Pharmacovigilance Privacy Policy

Purpose:

Your privacy is important to us, and we are committed to keeping your Personal Information securely and lawfully, in accordance with this Privacy Policy, our internal procedures, applicable privacy laws, and considering global standards and leading practices.

Innomar has implemented relevant internal procedures and policies and appointed a Privacy Officer to assist in any inquiries related to your Personal Information.

If you have any questions about this Privacy Policy or how we handle Personal Information and Personal Health Information, our designated Privacy Officer can be contacted at:

3470 Superior Court,Oakville, Ontario, Canada L6L 0C4
Tel: 905-847-4364
Toll free: 1-888-420-5457
Email: privacy.officer@innomar-strategies.com

Scope:

Innomar Strategies Inc. (“Innomar”, “we”, “our”, “us”) is part of a global network that provides innovative services to drug manufacturers for patient support programs (referred to as “Clients”).

We help our Clients by acting on their behalf to provide medical information for their products in response to inquiries from patients, pharmacies, and physicians and pharmacovigilance services including the collection of adverse reaction information, monitoring/responding to product quality complaints, and collecting safety data for regulatory reporting. The activities performed on behalf of our Clients are hereinafter collectively referred to as “Services”.

You may interact with us when we are representing our Clients for the Services described. During these interactions, we may collect and handle your Personal Information (including Personal Health Information) to help carry out our contractual obligations and comply with statutory or regulatory commitments required to execute our Services, as set out in this Privacy Policy.

This Privacy Policy describes how we collect and handle your Personal Information on behalf of our Clients. The phase “handle your Personal Information” means any personal information processing, whether or not by automated means. Such processing may include collection, storage, disclosure, destruction, and any other use.

You can find Innomar’s Privacy Policy covering other Innomar’s services using the link. www.innomar-strategies.com/privacy-policy.

What is Personal Information and Personal Health Information?

“Personal Information” is any information relating to an identifiable individual, whether alone or in combination with other information you choose to provide when interacting with us. This may include, but is not limited to, contact information, name, address, phone number or email address, gender, and date of birth.

Personal Information may also include Personal Health Information. However, Personal Health Information is considered a special category of Personal Information and we take suitable and specific measures to further safeguard this category of information and protect the fundamental rights and interests of individuals that may be potentially impacted.

“Personal Health Information” may include, for example, information relating to your physical or mental health, as well as your health history, symptom, medical records, and your prescriptions.

“Personal Information” and “Personal Health Information” hereinafter is collectively referred to as “Personal Information”.

Why do we collect Personal Information?

We may collect, handle, and disclose your Personal Information:

To respond to your inquiries when you request medical information for our Client’s products;
To comply with contractual and regulatory monitoring and reporting obligations when you report an adverse event, product quality complaint, or safety data for a product which we represent for our Clients.

We will obtain your consent before collecting, handling, or disclosing your Personal Information for new purposes unrelated to the ones described here. You will always be given the opportunity to withdraw consent for the collection and use of your Personal Information at any time.

What Personal Information do we collect?

We limit the collection of Personal Information to what is minimally required to fulfill the purposes for which it was collected.

We may collect and handle the following Personal Information to perform our Services:

When you contact us to request medical information the Personal Information collected may include your name, email address, home address, and phone number. We may also collect certain types of Personal Health Information including height, weight, health conditions, symptoms, prescription, and medical history to ensure the information we provide is right for you.
When you contact us to report an adverse drug reaction, complaint, or safety data the Personal Information collected may include your name, date of birth, home address, and phone number. We may also collect certain types of Personal Health Information including height, weight, age, health conditions, symptoms, prescription, medical history, name and contact information of prescribing or referring physician to ensure we meet our regulatory and contractual obligations.

You may choose to withhold providing certain Personal Information when you contact us, which in some instances may limit the support we can provide you.

When you use our website, other information may also be collected.

Aggregated and de-identified information may be collected to help us report data, understand trends, and meet our regulatory obligations. See What is aggregated and de-identified data and how is "it used?" for more information.

How do we collect your Personal Information?

We may collect your Personal Information through the following channels:

Directly from you or a Substitute Decision Maker* acting on your behalf.
You may provide Personal Information when inquiring about medical information or when reporting an adverse event, complaint, or safety data.
From our Clients that have retained Innomar to provide services on their behalf.
Our Clients may share Personal Information that you provided to them directly to us in order to complete our Services.
From healthcare providers that work with you or us.
We may combine the information you provide with other information we have collected from allied healthcare providers to assist in completing our Services.

If you contact us through our help-seeking information lines, we may record such telephone conversations if directed by our Clients to complete our Services. You may limit or restrict Personal Information provided during these calls at any time.

*”Substitute Decision Maker” is a parent, guardian, or other individual that represents and acts on your behalf.

How do we handle Personal Information of children and individuals with Substitute Decision Makers?

We care about your privacy and the privacy of children and individuals with Substitute Decision Makers. Through the consent and representation of a Substitute Decision Maker we may collect information for children under a specified age, or for individuals without sufficient capacity to consent or refuse medical treatment.

We do not knowingly collect or solicit Personal Information from these individuals, nor do we knowingly allow them to request or provide medical information through our websites or help-seeking information lines.

