Medicines and Medical Devices Bill — House of Lords, 2021-01-12
Topic: Health
Timothy Francis Clement-Jones (Liberal Democrats, Centre to centre-left): My Lords, on 4 November in Grand Committee, the noble Baroness, Lady Thornton, and my noble friend Lady Jolly introduced amendments designed to limit the ambit of the information-gathering powers under Clause 3, which deals with falsified medicines. I raised the subject at Second Reading but was unable to be present for the debate in Grand Committee The Minister, the noble Lord, Lord Bethell, said in resisting the amendments: "We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders." It was not at all clear what the Minister meant by "exploring creative uses of information", and in fact it was quite concerning given that these have not been set out anywhere in any consultation document. However, he went on to say: "I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee."—[Official Report, 4/11/20; col. GC 326.] Of course, as the result of the very welcome government Amendment 4, the safeguarding of public health is the key objective, and by Amendment 6, Clause 1(3) has been tightened up too. However, having carefully considered these amendments and the Minister’s previous response, I must still question his interpretation of Clause 3 and how it interacts with Clause 1. Clause 3(1)(b) currently says that the regulations may make provision about "the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines." At best there is a conflict between the two clauses, and at worst Clause 3 is open-ended and gives the Government far too much discretion in the scope of regulations under Clause 3 In the discussions we have had with the Minister between Committee and Report—for which I am grateful—it became clearer that we need to ensure that this information regarding falsified medicines is used for limited purposes. The Minister cited a whole range of possible uses for the data, which came as a considerable surprise. As I said earlier, there has been no industry consultation, despite considerable ambition on the department’s behalf. That is why in this amendment we have tied the purpose to "ensuring patient safety". What possible objection could there be to this limitation? Why would the Government want any wider scope, especially if the Minister believes that Clause 1 already provides a limitation I have now seen the brief announcement issued by the department on the consultation on the regulations to be carried out on a new national scheme. It says: "We are committed to public consultation around the need and details of any national scheme, as well as a specific consultation on the use of data collected as part of any scheme." That lacks detail, to say the least. Many noble Lords have been briefed by the Company Chemists’ Association about the commercial sensitivity of this data. As my noble friend Lady Jolly said in Grand Committee: "The Department of Health and Social Care already has access to a very wide range of data on the sales of medicines, and their use in the UK, under the Health Service Products (Provision and Disclosure of Information) Regulations 2018. These require manufacturers, wholesalers and pharmacies to provide summaries of products sold and prices paid. Ministers can request more detailed information if required."—[Official Report, 4/11/20; col. GC 324.] Given this access and the known sensitivities about falsified medicines directive data, it is unclear why the department has included this sweeping provision in Clause 3(1)(b). I described this as "legislative creep" at Second Reading. It goes well beyond the EU falsified medicines directive of 2011 and the associated delegated regulation of 2016. Of course, this was not acknowledged in the Commons by the Minister, Jo Churchill. As a result of the efforts of several noble Lords, the changes proposed to the FMD provisions are now out in the open—but that does not make it any more acceptable This might seem rather a specialised part of the Bill, but clarity about the scope of Clause 3 is vital if we are to have confidence that a suitable scheme for falsified medicines data will be put in place that does not go well beyond the current scheme in terms of the sensitive data that is collected and used. I hope the Minister can do better than last time in giving greater assurance about the ambit of Clause 3 so that I do not need to divide the House. I beg to move.