Unlicensed Medicines

When people hear the term “unlicensed medicine,” it often sparks confusion or concern. Some may associate it with illegality or potential harm. However, the truth is that unlicensed medicines play a crucial role in healthcare, and their use is both legal and often necessary. Let’s unpack what unlicensed medicines are and why they’re vital for patient care.

What Are Unlicensed Medicines?

An unlicensed medicine is one that hasn’t undergone the full process of obtaining a UK marketing authorisation (licence). This doesn’t mean the medicine is unsafe, illegal, or experimental. It simply indicates that it hasn’t been licensed for a specific use or population in the UK, even if it is licensed and widely used in other countries.

Examples of unlicensed medicines include:

Specials: Medicines specially prepared to meet the unique needs of a particular patient when no licensed alternative is available.

Off-label Use: When a licensed medicine is used in a way not covered by its licence, such as a different dosage, method of administration, or for an unapproved condition.

Why Are Unlicensed Medicines Necessary?

Unlicensed medicines are essential for addressing individual medical needs, particularly when licensed options are unavailable or unsuitable. For example:

Rare Conditions: For patients with rare diseases, there may not be enough demand for pharmaceutical companies to invest in licensing specific treatments.

Customised Treatments: Children, elderly patients, or those with allergies may require medicines in forms or dosages not available in licensed products.

Cannabis-Based Products for Medicinal Use (CBPMs): These fall under unlicensed medicines and are prescribed for specific conditions, such as severe epilepsy, when other treatments have failed.

Are Unlicensed Medicines Safe?

Safety is a top priority for all medicines, whether licensed or unlicensed. The Medicines and Healthcare products Regulatory Agency (MHRA) oversees the manufacture, importation, and supply of unlicensed medicines in the UK. These medicines must meet strict quality standards, including adherence to Good Manufacturing Practice (GMP).

Additionally, only qualified healthcare professionals, such as specialist doctors, can prescribe unlicensed medicines. This ensures that every prescription is carefully considered, balancing potential benefits against any risks.

The Legal Framework

It’s important to understand that the use of unlicensed medicines is entirely legal when prescribed by a qualified practitioner. These medicines are tailored to meet the specific needs of a patient, offering solutions where standard treatments may not suffice.

For example, the MHRA provides clear guidelines for the production and supply of unlicensed cannabis-based medicinal products, ensuring they are manufactured safely and responsibly.

Addressing Common Misconceptions

“Unlicensed means dangerous.” False. While these medicines lack a UK licence, they undergo rigorous scrutiny to ensure safety and efficacy.

“Unlicensed medicines are illegal.” Incorrect. They are legally prescribed to address individual patient needs.

“Only experimental drugs are unlicensed.” Not true. Many well-established treatments, including certain life-saving therapies, are unlicensed for specific uses but are widely trusted by healthcare professionals.

A Vital Part of Modern Medicine

Unlicensed medicines fill an important gap in patient care, offering tailored solutions when standard treatments fall short. Their use is carefully regulated, ensuring that they are both safe and effective. The next time you hear the term “unlicensed medicine,” remember that it represents adaptability and innovation in healthcare—not a cause for alarm.

By understanding their purpose and the safeguards in place, we can appreciate the critical role these medicines play in improving patient outcomes and quality of life.

Published: February 20th 2025