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Kyowa Kirin Privacy Notice for Medical Information, Pharmacovigilance Reports and Product Complaints

1. Data controller
2. Contact Information
3. Scope of this Privacy Notice
4. Information we collect and why we collect it
5. How we use Personal Data
6. Data retention
7. How we share Personal Data
8. International transfers
9. Your data protection rights
10. Security
11. Changes to this Privacy Notice

1. Data controller
Kyowa Kirin International plc, and its affiliates, https://international.kyowa-kirin.com/ (Kyowa Kirin ,and its affiliates, https://international.kyowa-kirin.com/), which has interacted with you or has collected data concerning medical information enquiries, pharmacovigilance reports and product complaints, are the data controllers of your personal data (“Kyowa Kirin”, “we”, “us”, “our”). You can find more information on the relevant local Kyowa Kirin affiliate here.

2. Contact Information
If you have any questions regarding this privacy notice or wish to exercise any of your rights, please contact us. You can also contact our Data Protection Officer (if applicable) for your country:
Post: Kyowa Kirin International Ltd, Head Office, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom and marking your query for the attention of The Data Protection Officer
E-mail : KKIDPOoffice@kyowakirin.com
We will use reasonable endeavours to answer your question promptly or resolve your problem.
For more detailed information about Kyowa Kirin’s privacy practices, please refer to our Privacy Notice, available on our corporate website here.

3. Scope of this Privacy Notice
This Privacy Notice is intended to explain how we will collect and process your personal data for the purposes of management of medical information enquiries, pharmacovigilance adverse event reports and product complaints (both including product complaints and service complaints (e.g., problem with delivery of the product)) related to Kyowa Kirin medicinal products.
In particular, this notice describes how we collect and use Personal Data to help us fulfil our duty to monitor the safety of all products including medicines we market or have in clinical development (also known as our pharmacovigilance obligations), to handle your medical enquiries appropriately, to manage any complaint you may have about our products and to ensure the quality and safety of all our products.
The notice is also applicable to medical devices since the international (including European) regulations on such products and devices require similar safety and quality monitoring. However, to facilitate the reading only reference to drug safety is made.
This Privacy Notice applies to information we collect from or about you online, by phone, fax, e-mail or post, or as part of the adverse event, the medical enquiry, or the product complaint or relevant regulations applicable to Kyowa Kirin. We may also collect this information about you through specific forms submitted by you on a site that is owned or controlled by Kyowa Kirin.

4. Information we collect and why we collect it
A. Medical information enquiries
Any personal data provided by you to Kyowa Kirin which relates to a medical enquiry may be used exclusively to manage your enquiry appropriately, follow up with you to request additional information in order to respond to your enquiry.
Your data will not be used for any other purposes. If you do not wish to provide your personal details to us, we will not be able to contact you back or further deal with your request.
For managing medical information enquiries, we may collect the name and surname of the requestor, their contact details (such as phone number and email address) and their affiliation or profession.
B. Pharmacovigilance Reports
Pharmacovigilance laws require us to take detailed records of any potential adverse event or event that may potentially impact patients' safety (e.g. Pharmacovigilance Special Situations or Pharmacovigilance-relevant information). This information is collated to be evaldevmed and collated with other recorded potential adverse events or events that may potentially impact patients' safety about that product and make efforts to prevent similar events from happening in the future.
Please note that if you are a patient on any of Kyowa Kirin's medications, we may also be provided with information about you, not directly by you but by a third party reporting an adverse event that affected you. Such third parties may include healthcare professionals (HCPs), our partners (e.g. distributors of our products, vendors etc), carers, relatives, other persons linked with you or other members of the public, competent authorities etc.
Any personal data provided by you as a patient or as reporter to Kyowa Kirin, which relates to the reporting of adverse events or other pharmacovigilance related activities, will be collected and used solely for pharmacovigilance management purposes.
The personal data that we may collect about you when you are the subject or the reporter of an adverse event report or Pharmacovigilance-relevant information is the following:
Personal data relating to the Patient:
• Patient’s name (if patient is the reporter for himself/herself) or initials (in case the HCP is the reporter);
• For effective follow-up activities, contact details (such as address, e-mail address, phone number) are requested on a voluntary basis to contact patients, in case the patient is also the reporter;
• Date of birth/age/age group, sex, weight, height;
• Information about health, ethnic origin; and
• Medical history and status, which may include but not limited to, for example, include administered treatments, test results, nature of the adverse effect(s), details of other treatments, medicines or remedies taken, personal or family history, sexual life in relation to associated reported events, associated diseases or events, risk factors, genetic data in relation to what is needed for the good use of our products, information on how medicinal products are prescribed and used and on the therapeutic conduct of the prescriber or of the HCPs involved in the management of the disease or adverse health event.
Personal data relating to the Reporter:
• Reporter’s Name;
• Contact details (such as address, e-mail address, phone number) needed to perform effective follow-up to ensure complete and accurate data is collected;
• Profession (if the reporter is an HCP; this information may determine the questions you are asked about an adverse event, depending on your assumed level of medical knowledge); and
• Relationship with the subject of the report.
C. Product complaints
Any personal data provided by you to Kyowa Kirin which relates to a product complaint will be used solely for the purposes of management of such product complaints.
We may collect the name, contact details of the individual reporting the complaint. As a rule, the complainant is an HCP. In such cases, we may also collect details regarding his/her affiliation/profession. To the extent permitted according to local laws to record complaints reported by patients, we do so in accordance with applicable legal limitations so as to ensure that only strictly necessary details belonging to patient-reporter are collected.

