PRIVACY NOTICE FOR INDIVIDUALS INVOLVED IN ADVERSE EVENT REPORTS, PRODUCT QUALITY COMPLAINTS AND MEDICAL INFORMATION ENQUIRIES

Shionogi B.V.

Registered office: Herengracht 464, 1017 CA, Amsterdam, Netherlands

Correspondence address: 33 Kingsway, London, WC2B 6UF, the UK

Email: dataprotectionlead@shionogi.eu

Phone: +44 (0)20 3053 4200

Website: https://www.shionogi.com/eu/en/

We collect and use the following categories of personal data for the purposes described in this privacy notice:   

·Information about the individuals who report adverse events and other safety information, report product quality complaints, or make medical information enquiries (including healthcare professionals and carers). We may collect your name, contact details, affiliation/profession and your relationship with the subject of the report.

·Information about the individuals who have experienced an adverse event  The personal data we collect may include:

o   name, age, date of birth, gender, race, weight and height, whether pregnant and/or breastfeeding, details of product causing reaction, information on dosage, frequency and administration modalities, reasons product was prescribed, changes to usual regime, possible medication errors and occupational exposure, details of other medicines or remedies being taken, details of the adverse reaction, treatment received, patient’s health condition and other medical history considered relevant.

o   health and lifestyle information (some of which is special category personal data) where necessary and relevant for the purposes set out in this notice, including physical exercise, diet, sexual life, contraception, consumption of drugs, tobacco, alcohol,  ethnicity, religion and sex life.

The personal data that we collect may come directly from you.

If you are a patient, we may also be given personal data about you by a third party (such as a healthcare professional) who has become aware of an adverse event, product complaint or medical information request that is related to you.

We process your personal data for the following purposes:

·monitoring the safety and benefit/risk balance of our medicinal products and medical devices (including detecting, assessing, following up on, and preventing adverse events, and reporting adverse events to health authorities).

·responding to medical information enquiries (e.g. in relation to availability of products, clinical data, dosing and administration, formulation and stability, and interactions with other drugs, foods, and conditions) and maintaining the information in a medical information database for reference.

·evaluating, classifying and responding to product quality complaints (such as any fault of quality and/or effectiveness, stability, reliability, safety, performance, or usage) and maintaining the information in a product complaints database for reference.

·complying with our policies and legal, regulatory, and compliance requirements.

·for record keeping purposes.

·conducting audits and defending litigation.

We collect and process your personal data based on one or more of the following:

·the processing is necessary for Shionogi to comply with applicable laws and regulations governing adverse event reports and other safety related information and product quality complaints.

·the processing is necessary for Shionogi’s legitimate interests in handling and following-up on your medical information queries, and this does not prejudice or harm your rights and freedoms.

·the processing is necessary in order to protect your vital interests or the vital interests of another person.

We may also process special category personal data about you (such as health information) based on one of more of the following:

·the processing is necessary for reasons of public interest in the area of public health, such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices.

·the processing is necessary for reasons of substantial public interest in ensuring the safety of medicines.

·the processing is necessary to protect your vital interests or the vital interests of another person.

None.

For the purposes set out above, we may share your personal data with:

·Shionogi group companies in other parts of the world (including Japan, the UK, the US and the Netherlands).

·other pharmaceutical companies if the adverse event, product quality complaint or medical information enquiry relates to one of their products.

·third parties who are Shionogi’s partners or service providers, such as adverse event processing service providers (including call centre providers), IT system and data hosting providers, insurers and professional advisors such as lawyers, accountants and auditors. These third parties are contractually required to protect the confidentiality and security of personal data.

·healthcare professionals involved in any adverse event, product complaint or medical information request.

·regulatory bodies, health authorities (in your home country and worldwide), tax authorities, data protection supervisory authorities, law enforcement bodies, government authorities, courts, tribunals, arbitrators where we are required to do so by applicable law, regulation or their request.

·third parties in relation to our business sale or reorganisation.

·any other person with your consent.

Personal data may be processed, accessed and stored in a country outside the country where you are located, which may not offer the same level of protection to personal data. If we transfer your personal data to any party mentioned above who is located outside the EEA, we will take appropriate measures to protect it and comply with law. Such measures may include entering into standard contractual clauses and a copy if the adequate safeguard put in place can be obtained by exercising your rights as set out below.  

We will only retain your personal information for as long as we reasonably consider necessary for achieving the purposes set out in this privacy notice, including satisfying any legal, regulatory, accounting or reporting requirements.  

You have the right to access your personal data and, in some cases, to require us to restrict, erase or rectify it or to object to our processing it, and the right of data portability. In some cases, exemptions may apply to the rights that you have in relation to your personal data.  For example, the law may prevent us from being able to erase or restrict processing of your personal data if processed for pharmacovigilance purposes.

To exercise your rights, see the “How to contact us” section below. For more detail see our Privacy Policy at https://www.shionogi.com/eu/en/privacy-policy.html.

If you are concerned about how we are handling your personal data, have questions, or want to exercise your privacy rights, please email our Data Protection Lead at dataprotectionlead@shionogi.eu or contact the People Team in the first instance. 

You can also make a complaint to the Information Commissioner’s Office at the relevant Data Protection authority for your country..