Resumption of the session
President
I declare resumed the session of the European Parliament adjourned on Thursday, 5 November 1998.

Approval of the Minutes
President
The Minutes of the sitting of Thursday, 5 November 1998 have been distributed.
Are there any comments?

Janssen van Raay
I should like it to be explicitly recorded in the Minutes that I said in Brussels that it is not only for reasons of principle that I am no longer voting in roll-call votes - which I have not done for some time -, but also for taxation reasons. I repeat: Dutch taxation reasons. I should like this to be recorded.

President
Thank you, Mr Janssen van Raay, that will be done.

Striby
Mr President, I do not want to speak about the Minutes, but I would like to ask you when the new parliament will be completed. Is the IPE4, which is still a 'forbidden city', something out of a science fiction novel? We are still here today in this lovely Hemicycle, which we are, of course, attached to, since we cannot sit in the new building. We hear rumours here and we wait. When will the inaugural sitting be held? Will it be in December, February or the summer of 1999?
Why are there such delays? We accept the argument that the complex process of moving in must be as well organised as possible, but I sincerely hope that it not a matter once again of politicking against Strasbourg. Mr President, we expect a clear response explaining all this wavering that damages Parliament's image of rigour, efficiency and credibility.

President
What I can tell you, Mr Striby, is that the building is not yet ready for occupation. Clearly, the company which had the task of constructing of the building should have made it available to Parliament last January. Parliament is not responsible for the fact that it is still not ready, since it has not yet been certified by the relevant authorities or the architects. For our part, we are doing our utmost to cooperate with the city of Strasbourg and the French Government so that it can be completed as soon as possible, in accordance with the regulations which apply. Once this has been done, we shall carry out our share of the dataprocessing work for Parliament and inaugurate the building as soon as possible. However, I cannot give you a date. That is outside our control.

Carnero González
Mr President, I took the liberty of writing to you last week on the situation in Central America. As each day passes it becomes clearer that the loss of life and physical damage experienced in that region have indeed been of biblical proportions.
The citizens of the Member States - Spain, for instance - are making an enormous effort to express their solidarity with the people of Central America. In keeping with this effort, I suggested in my letter to you that the Members of the European Parliament should open a special account. Members could pay their own contributions into such an account, and also any donations made through reputable non-governmental organisations to help rebuild the area. This symbolic gesture would supplement the effort the European Community is already making to respond to the situation.
I believe that on this occasion Members of the European Parliament should show they are on the same wavelength as the citizens and join with them in expressing solidarity with the victims.
I wonder, Mr President, if you are now in a position to voice your response to this letter I sent you last week.

President
Thank you, Mr Carnero. The matter was put before Parliament's Bureau, as you requested in your letter. The Bureau felt it was not appropriate for it - or, indeed, for Parliament - to open such an account, and that problems could well arise in connection with the Financial Regulation. However, if one or several Members were to take up your suggestion, we would publicise their initiative, drawing it to Members' attention so they could contribute if they wished.
I am sure many of us have already made a contribution through these organisations, as have large numbers of our fellow citizens in the Member States. Nevertheless, the sort of initiative you suggest is always welcome and worthy of commendation. However, it must be undertaken on an individual level. It is not for a parliamentary body to launch it, though every assistance and support should of course be offered.

Pompidou
Mr President, I would like to speak at this public sitting this evening in my capacity as chairman of Parliament's Delegation for relations with Japan. In the framework of the bilateral exchanges and meetings organised by the European Parliament, particularly by Parliament's sessional services, we are receiving an official visit from an important delegation of seven members of the Japanese Diet and four members of the Japanese Senate, including two former ministers, this week in Strasbourg.
According to the agenda, there are votes being held on Thursday morning. But on Thursday morning we also have a meeting that is authorised by the sessional services, which was even organised by Parliament's sessional services, during the votes on Agenda 2000. Therefore, I find myself caught between two stools. This is not a serious problem for me personally, as I have accepted my responsibilities and have decided, as chairman of the delegation, to attend the meeting, but there is a risk that I might be there on my own. Short of cutting themselves in two, my colleagues are, in fact, either going to have to appear impolite towards our Japanese guests or show a lack of consistency with the decision we had taken not to plan any meetings of Parliament's official bodies during voting time. I am in a situation where I feel totally schizophrenic and, although I am a doctor, I am having trouble sorting myself out. I would like to have a response on this matter, Mr President.

President
Normally there are no votes at that time on Thursday, Mr Pompidou, except in the case of those on the budget. This is a quite exceptional situation because of the large number of votes to be taken on Agenda 2000. That could not be foreseen when the time was fixed for the meeting of your delegation. We shall look into the matter and see what can still be done at such short notice, and I will keep you informed.

Nassauer
Mr President, would you please have it recorded in the Minutes that today I found my office ransacked and full of broken glasses and a radio missing, even though I had locked the office doors after the last part-session and, interestingly enough, found them locked again today. Would you please also record the question I am now putting to you in the Minutes: when will we finally be able to get on with our work without fear of the kind of violent attacks that occurred in Brussels or break-ins into our offices?

President
Mr Nassauer, I hope you have informed the security services of this incident. I should reassure you that to date, Parliament's security services have almost always resolved such incidents successfully. I trust this will not prove to be an exception and that the culprits will be identified. Should it appear necessary to tighten up on security, the appropriate measures will of course be introduced. Thank you for informing us of the incident. It will be noted in the Minutes and the security services informed so that they can take appropriate action immediately.

Killilea
Mr President, I would like to ask the Commission when they propose to deal with the report which was commissioned by DG XIV - reference PEM/306 - concerning the physical interaction between grey seals, fishing gear and the abnormal predatory conditions of the seals in the North Atlantic, the North-West Atlantic and now penetrating into the South Atlantic.
It is about time that the Commission had the courage to present that report and its scientific findings to Parliament so that we can deal with that particular matter. Predatory behaviour of seals around the Irish and Scottish coasts amounts to the total allowable catch plus one quarter. Something has to be done soon and we have to face up to it. I ask the Commission to act with haste.

President. -
Mr Killilea, you know perfectly well that that is not the way to put a question to the Commission.
There are several ways of putting your question. This is not the right time to ask it. You can ask it in one of the different ways provided for in the Rules.

Guinebertière
Mr President, I would also like to make a point concerning working conditions because for the second time my trunk has not arrived. Each time I put all the files I need here in the trunk and when I arrive, I find out that it is still in Brussels. This is very inconvenient because all my documents for work are in that trunk.
What is happening is that my office is on a corner and it must clearly get in the way, because people put it away in the photocopying room. When the removal men come, they obviously forget the trunk. I therefore took it out of there and put a label on it to let people know that when my trunk is put away in the photocopying room, it is not taken to Strasbourg. I presume that the removal men saw the second part of that note saying that it is not taken to Strasbourg. And I still do not have my trunk!

President
We shall take that up with the department which is responsbile, Mrs Guinebertière.

Puerta
Mr President, I must first apologise for my somewhat late arrival. Unfortunately, due to the considerable difficulties involved in reaching Strasbourg by air, many Members have arrived three hours late.
Secondly, I should like to express my group's concern over the arrest in Italy of Mr Abdullah Ocalan, who is in danger of being extradited to Turkey. We are all aware of the European Parliament's policy on supporting human rights, political rights in Turkey and the rights of the Kurdish people. My group believes it would be appropriate to take the necessary action to ensure that Abdullah Ocalan, who declared a unilateral cease-fire some months ago, is not extradited to Turkey from a European country.

Thomas
Mr President, as you are aware, recently I presented a report to Parliament on the banana regime. It was overwhelmingly supported with quite a lot of common consent within this House and was passed on to the Commission. We now have complaints from the United States in the guise of Chiquita, who are attacking the Commission and the proposals that the Commission finally brought forward after the original complaint from the WTO.
As a matter of concern, would the Commission be willing to come and explain to us how they are dealing with Chiquita's complaint?

President. -
Mr Thomas, I just told Mr Killilea that is not the way to put questions to the Commission. You know the way to put questions to the Commission, so use it.

Lindqvist
I did follow the procedure you just outlined and put down two questions - one to the Commission and one to Council - on building costs in Strasbourg and Brussels ...
(The President cut the speaker off)

President. -
This is not the time to put questions to the committee, nor to the Council. You cannot have the floor.

President.
Since there are no further comments, the Minutes are approved.

Order of business
President
The next item is the order of business.

Posselt
Mr President, I just wanted to make a point of order. I have heard that Question Time to the Council is to be deleted this week. I regard this both as an infringement of Rule 41(1) of the Rules of Procedure and as an infringement of the Treaty, which specifically guarantees us the right to put questions. The right to put questions is one of the most important, individual parliamentary rights and I believe no Conference of Presidents, not even in this House, can simply cancel that right; we have a right to a monthly Question Time to the Council. I and many other colleagues have tabled important questions to the Council within the deadline. Let me insist that we have this Question Time. If the Council wants to make statements, which are often merely upgraded press conferences, that is fine by me, but not in the place of Question Time, which is a key right of every Member of Parliament.

President
Mr Posselt, according to the Rules of Procedure you invoke, and in order to safeguard that fundamental right, the political groups may propose changes to the agenda agreed by the Conference of Presidents. On expiry of the deadline, no request had been tabled for Question Time to the Council to be reinstated on the agenda for this part-session. I am sorry. I cannot act without a request for the agenda to be changed. It is not in my power to do so.

Dell'Alba
Mr President, I have no objections to the draft agenda for Monday, but I would like to know if it is true that the Conference of Presidents has taken a decision concerning the legal basis of the Fabra Vallés report.

President
Yes, Mr Dell'Alba, and the Conference of Presidents has established that Article 206 was not the appropriate legal basis for the report. This report will therefore be put to the vote by simple and not absolute majority, and will not entail either approval or rejection of the Commission's management. The Conference of Presidents instructed me to convey to the president of the sitting its wish that this should be made very clear when the vote is taken. However, I am grateful that you have given me the opportunity to do that now.
Tuesday:

President
The PPE Group has asked for the Ferri report on supplementary pensions to be brought forward from Thursday and placed after the Añoveros Trias de Bes report on promoting innovation through patents.
Is there a speaker from the PPE Group in favour of this request?
Mrs Oomen-Ruijten has the floor.

Oomen-Ruijten
Mr President, we made this request because the Ferri report goes very well with and the Añoveros report, I and II. It is a very difficult report covering very complex issues relating to pensions. It is better to be able to count on the largest possible presence when voting on it.
(Parliament approved the request)
Wednesday: no changes
Thursday:

President
The Group of the Party of European Socialists has asked for the Commission statement on the results of the Buenos Aires summit on climate change to be postponed. It has also requested the inclusion, after the report by Mr Wiebenga on displaced persons, of the report by Mr Lehne on airport transit arrangements which is currently entered on Friday, so that the agenda for Thursday would be as follows: from 9.30 a.m. to 1 p.m., 3 p.m. to 4 p.m. and 6 p.m. to 8 p.m. we would have first voting time, and then the Wiebenga report and the Lehne report. Between 4 p.m. and 8 p.m. there would still be the topical and urgent debate, reduced to two hours and without returning to the normal length of three hours.
Is there a speaker in favour?

Graenitz
Mr President, let me justify my motion to postpone the Commission statement on the Buenos Aires climate conference on the grounds that I and the Members who took part in this conference on behalf of Parliament decided, after talking the matter over, that it would be more sensible to prepare carefully for this discussion in the appropriate committees; that would allow us to conclude with a motion for a resolution which was not drafted in haste, straight after hearing the outcome of the conference, but was based on careful and detailed preparation. I would ask the House to endorse my group's motion, so that Parliament's views can have some substance, rather than being put forward in a rush.

Spencer
Mr President, I led the Parliamentary delegation to Buenos Aires. I absolutely endorse the proposal that we take our time in responding to what was a very complex outcome in Buenos Aires. It missed failure by a very narrow margin. It was Mr Linkhorst's suggestion, as one of the other members of the delegation, that rather than going straight to a debate in plenary we should attempt to have a discussion in at least the three committees most clearly responsible, draft a careful resolution and come back either in December and January. That is certainly the opinion of Commissioner Bjerregaard, so I endorse the idea.

Aelvoet
Mr President, we addressed this question last week in a perfectly normal manner. It was handled positively at the meeting of General Secretaries and at the Conference of Presidents. Anybody who has looked at the media today and also over last weekend will know that it is now and not in January that the public debate is taking place. It is inconceivable to me that the European Parliament would not be able to make an initial political assessment of the outcome of Buenos Aires last week. If we wait until January to come up with a very searching, very balanced and very detailed response, we will find that nobody is listening any more. On the basis of the information currently available we are perfectly able to adopt a brief, well-founded political position this week while the matter is still in the news and not when it is past history. It is now that we must react, it is the European Union which has shouldered its responsibilities on this issue and it is this European Parliament which must now make its voice heard.

President
Thank you, Mrs Aelvoet.
I put to the vote the request from the Group of the Party of European Socialists
(Parliament approved the request)
Friday:

President
The Group of the Party of European Socialists has requested the removal of the debate on the oral questions on BSE in Portugal.

Colino Salamanca
Mr President, I should like to express my view as chairman of the Committee on Agriculture and Rural Development. This issue has already been discussed in committee, first in the presence of Mr Heine when the Veterinary Committee arrived at its decision and more recently, just a few days ago, when the Commissioner himself was present at our committee meeting.
I am not aware of any further developments that would justify this request for inclusion on the agenda. As far as we are concerned, this would serve no useful purpose.

Rosado Fernandes
Mr President, I asked for this oral question to be included in the agenda since, in my opinion, the situation in Portugal is sufficiently serious to justify that.
After all, despite our meetings in the Committee on Agriculture, the decision on the Portuguese meat embargo was taken at an extraordinary meeting for which I did not receive - nor did some of my colleagues - the respective agenda containing the item on the statement by Dr Heine, even though the Chairman of that committee told us here that it was sent to all Members. Dr Heine made a last-minute appearance to announce the reasons for the embargo. Everyone knew that many Members of the European Parliament would be unable to attend as it was an extraordinary meeting arranged at the last minute. That is why I have asked for a debate to be held here.
It should be made clear that this is not only an issue for the Portuguese but also relates to how the Commission acts in this kind of situation, a very serious situation for all Portuguese meat producers. That is why I tabled an oral question on behalf of my group.