Children and individuals with Substitute Decision Makers should work with their Substitute Decision Maker to report or request information on their behalf. By representing them, you are consenting, on behalf of the individual, to the collection, handling, and disclosure of Personal Information as described in this Privacy Policy.

If an individual has submitted Personal Information and you, as a Substitute Decision Maker, wish to request that such Personal Information be deidentified, please contact our designated Privacy Officer.

Why do we share your Personal Information with others?

When you interact with us there may be cases where your Personal Information must be shared with the Clients we represent or regulatory authorities that we report to in order to perform the Services identified in this Privacy Policy. The types of Personal Information we share is proportional to the determined purposes. For example, your Personal Health Information would not be shared for advertising and marketing purposes.

We may share your data in the following situations:

With your consent - If consent is required, you may adjust or withdraw your consent to the use and disclosure of your Personal Information by contacting the designated Privacy Officer, subject to legal or contractual restrictions and reasonable notice.
To meet our regulatory requirements, we may be required to disclose Personal Health Information to regulatory authorities or the Clients that we represent. We may also be required to disclose your Personal Information to data protection authorities under their request or under the established procedure of data breach reporting. The data shared may be de-identified, where applicable.
To fulfill our contractual obligations in providing Services on behalf of our Clients, we may be required to share data with regulatory authorities and Clients worldwide to support their product authorizations. The data shared will be de-identified.
To improve our Services and the way you interact with us. To learn more about how we interact with suppliers and service providers, see www.innomar-strategies.com/privacy-policy

Data that you provide may be aggregated and de-identified which we may use for reporting purposes to, understand trends, and meet our regulatory obligations.

What is aggregated and de-identified data and how is it used?

“Aggregated data” is data combined from multiple sources to the point that it cannot be reasonably attributed to an individual.

“De-identified information” is any data that has been collected in which all personal identifiers have been removed, such that the information could not reasonably be used to identify an individual when the appropriate safeguards are in place.

Aggregated and de-identified information that cannot be reasonably re-identified is not considered Personal Information. We may use this information to help us report data, understand trends, and meet our regulatory obligations.

Do we utilize cookies or other technologies to handle your Personal Information?

When you visit Innomar's website or other online services and applications, we may use cookies and other session related data. To learn more about our cookies policy, see www.innomar-strategies.com/privacy-policy

How do we store and protect your Personal Information?

We are committed to securing your Personal Information. We use commercially reasonable physical, organizational, and technical safeguards to protect your Personal Information. To learn more about our safeguards, see www.innomar-strategies.com/privacy-policy

We will retain your Personal information for only as long as it is needed or permitted for the Services for which it was obtained. Some of the data you provide us, is required to be retained according to pharmacovigilance regulations. All other data will be disposed of according to our Record Retention Policy.

The criteria used to determine our retention periods include:

The length of time we will have an ongoing relationship with our Clients or you;
Whether there is a legal obligation to which we are subjected to; and
Whether retention is advisable in light of our legal position (such as in regard to applicable statutes of limitations, litigation, or regulatory investigations).

If your Personal Information is compromised, we will notify you as required by law and will provide you with information on steps that can be taken by you to mitigate any potential harm.

Do we transfer your Personal Information to other countries?

Our Services are performed by pharmacovigilance personnel located in Canada. After collection, your Personal Information is stored in compliance with Canadian regulations which may be different than the jurisdiction which you are situated in.

As we provide Services on behalf of our Clients, we may be required to transfer your Personal Information from Canada to meet regulatory or contractual obligations. Hence, your Personal Information may become subject to the laws of the receiving jurisdiction, where level of protection may differ.

Whenever we transfer your Personal Information outside of Canada we will make sure that appropriate safeguards are in place including de-identification before transfer unless otherwise stipulated under Client requirements to meet reporting regulations.

When we work with suppliers or service providers there may be additional situations where your information is transferred.

What are your rights when we handle your Personal Information?

We respect your choices and right to access, correct, and request to delete your Personal Information.

You have control over your Personal Information, and you have the right to withdraw your consent to the use and disclosure of your Personal Information anytime, subject to legal or contractual restrictions and reasonable notice.

Except in the limited circumstances established by law, you have the right to obtain access to your Personal Information, inquire about where it is stored, or ask for it to be corrected or deleted by making a written request to our designated Privacy Officer. There may be cases when your request to delete Personal Information may not be satisfied, for example when we are obliged to keep a record by law.

Is there any additional information you should be aware of if you are a person residing in Quebec?

Innomar has appointed a Privacy Officer to oversee the handling of Personal Information and implemented relevant internal procedures and policies to meet legislative requirements.

If your Personal Information is compromised, we will notify you and regulatory authorities as required by law and will provide you with information on steps that can be taken by you to mitigate any potential harm.

If you have additional questions or complaints regarding the handling of your Personal Information, you may contact Innomar's Privacy Officer.

Is there any additional information you should be aware of if you are a person residing in the United States of America?

Innomar does not sell your Personal Information to any organization or person.
If you are looking to make sure your Personal Information will not be sold in the future, you have the right to object by contacting our Privacy Officer in the most convenient way.

How to request more information regarding the handling of Personal Information?
We take your privacy seriously and takes all the possible measures to further safeguard your Personal Information. If you have privacy concerns or experience any situation that does not correspond to this Policy, contact our designated Privacy Officer.