Euro Roundup: Lords tell UK government to protect drug, device regulation in trade bill

The House of Lords has voted in favor of an amendment intended to stop the UK government from striking trade deals that “undermine or restrict” the country’s ability to “regulate and maintain the quality and safety of medicines and medical devices.”
 
Politicians began debating the Trade Bill 2019-21, which covers the international agreements the UK hopes to strike after completing its split from the European Union, in March. Throughout that time, opposition politicians and members of the House of Lords have sought to place restrictions on what the government can agree in trade deals, including through provisions intended to limit access to the UK health service.
 
With the legislative process nearing an end, the House of Lords made another attempt to restrict the UK government. The Lords passed a healthcare amendment by 232 votes to 143 that would stop the government from forming international trade deals that negatively affect the ability of the Medicines and Healthcare products Regulatory Agency (MHRA) to regulate the industry, among other things.
 
The health-focused amendment was one of four changes supported by the Lords. Soon, the text will return to the House of Commons, which is made up of elected politicians, and the process of trying to agree to the exact wording will begin. In theory, the Lords and Commons can send amendments back and forth until they are unable to reach an agreement and the bill fails. In practice, the government, which is opposed to the health-focused amendment, typically gets its way.
 
Debate Transcript, Summary
 
MHRA posts guidance on registering to sell medical devices after Brexit
 
MHRA has released guidance on registering to sell medical devices after the UK finishes its split from the EU at the end of the year. The guidance details who needs to register and by when.
 
The guidance reiterates the previously disclosed staggered, risk-based set of deadlines for registering devices with MHRA, which starts with Class III devices on 1 May and ends with Class I products at the start of 2022. While that gives companies up to 12 months, MHRA is encouraging businesses to put a UK Responsible Person in place as soon as possible after 1 January.
 
Companies need to create accounts on the MHRA Device Online Registration System (DORS) before they can register devices. Once set up on MHRA DORS, companies will need to share details of their operations and the device being registered, including which regulations it is subject to and attributes such as sterility.
 
The guidance addresses the situation for manufacturers that want to sell devices in Northern Ireland, which will remain subject to EU regulation after Brexit. In some circumstances, manufacturers will need to inform MHRA when they first place a device on the Northern Ireland market.
 
MHRA Guidance
 
Ireland’s HPRA clarifies status of products placed on EU, UK markets before Brexit
 
Ireland’s Health Products Regulatory Authority (HPRA) has detailed the status of products placed on the EU and UK markets before they formally separate at the end of the year. The advice is based on a notice the European Medicines Agency (EMA) issued earlier this year.
 
Some products placed on the market before the UK separates from the EU will not be used until after the split is complete. The situation raises questions about how medicinal products legally placed on the market under the old regulatory regime will be handled once it changes.
 
The EMA notice allows products made available in the EU and UK before the end of the transition period to continue circulating between the two markets until they reach the end user. That means medicines certified by a Qualified Person and released in the UK before 11 pm on 31 December can be supplied in Ireland after that point in time.
 
HPRA said the receiving site in Ireland must confirm the product was manufactured, certified and released before the deadline and check it has been stored appropriately since then. The onus is on the receiving site to access documents that show those requirements have been met. A written statement from the marketing authorization holder is among the acceptable evidence.
 
The stipulations apply to products released in England, Scotland and Wales. From HPRA’s perspective, there will be no change to the existing regulatory requirements for products released onto the Northern Ireland market.
 
HPRA Notice
 
Finland starts pilot of incoming EU clinical trial assessment process
 
The Finnish Medicines Agency (Fimea) has begun piloting the new EU clinical trial assessment process. Fimea is seeking sponsors that want to participate in the pilot to help the agency prepare for the new regulations.
 
Trials accepted into the pilot will be assessed in accordance with the existing law but “the assessment procedure and processing times pursuant to the EU Regulation will be taken into account in the pilot where applicable.”
 
Participation in the pilot project will help sponsors to prepare for the new regulation, according to Fimea. A “limited number” of clinical trial applications will be chosen. Advanced therapy medicinal products and products related to COVID-19 are ineligible for the program. Fimea will determine the potential inclusion of substantial amendments during the pilot.
 
Working with the National Committee on Medical Research Ethics, Fimea will assess early results from the pilot and make changes to the process if needed. Fimea will seek feedback from sponsors that participate in the pilot.
 
Fimea Notice
 
MHRA details ‘around the clock’ review that enabled fast COVID vaccine OK
 
MHRA chief executive June Raine has outlined how the UK approved Pfizer and BioNTech’s COVID-19 vaccine before other regulators, describing a process that began in June and culminated in an around-the-clock review of the final data.
 
Officials in the EU and US have voiced reservations about the speed of the UK approval, in part due to fears it could undermine public confidence in vaccines. However, Raine, in a piece published in a UK newspaper and by MHRA, argued her agency “robustly and thoroughly reviewed” the data “with great scientific rigour.”
 
MHRA moved fast without cutting corners by putting an independent expert group in place in June and continuing to lay the groundwork over the following months, Raine wrote. MHRA then used a rolling review to assess aspects of the data before the final efficacy results became available. Other regulators are also performing rolling reviews.
 
“Our assessors have worked around the clock, reviewing hundreds of pages of data,” Raine said. “I can assure you without reservation that the standards we have worked to are equivalent to those around the world – no corners have been cut.”
 
Raine Statement