President
Thank you, Mr Rosado Fernandes.
Do you wish to speak in favour or against, Mr Graefe zu Baringdorf?

Graefe zu Baringdorf
Mr President, I am in favour of keeping this item on the agenda, and would add that our oral question has not been included in it. However, we have been told that it will be included in the final version of the agenda. So we also have an oral question on BSE, and I am very much in favour of debating this item.

President
Thank you, Mr Graefe zu Baringdorf.
I put to the vote the request from the PSE Group.
(Parliament approved the request)

MED Programmes
President
The next item is the report (A4-0404/98) by Mr Fabra Vallés, on behalf of the Committee on Budgetary Control, on repercussions in the case of the MED programmes.

Fabra Vallés
Mr President, the Spanish Secretary of State for Development Cooperation, Mr Fernando Villalonga, published an excellent article in the press last week entitled 'Felling the rotten tree to save the forest'. This age-old idea encapsulates the thinking behind my report. Through the resolution dated 31 March this year, Parliament entrusted me with its preparation, and I can assure you that it has been one of the least pleasant duties I have had to carry out in my 20 years as an elected representative.
Clearly, it is not and never has been the intention of Parliament, its Committee on Budgetary Control, or myself as rapporteur to obstruct the policy for decentralised cooperation with Mediterranean countries. Such cooperation aims to strengthen direct contacts with universities, cities, local groups and journalists in those countries, enabling the peoples on both shores of the Mediterranean to become acquainted, exchange views, and understand each other better. Our intention has always been to preserve such important cooperation, and to strengthen and improve its foundations.
In this context, I must remind you that it was not Parliament but the Commission - Commissioner Marín himself - that ordered such cooperation to cease at the end of 1995. In my opinion, this was entirely justified, following as it did a most critical report from the Court of Auditors, whose investigation had revealed very serious irregularities.
Since this report became public, Parliament has done everything necessary to restore the credibility of this policy and allow it to be relaunched, from the month of April. I am grateful for the Commission's efforts in this regard, Mr Liikanen. Nevertheless, it also has to be said, Mr Liikanen, that if we really want to save the forest we have to be sure to fell all the diseased trees. And, before felling them, we also have to be sure that we have identified them all first.
In this connection, I want to make it quite clear that on the basis of the documentation received and studied, it does not appear that there are grounds for bringing criminal charges against those in authority at the Commission's 'North-South' Directorate- General.
Thanks to the information made available by Mr Marín, we know that the Commission has paid ECU 600 000 for the projects to be audited. You are aware of this too, as you have had the findings on your desk since September. On the basis of the European Commission's own criteria, experts at the London firm that carried out the audit have identified costs totalling ECU 4 million that ought to be recovered. They have also identified a further sum of over ECU 20 million and additional checks will have to be done in this respect, not to mention the total of ECU 2.2 million to be recovered from the technical assistance firms. A further and as yet unknown sum must be added to this total. The exact amount will become known when we receive details of the audit from financial control concerning the MED-LINK aid offices.
Commissioner, I am about to conclude, but I must first call on you to show some courage, courage enough to recognise that you have been mistaken or misinformed as to the true extent of the problems and the sums concerned. You now have the opportunity to inform us that you are going to pass the whole file on to the judicial authorities. I urge you to take advantage of this opportunity, because it is not for the European Commission or for Parliament to decide whether or not punishable offences have been committed. That is a matter for the judicial authorities. It is a simple and fundamental principle that Parliament confirmed once again in its resolution on the discharge on 31 March this year. Furthermore, it is an obligation the European Court of Justice in Luxembourg has confirmed by case-law.
It is not only an obligation, it is a necessity, because it is a very complicated file, and many individuals are involved. Given the resources and rights it has, or rather does not have, at its disposal, UCLAF cannot successfully undertake an investigation of this magnitude without the support of the judicial authorities.
If matters take this course, I shall be able to say that I am in favour of granting the discharge where this issue is concerned, and at the same time, you will have the chance of restoring the credibility the Commission has been losing over the last few weeks.

Wemheuer
Mr President, ladies and gentlemen, nobody, including this Parliament, comes back to the same question twice without reason. We are not doing this to avoid boredom or because we do not know how to spend the day. It would have been better if we could have clarified everything that needs clarifying in a report. But in our view some important points were not clarified, and nor have they been in the meantime, unfortunately. I am emphasising this again, although Mr Fabra Vallés has already made the point.
If we assume that only a court or the appropriate judicial authority can decide whether the facts of the case constitute grounds for criminal proceedings, then the judicial authorities must be in possession of all the information. But then 'all' unfortunately really does mean all, because who could make a selection? The Commission's relationship with the Member States' judicial authorities is simply different from the situation that would apply within a Member State. A special relationship, or perhaps a too poorly defined relationship, exists between the Commission, the Commission officials, the buildings, the documents in the possession of the Commission and the other European institutions on the one hand, and the individual national judicial authorities on the other - and obviously only national judicial authorities can consider the case.
We are aware of this difficulty, as is the rapporteur, who has taken it into account in his report. Nevertheless, we must urge that decisions are taken in the place where they belong, namely by the national judicial authorities. So let me ask again, and for the last time in this form, please make all the files available to the judicial authorities and do not say, as also happened again with ECHO: first the Commission decides whether there is a case to answer, and then it also decides what facts are relevant to resolving or clarifying that case.
We would not be so persistent - as shown by my reference to ECHO - if this were a one-off case. But it is a problem we have been facing for quite some time. Hence our persistence here, the persistence of the rapporteur but also of the Committee on Budgetary Control and, in the end, of the House itself.
We all regret having to keep doing this. We hope we will come to a conclusion now and take a decision. I think perhaps we will, and we must also undertake to review these questions in depth in connection with the discharge. We must be prepared to do so, the Commission must be prepared to do so, but so must the Court of Auditors. I think we will also be discussing our relations with the Court of Auditors today and considering how rapidly we can deal with the questions that arise from this. After all, this report also shows that there is no point spending too long and too much time on formalities.
We have asked enough specific questions in committee and had to wait too long for answers. That is another reason why we have had to come back to the same question twice in the space of about a year. We shall have to find other ways; they will be more precise and will certainly not involve any lesser degree of care.
Let me perhaps make a final point on a question arising from this report but which has also come up repeatedly in the past. If someone criticises the implementation of a particular policy, it is always assumed that they are criticising the substance of that policy area. I believe that is unacceptable. It is done by public opinion, but it is also done here in this House, and I think the two are often confused during the debates.
Mr Fabra Vallés said it all at the outset. It was in our interest to resume the MED programmes. We did all we could to enable the Commission to resume the programmes. That was our priority. But this could not detract from, or in a sense overshadow the fact that we are also looking at how they were implemented in the past, because our criticism of their implementation is fundamental and concerns the management of programmes in general and personnel management in general; then, in a sense, the affair of the MED programmes is merely an example of something we are criticising on principle. Then ECHO is merely an example of something we are criticising on principle, the tourism case was an example of a matter of principle, and we must all learn that we can criticise general structures on the basis of one example, and that this criticism goes far beyond the report.

Theato
Mr President, ladies and gentlemen, did we not all believe, or at least hope, that we had finally got to the end of the long saga of the MED programmes and that the Commission had taken action, after adopting a resolution on it more than a year ago and emphatically repeating key points of it when we postponed the discharge in the spring?
We were well wide of the mark! As Mr Fabra Vallés has explained, instead of improvements, we have seen new information come to light which seems to show that the financial damage is far worse than we had hitherto assumed.
This was discovered by a British auditing company which - and we grant the Commission this - was commissioned by Brussels to investigate completed MED programmes and projects. The auditors are looking into about half the completed projects and believe that some 4 million euros can be reclaimed. Let me ask the Commission: how much money has it actually recovered so far? Have the rest of the projects been examined now, and what amount of repayments does that come to? What conclusions does the Commission draw from the serious defects found by the auditing firm, such as over-subsidised projects, evidence which had disappeared and so on? Why was UCLAF not brought in promptly, as the rapporteur says? As regards the financial management of the Agency for the Trans-Mediterranean Networks - ARTM - the UK auditors make a devastating assessment, as did the Court of Auditors in its special report No 1/96.
This brings us to one of the two main problems that led to the postponement of the discharge for 1996, namely the question of whether criminal fraud may be involved here, in addition to serious irregularities. For the Commission to entrust ARTM, an international association under Belgian law, with the financial management of the MED projects without any legal basis and without obtaining the opinion of the legal service or of financial control, for the management board members also to be managers of the technical assistance agencies and to be involved in awarding some project funds without tenders and thereby secure themselves a large slice of the cake, that is to say fat contracts, is to say the least an overlapping of interests, as is also the view of the Court of Auditors and UCLAF.
Evidently the Commission has until now disregarded the clear advice of the Court of Auditors to the effect that these kinds of facts are punishable under Belgian law. But this matter can only be settled by the courts, which is why we call on the Commission for the third and last time to forward the entire file to the judicial authorities, so that they can at least examine the question of their competence and then, where appropriate, bring proceedings!
The second question in relation to the discharge for 1996 is how the Commission handles disciplinary proceedings. We believe that administrative inquiries and processes are no substitute for disciplinary proceedings and are not the appropriate way to prove the innocence of a possible suspect.

Kjer Hansen
Mr President, let me begin by thanking the rapporteur for his cooperation. In particular, I have been very pleased with the support there has been for a number of amendments we have tabled, and I am glad that we are agreed on an approach which is aimed at placing the responsibility on the Commission and not singling out particular officials, but insisting that it is the Commission which accepts the political responsibility for the situation. It must in fact be the case that the Commission must neither cover up for its officials nor hide behind them, but simply accept the responsibility for the fact that things are as they are.
This is a very serious matter that we are dealing with today. How much time and effort we have spent on this which we would rather have used on other things! I can only deplore the course of events, because the fact is that we cannot close the matter with this report, but once again have to call on the Commission to take action and once again say what steps we in Parliament will be obliged to take if the Commission does not comply with our requirements.
I would therefore ask the Commissioner if we can have a clear answer here and now as to whether the Commission will respond to paragraph 3 of the report and take the specific action which is being requested. Let us be clear today if it is willing to do so, or if it is simply going to cock a snook at Parliament's requests. If there is one thing that can shake our citizens' trust in the EU system, it is the suspicion that certain things are not happening in accordance with the rules, that irregularities are occurring, or that some people are engaging in a cover-up. For that reason, Commissioner, I cannot urge strongly enough that we should bring this matter to a conclusion and see that the necessary action is taken, so that we can all honestly say that we have rectified the mistakes and the shortcomings, as well as the procedures which are necessary to enable the Commission to live up to its responsibilities.

Pompidou
Mr President, I am speaking here on behalf of Mr Giansily who has been detained at another meeting. In spite of the serious and expert work carried out by Mr Fabra Vallés, we find the report on the repercussions of the MED programmes affair highly unsatisfactory. In fact, we believe that, far from clarifying the debate on the 1996 discharge, this report only makes the issue more confusing. The irregularities discovered in the management of the MED programmes, which meant that these programmes were suspended until the Commission relaunched them in April, involve more than a third of the appropriations used and the financial loss is much greater than was first supposed.
As the rapporteur has clearly shown, the management of the MED programmes shows evidence of serious management problems for which the Commission is entirely responsible and for which it must accept the consequences, as provided for in the Treaties. This whole matter falls within the framework of the discharge procedure, which will be on the agenda in December. The instruments the European Parliament has at its disposal to mark its disapproval, or to punish the Commission, are the refusal to grant discharge and even the censure procedure. Further debate, in my view, is likely to weaken Parliament's position in the vote in December and I regret the fact that consideration of the MED programmes is not an integral part of the general report by Mr Elles on the discharge.
Secondly, the petition to the Commission in the rapporteur's resolution is of little use when the European Parliament should judge the Commission on its financial auditing rather than following it through the maze of its administrative inquiries that are not sufficiently transparent. It is unfortunate that the rapporteur has not included any mention of the link between the irregularities discovered and the refusal to grant discharge, which is, however, at the heart of the debate.
For our part, we are hoping for an objective debate on the discharge for the 1996 financial year. We hope, on the one hand, that genuine and frank questions will be asked regarding the irregularities and the fraud committed in the implementation of the MED programmes, for which responsibility lies with the Commission. And we hope, on the other hand, that Parliament shows no sign of weakness in exercising the powers of which it is guardian on behalf of Europe's citizens because, when all is said and done, is it not our citizens who have been deceived in this affair?

Miranda
Mr President, we agree with the rapporteur as regards both his assessment of this particular case and the criticism that he levels at the Commission. We also go along with some of his proposals. This is not an issue on which we are giving our opinion for the first time. In the light of its seriousness, in that it refers to a collapse of the Union's financial resources - undoubtedly far greater than was initially thought -, it is politically embarrassing for the Commission.
It is therefore to be hoped, in this case as in others, that there might be signs of rigour and commitment of a different kind for preventing irregularities and fraud. We might expect far more firmness and swiftness in starting disciplinary or judicial procedures against those responsible for the irregularities and fraud. Whenever there are suggestions that fraud has taken place, we might expect far more transparency and, in particular, an attitude of cooperation with the European Parliament, and especially with the relevant judicial authorities in the Member States.
At this stage, we think it is very important that the Commission should forward the whole MED case-file to the Belgian, French and Italian courts or the European Parliament should act in its stead, making available all the evidence at its disposal and forwarding it to those national authorities.
The Commission should do this as quickly as possibly, by 1 December, as our colleague Mr Fabra Vallés has asked. In any case, it should do so as soon as possible and if it does not, in my opinion, I do not see how we would grant the Commission the discharge. When assessing the discharge, a lot of things have to be taken into consideration, including whether or not the Commission has met our demands concerning this vital issue.

