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Pharmaceuticals: towards new EU regulation on personal data, Italy ahead

  Rome, February 22nd. (Adnkronos Salute) – What will be the impact on pharmaceutical organizations of the new European regulation on the processing of personal data, which should enter into force in the first months of 2014? This was discussed today in Rome on the occasion of a conference organized in the Senate, the scene of an in-depth discussion on the innovations introduced by the provision, which will affect the operations of companies, in particular in the management of medical archives compiled thanks to the activity ' of drug sales representatives. But Italy is ahead: there are already many companies that have obtained a conformity mark, anticipating the adoption of innovative measures, which provide for the establishment of certification mechanisms, seals and data protection marks not hitherto provided for in a mandatory form.

To date it appears that around 20% of the data collected by drug companies contain anomalies such as mismatched names or surnames, registered several times or which do not appear to be registered in the medical register, being for example nurses or other health professionals. With the arrival of the new regulation, the need to analyze the situation is therefore felt even more. "Today's one - he said Massimo Vari, undersecretary at the Ministry of Economic Development - is an important moment for verifying the consonance of Italian legislation with the European one, on issues of constitutional importance such as the protection of health and privacy". "Already in 2009 - he recalled Cesare Cursi, president of the Senate Industry Commission – Aifa had expressed his appreciation for the conformity mark of the archives" that some companies have obtained, requesting a voluntary verification. "We hope that the new regulation specifies how to best guarantee both the growth of the production system and the protection of citizens' health".

The regulation introduces substantial elements of innovation with respect to Directive 95/46/EC: in particular, in addition to the obligations of 'information' and 'consent', fundamental principles are taken up and strengthened such as that of transparency, data minimization, integrity (accuracy and updating) and liability. The application of these innovations, especially in pharmaceutical realities that need to manage the archives of health professionals visited, opens up interesting scenarios on the most controversial aspect of the 'quality' and 'quantity' of the data collected and processed by the organisations.

The 'Data Processor' envisaged by the new provision will have the obligation to take all reasonable measures to promptly cancel or correct the data entered with respect to the purposes for which they are processed

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco