Privacy Statement

Last Updated: September, 2024

This ptcbio.ie (the “Site”), is intended for residents of the European Economic Area (EEA), Switzerland and United Kingdom. This site is operated by PTC Therapeutics International Limited (collectively “PTC,” “PTC International,” “we,” “us,” or “our”), located at Unit 1, 52-55 Sir John Rogerson’s Quay, Dublin 2, D02 NA07, Ireland, Phone: +353 1 906 8700. This Statement outlines the types of personal information we may process; the means by which we may collect, use, or share your information; the steps we take to protect your information; and choices you have with respect to the use of your information.

For purposes of this Privacy Statement, “Personally Identifiable Information” (“PII”) is any information by which you can be individually identified directly or in conjunction with other publicly-available information, including, but not limited to your name, address, email address, telephone number, and any financial information you may provide for purposes of completing a transaction with us. This Privacy Statement does not apply to any third party websites linked to this Site. PTC Therapeutics is not responsible for the privacy practices or the content of such third party sites.

This Privacy Statement applies to all PTC online or digital services activities, including, but not limited to www.ptcbio.ie (the “Site“), our other websites, mobile applications (“Apps“) and digital services (“Services“) in which it is posted or linked. Please note that this Privacy Statement does not apply to information collected through third party websites or services that you may access through the Services.

PTC is a multi-national company which maintains datacenters around the world, including Europe and the United States (PTC Inc.’s global headquarters). PTC may process personal information in global databases that can be accessed by authorized PTC personnel worldwide.

Transfers of personal information between PTC and its group entities follow applicable laws and our Intra-Company Agreement for personal data processing.

This Privacy Statement is incorporated into and made a part of our Terms of Use. If you have not done so already, please also review PTC’s Terms of Use. The Terms of Use contain provisions that limit PTC’s liability to users of the Services.

By using this site you acknowledge the terms of this Privacy Statement, please read this entire Privacy Statement before using or submitting information to us. Whenever you submit information to us, you consent to the collection, storage, use, and disclosure (collectively, “Processing”) of that information in accordance with this Privacy Statement.

IF YOU DO NOT AGREE WITH ANY PART OF THIS PRIVACY STATEMENT, THEN PLEASE DO NOT USE ANY OF THE SERVICES.

Table of Contents

COLLECTION OF PERSONAL DATA

We collect PII about you in order to deliver services you have requested, process a request for information, and/or to personalize your experience. Any PII you provide to us will be Processed in accordance with this Privacy Statement.

In addition, we may collect information from your computer or Internet device to conduct statistical analysis of the use of this Site.

We collect and use the following types of information that we obtain from you online while you are navigating through or using our Site.

Personal Information that you voluntarily provide to us

General Enquires: When you send us an email at irelandoffice@ptcbio.com requesting general information, your email address and any other personal data contained or attached in your email will be collected and used in order to process and respond to your enquiry as well as stored for future compliance and auditing purposes. Such information may include, for example, your full name, email address and/or telephone number.

Medical Information Enquires: When you send us an email at medinfo@ptcbio.com requesting medical information, your email address and any other personal data contained or attached in your email will be collected and used in order to process and respond to your medical information enquiry as well as stored for future compliance and auditing purposes. Please see our Medical Information and Pharmacovigilance Privacy Statement.

Pharmacovigilance: The safety monitoring of medicines across the EU is regulated by the Directive 2010/84/EU and Regulation No. 1235/2010. According to these regulations PTC shall collect all the information necessary to deal with drug-related adverse events. Any personal data provided to PTC related to adverse events or any other activity related to pharmacovigilance will be used only for this purpose. Please see our Medical Information and Pharmacovigilance Privacy Statement.

Job Application: When you apply to a position at PTC via our dedicated Workday Career Site and/or via LinkedIn or other sites, we will collect and process any personal data provided by you such us your name, contact details, professional and business information, and any other related information typically provided in your CV. Such information may include your job title, education information, professional qualifications, work experience, professional networks, programs and activities in which you participated. If you wish to learn more on how PTC handles your personal information when submitting a job application, please visit our Recruitment Privacy Notice.