Holm
Mr President, I should like to thank Mr Fabra Vallés for this excellent report. Many of us, both in the Green Group and in Parliament as a whole, are extremely upset about events surrounding the implementation of the MED programmes. It is not their content that is in dispute, but the way in which they have been administered.
One of our foremost duties towards our electorate and the citizens of the EU is to act as a supervisory body. It is up to us to ensure that matters we discuss in this House are taken forward in a proper manner. The EU Treaties clearly give us the task of exercising this supervisory role.
Since the MED programmes were last examined, new facts have come to light. Yet the Commission has still not produced the information we asked for initially - and which we need in order to fulfil our remit as a supervisory body for the EU. We must have the data if the Committee on Budgetary Control is to do its job. This is a serious matter. People could end up thinking that the Commission has something to hide. There is, after all, a possibility that its own officials might be involved in activities which could - at worst - entail criminal prosecution. The only way for the Commission to allay such suspicions is to come forward with the relevant documentation. We in the European Parliament need the material, and so do the judicial authorities. This is the last chance for the Commission.
The Green Group naturally supports the tough - but patently necessary - conclusions drawn by the rapporteur.

Dell'Alba
Mr President, last month the Committee on Budgetary Control had tabled a report by Mr Bösch, on the basis of Article 138b of the Treaty. The Presidency had to make it change the legal basis. This month it is retabling a report by Mr Fabra Vallés on the basis of Article 206 and the Presidency has told it that another legal basis must be adopted. I think that this is a bit of a mess and I feel I must draw attention to it because, in my opinion, if it is acceptable once, we will have to be more careful in the future before presenting reports before the House.
The Court of Auditors has drawn up around 40 special reports over the last four or five years and Parliament has given its opinion on 10 reports in this House. As far as the MED affair is concerned, we have already had two reports and, in practice, we force the Commission to meet such short deadlines - by asking it, for example, to present documents within 10 days - that there may well be a third MED report. As a result, alongside Dynasty or Dallas, we will also have the MED soap opera with all the publicity it entails. I believe that Parliament has important control instruments at its disposal and that it must handle them well. It must not, in my view, resort to some sort of therapeutic persecution that hardly enhances the institutional balance or, more particularly, our own role. We have these instruments, and we must keep them. But please let us try to put an end to this saga.

Fabre-Aubrespy
Our resolution of 31 March informing the Commission of the postponement of the 1996 discharge stated, in particular, that the Committee on Budgetary Control was to draw up a new report on the MED programmes on the basis of a report by the Commission on the financial audit of these programmes.
It would appear today - and this has already been said - that the loss to the Community budget is significantly greater than had been originally assumed: a figure of almost ECU 10 million is mentioned. Indeed, the subsidies that were wrongly allocated are not spread evenly over all the projects; there are certain projects where more than 50 % of the subsidies paid are in serious doubt.
The report by financial control not only confirms the appalling quality of the service provided by the agency the Commission entrusted with financial control of the trans-Mediterranean networks, but it also provides a great deal of information about how this agency was run and the relations it had with the Commission. We thus learn that when the two board members of the agency who were also managers of two technical assistance agencies were called on to resign from the board in order to put an end to an obvious conflict of interests, they made their resignation conditional on their firms being awarded new technical assistance contracts, and this condition was met by the Commission. Financial control's inquiry provides clear evidence that the selection procedures could have been rigged to make sure that the contracts did in fact go to the firms of the board members involved.
So a whole network of firms largely managed to bring the implementation of a whole policy under their control, and they were able to do so because this was tolerated, if not encouraged, by Commission officials. The Commission can no longer claim that these are individual cases of fraud; we are most certainly dealing with an established system that has allowed firms to gain extensive access to Community funds. As such, we must now look at this in the context of the refusal to grant discharge and I am calling on the general rapporteur for the discharge to propose a decision to this effect.

Sarlis
Mr President, let me first congratulate the rapporteur Mr Fabra Vallés on the energy he showed in drawing up and preparing this report, which was solidly supported by nearly all the members of the Committee on Budgetary Control. It should be realised that the Committee on Budgetary Control addresses such issues because there are special reports by the Court of Auditors and these are becoming more numerous. Their number has increased significantly and it is impossible for the European Parliament not to react to those reports and to what they denounce. So it must be made clear - particularly to the Commission - that whilst we are neither the police nor detectives, we have to face up to our responsibilities in relation to denunciations by an official institutional body of the European Union.
The details of the matter have been examined, in particular the role of the well-known Belgian companies which the Commission uses and seems to have used quite extensively to deal with things like the MED programmes. The general conclusion from this whole affair, Commissioner, is that there will have to be a structural change in the internal organisation of the Commission, a thing which all these phenomena show to be more necessary than might appear at first sight. The way the Commission functions must be reformed and restructured, because nobody in this Assembly wants to downgrade or debase the Commission. What irritates us is what I might call an apathy, a lack of reaction by the Commission to what both the Court of Auditors and the European Parliament are complaining about. Please react, and please do so in the right way.

Liikanen
The MED cooperation programmes were initiated in 1990. The Council approved the legal basis for them in June 1992. The aim of MED programmes was to promote contacts and the transfer of know-how between the actors in the civil societies on both shores of the Mediterranean.
Between 1992 and 1995 the Community financed 496 decentralised projects involving 2 000 participating operators. A total of approximately ECU 53m was allocated to these projects. What conclusions should we draw from this? I would draw the conclusion that never have so many small projects been financed with such limited funds and limited administrative resources.
The aims and the administrative requirements of MED programmes were not in line with the human resources that the Commission had at its disposal. There was significant pressure from Parliament to use the allocated credits quickly. The Commission signed a management contract with a Belgian organisation, ARTM.
In October 1995, as has been mentioned here, a preliminary report by the Court of Auditors alerted the Commission to the alleged existence of irregularities in the management of the projects by ARTM. The Commission decided immediately to suspend the execution of MED programmes and the contract with ARTM in order to clarify the facts surrounding the alleged irregularities. On the basis of the audits carried out by the financial control of the Commission and the final report of the Court of Auditors published in May 1996, the Commission instructed its anti-fraud unit, UCLAF, to carry out an inquiry within and outside the Commission. UCLAF's final report of May 1997 could identify no cases giving rise to suspicion of fraud involving Commission officials.
The rapporteur asked the Commission to submit the whole MED file to competent national judicial authorities by 1 December. There are, however, provisions governing the transmission of documents to judicial authorities. A sufficient presumption of fraud has to be established and this is the task of UCLAF. In its inquiries no sufficient presumption of fraud could be established. I will come back to this later.
In order to shed light on the alleged mismanagement in the MED programmes, the Commission launched an administrative inquiry. I would like to stress that mismanagement is not the same thing as fraud. The latter would imply that the misappropriation of funds was intentional. The aim of an administrative inquiry is to establish facts for the appointing authority. The inquiry is carried out by a higher-ranking official or officials than the official who is the subject of the allegations of mismanagement. The outcome of the inquiry is a report that is submitted to the appointing authority. The administrative inquiry does not replace disciplinary procedure. It only establishes the basic information. The appointing authority decides on the opening of the disciplinary procedure as laid down in Article 87 of the Staff Regulations.
In the case of the MED programmes an initial inquiry was carried out by one Director-General of the Commission. His report depicted a situation where Commission officials, highly committed to their aim of running the programmes under considerable political pressure, were always stretched because of the lack of appropriate resources. This situation had led officials to breach the principles of sound financial management, in particular when using the services of ARTM.
In order to get the most complete picture of the programme management the competent Commissioners decided to complete the inquiry at the initiative of the Director-General for Personnel. A complementary inquiry was carried out by three DirectorsGeneral. They concluded in their report that there had been a failure to adhere to the principle of sound financial management. It was also noted that there had been a failure to recognise the risks of delegating administrative and technical tasks.
In view of the difficult circumstances surrounding the management of the programmes, these three Directors-General did not recommend that the disciplinary procedure should be opened. The Commission endorsed the findings and conclusions of the report. A letter signed by the Secretary-General on behalf of the Commission was sent to the officials concerned expressing the dissatisfaction of the institution with their management performance. Both of these above-mentioned reports have been transmitted to Parliament.
The rapporteur asked the Commission to submit to Parliament the minutes of the hearings carried out in its administrative inquiries. In this we must be careful to strike the right balance between two requirements. Firstly, the people who are questioned in an administrative inquiry have the right to confidentiality. Secondly, Parliament has a responsibility to monitor the implementation of the budget and the right to be provided with information as laid down in Article 206 of the Treaty.
In order to reconcile these two imperatives, the Commission has approached Parliament with the aim of the two institutions drafting a code of conduct together on access to documents.
The first meeting between the representatives of the institutions is scheduled for this week. The purpose is to involve the legal services of both institutions in the process. The Commission hopes that an agreement can be concluded at the highest possible level.
In addition to the abovementioned measures related to management of the programmes the Commission also ordered, as has already been said, an external audit with the aim of helping to identify all the expenditure that is not strictly in line with contracts or the rules of accounting. The audited projects equal 70 % of the net expenditure used. This audit was carried out by a firm of auditors. A private firm cannot decide whether the expenditure is appropriate. That is for the authorising services, under the financial control of the Commission.
On the basis of the external audit report submitted at the end of August this year, authorising services have begun to examine, project by project, the information gathered by the external auditor. The results of this examination will be verified by the financial control of the Commission as a whole. The Commission will submit an interim report of the results to Parliament by 1 December.
Taking into account the huge amount of work involved in examining the 233 audited projects, the interim report will cover approximately 50 to 70 projects, leading to the first issue of recovery orders. The work will have to continue and the services of the Commission expect it to be finalised by the end of January 1999.
If expenditure is found to be ineligible, recovery orders will be sent out. The Commission will do everything in its power to ensure as much money as possible is recovered.
Should there be any suspicion of fraud in relation to any operator, the case would be referred to UCLAF. If UCLAF then finds sufficient grounds for suspicion likely to lead to criminal charges, the file would be transmitted to the competent national judicial authorities. In any case, any operator who has not met his contractual obligations will be excluded from receiving financing for new programmes.

President
Thank you, Commissioner.
The debate is closed.
The vote will take place tomorrow at 12 noon.

Combating fraud - Protection of the euro - Action against organised crime
President
The next item is the joint debate on the following reports:
A4-0396/98 by Mr Schmid, on behalf of the Committee on Civil Liberties and Internal Affairs, onI.the Commission communication to the European Parliament, the Council, the European Central Bank and the Economic and Social Committee: A framework for action on combating fraud and counterfeiting of non-cash means of payment (COM(98)0395 (Annex 1) - C4-0455/98-98/0911(CNS))II.the Commission communication to the European Parliament, the Council, the European Central Bank and the Economic and Social Committee: A framework for action on combating fraud and counterfeiting of non-cash means of payment (COM(98)0395 (Annex 2) - C4-0455/98)III.the Commission communication to the Council, the European Parliament and the European Central Bank: Protection of the euro - combating counterfeiting (COM(98)0474 - C4-0527/98); -A4-0376/98 by Mrs Cederschiöld, on behalf of the Committee on Civil Liberties and Internal Affairs, on the draft Council resolution on guidelines and measures for the prevention of organised crime with reference to the establishment of a comprehensive strategy for combating it (9986/98 - C4-0494/98).
Schmid
Mr President, ladies and gentlemen, there are two mistakes which people make that seriously hamper us in our fight against organised crime. The first mistake is to say that we are dealing mainly with drugs-related crime. The second is to say that we are dealing mainly with the most serious crimes, such as murder. In fact, organised crime is crime that is organised on the basis of a division of labour, on a systematic, daily, hierarchical basis, rather like the way a company is organised, but using illegal means. The problems arise because of the sum of the damage, not the individual damage, and they arise because ill-gotten gains are channelled back into the normal economic cycle through money-laundering operations.
One example is fraud with non-cash means of payment - in short, plastic money and credit cards. I can illustrate this with an example. If a briefcase is stolen in Brussels, this may be an individual act by a criminal who wants money, perhaps to buy drugs. But it could also be part of a process: specialists, groups of pickpockets, are flown in from Latin America - there are special schools there to train them - work the city and then disappear again in the evening by plane. The stolen credit cards are flown on by plane to other parts of the world the same night and used there to buy goods, which receivers of stolen goods then convert back into cash, which is then channelled back into the normal economic cycle through money-laundering operations.
As far as we know, credit-card crime is usually organised crime and crime that operates internationally in the way I have described. The damage worldwide comes to about USD 3 billion a year, of which a quarter falls to the European Community's account. So there is a need for us to act, and it is therefore a good thing that the Commission has submitted proposals for a joint action. These proposals are aimed, firstly, at harmonising the law, because we have totally different criminal laws for the crimes I have described. To give one example: in my country, neither the manufacture nor the possession of forged credit cards was a crime until April this year. So I could have opened a factory to make them and could have marketed them freely. Nobody would have said a word.
The Commission wants to close these legal loopholes, and we welcome that. Secondly, we very much need to make means of payment such as credit cards more secure. The market does not automatically guarantee maximum security; the sector weighs up the goods and carries out a cost-benefit analysis between security on the one hand and the cost of security on the other. That is why the result does not provide maximum security, but only precisely the level determined by the cost-benefit calculation.
But it is important to society to have a high standard of security if it is to combat organised crime consistently. That is why, in my report, Parliament submits a number of proposals. Let me draw your attention to three of them, which are obviously reasonable. In future, we want a better method to be found for issuing credit cards, because sending them by post, as is usually done now, is too unsafe. These credit cards have security marks. Every credit-card issuer uses a different one. No cashier can remember them all. So we want to see them standardised. Thirdly, in the long term there is no alternative to replacing the signature used for paying by plastic card with a numerical code, as in the case of the Eurocheque card, and a chip.
Another problem we will have to tackle is counterfeit coins and notes. Here again, we must distinguish between two cases. There are what are known as home-worker counterfeiters, who try to counterfeit notes using a colour photocopier. We are less concerned with them. But then there is large-scale money counterfeiting, carried out by organised crime. Introducing the euro as cash will create special risks. Firstly, this is because the euro is a new currency whose appearance people are not yet familiar with. Secondly, it is because organised crime predominantly counterfeits what are known as reserve currencies, which means currencies that can be placed globally. Thirdly, it is because criminal prosecution authorities and the police in the various Member States of the European Community have different experiences, because, conversely, there are also currencies that have hardly ever been counterfeited in the past. That is why the national authorities have little experience there. So we welcome the fact that the Commission is presenting a communication and putting forward proposals. Much of it we endorse. But our specialist committee does not approve the special role the Commission has assigned itself in this communication in relation to combating counterfeiting of the euro in future. Underlying this special role is the assumption that, as in the case of fraud against the Community, the interests of the Member States as such are not really affected. Fraud against the Community is after all, according to this view, money lost to the Community budget and not the national budgets.
But in the case of counterfeit money, things are different. Here the Member States certainly have a marked interest. We have serious reservations about allocating too much responsibility to UCLAF in this respect when we look at the Bösch report, which described the situation of UCLAF clearly enough. Let me put it in somewhat provocative terms, Mr President: the euro is too important for the matter to be left in the hands of UCLAF. So we suggest retaining the existing and proven system of cooperation between criminal prosecution authorities, police forces, central banks and cash acceptance points and supplementing this system by organising the rapid exchange of information and by giving Europol new responsibilities.

