Privacy Notice

1. Theravia and your privacy

For the purposes of this Notice, « Theravia » means Theravia (SAS, with registered address 16 rue Montrosier, 92200 Neuilly-sur-Seine, and Trade Register n° Nanterre 816 420 301 00052).

This Privacy & Data protection Notice (“Notice”) describes Theravia’s practices to ensure an adequate protection of Personal Data, i.e. any information relating to an identified or identifiable natural person, for all data processing carried out in the framework of its business and activities (“Personal Data”).

2. What is the scope of this notice?

This Notice applies to all processing activities that Theravia is conducting towards the persons it deals with, in its professional business activities. This includes in particular:

  •     Patients and their relatives or close ones;

  •     Participants in clinical trials;

  •     Healthcare professionals;

  •     Users of our products and services, including websites and apps users;

  •     Representatives of our contractors and business partners;

  •     Representatives of the scientific community etc;

  •     Job applicants.

Specific Consent Forms and/or Specific Privacy and Data Protection Information Notices (“Privacy Notices”) will, if necessary, be communicated to you regarding specific situations where Theravia may process your Personal Data. These Privacy Notices shall describe in more detail how your Personal Data will be processed in relation with the processing in question. If the legislation of your country so requires, this Notice and/or Privacy Notices may be supplemented by local mandatory provisions, as the case may be.

Each Privacy Notice determines for what reasons ( “the purposes”) your Personal Data is processed as well as the resources (” the means”) allocated to such processing.

3. Validity and evolution of this Notice

This Notice may be modified by Theravia, from time to time, in particular to adapt its terms to evolutions or changes of applicable legislations and/or to Theravia’s practices. Changes will be available on this page.  If we make any material changes to this Notice, we will notify you by updating the Notice’s date and posting it on our site.

4. The purposes

Theravia will always collect your Personal Data for explicit and legitimate purposes.

Theravia collects your Personal Data for the following purposes:

  • To carry out our business operations; for marketing and sales purposes; to respond to your requests; to keep track of our interactions and meetings, such as when you contact us for information and support;

  • To comply with legal or regulatory obligations applicable to Theravia; to monitor safety; to manage adverse events; to carry out prevention and investigatory activities; to carry out administrative and registration formalities, declarations or audits;

  • To conduct research and development; to carry out clinical studies, registries and trials; manage and validate the recruitment and participation of individuals to studies, trials and other operations; to analyse demographic data; to offer special programs, activities, trials, events or promotions via our services; to carry out market or consumer studies;

  • To allow us to communicate with you; to respond to your requests or inquiries; to provide support for products and services; to provide you with important information, administrative information, required Notices, and promotional materials; to send you news and information about our products, our services, our brands, our operations; to organize and manage professional events and congresses, including your participation to such events;

  • To process payments we may need to issue in a specific situation; to verify your financial data; to facilitate further payments;

  • To offer donations and sponsorships;

  • To respond to legal requests from administrative or judicial authorities, in accordance with applicable laws; to comply with a subpoena, required registration, or legal process;

  • To protect our rights and interests; to protect the health, safety, and security of Theravia’s personnel and premises; to carry out internal audits, asset management, system and other business controls; to manage business administration (finance and accounting, fraud monitoring and prevention); to maintain the security of our services and operations; to protect our rights, privacy, safety or property, to allow us to pursue available remedies or limit the damages that we may incur as necessary; to protect ourselves against possible fraudulent actions.

5. On what ground?

Theravia will always process your Personal Data lawfully.

Depending on the data processing at stake, Theravia will generally process your Personal Data on either one of the following legal basis:

  • Your prior consent: where you have clearly expressed your approval of Theravia’s processing of your Personal Data. In practice, this will generally mean that Theravia will ask you to sign a document, or to fill-in an online “opt-in” form or to follow any relevant procedure to allow you to be fully informed and then either clearly accept or refuse the intended data processing;

  • A contractual relationship between you and Theravia: in such case, the processing of your Personal Data is generally necessary to the execution or the performance of the contract; this means that if you do not wish Theravia to process your Personal Data in that context, Theravia may or will be obliged to refuse to enter into such contract with you or will not be able to provide the products or services covered in this contract;

  • Legal obligations applicable to Theravia’s activities; for instance, Theravia is required to implement pharmacovigilance procedures to monitor adverse effects of marketed products, which generally involves the collection and retention of Personal Data;

  • The “legitimate interest” of Theravia in the sense of applicable data protection laws. In such a case, Theravia shall consider your fundamental rights and interests in determining whether the processing is legitimate and lawful.

