Tomislav SOKOL (EPP, HR) and Annalisa TARDINO (ID, IT), co-rapporteurs, hold a press conference on establishing a European Health Data Space. The draft position, prepared by the Environment and Civil Liberties committees, aims to give citizens the means to control their personal healthcare data and facilitate secure sharing for research and public health purposes. This transcription is a result of an authomatic process. Please check against delivery.

Strasbourg

press conference

cross-border healthcare (T)

SOKOL, Tomislav (EPP, HR)

TARDINO, Annalisa (ID, IT)

EU4Health Programme 2021-2027 (T)

Delivery EE2024 (T)

Press conference by Tomislav SOKOL (EPP, HR) and Annalisa TARDINO (ID, IT), co-rapporteurs, on establishing a European Health Data Space

SOUNDBITE (Italian), Annalisa TARDINO (ID, IT), co-rapporteur, Thank you to the concluding stage of this important piece of work was reached. I think that we've worked on this with a great deal of interest and the package, all the amendments, were adopted with a broad majority. And I'm also very happy to see what happened during the adoption stage. If we think about an overview of this, we worked together on the whole text.

SOUNDBITE (Italian), Annalisa TARDINO (ID, IT), co-rapporteur, And for myself as the rapporteur for the LIBE committee, the essential aspect of this was to ensure protection of privacy for our citizens and all those who will be subject to the new regulation. And also to try and make sure that we find the right compromises between the needs of the legislative proposal, i.e.. The effectiveness of health care across Europe, this is something which can very much be at the forefront in the sector, also at the forefront of the situation in the rest of the world as well.

SOUNDBITE (Italian), Annalisa TARDINO (ID, IT), co-rapporteur, We should all, I think, be able to enjoy the best health care we can in all the member states. This is important not just for practical reasons. For example, the possibility of being able to see a doctor or health care provision in another country. But also awesome can often unfortunately happen. It's just annoying. Some of these blood group can mean saving the life. So if we're in a situation in which who see health care needs to be provided in a different member states to the one which you're from, well, it's essential that we have rules for this.

SOUNDBITE (Italian), Annalisa TARDINO (ID, IT), co-rapporteur, Mobility is a key aspect of the European Union for all categories of European Union citizen. So a regulation which draws together these things with the harmonised rules I think is very important, to covers of European Union citizens across the board. And of course I think it's one as well. We should not be tainted by political ideologies. And I think that the political groups that we are from shows that we have tried to work together in order to improve the health care provided to our citizens. Thank you.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, Thank you very much. I would just like to add to what my colleague said. So so we have essentially two dimensions of the health data space. One area which is called primary use, the other which is secondary use.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, So primary use of health data means use of health data by professionals. So this essentially means that all of our data will be digitalised. Put in the common European electronic format, with the common European standard and it will be it will be accessed by any health care professional that we see anywhere in the EU, but not just in the EU, but also if you are temporarily in a town outside of your place of residence, in the same state, in the same country, or even or if it's a federal state like Germany.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, So travell from one federal state to the other, you will be able to see a doctor and this doctor will be able to see all of your health records, all of the important health data, and they could prescribe therapy, provide diagnostics much better and much faster than now. So they will not haveto duplicate medical diagnostics, tho duplicate test, etc.. But be able to see all the data right away and provide health care much more efficiently.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, Of course, for those who do not want their data to be visible, there is the possibility of the opt out. That means that those patients, maybe elderly people, etc., who do not want their data to build an electronic format for any kind of reason, if they have some concerns related to the privacy, will be able to get out of the system and say that their data is excluded from this, that it will not be put in this electronically format.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, Also, if you have an electronic format and you do not want that all of your data is visible to any doctor that you see, for instance, if you have some kind of a mental health condition, you will be able to restrict access to these parts of the data. So that your mental health issues are only seen, the data on this, are only seen by a psychiatrist and not other doctors that treat you.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, So the whole idea is that we make it possible that patients can travel abroad, but also within the same country, outside of the place of residence and receive health care in a much faster and much better way without the need to duplicate tests and diagnostics.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, On the secondary use that is definitely more controversial, the idea is that all of the health data that is gathered by hospitals, universities, research institutes, etc. is catalogued and that these catalogues will be publicly available so that everybody will be see what kind of catalogues exists. For instance, a university researcher from Berlin will be able to access these data sets on pancreatic cancer, for instance, from Paris, from Rome, from Madrid, etc.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, The whole idea is that to use this potential of this data that is now not tutelised, that use it much better, so that we can conduct research innovation also in a much better and more efficient way. This is especially important for patients suffering from rare diseases because in many cases, medicines which are developed for these patients cannot undergo phase of clinical trials because there's just not enough patients for phase of clinical trials. So gathering evidence, real world evidence in this way, will definitely be an added value for them.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, Of course, what is important is that this data will not be used in a way that it can identify individual patients. So any data which is requested for research will be anonymous of pseudonymous. It will be accessed in a secure environment. And only research that will be done or that data will be done there. So nobody will be able to download this data, take it with them, etc., etc..

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, So essentially there will be national bodies, data access bodies, which will decide on individual data access permits only in prescribed cases. So for the purpose of health care, innovation, research, policy making, etc., not, for instance, for social media profiling or something else. It has to be purpose related to health care.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, And when this grant, these requests, those who want to do research, will be able to do this only in the security environment on anonymous of pseudonymous data. So in this way, we are really protecting the privacy of patients. We are really protecting their data from any kind of misuse. And of course, what is also important compared to the commission proposal, what we had in the Parliament's report is that those patients who do not want their data to be available for a secondary use will be able to opt out as well. So they will be able to say that they don't want to be part of the system, that they don't want the data to be used for research by companies, by universities, etc., if that is their choice.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, Of course, some political groups propose that we go one step further to have a consent based system or an opt in system. That would mean, for instance, The Left has proposed is that if somebody wants to use a certain data set, every patient whose data is part of this will have to give consent each in every single time when this data is used. Of course, that will destroy the whole system because we will just not have enough data that it is useful and representative. This is why we refuse this.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, So on one side we allow the patient choice possibility to opt out. But, we believe that that in the end will have enough data that it is representative and useful for research. So this way we are really reaching the balance between the right right of privacy and data protection on one side and the need to use data on the other. And this approach has been supported by all relevant health stakeholders, especially patient groups. So patient groups, patient associations on national and European level really supported this opt out approach as well.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, So I think this is so I think this is a good compromise. We'll start negotiations with council as soon as possible. The first trialogue is due for tomorrow and here we'll have to find the compromise. Our objective is to have a harmonised approach, so not to leave it to Member states to decide whether to have an opt out or not because this will destroy the whole system.

SOUNDBITE (English), Tomislav SOKOL (EPP, HR), co-rapporteur, So we want the common European system, so we don't want anybody to be left behind. And so we want the common rules and standards so that all patients in Europe have the same possibilities, that it doesn't differ between member states. So that was on my part, and I'm open to questions.

Q&A, Questions on the possibility of achieving an agreement in trialogue before the end of the term, and also on the hardest points to negotiate with the council.

SOUNDBITE (Italian), Annalisa TARDINO (ID, IT), co-rapporteur, - -