Euro Roundup: UK rejects new agency to redress drug, device harms

The UK government has rejected a call to establish an independent redress agency. Baroness Cumberlege, a Conservative party member of the House of Lords, called for the government to create the agency after her review of patient safety in the UK identified a need for a new way to remedy harms caused by some medicines and medical devices.
 
Last year, the Independent Medicines and Medical Devices Safety Review advised the government to set up an independent redress agency for people harmed by medicines and medical devices. Patients with adverse events related to products such as pelvic mesh have not been well served by litigation, according to the authors of report on the subject. The proposed agency would give patients a redress structure that was easier to access and use.
 
In explaining the decision not to set up an independent redress agency, Nadine Dorries, minister for mental health, suicide prevention and patient safety, said the “government and industry have previously established redress schemes without the need for an additional agency.” The government also rejected the call for the creation of an independent taskforce to implement the recommendations of the review.
 
Dorries also spoke on a recommendation to substantially revise MHRA, explaining that the agency has “begun a substantial program of work to improve how it involves patients in all aspects of its work.”
 
The government is also acting on a recommendation to create an independent patient safety commissioner. Officials are enacting the recommendation by amending the Medicines and Medical Devices Bill now making its way through parliament. Dorries said the proposed commissioner “will act as an independent advocate for patients, and strengthen the ability of our health services to listen to the voice of patients.”
 
Government Update
 
MHRA forms consortium to support safer medicine use during pregnancy
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has set up a consortium to support the safer use of medicines by women who are pregnant, thinking about becoming pregnant or breastfeeding. The consortium includes 16 organizations that will work to improve the medicine safety information available to women.
 
Existing information available to women “can be both inconsistent and inadequate” due to “a paucity of evidence and data on the impact of many medications on pregnancy and breastfeeding,” according to MHRA. The agency aims to improve messaging and identify gaps in knowledge.
 
The National Institute for Care and Health Excellence (NICE) is participating in the consortium. NICE members will collaborate on the development of quality criteria and ways to make it easy for women and healthcare professionals to identify information that meets the standards.
 
MHRA published details of the consortium on the same day that it issued a report on improving data collection during pregnancy. The working group set out ways to address gaps in data collection, such as implementing Electronic Prescribing and Medicines Administration systems in maternity wards, and optimizing the linkage of existing datasets.
 
Other initiatives proposed by the expert working group include capturing more data, such as dosing duration, from general practice and prescription dispensing sources in a structured format. Through that action and other changes, the working group thinks the UK can improve the quality of data on the use of medicines during pregnancy and breastfeeding.
 
“This will enable the generation of better evidence on medicines used in pregnancy and will be vitally important when developing clear and consistent advice for women,” said Nadine Dorries, minister for mental health, suicide prevention and patient safety.
Press Release, MHRA Guidance, More
 
EMA updates Comirnaty label to permit an extra vaccine dose per vial
 
The European Medicines Agency (EMA) has changed the label for Comirnaty (Pfizer/BioNTech) to state each vial contains six doses of the COVID-19 vaccine.
 
In the original Summary of Product Characteristics (SPC), EMA stated “one vial (0.45 mL) contains 5 doses of 0.3 mL after dilution.” The statement was in line with the labels in other markets where the vaccine is available. However, healthcare professionals discovered material was still present in vials after administering five doses.
 
The Committee for Medicinal Products for Human Use (CHMP), echoing the actions of its peers in the US and UK, called for EMA to change the label to show the vials contain six doses. EMA moved quickly to make the change, which is now part of the vaccine’s online label.
 
CHMP advised healthcare professionals that low dead-volume syringes must be used to obtain six doses from each vial. If less than 0.3 ml is left after taking five doses, the healthcare professional should discard the vial and its contents. Healthcare professionals cannot pool the contents of vials to get an extra dose.
 
EMA Notice, Updated SPC
 
EMA drops need for structured risk management plan filings amid pandemic
 
EMA has dropped the requirement for companies to submit risk management plans (RMPs) in the structured electronic format known as EU-RMP Annex 1. The agency made the change as part of its response to COVID-19.
 
The change, which is based on EMA’s business continuity plan, means companies no longer need to file a structured electronic representation of the RMP as part of their risk management activities.
 
EMA plans to provide updated information “in due course.” For now, the webpage that used to link out to the user manual for EU-RMP Annex 1 and explain how the structured files are the interface between EU-RMP and EudraVigilance just features a brief note that submissions are paused.
 
The current version of the business continuity plan lacks direct references to RMPs. However, the document states that in the second phase of the plan, which is currently active, European agencies will need to prioritize certain activities as they are experiencing difficulties fulfilling normal regulatory tasks.
 
EMA Update
 
Other News:
 
EMA has finalized and adopted its reflection paper on dose review and adjustment of established veterinary antibiotics. The agency released the draft for consultation in 2018, attracting comments from five organizations. EMA presented the comments in a 150-page overview. The feedback led EMA to make significant changes to the structure and content of the draft paper. Reflection Paper
 
EMA is seeking feedback on a “minor revision” to its EudraVigilance access policy for medicines for veterinary use. The change is intended to increase transparency by making it simpler for marketing authorization holders to access event reports that reference their products. The change will end the need to file a formal request for access. EMA is accepting feedback until 12 March. Draft Document
 
Ireland’s Health Products Regulatory Authority (HPRA) has updated its guide to the renewal of the marketing authorizations of human medicines. The revised text states it is no longer necessary to file product information at the end of the renewal procedure unless minor editorial changes are being introduced. In that case, revised product information should be sent as the agreed national text. HPRA Guidance