President. − The next item is the recommendation by Gianluca Susta, on behalf of the Committee on International Trade, on the Protocol amending the TRIPS Agreement (08934/2006 – C6-0359/2006 – 2006/0060(AVC)) (A6-0403/2007)
Gianluca Susta (ALDE), rapporteur. – (IT) Mr President, Commissioner, ladies and gentlemen, I would first of all like to take this opportunity to thank the Secretariat of the Group of the Alliance of Liberals and Democrats for Europe in Parliament for the support it has given me. I would also like to thank all the shadow rapporteurs, as well as Mr Van Hecke, who preceded me in covering this dossier, for the excellent work carried out and for managing to maintain the unity of our institution right through to the end.
In my opinion, this has been Parliament’s greatest strength in the campaign to promote access to medicines in the developing and less-developed countries where they are most needed. The right to health and access to health at affordable prices are fundamental rights and should be guaranteed for all citizens. Unfortunately we know only too well that this is not always the case: all too often the prices imposed by the pharmaceutical industry are too high, with the result that countries where they are most needed find themselves in difficulty.
For this reason, as I have already said on several occasions, both in the Committee on International Trade and in plenary, Parliament could not blindly accept the Protocol amending the TRIPS Agreement as if it were a universal panacea, and then consider the matter resolved. Parliament wanted more to be done, at least within the European Union, because the European Union can and must do more.
Even in the light of the regrettable events of this summer, such as the exchange of letters with Thailand, even if partially resolved, the European Parliament, which has always been a great advocate of using all the flexibilities offered by the TRIPS Agreement, could not give the go-ahead for the ratification of the protocol without obtaining real and effective guarantees from the Commission and the Council.
I think it is fair to stress that during these months of close collaboration with the Commission and the Council, we have undoubtedly achieved an important goal for the European Union, by putting an essentially technical dossier at the top of the European political agenda.
I believe that the end result can be qualified as a success, not only for this reason, but above all because we have succeeded in making progress in extremely sensitive areas, such as encouraging the use of the flexibilities provided for under the TRIPS Agreement so that we can promote access to essential medicines at affordable prices within the framework of national public health programmes.
I particularly support the explicit reference contained in the Council Statement – presented on Monday – to Article 30 of the TRIPS Agreement. For my group, this represents a guarantee and an assurance that Member States will be able to use this instrument without coming under pressure and that there will be easier access to medicines in countries where they are most needed.
Secondly: I am also delighted at the results obtained in terms of TRIPS-plus, namely the more stringent provisions as regards those provided for under the TRIPS Agreement. Parliament, the Council and the Commission have agreed that there should be no negotiations in future bilateral or regional agreements with developing countries on provisions that might have negative consequences for health and access to medicines.
Despite this, while recognising the efforts of the Portuguese Presidency, I would like to ask whether the text of the statement can be further improved, particularly in the section referring to poor developing countries. This expression could create confusion, since it is now customary to refer only to developing countries and to the category of less-developed countries. To insert a new category would complicate the situation. Above all, it is important to stress that all developing countries, hence even countries such as Brazil, India, etc., must be able to use the current system without running the risk of pejorative provisions being introduced in future.
Last but not least, it is vital to underline the efforts made to date in terms of the transfer of research and technological development to southern countries. The ALDE Group is ready to give its assent because it believes that a ‘no’ would send out a negative signal to the countries most in need, and would be irresponsible on the part of the European Union given that the reopening of the WTO negotiations is unrealistic.
However, this does not change the fact that we continue to have reservations about the efficiency of the mechanism studied and approved by the WTO. For this reason, and I am almost at the end now, I would like to confirm that the EU will not stop here. Parliament will do everything it can to ensure that the guarantees that have been given over the past few months will be honoured in practice.
Therefore we ask Commissioner Mandelson, who in his letter confirmed that he did not intend to negotiate TRIPS-plus provisions, to remove from the draft Economic Partnership Agreement with the Caribbean countries the request for adherence to and acceptance of the obligations of the Patent Cooperation Treaty, the Patent Law Treaty and the intellectual property provisions of Directive 2004/48/EC on the enforcement of intellectual property rights, which unequivocally resemble TRIPS-plus provisions.
Peter Mandelson, Member of the Commission. − Mr President, I am very pleased that we have been able to find a solution agreeable to all on the important issue of access to medicines for poor, developing countries. Our debate during the last months has been fruitful and I would like to thank Parliament for the intensity and the quality of our exchanges. The Commission has always been receptive to the concerns expressed by Parliament and, indeed, shares most of them. That is why the Commission was at the forefront of the debate on TRIPS and access to medicines in the WTO.
