EMA proposal concerns: “Public health trumps commercial confidentiality”

By Flora Southey contact

- Last updated on GMT


Related tags: Pharmaceutical industry, World health organization

Proposed amendments to the European Medicines Agency’s (EMA) access to documents policy have been criticised by medicines watchdogs, including not-for-profit Health Action International and Prescrire.

The coalition – which counts the International Society of Drug Bulletins, NoGracias and the Nordic Cochrane Centre as members – issued a response​ to the revised policy​ this week, raising concerns about proposals that would require parties seeking access to documents to file a written request.

“While we commend the EMA for clarifying its approach to document disclosure, we regret that the revised access to documents policy falls short on proactive disclosure,” ​HAI senior policy advisor Ancel.la Santos Quinano told in-PharmaTechnologist.com.

“Public access to the EMA’s clinical data, decision-making and corporate documents is critical for strengthening accountability and trust in its regulatory processes,”​ she said.

The coalition argued that research and civil society organisations have experienced long delays and cumbersome administrative processes when accessing documents via written request.

“Regulators should not wait for requests to access documents, but actively disclose every piece of information that is relevant from a public interest perspective. Reactive disclosure results in a more controlled and cumbersome access, whilst proactive disclosure enhances transparency,” ​Santos Quinano told us.

Commercial confidentiality

Furthermore, the coalition says these documents would likely be redacted for commercial confidentiality.

It recommends the EMA organise a public register of all its documents, in order to prioritise health over commercial interests at all times.

“Arguments on commercial confidentiality are recurring amongst the pharmaceutical industry,” ​said Santos Quinano.

“We’d like to see the definition of commercial confidentiality being narrowed down and the question of the overriding public interest in disclosure to be taken in due consideration at all times.”

Industry pressure

Santos Quinano suggested industry pressure may in part be responsible for EMA’s reactive disclosure-based amendments.

“The EMA is again being challenged in court by some pharmaceutical companies over the issue of data disclosure.”

“We call for the EMA to continue expanding and deepening its access to documents policies amidst pressure from the industry. Public health always trumps commercial confidentiality,” ​she said. 

Campaign for transparency

Trial data publication has regularly been debated​ since 2013, when the British Medical Journal and Cochrane Collaboration-backed AllTrials group began campaigning for all past and present studies to be registered, and their methods and summary results disclosed.

“Trials with negative results are twice as likely to remain unreported as those with positive results. This means that people who make decisions about medicines don’t have full information about the benefits and risks for treatments we use every day,”​ said AllTrials.

In 2015, the World Health Organisation (WHO) similarly called​ for summary results from all trials to be published.

The EMA is reviewing submitted comments regarding its proposed amendments before a final version is submitted to the EMA’s management board for approval.

Related news

Show more

Related products

show more

Automating clinical trials for success

Automating clinical trials for success

Formedix | 06-Oct-2021 | Technical / White Paper

This article gives gives a brief overview of why automation is absolutely essential for clinical trial success.

Empowering Clinical Trial Sponsors with Analytics

Empowering Clinical Trial Sponsors with Analytics

PerkinElmer | 14-Jul-2021 | Technical / White Paper

Is your Clinical Data Review creating problems or solving them? Take Control of Your Data. PerkinElmer Informatics Clinical Solutions, powered by Tibco...

Covance Touchless Drug and Device Vigilance Vision

Covance Touchless Drug and Device Vigilance Vision

Covance Patient Safety | 01-Sep-2020 | Data Sheet

Automation tools enable organizations to identify patterns in structured and unstructured data and facilitate automation of the entire product vigilance...

Follow us


View more