Master data and contact information: We refer to master data as the basic data that we need to process our business relationships and that relates directly to your person and characteristics. This includes, for example, first and last name, home address, phone number, email address, username, language skills, nationality, ethnic origin, gender, relations to the company for which you are employed, government identification (e.g., driver’s license, passport), photo or image, login credentials, answers to security questions, medical license number, banking or credit card details. We usually obtain this master data from yourself, but may also obtain it from other persons who work for your company.

Contract data: Contract data are details that arise in connection with the conclusion or processing of a contract, e.g. details about contracts and the services to be provided, as well as data from the preparation of the conclusion of a contract, details about the conclusion of the contract itself (e.g. the date of conclusion and the subject matter of the contract), as well as the details required or used for processing. For example, we process information on the type and duration as well as conditions of the contract in question, data on the termination of the contract, contact details, information on the use of services, information on payments and payment methods, invoices, complaints, information on customer satisfaction, feedback, etc.

Health Data: in limited circumstances and for certain programs and services, we may process health information from individuals directly or indirectly from a third party, e.g. information regarding patients’ health status, medications, medical history, and other healthcare-related information.

Digital Information/ Usage Data (non-identifiable data): When you visit our Site, we automatically collect basic technical information through our automatic data collection tools, which may include cookies and other commonly used technologies. These tools collect certain standard information that your browser sends to the Site such as your browser type and language, access times, and address of the referring site. They may also collect information about your Internet Protocol (IP) address or click stream data within our Site (i.e. the pages you view, the links you click, and other actions taken in connection with the Site). The information we collect through cookies and other means does not individually identify you. This information helps us improve the functionality of the Site and optimizes your visit. More detailed information about our use of cookies by can be found on our Cookie Statement.

Social Media: The Site also uses social plugins (e.g., the Facebook share button) to enable you to easily share our content with friends and social or professional networks. When you share the videos, you will leave PTC’s Site, and your data will be processed by the social media operator. Videos hosted on YouTube and Vimeo can also be viewed directly on our Site. In this case, cookies and other similar means of tracking will be used by YouTube and Vimeo in accordance to their policies.

When you visit our Site, the operator of the social plugin may be able to place a cookie on your computer, enabling that operator to recognize individuals who have previously visited our Site. If you have previously logged into the associated social media Site (e.g., Facebook) before browsing on our Site, the social plugin allows that social media website to receive information about your visit to certain pages on our Site. The social plugin may collect this information for any visitors who have logged into social networks, whether they specifically interact with the plugin on our Sites (e.g., by clicking “Share”) or not. The social plugin may also allow the social media website to share information about your activities on our Sites with other users of their social media website.

Regarding the purpose and scope of data collection and further processing and use of the data by social networks as well as your rights in this respect and the setting options to protect your privacy, please consult the data privacy notices of the respective networks and/or web pages:

Further data: It is possible that we process further personal data which we cannot list here conclusively. We inform you separately about the processing of such data if this is possible or we are obliged to do so.

USE OF PERSONAL DATA

We will only process your personal information for purposes permitted by applicable local laws, which may vary depending on where you live and where operate as well as on the actual processing activities. The purpose of the data processing activities may include:

to contact you and respond to your enquiries regarding our products and services;
(ii) for business administration (e.g., statistical analysis, support hotlines, workplace security, building security including access controls and video monitoring of public access areas, protection of our data, secrets and assets, furthermore spam and virus filters or DLP (data loss prevention) systems, which in particular can check business emails for certain search terms or the like in order to reduce the risk of sending confidential information or personal data to unauthorized recipients, documentation of security or privacy incidents, complaints, interactions with authorities and other relevant business activities);
(iii) to personalize your visit to the Site, or assist you while you use the Site;
(iv) to provide you with product announcements or information regarding health topics or disease states and any other related scientific and educational updates related to our medicinal products and services;
(v) to improve the performance of the Site by helping us understand who uses the Site and how, and to better understand the needs and interests of Site visitors;
(vi) for collaboration and research purposes in order to make more informed and objective decisions when identifying and/or engaging with healthcare professionals and key opinion leaders;
(vii) to comply with applicable laws, regulations, or codes of practice;

