission. - In a week's time, we have a meeting with the Russian Government, and investment policy issues will certainly be discussed, because there are arguments on both sides. Russia also argues that some of its investments are not much appreciated in the European Union, so there are ongoing negotiations.
At the same time, I can clearly say that in the last year, relations on quite difficult issues have started to improve: there has been more openness on the Russian side to discuss issues in depth and in detail. I believe, nevertheless, that relations should build on the agreement, and that the new agreements I have mentioned that will follow the PCA should have very strong investment protection clauses. That is the only way we can really avoid having situations where one side accuses the other side of not playing by the rules.
The current political dynamic is giving rise to much hope that we can conclude this agreement, and include relatively strong provisions in it. It is very clear that in the last year, there have been some fundamental positive shifts in our relations.
Subject: EU support for the Global Fund to fight Aids, Tuberculosis and Malaria
In the 2011 budget, considerable amounts have been allocated to the Global Fund to fight Aids, Tuberculosis and Malaria (GFATM) (EUR 65 000 000 in commitment appropriations and EUR 47 608 950 in payment appropriations).
Recent reports have shown significant failings within the fund; and because of corruption and bribery problems involving the fund, some Member States have halted payments to it.
How will the Commission ensure that the funds allocated to the GFATM are not used for bribery and corruption?
What has the Commission done to ensure that the GFATM still complies with the rules on eligibility for EU funds?
Has the Commission considered halting funding to the GFATM?
Andris Piebalgs
Member of the Commission. - This is a very pertinent question on an issue which the Commission takes very seriously and is therefore following closely and with great concern. The Commission is a very strong supporter of the Global Fund to fight AIDS, Tuberculosis and Malaria. The Fund has been very successful and it is my full intention to work with the Fund to solve the issues as soon as possible in order for the Commission to continue to be one of the biggest contributors to the Fund.
It is important to underline that the problems identified did not arise from the Fund itself, but in individual countries from the people contracted to implement the programmes. These are countries where very careful attention always has to be paid to avoid such problems. It is public knowledge that the Office of the Inspector General of the Global Fund has been conducting enquiries in respect of the use of USD 4.8 billion in 33 countries. These enquiries have taken place either on a systematic basis or in response to information received on the potential misappropriation of funds. Its inquiry is now complete; in line with common practice, the OIG has issued a report and published it on the website of the Global Fund.
This practice has proven effective and transparent in implementing the Global Fund's stated policy of zero tolerance of corruption. For our part, the Commission has commissioned an independent five-pillar audit of the Global Fund, as required under European Union financial regulations for all organisations benefiting from EU financial support. The audit report delivered in November 2010 expressed the auditors' overall conclusion that the Global Fund's internal control environment respects the principles of division of responsibilities and of management control of country and regional financial reporting. So standard mechanisms and controls are in place to ensure that funds received from donors are properly handled.
However, the auditors made several suggestions to improve the management of funds in addition to existing risk management strategy. Following this report, my services are currently discussing the needed modifications designed to improve and speed up the Global Fund reform agenda approved on 4 January. We are also undertaking a second audit mission, including country visits, to follow up on the institutional assessment. Through a letter dated 27 January 2011 and a teleconference on 2 February, I have already contacted the Executive Director of the Global Fund, Mr Kazatchkine, to express the urgent need for additional reforms to further strengthen the Fund's ground management processes and operations.
In the meantime, during the Board meeting called on 2 February, the Secretariat of the Global Fund proposed an external review to be carried out by the Global Fund oversight mechanism. This was welcomed by Board members. So in reply to your question as to whether the Commission has considered halting EU funding to the Global Fund, I would inform you that the Commission has notified the Global Fund Executive Director and the Board members that the EU contributions are being put on hold. In parallel, I consider that the European Union, and the Commission in particular, must maintain its overall commitment to the Global Fund objectives, reform process and strategy of alignment to country and health systems.
