Profile Pharma Privacy Policy

Who We Are

 

Profile Pharma Ltd (hereinafter “Profile”) a subsidiary of Zambon SpA (‘we’ or ‘us’ or ‘our’) gather and process your personal information in accordance with this privacy statement and in compliance with the General Data Protection Regulation ((EU) 2016/679) (GDPR) and the UK Data Protection Act 2018, which are the relevant data protection laws. This statement provides you with the necessary information regarding your rights and our obligations, and explains how, why and when we process your personal data.

Profile’s registered office is at Suite 3, Bicentennial Building, Southern Gate, Chichester, West Sussex, PO19 8EZ, United Kingdom and we are a company registered in England and Wales under company number 4005203.We are registered on the Information Commissioner's Office Register; registration number Z174803X, and act as the data controller when processing your data. Our designated Data Protection Officer can be contacted at the following address: at Suite 3, Bicentennial Building, Southern Gate, Chichester, West Sussex, PO19 8EZ, United Kingdom or by e-mail at the address DPO.Profile@Zambongroup.com.

We reserve the right to amend this Privacy Statement from time to time. We encourage you to review this Privacy Statement on our website periodically.


What personal information we collect about you

 

We process your personal information to meet our legal, statutory and contractual obligations and to provide you with our products and services. We will never collect any unnecessary personal data from you and do not process your information in any way other than as specified in this statement.

The personal information we collect when you interact with us via this website includes:

  • your name and contact information
  • email communication sent to us

Such data, provided voluntarily by you, will be used and processed solely for processing the enquiry and to carry out the services you may have requested.

Is other personal data collected and processed?

If you report a possible side effect or adverse event associated with one of our products, or we have been made aware of it by other means (for example by your health care provider or carer) we may request further personal data such as your gender, age, health and medical data, ethnicity and sexuality. We are required by law to collect data on adverse events and side effects. Please refer to our Product Safety Privacy Policy for further information.


How we use your personal information

 

The purposes for which we use your information and the legal basis under data protection laws on which we rely to do this are explained below.

Profile takes your privacy very seriously and will never disclose, share or sell your data without having a lawful basis to do so as described below. 

 

Where you have provided CONSENT  

We may use and process your personal information where you have consented for us to do so for the following purposes:

  • to contact you via email or text with marketing information on events or about our products if you (i) register for an account with us online and indicate that you would like to receive such marketing from us; (ii) sign up to our newsletter or emails via our website or other medium where available; or (iii) when you refresh your marketing preferences when responding to a request from us to do so.

You may withdraw your consent for us to use your information in any of these ways at any time.

 

Where there is a LEGITIMATE INTEREST   

We may use and process your personal information where it is necessary for us to pursue our legitimate interests as a business, or that of a third party, for the following purposes:

  • to respond to your requests;
  • if you complete a registration form or send us an email, order products or services, submit enquiries to us, request medical information or register for various meetings;
  • to contact you for further information about the side effect or adverse event you reported and to monitor the safety of our products (please see our Product Safety Policy for further information);
  • to comply with applicable laws, regulations and guidance;
  • to comply with requests made by regulators, courts and law enforcement authorities;
  • for internal purposes such as auditing, data analysis and research to help us to improve our systems;
  • to verify the accuracy of data that we hold about you and create a better understanding of you as a customer;
  • for network and information security in order for us to take steps to protect your information against loss or damage, theft or unauthorised access;
  • for prevention of fraud and other criminal activities;
  • for the management of queries, complaints, or claims; and
  • for the establishment and defence of our legal rights.

 

Where it is in your VITAL INTEREST

Where we have supplied you with any products, we may use your personal information to contact you if there are any urgent safety or product recall notices to communicate to you or where we otherwise reasonably believe that the processing of your personal information will prevent or reduce any potential harm to you. It is in your vital interests for us to use your personal information in this way. For more information on this please consult our Product Safety Policy.