Cederschiöld
Mr President, it was a year ago that the European Parliament considered the action plan to combat organised crime. The focus then was on 'acute' intervention. This was to be enforcement-oriented, but I pointed out at the time that preventive action was just as necessary. Anti-crime strategies require a long-term perspective and this was one of the areas where I found the Council's approach wanting. Civil society has a key role to play in strengthening people's sense of identity, helping them to resist temptation and say no to crime. The family also bears responsibility for passing on decent values to children.
Citing my report as the trigger, the Council has now come back with a proposal for a preventive strategy. This is a novel occurrence in the third pillar area and I commend the Council's initiative. We now have some scope for constructive debate and a fruitful exchange of ideas.
What a pity Commissioner Gradin cannot be here. Although we all appreciate the need to set priorities, a key person's absence on a particular issue can only reflect the degree of importance which is attached to it. Perhaps this is primarily a Council matter. It is certainly good to see the Council represented, but I would have liked Commissioner Gradin to be in attendance too. I note with pleasure, however, that Commissioner Liikanen is here with us.
There was a remarkable show of consensus in committee, and I would thank my colleagues for their positive contributions. What we need is a strategy to develop a truly European civil society, alert to how early in life criminal behaviour is engendered and how fast it spreads. We can then take appropriate measures at national, local and regional levels to nip in the bud any drift towards a criminal lifestyle. Voluntary organisations, churches, schools, friends and family - all these make up civil society. And it is to civil society that we should look in order to derive the strength to resist crime. It is no good leaving everything to politicians and letting people think that the State will right all the wrongs. Social engineering, rather then protecting against crime, tends to weaken resistance. I have seen this happen in my own country, Sweden. We must be aware of the danger of 'everyday' crime and be ready to react before the petty offender becomes drawn into serious, international crime. People should take responsibility for one another, and this means empowering individuals so that they want to care. To put it figuratively, we need to create the software to be used with the hardware of law enforcement.
It is vital that Member States ratify the existing conventions. Full use is not being made of the instruments at hand. Nor has the action plan to combat organised crime been sufficiently developed. There were 30 points in the original text and barely half have been implemented. Progress is still awaited in 18 areas. We can learn from each other and promote those crime prevention measures that have proved effective. Everyone would like to live in a society where they can feel safe and secure. This is particularly relevant in the case of the applicant countries, where the crime problem is worse than here. Worst of all, though, is the transformation in attitudes that takes place in a society where crime becomes generally accepted as part of everyday life. If criminal behaviour becomes the norm in a community, that community is in trouble. The applicant countries should be encouraged to develop long-term crime prevention strategies; the impact will be felt across the Union. We need to vaccinate ourselves mentally against crime. Our societies will become less susceptible once the fundamental values we all share become more firmly enshrined through increased public awareness. Work will need to be done at both practical and 'human' levels.
Some of the EU states border on countries with crime levels that are inconceivable to us here in the West. The prevalence of protection rackets is an example. In one country not so very far away from here, up to 70 % of companies pay protection money to crime syndicates. Once criminal activity is allowed to penetrate so deeply into an economy, both democracy and market principles are under threat. Fundamental values go overboard and policy-making in other areas loses its meaning. If we lose our grip on crime, we shall be destined to fail elsewhere too. Pressure on each and every Member State must be maintained.

Michalek
Mr President, ladies and gentlemen, let me begin by thanking you for giving me the opportunity today to visit the European Parliament's plenary. As a member of the government who does not belong to any political party but will soon be able to look back on eight years of experience as Minister for Justice in the Austrian Republic, I have particular respect for the activities and responsibility of the Members of the European Parliament and very much appreciate the significant role the European Parliament plays in the pursuit of justice and democracy within the process of European integration.
Accordingly, the Austrian Presidency is endeavouring to cooperate closely with the European Parliament in its activities. Let me also use my visit here as an opportunity to make some comments on the subjects of this joint debate from the Austrian Presidency's point of view. Turning first to the non-cash means of payment: the possibility of obtaining services from third parties without having to carry the corresponding cash - generally by using a debit card - not only makes life easier and things more flexible, but also paves the way to new forms of abuse.
The Commission recognised this risk early on and submitted proposals on how to reduce it. The presidency welcomes the Commission's initiative, because we too realise that action is certainly needed here. The working group on Community law and national criminal law has already held an initial exchange of views on the matter. Without wishing to anticipate the working group's conclusions, I do regard it as very helpful with regard to our further progress that the Commission chose to forward its communication to Parliament quickly, thus enabling Parliament to give its opinion at an early stage and the Council to take due account of it in its deliberations.
The subject of the Commission's second communication, protection of the euro against counterfeiting, on which Mr Schmid has drawn up his report, is equally important for the future. The Austrian Presidency agrees with the Commission and the European Parliament that we must do our utmost to protect the euro against counterfeiting. On the one hand we must give special attention to the appropriate preventive measures, and on the other we must also ensure that we have sound measures for prosecuting counterfeiters from the moment the euro coins and banknotes are issued.
One key question here will probably be how to demarcate the responsibilities of the various institutions involved - where, as I know, there are different views - clearly and carefully enough to ensure effective protection of the euro; here, I believe, Europol will also have a major role to play.
With regard to criminal law, I can tell you that the Council working group responsible has already embarked on the necessary preparatory work. First we must gain an overview of the provisions in force in the Member States and establish to what extent we need to approximate the legal provisions. On the basis of this preparatory work, we will then have to propose a legal act, aimed at approximating the Member States' legal provisions. The aim will be to ensure that certain forms of conduct are regarded as punishable offences in all the Member States. However, the presidency regards it as rather difficult and not very useful to approximate the penalties so long as the general penal provisions, especially the prosecution system, the list of penalties, the imposition of penalties and the conditions governing mitigation are based on different systems. What we must ensure, however, is that we do not prevent the Member States from cooperating effectively in relation to mutual assistance and extradition provisions
Let me conclude with a word on the resolution on prevention which the Council intends to draw up. We followed with great attention the European Parliament's in-depth consideration of the action plan to combat organised crime. The presidency took the European Parliament's resolution of 20 November 1997 as an incentive to propose an amendment to the Council in the important area of the prevention of organised crime. That is why we also forwarded the presidency's draft resolution on preventive measures to combat organised crime to the European Parliament for information, although even the Amsterdam Treaty does not make provision for Parliament to be formally consulted on draft resolutions of the Council.
The multidisciplinary group on organised crime has discussed the draft in depth and will probably adopt it at the Justice and Home Affairs Council on 3 and 4 December. This resolution seeks to address all aspects of preventing organised crime in a comprehensive manner. Special emphasis is placed on the need to coordinate state measures with civil society in any attempt to reduce the incentive to commit crimes and take preventive measures against organised crime. In line with the horizontal nature of prevention, it addresses areas in the first and third pillar of the European Union, although emphasis is also placed on the Member States' responsibility at national, regional and local level.
In this context, we attach great importance to the preparation of national preventive programmes, the creation of interdisciplinary and interinstitutional crime prevention councils and, above all, the evaluation and assessment of preventive activities. I believe this resolution is a first major step forward, which I hope will be followed by others. Let me end on that note - I thank you for your attention and hope for further good cooperation between Parliament and the presidency!

Bontempi
Mr President, I should like to compliment both rapporteurs - both our colleagues have done a good job - and to make one preliminary remark. I think it is appropriate to point out that the House is now discussing for the umpteenth time matters related to the somewhat new institutional exercise of fighting for lawfulness, in other words against crime. I was very pleased to hear the President-in-Office stressing the value of Parliament's role and contribution. Now, post-Amsterdam, Parliament is playing a very important leading role in some ways, particularly in respect of an initiative which has perhaps been somewhat underestimated, namely the newly created area of freedom, security and law. These are new issues, but that is perhaps why Parliament's contribution is so significant, as the Minister clearly acknowledges: we are not restricting ourselves to requests and aspirations, but are attempting to identify tangible means of implementing aims and objectives which are of deep concern to the citizens of Europe.
I emphasise this point because I think that both rapporteurs rightly draw attention in their reports to the very important proactive role being sought by Parliament. I would dwell in particular on the question of crime prevention, as dealt with in the Cederschiöld report. I believe that this is the key point picked up by the Council from the first report on organised crime and proposed afresh in its draft resolution, given that any steps taken collectively by a society or community to reduce - if not avert - outbreaks of crime count as prevention. A range of measures therefore exists; we need only think of corruption. As far as corruption is concerned, most of what needs to be done is preventive: the culture of political back-scratching and patronage must be combated; the guiding rule in relations between institutions and citizens must be the transparency of operations. We have raised all these aspects of prevention in an amendment, calling for a code of conduct and attention to new occupational groups which can easily fall prey to corruption or organised crime. We have done so in order to stress the importance of preventive action when faced with change.
I would however point out here - as we state in another amendment - that preventive action is also very much a matter of partnership between institutions and civil society. I would remind you all of the concept of educating people to remain within the law. Two years ago, our committee held some remarkable consultations with an Italian organisation - called 'Libera' - which is an umbrella organisation encompassing some 600 civil associations. Its members described the work they are doing to combat organised crime in Italy, and told us how they were attempting to stamp it out in the worst affected regions. We heard from Rita Borsellino, the sister of Judge Borsellino, whose commitment testifies to the importance - not only for the sake of her brother's memory, but in order to combat the mafia - of a struggle based on a deep commitment by society to conveying the message of lawfulness.
I would just refer finally to preventive action against urban crime and petty crime. Here I think that there is now greater awareness: it has been understood that repression, where it is necessary, must be combined with prevention. The work being done on the ground, in a joint effort by institutions and civil society, inspires hope that it will be possible to reduce this huge amount of crime, this enormous sense of danger which is making our cities and citizens feel unsafe - according to a recent survey, 33 % of people felt unsafe in cities in 1996. But what is to be done? Should we put police on every street corner? No, that would serve no purpose; it would probably be both wrong and impossible. We must establish a close link between prevention, work on the ground, concrete measures, monitoring and controls.

Mendes Bota
Mr President, there can no longer be any doubt that the Single Market, the information society, technological inventions, the Internet, financial services and electronic commerce have revolutionised the use of non-cash means of payment. Turnover for payment cards alone exceeds $US 2 000 billion a year throughout the world. This huge market has also given rise to new forms of computer piracy and crime specialising in fraud and counterfeiting, or so-called cybercrime. Something therefore needs to be done to protect the interests of those issuing, using, being paid by or acquiring these new means of payment.
That is why we need to harmonise the systems of controls and penalties in the Member States to guarantee the euro's credibility and security, even in the intermediate phase from 1999 to 2002. The Commission should be congratulated on the initiatives that it is taking and, generally speaking, the rapporteur, Mr Schmid, deserves our support. But now allow me to turn to the report itself.
There are, however, some points for concern. For example, on the subject of combating the falsification of euro notes and coins, the Commission statement calls for close cooperation and mutual assistance between UCLAF, the ECB and Europol. But the future role of UCLAF still has to be clearly defined and, in the wake of cases of fraud at ECHO, the President of the Commission, Jacques Santer, has just publicly announced the Commission's intention to transform the UCLAF into OLAF, a body completely independent of the Commission, extending its inquiries and investigations to all Community institutions. That would then leave it for the Commission to focus on the legislative proposals and coordination with the Member States in the fight against fraud, in the interest of the European Union, as would be the case of counterfeiting the euro. But doubts linger and this lack of definition needs to be cleared up. In the end, who is going to supervise what? Will it involve UCLAF, OLAF or the Commission? We must in any case continue to compile, assess and update data on money counterfeiting practices, circuits and networks if we are to protect the euro.
It is therefore very worrying that there is no specific idea of the type of information to be included in the database, but we hope for a joint effort on the part of those actually responsible for issuing the coin, the courts, the police and financial bodies. In other words, we are looking into it. But time is short. These legislative instruments need to be adopted at the latest at some time in the year 2000 so that the comprehensive euro protection system can be operational as of 1 January 2002, in order to be tested before the euro notes and coins are brought into circulation.

Schaffner
Mr President, I would firstly like to thank the two rapporteurs for the work they have both done on this issue.
The fight against fraud and the need to establish a comprehensive system to prevent the counterfeiting of means of payment is of key importance, not only for governments but also for all the citizens of the European Union.
The Commission's communication on the counterfeiting and protection of the euro along with the amendments adopted are a positive and practical contribution to the fight against fraud. It is a start, but it is not the end. One of the main objectives is to ensure that these cases of fraud are treated as criminal offences in all the Member States. We also need an efficient system to protect the euro. The most important element is to make sure that the euro has a uniform level of protection throughout the entire Union.
Europol's responsibilities in combating counterfeiting should be extended. The euro has a very high potential circulation, which means that there is the risk of counterfeiting both within and outside the European Union. We are therefore going to call for an information system for the rapid exchange of data between the authorities responsible for combating counterfeiting.
It is very unfortunate that the implementation of the action plan to combat organised crime is so far behind schedule. The Council must ensure that all its recommendations enter into force and become effective by the end of next year.
The only aspect of the report by Mrs Cederschiöld that concerns me is the link between the measures to prevent organised crime and electoral procedures. That has no place in this report, which, apart from this, has my full support.

Svensson
Mr President, I have three points to make on this report. Firstly, it is common knowledge that any real semblance of control over movements of goods around the Union has gone, demonstrating that the much trumpeted vision of a Europe without frontiers is a dangerous illusion. The whole enterprise merely encourages criminal dealings. Experience has shown that free trade is not undermined by proper and efficient border controls. The free trade system should facilitate lawful activity, not crime. We therefore need effective controls for goods and persons at the EU's national frontiers.
My second point concerns corruption and mafia-style activities. Perhaps we could contribute to the fight against this type of crime by introducing a system of open government and public accountability. This is not something people necessarily think of in such a context, but the Nordic countries are committed to the principle of public access to official records. Ordinary citizens, as well as journalists, have a right to consult documents and paperwork produced by public authorities. This means that the general public is able to monitor financial management within government departments. I believe that the low levels of corruption we find in the Nordic countries can partly be attributed to this system of open access to documents. As well as enabling facts to be uncovered, the system also has a deterrent effect in terms of crime.
Lastly, the EU now boasts three groupings operating in the field of police cooperation: Schengen, Interpol and Europol. I wonder if we should be splitting up our anti-crime effort in this way.