In this respect, the Commission is identifying clear criteria to apply before further contributions to the Global Fund can be resumed. These measures for ensuring prevention and detection of fraud have no implication in the delivery of vital treatment to the patient but, at the same time, understand that we need to have in place new, strengthened control mechanisms very fast, because as time passes, indefinitely holding on to payments is not the best option. We need additional strengthened control mechanisms at country level which will decrease the risk of misappropriation of the funds and can then resume payment. The Commission will, as I said, remain a keen supporter of the Fund because the Fund has achieved fantastic results, but there has been fraud and we need to deal with that fraud appropriately.
Anne E. Jensen
(DA) Madam President, I would like to thank the Commissioner for his support for the Fund, but also for taking decisive action to deal with what has happened and for taking the matter very seriously. My question to the Commissioner, in specific terms, is what sort of timetable does he envisage with regard to the freezing of contributions to the Fund? How quickly does he expect to be able to find a solution to the problems? According to the Fund, some of those responsible for the misappropriation have been arrested. Action has been taken. I would like to know how long he expects it to be before the money can start to flow again.
Michael Cashman
Commissioner, do you agree that the Global Fund to fight AIDS, Tuberculosis and Malaria is vital and that it would be criminal to halt funding now because it would bring to an end these lifesaving projects?
Furthermore, do you agree that we must, as you said, reinforce control mechanisms as well as our commitment to ensuring that the Global Fund delivers for those most in need - people at threat from AIDS/HIV, malaria and tuberculosis?
This evil of corruption must not be paid for by the innocent who are living with AIDS/HIV and who are at threat from malaria and tuberculosis.
Georgios Papanikolaou
(EL) Madam President, I, too, thank you, Commissioner, for your reply. According to published statistics, the European Union earmarked funds of EUR 972.5 million for the Global Fund to fight AIDS, Tuberculosis and Malaria between 2002 and 2010. This accounted for approximately 50% of the Fund's total resources.
My question is this: apart from what you have told us about the problems you have identified, has the Commission drafted an evaluation report or carried out an investigation into whether all this money was channelled to its intended target?
Andris Piebalgs
Member of the Commission. - There are two sides to this issue. On the one hand, I recognise that the Fund is doing fantastic work, reaching those most in need. There is no question about that.
But, on the other hand, they are public funds. Public funds are taxpayers' money and one misappropriation or one fraud case could destroy the work of hundreds of thousands of people. So we need to find a solution very rapidly. My objective is to have the additional measures in place by the summer so that we can resume payments in the autumn. I believe that is doable.
We have identified the areas where we need this: at national level. The Central Office is being well audited, and when we transfer money, everything is in order, but when it comes down to implementation in a given country, there are too many risk elements. If you saw which countries were involved and the size of the specific budgetary envelopes for them, you would realise that the sums involved would be too huge to suspend payments, and we need the reforms to work very rapidly.
If it is discovered next year that there are misappropriations, you would be the first to tell me that I knew about the cases and asking why I did not take action. Then I would say that I was thinking only of sick people. That would not be a sufficient answer.
If we sort this issue out in half a year, by the summer, then we will not have made any substantial impact on the functioning of the Fund, but we will have lent greater credibility both to the fund and to the way EU taxpayers' money is spent.
Subject: The CE mark
Could the Commission outline what progress has been made on strengthening the CE mark in order to promote European exports in markets like South America and Asia, as this was one of the commitments that Commissioner Tajani made upon being appointed to office?
Antonio Tajani
Madam President, Mr Higgins, the CE mark is the visible part of a mechanism that is crucially important for the smooth operation of the internal market.
The adoption of the new legislative framework in 2008 strengthened the mark's reliability in three ways in particular. Firstly, it strengthened control of the CE product certification system; secondly, it introduced market surveillance by national authorities, which must check the manufacturers' declarations of conformity and the certificates issued by independent organisations that authorise the use of CE marks on products; and, thirdly, it requires the Member States to strengthen customs checks so that only products conforming to the legislation are allowed to circulate in European and world markets.
