Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 5 June (HL8118), (1) how many, and (2) what percentage of, Marketing Authorisation Holders had NHS sales below £5 million in the most recent fiscal year for which data is available.

The Medicines and Healthcare products Regulatory Agency (MHRA) has 800 Marketing Authorisation Holders (MAHs) registered on their system.

For medicine licensing purposes we do not hold information on MAHs in relation to the size of their business. The MHRA does have a payment easement scheme for small companies who voluntarily apply and can demonstrate they meet at least two of the following criteria:

- annual turnover must be not more than £6.5 million;

- the balance sheet total must be not more than £3.26 million; and

- the average number of employees must be not more than 50.

The MHRA has 17 MAHs who are currently registered on the MHRA’s payment easement scheme

We do hold information on companies making sales of branded medicines which had sales of less than £5 million to the National Health Service. However, this does not distinguish between companies which are the MAHs, and those which are not. Currently, there are 93 companies which, through membership of the 2014 Pharmaceutical Price Regulation Scheme (PPRS), are assessed as having NHS sales (as defined by the scheme) of less than £5 million. Of those companies which are not members of the 2014 PPRS and therefore fall under the statutory pharmaceutical pricing scheme, 85 are currently assessed as having NHS sales of branded medicines (as defined by the scheme) of less than £5 million. We do not hold this data for manufacturers of generic medicines.