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Privacy Notice for Pharmacovigilance, Medical Information and Product Quality Complaints of HUTCHMED
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  • |  Privacy Notice for Pharmacovigilance, Medical Information and Product Quality Complaints of HUTCHMED

PRIVACY NOTICE FOR PHARMACOVIGILANCE, MEDICAL INFORMATION AND PRODUCT QUALITY COMPLAINTS OF HUTCHMED

We take your privacy very seriously and are committed to being transparent with how we use Personal Data. This Privacy Notice (this “Privacy Notice”) sets out how HUTCHMED (China) Limited and its subsidiaries and affiliates (“HUTCHMED,” “we,” “us,” and/or “our”) collect, use, share , and otherwise process information that may identify you (your “Personal Data”) , including but not limited, reporting Safety Data and Product quality complaints to HUTCHMED or requesting Product medical information from HUTCHMED. HUTCHMED is committed to protecting your Personal Data collected for these purposes, as described below.

 

This Privacy Notice is limited to the collection, use, sharing and otherwise processing of your Personal Data to report adverse events or “Special Situations” (i.e., pregnancy; breastfeeding; lack of efficacy; overdose; misuse, abuse / overuse; medication and administration errors; occupational exposure; suspected transmission of infectious agents via a medicinal product (STIAMP); and counterfeits), together “Safety Data”. This may include, for example, a request for information received from an external stakeholder about HUTCHMED medicinal products (“Medical Information Inquiry/Request”) and any written, electronic, or verbal declaration or report alleging deficiencies or defects, either perceived or real, regarding the identity, quality, stability, durability, reliability, safety, performance of drug product (“Product Complaint”), required to fulfil our regulatory obligations for any pharmaceutical product that is developed, manufactured, or distributed by HUTCHMED, including investigational products that are not yet approved for manufacture or distribution (“Product”).

For more information regarding how HUTCHMED collects, uses , shares and otherwise processes your Personal Data in other contexts, please see HUTCHMED’s Privacy Notice (available at this link).

Click on the links below to jump to the different sections of this Privacy Notice:

>> Controller for processing of your Personal Data
>> Types of Personal Data we collect
>> How we collect Personal Data
>> How we process Personal Data
>> Legal bases for the processing of Personal Data
>> How we share Personal Data
>> International data transfers
>> Information security
>> Data retention
>> Minors or mentally incapacitated persons
>> Rights

Note: For the purpose of terminology consistency, this Privacy Notice follows the rules of terminology under the GDPR without prejudice to our obligations and rights under data protection regulations and rules in other applicable jurisdictions.

WHO IS THE CONTROLLER FOR PROCESSING OF YOUR PERSONAL DATA?

HUTCHMED Limited, a company organized under the laws of the People’s Republic of China, having its registered office at Building 4, 720 Cailun Road, China (Shanghai) Pilot Free Trade Zone, Shanghai 201203, P. R. China, and other HUTCHMED company registered as or to be registered as the clinical trial sponsor or marketing authorization holder for a relevant medicinal product is the controller for the processing under this Privacy Notice, unless we inform you otherwise in an individual case.

This Privacy Notice also applies where a HUTCHMED company other than HUTCHMED Limited (a “HUTCHMED Affiliate”) is the controller. This may be the case, in particular, if your data are processed by a HUTCHMED Affiliate in the context of its own legal obligations or where data are exchanged with a HUTCHMED Affiliate, or where you otherwise interact with a HUTCHMED Affiliate. Only if a HUTCHMED Affiliate, being a controller, starts processing your data for their own purposes and in their own way, they themselves become controllers.

There may be situations in which we are responsible for data processing along with third parties. In these cases, they process personal data either as sole controllers (if you have any questions regarding the data processing of sole controllers, please contact them directly) or, if they participate in determining the purpose or means of the processing, as joint controllers (we remain your primary contact, even if there are joint controllers). If you wish to receive information about the controllers for a specific processing activity, you are welcome to contact us as part of your access right.