By providing instruments designed to protect the CE mark, which were lacking until recently, the effective implementation of the new legislative framework strengthens the mark's credibility and therefore enhances the reputation of products bearing the mark in the European and, consequently, the international markets. Moreover, enhanced controls on imported products will ensure that there is less abuse of the CE mark in the world market. In addition, following the explicit request made by Parliament, the Commission has successfully launched an information campaign about the mark, aimed both at economic operators, particularly small and medium-sized enterprises, and at consumers.
The aim of the campaign is to give interested parties, particularly small and medium-sized enterprises, a better understanding of what the mark means and how the mechanism underlying it works, so that they can implement the rules on marking properly and defend themselves better in court in cases of counterfeiting or dangerous products. That will make European products more competitive.
Our agreements and talks with third countries, including Mercosur and Latin America, particularly Argentina, are designed to promote the regulatory and technical model underlying the CE mark. During my contacts with that part of the world, I intend to clarify these points and, of course, to push for the solutions that we have agreed to implement. I will be in Latin America in the spring, and this subject will also be on the agenda of the meetings I will have with government representatives in the countries I am to visit: Brazil, Argentina and Chile.
Of course, I reaffirm my commitment to work closely with you to ensure that the mechanism underlying the CE mark operates properly and that the Member States comply with the obligations aimed at making our products more competitive. I will, of course, keep you regularly informed about developments in this field, and let me remind you that the Commission will re-examine the situation and submit a report to Parliament in 2013, as required by Regulation (EC) No 765/2008.
Jim Higgins
I want to thank the Commissioner for his reply. I think the concept is very good. It is consumer-focused, it is about reputation, and the reliability of goods produced within the EU. But I cannot find any information from Eurostat, for example, as to how much this symbol is worth to European business, or what percentage of Europeans actually know what the CE does.
Secondly, I believe that we should be exploiting it more. In April 2010 at the Hanover Fair, there was a major campaign to promote the CE mark, but we are not exploiting it enough. It needs a far more concerted effort, as the potential is absolutely huge.
Silvia-Adriana Ţicău
(RO) Madam President, since you mentioned the European Union's competitiveness and because I welcome the efforts you are making to develop a European Union industrial policy, I would like to ask you the following: what percentage of products available in the European market carry the CE mark and what percentage of products available in the European internal market are manufactured in China?
Antonio Tajani
Madam President, I am grateful that a number of problems have been highlighted which are also the focus of our attention, because the honest truth is that products imported legally or illegally from outside the European Union are often counterfeit. Unfortunately, however, neither the Commission nor the Union's institutions have customs agencies or police forces to check imports, so we have to trust the checks carried out by the various Member States when products bearing this mark enter the EU and are placed on the market.
Later, I will explain the details in order to answer Mr Higgins's supplementary question, but I must make it clear that we have launched an information campaign designed not only to promote the CE mark, but also to ensure that the products are more guaranteed, by checking for counterfeit goods.
The suggestion of visiting the port of Rotterdam, which is where most toys arrive, is an idea that I have been nursing. I will probably go there myself in order to signal the fact that the Commission is focusing on checking products from outside the European Union that are coming in through one of its major ports.
I agree with the point that use of the CE mark needs to be encouraged. We are in the early stages, and I believe we should continue down this path. That is the purpose of the information campaign, which is also the result of a request made by Parliament. We achieved a lot when I was still a Member of the European Parliament by insisting on the need for the EU to have a mark that would primarily guarantee compliance with EU regulations. In fact, we should not forget that the CE mark is not a European quality mark, but it just means that certain EU rules have been complied with - a kind of self-certification, therefore, or third-party certification.
Some Members of this House hope that the CE mark will be followed by a quality mark and, in fact, Parliament pressed me on this at the hearing a year ago, when I put forward my candidacy for the Commission. I am certainly not against the idea, but I think we first need to encourage and increase the use of the CE mark by means of the information campaign within the EU. Even more needs to be done, and in the next stage, we need to think about further new initiatives. First of all, however, we must ensure that the CE mark becomes common practice for all EU companies, especially small and medium-sized enterprises, which probably require more information.
I assure you that I am committed to ever better information. I am delighted that there are debates and questions like these - and I thank Mr Higgins for them - because they spur on the debate through the work of the European Parliament and of its individual Members and the work of both the Commissioner and the representative offices of the Commission and Parliament in the European Union.
