MEDICAL INFORMATION AND PHARMACOVIGILANCE PRIVACY STATEMENT

MEDICAL INFORMATION AND PHARMACOVIGILANCE PRIVACY STATEMENT

This Medical Information and Pharmacovigilance Statement is intended to explain how PTC Therapeutics International Limited (together with its affiliates “we”, “us”, “PTC) collects and process Personal Data related to pharmacovigilance and medical information activities (“Personal Data”). In this respect, PTC collects and process Personal Data in accordance with the General Data Protection Regulation 2016/679 (“GDPR”), all other applicable privacy laws and regulations, and PTC internal policies, procedures, and guidelines. We collect and process your Personal Data to comply with our legal obligations (GDPR Articles 6(1)(c) and Art. 9(2)(i)). Your Personal Data collected for these activities, may be provided to regulatory authorities, if required by applicable local laws or regulations.

Purpose and legal basis for processing Personal Data

Medical Information – We are required by law to have a Medical Information team to answer enquiries regarding our products and/or treatments. For this reason, we may need to process Personal Data (i) to properly reply to the queries we receive via email or phone calls, either directly from doctors and patients or indirectly from doctors or sales representatives on behalf of patients and/or doctors and (ii) to maintain information in our medical information database for reference, compliance and auditing purposes.

The legal basis we rely on for such processing are:

legitimate interest (GDPR Art. 6.1.(f)); and
the public interest in the area of public health, ensuring high standards of quality and safety of health care and medicinal products or devices (GDPR Art.9.2(i)).

PTC also complies with the Directive 200/83/EC relating to medicinal products for human use, Art. 98 and Art. 104.

Pharmacovigilance- All Personal Data related to pharmacovigilance activities is very important for public health. Then, such Personal Data will be processed for the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Any Personal Data provided to PTC and related to adverse events or other activities related to pharmacovigilance will be used solely for these purposes.

Categories of Personal Data processed

For Medical Information, PTC will collect your name and contact details, and enquiry details

For Pharmacovigilance, PTC will collect:

From the reporter (person reporting pharmacovigilance information such as adverse events): name, contact details, profession and relationship with the subject of the report.
Regarding the patient: name or initials, age and/or date of birth, gender, weight, height and details of the product and other medicines that the patient is and/or was taking.

Recipients of your Personal Data

PTC may share this information with PTC affiliates and third-party service providers, such as medical information, information technology and pharmacovigilance service providers for safety reporting purposes.

Storage period

Personal Data retained as part of a medical information enquiries is kept by PTC for 10 years.

Personal Data collected for pharmacovigilance purposes is kept by PTC for a minimum 10 years after the product marketing authorization has expired, in accordance with legal regulations governing the storage and reporting of safety related information.

Security

We have appropriate technical and organizational measures to protect Personal Data, including safeguards and procedures designed to restrict access to Personal Data only to those PTC employees or designates who need this information to perform their job. Where possibly, we process Personal Data in pseudonymized form.

Information about your rights

Please note that you have the right to request information on which Personal Data we store and for which purpose. You can also request access to and rectification of your Personal Data. Notwithstanding the foregoing, due to PTC’s legal obligations as per pharmacovigilance applicable legislations, we may not be able to erase/delete or restrict processing of your Personal Data if processed for that purpose.

Because of our commitment to the protection of your personal data, we evaluate our privacy policies and procedures to implement improvements and refinements from time to time. We encourage you to check the Site frequently to see the current Privacy Statement and Terms in effect and any changes that may have been made to them. If we make material changes to this Privacy Statement, we will notify you by means of a prominent notice on this Site prior to the change becoming effective.