New legislation means the end of Scheme M

The government is to scrap the voluntary schemes that enable it to monitor the prices of medicines, particularly generics and specials, despite the fact that half the respondents to a formal consultation opposed the proposal.

The three schemes affected are:

  • Scheme M between the Department of Health and Social Care and the British Generic Manufacturers Association (BGMA)
  • Scheme W between the Department and the Healthcare Distribution Association UK (HDA)
  • Memorandum of understanding for manufactured specials between the Department and the Association of Pharmaceutical Specials Manufacturers.

The DH announced a consultation on the provision of information related to the sales and purchases of health service products last August.

New legislation published last month at the same time as the outcome of the consultation will require manufacturers, import-suppliers and wholesalers of unbranded generic medicines to provide information every quarter about their sales. Similar requirements will apply to manufacturers, importers and wholesalers of specials.

The requirement is to provide information by the 28th of the month following the end of the quarter. Those in the supply chain (pharmacies are excluded) will have to retain an extensive list of documentation to make available to the DH on request for a period of up to six years.

There will be a requirement on manufacturers, wholesalers and importers to provide information within 48 hours about available volumes and prices of generic medicines and special medicinal products that are listed in part VIII of the Drug Tariff. The Department plans to use such information to inform any concessionary prices.


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