It is vital to inform the individual Member States and business organisations of the importance of using this instrument, just as it is crucial - and I have already emphasised this in my speech - to put pressure on the Member States to maintain strict vigilance, both at the borders and within the market, in order to stamp out, or at least to try to curtail, the problem of counterfeiting and the unlawful use of the CE mark, for the sake of protecting our products and ensuring compliance with EU laws, which, above all, defend the interests of consumers.
Subject: Uneven environment for growth and development in Member States
One of the key priorities of the 'Europe 2020' strategy is to support entrepreneurship through policies aimed at promoting growth and improving the business climate, in particular, for SMEs. Nevertheless, among Member States there is a very uneven business environment since, in many of them, setting up a new business involves a lot of red tape and high costs: this discourages entrepreneurship. Moreover, the economic crisis has exacerbated the problem and is creating a map of the EU characterised by disparities as regards entrepreneurship and thus growth.
Does the Commission consider that the objective of business growth set out in the 'Europe 2020' strategy is realistic and can be achieved within the next decade in all Member States, given the existence of these disparities?
Will it recommend that Member States adopt specific policies and a common framework for addressing the problems which deter entrepreneurship?
Subject: Small to medium-sized enterprises
Can the Commission outline what measures are in place to help small to medium-sized companies based in Europe who wish to export and invest in developing economies such as China?
Subject: Entrepreneurship in countries implementing austerity measures
Are there any measures proposed to support entrepreneurship, particularly in those countries that are implementing severe austerity measures?
Antonio Tajani
Madam President, I will try to be succinct, as I was when I was a Member of the European Parliament. We are dealing with issues of great interest, above all, the Commission's willingness to support entrepreneurship and to improve the context in which businesses, especially small and medium-sized enterprises (SMEs), operate, while supporting them in gaining access to third-country markets. I regard these three topics as a priority.
That is why the Small Business Act for Europe, adopted by the Commission in 2008, is to be revised in the coming days. The principles and provisions of the Small Business Act are perfectly consistent with the priorities of the Europe 2020 strategy, and they are sure to be implemented at national level because all interested parties support them. In other words, everyone - Member States and business organisations alike - will be involved in monitoring the results obtained.
We intend to ensure that the principles warmly supported in the Small Business Act, which are designed to promote entrepreneurship and eradicate the practice of always 'thinking small' when drawing up policies, will be implemented at both Union and national levels.
We have already introduced a test for SMEs which is designed to take into greater account the procedure used in assessing the impact of the various policies and obligations that constrain SMEs. The revised Small Business Act will include measures to harmonise the use of this test and improve the quality of the assessments. In addition, all Member States will be encouraged to take the same approach in the procedures making up the national decision-making process.
As we are aware of the need to cut red tape and eliminate disparities between countries, we will indicate specific measures - such as setting up one-stop shops and the use of e-government - to try to speed up processes in this area. The Commission is also organising the exchange of best practices among national civil servants on specific topics.
In order to stimulate entrepreneurship among young people and encourage cross-border commercial cooperation in Europe, again at Parliament's instigation, we have set up an Erasmus programme for young entrepreneurs, the results of which have been positive. It is our intention, therefore, to try to give the project a legal basis, transforming it from a pilot action into a permanent programme.
We have also planned actions specifically targeting women entrepreneurs: we have a network now comprising 250 female ambassadors from 22 European countries. I hope this network can grow even stronger. Lastly, we are working to create mentoring programmes for women entrepreneurs in at least 12 EU countries.
As regards assistance to SMEs for exports and investments outside the Union, we launched a huge public consultation exercise at the beginning of last year on our intention to strengthen support measures. The results of the exercise will enable us to adjust the proposed guidelines aimed at strengthening SME support services while, at the same time, ensuring efficient use of public funds.