LEGAL BASIS FOR PROCESSING

We process personal information based on one or more of the following legal grounds where:

you have provided your consent: please note that when requested, you are not obligated to provide your consent. Your consent is provided on a purely voluntary basis, if you choose to refuse to provide it, this will only mean that we will not be able to provide you the requested information or service. If you do choose to provide it, you can later change your mind and withdraw it at any time and without giving any reason. To withdraw your consent, please contact Privacy and Data Protection Office at dataprivacy@ptcbio.com
it is necessary to comply with contractual obligations owed towards you;
the processing is necessary for compliance with a legal obligation to which we are subject;
the processing is necessary to protect the vital interests of an individual;
the processing is necessary in the public interest or for a public task; or
the processing is in PTC’s overriding legitimate interest; for example, processes information for scientific and statistical research purposes, information about visitors and supplier personnel, for scientific development, for the improvement of our products and services, to provide security measures to protect PTC’s employees, contractors, patients, information and other assets and to prevent crime (such as fraud, financial crime and theft of intellectual and industry property and to ensure the integrity of our manufacturing and other operations).

We may disclose your personal data to certain third parties listed below, including third parties who provide us with various business services. We will not sell or otherwise disclose your personal data without your consent, except where such disclosure is reasonably necessary for normal business operations and such disclosure is in accordance with all applicable data protection and privacy laws.

Affiliates and their subsidiary companies may also have access to personal data, provided to us by you including through or in connection with this Site for the purposes set out in this Privacy Statement.
Third Parties/Service Providers. We may also disclose your personal data to third party service providers who provide services to, such as but not limited to: Site hosting, professional services, including information technology services and related infrastructure, customer service, email delivery, auditing and other similar services as well as to business partners and collaborators. All Affiliates and any third party service providers are only permitted to use such data for the purposes of performing services for and on our behalf and in accordance with all applicable data protection laws.
Law Enforcement. In certain circumstances we may be called upon to share your personal data as required or permitted by law to comply with a subpoena or similar legal process or government request, or when we believe in good faith that disclosure is legally required or otherwise necessary to protect our rights and property, or the rights, property or safety of others, including to advisers, law enforcement, judicial and regulatory authorities. We may also transfer your personal data to a third party that acquires all or part of our assets or shares, or that succeeds us in carrying on all or part of our business, whether by merger, acquisition, reorganization or otherwise.
Regulatory Authorities. In cases where you wish to report any suspected adverse reactions, we may use the personal data you provide as necessary to submit complaint or adverse event reports to local and international health or pharmaceutical regulators, and as otherwise required by law.
In Connection with Business Transfers. If we sell or transfer a business unit (such as a subsidiary) or an asset (such as a website) to another company (including in connection with any bankruptcy or similar proceedings), we will disclose your personal data to such company and will require such company to use and protect your personal data consistent with this Privacy Policy. We may also disclose your personal data to companies that were formerly wholly or partly included in the PTC family of companies to whom we provide services during a transition period following separation.
In the Aggregate/De-identified. PTC may also disclose aggregate or de-identified data that is not personally identifiable to third parties for any purpose permitted under applicable law.

CHILDREN’S POLICY

The Services are not intended for use by children. If you are under the age of majority in your place of residence, you may use the Services only with the consent of or under the supervision of your parent or legal guardian.

If you believe PTC may have any information from or about a minor without a consent of the guardian, please contact our Privacy and Data Protection Office using the contact information at the end of this Privacy Statement.

NOTICE, CHOICE, AND CONTROL

Before you provide PII to us, we will provide you with notice (including through this Privacy Statement) about the purposes for which we collect and use PII, how to contact us with any inquiries or complaints, the types of third parties to whom we disclose PII, and the choices and means by which you can limit the use and disclosure of your PII. We also will provide you with notice before using or disclosing your PII for a purpose other than for which it was originally collected.

If you opt-in for services or communications, you will be able to unsubscribe or opt-out at any time by following the instructions included in each communication or by contacting us at dataprivacy@ptcbio.com

PERSONAL DATA TRANSFERS

As a global company, PTC operates in numerous countries including Europe, USA, Japan, Latin America and Canada. Personal data about you may be accessible to PTC headquarters as well as to some PTC affiliates outside European Union (“EU”)/ European Economic Area (“EEA”) or outside of the United Kingdom (UK) and/or Switzerland, and selected vendors and partners, established in the EU, UK, Switzerland or globally. Your personal data may be accessed by staff or suppliers in, transferred to and stored at, a location outside the EU or the EEA or UK or Switzerland in which data protection laws may not afford the same level of data protection as the one in the EU/EEA/UK/Switzerland.

