My Lords, as we have heard loud and clear today, this Bill is fraught with many critical flaws that the Government must address. However, I will focus on the concerns that have been expressed by pharmacists about the wording of Clause 3, relating to the development of a successor UK system to prevent the supply of falsified medicines, which is symptomatic of the Government’s high-handed approach.
The clause refers to
“the use, retention and disclosure, for any purpose to do with human medicines” of information collected by such a system, which considerably broadens the original data-collection provisions of the Falsified Medicines Directive. Yet the Explanatory Notes make no mention of this legislative creep and, indeed, the Health Minister, Jo Churchill, said in Committee in the Commons:
“The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices.”—[Official Report, Commons, 8/6/20; col. 7.]
In this context, data is sensitive, commercial currency. All parts of the medicines supply chain need access to broad patterns of medicines usage but, in the current scheme, access to pack information, which could highlight purchasing decisions and margins being made, is restricted to details such as the name, batch, expiry, serial number and active/inactive status, with some exceptions for investigating incidents and the national competent authority, MHRA, used for various purposes.
Because of the issue of the commercial sensitivity of data, Article 54a, regarding the protection of personal information or information of a commercially confidential nature generated by the use of the safety features, was inserted into the preamble of the Falsified Medicines Directive and the principle of “whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016, which followed the Falsified Medicines Directive.
The Department of Health and Social Care already has access to a very wide range of data on medicines sales and use in the UK under the Health Services Products (Provision and Disclosure of Information) Regulations. Ministers can request more detailed information if required. Given both this access and the known sensitivities around falsified medicines data, it is unclear why the department wants to extend the purposes for which data is collected under a future UK system and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme. Pharmacists have concerns not just that the department might accidentally release commercially sensitive data but that it might use such data to gain an unfair advantage, given its monopoly position as the main purchaser of medicines in the UK.
Of course, the details of a new scheme will need to be set out in regulation, but the regulation-making powers under Clause 1 are, as the Delegated Powers and Regulatory Reform Committee pointed out in very clear terms in its damning report—which many noble Lords have referred to—considerable, and they provide no guarantee at all that the use of falsified medicine data will follow the previously agreed pattern.
It is clearly important to ensure that primary legislation provides the necessary protection. I hope the Minister, on mature consideration, will agree to ensure that the Bill is amended to enshrine a duty of full consultation and agreement in the Bill over this data use as we go forward.