 

Where there is a LEGAL REQUIREMENT

We will use your personal information to comply with our legal obligations: (i) to assist any public authority or criminal investigation body; (ii) to identify you when you contact us; and (iii) to verify the accuracy of data we hold about you; and (iv) to monitor the safety of our products as further described in our Product Safety Policy.

 

Where it is required to complete a CONTRACT

We may use and process your personal information where we have supplied you (or continue to supply you) with any products or services, where we have arranged for the supply of another company’s products or services to you, or where you are in discussions with us about any new product or service. We will use this information in connection with the contract for the supply of products or services when it is needed to carry out that contract with you or for you to enter into it. Please see “What personal information we collect about you” above for details of the types of personal information we process for these purposes.


Your rights regarding your personal data

 

You have the right to access any personal information that Profile processes about you and to request information about:

  • what personal data we hold about you;
  • the purposes of the processing;
  • the categories of personal data concerned;
  • the recipients to whom the personal data has/will be disclosed;
  • how long we intend to store your personal data for;
  • if we did not collect the data directly from you, information about the source.

If you believe that we hold any incomplete or inaccurate data about you, you have the right to ask us to correct and/or complete the information and we will strive to do so as quickly as possible; unless there is a valid reason for not doing so, at which point you will be notified.

You also have the right to request erasure of your personal data or to restrict processing (where applicable) in accordance with the data protection laws; as well as to object to any direct marketing from us. Where applicable, you have the right to data portability of your information and the right to request the receipt for the transfer to another organization of the personal information that you have provided to Profile. You have the right at any time to withdraw your consent to the processing of your personal information (where Profile is processing your personal information based on your consent) and the right not to be subject to a decision based solely on automated processing.

For legal reasons, we cannot delete information that has been collected as part of an adverse event report unless it is inaccurate.

You will be required to provide proper identification before we comply with any request to access or correct your personal data; this is to ensure that your data is protected and kept secure. We hope that we can satisfy any queries you may have about the way in which we process your personal data.


Sharing and Disclosing Your Personal Information and transfer outside the EU

 

We do not share or disclose any of your personal information without your consent, unless there is a legitimate business purpose and/or where there is a legal requirement to do so.

We may share your personal information with:

  • members of the Zambon group companies
  • regulators, governments and law enforcement authorities
  • selected external service providers

All our data processors acting on our behalf only process your data in accordance with instructions from us, comply with relevant data protection laws and any other appropriate confidentiality and security measures.

We may share or disclose your personal information to a third party in the event of a sale, assignment, transfer, or acquisition of Profile 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.

Processing of data outside the EU/the EEA

Your personal data may in part also be processed in countries outside the European Union or the European Economic Area, which may have a lower data protection level than European countries. In such cases, we will ensure that a sufficient level of protection is provided for your data, e.g. by ensuring agreements are in place implementing standard data protection clauses, or we will ask your explicit consent to such processing.

Links to other websites

This privacy statement does not cover links within this site linking to other websites. Those sites are not governed by this Privacy Statement, and if you have questions about how a site uses your information, you will need to check that site’s privacy statement.


Security

 

Profile takes your privacy seriously and takes every reasonable measure and precaution to protect and secure your personal data. We work hard to protect you and your personal information  from unauthorized access, alteration, disclosure or destruction and have several layers of security measures in place, including access controls, stringent physical security, robust information collection, storage and processing practices, and written agreements with applicable third parties to keep your information confidential.


How long we keep your data

 

We store your personal data for as long as it is legally required or necessary for the provision of the service requested by you, or as long as it has been agreed upon in a declaration of consent.

Where you have consented to us using your details for direct marketing, we will keep such data until you notify us otherwise and/or withdraw your consent.


Amendments to this Privacy Statement

 

We may update this Privacy Statement from time to time. Updates of this will be published on our website. Any amendments become effective upon publication on our website. We therefore recommend that you regularly visit the site to keep yourself informed on possible updates.