5. How we use Personal Data
A. Medical information enquiries
Handling of your enquiry is based on our legal obligations and industry regulations to provide a medical information service for our products. We will also rely on our legitimate interests to further store and maintain medical information related data, to the extent required, in a medical information database for future historic reference, record keeping, auditing and compliance purposes as well as for the establishment, exercise or defense of legal claims. The processing of special categories of data, such as health data, is necessary for reasons of public interest in the field of public health.
If your medical information enquiry consists of or requires the further reporting of an adverse event, your data (including special categories of personal data) will be also processed to comply with our legal pharmacovigilance obligations imposed on Kyowa Kirin by European, national and local pharmacovigilance laws and regulations. Also, in case that your medical enquiry consists of a product complaint, your data may be processed to comply with our legal obligations in the context of drug and product safety.
B. Pharmacovigilance Reports
We will collect personal data which relates to the reporting of adverse events or other pharmacovigilance related activities and use such data to investigate the adverse event, to follow-up with the patient, or the patient’s doctor or the reporter, or in general, to collect additional information about the adverse event, to analyze the safety of the product by combining and collating the information from one adverse event with information about other adverse events and to provide relevant pharmacovigilance reports to the competent regulatory authorities in and outside of Switzerland, UK and EEA as necessary, to continuously assess the benefit/risk ratio of our products.
Processing is necessary for Kyowa Kirin to comply with international, European and local pharmacovigilance-related legal and regulatory obligations. In terms of a follow-up to a Reporter of an adverse event, Reporter’s consent is necessary for the processing of personal data.
The processing of special categories of data, such as health data, is necessary for reasons of public interest in the field of public health and aims to the detection, assessment and understanding of adverse events and any other medicine-related problem as well as to ensure compliance with high standards of quality and safety of health care and medicinal products, in accordance with applicable data protection laws.
C. Product complaints
Processing of personal data provided by you, which relates to a product complaint, might be required for Kyowa Kirin to comply with international, European and local legal obligations in the context of drug quality and safety. The processing of special categories of data is necessary for reasons of public interest in the field of public health and will be used for the evaldevmion, classification, and assessment of the product complaint, to follow up on such requests for healthcare purposes, to request additional information and/or to respond to you.

6. Data retention
A. Medical information enquiries
Personal data retained as part of a medical information inquiry are kept within our system for 2 years. At the end of this period the data will be deleted or archived in an anonymized form.
B. Pharmacovigilance Reports
Mandatory requirements oblige us, as market authorisation holders of products, to keep all product-related documents for at least the time period of the market authorisation, plus 10 years following its expiry, unless an additional territory imposes a longer retention period by regulation such as European Union or national law. At the end of this latest period imposed by a territory, the data will be securely deleted or archived in an anonymized form.
C. Product complaints
As information related to product complaints is necessary to comply with our legal obligations relating to our market authorisation of products, we must retain all product-related documents for at least for one year after expiry of the batch to which it relates or at least five years after certification of the batch by the Qualified Person, whichever is the longer.

7. How we share Personal Data
We may disclose your personal information with any member of our group or with selected third parties where we have a legal basis for doing so.
We may share your information with selected third parties including:
• Kyowa Kirin group: Kyowa Kirin affiliates exchange safety data and collaborate on related, medical information, pharmacovigilance and drug quality and safety activities on the products according to the defined uses in this notice.
• Partners: We may also share Personal Data with our business Partner e.g. other pharmaceutical companies who are our co-marketing, co-distribution, or other license partners, where obligations deriving from relevant medical information, pharmacovigilance or drug quality and safety for a product require such exchange of information.
• Service providers: When we use other companies to provide services on our behalf, e.g. technology, IT and cloud providers, professional advisors and support services such to operate a Kyowa Kirin global or regional medical information, pharmacovigilance or product complaint database.
• Business transfers: Personal Data collected from you in accordance with this Privacy Notice may also be transferred to a third party in the event of a sale, assignment, transfer, or acquisition of the company or a specific product or therapeutic area, in which case we would require the buyer, assignee or transferee to treat that personal data in accordance with applicable data protection laws.
We may disclose your personal information to public authorities, regulators or other third parties:
• We share information with national and/or regional authorities, such as the European Medicines Agency in accordance with our obligations to to report certain pharmacovigilance and product relevant information to competent authorities; These reports will contain details about the incident but will only contain limited personal data and in particular:
- Patients: Information as provided, including date of birth/age/age group and gender (note that patient name will never be provided);
- Reporting Individuals: Information as provided, including name, profession, initials (to identify any duplications), address, email, phone number, to allow the regulatory authority to follow up with the reporting individual.
• To comply with any court order or legal obligation;
• When data is requested by our regulators, government agencies or law enforcement agencies or is required by any stock exchange rules;
• We may publish information about adverse events and/or drug quality and safety (such as case studies and summaries); in this case, we will remove identifiers from any publications so that no individual can easily be recognized.

