Controlled Access Programme Portal Privacy Policy

Who We Are And How You Can Contact Us

UCB or we means UCB Pharma Limited and its affiliates. Zogenix International Limited and its affiliates are now part of the UCB Group of Companies.

As the controller, i.e. the legal entity that decides why and how information relating to you (personal data) is collected and processed in the context of this CAP Portal (the Portal), we respect your right to privacy. 

We will only process your personal data as described in this CAP Privacy Policy (the Policy) and in accordance with the relevant data protection legislation, including Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (the General Data Protection Regulation or GDPR), the Data Protection Act 2018 and UK GDPR.

We have a data protection officer (DPO), who can be contacted by any of the following means for any privacy-related questions, including regarding how we collect, store and use your personal data:​

  • E-mail: dataprivacyuk@ucb.com 
  • Regular mail: UCB Pharma Limited,
    To the attention of the data protection officer
    208 Bath Road, Slough, Berkshire, SL1 3WE

The Reason Behind This Privacy Policy

The Policy governs the collection, use and retention by UCB of personal data relating to your use of the Portal. This Policy applies to all Portal users. 

The Policy consists of five main components and informs you about: ​

  1. Who we are and how you can contact us;
  2. The reason behind this Policy;
  3. The purposes for which we process your personal data, the related legal basis under the GDPR and applicable retention periods;
  4. What your rights are in relation to the personal data we hold about you and how you can exercise them; and
  5. Further details on how we process (including transfer) your personal data.

This Policy may be updated periodically to reflect changes in our personal data processing activities. In that case, we will inform you of any significant changes via an appropriate channel, in the same manner as we have informed you before, e.g. by posting a prominent notice on the Portal

The Purposes For Which We Process Your Personal Data And Applicable Legal Basis

The table below indicates per purpose (i) the categories of personal data we collect and process concerning you, (ii) the source, (iii) how long we retain your personal data, (iv) who we share it with, and (v) the relevant legal basis.