Lodging a Complaint

 

Profile only processes your personal information in compliance with this privacy statement and in accordance with the relevant data protection laws. If you have any concerns about how we process your personal data, you can get in touch with us by e-mailing at info.profilepharma@zambongroup.com. If, however you wish to raise a complaint regarding the processing of your personal data or are unsatisfied with how we have handled your information, you have the right to lodge a complaint with The Information Commissioners Office.

The ICO website is ico.org.uk and the helpline number is:  0303 123 1113.


Cookies

 

We use cookies on our website. The function of the cookies is to streamline web traffic analysis or indicate when a specific website or part of it is visited, and to distinguish between visitors in order to provide personalized content. Through cookies we cannot access other information stored on your device, even if the cookies are downloaded there. Cookies cannot upload codes of any type, carry viruses or malware, and they do not harm the user’s terminal. If you do not want to take advantage of our cookies, you can find out in the help function of your browser how to set your browser to prevent it from accepting new cookies or delete existing ones. There you will also find how to block your browser for all new cookies or which settings you should select to receive notifications of new cookies.

The data we collect using cookies is browsing data, such as:

  • IP address of the requesting computer
  • name and URL of the retrieved file
  • date and time of access
  • transferred data volume and methods
  • access status in numeric codes (successful, error, etc)
  • other parameters related to the user’s operating system and computer environment

Such data will be solely used for collecting anonymous statistical information on the use of the site, system security and monitoring its correct functioning. This data will be deleted immediately after processing, and/or shall expire within seven days, whichever comes first.


Contact Information

 

If, at any time, you have questions or concerns about this Privacy Statement, please e-mail our Data Protection Officer at DPO.Profile@Zambongroup.com.


Profile Pharma Product Safety Privacy Policy

 

Profile and your privacy

Ensuring patient safety is extremely important to Profile Pharma and we take the use of all our products seriously. Profile needs to be able to get in touch with people who contact us about our products in order to follow-up and obtain further information, give answers to medical requests or to send requested material.  When safety information is reported to us by consumers we also have legal obligations to medically confirm the reports and request further information from patients’ treating healthcare professionals. This Product Safety Privacy Policy describes how we collect and use personal data to help us fulfil our duty to monitor the safety of all medicines and/or medical devices we market in the United Kingdom.

Definitions used in this Product Safety Privacy Policy:

Product Safety Information*:

means any information about the safety, quality or performance of a Zambon/Profile product received from any source, including potential adverse event notifications, reports on certain circumstances that may increase a patient’s risk of developing an adverse event, as well as other reportable information, including medical device complaints, product complaints and unexpected therapeutic effects.

“Adverse event” (AE) means any untoward medical occurrence in a subject or in a patient administered a medicinal product.  The event need not necessarily have a causal relationship with the product treatment or usage. 

Adverse events include, but are not limited to:

  • Abnormal test findings
  • Clinical symptoms and signs and/or new diagnoses
  • Changes in physical examination findings
  • Progression/worsening of underlying disease
  • Allergic reactions
  • Lack of efficacy
  • Drug abuse
  • Drug dependency
  • Hospitalisation
  • Death
  • Any suspected transmission of an infectious agent via a Zambon product
  • Drug misuse (symptomatic or not)
  • Drug overdose (symptomatic or not)
  • Drug withdrawal symptoms
  • Exposure during pregnancy (symptomatic or not)
  • Transmission of drug via semen (paternal exposure, symptomatic or not)
  • Exposure during breastfeeding (symptomatic or not)
  • Extravasation (occurs when a drug given intravenously leaks from a vein into the surrounding tissue; symptomatic or not)
  • Interactions with other drugs, food, drink, vitamins or herbal remedies
  • Medication errors including near misses (symptomatic or not)
  • Occupational exposure (symptomatic or not)
  • Off label use (symptomatic or not)

We also collect data on use of products in children and elderly, and in those with hepatic and renal impairment.

“Product Complaint” means any expression of dissatisfaction relative to the physical properties, condition, package insert, and/or packaging of a product.  We also collect data on suspected or confirmed falsified Zambon medicinal products.