8. International transfers
As part of our activities as above described we may need to transfer your data outside the UK, Switzerland and the EEA. For example, to meet our pharmacovigilance obligations that require us to review patterns across reports received from every country where we market our products, information provided as part of an adverse event report is shared within Kyowa Kirin on a worldwide basis through Kyowa Kirin’s Global Database. This database is also the platform through which Kyowa Kirin uploads adverse event reports to various oversight authorities as required by law. The same applies for the appropriate and lawful handling of medical enquiries and product complaints.
This means that your personal data relating to medical information, pharmacovigilance or product complaints is transferred to Japan and countries outside the UK, Switzerland or the EEA, such as the United States, which may not provide a level of data protection equivalent to that provided in your country.
If we do this, your personal information will continue to be subject to an adeqdevme level of protection or appropriate standard contractual clauses and/or other safeguards approved by the regulators. A copy of the relevant transfer mechanism can be provided for your review on request to the contact details above.

9. Your data protection rights
You may be entitled under applicable law to ask Kyowa Kirin for a copy of your information, to correct it, erase or restrict its processing, or to ask us to transfer some of this information to other organisations. You may also have rights to object to some processing. These rights may be limited in some sitdevmions – for example, where we can demonstrate we have a legal requirement to process or keep your personal data. You may exercise these rights by contacting Kyowa Kirin, as above described . If we do not handle your request in a timely manner, or if you are not satisfied with our response to the exercise of these rights, you are entitled to submit a complaint with the competent supervisory authority of your country of residence or place of work. Further information and contact details of the European competent supervisory authorities can be found https://edpb.europa.eu/about-edpb/about-edpb/members_en. UK residents may submit a complaint to the UK Information Commissioner’s Office (ICO) here: https://ico.org.uk/make-a-complaint/. Swiss residents may contact Federal Data Protection and Information Commissioner (FDPIC) here: https://www.edoeb.admin.ch/edoeb/en/home/deredoeb/kontakt.html.
Please note that for legal reasons, we cannot delete information that has been collected as part of an adverse event report unless it is inaccurate.
If you would like to exercise any of these rights, please contact us using the details set out in the ‘Contact Information’ section above. We may require you to provide proper identification before we comply with any request to access or correct Personal Data.
If you have unresolved concerns you also have the right to complain to the data protection authority in the country of your habitual residency.

10. Security
Kyowa Kirin uses reasonable technical, administrative and physical safeguards to ensure appropriate security of personal data being collected and processed in relation to the management of medical information enquiries, pharmacovigilance reports and product complaints. Your data will be securely stored in information assets owned by or managed on behalf of Kyowa Kirin by third party service providers and may be hosted outside your home/work jurisdiction. We will take necessary steps to ensure that adeqdevme safeguards are put in place.
Kyowa Kirin will maintain any information related to a medical enquiry, a pharmacovigilance report or a product complaint in the respective database, for as long as necessary (see above more specific retention periods) and to the extent permitted under applicable legal and regulatory requirements governing storage and reporting of related information for future historic reference, record keeping, auditing, regulatory and compliance purposes, as well as for the establishment, exercise or defense of legal claims.

11. Changes to this Privacy Notice
We may change this Privacy notice from time to time in response to technical, legal or business developments.
If we decide to change the substance of this Privacy Notice materially, we will post those changes through a prominent notice on our corporate website.

Effective: February 2024

Kyowa Kirin Regional Privacy Notice

Please read this Privacy Notice, together with any other privacy notice that we may provide to you, as it contains important information about how we collect, manage, use and protect your personal data. It also describes your data protection rights, including a right to object to some of the processing which we carry out. More information about your rights, and how to exercise them, is set out in the “Your rights” section below. 

This Privacy Notice may also be used in conjunction with other privacy notices that we may provide you with in certain sitdevmions. 

We may change this Privacy Notice from time to time. Please check this notice frequently to ensure you are aware of the most recent version and the date that it was last updated. 

This policy was last updated in March 2024. 

Who are we? 

Kyowa Kirin International plc is part of the Kyowa Kirin Group. The Group is made up of different legal entities, details of which can be found here and which may be updated from time to time. When we say ‘KKI’, ‘we’ or ‘us’ in this policy, we are referring to the relevant company in the Kyowa Kirin Group responsible for processing your personal data. 

KKI is a “data controller” of the personal data that we hold about you. This means that we are responsible for deciding how we hold and use personal information about you. We are required under data protection legislation to notify you of the information contained in this privacy notice. 

What information do we collect? 

Personal data, or personal information, means any information about an individual from which that person can be identified. It does not include data where the identity has been removed (anonymous data). 

We may collect, use, store and transfer different kinds of personal data about you. What information we collect depends on your interactions with us, for example, if you are a patient then the information collected may vary from the information we collect from health care professionals. 

Please note that if you are a health care professional or a candidate for a job vacancy at KKI, dedicated Privacy Notices apply concurrently to the  processing of your personal data.  

We have grouped together the types of information that we may collect from you as follows: 

When you register for our newsletters or meetings or if you correspond with us: 

  • Identity and Professional Data including name, date of birth, occupation, place of work, professional registration number, professional background and interests, medical specialization (if you are a health care professional); 
  • Contact Data including home address, business address, email address, phone numbers; 
  • Transaction Data including details about payments to and from you; 
  • Communications Data including your preferences in receiving communications from us; 
  • Profile Data including your username and password, preferences, feedback and survey responses. 