Where PTC processes personal data in countries that may not provide the same level of data protection as in the EU/EEA/UK/Switzerland or in your own country, where you are resident, PTC will implement reasonable and appropriate legal as well as technical and organizational security measures to ensure the security of the processing and in particular to protect your personal data from unauthorized access, use or disclosure including, but not limited to, maintaining binding contractual arrangements with all third parties processing personal data of individuals, for and on behalf of PTC, as well as executing, where necessary, adequate data transfer mechanisms, in the form of standard contractual clauses, for any cross-border data transfers from the EU/EEA/UK/Switzerland to controllers or processors established in third countries, as adopted and approved by the European Commission, or by the competent supervisory authorities, with the aim to achieve an adequate level of data protection of the personal data of those individuals and to ensure the security of the processing.

For residents of EEA/UK/Switzerland – whenever we transfer your data outside of the EEA/UK/Switzerland, we will either (i) take any and all necessary steps to ensure that adequate safeguards are put in place to protect your data or (ii) exceptionally as needed ask for your explicit consent (unless we are permitted under applicable data protection law to make such transfers without additional formalities e.g. where the recipient country is considered an adequate destination). Such safeguards include the use of European Commission approved standard contractual clauses as mentioned above, as adjusted to comply with the Swiss or UK legal frameworks, as applicable, or the UK specific legal transfer mechanisms (IDTAs).

YOUR PRIVACY RIGHTS AND CHOICES

You have the right to request from us, in accordance with applicable laws in your country, to:

a) provide you with further details on the processing of your personal data;

b) provide you access to your personal data that we hold about you and copies thereof;

c) update any inaccuracies in the personal data we hold that is demonstrated to be inaccurate or incomplete;

d) delete any personal data the we no longer have a lawful basis to use;

e) provide you or a third party, with a copy of your data in a digital format (data portability);

f) stop a particular processing when you withdraw your consent;

g) object to any processing based on the legitimate interests or public interest to process information, unless our reasons for undertaking that processing outweigh any prejudice to your data protection rights; and

h) restrict certain aspects of the processing of your information.

In case we do not handle your request timely or if you are not satisfied with our response to any exercise of these rights, you are entitled to lodge a complaint with the competent supervisory authority of your place of residence. Further information and contact details of the European competent supervisory authorities can be found here: https://edpb.europa.eu/about-edpb/board/members_en.

If you wish to exercise one of the above-mentioned rights, please send us your request in writing to the following address: PTC Therapeutics International Limited, Privacy and Data Protection Office, Unit 1, 52-55 Sir John Rogerson’s Quay, Dublin 2, D02 NA07, Ireland or send us your request via email to dataprivacy@ptcbio.com

SECURITY

The security of your personal data is important to us. All information you provide to us is stored on secure servers and accessed and used subject to our security policies and standards. We take reasonable steps, consistent with generally accepted industry standards, including technical, administrative, and physical safeguards to protect the personal data submitted to us from loss, misuses and unauthorized access, disclosure, alteration, and destruction. However, no method of security or transmission over the Internet is entirely secure. You should always use caution when transmitting personal data over the Internet. Access to your personal information is limited to a restricted number of employees whose duties reasonably require such information and third parties with whom we have contracts to carry out business activities on their behalf. Our employees have been trained on the importance of privacy and how to handle and manage personal information appropriately and securely.

DATA RETENTION

In the context of each activity involving collection, processing, or storage of personal information, we will keep your personal information for no longer than the relevant period necessary for the specific processing purpose(s) for which your information was collected and any other permitted associated purpose. Such retention periods will be shared, as applicable, in the documentation relevant to the activity. Information may be retained for a longer duration where applicable laws or regulations require, or allow, to do so. Information that is no longer needed is either irreversibly anonymized (and the anonymized information may be retained for longer periods) or securely destroyed.

COOKIES

Cookies are small, sometimes encrypted text files that are stored on computer hard drives by websites you visit. Their purpose is to help users navigate websites efficiently as well as to provide information to the owner of the website in order to personalize and optimize your visit.

There are a variety of tools to control cookies and similar technologies, including browser controls to block and delete cookies. If you elect to block cookies, please note that you may not be able to take full advantage of the features and functions of the Site. Please refer to your browser’s documentation for information on these functions. You may also wish to refer to http://www.allaboutcookies.org/manage-cookies/index.html.