We have already gained plenty of experience in terms of helping SMEs become international. I am referring to projects that have enjoyed considerable success, such as the China Intellectual Property Rights SME Helpdesk, the EU-Japan Centre for Industrial Cooperation, the Enterprise Europe network, and training programmes. In addition, based on the results of a study funded by Parliament, we are preparing a communication on strengthening support for SMEs in third-country markets.
With regard to emerging economies such as China, I can confirm that in the framework of the Small Business Act, the Commission has used the funds allocated by Parliament for the preparatory work, which has enabled us to set up SME assistance and support centres in China and India. I myself was in Beijing last November at the opening of the Centre for European Union SMEs in China.
I can also tell you that tomorrow, the Commission is appointing a new Special Envoy for SMEs, Daniel Calleja Crespo, Deputy Director General for Enterprise and Industry, who will be responsible for closely monitoring the implementation of the Small Business Act and acting as a contact point for SMEs.
The Commission document currently being adopted invites all the Member States and local authorities to appoint an Envoy for SMEs to supervise the implementation of the Small Business Act within the regions of the European Union. I am pleased to tell you that I have already received positive replies from a number of Member States and several EU regions.
Georgios Papanikolaou
(EL) Madam President, thank you very much for what you said, Commissioner; this is all very ambitious. However, to go back a bit, the Competitiveness Council called on the Member States in December 2008 to reduce company start-up times to a maximum of three days and, of course, the Commission promised to monitor that development.
Three years later, and in the midst of an economic crisis, we see that it takes 15 days to incorporate a company in Greece, 11 days in Austria, 8 days in Finland and, in Belgium, just a day and a half. In other words, there are huge discrepancies.
My question is this: as we all agree that entrepreneurship is a prerequisite to growth, how can the Commission move from simply urging to putting serious pressure on governments, so that we can harmonise the procedures?
Brian Crowley
I would like to make three points.
First of all, with regard to the China helpdesk. Whilst a wonderful idea, SMEs find it very difficult to get access for the sectors that they are specifically involved in. It seems to be more suited to larger-scale enterprises.
Secondly, the one-stop shop idea, which is already in use internally within the EU, could be put to better use in the BRIC countries - that is Brazil, Russia, India and China - to increase the amount of exports and outward investment that European companies can make.
Thirdly and finally, the model that has worked best so far has been the EU-Japan relationship. That has worked best for trade and investment in both areas. Perhaps that should be the standard to be followed.
Marian Harkin
I suppose my question is a slightly difficult one, in that it relates to countries that are implementing severe austerity measures like my own, Ireland.
This is the bottom line: SMEs need access to credit and they are not getting that for a number of reasons, perhaps because banks are looking for more collateral than they can provide, or sometimes, SMEs just do not want to risk borrowing in the current climate when there is no growth.
My question is, in that context, could the Commission endorse other measures such as loan-guarantee schemes or, indeed, an extension of the EU microfinance facility?
Antonio Tajani
Madam President, honourable Members, I am really delighted that the issue of small and medium-sized enterprises is at the heart of parliamentary debate for the second day in a row. Yesterday evening, we looked at the Competitiveness and Innovation Framework Programme (CIP) as well as how to help small and medium-sized enterprises and micro-enterprises to access EU financing in the context of the forthcoming Eighth Framework Programme. We also noted what we have already done and what we are currently doing for this category of enterprises.
As I said in my speech - and as I also stated yesterday evening - I think that supporting small and medium-sized enterprises is a priority for a number of reasons. First of all, we cannot but consider small and medium-sized enterprises as an essential tool for recovering from the current crisis. Through the Europe 2020 document, we put the real economy back at the heart of economic policy. Small and medium-sized enterprises are the lifeblood of our real economy and, above all, moving forward, I think that SMEs can also play a crucial social role because they are the ones that will create new jobs in the European Union, even while big industrial corporations are undergoing restructuring.
We therefore need to create the conditions for small and medium-sized enterprises to be competitive. Competitiveness is another word for innovation, and to be innovative, we need to help SMEs to access credit. Thanks to the support of the European Parliament, we have adopted the directive on late payments by public authorities and in business-to-business transactions, which falls under the Small Business Act. This is a fantastic result and I hope that the Member States implement this directive, which is now binding for the whole European Union, within 24 months from last October and perhaps even before the final deadline. This will inject around EUR 180 billion of liquidity into the market, to the benefit of small and medium-sized enterprises.