When you access our websites or consult our online materials: 

  • Technical Data including the Internet protocol (IP) address used to connect your computer to the Internet, your login information, browser type and version, time zone setting, browser plug-in types and versions, operating system and platform; 
  • Usage Data including the full Uniform Resource Locators (URL) clickstream to, through and from our site (including date and time), page response times, download errors, length of visits to certain pages, page interaction information (such as scrolling, clicks, and mouse-overs), and methods used to browse away from the page and any phone number used to call us; 

We may also gather personal data about you and your opinion of KKI, on the basis of publicly accessible social media content you post about KKI and our products and services. 

Special Categories of Personal Data 

We may also collect, store and use information about your health, including any medical conditions or disabilities whether through a clinical trial programme or otherwise. 

How do we collect your information? 

  • Information you give us. You may give us such information directly by registering with us, by participating in a clinical trial, completing forms, corresponding or speaking with us by phone, email, letter or otherwise, submitting a query, providing us with feedback about a product, visiting our website, requesting that we provide you with services / communications, or when we appoint you as a service provider. 
  • Information we collect about you. 
  • When you visit our website and receive e-mails from us we may automatically collect technical information about your equipment, browsing actions and patterns, if you have consented to us doing this. We collect this by using cookies. 
  • Information provided by cookies. Cookies are used to improve your experience while visiting our website.  This website uses a cookie control system allowing you on your first visit to the website to allow or disallow the use of cookies on your computer/device. Please consult our Cookie Notice for more details. 
  • When we e-mail you, such e-mails may contain tracking facilities if you have consented to this. Activity is tracked and stored in a database for future analysis and evaldevmion. Such tracked activity may include but is not restricted to: the opening of emails, forwarding of emails, the clicking of links within the email content, times, dates and frequency of activity. 
  • Information we receive about you from other sources. 
  • We may receive information about you if you use any of the other websites we operate or the other services that we provide. In this case we will have informed you when we collected that data that it may be shared internally and combined with data collected on this site. 
  • We may receive information about you from healthcare professionals or pharmacies as a result of an adverse event report or complaint. A dedicated Privacy Notice regarding Pharmacovigilance-Medical Inquiries-Product Complaints may concurrently apply.  
  • We also work with third parties (including, for example, business partners, contractors and sub-contractors in technical, payment and delivery services, advertising networks, analytics providers, search information providers, social listening providers and credit reference agencies) and may receive information about you from them. If you are a health care professional, we may receive information about your professional life (such as medical specialization and professional background) from external third parties (such as IQVIA). 
  • We may receive information if you have provided permission to other organisations to share it with us. Before providing permission to such third party organisations to share your personal data, you should check their privacy notices carefully. 
  • We may take information from publicly available sources (where possible) to keep your information up to date, for example, from any professional registration database. 
  • We may occasionally purchase the contact details of people who might be interested in hearing from us. Before purchasing such information, we will check with the vendor that your information was originally collected in a compliant manner, to make sure that we only contact people who have actively expressed an interest in receiving information from third parties and where it is lawful to do so. 
  • We may receive information about you if you apply for a vacancy at KKI. 

How we might use your information? 

We use information held about you in the following ways:  

  • To manage and administer our relationship with you 
  • To conduct clinical trials 
  • To carry out our obligations arising from any contracts entered into between you and us  
  • To respond to your requests 
  • To provide you with information about our activities or tailored information about a programme that you have signed up to  
  • To improve our level of service 
  • To notify you about changes to our service and notify you of new products and services  
  • To seek your views on our products and services 
  • To consider your application for employment 
  • For administrative and quality assurance purposes 
  • To ensure that content from our website is presented in the most effective manner for you and for your computer  
  • For the purposes of the establishment, exercise or defense of legal claims 
  • To administer our site and for internal operations, including troubleshooting, data analysis, testing, research, statistical and survey purposes  
  • To allow you to participate in interactive features of our service, when you choose to do so as part of our efforts to keep our site safe and secure  
  • To manage and follow up on Adverse Events reports 
  • To record, investigate and respond to complaints 
  • To analyze and evaldevme your online interaction with us, upon your permission, when needed, so as to have a more tailormade content for you  
  • To understand our stakeholders’ needs and sentiments and market trends, so that we can improve our products and services 
  • Information we receive from other sources. We may combine this information with information you give to us and information we collect about you. We may use this information and the combined information for the purposes set out above (depending on the types of information we receive). 

Communications with you 

We may text or e-mail you, with your permission when needed, to provide you with information about our activities and products and services supplied by us. You can un-subscribe at any time through an automated system. This process is detailed at the footer of each email. If an automated un-subscription system is unavailable, clear instructions on how to un-subscribe will be detailed instead. 

We may occasionally, with your consent when needed, call you to provide you with information about our activities or provide you with information about products and services supplied by us. You may unsubscribe to calls by instructing the person calling you or by contacting us at any time on the details set out in the ‘Contact Us’ section of this notice. 

We may also communicate with your through postal marketing when it is in our legitimate interests to do this and when these interests do not override your rights. Those legitimate interests include providing you with information on our services, products and other activities and those of other carefully selected organisations. You have the right to contact us at any time and opt-out of receiving postal communications. 

Profiling 

We may use profiling and screening methods to produce relevant communications and provide you with a better experience. 

To do this we may use additional external sources of data to increase and enhance the information we hold about you. This may include obtaining details of address and other contact details. 

If you do not wish for your information to be used in this manner, or have any queries about how we use your information, you can contact us on the details provided in the ‘Contact us’ section of this notice, at any time. You have an absolute right to opt-out of direct marketing, or profiling we carry out for direct marketing. 