I have seen in this debate an opportunity for the Commission to clarify its position on a number of issues. We all agree that the amendment of the TRIPS agreement is one part of the solution among many others to the problem of access to medicines. Obviously, other measures are needed, in particular to improve health care systems and the infrastructures, notably in poor, developing countries.
Some Members fear that the mechanism will not work. This is certainly too early to assert. In our regulation implementing the waiver, and together with Parliament, we agreed to evaluate it three years after its entry into force, and we will do it.
We also support the work of the intergovernmental working group with the WHO to explore other measures to further improve access to medicines.
The Commission has been able to reaffirm its attachment to the Doha declaration on the TRIPS agreement on public health and its support for the flexibilities contained therein.
Similarly, this debate allows me to dispel any misunderstanding about what the Commission is doing in the economic partnership agreements with ACP countries. Let me confirm that, in those agreements and in other future bilateral and regional agreements with poor developing countries, the Commission is not asking and will not ask for provisions which could affect access to medicines or undermine the TRIPS flexibilities contained in the Doha declaration on the TRIPS agreement and public health.
Thanks to this frank and direct debate Parliament is now in a position to give its assent to the Commission proposal. The European Community will then join the other WTO members which have already accepted the TRIPS agreement. This acceptance will enable the EC to continue to play a leading role in the WTO on the issue of access to medicines.
To conclude, I would like to insist that access to medicines remains a priority for the Commission and I am willing to continue to work in a constructive spirit with Parliament on this matter in the future.
Michel Rocard (PSE), draftsman of the opinion of the Committee on Legal Affairs. – (FR) Mr President, Commissioner, ladies and gentlemen, I am sorry that the Council is not represented in our debate this evening because for once it is our main contact. The atmosphere here is euphoric, everyone is in agreement and tomorrow we are going to vote – by a crushing majority, I think – for the ratification of this amendment to the TRIPS agreement, which is supposed to provide and should provide better access to medicines for countries that are not sufficiently developed and do not have a pharmaceutical industry that allows them this access.
What happened during the long debate we have had on this, is that Parliament was a little more doubtful than the Commission about the efficacy of this system. I believe – and I would like to thank the Council here for having listened to Parliament more than the Commission, for once – that this is what led to the statement distributed on Monday morning, thanks to which we have accepted that an agreement between us enables us to make this small step forward. It is an improvement, but it is an improvement the inadequacy of which we are aware of and regarding the effectiveness of which we have a few doubts. These few doubts need to be removed by the stringency with which the Member States and the Council apply the recommendations.
I am delighted, however, by what has just been said by Mr Mandelson, who has himself announced a group of experts to find other measures, and an evaluation of these measures, and I think we will be discussing these matters again once we have seen whether the effectiveness meets our expectations. In any case, I am pleased about the positive conclusion to this necessary stage, even if it does not go far enough.
Georgios Papastamkos, on behalf of the PPE-DE Group. – (EL) Mr President, as rapporteur of the European People’s Party I should like to thank the rapporteur, Mr Sousa, and my other fellow Members for the productive cooperation we have enjoyed, for it enabled us to overcome certain differences between political groups and to maintain a united position on this important issue. The European Parliament has not been limited to areas of responsibility as laid down by the Treaty; it has not been restricted merely to giving its assent. In the July resolution a political victory was achieved expressing a united will transcending party politics.
Making commitments by the Commission and the Council was sought and achieved. They coincide to a great extent with the views of the European Parliament. It could be said to have been a rehearsal for institutional cooperation in light of the new role the European Parliament will play once the Reform Treaty has been adopted.
The acceptance by the Union of the amendment is thus backed up by real commitments, which ensure the process works successfully. The commitments also go much further: they lay down guidelines for an integrated approach to the issue of the public health of developing countries. The acceptance by the Union of the amendment to the TRIPS Agreement sends a positive and hopeful message to developing countries. We hope that it will also involve the active cooperation of other members of the WTO.
Kader Arif, on behalf of the PSE Group. – (FR) Mr President, Commissioner, ladies and gentlemen, during our last debate in July on access to medicines, I concluded my comments by calling on the Council and the Commission to make clear and formal commitments that would guarantee Europe’s active involvement in finding new solutions and its desire to be a front runner in the fight for access to affordable medicines for everyone. We could not be content with a debate in which no precise commitments were made, and I note today that, after several months of exchanges between the three institutions, certain proposals we had made and that we really wanted are becoming a reality.
First allow me to applaud the parliamentary work done, and done with a constant concern for accountability and openness. The three successive postponements of the vote in Parliament were motivated by a commitment to global public health. This showed us that the word ‘solidarity’ still had meaning in European policies.
