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Ellie Handy

Working with companies in the life sciences and technology sectors, Ellie Handy focuses on EU, Irish, and UK life sciences regulatory and commercial matters.

Ellie advises clients on regulatory issues including classification, biologics, orphans, paediatrics, GxP, market and data exclusivity, clinical research, labelling and promotion, reporting obligations, medical devices, and digital health. Ellie also advises companies in the food, cosmetic and consumer products sectors regarding regulatory compliance and borderline issues. Ellie provides advice in relation to corporate transactions and restructuring, in particular performing regulatory due diligence.

Ellie represents and works with a wide range of clients working in the life sciences and technology sectors on both contentious and non-contentious regulatory matters.

Ellie’s pro bono work includes assisting charities. In addition to her role at Covington, Ellie spent three years working life sciences regulatory practice in London.

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Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there is a “public health emergency.”  The TEMA will be an “agile, fast and streamlined” process to allow products to be developed and made available as soon as possible in emergency situations.  However, it remains to be seen whether in practice the TEMA process will provide a faster procedure than existing routes for early and expedited approval of medicinal products, such as conditional marketing authorizations (“CMAs”) or Member State procedures for temporary approval.

Reason to Introduce the TEMA

The EU took a coordinated approach to approval and procurement of vaccines during the COVID-19 pandemic.  In the EU, COVID-19 vaccines were approved using the CMA procedure combined with a rolling expedited review.  According to the European Medicines Agency (“EMA”), CMAs were the “the most appropriate tool to grant access to COVID-19 vaccines to all EU citizens at the same time and to underpin mass vaccination campaigns.”  Vaccines approved with a CMA included Comirnaty, Nuvaxovid and Spikevax (amongst others).

However, the approval of COVID-19 vaccines in the EU was slower than in other jurisdictions.  For example, the UK MHRA granted Comirnaty a temporary authorization on December 2, 2020.  The US FDA gave the vaccine an Emergency Use Authorization on December 11, 2020.  Whereas, the Commission did not grant a CMA for the vaccine until December 21, 2020.Continue Reading EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations

On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).

Purpose

AI…