Thank you for your interest in the ADVEVA® program: a free of charge post prescription service to provide your patients with assistance, training and education concerning the use and administration of MAVENCLAD® or Rebif® using the RebiSmart® or Rebiject® device.
The ADVEVA® program is provided by Merck NV/SA, with registered offices at Brusselse-steenweg 288, 3090 Overijse, 02/686.07.11 ("Merck") and executed by DECAT, DENEWET & VAN BERCKELAER BVBA/SPRL (part of NOVELLAS HEALTHCARE NV/SA, designated as ‘Novellas’), with its registered offices at Jan De Keersmaeckerstraat 25, 1731 Asse.
In the course of ADVEVA® program, the following data on you are collected: your name, address, INAMI/RIZIV number, specialty, institution, telephone number, email, signature, the number of patients enrolled in PSPs. Your data will be used, stored and protected as follows:
- Merck, Novellas and its call centre, staff and nurses will have access to your data and will use it (i) to provide the services of ADVEVA® program to your patients and/or (ii) to fulfil its obligations with respect to reimbursement of the products involved.
- Supervisors and local administrators of Novellas and/or Merck may occasionally access your data in order to review the program and to communicate with you in case of medical concerns related to your patient’s treatment if deemed necessary, for example in case of adverse events, for the purpose of drug safety surveillance. In that case, data may be shared with health authorities (such as the European Medicines Agency (EMA)).
- All data will be stored in a centralised database located in the European Union provided by salesforce.com and operated by a technical service provider who can access data for the maintenance, operation or administration of your data, the software or database but only to the extent required.
- That access may also take place from outside the European Union. Merck will take all steps reasonably necessary to ensure that the data you provide is adequately protected according to the requirements of the applicable data protection laws of the European Union and where needed by means of Standard Contractual Clauses approved by the EU Commission.
- In order to better understand the use and to improve ADVEVA® and similar programs, Merck will receive anonymized aggregated statistical reports, business reviews, as well as adherence reports.
- The liability of Merck and Novellas is limited in any case of negligence for the breach of a contractual obligation which gives distinction to the contract and on which the contractual partner may rely on (essential obligation) and limited to the typical and foreseeable damage only; this exception does not apply on culpable damage to life, body or health nor in cases of mandatory liability.
- During the term of the ADVEVA® program, Merck may replace Novellas with another provider. Of course, the data collected and the purposes for which your data will be used will not change. In such case, you will be informed reasonably in advance about the new provider and you will be asked to give your consent to this change. If you do not consent with the change of service provider, your participation in the ADVEVA® program will end with effect for the future.
- Novellas and Merck guarantee that your data is processed in a manner that ensures appropriate security, including protection against unauthorized or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organizational measures, including an appropriate data breach procedure.
- Voluntary participation, right to withdraw and further rights:
You are free to withdraw your consent to suggest your patients’ participation in ADVEVA® programs for the future at any time, by informing Novellas and/or Merck. Your data will then be removed of the list of doctors using ADVEVA® for the future.
Of course, your data processed until the date of withdrawal, useful to prove your agreement with patient participation in ADVEVA® programs and/or reimbursement conditions, will remain stored for as long as useful.
You have a right to request access to your personal data, receive a copy of your personal data in a common electronic data format, the copy of clauses used for access of your data from outside the EU and the right to have your data rectified or erased or to request for the processing of your data to be restricted. If you have any questions, request or wish to lodge a complaint you can contact Novellas at email@example.com or at +32 2 456 00 00 or the Belgian Data Protection Authority, Rue de la Presse 35, 1000 Brussels, email: firstname.lastname@example.org.