I would therefore like to thank first of all our rapporteur Mr Susta for his powers of persuasion and capacity for resistance, and all the shadow rapporteurs from the political groups, who throughout these months of collaboration, effort and Common conviction, have risen above party politics to show the quality of work that Parliament can produce. I therefore hope that the Council and the Commission will be able to demonstrate that the commitments made over the last few months during our various exchanges and in the written statement we have received will be respected.
These commitments are: that the Member States are free to use all the clauses allowing them to produce generic medicines and export them to developing countries, and not only to poor developing countries; that these developing countries can use all the flexibilities in the Doha Declaration to provide their populations with the essential medicines they need; that the European Union will not negotiate public health-related provisions in negotiations on trade agreements – and I also note the statements by the Commissioner; and finally that the EU will finance projects to develop research and manufacturing capabilities in these countries.
These are positive steps forward, and we want to make capital of them now, but I would like nevertheless to say that not all the issues raised by Parliament, or its legitimate concerns, have necessarily met with the desired responses from the other institutions. Our fight for access to medicines for everyone in the world goes on. That is why we will remain extremely vigilant regarding the application of the commitments made by the Council and the Commission today, and at the same time we will continue to demand that all our concerns receive a rapid, adequate response in the coming months. I recall that the first of the commitments made to Parliament was to complete the evaluation of the mechanism that we are to adopt tomorrow. Doubts persist over this, and they need to be addressed. Should that not be the case, in line with the commitments made to the developing countries concerned, the EU should draw the appropriate conclusions to come up with a truly viable, sustainable solution.
I am therefore pleased about the commitments made by the Council and the Commission, and I will therefore call upon my group to vote in favour of ratification tomorrow, even though the long weeks of work we have just experienced lead me to think that, far from reaching an end, the collective agreement we have made is only just beginning.
Johan Van Hecke, on behalf of the ALDE Group. – (NL) The WTO decision of 30 August 2003, which provided for a temporary derogation from the TRIPS Agreement, has now been transformed into a permanent derogation by a new decision of 6 December 2005. In his report, Mr Susta makes a number of very pertinent remarks on the practicability of compulsory licensing. I recognise very many elements from my 2005 report transforming the temporary derogation into a European regulation.
I fully support the recommendations of the Council and the Commission, which Mr Susta links with the avis conforme. The mechanism created is indeed only a limited solution to the problem of inadequate access to medicines in poor countries. The EU must help developing countries find a long-term solution in terms of obtaining the most essential medicines at affordable price, and must stimulate investment in local production facilities. The transfer of technology, research and technical assistance are of course essential in this respect.
In this regard, I would refer to recent reports stating that the market share of generic medicines is falling once again, and giving the cause as the cheap production by pharmaceutical companies themselves of medicines whose patent protection has expired. This must present opportunities for poor countries, where, in line with the WTO decision, compulsory licensing can offer a solution in respect of medicines still protected by patents.
If we do not want to give vain hope to the millions of people still unable to benefit from the most essential medicines, more – much more – will be needed than a mechanism whose practicability is and remains highly dubious.
Ryszard Czarnecki, on behalf of the UEN Group. – (PL) Mr President, as it happens, 14 years ago I was involved in the issue of intellectual rights in the Polish Parliament, as chairman of a special subcommittee. Today I have the honour of doing the same in our European Parliament.
Like those who have spoken before me, I would like to emphasise the significant progress that we have made over the last few months, and I would like to stress that, as we see it, the European Parliament has done a lot to put right what was proposed by the European Commission. I am thoroughly convinced that the compromise we are proposing will help to improve access to pharmaceutical products in Third World countries, as they are what mainly concern us.
Carl Schlyter, on behalf of the Verts/ALE Group. – (SV) Mr President, if I have understood correctly the Council will read the statement before the vote, otherwise there will be no binding commitment. I would then ask you to omit the word poor developing countries. It is completely irrelevant and meaningless in previous agreements. There are developing countries and there are the least developed countries, and Parliament wants both these groups of countries to be able to benefit from these mechanisms. It is clear that we are speaking the same language here. It is something I was wondering about in your speech, Mr Mandelson: you said that ACP countries had nothing to worry about, but then you also said poor developing countries, ACP countries. I hope that we are not restricting the discussion to them, and that your letter to Thailand does not set the limits for this, but that we are perfectly clear that developing countries which are not among the poorest also really need to be able to protect public health in order to be able to develop effectively, and that we must give them all the help and support we can. I hope that we agree on this.
Umberto Guidoni, on behalf of the GUE/NGL Group. – (IT) Mr President, ladies and gentlemen, the European Parliament has been called upon to express an opinion on whether the amendment to the WTO agreements on intellectual property – the ‘TRIPS Agreements’ – can be made permanent, as this would represent a swift solution to the problem of access to medicines by developing countries.
