MHRA will take a ‘more proactive approach’ to reclassification, says chief executive

The Medicines and Healthcare products Regulatory Agency (MHRA) will take a more proactive approach towards reclassification of medicines, according to its chief executive.

Speaking at an event held by the Proprietary Association of Great Britain (PAGB) in central London on 12 December 2023, June Raine told attendees that the medicines regulator would look to streamline its processes that oversee drug reclassification from prescription-only to pharmacy (P) or over-the-counter (OTC) status.

Raine told the audience that, since it marked its 75th anniversary in 2023, the NHS’s “focus is going to be on prevention, personalisation and participation in healthcare, and care closer to home”.

“Those themes chime exactly with reclassification, so we can begin to see that strong push to make more medicines available OTC as soon as it’s safe to do so,” she added.

Citing a paper published by the PAGB in July 2023 — which said that greater use of existing OTC medicines could save the NHS £1.7bn annually — Raine said that a reduction in medicine prescribing of 5% through reclassification could save the NHS an additional £1.4bn each year.

“So there are powerful arguments to put our energy into reclassification,” she said.

“We are a lifecycle regulator. We have said that the blueprint of a regulator is to see that lifecycle from scientific innovation through to accelerating access and strengthening patient safety, always putting the patient and the consumer first.”

Raine added that one of the MHRA’s three priorities on reclassification for the future would be to take “a more proactive approach”.

“There are plenty of companies busy safeguarding their molecule who may not have reclassification front of mind, maybe it’s not the first thought of developers.

“And then let’s streamline our processes, make them simple and straightforward and improve our safety monitoring, which is the bedrock of taking those risks.”

In May 2023, the government published its ‘Delivery plan for recovering access to primary care’, which said that the MHRA should work with the Department of Health and Social Care (DHSC) and NHS England to identify medicines that could be reclassified from prescription-only to P, “based on international practice and real-world evidence of safety”.

Raine said that the MHRA’s ‘route map’ would be based on this delivery plan.

“Let’s think about international best practice and real-world evidence. We live in a land now of federated databases and access to safety data that should speak to us about when products are ready for a switch,” she said.

“And we must think more about the different strengths and formulations that the public would like to be accessing.”