Schörling
Mr President, I should like to begin by thanking the two rapporteurs for the work they have done. Democratic societies do indeed have a duty to make maximum efforts to combat organised crime and corruption in all their guises. Yet a balance has to be struck between effective anti-crime strategies, on the one hand, and the freedom of the individual and legal certainty on the other. We cannot allow ourselves to become a Big Brother society. My group has been highly critical, for example, of the holding of detailed files on individuals under the umbrella of Schengen and Europol. I also have reservations about the widespread use of global interception systems. These may well yield results in terms of combating crime, but the effects on democracy and civil liberties are not to be countenanced.
I commend the way in which Mrs Cederschiöld has managed to find a balance between ends and means in this report. I fully support her call for more work on crime prevention, and she is right to point out that the proposals still fall short on specific prevention measures. I agree on the role of civil society and the importance of setting long-term targets, and transparency and public accountability are essential in this context. Yet there is another dimension if we want to stop the rifts that already exist in our societies from widening. We need more job opportunities, better education provision and a fairer distribution of resources.
I have one final point. Mrs Cederschiöld talks about combating crime at European level, but we know that organised crime reaches beyond the frontiers of Europe. I am therefore in favour of working with Interpol and other international bodies too.

Pradier
Mr President, the report by Mrs Cederschiöld must be congratulated for having highlighted the often subtle distinction between organised crime and less serious crime and between prevention and repression, despite the complexities all these concepts involve.
We will certainly vote in favour of this report, even though it appears to be somewhat reliant on a political magic wand. We must of course - and I am merely quoting here - encourage citizens to cooperate with the judicial authorities, guarantee the protection of witnesses, and promote policing at a level that is closer to citizens. We need a reduction in factors that encourage and a promotion of factors that discourage crime. We must promote the integration of marginalised groups. Everyone will be in complete agreement with these issues.
There is one specific area that needs to be defined here, and that is the prevention of repeat offending, which falls somewhere between prevention and repression. Prevention is an extremely important factor and is linked to the quality of penal institutions and their ability to assist the social reintegration of offenders.
Significant efforts must be made in this area and they must be targeted. They are going to cost money and will require a great deal of imagination and intelligence. Whatever else happens, we must at least be prepared to agree to make this effort. Let us remember that.

Buffetaut
Mr President, the European Union only has legitimacy when it acts more efficiently than the Member States acting individually. Organised crime is the very type of harmful activity that calls for action at European level.
The report by Mrs Cederschiöld rightly stresses the need for the Council to propose concrete measures and to involve the applicant countries that hope to join the European Union in whatever prevention measures might be established by the Council. Unfortunately, we know that those countries, and particularly the countries of central and eastern Europe, have been left in a dreadful state of moral and economic decline by Marxist-Leninism. It is therefore highly desirable that from now on they should be involved in the work we ourselves can do within the European Union.
The rapporteur also rightly emphasises the need to involve civil society in the prevention of organised crime.
Prevention from within society is necessary but its effectiveness depends on society's general state of mind and on the promotion of values that are all too often scorned, such as a sense of responsibility, of duty, of honesty and of work. In short, it is also a matter of how civilised we are.
The prevailing relativism, the loss of reference points, a libertarian idea of freedom, individualism taken to its extreme, and the puerile desire to reject what are known as supposedly middle-class social conventions are all elements that, in fact, fuel everyday crime, which itself undermines the foundations of civil peace and acts as a basis for organised crime. Mrs Cederschiöld has also rightly highlighted the damaging effects of poor town planning.
We will support her report apart from the elements that relate, strangely, to voting rights and the prevention of crime.

Hager
Mr President, Commissioner, Mr President-in-Office, I share your concern about the problems raised in the Schmid report. There can be no question that we need a coordinated approach at European level here. Some time ago I put a question to the Commission on protecting the euro from counterfeiting, but only received a rather evasive answer. The fact that the rapporteur believes that the euro will act as a magnet for criminal activity and that the Committee on Economic and Monetary Affairs also believes that the euro will be an extremely attractive target for counterfeiting confirms me in my view.
The overall package of proposals to protect the euro from counterfeiting and fraud does, however, seem to be a useful instrument for tackling these problems. Here I wish to highlight the new regulatory system for harmonising criminal law, which I regard as very useful. I see the idea of laying down the framework, determining the crucial features, but leaving it to the Member States to formulate them in terms of their own criminal law systems, as a step forward in the right direction. Past attempts to formulate case materials on a Europe-wide basis, as in the corpus juris , gave rise to a great many problems and conflicts between systems. I believe that the legislative method which has now been proposed for approximating the Member States' different, historically based legal systems is a better one, and we approve it, as we do all the other points made in the report.

Ford
Mr President, I congratulate the two rapporteurs on their two reports and the three accompanying resolutions. Mr Schmid and Mrs Cederschiöld have done an important job here in dealing with issues that are vital to the future of the European Union. I am talking about combating fraud in the non-cash sector, combating counterfeiting and action against organised crime.
Most of the points I want to make are in relation to Mr Schmid's report. There are three main points. Firstly, it is a wonderful opportunity, with the switch-over to the euro from national currencies, to catch those who have currently got large sums of illgotten gains hidden under the bed or somewhere else and are going to have to switch from deutschmarks or francs, from pesetas or lire into euros. What I hope we are going to see is some coordinated action at European level to try and take advantage of this opportunity. We need special reporting requirements on currency exchanges around the time of the switch-over to the euro and we need a European-wide organisation of police and customs officials working together to see how much of the grey or black money we can detect when criminals have to move across from their own national currencies to the euro.
Secondly, with respect to non-cash fraud: I am pleased that in the report we complain about the fact that the banks do not worry very often because they offload the cost onto the customers. We should be looking at using new technologies for identification to help protect the customer - via new biometric patterns for example. Retinal patterns are very successful in allowing you to identify unambiguously the owner of a car. That will be something that can be used at cash points.
But, secondly, we should be allowed to use the highest available means of encryption that cannot be broken to protect these transactions. At the moment I understand the Commission is apparently negotiating with the US Government to limit our ability to encrypt electronic transactions. This is very foolish in the light of this particular report.
With respect to cash fraud, the euro will be reasonably well-protected. We have a problem with the euro coins, where we are allowing national characteristics on coins. Unless we have a plan to sort out those coins and send them back to their countries of origin, the average shop, after a comparatively short period of time, will have to deal with recognising 120 different coins if we are going to have six coins from the 15 states of the European Union, and added to that coins from Andorra, Monaco, San Marino, the Vatican City and Gibraltar. That seems to me to be complete nonsense and we should try to remove it later with legislation to enable shops to have a fairly small number of coins to identify rather than the enormous number that the rather foolish earlier decision will lead to.

Pirker
Mr President, ladies and gentlemen, we know from a reliable source that about 30 % of all crime is now organised crime. Given that the business of organised crime now extends from credit-card fraud to traffic in human beings and to money laundering, there is obviously an absolute need for action not just in the Member States but also by the European Community.
We must give absolute priority to combating organised crime, as both the rapporteurs say. What we need, without any doubt, is a combination of repressive and preventive measures. Let me just take up three points which I see as especially important in terms of combating crime. The first is that we, the European Community, must finally transpose the measures and the action plan which the Community has adopted. We must set aside national animosities in the interests of Europe-wide cooperation in combating crime and make efficient use of the instruments we have at our disposal, such as Europol and UCLAF.
The second point concerns expanding judicial cooperation. We are still at the beginning here: we have proposed some useful steps forward, but what we need to do is to harmonise criminal provisions relating to new types of offences, such as credit-card fraud, money laundering, environmental crime and gangs.
The third point, which I think needs very special emphasis, is that we must export security to the applicant Central and Eastern European countries that are seeking to join the European Union. We should help them to implement these programmes in the interest of Europe and in their own interest. The fight against organised crime must be intensified and expanded. That is what our citizens expect of the European Union, and it is absolutely vital to the security of the European Union as a whole.

Gallagher
Mr President, I am very pleased that the European Central Bank is set to establish an Analysis centre for counterfeits. The relevant statistical and technical data will be stored as a database to which national central banks will have full access. As of now no more precise details have been given by the European Central Bank but I am sure these will come in due course.
I welcome the fact that the Central Bank is taking this initiative at such an early stage of its inception. This is important because 13 billion euro banknotes will be printed by January 2002 when they will be brought into circulation within the 11 Member States encompassing a population of some 290 million people. It is very important that this Analysis centre for counterfeits should work closely not only with national central banks but also with Europol and the national police forces within the 11 Member States participating in the new single currency regime.
The Amsterdam Treaty is giving more powers to Europol in the area of judicial and police cooperation and this Treaty is set to be ratified shortly. Parliament must ensure that any financial resources which will be required by the Central Bank for the working of this new Analysis centre for counterfeits should be supported so that the evil of this prospective counterfeiting of euro notes is defeated.

Vanhecke
Mr President, we all - I believe - agree on the need to combat crime effectively. But I must add that we must not be too naive about the real effectiveness of the various preventive measures summarised in the second report we now have before us. The simple reality is that in many large and medium-sized towns in Europe there are whole streets and neighbourhoods which the police no longer dare enter, where there is virtually no longer any public transport and where the plucky citizens who remain, those who lack the resources to move elsewhere, are exposed to the laws of the jungle. In other words, we must have the courage to acknowledge that this prevention policy of ours has failed. Out there, in these neighbourhoods, it is well past the eleventh hour. The time has come to crack down hard and to take repressive action in order, if necessary, to restore law and order by force. First things first. Prevention is important but I believe this tough approach must take first priority, contrary to what is stated in this report.
I also regret that Parliament is afraid to speak out clearly when it comes to the subject of crime committed by foreigners. The second report just beats about the bush. We all know that, regretfully, 90 % of so-called street crimes in the major towns and cities are committed by uprooted people, uprooted foreigners, often second or third generation immigrants. We are not going to solve this huge problem by continuing to deny its existence or by trying to falsify the statistics by means of more flexible naturalisation procedures. We will also certainly not solve it by granting active and passive voting rights such as this report, to everyone's surprise, I would imagine, dares to propose. The only short-term solution is a courageous policy which presents those involved with a choice. Either integrate yourselves into our society, and thus respect its laws, customs and culture, or opt for supported and accompanied return to your cultural home where you will no longer be uprooted. Just because this solution has been declared taboo does not mean that it is not a decent and proper solution.

Schmid
Mr President, I am glad to be able to make a few more comments on the problem of preventing organised crime. Repression and prevention are two equally valid means of combating crime, including organised crime. However, we must realise that the traditional concepts of prevention will not work here. Let me explain this: the common belief that we can do something about organised crime by combating poverty and unemployment overlooks the real problem. Organised criminals are not usually poor people - on the contrary!
There are some chances of success in the field of technical prevention, that is to say technical precautions to prevent crime. These include the prevention of car theft by fitting immobilisers, preventing credit-card fraud by making this means of payment more secure, introducing better rules with regard to some areas of what is called hi-tech crime, and introducing better data comparison precautions in fields such as social security fraud, as are widely found in the United States.
Another question concerns the drying-up of markets. Organised crime often involves the supply of illegal goods and services. We will not manage to combat that in all cases. With regard to drugs, for instance, there are good reasons for not legalising them. On the other hand, there is no reason whatsoever for the state to retain its monopoly on gambling. Nor is there any reason for driving a system which has obviously been a social need for centuries, namely prostitution -whatever we may think of it as such - into the grey area of the semi-legal, which would only turn it into a seedbed for organised crime.

Pomés Ruiz
Mr President, I should like to comment briefly on matters related to the euro. I am particularly anxious to speak about this issue because I am concerned about the way this debate is developing.
The euro needs to generate confidence. However, the debate has not been particularly helpful in this regard. Too many speakers have expressed concern about the risks of counterfeiting even coins, which is in fact quite difficult to achieve. The first thing that should be said is that the European Central Bank guarantees the notes and coins issued. Furthermore, Interpol, Europol, the police forces of the Member States and the Member States themselves now have at their disposal means of controlling fraud and counterfeiting through the legal and penal systems. This should boost confidence.
Our role is not to be alarmist nor to think of the arrival of the euro as the very opportunity for deceit all the European mafias are eagerly awaiting. Our role in this House is to support the Commission and the European Central Bank, and to facilitate their task. For instance, we should try to ensure that Europol has arrangements in place to coordinate the attack to be launched by all the national police forces and by Interpol. We must also support the Commission once it has prepared more detailed proposals and presented them to Parliament. The citizens need to know that we are aware of the possible risks of counterfeiting, but they must also know that in this instance, 15 police forces will be working alongside Interpol and Europol. Our task is to enable appropriate legal provision to be made to ensure that detailed particulars on the type of offences are readily available, as stated in the report.
We should do all we can to promote confidence in the euro. It does need it. Fortunately, control does not depend solely on us, as we shall be assisted by many others.