Theravia may, on a case-by-case basis, rely on other legal grounds, such as the protection of your vital interests, in accordance with applicable data protection law, as set forth in the applicable Privacy Notice.

6. Where does the Personal Data come from?

Theravia will always collect Personal Data from trusted sources.

Theravia may collect your Personal Data from different sources:

    Data that you communicate to us through various media, through registrations, surveys or direct and indirect interactions with Theravia. For example, data you provide to register to scientific events sponsored by Theravia, to submit an online application, to send us a request for information, etc;

    Data that we collect in accordance with applicable laws from public sources available, including data published by you in all kinds of supports;

    Data that we legally obtain from third parties, for example, when we may need to confirm contact or financial information or to verify the licence to practice of healthcare professionals. In such case, we generally receive such Personal Data from third-parties that are authorized to do so in the framework of their own Privacy and Data Protection Notices or in accordance with the law. We will inform you of the identity of those third-parties, if applicable, and will invite you to refer to their Privacy and Data Protection Notices for any inquires on the origin of such Personal Data and the conditions of their collection.

7. About children Personal Data

While in some instances we may collect Personal Data about children with their parents’/ guardians’ consent, for the provision of our services such as clinical activities or patient support programs, we do not otherwise knowingly solicit Personal Data from, or market to, children. If a parent or guardian becomes aware that their child has provided us with Personal Data, he or she should contact us as described in the “How to Contact Us” section below. We will take reasonable steps to delete such information from our database in accordance with applicable legal requirements.

8. Who has access to Personal Data

Theravia will share your Personal Data only with authorized parties.

For the purposes described above, Theravia may need to share your Personal Data with the following authorized third-parties:

  • Theravia’s affiliates;

  • our partners (healthcare professionals and organizations, distributors, other members of the healthcare and pharmaceutical industry);

  • selected suppliers, service providers or vendors acting upon our instructions for website hosting, data analysis, payment processing, order fulfilment, information technology and related infrastructure provision, customer service, email delivery, auditing, etc;

  • legal or administrative authorities, as required by applicable laws including laws outside your country of residence;

  • potential acquirers and other stakeholders in the event of a merger, legal restructuring operation such as, acquisition, joint venture, assignment, spin-off or divestitures.

Theravia may need to share your Personal Data with other third-parties, in which case you will be duly informed through the applicable Privacy Notice.
In any case, Theravia will require that such third-parties:

  • undertake to comply with data protection laws and the principles of this Notice;

  • will only process the Personal Data for the purposes described in this Notice; and;

  • implement appropriate technical and organizational security measures designed to protect the integrity and confidentiality of your Personal Data.

9. Where Personal Data may be transferred

Theravia will ensure that transfers of your Personal Data outside EU are safeguarded.

Theravia works with partners and subcontractors located in many countries around the world. For that reason, Theravia may need to transfer (via access, visualization, storage...) your Personal Data in other jurisdictions, including from the European Economic Area to outside the European Economic Area, in countries which may not be regarded as providing the same level of protection as the jurisdiction you are based in.

10. Safeguards for international transfers of Personal Data

In cases where Theravia needs to transfer Personal Data outside the European Union, it shall ensure that adequate safeguards, as required under applicable data protection legislation, will be implemented (including, notably, the European Commission’s Standard Contractual Clauses, if applicable).

11. How secure?

Theravia will implement security measures to protect your Personal Data.

We have implemented a variety of technological and organizational procedures and measures to ensure the integrity and confidentiality of your Personal Data from unauthorized access, use and disclosure. These measures shall take into account the state of the art, the costs of implementation and the nature, scope, context and purposes of processing as well as the risk of varying likelihood and severity for the rights and freedoms of natural persons.

For instance, we store your Personal Data on servers that have various types of technical and physical access controls, which may include, for instance, if appropriate, encryption. We may also aggregate, pseudonymize or anonymize Personal Data to ensure that no personally identifiable information is communicated to third parties.

