The General Data Protection Regulation (GDPR) has become a cornerstone of data protection legislation globally. Though enacted by the European Union, its influence extends far beyond, impacting any organisation handling the data of EU residents. For the pharmaceutical industry, with its abundance of sensitive personal data, understanding and complying with GDPR is not just a legal obligation, but a critical component of ethical and responsible operations.
What is GDPR?
The GDPR is a comprehensive data protection law that came into effect in May 2018. It harmonises data privacy laws across Europe and reshapes the way organisations approach data privacy globally.
What are the objectives of GDPR?
- Protecting the fundamental rights and freedoms of individuals: GDPR prioritises the rights of individuals regarding their personal data.
- Harmonizing data protection laws across Europe: It creates a single set of rules for all EU member states.
- Holding organisations accountable for data protection: It places the onus on organisations to demonstrate compliance.
- Enhancing transparency and control over personal data: Individuals have greater access to and control over their data.
What are the Cornerstones of GDPR?
- Lawfulness, fairness, and transparency: Data processing must be lawful, fair, and transparent to the data subject.
- Purpose limitation: Data can only be collected for specified, explicit, and legitimate purposes.
- Data minimization: Only necessary data should be collected and processed.
- Accuracy: Data must be accurate and kept up-to-date.
- Storage limitations: Data should be kept only as long as necessary.
- Integrity and confidentiality: Data must be protected against unauthorized access, processing, or disclosure.
- Accountability: Organizations are responsible for demonstrating GDPR compliance.
Requirements of GDPR
| Requirement | Description |
|---|---|
| Lawful basis for processing | Must have a valid reason (consent, contract, legal obligation, etc.) for processing data. |
| Data subject rights | Individuals have rights to access, rectify, erase, restrict processing, and object to processing of their data. |
| Data protection by design and default | Data protection must be integrated into systems and processes from the outset. |
| Data breach notification | Data breaches must be reported to authorities within 72 hours of discovery. |
| Data Protection Impact Assessment (DPIA) | DPIAs are required for high-risk data processing activities. |
| Data Protection Officer (DPO) | A DPO must be appointed in certain circumstances. |
| Record of processing activities | Organizations must maintain records of their data processing activities. |
| Data transfer restrictions | Strict rules govern transferring data outside the European Economic Area (EEA). |
GDPR compliance for pharmaceutical companies
Pharmaceutical companies handle highly sensitive personal data, including patient medical records, clinical trial data, and research findings. Here's what they must do to comply with GDPR:
- Map and inventory data: Identify all personal data collected and processed, its source, purpose, and storage location.
- Establish a lawful basis for processing: Ensure a valid legal basis for each data processing activity.
- Implement data protection by design and default: Embed data protection into all systems, processes, and products.
- Obtain valid consent: Obtain explicit and informed consent for data processing when necessary.
- Facilitate data subject rights: Establish procedures to respond to data subject requests (access, rectification, erasure, etc.).
- Conduct DPIAs: Assess and mitigate risks associated with high-risk data processing activities.
- Implement data breach response plan: Develop and regularly test a plan for responding to data breaches.
- Train employees: Provide comprehensive GDPR training to all staff.
- Appoint a DPO: Designate a DPO if required based on data processing activities.
GDPR and document review & approval systems
In the pharmaceutical industry, document review and approval systems are critical for maintaining compliance, quality, and safety. GDPR has significant implications for these systems:
- Data security: Systems must be secure to protect personal data from unauthorized access or disclosure.
- Access control: Only authorized personnel should have access to documents containing personal data.
- Audit trails: Systems should maintain comprehensive audit trails to track document access, modifications, and approvals.
- Data retention: Documents containing personal data should be retained only for as long as necessary.
- Data subject rights: Systems should facilitate data subject requests related to their personal data within documents.
Conducting a DPIA
A Data Protection Impact Assessment (DPIA) is a process for identifying and mitigating privacy risks. Here are the key steps:
- Describe the processing: Clearly define the purpose, data involved, and processing activities.
- Assess necessity and proportionality: Determine if the processing is necessary and proportionate to the purpose.
- Identify risks: Assess the risks to individuals' rights and freedoms.
- Identify measures: Implement measures to mitigate identified risks.
- Review and monitor: Regularly review and monitor the effectiveness of the DPIA and update as needed.
Duties of the Data Protection Officer (DPO)
The DPO plays a crucial role in ensuring GDPR compliance. Key responsibilities include:
- Advising on data protection obligations: Provide guidance and expertise on GDPR requirements.
- Monitoring compliance: Oversee data protection activities and ensure compliance with GDPR.
- Acting as a point of contact: Serve as the contact point for data subjects and supervisory authorities.
- Providing training and awareness: Educate employees on data protection principles and best practices.
- Conducting DPIAs: Lead and participate in DPIAs.
Adapting document management systems for GDPR compliance
To conform to GDPR, document management systems in the pharmaceutical industry should be adapted to:
- Implement strong access controls: Restrict access based on roles and responsibilities.
- Enable data encryption: Encrypt sensitive documents to protect confidentiality.
- Maintain detailed audit trails: Track all document activities, including access, modifications, and deletions.
- Facilitate data subject requests: Enable efficient retrieval and modification of personal data within documents.
- Ensure data retention policies are enforced: Automatically delete or archive documents containing personal data according to predefined retention policies.
- Integrate with consent management tools: Connect with consent management platforms to track and manage consent for data processing.