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The Role Of EU Data Privacy Regulations For Pharmacovigilance Data

April 23, 2012 | Comments: 0 | Views: 101

All data within the European Union is subject to regulations which protect the privacy of any personal information it may contain. Pharmacovigilance is reliant on clinical data, which is likely to contain such personal information about patients (or about healthy volunteers participating in clinical trails). This article provides a brief overview for the interested lay reader on some of the key aspects of the way all data used within this work must be processed to comply with these regulations.

Before And After 1995

Before the introduction of the 1995 Directive 95/46 EC, there were some concerns that the Directive would have negative consequences for drug safety work. It allowed for a three year period during which all EU member states were to implement adequate data privacy protection laws in order to at least comply with its principles. Those principles apply to personal information held in any medium, including data that is handwritten or printed on paper, stored on a computer or held as an image. Examples of the type of personal data important within pharmacovigilance work include handwritten or printed entries on clinical forms, printed medical notes, images for scans or X-Rays, laboratory test results, etc. Over time, as each member state began to implement their own national regulations, drug safety practice simply adapted wherever this was required and it became clear that those initial concerns would prove unfounded.

Drug Safety Work Has Not Been Impeded - But Advice Is Often Essential

In order to ensure the uninterrupted flow of data obtained through clinical trials and spontaneous reporting, and to facilitate accurate reporting to the regulatory authorities, pharmacovigilance has adopted various strategies. These protect patient privacy, comply with the regulations yet still provide the vital clinical information required, for example, using data which has been rendered anonymous. It is important to note however that some member states chose to enact regulations which provided a higher degree of protection than the Directive originally required. This can mean that pharmaceutical companies need robust professional advice on how to proceed to comply with those laws. Nonetheless, the challenges presented are not insurmountable. There are also additional regulations which apply to regulatory agencies.

It is also important to note that data which is not anonymised cannot be moved from the EU to countries which are considered to fail to provide adequate data privacy protection laws. For example, pharmaceutical companies may need professional advice on how to correctly attempt to export data obtained and processed from within the EU to another branch of the company located within the USA. Again, this does not mean the data cannot be moved; simply that the manner in which it is provided and moved must be carefully considered for legal compliance. It is also worth noting that with twenty-seven member states (and more candidates for entry), regulations can rapidly change and it is essential to seek professional advice to keep abreast of all the latest legal developments. Please note that this article therefore simply provides a brief outline of key issues rather than any form of professional advice.

Jon Barton writes articles containing information on aspects of drug safety as an introduction to the topic for interested lay readers. More information on key components of pharmacovigilance work is provided by leading European pharmacovigilance services provider "PrimeVigilance" at their company website. In terms of what data is collected, and by whom, and where it is stored, and why, the following page here gives something of an outline, as a basis for further reading in terms of what data is being stored in compliance with the aforementioned directives. Information on the pages linked is not exhaustive but it's a lot easier to read than the EU directives themselves.

Source: EzineArticles
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