What is our legal basis for using your information? 

There are a number of lawful reasons for us to process your personal data. 

One of these is called ‘legitimate interest’ and means that we can process your personal data if (i) we have a genuine and legitimate reason; and (ii) are not harming any of your rights and interests. 

Our aim is the development and commercialisation of innovative medicines for the treatment of unmet therapeutic needs. 

We will use your personal data in order to help us achieve those goals and to give you the most appropriate information, products and services and to provide you with the best experience when dealing with us. 

Whenever we process your personal data for our legitimate interests, we will consider and balance any potential impact on you and your rights under data protection law. 

Other legal bases that we will rely on include the following: 

  • If you are interested or request for a product or service from us, we may process your personal data in order to fulfil our contract with you. 
  • Where required, we will rely on your consent to send you e-mail marketing material or to make a call to you. In some cases we will rely on our legitimate interest to do so instead – for example if this is not needed according to local laws or if you have expressed your interest or requested a product or service from us or you represent a business. See the "Communications with you" section above for information about how to un-subscribe. 
  • Where we are required to comply with our legal obligations, or to establish and defend our legal rights, or to prevent and detect crimes such as fraud. 

Where we use special categories of personal data, for example, information about your health or genetic information, we may ask for your consent to such use. However, sometimes, for example if you are participating in a programme, there may be reasons of public interest or law that enable us to use this information without consent, for example, to ensure high standards of quality and safety of medicinal products. We may not rely on your consent if such processing is required for pharmacovigilance purposes. Pharmacovigilance is about drug safety means the monitoring of the effects of medical drugs in order to identify potential adverse reactions. 

Sometimes your personal data may be used for statistical research but only in a form that no longer identifies you. 

How long will we hold your information for? 

We will hold your personal data on our systems for as long as is necessary to fulfil the purposes that we collected it for, including for the purposes of satisfying any legal, accounting or other reporting requirements. 

By law, we are required to retain certain information for a prescribed period of time. In circumstances where there are no such legal requirements, to determine the appropriate retention period, we will consider the amount, nature and sensitivity of the personal data, the potential risk of harm from unauthorised use or disclosure of your personal data, the purposes for which we are processing your personal data and whether we can achieve those purposes through other means. 

We review our retention periods for personal data on a regular basis. 

In some circumstances we may anonymise your personal data (so that it can no longer be associated with you) for research or statistical purposes in which case we may use this information indefinitely without further notice to you. 

If you ask us to delete your information in accordance with your rights set out below, we will retain only some basic information on a suppression list to record your request and to avoid sending you unwanted materials in the future. 

Who we might share your information with 

We will NOT sell your personal data to any third parties. 

We may share your personal information with any member of our group where we have a legal basis for doing so. We may share your information with selected third parties including: 

  • When we use other companies to provide services on our behalf, e.g. answering questions about products or services, sending mail and emails, patient analysis, assessment and profiling and when using auditors or other professional advisors. 
  • Business partners, suppliers and sub-contractors for the performance of any contract we enter into with them or you. 
  • Analytics and search engine providers that assist us in the improvement and optimisation of our site.  
  • IT service providers. 
  • Clinical Research Organisations.  
  • Healthcare Professionals. 
  • If we run an event in partnership with other named organisations your details may need to be shared. We will be very clear about what will happen to your data when you register. 
  • If we merge with another organisation or form a new entity, your personal data may be transferred to that new entity, and you will be duly informed regarding this. 

We may disclose your personal information to third parties to: 

  • To support with our legal obligations and services to the pharma community and you; 
  • Comply with any court order or other legal obligation or when data is requested by our regulators or by government agencies or law enforcement agencies or is required by any stock exchange rules where a member of the Kyowa Kirin Group is listed; 
  • Enforce or apply our terms of use and any other agreements; 
  • Protect the rights, property, or safety of us, our employees or others. This may include exchanging information with other companies and organisations for the purposes of fraud protection and credit risk reduction. 

International transfers of personal data 

As KKI is an international enterprise that consists of numerous entities worldwide, the data that we collect from you may be transferred to, and stored at, a destination outside the United Kingdom, the European Union (“EU”) and European Economic Area ("EEA") for the purposes described in this policy, in particular to our parent company Kyowa Kirin in Japan. For a list of the other entities that your personal data may be shared with, please see here.  

It may also be processed by staff operating outside the UK, EU, EEA who work for us or for one of our suppliers. Such staff may be engaged in, among other things, the processing of your payment details and the provision of support services. 

Data may be transferred to and hosted by a third-party IT service provider in the countries outside of the UK, EU, EEA as part of selected ‘Cloud’ services adopted by Kyowa Kirin International for the purposes of carrying out normal business practices. We may also share your data with other selected unaffiliated service providers or consultants acting on our behalf, such as external marketing agencies,  advisory services or lawyers. 

If we do this, your personal information will continue to be subject to one or more appropriate safeguards set out in the law, for example we may use model contracts in a form approved by regulators. We will take all steps reasonably necessary to ensure that your data is treated securely and in accordance with this Privacy Notice. A copy of the relevant mechanism can be provided for your review on request to the contact details below. 

If you fail to provide personal data 

Where we need to collect personal data by law or under the terms of a contract we have with your or if you wish to participate in a programme and you fail to provide that data when requested, we may not be able to perform the contract we have with you or permit you to participate in the programme. If this is the case, we will notify you at that time. 