Considering that up to now, this amendment has offered no proof of its real effectiveness, it is important for the European Parliament to seize the opportunity offered by the ratification of the TRIPS amendment to secure greater guarantees that EU policy on access to medicines will be comprehensive, coherent and effective.
The TRIPS Agreement, as the Council has recognised, represents only part of the solution to the problem of access to medicines and public health; it is important therefore that the Council, as emphasised several times by Parliament, should declare its support for all those countries who intend to take advantage of the flexibilities offered by the TRIPS Agreements, to be able to provide essential medicines at affordable prices.
The European Union must do more to stem the health crisis in the world’s poorest countries, particularly by ensuring that these countries can meet their own needs, without burdening them with bilateral or regional agreements, the ‘TRIPS-plus’ Agreements, on provisions relating to pharmaceutical products that risk having a negative impact on access to public health and medicines.
We also believe that it is the task of the Commission and the Council to support WTO initiatives to make TRIPS rules less complex, and specifically to maximise product availability.
Zbigniew Zaleski (PPE-DE). – (PL) Mr President, halfway through it has transpired that among the millennium goals, we have done worst in combating TB, HIV and malaria. World Health Organisation statistics show that in 2005 more than one and a half million people died of TB, which had a high mortality rate in Europe before World War II. Each day 27 000 people die because of a lack of access to basic medicines.
Health is an inseparable condition for wellbeing and economic development, and I believe it is our moral duty to help less well developed countries in this respect. One positive step is to provide support for the protocol amending the TRIPS Agreement in order to allow access to medicines. It is not a complete solution, but we cannot not take the risk if we are to protect the lives of millions of people.
There is a risk. To begin with, obtaining a licence for the production of generics for export to countries in need is hedged round by numerous conditions that might put people off such an undertaking.
Secondly, production of medicines of this type may create circumstances for abuse on the part of both the beneficiaries and the exporters themselves, and on top of that the infrastructure in poor countries is so weak that it is just not possible to undertake production there. For this reason some kind of extra, multi-level aid instruments are needed. It seems to me that the most important thing is financial aid intended for setting up local production centres, technology transfer, and investment in development and innovation. We are obliged to show social solidarity with these countries, but we are the ones who have to work out a way that will do most to increase the effectiveness of the aid provided while at the same time protecting our own market.
Finally, Commissioner, I want to say that the Commission – and you, yourself, as head of a specific committee – have plenty of scope for new ideas to think about.
Erika Mann (PSE). – (DE) Mr President, Commissioner, ladies and gentlemen, what we are discussing tonight and will be voting on tomorrow will be a small but important building block in the cooperation between the institutions, the Commission, the Council and Parliament.
In this procedure, Parliament's only options are to agree with the proposal or reject it. The way that Mr Susta, the rapporteur, and all the shadow rapporteurs – and here I would like to thank particularly Kader Arif from my group – have handled it increased considerably the predefined scope for Parliament to take action.
However, I would also like to thank the Commissioner for expressly pointing out that this accord, this Protocol, which we will vote on tomorrow and which Member States will then be able to ratify, is only a building block – an important one, but only a building block – and that there are many more steps to be taken to give developing countries with no manufacturing capacities in the pharmaceutical sector a real opportunity, which they need, to provide their citizens with essential medicines.
This step will help us in our cooperation and it will especially help us when Parliament gains further rights of consent in the many other policy areas, in the area of trade, for example.
I extend sincere thanks to the Council and the Commission and all the Members who made it possible actually to achieve the flexibility that we now have.
Francisco Assis (PSE). – (PT) Commissioner, ladies and gentlemen, given the ethical importance of this issue, the discussion that we are engaged in is of great political relevance. The dichotomy between protecting intellectual property and promoting the health and well-being of the populations of less-developed countries arises out of a conflict of interests that can be resolved only by a comparison of values.
Simply put, this opposition is clear. On the one hand we have a certain debatable model of protecting intellectual property based on the argument of the incentive for innovation and the consequent expansion of scientific knowledge, while on the other are millions of poor human beings, living in countries with scarce resources who cannot be condemned to suffer and die for economic reasons at a time when we have the knowledge that can save their lives.
This comparison makes it clear on which side the fundamental values lie. In this light, at various times and in various places certain steps have already been taken to make the intellectual property protection system more flexible so as to promote access to medicines for all. However, it turns out that progress so far is not sufficient. The mechanism now being considered is merely a means of easing such a distressing problem.
We need to go further. Parliament has pointed in this direction, making a decisive contribution to encourage the EU to adopt a position in line with its underlying values. The solution now found reveals this concern and I would therefore like to commend the Presidency of the Council for its efforts to achieve, through statements and commitments, a position that shows Europe at its best: a political community always set on irrecusable humanist values.