12. How long?

We will retain your Personal Data for no longer than necessary.

Theravia will retain your Personal Data only for the period necessary to fulfil the purposes outlined in this Notice.

As an exception, Theravia may be required to retain your Personal Data for longer periods as required or permitted by law, or as necessary to protect its rights and interests. In such a case, you will be informed of the intended retention period in the applicable Privacy Notice.

13. Your rights:

Theravia will ensure that you can exercise your rights pertaining to your Personal Data.

You can exercise your rights as provided by data protection laws.
To that end, Theravia informs you that you are entitled:

  • to access upon simple request your Personal Data – in that case you may receive a copy of such data (if requested);

  • to obtain a rectification of your Personal Data should your Personal Data be inaccurate, incomplete or obsolete;

  • to obtain the deletion of your Personal Data in the situations set forth by applicable data protection law (‘right to be forgotten’);

  • to withdraw your consent to the data processing without affecting the lawfulness of processing, where your Personal Data has been collected and processed on the basis of your consent;

  • to object to the processing of your Personal Data, where your Personal Data has been collected and processed on the basis of legitimate interests of Theravia; in that case you will need to justify your request by explaining to us your particular situation;

  • to request a limitation of the data processing in the situations set forth by applicable law;

  • to receive your Personal Data from Theravia for transmission to a third-party or to have your Personal Data directly transferred by Theravia to the third-party of your choice, where technically feasible (this data portability right is only allowed where the processing is based on your consent).

If you would like to exercise any of these rights, please contact us as described in the “How to Contact Us” section below and we will take necessary steps to respond as soon as possible.

You may also file a complaint before a competent data protection authority regarding the processing of your Personal Data. While we suggest that you contact us beforehand, if you wish to exercise this right, you should contact directly the competent data protection authority.

https://edpb.europa.eu/about-edpb/about-edpb/members_en

14. How to contact us

Theravia welcomes any questions or comments you may have regarding this Notice or its implementation. Any such questions or comments should be submitted using the contact information: data.protection@theravia.com

Specific Information about data processing by Theravia

Processing : Vigilance and Medical Information

  • Processing of Healthcare Professionals’ Personal Data

In order to comply with the applicable laws, Theravia collects and processes your last name/first name/professional contact details (“Personal Data”) in order to allow us to answer your medical questions and/or carry out pharmacovigilance or materiovigilance (the “Purposes”).

When the processing relates to medical information, Personal Data is processed for a period of 10 years after our last exchange with you (even after the end of the marketing authorisation of the product) for health authority inspection purposes.

When the processing relates to pharmacovigilance or materiovigilance purposes, Personal Data is archived and processed for a minimum period of 10 years after the withdrawal of the marketing authorization.

We ensure the confidentiality of your Personal Data and will only disclose it to our authorized personnel and third parties involved in the Purposes within the limits of applicable laws. In case Personal Data is stored outside the European Union, we shall ensure that our service provider complies with applicable laws. You have the right to request (i) access and/or (ii) rectification and/or (iii) restriction of your Personal Data. To exercise these rights, you can contact us by email at the following address: data.protection@theravia.com. You also have the right to lodge any complaint relating to these prerogatives to the national data protection authority of your country.

  • Processing of Personal Data of Patients

In the context of non-promotional medical information and pharmacovigilance, and for regulatory purposes, Theravia collects and processes your initials, gender, age, medical history, relevant medical data, contact details (“Personal Data”) in order to allow us to answer your medical questions and/or carry out pharmacovigilance (the “Purposes”).

In accordance with applicable laws, Personal Data are archived and processed for the duration of our exchanges and destroyed thereafter, except for pharmacovigilance and materiovigilance purposes where your Personal Data are pseudonymized and shall thereafter be kept for a minimum duration of 10 years after the withdrawal of the marketing authorization.

We ensure the confidentiality of your Personal Data and will only disclose it to our authorized personnel and third parties involved in the Purposes within the limits of applicable laws. In case Personal Data is stored outside the European Union, we shall ensure that our service provider complies with applicable laws. You have the right to request (i) access and/or (ii) rectification and/or (iii) restriction (only if applicable), and/or (iv) to obtain the portability of your Data Personal (only if applicable). To exercise these rights, you can contact us by email at the following address: data.protection@theravia.com. You also have the right to lodge any complaint relating to these prerogatives to the national data protection authority of your country.