Liikanen
Mr President, the Commission is very satisfied with Mrs Cederschiöld's report on ways we may best prevent organised crime from taking root in society. We have to get to the core of the problem and devise a strategy for the prevention of problems, with all parties in the Community taking part at national and local level. Ridding ourselves of crime can only succeed if we make use of all the means available to the constitutional state. The rapporteur justifiably stresses the need to support common measures taken by citizens against organised crime in the constitutional state.
In the area of money laundering the Commission has applied legislation under the first pillar to prevent the circulation through laundering of money obtained from selling drugs. At the start of 1999 the directive will be broadened to cover suspect business activity linked with smuggling, other than drug-smuggling. In the area of telecommunications the Commission issued a communication in May 1998 on the protection of minors and human dignity in general in audio-visual and Internet contexts. This is a good example of a case where national legislation is not enough to ensure that we are rid of crime, but where action at Union level is needed. As Members of Parliament know, the Commission has initiated a number of projects under the Falcone programme in conjunction with the Member States and NGOs.
The rapporteur made special mention of the need to support employment, health, family, and social policy, so that the security of the immediate environment of our citizens might be improved. The Commission fully supports these objectives. Similarly, there is support for citizens' local services. The issue has been raised in a communication on city policy, which is to be presented at the Europaforum Wien Centre for Urban Dialogue in Vienna at the end of November. Crime in our cities is a real problem, as it is based on organised crime, which threatens cross-border social order.
The unambiguous aim of the Commission is to create a pan-European area where freedom, safety and justice prevail. With the ratification of the Treaty of Amsterdam this goal has moved a lot nearer. The heads of state and government have already agreed to meet in Tampere, Finland, in October 1999, to discuss priority aims and deadlines in this important area. The report by Charlotte Cederschiöld will form part of the foundations upon which the Commission's work will be built.
Moving on to Mr Schmid's report, I would like, on behalf of the Commission, to congratulate the rapporteur, who, in very clear terms, raises the issue of the connection between the Commission's proposal on fraud and counterfeiting in non-cash transactions with fraud and counterfeiting specifically in respect of the euro. The amount of fraud in non-cash transactions is growing fast. Payment card fraud accounts for around ECU 2.7 billion in losses a year. At the same time the legal authorities in the Member States are able to combat these types of crime only semi-effectively simply because there are no laws on the matter. The aim of the Commission's proposal is to correct this situation. It calls for joint action to ensure that all fraud in non-cash transactions is looked on as a punishable offence in all EU Member States.
Mr Schmid's report opposes the inclusion in the proposal of provisions on money laundering and mutual assistance. He believes that satisfactory results will be achieved in these important areas only through horizontal regulation covering all forms of crime. The Commission agrees, but as, unfortunately, there is not yet enough of this sort of regulation, legislation needs to be created jointly. The Commission cautiously supports all the proposals for action put forward by Mr Schmid and the other agencies concerned and will take them into consideration in future planning.
The other subject covered in Mr Schmid's report is protecting the euro from counterfeiting activity. This is an important matter that needs to be addressed urgently. We expect the euro to be legal tender internationally. That being the case, it may well fall prey to internationally organised crime. The Commission thus believes that before the euro is allowed to circulate we must devise an effective system to prevent the manufacture of counterfeit euros. The Ecofin Council has itself emphasised that an effective protection mechanism must be in place for the new currency before its introduction. Ecofin also stressed the role of Europol here and urged the Commission to continue with its initiative.
The main protection targets will be set out in a Commission communication to be issued in July, reflecting the Commission's views. It will focus on the following: education, information, communications systems and databases, cooperation and mutual assistance in investigations, defining what constitutes criminal counterfeiting activity and the introduction of penalties that will act as a deterrent. The Commission believes that the institutions concerned each have their own job to do: the European Central Bank, Europol, the Commission, especially in its capacity as the initiator of legislation, the Member States, their central banks, their police forces and their courts.
Finally, I would like to say a few words about Europol. Much has been spoken about how the workload should be divided between Europol on the one hand, and the European Central Bank and the Commission on the other. Each will have its own job to do in any future system. The sole guiding principle in making decisions will be how effectively we can protect the euro. As we know, difficult compromises had to be reached before the Europol Treaty was introduced, relating to the delicate issue of cooperation in matters of crime and punishment when it comes to combating international crime, as these issues are regarded as too tightly bound up with the notion of national sovereignty. The protection of the euro will be the responsibility of both the Community and the Member States, however. For that reason, we need a properly functioning legislative framework, which might go further than the Europol Treaty. Until then we must give Europol the necessary authority to act to prevent counterfeiting activity in respect of the euro within the limits of its present powers.
I would once more like to thank the rapporteurs for their thorough work.

President
Thank you, Commissioner.
The debate is closed.
The vote will take place tomorrow at 12 noon.

Safer use of Internet
President
The next item is the recommendation for second reading (A4-0377/98), on behalf of the Committee on Civil Liberties and Internal Affairs, on the common position adopted by the Council (C4-0535/98-97/0337(COD)) with a view to adopting a European Parliament and Council decision adopting a Multiannual Community Action Plan on promoting safer use of the Internet by combating illegal and harmful content on global networks (Rapporteur: Mr Schmid).

Schmid
Mr President, ladies and gentlemen, there is a saying that goes: 'knowledge is power'. If that is true, then we are currently witnessing a shift in power from those who have to some extent enjoyed a monopoly to the many people who have gained access to unheard-of power through the Internet. The Internet offers an enormous opportunity. But we also know that it involves risks. The Internet contains content that can be either unwanted or criminal. So the Commission was right to propose a programme to deal with this problem.
We approved the core of this programme at first reading, but tabled some amendments. Most but not all of these amendments were accepted. Our committee is therefore retabling some of the amendments from the first reading. Basically they can be divided into two groups. The first groups is addressed to the Commission, and concerns the implementation of the programme or things that we do not necessarily have to incorporate in a legal text, but which the Commission can ensure are done. Firstly, these are actions to prevent the Internet from being misused any longer for trafficking in women or children. Secondly, and in particular, we want preparatory studies to be carried out with a view to making it clear to all concerned what is needed in the way of harmonisation of legislation. This is important, because any criminal prosecution, for child pornography for instance, is in fact bound to fail so long as we have different age limits for the protection of children, so long as a server can be operated anonymously, or e-mail sent anonymously.
If the Commission makes a satisfactory statement on implementation during this debate, I can withdraw Amendments Nos 1, 2 and 6, with the committee's approval. That depends on what Mr Liikanen tells us in a moment.
So I would ask the President to allow me to speak again briefly at the end of the debate, in response to the Commissioner.
The other group of amendments is addressed to the Council. Here we have managed, in cooperation with the Austrian Presidency, to find some compromise formulas which both we and the Council can endorse. Firstly, they concern the idea of a quality label for Internet service providers who voluntarily adhere to a code of conduct agreed within the sector. That will make it easier for parents to decide which Internet provider's services to use. The other concern was to use as little paper as possible for the awareness actions and, wherever possible, to opt for cheaper electronic information.
As I said, we have reached compromises with the Council. This means that we are withdrawing Amendments Nos 3, 4 and 5 in favour of Amendments Nos 8, 9 and 10, which we have tabled as compromise amendments in accordance with the Rules of Procedure. There are other amendments, which I reject without exception, because if we were to accept them we would have to go into a conciliation procedure. By handling the matter as we have so far, namely reaching agreement with the Commission and the Council, we avoid the conciliation procedure and save about three months of time. For that reason alone, I would advise against accepting the other amendments, from No 12 onwards. Furthermore, the importance and quality of these amendments is not such that not accepting them would significantly harm the programme.

Iversen
I am pleased that we have made such progress with this action plan, and I would like to compliment the rapporteur on what is an excellent report. The Internet is first and foremost a wonderful invention, which breaks down boundaries and opens doors on a scale we could not possibly have imagined only ten years ago. In this sense, the Internet is part of a revolution which enables us to communicate with people throughout the world. However, if the Internet is organised in an anarchical way, it also means that dishonest and criminal individuals will more or less have a free hand to disseminate illegal images or text, for example child pornography or incitements to racism. This is very difficult to stamp out, as we all know, and I am glad that we are proceeding with this European action plan, which can try to prevent the spread of illegal material. Users of the Internet will have full control and be able to filter out this kind of material automatically, and so there should be complete transparency.
However, it is very important for us to distinguish between what is illegal and what is offensive or morally damaging. Who is to decide what is damaging, and whose morals are the best? The great thing about the Internet is precisely that there is no censor in the middle of it. In the opinion of the Danish Social Democrats, therefore, we should not have a quality label, awarded by the Commission. The Commission should not have a monopoly on deciding what is morally correct. Nor should we be harmonising civil law in the Member States, but rather working and cooperating to combat such things as child pornography. This is illegal in all the Member States, and we can all agree that it is damaging to children's rights. So let us begin a joint action to combat child pornography as soon as possible and extend the competence of Europol, so that we can combat international networks which produce, sell and distribute pornographic material of this kind.

Cederschiöld
Mr President, the Internet was virtually unknown a few years ago. Now, nearly all of us make use of it every day. Wherever in the world we happen to be, there is a good chance that we will be able to follow the news and keep ourselves up to date. In this sense, the Internet is bad for dictatorships and good for democracy. Many of us connected to 'Sarajevo on-line' at a time when that city was otherwise cut off from the world. This might sound exaggerated, but I believe that the Internet will one day go down in history books alongside Gutenberg's printing press.
As to the specific proposals in the report, I am in favour of websites which offer information and assistance on unlawful material coming over the Internet. I particularly support the idea of self-regulation for service providers. I myself suggested a system of quality labelling to reward those who observe the sector's code of conduct, and I hope that the Commission will go along with this. There appeared to be some reticence in the beginning, but I sense that both the Commission and the Council have now been won over. Let us hope that we will reach an accommodation on this issue. Since we are dealing with an international problem, I remain convinced that effective self-regulation is the best way of achieving sustainable results. It must be possible both to offer the necessary safeguards regarding personal integrity and to halt the spread of unlawful or damaging material.
I should like to congratulate Mr Schmid on his fine report. It has been a pleasure to work with him, and he deserves praise for the excellent results he has achieved.

Thors
Mr President, it is a pity that the Council of Ministers is not present to hear me say how much I deplore the decision not to accept the proposal on judicial cooperation. I would encourage the Commission to pursue the matter and exploit the possibilities offered by the Treaty of Amsterdam.
I also have high expectations of the fifth RTD framework programme, which we have often discussed here. Many important proposals are likely to be forthcoming as regards safe use of the Internet. This is only right and proper if people are to have faith in the system. Copyright too will need protecting. And coordination between this action plan and other measures is vital.
We are confronted by a twofold problem. Individuals want to know that it is safe for them to pay their bills via the Internet, to send messages and so on. Equally, society has a duty to intervene where necessary. The first step is to win people's confidence by ensuring that the Internet is safe. The Commission could do a great deal to facilitate the use of encryption. One Member State actually prevents the unfettered sale and use of encryption services. The US is also putting obstacles in the way of trade. Action by the Commission is particularly necessary if the Internet is to become safe to use.

Dupuis
Mr President, Commissioner, ladies and gentlemen, there is no surprise here. We are witnessing how a great invention such as the Internet is growing. There is an increase in the number of people using it and in the attempts to control and censor this brilliant invention, and Mr Schmid, our rapporteur, is acting as their spokesman.
My group will oppose this report because it is not by claiming to defend groups that are particularly vulnerable - we have mentioned here the victims of paedophiles and victims of drugs - that we are going to tackle these problems. We know very well that the problem of drugs can be tackled by giving the State the opportunity to regulate and legalise this phenomenon. We also know very well that paedophile rings - rings that the judicial authorities in many countries, including Belgium, are failing to clamp down on - do not work via the Internet, and we are attacking something that has nothing or very little to do with these crimes. I therefore believe that we must look at the problems facing us and begin to tackle the real issues.

Ford
Mr President, in an earlier life I was chairman of a film censorship committee in Manchester. In my time on that committee I never voted to censor a single film. I am in favour of minimal censorship but not of none. Certain material needs to be kept out of the hands of children; certain material needs labelling so that those who, if you want, investigate it know what they are getting. Certain material - paedophile material, pornographic material of certain kinds, particularly snuff movies, and certain racist material - should be banned.
If it is illegal in written form, it should be illegal on the Internet. I know the librarian argument: a librarian does not know what is in every book. But when you point out what is in some of the books, you expect them to take action. The same should be true of service providers on the Internet.
I also want to say that STOA conducted a study recently on the subject of whether material on the Internet can be controlled technically. Slightly to our surprise, as a member of the STOA panel, there seemed to be good technical means for controlling what is on the Internet, for example, pornography, so that you can signal areas which you need to investigate and look up.

De Esteban Martin
Mr President, I should first like to congratulate Mr Schmid on his report. It is not the first time that this issue has been debated in the House. The action plan results from the reply obtained by the Commission when it raised the issue for the first time. It has been developed in conjunction with the Council's recommendation on the protection of minors and human dignity taking the European Parliament's resolutions into account.
I would like to highlight the positive aspects the House has tried to include in all its resolutions on this information network, taking into account the role of the Internet in the daily lives of our citizens. Nevertheless, like any other source of information, it has to be governed by certain rules on security, particularly where children are concerned and particularly because it is so accessible. As always, allowing complete freedom of information and expression, in conjunction with the development of new technologies can make it possible to disseminate illegal material that may affect other rights and freedoms.
This issue has been much debated and has awakened great interest in international forums as well as in the Council of Europe and the OECD. The amendments tabled at first reading have allowed it to be discussed again here today.
These amendments enabled us to change its legal basis and adopt this proposal for a decision through the codecision procedure and not through simple consultation. The involvement of this House in an issue that does indeed come under the protection of consumers and Internet users, that is, of the citizens, was therefore enhanced.
As the report emphasises, I should like to stress the need for police and judicial cooperation, and for the approximation of the systems for prosecuting these offences under the legislation of the various Member States. Further studies on this subject are called for too. This could bring us closer to concrete solutions.
By granting a legal basis to its budgetary line, this action plan will enable us to reach these solutions. I would therefore like to stress the need for interinstitutional cooperation to smooth the way towards solutions that would be of real benefit to our citizens.

Neyts-Uyttebroeck
Mr President, Commissioner, ladies and gentlemen, the vast increase in the use of the Internet is prompting outpourings from many opinion-leaders which are comparable to the reactions 500 years ago in response to the advent of printing. Then too there were claims that this new technology would sow confusion among the more vulnerable souls and undermine established values and practices.
It is to the credit of the Commissioner, the Council and Parliament that the multiannual action plan for safer use of the Internet is based more on information, increasing awareness, self-regulation and voluntary codes of behaviour than on repression and censorship. The Union has not yet given way to what is said to be a Marxist principle - but I leave that to those who say it - which claims that trust is good, but control is a lot better.
That said, I am not so naive as to believe that this is the reason why the Council has omitted any reference to cooperation in the field of justice and prosecution. This omission indicates that it is mainly with words that the governments of the Member States are urging a joint approach to combating cross-border crime, while shrinking from even considering such cooperation in practice. Simply calling with words for more security, while refusing to prepare the necessary action, let alone actually taking it, will only increase the sense of insecurity and threat among our citizens. That, ladies and gentlemen, is ultimately very damaging to democracy.

