Reclassification

What is reclassification?

Reclassification is the process of changing the legal status of a medicine. It is also referred to as “switching”.

When data shows that a medicine can be used appropriately and effectively without intervention from a doctor, its legal status can be changed via reclassification. This makes it available over-the-counter without a prescription, empowering patients to self-care and alleviating demand for NHS services.

In the UK the legal classification of a medicine determines the level of control over its supply.

Categories of medicines

There are three categories that a medicine can be classified within:

Prescription-Only Medicine (POM) – which has to be prescribed by a doctor or other authorised healthcare professional and must be dispensed from a pharmacy or another specifically licensed place
Pharmacy (P) – which can be bought only under a pharmacist’s supervision within a pharmacy
General Sales List (GSL) – which can be bought from retail stores, such as newsagents, supermarkets or vending machines in a shop

P and GSL medicines are collectively known as over-the-counter (OTC) medicines.

Types of reclassification

The underlying principle for classifying medicines is to maximise timely access to effective medicines, while minimising the risk of harm from inappropriate use.

As such, all new medicines or new combination products are initially granted a POM licence. Overtime, growing confidence of the medicine’s role and improved understanding of its side effects can lead to a change in classification – known as ‘reclassification’ or ‘switching’.

Reclassification may involve three types of switches:

Prescription-Only Medicines to Pharmacy
Pharmacy to General Sales List
Prescription-Only Medicines to General Sales List

How does Reclassification help patients and the NHS?

By making a medicine available OTC, there are a number of benefits to an individual looking to self-care:

People can have rapid and convenient access to medicines
Exercise more autonomy and choice
Quickly relieve their ailments

Pharmacies have longer hours than GP surgeries and are often open at the weekends. Furthermore, over 99% of those living in areas of the highest deprivation are within a 20-minute walk of a community pharmacy,^[1] making the medicines available at pharmacies an accessible resource for people with health concerns.

For the system more broadly, a greater availability of OTC medicines means:

Fewer GP visits
Fewer A&E interactions
Prevention of worsening of conditions

[1] https://selfcarestrategy.org/wp-content/uploads/2021/10/Realising-the-potential-developing-a-blueprint-for-a-self-care-strategy-for-England-WEB-VERSION_final.pdf

Statistics from our report on the Economic Impact of Over-The-Counter Products in the UK

96% of people in the UK

have at least one self treatable condition annually

Statistics from our report on the Economic Impact of Over-The-Counter Products in the UK

43% of people in the UK

have four or more self treatable conditions annually

Statistics from our report on the Economic Impact of Over-The-Counter Products in the UK

There’s potential to save the NHS £1.4 bn per year

by switching 5% of prescription-only medicines to OTC

Our work on reclassification

Developed a proposal to reinvigorate reclassification to support industry in making more reclassification applications

The proposal detailed in our ’40 years on: setting a new ambition for reclassification’ briefing provides an overview of asks, which included:

• Establishing a reclassification Alliance

• Producing a list of conditions or categories that could be switched

• Adapting the process relating to reclassification to streamline applications and encourage applications

• Widening the parameters for exclusivity

During 2023, we were able to activate work on all of these asks and began engaging with relevant governmental and pharmacy stakeholders to deliver this work.

As we are moving through 2024, the ongoing work in all of these areas remains live and the aim is to continue the progress with the new government following the general election.

Working with government to implement the delivery of the Primary Care Recovery Plan

Following the announcement in May 2023 that reclassification is included in the government and NHS England’s ‘Delivery plan for recovering access to primary care’, we have:

• Met with No.10

• Co-ordinated the reestablishment of the Reclassification Alliance in September 2023 with MHRA and DHSC, and attended subsequent meetings

• Been leading the Conditions and Categories workstream to produce a list of categories and conditions in Q1 2024 (N.B. this list has been developed but has yet to be published)

• Provided additional insights and championed ideas about how categories and products that have already been switched could have their indications widened

• Supported by inputting into other workstreams

In 2024, we have also led on phase two of the Conditions and Categories workstream to explore in more detail opportunities that could be added to the list that has already been developed.

As part of PAGB’s self-care manifesto asks, we remain committed to continuing this important work with future government and have called on them to all political parties to ensure this is included in their plans. We have also highlighted this in a report that PAGB are drafting to be shared with new administration detailing actions for the ‘First 100 days’ following the general election.

Actively engaging with key stakeholders

The work we have delivered so far includes:

• Hosting an event in December 2023 to celebrate 40 Years of Reclassification

• Fortnightly meetings with MHRA and DHSC to activate work

• Attending workshops and meetings in relation to all workstreams within the Reclassification Alliance

• Liaising with key pharmacy associations and stakeholders

• Engaging with trade press to raise awareness of reclassification and the work being undertaken

Engaging with our members

We support our members through:

• Our active Reclassification Working Group which feeds into regulatory policy and activities with MHRA, and includes developing process proposals to share with MHRA

• Keeping the Reclassification Working Group up to date with the ongoing collaborations with MHRA, DHSC and the Reclassification Alliance

• Reclassification Guidance produced for PAGB Members

• Our Reclassification Training Workshops, developed in 2023 and running every 6 months for members

• Bespoke advice pre, during and post reclassification submissions and assessment

• Advertising advice and support for new launch campaigns

Wider international support

At an international level, our work includes:

• Providing overviews and support to other trade associations and/or countries, including Sweden and Brazil in 2023

• Providing advice to companies outside of UK via consultancy work

Member briefing on Reclassification

PAGB members can read our briefing – ’40 years on: setting a new ambition for reclassification’ here.

Find out more

Watch our video: PAGB – the expert voice on reclassification

Key milestones for reclassification in 2023

January 2023: We launched guidance for members on reclassification.

February 2023: We held our first Reclassification Workshops, which were so in demand with our members that we ran 2 sessions in one day!

March 2023: Michelle Riddalls, PAGB’s CEO, went to Sweden to present on UK history of reclassification.

April 2023: Michelle Riddalls presented on Reclassification Proposals at Nicholas Hall’s CHC European Conference.

May 2023: Reclassification was included in the Delivery plan for recovering access to primary care (Primary Care Recovery Plan) – a huge win for PAGB, our partners and the public.

June 2023: We attended a meeting with No.10 with the DHSC and MHRA to discuss the implementation of the Primary Care Recovery Plan.

July – August 2023: We attended several meetings: with DHSC and MHRA to discuss implementation; with our members’ Reclassification working group; and with MHRA to discuss to review processes.

September 2023: Marked the inaugural meeting of the Reclassification Alliance.

November 2023: PAGB kicked of the Categories and Conditions work for the Reclassification Alliance, and shared input into other DHSC and MHRA led workstreams, as well as liaising with members.

December 2023: We hosted a celebratory event to mark the 40 year anniversary of reclassification in the UK. We also attended meetings on Categories and Conditions and a processes workshop with MHRA.

Self-care

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