ALL PORTAL USERS
1. In order to make the Portal and its content available to you, UCB:
Collects the following personal data about you:
  1. *Electronic identification data: IP address;
  2. *Information collected through cookies.
Failure to provide the personal data with an (*) may result in (some features of) the Portal not being accessible.
Obtains this personal data from:
  • You (through the device you use to access the Portal).
Retains (**) your personal data for:
  • IP addresses are deleted after 14 days;
  • For cookies, see our Cookie Policy for more information.
Shares your personal data with:
  • UCB affiliates
  • Third-party processors: external service providers that we use to implement, manage and monitor the CAP and CAP Portal. These processors can use the Personal Data exclusively upon our instructions and on the basis of required data processing agreements
Relies on the following GDPR legal basis:
  • Processing necessary for the performance of a contract with you;
  • For cookies, processing based on your consent except for functional cookies (see our Cookie Policy for more information).
2. In order to maintain our Portal security, we deploy cookies and log files to monitor access to and traffic on our Portal in order to detect and prevent malicious activity or invalid traffic. In this context, UCB:
Collects the following personal data about you:​
  1. *Electronic identification data: IP address;
  2. *Information collected through cookies.
Failure to provide the personal data with an (*) may result in (some features of) the Portal not being accessible.
Obtains this personal data from:
  • You (through the device you use to access the Portal).
Retains (**) your personal data for:
  • IP addresses are deleted after 14 days;
  • For cookies, see our Cookie Policy for more information.
Shares your personal data with:
  • UCB affiliates
  • Third-party processors as described in section 1;
Relies on the following GDPR legal basis:
  • Processing necessary for the purpose of the legitimate interests pursued by UCB to protect its IT infrastructure and the data it holds. To this end, UCB strives to maintain a fair balance between its need to process your personal data and the preservation of your rights and freedoms, including the protection of your privacy. For more information or if you have any questions regarding how we assess this balance, please contact us through any one of the channels set out under Section 1 above (“Who we are and how you can contact us”).
  • For cookies, processing based on your consent except for functional cookies (see our Cookie Policy for more information).
3. In order to improve our Portal functionality, we use cookies to support and improve the Portal and to better understand usage patterns relating to our Portal, including by retaining and evaluating information on recent use you made of our Portal and how you access different features of our Portal for analytics purposes so that we can make our Portal more intuitive. In that context, UCB:
​Collects the following personal data about you:​
  1. Electronic identification data: IP address;
  2. *Information collected through cookies.
​Failure to provide the personal data with an (*) may result in (some features of) the Portal not being accessible.
Obtains this personal data from:​
  • You (through the device you use to access the Portal).
Retains (**) your personal data for:​
  • IP addresses are deleted after 14 days;
  • For cookies, see our Cookie Policy for more information.
Shares your personal data with:​
  • UCB affiliates
  • Third-party processors as described in section 1;
Relies on the following GDPR legal basis:​
  • Processing necessary for the purpose of the legitimate interests pursued by UCB to protect its IT infrastructure and the data it holds. To this end, UCB strives to maintain a fair balance between its need to process your personal data and the preservation of your rights and freedoms, including the protection of your privacy. For more information or if you have any questions regarding how we assess this balance, please contact us through any one of the channels set out under Section 1 above (“Who we are and how you can contact us”).
  • For cookies, processing based on your consent except for functional cookies (see our Cookie Policy for more information).
4. In order to enable you to create a log-in, to authenticate and manage your profile and to receive relevant and/or necessary communications from us relating to Portal use, UCB:
​Collects the following personal data about you:​
  1. Title*;
  2. First and last names*;
  3. Work address*;
  4. Credentials for login* (email address and password);
  5. Confirmation that you are an HCP*;
  6. Your professional background: your (job) title, your speciality/area of expertise (*)
  7. Personal details/identification data: your birthdate, gender.
  8. Your opt-in to receive communications from us.
  9. Contact details including phone number and email address
Failure to provide the personal data with an (*) will prevent you from creating a personal account and therefore being able to access the dedicated parts of the Portal.
​Obtains this personal data from:​
  • Directly from you.
​Retains (**) your personal data for:​
For the duration of the CAP programme as stipulated by the Health authorities. In relation to HCP retirement or cessation of professional activities: for a maximum of 36 months after we are informed of your retirement / cessation of professional activities.
​Shares your personal data with:​
  • UCB affiliates
  • Third-party processors as described in section 1;
​Relies on the following GDPR legal basis:​
  • Processing necessary for the performance of a contract.
5. In order to enable UCB to comply with its legal and regulatory (including pharmacovigilance) obligations, UCB:
​Collects the following personal data about you:​
  • *Patient’s details as legally required;
  • *Information regarding adverse event (seriousness, date and unique identification number) or any other information that may be legally required.
  • Your contact information to enable us to conduct the safety survey required bv the EMA and MHRA to measure the effectiveness of the risk minimization process (including the CAP portal, HCP and patient materials) for Fintepla (Fenfluarmine).
    Note: We aim to do this by following up with prescribers after registration to the CAP portal, inviting them to participate in a short online survey. In case you agree to participate in this survey, we will process the personal data provided by you for the purposes of managing, analysing and documenting the survey, including, as necessary, handling any potential follow-up questions and provide results to the competent regulatory authorities.
Failure to provide the personal data with an (*) will prevent UCB from complying with its legal obligations, including but not limited to reporting an adverse event in accordance with applicable laws.
​Obtains this personal data from:​
  • Directly from you;
​Retains (**) your personal data for:​
  • 10 years after the end of the marketing authorisation in any country where the UCB medication mentioned in the adverse event report was placed on the market
​Shares your personal data with:​
  • Competent regulatory and government agencies
  • UCB affiliates
  • Third party processors as described in section 1
​Relies on the following GDPR legal basis:​
  • Compliance with our legal obligations (including but not limited to pharmacovigilance/ adverse event reporting legislation) and processing necessary for reasons of public interest in the area of public health
    Please check UCB’s Patient Safety Reporting Privacy Notice, accessible online at https://www.ucb.com/Pharmacovigilance-privacy-policy

(**) We will retain your personal data in accordance with the retention periods set out in the table above. These retention periods, included in our data retention policy, are dictated by: ​

  • applicable statutory/legal requirements; 
  • industry guidelines; and 
  • for those data categories for which no express statutory or legal requirements apply, certain other determining factors such as the need to prove or enforce a transaction or contract, enforce our policies, etc. 

