Tag Archives: AbbVie

Consumer lobby group supports EMA in transparency battle

In a statement, the European Consumer Organisation (BEUC) has said that it will intervene to support the European Medicines Agency (EMA) in the pending proceedings before the European Court of Justice (ECJ).

EMA was sued in February 2013 by pharmaceutical companies AbbVie and InterMune for releasing the clinical trial data for some of their products. After an interim judgement, the EMA halted release on any further data relating to the proceedings, but is continuing to treat other applications on a case-by-case basis. The EMA published proposals for new policies and processes around clinical trial data transparency earlier this year, with a public consultation to close later this month.

BEUC had lodged a request to intervene a few months ago. The news about the application being officially accepted have been freshly delivered.

Monique Goyens, BEUC Director General commented: “This is great news for consumers. Our participation in the Court case will show that the public at large is interested in test results, be they good or bad. The European Medicines Agency chose to stand for transparency, and this is where we stand too.

“Consumers, as patients, carers and potential users of medicines, increasingly want to be involved in the decisions regarding their health. They have the right to access information on clinical trials. Therefore keeping such results confidential boils down to denying this right. We hope our intervention will contribute to make headway towards more open data and serve as a precedent for future cases.

“While waiting for the court ruling, we are concerned about the various delays imposed to the revision of the clinical trials’ legislation. We urge Member States to support the Parliament’s position advocating for more transparent clinical trials results. The ball is now in the European Council’s court. It is time consumers’ concerns were listened to and their safety put on the forefront of negotiations.”

Updated webinar on clinical trial transparency running through September

I’ve updated my 60-minute webinar to reflect the latest changes to policy around clinical trial transparency. Running on multiple dates through September, ClinDev subscribers and ICR members can save £20 on the standard delegate rate.

To find out more, and to book your place, visit https://clinicaltrialtransparency.eventbrite.co.uk/

ClinDev runs first webinar on clinical trial data transparency

ClinDev has run its inaugural webinar, giving delegates in the pharma and biotech sector an update on the important and fast-changing topic of clinical trial data transparency.

The rapid development on this issue is highlighted by the fact that we were able to inform delegates of the EU General Court interim ruling that halted the EMA’s disclosure of documents and data that are subject to ongoing legal action by AbbVie and Intermune. This news only emerged minutes before the 90-minute webinar was due to start!

Three more webinars are scheduled in May, with delegate rates starting at £99 for ICR members. To book your place, visit http://clinicaltrialtransparency.eventbrite.co.uk/

EMA halts study data disclosure in AbbVie & Intermune cases

EMA logoThe European Medicines Agency has halted disclosure of study documents relating to legal action currently being taken by AbbVie and Intermune, following interim rulings by the General Court of the EU. The EMA is considering whether to appeal the interim decisions and will continue with its policy to grant access to documents relating to other studies, considering requests on a case-by-case basis in the light of the Court Orders.

The companies are challenging the EMA’s decisions to grant access to non-clinical and clinical information (including clinical study reports) submitted by companies as part of marketing-authorisation applications in accordance with its 2010 access-to-documents policy. The EMA welcomes the opportunity for legal clarification of the concept of commercially confidential information.

Since November 2010, the Agency has released over 1.9 million pages in response to such requests. This is the first time that the policy has been legally challenged. Since the two pharmaceutical companies filed these legal actions, the EMA has received more than 30 statements of support from various stakeholders, including the European Ombudsman and national competent authorities.

The interim ruling has been welcomed by PhRMA but branded ” a disgrace” by Ben Goldacre, writing on AllTrials.net.

Institute of Medicine to develop consensus study on strategies for sharing clinical trial data

The Institute of Medicine (IOM) recently held a workshop on Sharing Clinical Research Data. Following on from this event, the IOM has announced plans to develop a consensus study on strategies for sharing clinical trial data. The IOM is currently organizing a planning activity that will focus on developing an independent study that would provide guidance. A small planning meeting for potential sponsors and key stakeholders will be held in the near future.

The news has been welcomed by a group of pharma companies including AbbVie, AstraZeneca, Serono, GSK, Roche and Novartis.

Discussions at the IOM workshop has moved the conversation around clinical trial data sharing from whether it should occur, to how it can be enabled, which also mirrors the view of the European Medicines Agency. As data holders are beginning to individually generate policies for clinical trial data access, better alignment among stakeholder actions will be necessary to harness the full potential of data sharing.

AbbVie sues EMA over trial data transparency

EMA logoRecently de-merged pharma company AbbVie (until this year, the human medicines arm of Abbott) is sueing the European Medicines Agency (EMA) over its release of raw clinical trial data relating to its top-selling rheumatoid arthritis drug, Humira, in 2012 following requests under European Freedom of Information laws.

There is no mention of the action on the AbbVie website, but the development was originally reported by Andrew Jack in the Financial Times.

Among the companies who made these requests were UCB and InterMune, who both have competing drugs. AbbVie argues that the disclosed data contains information that should be considered commercially confidential.

This development comes at a time when the EMA are in the process of developing guidelines and a platform for the routine sharing of clinical trial data submitted in a Marketing Authorisation Application when that application is granted. This workstream was announced in November 2012, following judgements by the European Data Ombudsman that data protection legislation is not a barrier to sharing this data. The project has an ambitious deadline of January 2014 to go live. Guidelines on how that data may be accessed and by whom should be published within the next few weeks.

The EMA has argued that most Freedom of Information requests have been from academic groups, such as the Cochrane Collaboration. However, industry lobbying group EFPIA have argued that clinical trial protocols and data may be used to infer commercially sensitive information about a company’s development strategy.