That is not all. I have also created the SME Finance Forum, as noted in Parliament's report on policies for SMEs and the CIP. This is a new creation of the Commission, where we will examine the difficulties involved in accessing credit and formulate solutions to these problems. It is not by chance that we have convinced the London Stock Exchange to take part in this initiative for the first time. This is a strong signal from Great Britain too, which is tantamount to powerful support for small and medium-sized enterprises from the world of finance. Therefore, the financial economy is working to support and serve the real economy, which I think is an important sign. I will take steps to continue supporting the work of the SME Finance Forum in terms of access to credit and will also identify all available initiatives, including cross-border venture capital and the attempt to ease the 'bottlenecks' between the European Investment Bank and domestic credit institutions, which are the ones that grant the financing in the end.
What should we do to make it easier to access EU financing? We are currently working on the forthcoming Eighth Framework Programme and a number of victories have been won for SMEs. I will repeat what I said yesterday evening because I do not know if the honourable Members here this evening were also here yesterday: regarding the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), I have cut back registration taxes to 60% for SMEs and 90% for micro-enterprises. I also made sure that the rules for the implementation of the REACH Regulation were translated into all the languages of the European Union. SMEs are therefore seeing signs of real support from this direction as well. It is our intention to do the same for micro-enterprises in the construction sector, too.
I have held quite a number of meetings on microcredit as well. I also examined the issue carefully during a meeting held two weeks ago in Brussels with the representative of the Italian Government's new microcredit organisation, which looks like a well-run example. I hope to be able to spread knowledge of the best practices of the various Member States in this sector, so that they can be implemented.
In terms of the disparities in the time needed for authorisation, this is a real problem. There is no doubt that we must exert pressure on the Member States to cut red tape. Much is made of European bureaucracy - which certainly has its own burdens - but sometimes bureaucracy in the Member States runs it pretty close. In any case, I think that it is in the interest of citizens to streamline procedures. When we say that we should 'think small', we need to make sure that the Member States also apply this test, just as the Commission has begun to. The presentation of the review of the Small Business Act in the various European capital cities will also provide a chance to urge the Member States to reduce the time required to issue authorisations for the creation of SMEs.
Subject: Commission's equal opportunities strategy
On 17 December 2010, the Commission launched a new equal opportunities strategy for the period to 2014, in which it set new targets for the number of women in senior and middle management positions and for the recruitment of women to administrator (AD) posts in the Commission's directorates-general, departments and services.
The new equal opportunities strategy will thus seek to guarantee equal opportunities for men and women working at the Commission, but does not extend to the EU's other institutions and agencies. Will the Commission's equal opportunities strategy affect women working in other EU institutions? Does the Commission see a need to draw up a common strategy on equal opportunities, in order to guarantee equal opportunities for men and women working in other European agencies and institutions as well? Gender equality and equal opportunities are fundamental EU principles and should therefore apply universally, without exception, to all EU workers.
Maroš Šefčovič
Member of the Commission. - I am very happy to have received this question, because I have good news to report. Since 1 January, there have, for the first time, actually been more women than men working for the Commission. We are very proud of this result, but we know that this is not the end of it. We still need to continue with our policy of also improving the figures for our female colleagues in managerial positions and non-managerial posts (AD) in the Commission.
We therefore adopted this strategy from 2010 to 2014, until the end of this Commission's mandate. We really would like to achieve a result where women would represent 25% of senior management positions, 30% of middle management and 43% of AD non-management posts. We have already achieved quite a lot over the last 15 years with the tremendous increase of women in managerial positions. We would, of course, like to continue with this same effort. The method we are going to use would be that retirements would be replaced with women, who would represent 30% of recruitment among senior management and 50% among middle managers and ADs. So that means that when these managers retire, 30% or 50% of them should be replaced by women.