We will delete your personal data once the abovementioned retention periods will have expired or if you object to or if you withdraw your consent in relation to our processing of your personal data (to the extent such processing is based on your consent), except where we need to hold on to such data for the establishment, exercise or defense of legal claims, for the protection of the rights of another natural or legal person, for compliance with a European Union or European Union Member State legal obligation which requires such further processing or where we need to prove or enforce a transaction or contract or enforce our policies

YOUR RIGHTS AND HOW YOU CAN EXERCISE THEM

Your rights

Right to access

You have the right to obtain confirmation from us as to whether or not we process personal data concerning you, and if so, the right (as far as this does not adversely affect the rights and freedoms of others) to obtain a copy of your personal data from us. 

For more information, please check Section 4.B “How to exercise your rights”.

Right to rectification

You have the right to ask us to rectify without undue delay any inaccurate personal data concerning you. You can also ask us to complete incomplete personal data regarding you by providing us with a supplementary statement containing such additional information. 

For more information, please check Section 4.B “How to exercise your rights”.

Right to erasure

You have the right to ask us to erase without undue delay personal data concerning you, where one of the following grounds applies:​

  • your personal data are no longer necessary in relation to the purposes for which they were processed;
  • you have withdrawn your consent - for those processing activities based on your consent – and we have no other legal ground for such processing;
  • you object to the processing of your personal data (for more information on the right to object, see further below) and there are no overriding legitimate grounds for such processing;
  • your personal data have been unlawfully processed;
  • your personal data must be erased for compliance with a European Union or European Union Member State legal obligation to which UCB is subject.

Please note that your right to erasure will not apply to the extent that processing is necessary for:​

  • exercising the right of freedom of expression and information;
  • compliance with a European Union or European Union Member State Law to which UCB is subject;
  • reasons of public interest in the area of public health in accordance with article 9(2)(h) and (i) GDPR as well as article 9(3) GDPR;
  • archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with the relevant provisions of the GDPR;
  • the establishment, exercise or defense of legal claims.

For more information, please check Section 4.B “How to exercise your rights”.

Right to restriction of processing

You have the right to obtain from UCB restriction of processing by UCB of your personal data where one of the following applies:​

  • you contest - in good faith - the accuracy of personal data regarding you and held by us, in that case the restriction of processing will apply for a period enabling us to verify the accuracy of your personal data;
  • the processing is unlawful and you oppose the erasure of your personal data and request restriction of their use instead;
  • we no longer need your personal data, but you require them for the establishment, exercise or defense of legal claims;
  • you have objected to the processing of your personal data by UCB in accordance with the relevant GDPR provision, in that case the restriction of processing will apply for a period enabling us to verify if our legitimate grounds override yours.

Please note that notwithstanding the above, we are still allowed to continue storing your personal data (throughout the period of restriction) or to process your personal data for the establishment, exercise or defense of legal claims or for the protection of the rights of another natural or legal person.

If you have requested restriction of processing, we will inform you before the restriction of processing is lifted. 

For more information, please check Section 4.B “How to exercise your rights”.

Right to data portability

You have the right (insofar this does not adversely affect the rights and freedoms of others) to receive the personal data concerning you, that you have provided to UCB, in a structured, commonly used and machine-readable format and to transmit those data to another controller, without hindrance from UCB, where the processing is:​

  • based on your consent or on a contract; and
  • carried out by automated means.

For more information, please check Section 4.B “How to exercise your rights”.

Right to objection to processing

You have the right to object at any time, on grounds relating to your specific situation, to the processing of your personal data by UCB which is based on UCB’s pursuit of its legitimate interests as a controller. In that case UCB will no longer process your personal data, unless:​

  • UCB demonstrates compelling legitimate grounds for the processing which override your interests, rights and freedoms; or
  • for the establishment, exercise or defense of legal claims.

You have the right to object at any time to the processing of your personal data for direct marketing purposes, which includes profiling to the extent that it is related to such direct marketing. 

