Privacy Policy

Content

1. BIAL

BIAL's mission is to discover, develop and provide therapeutic solutions within the area of health.

The privacy, protection and safety of the personal data we have access to are part of our daily activity priorities. BIAL and its affiliates undertake to process personal data only for the purposes for which it was collected, in a transparent, safe, responsible and ethical manner.

This privacy policy applies to all the personal data collected through the website, owned by BIAL - PORTELA & CA, S.A., a company with headquarters at Avenida da Siderurgia Nacional, 4745-455 Coronado (São Romão and São Mamede), municipality of Trofa, district of Porto, Portugal, legal entity number 500220913 and headquarters of the BIAL Group.

When visiting the website, only, it does not require the collection, in an automatic manner, of any personal data that identifies the user, unless the user voluntarily provides information through the available forms for each purpose.

It is only following a direct contact by the users through the website that BIAL processes the personal data, within the scope of its activity, as better described in the present Policy, so that data subjects can better understand the purpose of their data and the operations performed using it. The user can choose to contact BIAL through other available means indicated herein, and the same conditions and safety measures are applicable as long as the same purposes are concerned.

2. Processing of Personal Data

2.1. Conditions for lawfulness

In order to process the user’s personal data under the provisions of Regulation (EU) 2016/679 (General Data Protection Regulation or “GDPR”) and additional legislation on data protection in force in the countries of operation, BIAL will act under the condition for lawfulness according to article 6 (Conditions for lawfulness) or 9 (Processing of special categories of personal data) of the GDPR.

Throughout this document, the following conditions for lawfulness are mentioned, depending on the purpose and context of the data processing:

• Consent: whenever the data subject previously consented, by means of an affirmative action, to the processing of its personal data;
• Pre-contractual measures or performance of the contract: whenever the processing of data is necessary in the context of a service provision or product acquisition;
• Legitimate interest: whenever BIAL processes personal data by virtue of a legitimate interest, which, in a balancing test, is not surpassed by the rights and interests of the data subjects;
• Legal obligation: whenever the processing of personal data is necessary to comply with a legal obligation to which BIAL is subject;
• Important public interest or public interest regarding public health: whenever the processing of special categories of personal data (such as health data) is concerned, necessary to ensure a high level of quality and safety of healthcare and medication or medical devices, anticipating appropriate and specific measures that safeguard the rights and freedoms of the data subject.

2.2. Purposes

BIAL processes personal data, i.e. it collects, registers, organizes, structures, stores, consults, uses, discloses by forwarding, broadcasting or any other form of availability, among others, information that can be associated to an individual (the “data subject”) and it is responsible for said processing, determining the data operations, whenever there are appropriate conditions for lawfulness.

The website is an informative website that aims to communicate to our visitors who we are, what is our mission, what are our commitments, where we are, as well as our activities and the career opportunities at the BIAL Group.

Personal data is not necessary for the informative use of our website. However, we offer various communication channels so that you know how to contact us. It is through these voluntary contacts that we might need to process some personal data directly provided by those who visit our website, with one of the following purposes:

• Management of contacts, information or requests;
• Pharmacovigilance and safety information;
• Quality suggestions and complaints;
• Recruitment of human resources.

This privacy policy is only applicable to personal data directly provided through our website and our online resources and communications (such as other websites operating under direct responsibility of BIAL, mobile applications [apps], e-mail and other communication tools) with a link to this policy.

This privacy policy is not applicable to personal information collected through offline resources and communications, except in cases where said personal information is consolidated with personal information collected online by BIAL or by a subcontracting party acting on behalf of BIAL. This Policy is also not applicable to other third-party websites and online resources to which or websites might provide links, when BIAL neither controls nor is responsible for the content or the data processing of those resources.

2.2.1. Management of contacts, information or requests

If you wish to contact the BIAL Group, you can do so by phone, e-mail or by filling out a form on our website, indicating the subject and reason for your contact. Through the form available on the website, we will collect a set of personal data, which will be processed in order to respond to your request, question or suggestion. For this purpose, the following personal data is collected from the contact form: first and last name, e-mail address and the subject of your request. Provision of this data is mandatory, otherwise we might not be able to process and respond to your request.

