Pharmacovigilance and Drug Safety

Pharmacovigilance and Drug Safety for the UK and Europe.

Drug Safety Data: The Effect Of EU Regulations Protecting Data Privacy

Information outlining the need for compliance with data privacy protection laws in force throughout the EU is posted here. This page provides some further background to this important topic. All personal data within the EU must be treated in accordance with EU laws on Data Privacy. In order to protect patients’ rights to privacy, pharmacovigilance data must likewise comply with these laws. There will inevitably be clinical data which is vital to identify and analyse any adverse reactions which may be caused by taking a certain drug. While the ultimate aim of protecting patients from harm caused by any potential or actual drug safety issues, this cannot be allowed take priority over the need to protect personal privacy.

Would The 1995 EU Data Privacy Laws Stop The Flow Of Drug Safety Data?

It was in 1995 that the Directive 95/46 EC provided a framework for how all personal data should be treated within all EU member states. The Directive gave all EU member countries a period of three years to formulate and implement national laws complying with its principles. Some states chose to go further, implementing legislation which provided more stringent protection than the stipulation of the Directive originally called for. The relevant point for pharmacovigilance was that there was no exemption for any type of health care records. This means that doctors, hospitals, clinics and other health care providers must comply with national legislation – without exception. It applies to all media – whether the personal data is held on hand written forms, computerised records, captured images such as name X-Rays and scans, etc. The Directive had initially caused concerns that it could impede drug safety work by placing legal obstacles in the way of investigators who needed such clinical data to perform their professional duties.

After 1995: The Impact On Pharmacovigilance Work

In reality, these concerns proved unfounded as there are now various methods pharmaceutical companies and regulators use to balance the pressing need for data with legal compliance. It can be the case that it has become more complex to investigate (and perform the follow ups) since 1995. Nonetheless professional pharmacovigilance services can advise pharmaceutical companies on which options are open to them to fulfil their drug safety obligations without compromising their position under national data laws. When processing personal data, Regulatory agencies are also bound by additional privacy legislation (Regulation (EC) No 45/2001 Protection of Individuals). Again, in practice this has not meant that pharmacovigilance work has been impeded, rather that regulators are aware of regulations they must follow for such processing, including when data is transferred between countries, and in and out of the EU itself. As a generalised rule, it is not permitted for data which has not been rendered in an anonymous form to be exported to countries outside the EU. However, a note of caution is required regarding this last statement. National and EU wide laws are always subject to change and as such, pharmaceutical companies need accurate advice reflecting the latest legal reality within any given situation. This page therefore cannot be considered as any type of legal or other professional advice, which should be only sought from appropriately qualified persons.

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