We previously wrote about the new Health Services Medical Supplies (Costs) Act (see here). This important Act paved the way for the Government to gain greater control over excessive pricing of health services medicines and greater access to information about supply pricing and sales information. Consultations on the following have now been opened to explore how these new powers will be exercised:
- The proposal to amend the Statutory Scheme Controlling the Price of Branded Medicines (The Branded Health Service Medicines (Costs) Regulations); and
- The proposed legal requirements for the provision of information relating to the sale and purchase of health service products used in the NHS (The Health Service Products (Provision of Information and Disclosure) Regulations).
These consultations will close on 17 October 2017 and 14 November 2017 respectively, with the intention that both regulations will come into force in April 2018.
The Branded Health Service Medicines (Costs) Regulations
The proposed changes to the Statutory Scheme to be implemented by the regulation are:
- The introduction of a payment system similar but not identical to that in the 2014
- Changes to the provisions on maximum pricing systems; and
- Changes to the information requirements placed on companies, specifically information needed to enable the operation of the payment system.
The aim of these changes is to bring the Statutory Scheme closer in line with the PPRS.
The Health Service Products (Provision of Information and Disclosure) Regulations
The proposed Health Service Products (Provision of Information and Disclosure) Regulations prescribe who will have to provide information regarding health service products on a regular basis, what information must be retained and what information would have to be provided on request. The Regulations also contain requirements for notification of the discontinuation or shortage of supply of health service medicines.
Specifically, the consultation document contains the following proposed requirements:
- Quarterly provision of transaction information related to unbranded generic medicines and special medicinal products;
- Recording, retaining and providing on request transaction information regarding health service products impacting those in the supply chain;
- Provision of information on request about costs in connection with the manufacture, distribution or supply of health service products, or other aggregated business costs impacting manufacturers and wholesalers;
- Provision of information within 24 hours about volumes and prices of unbranded generic medicines and special medicinal products from manufacturers and wholesalers; and
- Notification of discontinuations and supply disruptions of health service medicines.
The consultation documents are available at: https://www.gov.uk/government/consultations/information-about-health-service-products-proposed-requirements and https://www.gov.uk/government/consultations/statutory-scheme-to-control-cost-of-branded-medicines-consultation