33764 - Drugs: Regulation (Answered)

Justin Madders
To ask the Secretary of State for Health, which medicines have been reclassified from (a) prescription only medicine to pharmacy medicine status, (b) pharmacy medicine to general sales list medicine status and (c) prescription only medicine to general sales list medicine status in each of the last 25 years; for each of those medicines so reclassified what condition that medicine was designed to treat; and if he will make a statement.

George Freeman

The Government is committed to the continued reclassification of medicines from prescription only to pharmacy classification and from pharmacy to general sales list classification when it is safe to do so and there is a clear benefit to public health. This is an important part of empowering patients to manage their own care. The Government’s medicines regulator, the Medicines and Healthcare products Regulatory Agency, is at the forefront of moves to reclassify medicines to non-prescription and is recognised as a leader in Europe in this regard.

Over the years reclassification has been facilitated by improving the regulatory environment for manufacturers to achieve successful reclassification of their products. Amendments to legislation were introduced in 2002 to reduce the legislative burden for reclassification; new guidance was published in 2012 to streamline the process; and in 2015 a United Kingdom platform was set up to maximise stakeholder engagement with the aim of encouraging further reclassification of medicines.

Patient safety remains the prime consideration in any decision to make a medicine available without prescription.

We are unable to calculate the total difference in cost to the public purse following these medicine reclassifications.

The attached tables contain the information for each of the last 25 years on medicines reclassified from prescription only medicine (POM) to Pharmacy (P) medicine and P medicine to general sales list (GSL) medicine. There are no examples of medicines which have been reclassified from POM to GSL. Where relevant, brand names have been included in brackets.

The lists represent the first reclassification either from POM to P or P to GSL of the product and further extensions such as wider indications, additional pack sizes or higher strengths have not been included.

Not all products listed are currently available, for various reasons, including both commercial and regulatory.