Jurisdiction(s):
European Union

CJEU annuls Commission refusal of conditional marketing authorisation: EMA experts’ conflicts and failure to consult Psychiatry SAG breached impartiality under Article 41 of the EU Charter

Published on: 02 April 2024

Published by a LexisNexis EU Law expert

Legal News

Article summary

What are the practical implications of the case?

The case offers significant clarification of the impartiality obligations under Article 41 of the Charter and confirms that substantive links between an expert and the pharmaceutical industry, for example consultancy arrangements or acting as principal investigator in clinical trials, could compromise such impartiality when assessing an application for a marketing authorisation concerning a potentially rival medicinal product, even where no demonstrable bias on the part of the expert can be shown. The judgment provides reassurance for industry in a context where a narrow reading of conflicts of interest has long been regarded as unsatisfactory and proof of actual bias is frequently hard to secure. However, the Court of Justice’s decision appears likely to create difficulties for the EMA and comparable bodies, particularly in rare diseases where there are few well qualified experts and most of these inevitably undertake advisory and clinical trial work for the pharmaceutical industry.

What was the background?

In 2018 D&A Pharma lodged an application with the EMA for a CMA for its medicinal product, Hopveus, with a proposed therapeutic indication of alcohol dependence in persons seeking to abstain from alcohol ingestion as such...

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Popular documents

Using the Judicial College Guidelines to assess general damages in personal injury claims

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

Tomlin orders in England and Wales: CPR guidance on drafting, confidentiality, approval, variation, enforcement, limitation, CCA issues, court-specific requirements, sample wording and precedents

This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

Precedent: Deed of Surrender of Lease with Optional Premium, Settlement and Release, Landlord, Mortgagee and Guarantor Consents, Reimbursement and HM Land Registry Provisions (England and Wales)

Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...

Precedent Statutory Declaration: Standard Wording under the Statutory Declarations Act 1835

I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...