 

You may contact us for data protection concerns and to exercise your rights as follows:

HUTCHMED
Attention: Legal Department
Level 18, The Metropolis Tower
10 Metropolis Drive
Hung Hom, Kowloon, Hong Kong
+852 2121 8200 (Tel)
+852 2121 8281 (Fax)

TYPES OF PERSONAL DATA WE COLLECT

We will only collect the minimum amount of Personal Data required for the purposes of fulfilling our regulatory obligations related to Safety Data reporting, medical information provision and processing of product complaint. The Personal Data collected may include, for example, the following categories of data, as necessary:

Categories of Persons Scope of Personal Data Collected May Include
 Patient; Patient’s partner in case of pregnancy exposure ·  Date of Birth, year of birth, age or age group, race;
·  Patient ID if available;
·  Full name or Initials;
·  Gender, weight, height;
·  Ethnicity and Nationality;
·  Medical history and status, which may for example include:
o   details of other medicines or remedies taken by the patient prior or during use of a Product or Special Situation, including the dosage the patient has been taking or was prescribed, the period of time the patient was taking that medicine, the reason the patient has been taking that medicine and any subsequent change to their medication regimen;
o   medical history, including documents such as lab reports, medication histories, allergy histories, family histories and patient histories; and
·  Physical address, telephone number, email address.
 Reporters / External Stakeholders
(i.e., persons who provide information concerning Safety Data, Product Complaint or submit a Medical Information Inquiry/Request)
·   name, title, job title;
·   contact details (which may include your address, e-mail address and/or phone number);
·   relationship with the subject of the report, as applicable

HOW WE COLLECT PERSONAL DATA

Personal Data received through an adverse event / Special Situation reporting, medical inquiry or Product Complaint reporting may be communicated to HUTCHMED in different manner (e.g., through emails, Phone Calls or Websites from Patients and Healthcare Professionals, comments on certain social media platforms or channels for which we become aware, academic journals, completion of website forms, regulatory authorities, pharmacies, HUTCHMED’s service providers, distributors, or licensing partners).

HOW WE PROCESS PERSONAL DATA

As required by pharmaceutical regulations, HUTCHMED must collect Safety Data and Product Complaints for our Products and process the reports we receive in accordance with applicable laws and processes. In addition, we must ensure timely and accurate provision of medical information to the inquirer. To meet our regulatory obligations, your Personal Data maybe used in the activities below:

  • Process Safety reports and investigate Product Quality Complaint;
  • Generate adverse event reports, periodic safety update reports, annual reports and other reports regarding our Products as required by applicable laws and regulations, and submit these reports to the competent regulatory authorities;
  • Contact you for further information about Safety Reports  and Product Quality Complaint you reported; and contact you to provide response to your Medical Information Inquiry/Request.

LEGAL BASES FOR THE PROCESSING OF PERSONAL DATA

HUTCHMED processes Personal Data to comply with its regulatory obligations to monitor and report Safety Data and Product complaints and to ensure timely and accurate provision of Product medical information.

If and to the extent the data processing is subject to the European Union General Data Protection Regulation (“GDPR”), we collect and process your data for these purposes to comply with our legal obligations (GDPR Articles 6(1)(c) and 9(2)(i)). If and to the extent the data processing is subject to the Personal Information Protection Law of the People’s Republic of China (“PIPL”), we collect and process your data for these purposes to comply with our legal obligations (PIPL Article 13(3)). If the data relevant to you is reported to a regulatory agency as part of HUTCHMED regulatory obligations, it will be pseudonymized or anonymized beforehand, as appropriate and permitted. Your data will not be used for any other purposes beyond the scope of this Privacy Notice.

HOW WE SHARE PERSONAL DATA

In the course of the activities under the scope of this Privacy Notice, your Personal Data can be accessed by, or transferred to the following categories of recipients or third parties, on a need-to-know basis to achieve such purposes:

  • Other HUTCHMED subsidiaries and affiliates;
  • Regulatory authorities (including but not limited to the US Food and Drug Administration (FDA), European Medicines Agency (EMA), China's National Medical Products Administration (NMPA), etc.)
  • Ethics committees, study monitors and auditors, central laboratory, and clinical investigators;
  • Our employees and third parties, contractors, consultants and vendors acting on our behalf; Our licensing partners;
  • Our services providers that provide services and Products to us (including contract research organizations and other vendors);
  • Our IT systems providers, cloud service providers, translation service providers, database providers and consultants;
  • Any third party to whom we assign or novate any of our rights or obligations, including any third party to which we provide data in the event of any reorganization, merger, sale, joint venture, assignment, transfer or other disposition of all or any portion of our business, assets or stock (including in connection with any bankruptcy or similar proceeding); and
  • Our advisors and external lawyers.