“Medical Device Complaint” means any communication of dissatisfaction relative to the appearance, identity, quality, durability, reliability, safety, effectiveness, instruction for use, or performance of a medical device or a product with a medical device component, including software products that are regulated as medical devices (e.g. mobile applications, website functionality etc.)

“Unexpected Therapeutic Effect” means a beneficial therapeutic effect of a product aside from the use for which it had been given.

Adverse Drug Reaction” (ADR) means a response to a medicinal product that is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility

* To facilitate the reading of this policy, all product safety information listed above is referred to throughout this policy as an ‘adverse event’.

“Personal Data” means any information relating to an identified or identifiable natural person; an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to a physical, physiological, genetic, economic, cultural or social identity of that natural person.

“Pharmacovigilance” means activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug or medical device-related problem. 

“Profile” means Profile Pharma Ltd (a subsidiary of Zambon SpA) having its principal office at Bicentennial Building, Southern Gate, Chichester, West Sussex, PO19 8EZ, United Kingdom, also referred to in this Privacy Policy as “we”, “us” and “our”.

 

Scope of this Privacy Policy

This Privacy Policy applies to information we collect from or about you online, by phone, fax, e-mail or post, or as part of the safety information reporting regulations applicable to Profile.

If you are a patient we may also be provided with information about you by a third party reporting an adverse event that affected you. Such third parties may include regulatory authorities, medical professionals, lawyers, relatives or other members of the public.

 

Information we collect and why we collect it

 

In accordance with Medicines Act 1968 as amended by The Human Medicines Regulations 2012 in the United Kingdom (UK) and Regulation (EC) No 726/2004, as amended in 2010 with Regulation (EU) No 1235/2010 in the European Economic Area (EEA), Profile is under legal obligations to collect specific data. This may include the following details:

 

Patients (subject of report)

We collect personal data about you when you or a third party provides us with information in relation to an adverse event that affected you or someone else. Where you are reporting the adverse event yourself, please also refer to the Reporters section.

Pharmacovigilance laws require us to take “detailed records” of every adverse event passed to us to allow the event to be evaluated and collated with other adverse events recorded about that product. The personal data that we may collect about you when you are the subject of an adverse event report includes:

  • name or initials;
  • age and date of birth;
  • gender;
  • weight and height;
  • details of the product causing the event.

We will also collect some “special category personal data” including:

  • details of other medicines or remedies you are taking or were taking at the time of the event,
  • details of the adverse event  you suffered, the treatment you received for that event, and any long-term effects the event has caused to your health;
  • other medical history considered relevant by the reporter, including documents such as lab reports, medication histories and patient histories; and
  • in some cases  data such as ethnicity, religion and sexual life.

This information is only processed where:

  • we reasonably believe that the processing of your personal information will prevent or reduce any potential harm to you and it is in your vital interests for us to use your personal information in this way; and/or
  • it is relevant and necessary to document your adverse event properly and for the purpose of meeting our pharmacovigilance and/or legal requirements. These requirements exist to allow us and competent pharmacovigilance authorities (such as the European Medicines Agency and other authorities) to manage adverse events and make efforts to prevent similar events from happening in the future.

 

Reporters of an adverse event

We will collect information about you when you provide us with information in relation to an adverse event you report.

Pharmacovigilance laws require us to ensure that adverse events are traceable and available for follow-up. As a result, we must keep sufficient information about reporters to allow us to contact you once we have received the report. The personal data that we may collect about you when you report an adverse event includes your:

  • name;
  • contact details (which may include your address, e-mail address, phone number or fax number);
  • profession (this information may determine the questions you are asked about an adverse event, depending on your assumed level of medical knowledge); 
  • relationship with the subject of the report (e.g. family member/carer/friend/lawyer/doctor).
  • where you are also the subject of a report, this information may be combined with the information requested/provided under patient section above.

 

If you are a patient reporting an adverse event, we will request written consent from you to contact your treating healthcare professional to confirm the adverse event and provide any relevant information related to the event you experienced as necessary.