Your rights 

You have a number of rights. If you would like to exercise any of these rights, please contact us using the details set out below in the ‘Contact Us’ section. If you exercise any of these rights we may ask for proof of identity and sufficient information about your interactions with us so that we can locate your personal information. If we agree that we are obliged to provide personal information to you (or someone else on your behalf), we will provide it to you or them free of charge except in exceptional circumstances. 

You also have the right to lodge a complaint with the data protection regulator, the Information Commissioner’s Office, if you have concerns about how we use your personal information. You can contact the Information Commissioner’s Office at: https://ico.org.uk/global/contact-us/. 

Your rights include: 

  • transparency over how we use you data and to make a subject access request (right of access); a right to have your personal data updated and corrected (right of correction/rectification) 
  • a right to ask us to delete your information (right to be forgotten); 
  • a right to ask us to stop processing your information (right to restriction); 
  • a right to object to (i) processing based on our legitimate interests; (ii) processing of your information for direct marketing purposes; and (iii) automated decision making and profiling (right to object); 
  • a right to receive a copy of your information, or have this sent to a third party (right to data portability); and 
  • a right to claim compensation for material or non-material damage caused if we breach the data protection rules (right to compensation). 

Contact Us 

If you have any questions regarding this policy or about our privacy practices, wish to exercise any of your rights or wish to make a complaint, please contact our Data Protection Officer at: 

  • E-mail: KKIDPOoffice@kyowakirin.com 
  • Post: Kyowa Kirin International Plc, Head Office, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom and marking your query for the attention of The Data Protection Officer 
  • Telephone: +44 1896 664 000 

 

Kyowa Kirin Terms and Conditions of Use

 1. Who we are

1.1  These terms and conditions of use (“Terms of Use”) govern your access and use of this website, including all information, tools and services available on the website (together, the “Website”). 

1.2  When we say “you” or “your”, we mean any person who visits, accesses or uses the Website. If you are using or accessing the Website on behalf of your firm or organisation, you confirm that you have the legal authority to bind them to these Terms of Use. 

1.3 This Website is operated by Kyowa Kirin International plc (hereafter, “Kyowa Kirin”), a company incorporated in Scotland with company number SC198780 and its registered offices at Galabank Business Park, Galashiels, TD1 1QH, UK or its affiliate(s) or agents. In this document, when we refer to "we", "us" or "our", we mean Kyowa Kirin. 

1.4 Prior to making use of this Website, please carefully read the Terms of Use and use this Website only if you agree with them. 

 

2. Applicable Terms

2.1 As well as these Terms of Use, please also see our (i) Privacy Notice, and (ii) Cookie Notice for information on how we may collect and use your data on the Website, which is not part of these Terms of Use. 

2.2 You should familiarize yourself with these Terms of Use and all of the documents listed above as they form the basis of our legal relationship with you and they affect your rights and liabilities under law.  

2.3 By using the Website, you acknowledge that the transmission of data over the internet can never be completely secure and you accept the risk that others may be able to read or intercept any of your content or other information, text, media, graphics you submit or send to or through the Website. This includes transmissions that are identified as secure or encrypted. 

2.4 By accessing this Website you accept, without limitation or qualification, these Terms of Use and you agree to comply with them. If you do not agree to these Terms of Use, you must not use this Website. 

 

3. Medical information

This Website may contain information about medical conditions, medical or scientific research and pharmaceutical products, but it is NOT intended to be a substitute for professional medical advice, help, diagnosis, or treatment. Information and statements about products are not intended to be used to diagnose, treat, cure, or prevent any disease or health condition. You should not rely on the materials on this Website in deciding on a treatment plan, drug usage, or any other medical advice. You are strongly urged to consult with a physician in connection with any and all treatment options. 

 

4. Copyrights and Trade Marks

4.1 We are the owner or licensee of all intellectual property rights in the content posted on this Website including documents, podcasts, pictures, illustrations, images, user interfaces, visual interfaces, trademarks, logos and computer code, the design, structure, arrangement, selection, coordination, expression, diagrams, videos, audio and programs, etc. (“Our Content”). All of these rights are protected by copyright and related intellectual property laws. No license is granted to you in these Terms of Use or elsewhere to use any of our Content owned by us or any of our affiliates. 

4.2 Reproduction or transfer of Our Content without our permission is strictly prohibited. Furthermore, if all or a portion of Our Content posted on this Website is intended to be altered, reproduced or republished, sold, disseminated, distributed, transmitted or broadcasted or commercially exploited in magazines, books or other print media, or homepages, CD-ROM or other electronic media, our prior written permission is required. You may not store, link, frame, scrape or deep-link Our Content on any other website or app or in any other medium or format unless we agree in writing in advance. 

4.3 You must always acknowledge our status and that of any identified contributors as the authors of material on our Website. 

4.4 We are entitled to investigate any suspected or actual improper, illegal, or unauthorised use of Our Content or the Website (or any part of it) and we are entitled to take any legal action we deem appropriate. 

