The General Court of the European Union has ordered the European Medicines Agency (EMA) not to release documents on clinical trials, after two access-to-documents were requested, at least until the Court has issued a final ruling.
The two pharmaceutical companies AbbVie and InterMune challenged the agency’s decision to grant access to non-clinical and clinical information (including clinical study reports) submitted by companies as part of marketing-authorisation applications.
This is in accordance with the EMA's 2010 access-to-documents policy.
Since November 2010, the Agency has released more than 1.9 million pages in response to such requests. This is the first time that the policy has been legally challenged.
In 2012, the EMA also started a process towards proactive publication of data from clinical trials supporting the authorisation of medicines once a marketing-authorisation decision has been taken.
The EMA is a decentralised agency of the EU, responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the Union.
After the interim ruling on Tuesday (30 April), the EMA said it "noted with regret" the decisions of the president of the General Court and is considering whether to appeal the interim decisions.
"The EMA remains committed to transparency and openness of information to meet the legitimate public interests to enable scrutiny of the Agency’s recommendations on medicines," the agency said in a statement.
EMA continues with the same policy
In the meantime, the EMA said it would continue with its policy to grant access to documents. Requests for access to documents similar to those contested by AbbVie and InterMune will be considered on a case-by-case basis in the light of the orders of the court.
Since AbbVie and InterMune filed legal actions, the EMA said it has received more than 30 statements of support from various stakeholders.
One of them, the European Consumers' Organisation (BEUC), told EURACTIV that if accepted to intervene in support of EMA, BEUC hopes to lend additional support in EMA’s effort to continue its policy of openness.
“Openness and transparency are key to restore consumers’ trust in regulators. EMA’s policy on access to documents contributes to society’s medical knowledge thus empowering patients and helping the scientific community,” BEUC said.
The European Ombudsman, who has previously criticised the EMA for not granting access to two case study reports over protection of commercial interests, is according to the EMA also backing the agency in the court case.
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The EU's Clinical Trials Directive was adopted in 2001 with a view to improving research standards and protecting patients.
But the directive has been heavily criticised by researchers who say insurance costs and red tape has increased without bringing any major benefit to patients, researchers or industry.
The Commission has therefore proposed revamping the directive to address those challenges.
Enhancing the competitiveness of clinical research was a primary aim of the directive's revision amid claims that Europe would become an unattractive place to conduct large-scale trials on potentially lucrative new medicines.
The new draft directive also speeds up how researchers get ethical approval for medical trials and seeks to improve standards in how new medicines are tested and manufactured.
- 29 May: Vote on the draft Clinical Trials Directive scheduled in the Parliament's Committee on Environment, Public Health and Food Safety (ENVI)
- 8 Oct.: Tentative date for vote in Parliament plenary
- European Medicines Agency: European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information
- European Ombudsman: Website
- The European Consumer Organisation (BEUC): Website
EURACTIV Slovakia: Súd zastavil zverenenie informácií o klinických skúškach