Government publishes its response to consultation on mandatory disclosure of information about health service products
The Government has published its response to the consultation on legal requirements for the provision of information related to the sales and purchases of health service products, along with the finalised regulations and an impact assessment. Between 26 August and 14 November 2016, the government had consulted on their proposals, of which the principle ones were:
- The quarterly provision of aggregated transaction information about unbranded generic medicines and special medicinal products by manufacturers, importers and wholesalers.
- That companies record, keep, and provide, on request, transaction information about any health service product.
- That information be provided on request about the costs in connection with the manufacture, distribution or supply of health service products, or other aggregated business costs, impacting on manufacturers and wholesalers.
- That information be provided within 24 hours about volumes and prices about unbranded generic medicines and special medicinal products from manufacturers and wholesalers (concessionary prices).
- That notification of discontinuations and supply disruptions of health service medicines by marketing authorisation holders/manufacturers/importers be given with six months’ notice, and that urgent provision of information be given within 24 hours on request.
As a result of the consultation, which received 60 responses, the government has made the following changes to its proposals:
On the quarterly provision of aggregated transaction arrangements:
- Despite companies arguing that the voluntary regulations had worked well, the government concluded that it would be burdensome to maintain both sets of regulations, and therefore decided to terminate them.
- The proposed requirement to provide the government with information about the different categories of purchasers was dropped.
- For special Medicines manufactured in the UK, a requirement to provide information about the type of manufacture is now included.
- Following concerns raised by respondents, companies will be able to provide a reasonable estimate of their net sales income and/or the net purchase amount paid as it may not be possible to provide actual amounts for discounts, including rebates and other payments.
- As the government argued that it had reduced the amount of information companies were now required to provide after the consultation, it saw no reason to reduce the frequency with which information be provided, and so information must still be provided quarterly.
On the provision of transaction information on request:
- The government decided to limit the scope of the requested information to appliances and chemical reagents listed in Part IX of the Drug Tariff for England and Wales and equivalent lists in the Drug Tariffs for Scotland and Northern Ireland, as to include food and dermatological products would cause too much uncertainty.
- The government clarified that information about the categories of purchasers and whether a product is an English, Welsh, Scottish or Northern Ireland product, only had to be provided if known to the producer.
- The period for which information has to be kept has been reduced from six to four years.
- The definition of small producers has been broadened.
On information on costs:
- The government has clarified that for branded medicines, they can only require cost information related to the distribution or supply of a particular presentation of health service medicine and not in relation to its manufacture.
On concessionary prices:
- The deadline for providing information about available volumes and prices of generic medicines and special medicinal products, with a price list in part VIII of the Drug Tariff, has been reduced from 24 hours to within two working days.
On discontinuations and supply disruptions:
- The government has clarified that producers are only required to provide the uses of the medicines that the producer is aware of and that the producer can estimate its market share.
- Producers must also clarify whether the medicine is available under an NHS framework contract.
- The deadline for providing the information has been changed from 24 hours to within two working days.