Translation of "Unterlagenschutz" in English

The provisions on data protection were another controversial topic.

Let me also be very clear as regards data protection and data exclusivity for pharmaceutical products.

Pushing for data exclusivity in any form is a problem, no matter how it is done.

Are you prepared, in the event of a pandemic, to suspend the relevant patent rights and data exclusivity?

We call on the Commission to stop demanding data exclusivity, since all the NGOs say it is liable to harm the distribution of those medicines.

What we are saying - and it seems reasonable to me anyway - is that, if India ever decides by itself to apply data exclusivity, then it will apply to us too.

Furthermore, this FTA agenda and its drive to enforce intellectual property rights and data exclusivity endangers access to cheap generic medicines that are produced in India.

I also greatly welcome the fact that we have been able to achieve an additional year of protection for existing substances.

Regarding the protection of commercial data, the compromise adopted in committee, by 8 Members with 2 abstentions, balances the requirements and is, in my view, perfectly suitable.

The case of Germany and the United Kingdom, with ten full years of data protection and generic products which in fact have a 20% market share, illustrate this point remarkably well.

The achievements of industrial research as regards innovative therapeutic uses should be recognised by means of appropriate data exclusivity for what are termed 'original products'.

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.

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 most important point, in my view, is that we will have a uniform system of protection in Europe.

Above all, however, I would also have liked to tell Mrs Jackson that, this morning, I received a letter from one of our observers from the Czech Republic who declared that he fully supported protecting data for eight years, plus two, plus one, feeling that this was an acceptable compromise between protecting data for six years and the proposal to protect it for ten years plus one.

The proposal for a regulation and the two directives before us do, however, at the same time demand that the pharmaceutical industry, in view of the almost ideal framework conditions - data exclusivity standards are nowhere else as high as in Europe - should demonstrate its capacity for innovation.

I feel it is important to have a sufficiently long period of data protection for well-known medicinal products too, wherever there are new therapeutic indications.

I am, however, also supporting Amendment No 40, which grants existing medicinal products an additional three years' data exclusivity in the event of a new indication.

The Commission's proposal to allow a data protection period of ten years must, in my opinion, remain a solid, immovable pillar.

Out of the 17 studies submitted in support of the application, the following 11 studies did not form the basis of the applicant's request for data exclusivity:

Out of the 17 studies provided by the applicant, the following 6 studies formed the basis of the applicant's request for data exclusivity:

Such exclusivity requires that the change of classification “has been authorised on the basis of significant preclinical tests or clinical trials”.

With reference to Article 74a of Directive 2001/83/EC, as amended, the applicant requested one year data exclusivity for the data submitted for the change of the classification of the medicinal product

However, data protection must be guaranteed and competition between the manufacturers of generic medicinal products must not be hampered unduly;

The harmonisation to ten years (plus, for medicines for human use, one year for new therapeutic indications) of the period of data protection afforded to innovator companies will prevent an applicant for a generic (copy) product from making an abridged applications in Austria64, Denmark, Greece, Finland, Ireland, Luxembourg, Portugal, and Spain on the expiry of six years from the date of first authorisation of the innovator product in the EU.

It should be possible for the name of the medicinal product that has been granted a Paediatric Use Marketing Authorisation to retain the existing brand name of the corresponding product authorised for adults, in order to capitalise on existing brand recognition, while benefiting from the data exclusivity associated with a new marketing authorisation.

The harmonisation to ten years (plus, for medicines for human use, one year for new therapeutic indications) of the period of data protection afforded to innovator companies will prevent an applicant for a generic (copy) product from making abridged applications in Austria88, Denmark, Greece, Finland, Ireland, Luxembourg, Portugal, and Spain on the expiry of six years from the date of first authorisation of the innovator product in the EU.

Following expiry of patent and data protection periods, the proposals aimed at stimulating the prompt approval of generic copies, will provide competition which will exert downward pressure on pricing, thereby helping to facilitate the delivery of affordable medicinal products to Member States’ healthcare systems.