Changes to the statutory scheme to control the costs of branded health service medicines

Closed 18 Sep 2018

Opened 7 Aug 2018

Results Updated 3 Dec 2018

Thank you for your responses and feedback as part of this consultation. Following analysis and consideration of the responses, the Government has laid the Branded Health Service Medicines (Costs) (Amendment) Regulations 2018 in Parliament. These can be found at

This will change the statutory scheme for medicines pricing from 1 January 2019, with the reasons for the changes set out in full in the Government response to the consultation which is held on The final Imapct Assessment, which was revised from the consultation version as a consequence of feedback from the consultation, is also held on that page.


The statutory scheme for pharmaceutical pricing safeguards the financial position of the NHS by limiting the cost of branded health service medicines for companies who choose not to join the accompanying voluntary Pharmaceutical Price Regulation Scheme (PPRS).

The current voluntary scheme expires on 31 December 2018. Negotiations are underway on a successor. Concurrently, the Government is proposing to amend the Branded Health Service Medicines (Costs) 2018 Regulations to alter the statutory scheme from 1 January and we are seeking views on proposals regarding:

  • Changing the payment percentage;
  • Changing the application of the payment system for sales of medicines supplied under a contract with a contracting authority based on a framework agreement or under a public contract; and
  • Including all biological medicinal products (including biosimilars) within the scope of health service medicines captured by the payment mechanism, price controls and information requirements.

Please read the consultation document and draft Impact Assessment before responding to this consultion. These documents are available at:

The consultation will run for 6 weeks and close at 23:59 on 18 September 2018. The timing ensures there is enough time to complete the required parliamentary process as well as providing a sufficent period for consultees to consider responses. You will be asked a series of questions and required to input your responses either by clicking the corresponding button or by typing in responses where this is appropriate.

What Happens Next

We will evaluate your views and any additional evidence provided to finalise our proposals. A response to this consultation will be published on GOV.UK and amendments to Regulations made in Parliament in December 2018, so that a revised statutory scheme can begin from 1 January 2019.


  • NHS Commissioning Board
  • Clinical Commissioning Groups
  • patient groups and patient advocates
  • Members of the public
  • Patients
  • Suppliers


  • Regulation