There is a fine line between protecting patients’ interests and releasing information for the public good, says EURORDIS spokesperson
The European Ombudsman Emily O’Reilly has joined civil society groups and members of the European Parliament (MEPs) in calling for more transparency on existing clinical trials than foreseen under the European Union (EU) clinical trials regulation.
'The public just wants to know about medicines and we don’t particularly care about when they came on the market,' she said at a European Parliament, in Brussels in September. O’Reilly’s role is to investigate complaints about maladministration in the EU institutions.
The clinical trials regulation, which was approved in April, requires a summary of clinical trials conducted after 2014 to be published on a public database managed by the European Medicines Agency (EMA), starting mid-2016. But it does not make this demand for older medicines.
'It would seem rational to the ignorant people that the information used to assess that the medicine is safe would be widely reviewed,' said O'Reilly. She was backed by Ben Goldacre, physician, academic and author of the book Bad Pharma, who told participants at the event: 'We prescribe medicines that came on the market 15 or 20 years ago. If you say to industry that we want access to these trials they say it’s difficult for them to provide information and find the documents,' he claimed.
If we can get from civil society a wish list for particular products where there is a debate, I am sure that our companies would deliver
Responding to the criticism, Richard Bergström, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) said that more than half of his association’s membership promised to provide information on historical data. 'If we can get from civil society a wish list for particular products where there is a debate, I am sure that our companies would deliver,' he said.
The event took place days before the European Medicines Agency (EMA) approved a policy on the publication of clinical data of medicinal products for human use. This allows those interested in science and not in the commercial use of the data to see, watch, download and use it to the best of their knowledge, said Guido Rasi, EMA’s Executive Director.
The new policy, due to apply from 1 January 2015, 'will serve as a useful complementary tool ahead of the implementation of the new EU clinical trials regulation that will come into force not before May 2016,' said the EMA.
The policy lists criteria used to decide if some clinical trials data will stay private over commercial confidentiality concerns and Rasi added: 'We are now releasing clear criteria for redaction and the company will have to justify [its confidential information claim].'
These criteria will refer to situations where the knowledge of particular information or a dataset may help a company’s competitor in ongoing drug development, explained Rasi.
'We are thinking about some innovative bioassays, analytical issues; we expect this to be about 5%” of the information contained in a clinical trial report,' he said.
Confidential information claims brought EMA to court when US company AbbVie tried to stop the agency releasing clinical study reports relating to its anti-inflammatory medicine Humira. After two years of legal battles, the two parties agreed that EMA will release the report with some redactions.
'We succeeded in two years in having AbbVie come back to us in accepting what they didn’t accept before,' said Rasi, noting that a similar case against the Agency was still pending in court.
But Goldacre was still critical, stating that the edits referred to changes in the protocol of the clinical trial. 'I can’t see how that is secret; if someone changes something in the trial once they’ve started it means that they found something they didn’t like,' he said. This sets a bad precedent regarding information that could remain private once clinical trial reports start being released under the new regulation in 2016, he argued.
If researchers want to obtain data of individual patients from clinical trials, they should ask the pharmaceutical companies directly
An investigation into the settlement between EMA and the US drug manufacturer opened by the European Ombudsman in April is still ongoing. EFPIA’s Director General said that in most clinical study reports there is no confidential information included. However, if researchers want to obtain data of individual patients from clinical trials, they should ask the pharmaceutical companies directly. 'We are the only ones who have this data,' he added.
Danish Green MEP Margrete Auken took a different view: 'A clinical trial belongs to the patient that has exposed himself. I cannot see legitimate interest in keeping secrecy, besides personal information,' she said.
However, a representative from patient group the European Organisation for Rare Diseases (EURORDIS) said there is a fine line between protecting patients’ interests in clinical trials and releasing information for the public good. This was especially for patients with rare diseases, who could be easily identified in clinical trials.