Biomedica privacy policy

Effective August 21, 2023

This Privacy Policy describes the information that we collect about you on the website from which you linked (“Site”); how we use that information; how we protect it; and the choices you may make with respect to it.

This Privacy Policy does not apply to any other information collected by Biomedica or by or through any other means, such as information collected offline. When we refer to ourselves as “we" or "Biomedica," we mean Biomedica GMBH and all its subsidiary companies. Our Site may contain links to third party websites/content/services that are not owned or controlled by Biomedica.

Biomedica is not responsible for how these properties operate or treat your personal data, so we recommend that you read the privacy policies and terms associated with these third parties’ properties carefully.

THE DATA WE COLLECT ABOUT YOU

Personal data means any data about an individual from which that person can be identified. It does not include data where the identifiers have been removed (anonymous data). We may collect, use, store and transfer different kinds of personal data about you which we have grouped together as follows:

• Contact data including billing address, delivery address, email address and telephone numbers.
• Technical data including internet protocol (IP) address, your login data, browser type and version, time zone setting and location, browser plug-in types and versions, operating system and platform and other technology on the devices you use to access this website.
• Usage data including information about how you use our website, products, and services; and
• Marketing and communications data including your preferences in receiving marketing from us and our third parties and your communication preferences.

We also collect, use and share aggregated data, such as statistical or demographic data, for any purpose. aggregated data may be derived from your personal data but is not considered personal data in law as this data does not directly or indirectly reveal your identity. For example, we may aggregate your usage data to calculate the percentage of users accessing a specific website feature. However, if we combine or connect aggregated data with your personal data so that it can directly or indirectly identify you, we treat the combined data as personal data, which will be used in accordance with this Privacy Policy.

HOW WE OBTAIN PERSONAL DATA

In most cases, Biomedica will collect data directly from you.

When you are asked to provide personal data, you may decline. But if you choose not to provide data that is necessary for us to provide the requested services, we may not be able to provide you those services.

PURPOSES OF PROCESSING PERSONAL DATA

Biomedica will process your personal data only for purposes permitted by applicable laws, which may vary depending on where you live, and where Biomedica operates, and on the terms set forth in this Privacy Policy. The purposes of the data processing activities may include:

• Market access and specialty distribution services of unlicensed and licensed products.
• Management of any adverse events for pharmacovigilance purposes and any complaints for quality assurance purposes.
• Marketing purposes (including contact of HCPs for disease awareness activities and for in-depth studies on pathology issues);
• Medical information activities;

Biomedica will process personal data for further purposes, where lawful to do so (such as for archiving or scientific purposes) or when legally obliged to do so.

LEGAL BASIS OF PROCESSING

Biomedica personal data based on one or more of the following conditions:

• The individual has provided consent (in which cases, such consent can be withdrawn at any time and without giving any reason);
• It is necessary to comply with contractual obligations with the individual.
• The processing is necessary for our compliance with a legal obligation.
• The processing is necessary to protect the vital interests of an individual.
• The processing is necessary in the public interest or for a public task; or

For instance, where the processing of data is referred to the provision of market access and specialty distribution services, the performance of a contract constitutes the legal basis for the processing in accordance with Article 6, paragraph 1, letter b) of the GDPR.

Where the processing of data is referred to marketing purposes, consent constitutes the legal basis for the processing in accordance with Article 6, paragraph 1, letter a) of the GDPR.

Respectively, the legal basis of the processing of data for pharmacovigilance purposes is the fulfilment of legal obligations provided by law and by the regulations applicable to pharmacovigilance pursuant to Article 6, paragraph 1, letter c) of the GDPR.

SPECIAL CATEGORIES OF DATA

In addition to the above, where Biomedica processes special categories of data about individuals (information about individuals’ health, ethnicity, religion, trade union membership, genetic and biometric data etc.) – it shall only do so in accordance with applicable laws and regulations. For such processing Biomedica relies on the following conditions:

• Where individuals provide explicit consent;
• Where required for rights and obligations related to employment;
• Where required for vital interests of any individual;
• Where processing is necessary for the purposes of provision of healthcare or occupational medicine, pursuant to a contract with a health care professional and;
• Where processing is necessary for scientific research.

MARKETING

We strive to provide you with choices regarding certain personal data uses, particularly around marketing and advertising. We will not send you unsolicited marketing information without your consent, and we will get your consent before we share your personal data with any company outside the Biomedica of companies for marketing purposes.