The above third parties may act as separate controllers, joint controllers with us or as our processors, and are contractually obliged to protect the confidentiality and security of your Personal Data, in compliance with applicable law.

INTERNATIONAL DATA TRANSFERS

Your Personal Data may be transferred outside of your country of residence to countries that may have different data protection laws which may not provide the same data protection guarantees as your country of residence; in principle in any country in the world. In such case, HUTCHMED will take all necessary steps to ensure the safety of your Personal Data in accordance with the applicable privacy and data protection laws (e.g., enter data protection contracts with the new EU Standard Contractual Clauses/ the Standard Contractual Clauses released by the Cyberspace Administration of China (“CAC”) or pass a security assessment led by CAC, as appropriate), unless we can rely on an exception or the recipient is subject to a legally accepted set of rules to ensure data protection.

For the purpose of fulfilling our regulatory obligations related to Safety Data reporting, medical information provision and processing of product complaint, your Personal Data mentioned above may be transferred to our oversea affiliate, HUTCHMED International Corporation (Contact: 25A Vreeland Road, Suite 304, Florham Park, NJ 07932, USA). Subject to applicable laws and regulations, you may contact us at dpo@hutch-med.com for assisting you to make request to our oversea affiliate for exercising your right. The period of such overseas access will continue until 15 (fifteen) years after all the marketing authorizations have expired/cancelled, unless otherwise for a longer period where applicable law so requires.

HOW WE PROTECT YOUR PERSONAL DATA

HUTCHMED takes appropriate technical and organizational security measures in order to maintain the required security of your Personal Data and ensure its confidentiality, integrity and availability, and to protect it from accidental loss and from unauthorized access, use, alteration, tampering, or disclosure. These measures may include access restrictions, providing instructions to our employees, entering confidentiality and data encryption or de-identification measures, and monitoring.

DATA RETENTION

Data and documents relating to activities described in the scope of this Privacy Notice will be retained as long as the Product is authorized and for 15 (fifteen) years after all the marketing authorization has expired/cancelled.

However, the documents shall be retained for a longer period where applicable law so requires.

MINORS OR MENTALLY INCAPACITATED PERSONS

We do not deliberately collect Personal Data from minors under the age of 18 and/or mentally incapacitated persons. If you are a minor under the age of 18 and/or mentally incapacitated person, please obtain the consent of parents or guardians before providing your Personal Data to us. If you think that we have collected Personal Data from a minor under the age of 18 and/or mentally incapacitated person, please contact us at dpo@hutch-med.com.

RIGHTS

You are at any time entitled to access and to be informed of the Personal Data about you that is being processed. You have the right to:

  • Request information from us as to whether and what Personal Data we process about you;
  • Object to the collection and further processing or sharing of your Personal Data;
  • Request to correct, update, supplement your Personal Data if you believe it is incorrect, outdated or incomplete;
  • Request to review or copy your Personal Data collected by us;
  • Request erasure of your Personal Data
  • Request that we provide certain Personal Data in a commonly used electronic format or transfer it to another controller (data portability); and
  • Withdraw consent, where our processing is based on your consent;
  • Complain to the competent data protection authority if you believe your privacy rights have been violated.

Nevertheless, it is possible that exceptions to the exercise of your rights apply in accordance with local privacy law. Especially, we might not be able to fully satisfy some of your requests in cases where we have compelling legitimate reasons to continue processing your Personal Data, we are required to continue processing your Personal Data to comply with applicable laws, or if it is necessary for us to continue processing your Personal Data in connection with certain types of legal claims. In each case, we would inform you thereof in a due time and in accordance with applicable laws.

 

Last updated: September 8, 2023