Drug firms voice fears over data protection rules

Date: 01/05/1997

By Rory Watson

THE pharmaceutical industry is stepping up its lobbying of member states to ensure that new pan-European rules on data protection do not harm its research operations in the EU.

Drug companies fear that a strict interpretation of the legislation to be introduced next year on the transfer and use of personal data might jeopardise their current multi-billion-ecu efforts to develop new medicines by using information from clinical trials conducted in several countries at the same time.

“In developing new medicines, we try to carry out clinical research on a global scale in as many different environments as possible where the drug could be used. That implies collecting and transmitting data between EU member states and between the Union and third countries,” explained an industry source.

Pharmaceutical companies are not alone in casting a wary eye at the new legislation. Its contents would apply to a host of other business sectors - such as banks, travel agencies and insurance firms - which make extensive use of personal data and increasingly transfer such details from one country to another.

But the drug industry is particularly concerned at the possible impact and is trying to convince governments throughout the EU to use the degree of national leeway provided for in the legislation to agree on specific exemptions.

The industry wants pharmaceutical-related operations to be recognised as being of 'substantial public interest' and, like personal health services, to be exempt from the general principle that personal data can only be processed with the explicit consent of the person concerned.

The campaign is being coordinated by the European Federation of Pharmaceutical Industries' Associations (EFPIA), which represents some 2,200 companies in the Union and the four members of the European Free Trade Association: Switzerland, Norway, Iceland and Liechtenstein.

But time is running short. Member states must put the Union rules, complete with any exemptions they agree to grant, on to national statute books before the end of October 1998.

Although Italy and Greece already have similar regulations, and Belgium and the Netherlands are currently drafting their own legislation, at least six member states - including major pharmaceutical centres such as Germany and France - had made no move to prepare the necessary measures by the beginning of this year.

“There is very little indication that member states are thinking about these issues. We must increase their awareness about how particular sectors could be handled more favourably,” commented one industry source.

The EU legislation, approved in 1995, is designed to avoid placing unnecessary obstacles in the way of personal data moving freely between member states while ensuring that the fundamental rights of individuals are safeguarded.

It also limits the transfer of such data to countries outside the Union which fail to provide adequate levels of protection. Industry sources insist that strong safeguards are already in place to prevent any abuses.