Generally, we do not rely on consent as a legal basis for processing your personal data other than in relation to sending direct marketing communications to you via letter, email or text message, or where we are processing your sensitive personal data.

You can ask us or third parties to stop sending you marketing messages at any time by contacting us or directly those third parties.

Where you opt out of receiving these marketing messages, this will not apply to personal data provided to us that we are required to retain as a result of any product/service purchase or other transactions.

THIRD-PARTY LINKS

This website may include links to third-party websites, plug-ins and applications. Clicking on those links or enabling those connections may allow third parties to collect or share data about you. We do not control these third-party websites and are not responsible for their privacy statements. When you leave our website, we encourage you to read the privacy policy of every website you visit.

COOKIES

You can set your browser to refuse all or some browser cookies, or to alert you when websites set or access cookies. If you disable or refuse cookies, please note that some parts of this website may become inaccessible or not function properly. For more information about the cookies we use, please see our Cookie Policy

PLACE OF DATA PROCESSING AND WAYS OF TRANSMISSION

Biomedica is headquartered in Federal Republic of Germany, but also operates across other countries. Personal data about you may be accessible to Biomedica affiliates as well as to some Biomedica’s affiliates inside and outside European Union (“EU”)/European Economic Area (“EEA”), and selected vendors and partners, established in the EU/EEA or globally.

Your personal data may be accessed by staff or suppliers in, transferred to and stored at, a location outside the EU or the EEA. Where Biomedica processes personal information in countries that may not provide the same level of data protection as in the EU/EEA or in your own country, where you are resident, Biomedica will implement reasonable and appropriate legal and technical and organizational security measures with the aim to ensure the security of the processing and in particular to protect your personal data from unauthorized access, use or disclosure.

Such measures include, but not limited to, maintaining binding contractual arrangements with all third parties processing personal data of individuals, for and on behalf of Biomedica, executing, where necessary, adequate data transfer mechanisms, in the form of EU Standard Contractual Clauses (SCCs). These SCCs are used for any cross-border data transfers from the EU to controller or processors established in third countries, as adopted and approved by the European Commission, or by the competent supervisory authorities, in the absence of an adequacy decision and/or any other data protection related certifications in place, with the aim to achieve an adequate level of data protection of the personal information of those individuals.

For residents of EEA – whenever we transfer your information outside of the EEA, we will take all reasonable steps to ensure that adequate safeguards are put in place to protect your information (unless we are permitted under applicable data protection law to make such transfers without additional formalities e.g. where the recipient country is considered an adequate destination). Such safeguards include the use of European Commission approved standard contractual clauses as mentioned above. Where appropriate we may also ask for your explicit consent.

CONTRACTUAL ARRANGEMENTS AND INTERNATIONAL DATA TRANSFERS

As a data controller, Biomedica aims to establish a high level of data protection and privacy for its data subjects and partners alike. To that end, Biomedica has developed and uses specific privacy and security related language in its contractual arrangements with third party service providers acting for the benefit of Biomedica as data processors in compliance with applicable data protection legislation.

Through its privacy-compliant contractual arrangements, Biomedica sets out the scope, subject-matter, duration, and purpose of the data processing activities carried out by its data processors and their sub-processors (if any) as well as the types of personal data processed and the involved categories of data subjects. Moreover, details are provided with regard to the service provider’s obligations in its role as data processor which include indicatively its confidentiality obligations, the procedure to be followed in case of a data breach incident, cooperation regarding inquiries from data subjects and authorities, assistance for the performance of data protection impact assessments, international data transfer mechanisms to be executed in the case of cross border data transfers, specific rules for the due diligence and engagement of sub-processors, implementation of appropriate security measures and personal data breach indemnification commitments.

Our service providers are required to be transparent and inform us in advance about their affiliates and any external collaborators (acting as sub processors) that might be involved in processing activities. In case that a service provider and/or any of its collaborators, are located outside the EU and/or the EEA, we request that they also execute appropriate data transfer mechanisms with such third parties to cover any onward transfers; in particular the EU Standard Contractual Clauses (SCCs) as approved by the European Commission, in the absence of an adequacy decision and/or any other data protection related certifications. This approach establishes and maintains a high level of data protection and privacy for the individuals we interact with in the EU and beyond.