Processing: Quality products Complaints

As part of our regulatory obligations, Theravia is required to collect and process your Personal Data (name/first name/ contact details and any other helpful personal information) in order to respond appropriately to the complaints you have lodged (the “Purpose”).

The Personal Data collected as part of the follow-up to your report is kept for a period of 10 years in order to comply with our regulatory obligations.

We undertake to ensure the confidentiality of Personal Data, and to disclose it only to our authorizsed personnel and/or to third parties involved in the Purposes and within the limits of applicable laws.

In case Personal Data is stored outside the European Union, we will ensure that our service providers comply with applicable laws.

You have the right to request: (i) access and/or (ii) rectification and/or (iii) limitation of your Personal Data. To exercise these rights, you may contact us by e-mail at the following address: data.protection@theravia.com. You also have the right to lodge any complaint relating to these prerogatives to the national data protection authority of your country.

Additional Information Notice for Research Study

Dear Madam, Dear Sir,

You have consented to your participation or to the participation of your child in a clinical research study which involves a product of Theravia (referred hereinafter as “Study”).

The Sponsor of this Study (the legal person responsible for the research study) is Theravia or another entity.

Participant means: You or your child.

Personal Data means: any Participant’s data collected for the purpose of the Study, such as demographic data (age, gender) and health data.

All Personal data will be coded, meaning that such Personal Data can no longer be attributed to a participant without the use of additional information that is kept separately and is subject to technical and organizational measures to ensure that those data cannot be attributed to the participant.

We would like to bring you more information about the use of Personal data:

Unless opposed,

  • The Personal Data collected for the Study may be used for further scientific research about Participant’s illness and/or for the Study drug development (always in accordance with laws and regulations). Personal Data may also be reported in scientific journals. However, any information that identifies participant will never be mentioned in the Study report or in a publication. For any information about the Personal Data collected in the Study and your rights, you can contact the investigators of the Study.

  • Personal Data can be used to document a file with the competent authorities internationally, relating to Theravia’s product evaluated in this Study (the ”Drug”) in order to obtain a new indication for the Drug (“Regulatory purpose”). Thus, a greater number of patients can benefit from Study results. Consequently, Personal Data will be transmitted by the Sponsor or its representative to Theravia in France (European Union), in order to allow Theravia to process those Personal Data for the Regulatory purpose (the “Processing"). Theravia is the “Controller” of this Processing, meaning that Theravia determines the purposes and means of the Processing of Personal Data. The legal basis of this Processing is the legitimate interest of Theravia. The handling of Personal Data obtained in clinical research is governed by national and international data protection regulations and medical confidentiality. Personal Data will be processed in accordance with applicable laws, including, but not limited to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation, “GDPR”). According to these regulations, you have:

-      The right to access to your Personal Data, to request their rectification, or erasure.

-      The right to request the restriction of the Processing or to object to the Processing.

In addition, certain Personal Data that aimed at ensuring the quality and safety of the Study (for example: adverse effects of the Drug tested) must be collected by Theravia. In such case, no right of opposition or erasure is granted regarding this Processing of Personal Data.

-   The right to lodge a complaint with the Data Protection Authority of your country: https://edpb.europa.eu/about-edpb/about-edpb/members_en

For any information regarding this Processing, you can contact Theravia’s Data Protection Officer:

Theravia 16 rue Montrosier 92200 Neuilly-sur-Seine France

Email: data.protection@theravia.com

All information obtained for the Regulatory purpose will be kept strictly confidential and will be stored for at least 15 years after the end of marketing authorization of the Drug.

Personal Data may be transferred within the European Union (“EU”) or to countries outside the EU. The transfer of Personal data outside of EU countries will be in accordance with GDPR. Theravia ensures the same level of protection for your child’s Personal data as within the EU and according to article 49 of GDPR.

Only health authorities, Theravia and its authorized representatives may have access to Personal Data, and solely for the Regulatory purpose described herein. All these persons are bound to confidentiality obligations.  

September 2024