In that respect, an open-message field is also made available where you can fill out your request, question or suggestion, where other personal data can be provided, spontaneously.

Any personal data provided to BIAL and related to an information request can be processed in order to respond to your request. This processing is of the legitimate interest of BIAL and is indispensable so that we can respond properly to your request. In this case, BIAL will store this information for up to two years from the date of the request.

2.2.2. Pharmacovigilance and safety information

BIAL receives notifications of adverse events, adverse drug reactions or other safety information through telephone, face-to-face or electronic contact.

In order to protect public health, there are pharmacovigilance systems, which are essential for the safety of patients using medicines, which play a key role in collecting and evaluating information on adverse drug reactions. Regulatory authorities in each country are responsible for monitoring, coordinating and implementing national pharmacovigilance systems for medicinal products for human use, together with the marketing authorization holders of medicinal products or local representatives, who are responsible to implement pharmacovigilance systems to collect any suspicion of adverse drug reactions in a timely manner and keep detailed records of it for further notification to regulatory authorities.

In this sense, information of a personal nature is processed, of the persons for whom safety information of a particular medication has been notified and of whom notifies it. The categories of data recorded and processed are as follows:

(i) Pseudonymised identification (name initials, sex, date of birth, age, age range);
(ii) Anthropometric data (weight and height);
(iii) Safety information (description, beginning, duration, severity, evolution);
(iv) Details of the suspected medicinal product: dates of treatment (date of start and end of intake), daily dose, route of administration, therapeutic indication, batch number, first use, previous reactions to the same drug, reintroduction of same medication;
(v) Clinical data, ancillary diagnostic tests, allergies, pregnancy, medical history, concomitant medication [dates of therapy (start and end date of intake), daily dose, route of administration, therapeutic indication], and suspected interaction;
(vi) Opinion on the causal relationship.

The following data are also recorded from the notifiers transmitting the information:
(i) Name;
(ii) Contact.

The aforementioned pseudonymised personal data shall be transmitted to the competent regulatory authorities.

When processing for the purpose of pharmacovigilance, the data relating to medicinal products which have been subject of a marketing authorization shall be kept by the sponsor in accordance with Regulation (EU) No 1235/2010 of the European Parliament and of the 15 December 2010 and Directive 2001/83 / EC of the European Parliament and of the Council at least 10 years after the end of the product cycle, ie at least 10 years after the last marketing authorization was granted and there is no pending or anticipated marketing application anywhere in the world.

BIAL processes the personal data provided in the scope of pharmacovigilance, based on reasons of important public interest and compliance with a legal obligation, communicating this information to the authorities and partners.

With regard to these personal data, because it is sensitive information, BIAL proceeds to its pseudonymisation as a security measure.

2.2.3. Quality suggestions and complaints

The suggestions and complaints that we might receive through our website are considered an important resource for internal analysis and a possible starting point for the implementation of measures aimed at the continuous improvement of BIAL’s products.

If you wish to contact the BIAL Group to make a suggestion or a complaint, you can fill out the form available on the website dedicated to Quality or, alternatively, you can contact the BIAL Group by telephone or e-mail.

Through the form available on the website, we collect a set of personal data, which will be processed in order to respond to your request/question/suggestion: first and last name, e-mail address and the subject of your request. Provision of this data is mandatory, otherwise we might not be able to process and respond to your request. In that respect, an open-message field is also made available where you can present your suggestion and/or complaint and where other personal data can be provided, spontaneously.

Any personal data provided to BIAL regarding a quality suggestion or complaint can be processed to respond to your contact, or for consideration in the context of external or internal audits, to verify the observance of our internal procedures and compliance with the legal, regulatory or contractual requirements.

In case of a product complaint for quality reasons, BIAL will store the data for a period of six years following the receipt of the quality complaint.