 

5. Links

5.1 Kyowa Kirin makes no warranties or guarantees whatsoever regarding the contents of the third-party website(s) linked to or from this Website (“Linked Sites”) and assumes no responsibilities or liabilities for any losses, expenses or damages occurred in making use of such Linked Sites that are independently operated by third parties. We are not liable for any harm or damages related to the purchase or use of goods, services, resources, content or any other transactions made in connection with any Linked Sites. When making use of Linked Sites, you should carefully consult the terms and conditions of such Linked Sites. You must direct any complaints, claims, concerns or questions regarding third-party products to the relevant third party. If you want to link to our Website, please contact Kyowa Kirin regarding the operator and subject of the Linked Site, the purpose of the link, and the URL of the page of the originating link. The prior written permission of Kyowa Kirin is required to link to our Website. We reserve the right to withdraw linking permission without notice.  

5.2 Use of the Kyowa Kirin's logo and Our Content by opening this website inside a frame at a Linked Site is prohibited. Furthermore, Kyowa Kirin is not responsible for the contents of Linked Sites. 

 

6. No offer and no solicitation

The information provided on this Website does not constitute an offer of or solicitation for the purchase or disposal of, trading or any transaction in any Kyowa Kirin securities. Investors must not rely on this information for investment decisions. 

 

7. Forward-looking information

This Website may contain forward-looking information. Such information is subject to a variety of significant uncertainties, including scientific, business, economic and financial factors, and therefore actual results may differ significantly from those presented. 

 

8. Our Liability

8.1 We accept no responsibility, to the extent permitted by law, for any loss, damage or problems to you caused by your use of this Website or by information posted on this Website.  

8.2 We reserve the right to interrupt or discontinue the publication of this Website at any time for any reason without prior notice and shall not be liable for any unavailability of this Website for any period. 

8.3 To the extent allowed by applicable law, the Website and Our Content are provided on an ‘as is’ and ‘as available’ basis. We make no warranties, undertakings or representations, (either express or implied or statutory), in respect of any of the content of this Website (including, without limitation, the timeliness, currency, accuracy, completeness, merchantability or fitness for any particular purpose, non-infringement, title, availability, compatibility, or security). 

8.4 To the fullest extent allowed by applicable law, we and our affiliates and business partners and our and their respective directors, officers, employees, affiliates, agents, contractors, interns, suppliers, service providers or licensors, are not liable for:  

  1. a) any direct, indirect or consequential loss or damage; or 
  2. b) any loss, corruption or damage to equipment, property or systems; wasted management or office time; any business interruption; or any loss of profits, income, revenues, goodwill or reputation, data, contracts, use, opportunity, business or anticipated savings, or any similar damages; or any other loss or damage of any kind, however arising and even if foreseeable, whether based in contract, tort (including negligence), strict liability or otherwise, arising out of or in connection with the Website, any of Our Content, these Terms of Use, or from your use of, or inability to use, the Website, our services and products (or any part of them), or the information displayed on it (including any errors, inaccuracies or omissions in such information or any faults, interruptions or delays in connection with the Website).

 

9. Acceptable Use

9.1 You may freely browse the Website, but you may only access, download or use information from this Website and the Content for your own non-commercial use. You may not distribute, modify, transmit, reuse, repost, or use the Content for commercial purposes, without written permission of Kyowa Kirin. You must retain and reproduce each and every copyright notice or other proprietary rights notice contained in any Content you download. You should assume that everything you see or read on this Website is copyrighted unless otherwise noted and may not be used except as provided in these Terms of Use or in the text on the Website without the written permission of Kyowa Kirin. 

9.2 You agree not to circumvent the security features of the Website or reproduce, duplicate, copy, sell, resell or exploit any portion of the Website, use of the Website, or access to the Website, unless you first receive our express written permission. 

9.3 In the event that we believe that you violate this clause 9, we shall have the right to immediately and permanently suspend your access to this Website and any related services. 

 

10. Privacy Policy

Kyowa Kirin, respects the privacy of users of this Website and we will use your personal information based on our Privacy Policy. 

 

11. Applicable Laws and Jurisdiction

11.1 The existence, formation, interpretation, operation and termination of these Terms of Use and any matters or disputes arising out of or in connection with them (whether contractual or non-contractual) are governed by the laws of England and Wales. 

11.2 You can bring proceedings in respect of this Website in the English courts.  However, if you are a consumer who is resident in the England and Wales or the European Union, you may bring any dispute which may arise under this Website to - at your discretion - either a competent court of England and Wales, or to the competent court of your country of habitual residence if this country of habitual residence is within the England and Wales or is an EU Member State, which courts are - with the exclusion of any other court - competent to settle any of such a dispute. We shall bring any dispute which may arise under this Website to the competent court of your country of habitual residence if this is in an EU Member State, or otherwise a competent court of England and Wales. 

11.3 If you access the Website from a country other than England and Wales, you are responsible for compliance with the applicable laws in that jurisdiction. 

 

12. Amending these Terms of Use

We may change these Terms of Use or any other policies and terms from time to time. If we make a change to the Terms of Use, we will provide you with notice of the change by email to your registered email address, or by posting the changes on our Website indicating the date of the new version. If you don’t agree to the amended Terms of Use, you should not continue to access our Website. We therefore recommend that you check these Terms of Use regularly to ensure you understand the terms that apply at that time. Your continued use of or access to the Website following the posting of any changes constitutes acceptance of those changes. 

 

13. Other Important Terms

13.1 Each of the paragraphs of these Terms of Use operates separately. If a court of competent jurisdiction determines any provision or part-provision of these Terms of Use to be invalid, illegal or unenforceable, it will be deemed deleted, but that does not affect the validity and enforceability of the rest of the Terms of Use. 

