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EFPIA rejects ‘indiscriminate’ transparency

Published on 16/11/12 at 10:11am

Europe’s pharma trade body has poured tepid water on the idea of open access to clinical trial data, saying that an‘indiscriminate’ approach may cause ‘significant harm’.

Lack of trial transparency is one of the key accusations that critics such as Ben Goldacre, author of Bad Pharma, routinely level against the industry.

But the European Federation of Pharmaceutical Industries and Associations (EFPIA) believes that what it calls ‘responsible’ transparency is the only sensible way forward.

Richard Bergström, the body’s director general, said: “We recognise that we have a responsibility to show leadership in advancing transparency.”

But he went on: “There is a potential for significant harm to the interests of innovators and individuals if transparency is approached in an indiscriminate way.”

The needs of personal privacy and commercial confidentiality can be balanced with the provision of information to allow regulators and doctors to make decisions about what medicines to use, he says.

“We would like to see further reflection on the timing of disclosure and its implications for the regulatory decision-making process,” Bergström said.

“For example, many products and new uses are not protected by patents but by regulatory data protection,” he added. “It would be damaging to companies if competitors could circumvent this by printing all the data from the internet.”

EFPIA’s intervention comes as the European Commission gets ready to discuss legislation to replace trial rules that have been in place since 2001.

The existing Clinical Trials Directive has been under attack from patients, industry and academics and the EC’s proposal aims to address concerns.

Goldacre’s point is that unsuccessful trials are often unpublished, yet this sheer lack of evidence has an impact on the way future research is conducted and public health decisions are made.

The doctor and author also suggests there is not enough clarity around company involvement, researcher payment or sponsor interference in trials, and he says that pharma uses data highly selectively.

The worry for pharma is that publishing everything would mean that patients and doctors - and perhaps investors - may draw the wrong conclusions from research that has not hit the mark.

EFPIA points out that it, and various other international pharma trade bodies, are committed to registering trials on a public registry and disclosing results of pharma-sponsored trials through open databases.

This commitment comes with caveats, however. Publication “must maintain protections for individual privacy, intellectual property and contract rights, as well as conform to legislation and current national practices in patent law”, EFPIA says.

Adam Hill

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