EU Regulatory Roundup: MHRA puts speed-to-market at center of post-Brexit vision

Speed-to-market is the cornerstone of the 2020-2021 post-Brexit strategy for the UK Medicines and Healthcare products Regulatory Agency (MHRA), according to the agency’s business plan published 10 June 2020.
 
The UK left the European Union earlier this year but remains covered by its rules until the end of 2020. Unless the UK and EU agree to a delay by the end of June, the two parties will fully separate at the start of next year. Exactly how the separation happens will depend on whether a trade deal is reached; however, to some extent, MHRA will be free to plot a course as an independent regulatory agency.
 
In its business plan, MHRA sets out “three fundamental shifts” to how it plans to operate going forward. The first shifts is a “focus on UK patient access to highly innovative products, with oversight of safety and clinical impact from earliest (including ‘experimental’) use.”
 
To that end, one goal for the period is to “develop streamlined approaches to supporting innovation in medicines and medical devices, so that new products can come safely and more quickly to the UK market to the benefit of patients.” MHRA also plans to “develop a new compelling innovation offer” that encourages the development of new products for use in the UK.
 
The focus on speed overlaps with the two other fundamental shifts. One of the shifts relates to post-market surveillance, which MHRA wants to transform through “systematic data-driven analysis of real-world use in the NHS, underpinned by data analytics and increased artificial intelligence capacity.” More effective post-market oversight could complement MHRA’s push to get drugs to patients sooner.
 
The third fundamental shift relates to patients themselves. MHRA wants to “engage patients in the agency’s work, drive real influence on clinical practice and enable patients to make informed decisions.”
 
Exactly how those priorities shape MHRA will depend on the terms of the ongoing relationship between the UK and EU. The regulation of medicines and medical devices is an area in which the UK has expressed an interest in continuing to work closely with the EU. However, if negotiations covering the broader trade deal collapse, MHRA could be completely cut off from the EU regulatory network, forcing it to handle more tasks itself but also giving it the freedom to create new policies.
 
MHRA Plan
 
EMA adds potential COVID-19 drugs to pharmacovigilance program
 
The European Medicines Agency (EMA)  has extended its medical literature monitoring program to cover nine possible treatments for COVID-19. The change could improve the monitoring of the safety of the medicines.
 
Typically, marketing authorization holders (MAHs) are responsible for monitoring the medical literature for reports about their medicines. However, since 2015 EMA has kept track of a number of drugs to avoid duplicated efforts by MAHs that sell products containing the same active ingredient, enhance the consistency of data and improve safety monitoring.
 
Recently, EMA added chloroquine, darunavir, emtricitabine-tenofovir, filgrastim, ivermectin, nitric oxide, oseltamivir, prednisone and ritonavir to its monitoring program. EMA selected the drugs as they are being investigated in COVID-19 and are sold by multiple MAHs.
 
EMA also expanded the search terms for six active substances already covered by the program. The change is intended to enable EMA to detect reports related to the use of azithromycin, ciclosporin, dexamethasone, hydrocortisone, ribavirin and prednisolone to treat COVID-19.
 
EMA Update
 
MHRA releases guidance on 3D printing devices during COVID-19 pandemic
 
Guidance from MHRA aims to support companies that want to use 3D printing technology to address COVID-19-related shortages of medical devices and personal protective equipment.
 
3D printing has emerged as one way to ensure healthcare providers can access personal protective equipment (PPE), ventilator components and other devices essential to the management of the virus and the patients it infects.
 
The MHRA guidance highlights the regulations that apply to different types of products. The set of regulations that apply differs depending on whether a product is classed as PPE or a medical device.
 
Organizations that want to 3D print non-CE marked medical devices must seek MHRA exceptional use authorization. Before doing so, MHRA wants organizations to consider whether original parts, or alternatives with the same specifications, are available. If 3D printing is the only option, MHRA wants people to consider the risks, perform technical assessments and assess biological safety.
 
The rules covering PPE depend on whether the device is intended to protect the wearer, the patient or both. MHRA provides links to the relevant regulations for different types of PPE in the guidance.
 
MHRA Guidance
 
EDQM grants COVID-19 vaccine developers free access to quality standards
 
Vaccine quality standards from the European Directorate for the Quality of Medicines (EDQM) are temporarily available for free to support development of vaccines against coronavirus.
 
Noting that universities and small and medium-sized enterprises are among the groups developing COVID-19 vaccines, EDQM said access to the resources could inform the design of suitable analytical strategies for experimental candidates. EDQM also thinks access to the standards may help to ensure the quality and safety of the final product.
 
There is also scope for the quality standards to help vaccine developers avoid time-consuming delays. According to EDQM, the application of the quality requirements could support regulatory acceptance of filings for marketing authorization.
 
EDQM Notice
 
UK committee probes effect of US trade talks on drug pricing
 
A House of Lords subcommittee is seeking expert input on the medical aspects of ongoing trade talks between the UK and US.
 
Striking a free trade deal with the US is critical to the UK government’s plans to use Brexit to expand the opportunities for British businesses and workers. However, there are concerns that the deal will drive up drug prices and give private companies greater access to the UK’s state-funded healthcare service, leading the government to state “the NHS will not be on the table” in the talks.
 
Now, a House of Lords subcommittee is gathering evidence to inform an inquiry into the trade negotiations. The call for evidence features two questions that relate directly to medicines and medical devices.
 

• How realistic is the UK’s approach to pharmaceutical and medical devices?
• What would be the effects if the cap on NHS drug prices were removed or raised?

 
The questions probe whether the UK government can deliver on its assertion that “the price the NHS pays for drugs will not be on the table,” and what it will mean for the country if pricing is affected by the trade deal.
 
Press Release