13.2 If you breach any provision of these Terms of Use and we do not take any action, this does not affect our ability to rely on these Terms of Use at a later date. 

13.3 If you are a consumer, you will benefit from any mandatory provisions of the law of the country in which you are resident. Nothing in these Terms of Use, including the paragraph above, affects your rights as a consumer to rely on such mandatory provisions of local law. 

13.4 Although this Website and Content may be accessible worldwide, not all products or services discussed on this Website are available to all persons or in all geographic locations or jurisdictions. Any offer for any product or service herein or access to information made on this Website is void where prohibited by law. Accessing the Website from territories where its contents are illegal or unlawful is prohibited. 

 

14. Contacting us 

14.1 If you wish to complain or raise a dispute about our Website or provide any comments or suggestions, please contact us through the following channels: 

kkihub.support@kyowakirin.com     

 01896 664000 

 14.2 These Terms of Use were last updated on [please insert]. We may change these Terms of Use at any time. Please review the Terms of Use each time you visit the web site. By using this web site, it means you accept the most recent version of the Terms of Use. 

Kyowa Kirin Modern Slavery Act Transparency Statement

This statement is made by Kyowa Kirin International plc ("KKI"), a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (a company incorporated in Japan and listed on the Tokyo Stock Exchange), pursuant to Section 54(1) of the Modern Slavery Act 2015 (the "Act"). This statement sets out the steps taken by KKI and its subsidiaries (together referred to as the "Kyowa Kirin Group") to prevent modern slavery, human rights violations and trafficking in its business and supply chains during the financial year ended 31 December 2023.

The Kyowa Kirin Group's business is R&D based pharmaceuticals. The Kyowa Kirin Group strives to contribute to the health and well-being of people around the world through the pursuit of advances in life sciences and technologies.

KKI has its head office in the UK and the Kyowa Kirin Group has trading companies across Europe and the GCC which market and distribute our pharmaceutical products.

 Our Principles and Policies

The Kyowa Kirin Group is committed to ensuring that there is no modern slavery or human trafficking in our supply chains or in any part of our business. We are committed to acting ethically and with integrity in all our business relationships and to implementing and enforcing effective systems and controls to ensure slavery and human trafficking is not taking place in our business or any of our supply chains. We have a zero tolerance to slavery and human trafficking. As such, the Kyowa Kirin Group has in place a Human Rights Policy and a Procurement Policy.

We undertake appropriate right to work checks on all employees across the Kyowa Kirin Group and do not employ anyone who does not provide the appropriate documentation. This policy minimises the risk of the Kyowa Kirin Group employing anyone who has been forced to work or trafficked. We also require our employees to provide proof of age to ensure we do not employ anyone who is not of legal age to work.

 Our Supply Chains

We outsource our manufacturing and packaging requirements to third parties, including the supply of active pharmaceutical ingredients. 

Risk Assessment and Management

Some of our suppliers and business partners are based in countries where there is a higher prevalence of modern slavery, based on the Global Slavery Index.

However, the nature of the services that these suppliers and business partners offer are not associated with a high risk of modern slavery. Therefore, we consider the inherent risk of modern slavery, trafficking and / or human rights violations to be low.

Notwithstanding the low inherent risk associated with our supply chain, we undertake regular supplier diligence, as noted below, and where concerns are identified we will take targeted remedial or preventative action, as appropriate. 

Supplier Diligence

The Kyowa Kirin Group operates an ongoing supply chain surveillance exercise in order to ensure that our third party suppliers do not engage in any activities or behaviour in contravention of the Act. This includes:

  • Ensuring that new supplier contracts include reference to the Act, and existing contracts are amended to do so at the earliest opportunity.
  • Including compliance with the Act as part of our internal supplier Risk Management Assessment processes.

The Kyowa Kirin Group is engaged in continuous improvement to its management of contracts and third party diligence and oversight with the introduction of digital tools for pre-engagement due diligence and monitoring.

In 2023, KKI published its Third Party Code of Conduct (“the Code”), which communicates its expectations in terms of respect of human rights. All new supplier and distribution agreements include a commitment to comply with the Code and to complete training on the Code if requested.

Performance Indicators

We are committed to ensuring the direction and focus of any performance incentives implemented by us do not contribute to or create a risk of modern slavery within our business or supply chain. Our policies and procedures prioritise our commitment to a zero tolerance of modern slavery over the implementation of performance incentives either in our business or to our suppliers.

Training

We require all employees to complete training annually in respect of prevention of bribery and corruption. 

This Modern Slavery Act Transparency Statement was approved by the Board of Directors of Kyowa Kirin International plc on 12th June 2024.

 

Jeremy Morgan
President, Kyowa Kirin International plc

Kyowa Kirin Third Party Code of Conduct

We believe a strong relationship with our business partners and suppliers (our “third parties”) is key to achieving our mission to make people smile. 

To support these relationships, we have created our Third Party Code of Conduct. Our intention is that it enables a mutual understanding of our company's core values and beliefs, as well as the standards we expect our third parties to uphold.

Click here to access our Third Party Code of Conduct

ADVERSE EVENTS SHOULD BE REPORTED HERE

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Copyright © Kyowa Kirin International plc. All rights reserved. This website is developed and funded by Kyowa Kirin International plc.

Kyowa Kirin International plc is a company registered in Scotland (company number SC198780) with registered address at Galabank Business Park, Galashiels TD1 1QH, United Kingdom.

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