Liikanen
Mr President, Parliament has expressed the wish for changes to the common position. The Commission has no difficulty with the substance of most of these amendments. In order to be consistent with its position on first reading and its original proposal, the Commission cannot accept Amendments Nos 1, 3 and 13. The Commission can accept the remaining nine amendments. However, time is now of the essence. I urge Parliament to consider carefully the proposed amendments so that delays that would occur in the conciliation procedure can be avoided. There is little doubt that there is overwhelming support for the action plan; there is no substantial disagreement that should prevent the action plan from being adopted without further delay.
In three cases - Amendments Nos 1, 2 and 6 - the Commission proposes dealing with Parliament's concern by making the following declaration: 'Liability of intermediaries for Internet content will be dealt with in the proposal for the directive on certain legal questions relating to electronic commerce which the Commission has undertaken to bring forward. Counteracting violence and the abuse of women and children is covered by the Daphne programme. The Commission will ensure that due account is taken of Parliament's concerns in implementing action lines 1 and 3 with respect to violence and the abuse of women and children on the Internet. As a follow-up to the crime study and in conjunction with the forthcoming Commission communication on computer crime, the Commission will arrange for studies on the issues of substantive provisions of criminal law, referred to in Amendment No 6 by the Committee on Civil Liberties and Internal Affairs, subject to the availability of budgetary appropriations and to obtaining the necessary approval under the Financial Regulations.'
I hope that this will enable an agreed text to be voted and so allow the action plan to be implemented as soon as possible. In the light of the sad evidence this summer, with child pornography on the Internet receiving much attention, everybody agrees that there is an urgent need to act. Adoption now is vital if the European Union is to maintain its lead in dealing with illegal and harmful content on the Internet.
I wish to thank the rapporteur, Mr Schmid, for his very constructive approach to the proposals contained in the action plan.

Schmid
Mr President, following the Commission's statement, I am authorised by the committee to withdraw Amendments Nos 1, 2 and 6. They are redundant. Let me point out again that we are withdrawing Amendments Nos 3, 4 and 5 in favour of the compromise wording of the Council's Amendments Nos 8, 9 and 10.
I should like to make another formal comment. There is an Amendment No 7 which concerns the entry into force of the programme by 1 January next year, since the date of 1 January this year is now obsolete. That obsolete date is repeated elsewhere in the programme, so the amendment obviously applies there as well.

President
Thank you, Mr Schmid. Your explanations will be taken into account tomorrow during the vote.
The debate is closed.
The vote will take place tomorrow at 12 noon.

Clinical trials
President
The next item is the report (A4-0407/98) by Mr Amadeo, on behalf of the Committee on the Environment, Public Health and Consumer Protection, on the proposal for a European Parliament and Council directive on the approximation of provisions laid down by law, regulation or administrative action relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (COM(97)0369 - C4-0446/97-97/0197(COD)).

Amadeo
Mr President, ladies and gentlemen, a long-awaited directive is coming before the House today; it is a very important one because of its implications for the use of medicinal products, and therefore because of the substantial health benefits to be gained by citizens and patients in Europe.
It may seem surprising that, at a time which I would describe as a significant one in the life of the European Parliament, a nonattached Member is presenting a report. I consider this to be a most noteworthy sign of the democratic, respectful and impartial nature of this Parliament, and I am grateful to all my fellow members of the Environment Committee, in particular its chairman Mr Collins, and to the coordinators of the political groups: they not only allowed me to draw up this report, but pulled out all the stops to improve its content through a series of well-considered, sincere and truly valuable amendments.
It is now my duty to report to the House on the background to this presentation in the plenary and on the content of the directive.
I shall comment first of all on the working method. Having noted immediately the importance of and expectations concerning the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, I considered that my task should mainly be one of meticulously and objectively coordinating a series of proposals from experts in the field. I therefore held a number of meetings with European consumer groups and associations, patients' groups of different nationalities, representatives of ethics committees in various countries, independent voluntary bodies, groups of university and hospital researchers, and European representatives of drugs companies. At the same time, I took on board the views of all those - individuals or groups - who approached me either in person or in writing with particular comments and considerations. In short, in the explanatory statement and the amendments, I have attempted to summarise all the different opinions I have heard, so as to bring to bear the greatest possible measure of democratic spirit, openness and active participation on a proposal which must not be handed down from above, but rather should be the fruit of concerted action on the part of everyone.
The basic aim was as follows. The adoption of this directive could give a major boost to the long-standing eager expectations of the Union's scientific community, provided that it really does bring about harmonisation. In other words, all 390 million European citizens, exercising the same rights and duties, should be in a position to benefit from the outcome of clinical trials on human subjects. It is likewise imperative that research institutes as a whole, whether public or private, in all 15 Member States should enjoy equal opportunities and compete with one another on proper terms.
At present, the guidelines on good clinical practice are intended purely for information and not enforced in the same way in individual Member States, which are responsible for legislative regulation. Our task is to convert the principles and guidelines into a binding Community legislative act to regulate an activity now largely carried on at trial sites, often operating in different Member States.
My first remark is that the directive contains proposals relating to the conduct of clinical trials of medicinal products on human subjects and the implementation of GCP. This text acknowledges the need to harmonise within the Community the administrative procedures and documents used, especially in multi-centre trials. Its stated aim is to rationalise the administrative procedures required for the launch of a clinical trial, thus making Europe more competitive as compared, for example, to the United States, whilst maintaining a high level of protection for trial subjects.
Secondly, it is necessary in our opinion to provide a simple, unambiguous legislative frame of reference for European clinical research. Europe should improve its ability to supply clinical data needed to develop and register pharmaceutical preparations, for instance by stipulating that replies and documents requested must be produced within standard time limits, thus enabling trials to be conducted in several countries at once. Rapid access to clinical trials, however regulated, is ethically beneficial to the extent that it allows patients, especially those suffering from serious diseases, to be treated at an early stage. Moreover, trials are scientifically beneficial, since the researchers involved can publish and discuss the findings of their experiments and in that way further their careers.
Lastly, clinical trials are economically beneficial because they can attract substantial corporate investment which can also be used to fund basic research in the centres concerned.
Thirdly, the technical aspects of the proposed directive must be harmonised with documents already issued or currently being drawn up, and in particular those relating to the ICH, those on GCP and those on pharmacovigilance.
Fourthly, one particular weakness in the current proposal for a directive is its provision for two possible procedures, one based on authorisation and the other on notification. After lengthy deliberations, we resolved that harmonisation must be based on one procedure only, and the Environment Committee expressed this view when voting on the amendments. In our opinion, when an application for authorisation is submitted to the ethics committee, the regulatory authority should merely be notified and would then have 30 days in which to raise objections, should it think fit. Under that procedure, patients would be doubly protected - by the ethics committee and because the regulatory authority would have the option of intervening - but clear-cut and brief time limits would be laid down, and time is, at present, the most decisive factor where clinical trials in Europe are concerned. All countries must make the same undertaking: to harmonise - that is, to determine a single procedure based on the system of notification. Such a procedure would ensure, firstly, scrupulous protection for patients, in that GCP rules must be complied with, the green light must be obtained from the ethics committee and the Member States may put forward any reasoned objections within the 30-day period; secondly, certainty as to the starting date of the trials; and, thirdly, uniform procedures in all the Member States.
In conclusion, our task as the European Parliament goes beyond single market and competition issues, and encompasses a human dimension that should be a matter of particular concern to us all. It is to be hoped that Parliament will manage to provide the democratic impetus to persuade the Commission and Council to lay down a single clear-cut rule for all the Member States.
I have one brief final point, Mr President. Amendments Nos 29 and 30 have been resubmitted so as to ensure that trials can also take place in centres engaged in research other than for the registration of medicinal products. Amendment No 14 should, in my opinion, be put to the vote after No 31, which is more comprehensive and which, if adopted, will cause No 14 to fall. Amendment No 35 should be put to the vote before No 16 because, if adopted, it will cause the last paragraph of No 16 and the whole of No 17 to fall.

President
Thank you, Mr Amadeo. Since you were so courteous, at the beginning, as to thank all the groups for having permitted you to draw up this report, I allowed you three or four brief points at the end, and not just the one.

Heinisch
Mr President, ladies and gentlemen, in the approximation of these provisions, we must pursue two aims. The first is to ensure the protection of the patient, which is the prime concern of good clinical practice. To that end, the Committee on Research, Technological Development and Energy has called for it to be made absolutely plain in the wording of the directive that an investigator means a doctor and not, as proposed by the Commission, a person responsible.
Another means of improving patient protection is to ensure that resources allocated to pharmaceutical research are not squandered on obsolete trials or trials also carried out at another site. If the standards established through good clinical practice are observed, we shall be able to avoid that kind of duplication. The second point is that we must bear in mind the interests of the pharmaceutical industry which is conducting the clinical trials. These trials are essential to bringing new medical products on to the market. The extent to which the pharmaceutical industry can be innovative depends largely on the efficiency of the administrative procedures that have to be gone through before trials can be conducted. The Commission has taken a major step towards tightening up these administrative procedures by obliging the authorising authorities to decide within 30 days whether or not a clinical trial may be conducted.
In some Member States, such as Germany, it has already been shown that it is quite possible for the authorities to take an informed decision within that period. The procedures have been tightened further by allowing the decision on the conduct of certain clinical trials to be based purely on a notification procedure. Another important aspect is that the directive approximates good clinical practice rules with the guidelines laid down by the International Conference on Harmonisation, because clinical trials conducted in Europe must not be subject to stricter requirements than those carried out in the rest of the world. At the same time, however, they must comply with international requirements in this field. That is what we proposed, and I warmly thank Mr Amadeo for his report.

Needle
Mr President, I want to welcome the Commission proposal this evening and to recognise the work done by Mr Amadeo in producing a very well thought-out report. He has been very courteous to the other groups tonight and we can all say that we appreciate the time he has taken and the strenuous efforts he has made to find a compromise in certain particularly difficult areas of this report.
I would like to emphasise that European legislation on clinical trials has to be in line with international guidelines as laid down in the International Conference on Harmonisation of Good Clinical Practice Guidelines. This is something that should be included in the directive in order to ensure harmonisation. The report is a very important one which aims to reduce the amount of bureaucracy surrounding the conduct and application procedure of clinical trials while, at the same time, ensuring that the health, safety and confidentiality of clinical trials subjects are of utmost priority.
The issue of timescales of the application procedure has proved a problematic factor in the discussions on this issue and it has been of some concern particularly among the pharmaceutical industries. We have looked at this further in the Committee on the Environment, Public Health and Consumer Protection and it is especially of concern in the case of multicentre trials where administrative procedures can lead to extensive delays and confusion even before the commencement of the trial. Some rationalisation has therefore been achieved in this report to ensure that multicentre trials, especially those covering a number of EU Member States, are using the same information and products of the same high quality.
In committee we agreed that the procedure for applying to conduct a clinical trial had to be looked into very closely. At present companies or researchers may commence with a clinical trial without an obligation to notify. Between the systems of authorisation and notification we favour the system of notification because with this system, when an application is submitted to the Ethics Committee, the regulatory authority will be notified, and the investigator may commence with the trial thereby cutting the bureaucracy to a minimum. Moreover, the Ethics Committee would have the possibility of raising its concerns and the investigator would have to act on those concerns.
I also welcome the rapporteur's views on the role of ethics committees and agree that the safety and dignity of patients must remain the utmost priority. The introduction of ethics committees under EU law seeks to ensure the safety of subjects in such trials. When red tape is reduced and the safety of trial subjects is ensured, particularly through the involvement of ethics committees, EU citizens can benefit from exciting new drugs and discoveries and innovative medicinal products that result from efficiently conducted clinical trials carried out in a more timely manner than hitherto.
Finally, I thank the rapporteur for the commitment he has shown in drafting a highly appropriate report, and I look forward to a positive response from the Commission.

Valverde López
Mr President, we feel that the Commission's proposal is sound and one we can accept and support. Nevertheless, quite a number of amendments were tabled in the Committee on the Environment, Public Health and Consumer Protection, where all the political groups worked closely together. I support my colleague Mr Needle's statement, which proves that the work in committee was fruitful and that we come to the House with a widely accepted position.
Nevertheless, too many amendments were adopted in committee, as has tended to be the case of late. Some of these amendments are not entirely appropriate and it does not seem very likely that they could be incorporated into a coherent text. That is why we need to repeat Amendment No 31, which does not change what was adopted in committee but makes it easier to understand and enhances the legal certainty of the wording.
I also believe it is important to repeat here in the House and for the benefit of the sector and the patients themselves, that the work would be facilitated and the trials harmonised with a fairly efficient system. Its key features are the mere notification of the start of the clinical trial, a time limit of 30 days and a single ethics committee. Speed and legal certainty will be gained. Finally, there will be adequate safeguards for the fundamental rights of individuals, which has been one of our main concerns since the beginning. In addition, the proposal will result in a text that is in line with international regulations, which was another of the goals we set ourselves.

Dybkjær
Mr President, I too would like to thank the rapporteur for the work which he has done in committee, and I welcome the broad support for this proposal. The proposal codifies the Helsinki declaration while allowing the Member States to go further in terms of strengthening the protection of patients, which is also a focus of the committee's amendments. There are three main problems which may be a cause of division. Firstly, there is the question of whether the Member States should authorise a clinical trial when the ethics committee has said yes, or if authorisation can be withheld in some cases. Secondly, there is the question of whether authorisation is obtained automatically when an application has been made and no answer has been received, or if notification actually has to be given before proceeding with clinical trials, regardless of the fact that nothing has been heard from the official authorities. And thirdly, there are the time limits which are to apply to the work of the ethics committee.
I would firstly like to say that the Liberal Group supports the main thrust of the amendments, but I personally have some reservations about the three points I have mentioned. I think it is extremely important to preserve the Member States' ability to reject an application, even if the ethics committee has said yes. I do not in fact see this as a major problem in practice, because the ethics committee will not normally be operating in a political vacuum. As regards the question of whether it is possible to proceed automatically, or if notification has to be given or a positive authorisation obtained, I would emphasise that I think this is also important in terms of patient protection. I do not agree with the amendments concerning time limits. Experience with the present ethics committees shows that ethical considerations and decisions take time, and so we should not set too short a time limit for the ethics committee to do its work.