Moreover, BIAL might need to store, for an equal period, the audit reports and its support documents, including the suggestions and complaints received through our website.

2.2.4. Recruitment and selection of human resources

BIAL publishes on its site career opportunities available within the Group, while also encouraging spontaneous applications. The communication of personal data for recruitment process purposes is voluntary. However, the supplied data is necessary to the recruitment process to which the data subject applied, wherefore the omission or refusal to communicate said data might prevent its fulfilment and, therefore, the potential consideration of the application that was sent.

BIAL processes personal data regarding the data subjects that send in applications, also researching and analysing profiles, through publically available professional information, and, in some cases, performing interviews and tests to assess the candidate’s potential. No decision based on the personal data supplied by the subject is automated.

BIAL stores the records of the recruitment processes and proceeds with processing this data in the context of pre-contractual proceedings and obtaining consent. By submitting an application through the recruitment platform available on the BIAL website, the candidate is given direct control over the submitted data, being able to edit it, update it, complete it or delete the application at any time. If you wish to maintain your candidate profile active, the data will be stored for up to five years from the last access (login) to BIAL’s recruitment platform. Furthermore, BIAL can store the candidates’ data for a longer period in order to contact them during future recruitment processes, upon consent.

2.3. Recipients of your personal data

So that BIAL can fulfil its duties and provide the best possible service, it might need to communicate or provide access to your personal data to the following categories of entities:

• Other entities belonging to the BIAL Group, with registered offices inside the European Economic Area, with the same aforementioned purposes.
• Entities offering services to Bial, regarding:
• IT support;
• Marketing and communication services;
• Document management;
• Legal and accounting support;
• Logistics support;
• Support regarding human resources;
• Support regarding the management of the pharmacovigilance global database.
• Public authorities, such as, for example, regulators, regulatory authorities, tax authorities or judicial courts.

To learn about the entities that are part, at any time, of the BIAL Group, see the list at the end of the Policy.

2.4. Exercise of rights by the data subjects

2.4.1. Rights of the data subject

In regard to the processing of his/her personal data, the data subject has the following rights:

2.4.2.  How to exercise your rights

You can exercise your rights before BIAL through the following channels:

• In person: at BIAL’s headquarters, in person with the Data Protection Officer, at Avenida da Siderurgia Nacional, 4745-455 Coronado (São Romão and São Mamede), Portugal, or at the BIAL’s branch in your country[i];
• Online: through the relevant form available online;
• E-mail: through an e-mail addressed to the Data Protection officer at dpo@bial.com;
• Letter: in writing, through a letter addressed to the Data Protection Officer, at Avenida da Siderurgia Nacional, 4745-455 Coronado (São Romão and São Mamede), Portugal; or
• Telephone: through a telephone call with the Data Protection Officer at: +351 229 866 100.

Exercising your rights is free, without prejudice to, whenever there are reaffirmed requests, clearly unjustified and repetitive, BIAL demanding payment of a reasonable fee, regarding administrative costs related to the supply of information or execution of the requested actions or even refusing to comply with the request.

When BIAL is in reasonable doubt regarding the identity of the individual submitting the request, they can request additional information to confirm his/her identity. 

2.5. Updates to the Privacy Policy

The information provided in this document may need to be altered over time.

Therefore, we advise you to visit the website, where this information will always be up to date.

Whenever there are changes regarding the processing of your personal data, BIAL will inform you through the website or by means of other communication channels commonly used.

2.6. Data Protection Officer and Point of Contact

Whenever you have doubts regarding the processing of your personal data or the information you provided by BIAL, you can contact BIAL through the usual communication channels, indicated in paragraph 2.4.2 above, or our Data Protection Officer through the following contacts:

Bial – Portela & C.ª S.A.
At Av. da Siderurgia Nacional,
4745-457 Coronado (S. Romão and S. Mamede)
Portugal
E-mail: dpo@bial.com
Tel.: +351 229 866 100
Fax: 351 229 866 199
www.bial.com