 

How we use and share Personal Data

As part of meeting our pharmacovigilance obligations, we may use and share Personal Data to:

  • investigate the adverse event;
  • contact you for further information about the adverse event you reported;
  • collate the information about the adverse event with information about other adverse events received by Profile to analyze the safety of a batch, Profile product or active ingredient as a whole; and
  • provide mandatory reports to competent authorities, such as the European Medicines Agency (Eudravigilance database), so that they can evaluate the information as a whole alongside reports from other sources. We are unable to control their use of any information we share.

Personal Data collected from you in accordance with this Product Safety Privacy Policy may also be transferred to a third party in the event of a sale, assignment, transfer, or acquisition of Profile 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 also share Personal Data with other pharmaceutical companies who are our co-marketing, co-distribution, or other license partners, where pharmacovigilance obligations for a product require such exchange of safety information or with other pharmacovigilance service providers in relation to processing the data in the global safety database.

 

Global Safety Database

Our pharmacovigilance obligations require us to review patterns across reports received from every country where we market our products. To meet these requirements, information provided as part of an adverse event report is shared within Profile’s parent company, Zambon, on a worldwide basis through Zambon’s Global Safety Database. This database is also the platform through which Zambon uploads adverse event reports to various oversight authorities, including the Eudravigilance database (European Medicines Agency) and other similar databases as required by law.

 

Your rights regarding your personal data

You may be entitled to:

  • ask Profile for a copy of the information we hold about you;
  • request the correction and/or deletion of your personal information;
  • request the restriction of the processing of your personal information, or object to that processing;
  • withdraw your consent to the processing of your personal information (where Profile is processing your personal information based on your consent);
  • request the transfer to another organization of the personal information that you have provided to Profile

These rights may be limited in some situations – for example, where we can demonstrate we have a legal requirement to process your personal data.

For legal reasons, we cannot delete information that has been collected as part of an adverse event report unless it is inaccurate.

You may be required to provide proper identification before we comply with any request to access or correct Personal Data. We hope that we can satisfy any queries you may have about the way in which we process your personal data.

 

Security

Profile takes your privacy seriously and takes every reasonable measure and precaution to protect and secure your personal data. We work hard to protect you and your personal information  from unauthorised access, alteration, disclosure or destruction and have several layers of security measures in place, including access controls, stringent physical security, robust information collection, storage and processing practices, and written agreements with applicable third parties to keep your information confidential.

 

International transfers

Patient information may also be transferred worldwide as part of our Global Safety Database. Personal data in the European Union is protected by the General Data Protection Regulation but some other countries may not necessarily have the same high standard of protection for your personal data.  Profile also engages a data processing company in India for data entry of a limited part of the pharmacovigilance database.

Profile ensures agreements are in place with such parties that ensure the third party also has adequate security measures in place.

 

How long we keep your data

Profile only retains personal information for as long as is necessary and we have strict review and retention policies in place to meet these obligations.

Any adverse event related documentation must be retained as long as the marketing authorization exists for that medicinal product and for at least 10 years after the marketing authorization has ceased to exist.

 

Amendments to this Privacy Policy

We may update this Product Safety Privacy Policy from time to time. Updates of this will be published on our website. Any amendments become effective upon publication on our website. We therefore recommend that you regularly visit the site to keep yourself informed on possible updates.

 

Lodging a complaint

Profile only processes your personal information in compliance with this Product Safety Privacy Policy in relation to product safety and adverse events and its Privacy Statement for all other circumstances and all in accordance with the relevant data protection laws. If you have any concerns about how we process your personal data in relation to product safety and adverse events, you can get in touch with Profile’s Pharmacovigilance team at profile.drugsafety@zambongroup.com. If, however, you wish to raise a complaint regarding the processing of your personal data or are unsatisfied with how we have handled your information, you have the right to lodge a complaint with The Information Commissioners Office.

The ICO website is ico.org.uk and the helpline number is:  0303 123 1113.

 

Contact Information

If at any time you have questions or concerns about this Product Safety Privacy Policy, please e-mail our Data Protection Officer at DPO.Profile@Zambongroup.com.