Cabrol
Mr President, ladies and gentlemen, the rules on conducting clinical trials are to apply from now on to socalled 'multi-centre' trials, that is, trials that apply the same protocol in 50 or 60 different investigational sites, thereby ensuring that between 2 000 and 3 000 patients are used at a total cost of between ECU 300 million and ECU 500 m for one single trial. That goes to show that when the human, social and economic resources of these trials, which are aimed at developing new medicinal products, are better targeted, they are therefore more effective and better tolerated by patients.
Besides having to notify the relevant local authorities of the trial, or using a centralised procedure through the European Agency for the Evaluation of Medicinal Products, a certain number of rules must be respected, and they were the subject of amendments in committee. These amendments, which are supported by the UPE Group, have various objectives. Firstly, they aim to guarantee full and objective information for the patients likely to take part in the trial. Secondly, they are aimed at ensuring that the participants give their consent voluntarily by means of a written document that must be dated and signed, and, as a result, the necessary arrangements must be made for the mentally handicapped. Thirdly, they aim to obtain the opinions of multidisciplinary and independent ethics committees, that is, committees consisting of doctors and paramedical staff that are not directly involved in the clinical trial. Fourthly, they hope to oblige the Member States to take the necessary measures to respect good manufacturing practices with a view to guaranteeing the quality and safety of medicinal products. And fifthly, they aim to make third countries exporting to the European Union provide proof that quality control and batch approval have been carried out, so that the products can actually be traced if something happens.
Notification must, of course, be given of any undesirable and serious occurrence in a Member State where the trial is taking place. Finally, the researchers must be qualified doctors, who are responsible for the trial and, therefore, capable of assessing whether it is running smoothly and the effects on the patients voluntarily taking part in the study.
We are in favour of the proposal for a directive as amended, which aims to establish a framework designed to promote efficient clinical research to the benefit of patients.

Ephremidis
Mr President, Mr Amadeo's report is extremely interesting, and is indeed improved in certain respects by some of the amendments. I think, however, that there should have been more criticism of the loopholes and omissions in the Commission's proposal, and that we should be more daring about more specific proposals and more advanced measures for carrying out checks, both preventive and repressive, and imposing sanctions as and when criminal intentions are exposed that stem from profiteering by the all-powerful multinational pharmaceutical groups. This is because those groups, involved as they are with other interests too - even political interests, as we all know - use and exploit a whole range of people without any accountability at all, for example people suffering from incurable diseases, people committed to psychiatric clinics or similar institutions because of psychiatric disorders, or people whose freedoms are restricted - I am talking about prison inmates who become experimental animals without their consent so that new drugs can be clinically tested. Such people must of course be protected, but we must not forget that declarations alone do not suffice for their protection. For this, there must be specific measures, which are unfortunately missing from the Commission's proposal. Unfortunately, despite the amendments, the Amadeo report does not criticise those omissions and does nothing to make them good.
It amazes me that payments and compensation are provided for; payments for those who undergo trials and compensation for those whose physical or mental health is damaged in trials of new drugs. In other words, the human body and mind have become a commodity. Here we see the prevalence of the law, the taboo of free competition, the right of industrial ownership, the prevalence of lack of transparency in programmes, research and funding. With the opportunity this report gives us, we must overcome these things so that clinical trials of new drugs for diseases will be beneficial for the health of mankind...
(The President cut the speaker off)

Breyer
Mr President, ladies and gentlemen, we all agree on the need to protect patients - and many here have spoken of a high level of protection; but I too feel that the level of patient protection should be defined in far more specific terms.
I too am concerned with defining this high level of protection. It is not enough for us to say: someone else has to give consent for those who are incapable of giving their informed consent. No! That is why we have tabled an amendment which provides quite plainly that no research may be carried out on people who are incapable of giving their informed consent unless it is of direct use. This is a crucial point, because what would happen in the reverse case? If we do not endorse this amendment, then that would surely automatically mean that anyone at all can consent on behalf of these people who are incapable of giving their informed consent, and that research can be carried out on them which is of no use at all.
Then we really will be treating people to whom we have promised a high level of protection just like guinea pigs. In my view, we must not forget either that we are running a risk of opening the door to eugenics, unless we guarantee a direct level of protection. The past has after all proved that we must not carry out research on the mentally handicapped who are incapable of giving their consent, unless it is of direct use.
So I would very urgently ask you to support this amendment by the Green Group, so that we can ensure precisely that. Let me also place special emphasis on this aspect against the background of the heated discussions we have already seen here in the European Parliament, and especially also among many social groups, concerning the bioethics convention. The Federal Republic has not signed this bioethics convention, for precisely the reasons I have just given. That is why our prime concern should be that we do not approve a directive which does not specifically guarantee protection for people who are incapable of giving their informed consent.
I would therefore ask the House to endorse our amendment, which makes it clear that research may only be conducted if it is of direct use, and that any other research is quite out of the question.

Correia
Mr President, everyone knows that since 1990 the rules governing clinical trials in the European Union, and internationally, have been codified in directives on good clinical practice. The globalisation of the pharmaceuticals industry has necessarily led to the harmonisation of international rules set at the International Conference on Harmonisation.
Nonetheless, the Member States can still take different legislative or administrative measures, and that can lead to significant delays in starting clinical trials. This, in turn, is bound to lead to delays in the application of the benefits of those trials to the treatment of patients.
That is why, without prejudice to the principle of subsidiarity, we need to take decisive steps towards rationalising and harmonising clinical trials. Nonetheless, while scientific research has to be supported and encouraged, we must also ensure that those who take part in the trials are guaranteed protection, so that their human rights and dignity are respected.
That is why it is important to have ethics committees and for them to be transparent and independent. If there were one national ethics committee, coordinating the regional and local committees, then each Member State could have a single set of rules while safeguarding the independence of local committees and allowing them to agree to or ban trials. There would also have to be an ethics committee, whose opinions would be binding, at every centre where clinical trials take place.
Those opinions would be issued by doctors not involved in the trials, along with nurses and other health professionals, as well as non-medical staff, to guarantee patients' safety and the wellbeing of those taking part. Researchers, whether medical or not - and if not then medical supervision should be provided - ought invariably to obtain the informed consent of everyone taking part in trials - or of their guardians - and honour their confidentiality. We could then promote research, safeguarding the interests of patients and of the pharmaceuticals industry alike.

Liese
Mr President, ladies and gentlemen, I too am grateful to the rapporteur. Two thirds of all diseases can still not be treated or treated adequately. Some of them are quite dreadful diseases, and often fatal. Hence the need for medical research, and especially research into medical products. The directive we are discussing can help improve clinical research in Europe. In particular, the standardisation of procedures offers a chance to avoid duplication.
However, we must guarantee comprehensive protection of the trial subjects under all circumstances. Special attention must be given to protecting people who are incapable of giving their informed consent, such as children and the mentally handicapped. The Commission proposal does not take adequate account of this. Instead, it refers mainly to the Council of Europe Convention for the protection of human rights and biomedicine. But that convention is a subject of dispute, and some Member States have not yet decided whether or not to ratify it. The European Commission - and I would ask Commissioner Liikanen to pass this on - should stop writing this convention into EU legislative documents, rather on the assumption that 'we need not concern ourselves with the ethical questions; the Council of Europe has already done so'.
We need very strict provisions to protect individuals who are incapable of giving their informed consent. Under no circumstances may children or the mentally handicapped be misused as guinea pigs. However, I do not accept Mr Ephremidis's statement as it stands, since I believe that the overwhelming majority of responsible persons in industry and in the clinics do not carry out research in an abusive manner, but abide by the rules on the protection of trial subjects. But we must also make that clear under this directive. I do not endorse the amendment by the Green Group to the effect that people who are incapable of giving their informed consent should be totally excluded from the research, because I believe we would then be bringing research to a standstill, for children's diseases in particular. Some children's diseases do not occur among adults, which is why it is not possible to conduct the relevant studies in full on adults. That is why we need strict rules, but not a total ban.

Poggiolini
Mr President, ladies and gentlemen, I too should like to begin by thanking Mr Amadeo for his excellent work and outstanding readiness to cooperate with all members of the committee, as well as for taking up so many amendments and being so open to suggestions. This proposal for a directive is of particular importance because it sets out to regulate such a sensitive sector, seeking to harmonise standards for the conduct of clinical trials of medicinal products on human subjects. The good clinical practice guide has existed since 1990, but as we all know is not binding; that is why national provisions must be harmonised. It is advisable to lay down a single procedure in a field where the rules currently vary from one Member State to another.
We have opted for notification rather than authorisation, and the reasons why have been explained. But what is even more vital is to protect the health of subjects who volunteer for trials. To this end, an amendment submitted by me and adopted unanimously by my colleagues in the Environment Committee provides for an explicit definition of informed consent: before taking part in a clinical trial, the subject of that trial must receive full and easily understandable information about the trial, and must sign a written statement indicating consent. Ethics committees play a particularly important role in protecting subjects who volunteer for trials: it will be they who evaluate the relevance of the trial, the protocol, the suitability of the investigators and the available facilities. Ethics committees will assess the adequacy and completeness of the written information. In the case of injury, the sponsors and the ethics committee should be informed immediately.
In this way, we shall ensure that trials are completely safe. The Member States will furthermore be cooperating with one another in the interests of research by the European pharmaceutical industry and, ultimately, the health of their citizens, who will receive early treatment with the new products.

Schleicher
Mr President, ladies and gentlemen, like Mr Liese, I too wish to emphasise once again that despite the undoubted success in curing illnesses by the use of medicines, there are still at present some 20 000 diseases that we cannot treat with much hope of success. That is why new, effective and safe medicines will still be essential in the future.
Clinical trials, in other words studies of the potential effects of a medicine on human beings, are extremely important to medical research and development. Various speakers have referred to the need for international networking. We consider it urgently necessary not just to take joint action on a Europe-wide basis, but to have international agreements. That is why Mr Valverde and I have tabled three amendments, to emphasise that point again. This is all the more important because - as has already been said - all these safety requirements also concern the protection of human beings, and in particular the protection of people who are incapable or less capable of giving their informed consent.
Our group aims to ensure that human beings are comprehensively protected in the conduct of clinical trials, that all patients have access to therapeutic progress, but also that we have and maintain reliable and innovative framework conditions for research and for the development and production of innovative medicines. Mr Amadeo has done some valuable work towards achieving these aims, and we can basically support his report.

Trakatellis
Mr President, the characteristics we demand from pharmaceutical products are quality, safety and efficacy. The most important information regarding those characteristics comes from clinical trials in man. I believe it is quite clear to us all that such trials must be carried out in accordance with firm and inviolate rules which go as far as possible towards protecting the physical and mental integrity of those who take part in them, and at the same time provide air-tight guarantees of the inviolability of their private life.
Most of the amendments the European Parliament will be voting on go some way towards strengthening the Commission's text in relation to the safeguarding, if I can use this expression, of the human experimental animals used in clinical trials, with detailed provisions ranging from full information for participants about the clinical trial and their written consent, to restoration and compensation in the event of damage or death.
I would like to believe that the Commission will accept all these amendments. We must not forget that we owe a lot to the volunteer subjects who undergo clinical trials, because it is thanks to them that the final assessment can be made, particularly of a drug's safety and efficacy, with records of any side effects it may have. This has benefited mankind in the past, and it is still a benefit and will remain so in the future, thanks to valuable drugs that protect human health and provide means of restoring it when it fails.
Finally, Mr President, it is self-evident that the provisions of this directive must be implemented in a uniform manner in all the Member States if we really want to ensure proper clinical trials and fair competition in the production and marketing of drugs. Here, I would like to thank the rapporteur Mr Amadeo, who worked so well with the Committee on the Environment.

Liikanen
Mr President, Parliament has recommended some thirty amendments to the proposal for a directive. The Commission accepts half of them, as they either complement the Commission's original proposal satisfactorily or they simplify it. The Commission unreservedly accepts seven amendments. In addition, we can accept two amendments if we alter the wording slightly. The Commission accepts Amendments Nos 1 and 6, paragraphs 1, 2 and 4 of Amendment No 10, and Amendments Nos 13, 14, 15, 18, 19, 21, 22, 23, 24 and 27.
The Commission will take the following into consideration in its amended proposal.
The Commission intends to include in its proposal Amendments Nos 1 and 6 and paragraphs 1, 2 and 4 of Amendment No 10. The amendments serve to improve the degree of protection afforded to participants in clinical trials in particular by imposing the condition of informed consent and the protection of the sponsor in Amendment No 19. The Commission agrees with Parliament's competent committees that we need to confirm the status of the ethics committee as the recipient of certain types of information especially with regard to medical safety during a clinical trial, as well as the tasks connected with undertaking the clinical trial itself. The trial could last as long as five to ten years. This concerns Amendments Nos 21, 22 and 27.
The most major amendment put forward by Parliament's competent committees concerns deleting the reference to alternative commencement procedures. In the Commission's original proposal the alternatives were either to notify the competent authorities, which is the normal legal procedure, or to obtain an official licence issued by the competent authority, which was suggested in consideration of special or exceptional circumstances. Parliament's competent committees only support the notification procedure, which is the purpose behind Amendments Nos 13, 14, 15 and 18. The Commission accepts this position and will amend its original proposal accordingly. In addition, the purpose behind Amendments Nos 23 and 24 is to clarify or specify more precisely the principles of good manufacturing practices applicable to investigational medical products to be used in clinical trials.
The Commission cannot accept amendments that do not improve on the original as it stands, especially when it comes to the readability of a complicated text. This applies to Amendments Nos 3, 8, 9, paragraphs 1 and 2 of Amendment No 12, and Amendments Nos 16, 17, 20, 25 and 26. Neither can the Commission accept amendments which dramatically alter the original text, or stray too far way from its spirit or legal basis. This is the case with Amendments Nos 4, 7, paragraph 3 of Amendment No 10, and Amendments Nos 11 and 20, and, similarly, Amendments Nos 28 and 36, which reiterate amendments the Commission cannot accept.
I would further like to emphasise that the Commission is very satisfied with the constructive view taken by the rapporteur and is confident that there will be effective cooperation with the European Parliament so that the statute can be adopted reasonably quickly.

President
The debate is closed.
The vote will take place tomorrow at 12 noon.
(The sitting was closed at 8.30 p.m.)

