Collective information for patients

Note d’information collective relative à la protection des données personnelles dans le cadre des études nécessitant l’accès aux données du Système National des Données de Santé (SNDS)

Conformément aux dispositions de l’article 14 du RGPD, cette mention d’information collective décrit les mesures mises en œuvre dans le cadre des études ne permettant pas d’information individuelle et nécessitant l’accès aux données du Système National des Données de Santé (SNDS) français.

These data will not be the object of a transfer away from the European Union.

The study carried out by TECNIFAR – INDÚSTRIA TÉCNICA FARMACÊUTICA, S.A., a member of the Valproate Consortium, in the context of this SNDS data access device, is described below:

– Study: Extension of the study on the use of valproate drugs and related substances in Europe with the help of databases.

– Responsible for the implementation of the treatment: The study was implemented by the intermediary of IQVIA France, which carried out a compliance engagement with the CNIL.

– Base légale: In accordance with articles 6 of the GDPR and 5 of the French Data Protection Act, the processing carried out in the context of this study is based on the legitimate interest of TECNIFAR – INDÚSTRIA TÉCNICA FARMACÊUTICA, S.A. as a health industry, pursuing an objective of research, study, evaluation and innovation in health.

In accordance with Article 9 of the GDPR, the processing of these personal data concerning health is for scientific research purposes; on 20 July 2023, the Ethical and Scientific Committee for Health Research, Studies and Evaluations (CESREES) stated that the study was of public interest.

Cette étude a été autorisée par la Commission Nationale de l’Informatique et des Libertés (CNIL) conformément à l’article 66 de la loi n°78-17 dite “Informatique et Libertés” du 6 janvier 1978 modifiée (décision DR-2023-174).

– Finalité: The main objective of this study is to evaluate the impact of the implementation of risk minimization measures (RMM) and the grossness prevention program (PPP) on the real-life use of valproate and apparent substances among women of childbearing age (WCBP) in Europe.

– SNDS data used: Data extracted from the Datamart data base of the Inter-Regime Health Consumption (DCIR) and from the data base of the Medicalization of Information Systems Programme (PMSI) between 2008 and 2022.

Duration of data conservation: 6 years after they are made available (foreseen in 2027).

– Responsable de Traitement: TECNIFAR – INDÚSTRIA TÉCNICA FARMACÊUTICA, S.A., R. José da Costa Pedreira 11B, 1750-130 Lisboa – Portugal, organisme responsable conjoint de traitement au même titre que les autres membres du Consortium Valproate.

– Data Protection: This can be linked to the address dpo@tecnifar.pt.

In order to exercise their rights of access and rectification of data, as well as their rights of opposition and limitation of the processing of such data, the persons concerned by the processing must submit their request, justifying their identity by any means, to the director of the Health Data Platform or to the director of the compulsory health insurance management body from which they are related.

Les personnes concernées disposent également du droit de déposer une réclamation auprès de la Commission Nationale de l’Informatique et des Libertés (CNIL), 3 Place de Fontenoy, 75007 Paris.

Collective information note on the protection of personal data in the context of studies requiring access to data from the National Health Data System (SNDS)

In accordance with the provisions of article 14 of the GDPR, this collective information notice describes the measures implemented in the context of studies which do not allow individual information and which require access to data from the French National Health Data System (SNDS).

This data will not be transferred outside the European Union.

The study implemented by TECNIFAR – INDÚSTRIA TÉCNICA FARMACÊUTICA, S.A., member of the Valproate Consortium, as part of this system for accessing data from the SNDS, is referenced below:

– Study: Drug Utilization Study extension of valproate and related substances, in Europe, using databases.

– Data processor: The study is carried out by IQVIA France, which has made a compliance undertaking to the CNIL.

– Legal basis: In accordance with article 6 of the GDPR and article 5 of the law Informatique et Libertés, the processing carried out as part of this study is based on the legitimate interests of TECNIFAR – INDÚSTRIA TÉCNICA FARMACÊUTICA, S.A. in its capacity as a healthcare industrial company, pursuing an objective of research, studies, evaluation, and innovation in healthcare.

In accordance with article 9 of the GDPR, the processing of this personal data concerning health is for scientific research purposes; on July 20th 2023, the Comité Ethique et Scientifique pour les Recherches, les Etudes, et les Évaluations en Santé (CESREES) indicated that the study was in the public interest.

This study has been authorized by the Commission Nationale de l’Informatique et des Libertés (CNIL) in accordance with article 66 of law no. 78-17 of 6 January 1978, as amended (decision DR-2023-174).

– Purpose: The main objective of this study is to assess the impact of the implementation of the risk minimization measures (RMM) and pregnancy prevention program (PPP) on the real-world use of valproate and related substances in women of childbearing potential (WCBP) in Europe.

– SNDS data used: Data extracted from the Datamart de Consommation de soins Inter-Régime (DCIR) database and the Programme de Médicalisation des Systèmes d’Information (PMSI) database between 2008 and 2022.

– Data retention period: 6 years after availability (scheduled for 2027).

– Data Controller: TECNIFAR – INDÚSTRIA TÉCNICA FARMACÊUTICA, S.A., R. José da Costa Pedreira 11B, 1750-130 Lisboa – Portugal, joint data Controller with the other members of the Valproate consortium.

– Data Protection Officer (major member): Can be reached at dpo@tecnifar.pt.

In order to exercise their rights of access and rectification of data, as well as their rights to object to and limit the processing of such data, the persons concerned by the processing shall send their request, providing proof of their identity by any means, to the director of the Health Data Platform or to the director of the compulsory health insurance body to which they belong.

Data subjects also have the right to lodge a complaint with the Commission Nationale de l’Informatique et des Libertés (CNIL), 3 Place de Fontenoy, 75007 Paris.