DISCLOSURES OF YOUR PERSONAL DATA

We may have to share your personal data with the parties set out below for the purposes set out in the table in paragraph 4 above:

• other companies in the Biomedica that may be based inside and outside of the Federal Republic of Germany and that may carry out centralized administrative and reporting activities as processors and joint controllers;
• External third parties such as:
• Service providers acting as processors based inside or outside the EEA who provide outsourced services such as IT and system administration services;
• Professional advisers acting as processors or joint controllers including lawyers, bankers, auditors, and insurers based inside or outside the EEA who provide consultancy, banking, legal, insurance and accounting services; or
• Revenue & Customs authorities, regulators and other authorities acting as processors or joint controllers based inside or outside the EEA who require reporting of processing activities in certain circumstances; or
• Regulatory authorities.
• Third parties to whom we may choose to sell, transfer, or merge parts of our business or our assets. Alternatively, we may seek to acquire other businesses or merge with them. If a change happens to our business, then the new owners may use your personal data in the same way as set out in this Privacy Policy.

We require all third parties to respect the security of your personal data and to treat it in accordance with the law. We do not allow our third-party service providers to use your personal data for their own purposes and only permit them to process your personal data for specified purposes and in accordance with our instructions.

SECURITY OF PERSONAL DATA

We will take all steps reasonably necessary to ensure that your data is treated securely and in accordance with this Privacy Policy, applicable data protection laws and regulations as well as international security standards. All data you provide to us is stored on secure servers and accessed and used subject to our security policies and standards. Biomedica has implemented reasonable physical, technical and managerial controls and safeguards to keep your personal data protected from unauthorized access, disclosure, alteration, and destruction. Such measures may include, but are not limited to: firewalls, access controls, encryption of information while it is in storage, separation of duties, and similar security protocols. Access to your personal data is limited to a restricted number of Biomedica employees whose duties reasonably require such information and third parties with whom Biomedica contracts to carry out business activities on its behalf. Our employees have been trained on the importance of privacy and how to handle and manage personal information appropriately and securely.

We have put in place procedures to deal with any suspected personal data breach and will notify you and any applicable regulator of a breach where we are legally required to do so.

HOW LONG WE WILL USE YOUR PERSONAL DATA

We will retain your personal data for the time strictly necessary to achieve the purposes for which the data were collected and any other permitted associated purpose. Data may be retained for a longer duration where applicable laws or regulations require or allow Biomedica to do so. When your data is no longer needed it will be either irreversibly anonymized (and the anonymized information may be retained) or securely destroyed.

To determine the appropriate retention period for personal data, we consider the amount, nature, and sensitivity of the personal data, the potential risk of harm from unauthorized use or disclosure of your personal data, the purposes for which we process your personal data and whether we can achieve those purposes through other means, and the applicable legal requirements.

In some circumstances we may anonymize 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.

AUTOMATED DECISION MAKING

Biomedica does not undertake through its website or in general decisions based solely on automated processing, including profiling, of an individual unless we inform you otherwise.

YOUR DATA PROTECTION RIGHTS

Under applicable laws and subject to any legal restrictions, you may have the right to request us to:

• Provide you with further details on the processing of your personal information;
• Provide you access to your personal data that we hold about you;
• Update any inaccuracies in the personal information we hold that is demonstrated to be inaccurate or incomplete;
• Delete any personal information that we no longer have a lawful basis to use;
• Provide you or a third party, with a copy of your data in a digital format (data portability);
• Stop a particular processing when you withdraw your consent;
• Object to any processing based on the legitimate interests or public interest to process information, unless our reasons for undertaking that processing outweigh any prejudice to your data protection rights; and
• Restrict certain aspects of the processing of your information.

You are also entitled to lodge a complaint with the supervisory authority for the protection of personal data of your country of residence or place of work, if you consider that your statutory rights have not been respected or that you have not received a response to your requests according to the specifications of law.

POLICY UPDATING

Biomedica reserves the right to amend this Privacy Policy from time to time to reflect technological advancements, legal and regulatory changes, and Biomedica’s business practices, subject to applicable laws. If Biomedica changes its privacy practices, an updated version of this Privacy Policy will reflect those changes by posting any revisions on with the respective update of the effective date listed on the bottom of this Privacy Policy. We therefore encourage you to periodically visit this page to stay informed of how we are using your personal data.

CONTACT INFORMATION

If you have any questions in relation to this Privacy Policy, or you want to obtain more information about Biomedica’s privacy practices, please contact our Privacy Office by email at dp@biomedicagmbh.com

Last updated on August 21, 2023