In answer to your question, I checked the situation in other institutions and I must say that you are doing quite well in Parliament. The figures are very impressive. It is not quite the same in the case of the Council, though to be honest, we have slightly different results. But I think that the best method to progress further would be if we continued with our policy of exchanging best practice, and in exchanging experience about the implementation of our policies.
I know that our heads of administration, our secretaries-general, are discussing this issue on a regular basis also, and I believe that this exchange of good practice will lead to the appropriate results in all EU institutions.
Vilija Blinkevičiūt
(LT) Madam President, Commissioner, thank you for the good news. I welcome the fact that there are more women than men in the Commission. However, here is an additional question I would like to ask you. How much time do you think the European Commission would need for the percentage of women in management positions to reach not 25%, not 42%, but 50%? How long do you think that would take? You said that you will only have achieved this by the end of your mandate.
Nevertheless, you did not answer my question very clearly. As a Commissioner, what is your view of the European Union institutions' equal opportunities strategy? That of all of the European Union institutions? This would be a very good example to the Member States, both to people working in the public and in the private sectors.
Silvia-Adriana Ţicău
(RO) Madam President, I would like to expand a little on the question from my colleague and ask the Commissioner whether there is also an equal opportunities strategy. I am referring here to the appointment of persons from the new Member States to middle and senior management positions in EU institutions.
Maroš Šefčovič
Member of the Commission. - Thank you very much for your supplementary questions.
I agree with you that the figures you mentioned might not seem as ambitious as you would like them to be in the future, but the truth is that since we started with equal opportunity policies within the Commission in 1995, we have managed to increase the presence of women in top positions fivefold. This means that now there are five times as many women in these positions than before. Of course, we have to look at the baseline. I agree with you that it was very low. We also have to compare in what kind of environment in Europe we are operating.
This is also part of the response to the second question, namely, that policies for creating these conditions for women, not only in the EU institutions but also in the Member States, must still be improved. First, we need to create suitable conditions for women so that they can actually work in these high positions, which means adequate childcare, adequate working facilities, flexitime and other conditions which actually allow women to be in these high positions. Of course, these conditions are being created gradually. I think we have achieved quite high standards in the European institutions and you can see the various levels at which these conditions have been secured among the Member States.
Therefore, my colleague, Vice-President Reding, is now proposing a strategy which will be called gender balance in business leadership. So far, this is a staff working document, which will be discussed with business leaders in two months' time, and then the public consultations will start. What are the lessons to be learned in this process? Should we go through an obligatory quota system? Should we go for the system we have in the Commission, where we are trying to create a conducive environment and managerial incentives for those DGs which can actually fulfil the goals established for women? I think that after that, we will see appropriate results.
President
Questions which have not been answered for lack of time will receive written answers (see Annex).
Seán Kelly
Madam President, on a point of order, I just want to make an observation and I know many Members would agree with me. It is nothing to do with you personally, but concerns the way Question Time is organised.
From night to night, no Member knows how many questions are going to be taken, how many supplementaries are going to be taken, how long the answers will take, and whether or not we will have a Question Time to the Commission or Council at all. That is unsatisfactory. I met Baroness Ludford. She was an hour late for a dinner because she expected her question to be taken. I calculated that my question would be taken and I refused an invitation to dinner. At the very least, Members should be told in advance how many questions are going to be taken, and then they can plan accordingly.
I know I will get a written answer, but if I and other Members want a written answer, we could send an email from the comfort of our own homes and we would get a reply to our email.
That is all I want to say. I think it should be taken on board. Madam President, it is nothing to do with you: you handle it very well. I mean no disrespect whatsoever to you.
President
Mr Kelly, thank you for your intervention. I should say as one of the Vice-Presidents responsible for Question Time that I am concerned that we have not moved, as an institution, with the Commission, to implement what we agreed in our interinstitutional agreement, which was to improve Question Time. I am glad that Commissioner Šefčovič is here tonight and has seen the problems that we are experiencing at first hand. I hope therefore there may be a new dynamic to try to move to the situation that we had envisaged when negotiating the interinstitutional agreement.
(The sitting was suspended at 20:50 and resumed at 21:00)
