Mr President, Commissioner Liikanen, I too should like first of all to congratulate my two fellow Members, Mrs Grossetête and Mrs Müller, on their excellent work on this review of pharmaceutical legislation, which is undoubtedly one of the most important public health dossiers of this parliamentary term. What we have on the table today is a package of amendments that has been negotiated by the two rapporteurs, the shadow rapporteurs and the Italian Presidency. It is an overall compromise, a balanced compromise, which has been accepted by the majority of the Member States and which gives guarantees and proposes measures to foster the growth of both branded and generic medicinal products. The agreement with the Council incorporates a series of proposals that are dear to our hearts. I am not going to repeat what has already been said by previous speakers, particularly on the subject of pharmacovigilance or the EMEA and the centralised procedure. However, I would like to take this opportunity to highlight the five-yearly renewal of authorisations, which will enable the national authorities to remove medicinal products from the market if they are no longer effective; the clear distinction that needs to be drawn between information and advertising, together with the Commission’s undertaking to table a report on current practices; the collection of waste and the environmental impact of medicines, and the Braille inscription on the packaging – which has not yet been mentioned – for the partially sighted. Finally, and most importantly, I would draw your attention to the fact that the definition of generic medicines has been broadened and the eurogenerics concept has been introduced. This will harmonise and facilitate conditions for launching generics across Europe, and constitutes a major step forward in this review. Our rapporteur mentioned it, but it has not been stressed enough so far. I was also delighted with Commissioner Liikanen’s response to Mrs Grossetête’s question about so-called ‘borderline’ products, whose status does require further clarification. This brings me to what has been – it has to be said – the real battleground in Parliament and between the Member States from the outset: the question of data protection. The 8+2+1 formula should be supported, as that is what we need today: a win-win approach, I would say, which will promote research, which is crucial for Europe, and provide better patient access to less expensive medicines, with the impact that we know this will have on our governments’ health budgets. To my fellow Members and representatives of the four Member States who voted against this fair compromise and continue, in their efforts to defend health at a lower cost, to take data protection as their main, if not in many cases their only, target – as if the debate could be limited to this question alone – I should like to say that they are taking a huge risk. The risk that they are taking is no more and no less than that of seeing Europe become nothing but a sales counter and of letting the United States become the only country where innovation takes place. I will remind you of just one figure. Since 1996, the proportion of new medicinal products launched worldwide by Europe has fallen from 55% to 28% – in other words, it has halved – and I am not talking here about turnover but about insufficient investment in research and development. In conclusion, it is important that we do not choose the wrong target or strategy in this debate. If the essential objective for Europe is to continue to care for its patients, and care for them well – and we all agree on this – then we need to pursue a genuine policy of innovation, stem the brain drain, fight against parallel imports and, as I was saying, promote, not a head-on collision between industry and generics, which would be fruitless, but a win-win approach, which will be of the greatest benefit to patients. On behalf of the , which I am representing, I think that this is what we have succeeded in achieving here at the end of two years of work together.

Political group: ELDR