Study calls for rules to be tightened over disclosure of money received from drug makers

Most patient groups involved in the appraisal of drugs or medical devices for use in the NHS have received money from the manufacturers that they have not declared, research has found.

Patient groups are asked to give their views when the National Institute for Health and Care Excellence (Nice) is deciding whether to approve a drug for use in the NHS in England. However, the researchers said Nice did not have stringent enough rules on the disclosure of any and all funds that patient organisations receive from companies.

The review – carried out by scientists from the London School of Hygiene and Tropical Medicine and published in the British Medical Journal on Thursday – calls for greater transparency from patient groups and companies “to reassure the public that healthcare decisions are not unduly influenced by industry”. It also says Nice needs to tighten up its rules on disclosure.

Dr Kate Mandeville and colleagues looked at all the Nice “technology appraisals” carried out in 2015 and 2016. They found that 53 patient organisations – set up to represent and support people with a specific disease or condition – contributed to 41 appraisals on 117 different occasions. That included submitting evidence and contributing to discussions.

“Virtually all Nice’s appraisals of medicines and treatments for use in the NHS in 2015 and 2016 received contributions from patient organisations, with many such organisations contributing to multiple appraisals,” the paper says.

“More than two thirds of patient organisations had accepted funding from the manufacturer(s) of a technology or a competitor product(s) in the same year that they had contributed to the appraisal of that technology or in the previous year.”

But, it says, the Nice committee carrying out the appraisal only knew of a quarter of those financial conflicts. Nice policy requires individualss to declare any money or grants they have received, but does not require the patient organisation itself to reveal funding. In two-thirds of the financial conflicts identified, the patient group was not required to disclose them.

“I was surprised that Nice hasn’t remedied this loophole,” Mandeville said.

Nice had pioneered the involvement of patients in its decision-making processes, but organisations in other countries were now doing better on the disclosure of conflicts of interests, she said, adding that only a small policy change was required to address the problem.

“Scotland already has made this change. For all of their appraisals they ask patient organisations to provide details of any industry funding relevant to that appraisal. It is published alongside that appraisal.”

France operates a database where patient organisations must declare all their funding.

In England, however, it was not clear; some patient organisations were transparent but others declined to help, Mandeville said. “It was really quite difficult to find information on funding and it was quite fragmented.”

Nice said it knew patient groups received industry funding but “we were not aware of the extent of these interests”. It said it had already decided to review its policy and would give careful consideration to the study’s recommendations.

Gillian Leng, the deputy chief executive, said: “Ensuring that organisations and individuals declare potential conflicts of interests in accordance with our policies is central to how we develop guidance and is essential in maintaining public and professional confidence in our work. This study is an important contribution in making sure that we achieve this aim.”