To find out more about cookies, including how to see what cookies have been set and how to manage and delete them, please read our Cookie Statement.

CONTACT US

If you have any questions, comments or suggestions about this Privacy Statement or our privacy practices, please contact us at: dataprivacy@ptcbio.com.

UPDATES TO OUR PRIVACY STATEMENT

From time to time, we may update this Privacy Statement. Any changes will be effective when we post the revised Privacy Policy. This Privacy Policy was last updated as of the effective date listed above. Minor changes to the policy may occur that will not significantly affect our use of personal data without notice or consent. We encourage you to periodically review this page for the latest information on our privacy practices.

MEDICAL INFORMATION AND PHARMACOVIGILANCE PRIVACY STATEMENT

This Medical Information and Pharmacovigilance Statement is intended to explain how PTC Therapeutics International Limited (together with its affiliates “we”, “us”, “PTC) collects and process Personal Data related to pharmacovigilance and medical information activities (“Personal Data”). In this respect, PTC collects and process Personal Data in accordance with the General Data Protection Regulation 2016/679 (“GDPR”), all other applicable privacy laws and regulations, and PTC internal policies, procedures, and guidelines. We collect and process your Personal Data to comply with our legal obligations (GDPR Articles 6(1)(c) and Art. 9(2)(i)). Your Personal Data collected for these activities, may be provided to regulatory authorities, if required by applicable local laws or regulations.

Purpose and legal basis for processing Personal Data

Medical Information – We are required by law to have a Medical Information team to answer enquiries regarding our products and/or treatments. For this reason, we may need to process Personal Data (i) to properly reply to the queries we receive via email or phone calls, either directly from doctors and patients or indirectly from doctors or sales representatives on behalf of patients and/or doctors and (ii) to maintain information in our medical information database for reference, compliance and auditing purposes.

The legal basis we rely on for such processing are:

legitimate interest (GDPR Art. 6.1.(f)); and
the public interest in the area of public health, ensuring high standards of quality and safety of health care and medicinal products or devices (GDPR Art.9.2(i)).

PTC also complies with the Directive 200/83/EC relating to medicinal products for human use, Art. 98 and Art. 104.

Pharmacovigilance- All Personal Data related to pharmacovigilance activities is very important for public health. Then, such Personal Data will be processed for the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Any Personal Data provided to PTC and related to adverse events or other activities related to pharmacovigilance will be used solely for these purposes.

Categories of Personal Data processed

For Medical Information, PTC will collect your name and contact details, and enquiry details

For Pharmacovigilance, PTC will collect:

From the reporter (person reporting pharmacovigilance information such as adverse events): name, contact details, profession and relationship with the subject of the report.
Regarding the patient: name or initials, age and/or date of birth, gender, weight, height and details of the product and other medicines that the patient is and/or was taking.

Recipients of your Personal Data

PTC may share this information with PTC affiliates and third-party service providers, such as medical information, information technology and pharmacovigilance service providers for safety reporting purposes.

Storage period

Personal Data retained as part of a medical information enquiries is kept by PTC for 10 years.

Personal Data collected for pharmacovigilance purposes is kept by PTC for a minimum 10 years after the product marketing authorization has expired, in accordance with legal regulations governing the storage and reporting of safety related information.

Security

We have appropriate technical and organizational measures to protect Personal Data, including safeguards and procedures designed to restrict access to Personal Data only to those PTC employees or designates who need this information to perform their job. Where possibly, we process Personal Data in pseudonymized form.

Information about your rights

Please note that you have the right to request information on which Personal Data we store and for which purpose. You can also request access to and rectification of your Personal Data. Notwithstanding the foregoing, due to PTC’s legal obligations as per pharmacovigilance applicable legislations, we may not be able to erase/delete or restrict processing of your Personal Data if processed for that purpose.

Because of our commitment to the protection of your personal data, we evaluate our privacy policies and procedures to implement improvements and refinements from time to time. We encourage you to check the Site frequently to see the current Privacy Statement and Terms in effect and any changes that may have been made to them. If we make material changes to this Privacy Statement, we will notify you by means of a prominent notice on this Site prior to the change becoming effective.