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On 31 January 2022, Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal products and medical devices was published in the Official Journal of the EU. This Regulation sets out a stronger role for the EMA in managing public health crises, and aims to formalise the ad-hoc structures and processes that have been used by the EMA during the COVID-19 pandemic. The intention is that these ad hoc process can now serve as a blueprint for a more harmonised EU response to future public health emergencies.

The reinforced role of the EMA is seen as an important development for the European Health Union. It aims to ensure that the EU is better prepared to manage future health crises by tackling shortages of medicines and medical devices more effectively and to develop medical countermeasures to address the threats posed to public health at an early stage and in a harmonised way. As part of this, the Regulation sets out important provisions on monitoring shortages of medicines and devices, and a greater role of the EMA in overseeing medical devices.…

Continue Reading New EU Regulation Reinforcing the Role of the EMA

The European Commission has published a proposal for a Regulation reinforcing the European Medicines Agency’s (EMA) role in crisis preparedness and management for medicinal products and medical devices. According to the European Commission, the COVID-19 pandemic demonstrated that the EMA has a limited ability to manage availability issues relating to medicinal products and medical devices and lacks a framework for crisis response. The aim of the proposed Regulation is to set up such a framework which will allow the EU to respond effectively to health emergencies through broader engagement with the relevant stakeholders in a coordinated and timely manner to achieve the over-arching objective of public health protection.
Continue Reading Draft EU Framework for Coordinated Approach to Addressing Emergency Public Health Threats

On 28 August 2020, the UK Department of Health & Social Care published a consultation on proposed changes to the Human Medicines Regulations 2012 (HMRs) to support the rollout of COVID-19 vaccines.…
Continue Reading Consultation on legislative changes to support the rollout of COVID-19 vaccines in the UK

Earlier this month, we commented on the European Commission proposal for a Regulation accelerating existing procedures for clinical trials where medicinal products containing or consisting of Genetically Modified Organisms (GMOs) are tested for the development of vaccines and therapies to treat COVID-19. The European Commission had proposed that, during the pandemic and by derogation to the GMO regulatory framework, the requirement of a prior environmental risk assessment or consent by the national competent authorities should not apply. …
Continue Reading Update: Regulation for COVID-19 clinical trials conducted with medicinal products containing or consisting of GMOs has now been adopted

On 4 May 2020, the European Medicines Agency (EMA) issued a guidance to support development and regulatory approval for treatments and vaccines for COVID-19 with the involvement of the dedicated EMA Pandemic Task Force (COVID-ETF). It sets out the available regulatory pathways to fast-track assessment of both new or repurposed methods of treating or preventing COVID-19.

Background

This guidance is part of EMA’s efforts to support the development and availability of medicinal products for COVID-19 to address this public health emergency. See also EMA’s guidance on clinical management trials (which we have summarised in a prior Advisory)

This latest guidance is based on the existing and established regulatory procedures to accelerate regulatory review and approval with appropriate adaptations  in direct response to COVID-19 pandemic.
Continue Reading EMA Guidance on fast-tracking the development and approval of treatments and vaccines for COVID-19

The spread of SARS-CoV-2 has created an urgent need to scale up the production and supply of essential medical equipment, including so-called Rapidly Manufactured Ventilator Systems (RMVSs), to treat COVID-19 patients. To help meet this challenge, the UK government announced on 3 April 2020 that it will indemnify designers and manufacturers of RMVSs for claims relating to infringement of third-party intellectual property (IP) rights and for product liability claims resulting from defective equipment.

Formal notification of the two indemnities was given by the Minister for the Cabinet Office, Michael Gove, to the Public Accounts Committee on 3 April 2020.[1] In the notice, Minister Grove noted that he could not give the normal fourteen sitting days’ notice because “commercial negotiations have only just concluded and contract signature did not allow further delay”. Details of the terms of the referenced agreement have not, however, been provided, as they were said to be commercially sensitive and would continue to be until negotiations had been finalised. It is therefore not yet clear who are the parties to the agreement, whether any cap will apply to the indemnities, whether the government will offer the same terms across the board, or whether it will negotiate them in individual supply agreements.…

Continue Reading UK Government Offers IP Indemnity to Designers and Manufacturers of Ventilators for COVID-19 Patients