For more information, please check Section 4.B “How to exercise your rights”.

Right to withdraw consent

Where the processing is based on your consent, you have the right to withdraw that consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal.

For more information, please check Section 4.B “How to exercise your rights”.

How to exercise your rights

If you wish to exercise any of the rights mentioned above, you can always contact the local UCB Data Protection Officer by e-mail at dataprivacyuk@ucb.com or otherwise reach out to us by postal mail at UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, to the attention of the Data Protection Officer. Please clearly identify the right(s) you wish to exercise and include your contact details (including a valid e-mail or postal address) so that we can respond to your request. Please note that you may be asked to provide proof of your identity. 

When you contact us to exercise any of the rights mentioned above, we will respond to your request within one month following receipt of the request. This period may be extended by two additional months where necessary, but in that case we will inform you of any such extension within one month of receipt of your initial request together with the reasons for the delay.

Right to lodge a complaint with supervisory authority

In accordance with article 77 GDPR you have the right to lodge a complaint with a supervisory authority, in particular in the European Union Member State of your habitual residence, place of work or place of the alleged infringement, if you consider that UCB’s processing of your personal data infringes the GDPR. Please visit the website of the relevant national supervisory authority for more information on how to submit such a complaint.

MORE DETAILS ON HOW WE PROCESS YOUR PERSONAL DATA

Who we share your personal data with.

Principle 

We will disclose your personal data only as described in this Policy, as may be updated from time-to-time.

Affiliates and third party processors

UCB transfers or discloses your personal data to its personnel, affiliates and to third party service providers processing personal data on UCB’s behalf for the purposes set out above and our partners (including e.g. other pharmaceutical companies) with whom we have a collaboration agreement and who have a need to know this information. 

Other third parties include regulatory and government agencies (see further below in this Policy), our advisors and external legal counsel, our auditors, and potentially, third parties with whom UCB may merge or which may be acquired by UCB (see further below in this Policy).  

Compliance with laws and legal proceedings

UCB will disclose your personal data where:​

  • UCB is required to do so by applicable law, by a governmental body or by a law enforcement agency;
  • to establish or exercise our legal rights or defend against legal claims;
  • to investigate, prevent or take actions against illegal activities, suspected fraud, situations involving potential threats to the physical safety of any person, violations of our policies or as otherwise required by law.

Other

If a third party acquires all (or substantially all) of our business and/or assets, we will disclose your personal data to that third party in connection with the acquisition. However, such disclosure will occur subject to and in accordance with applicable data protection laws, including the GDPR.

International Transfers

UCB will transfer your personal data to its affiliates, including our affiliates outside of the EEA. In that case UCB relies on UCB’s Binding Corporate Rules, which can be accessed through the following link: https://www.ucb.com/UCB_BCRs.pdf.

As indicated above, your personal data may have to be transferred to certain third party service providers both within the EEA and outside the or the EEA, including for processing, storage, back-up, and to guarantee a continued service in case of major IT issues and outside of the EEA. Such non-EU countries may not offer the same level of personal data protection as the EEA countries. We will therefore put in place suitable safeguards to ensure such transfer is carried out in compliance with the applicable data protection rules. 

You may request additional information in this respect and obtain a copy of the relevant safeguard by exercising your rights as set out above.

The transfer of your personal data to (other) third party service providers outside of the EU (as set out above under Section 5.B) occurs on the basis of Standard Contractual Clauses that have been executed between UCB and the relevant third party service provider. For more information on these Standard Contractual Clauses, please reach out to us as set out above under Section 4.B (“How to exercise your rights”).

In the absence of the aforementioned appropriate safeguards, UCB may – to the extent permitted under and in accordance with applicable data protection laws (including the GDPR) - rely on a derogation applicable to the specific situation at hand (e.g. the data subjects’ explicit consent, the necessity for the performance of an agreement, the necessity for the establishment, exercise or defense of legal claims).


Links to third party sites

This Portal may contain links to other websites operated by third parties. This Policy does not apply to any website, other than this one. Third party websites are governed by their own terms and conditions. You should therefore always carefully check the privacy and cookie policies of third party websites before accepting to be redirected to them.