This is the fourth post looking at the main points of contention so far at Committee Stage in the House of Lords for the Medicines and Medical Devices Bill 2019-20.
[Part I available here, Part II available here, Part III available here]
Another week, another Committee session in the House of Lords on the Medicines and Medical Devices Bill, but this time debate was cut short due to the need for Lords to vote on the new covid-19 restrictions. This fourth sitting of the Committee (04/11/20) saw the Government respond to challenges to their amendment on international information sharing raised at the end of the previous session. Information sharing also formed the basis of concerns relating to falsified medicines. Less vociferous debate followed on access to innovative medicines and a mechanism to ensure research in paediatric medicine post-Brexit. However, the session ended once again in heightened tension as the Government were challenged on the breadth of their emergency powers clause.
Government Responds to Concerns on International Information Disclosure
As our previous post highlighted, the Government’s amendment permitting data-sharing with any ‘person’ outside of the UK caused alarm amongst Peers. These concerns focused on the circular nature of one of the sub-clauses establishing exceptions to data protection legislation. Baroness Penn responded to these concerns, stating that the provision was to ensure that the MHRA could continue to share intelligence on medicines and medical devices as part of the future relationship with the EU and to comply with future international agreements. The breadth of the term ‘person’ was argued to be necessary as it was not possible to say which organisations information will need to be shared with in future. However, this response is extremely problematic. It is impossible to know what any future international agreements might entail and thus the purposes such data could be used for. Nothing in this clause limits the purposes of information sharing except the general requirement that the appropriate authority be satisfied that any regulations created using the Bills powers promote public health.
The Government’s position is that the clause creates a ‘lawful basis’ for information disclosures to comply with the existing principle in data protection. However, Baroness Thornton continued to express anxiety over the justification of the term ‘person’ stating ‘that alarmed me more than reassured me’ in reference to the Government’s explanation, a sentiment shared by Lord Patel over the ‘amorphous’ nature of this concept. It is likely that this point will be returned to at Report Stage.
Falsified Medicines and Information Use
Data-sharing and protection continued to dog discussion as the Committee moved to consider amendments relating to falsified medicines. Baroness Thornton and others sought to limit the purposes for which information gathered on medicines could be used to that of ensuring medicines safety. Industry stakeholders had been in touch with Members to express alarm at the powers in relation to falsified medicines in the Bill, which are broader than those under the EU Falsified Medicines Directive. The key objection is that the wording of the clause is ambiguous as to the purposes for which data can be retained and shared beyond ensuring the authenticity of the medicine and its safety. Lord Hunt also questioned the Government on why, when it was stated that the Bill was not introducing immediate changes to regulations on medicines and medical devices, these provisions – which seem to do just that – were not properly set out in the explanatory notes accompanying the Bill.
Lord Bethell responded that the purposes for data sharing under the existing Falsified Medicines Scheme have already been expanded to, for example, pharmacovigilance. He further argued that until they had worked out how a new scheme for falsified medicines could work they could not consider for what purposes information could be used that could benefit the UK and patients. On this he said that the Government wanted to explore “creative uses of information as long as they are for public interest purposes” and that “[t]herefore, we do not want to constrain or limit options ahead of engagement with stakeholders.” As pointed out by Baroness Thornton, however, it is not clear why consultation could not have taken place before this Bill was drafted, and neither is it clear why stakeholders would not be consulted before such a scheme is established.
Innovative Medicines and Information Gathering for Paediatric Medicine
Probing amendments tabled by Lords Lansley and Patel attempted to draw the Government on their plans to implement the 2019 Conservative manifesto pledge on introducing an innovative medicines fund. All parties agreed that this fund is welcome and necessary to bridge gap between the introduction of innovative medicines and their uptake in the NHS. Baroness Penn assured Members that an ‘engagement’ exercise was due to be carried out in the first quarter of 2021.
Another amendment from Lord Patel raised the issue that the UK will no longer be subject to EU legislation requiring drug sponsors to have a plan for paediatric investigations for their new drugs. He sought assurances from Government that the distinct issues of children’s reactions to drugs would not be overlooked and the Government responded positively to provide these.
Emergency Powers
The session ended yet again in drama. Baroness Wheeler presented amendments to the clauses that would allow the appropriate authority to disapply certain provisions of medicines and medical devices regulation when there is a threat to public health. The Government has already tabled amendments to deal with the criticisms that the Delegated Powers and Regulatory Reform Committee had raised in relation to these clauses, ensuring that any regulations disapplying provisions would need to be passed by the made affirmative procedure, rather than the negative procedure as was previously specified in the Bill. These, however, did not remove the proviso that any disapplication may be subject to conditions that can passed by protocol. Protocols, akin to guidance documents, are issued to inform relevant bodies and stakeholders of how to act but by-pass Parliament. This was challenged as an inappropriate overreach of executive power by Baronesses Wheeler and Jolly, as well as Lords Hunt and Patel.
Lord Bethell sought to deflect criticism on this by invoking the current pandemic situation as an illustration of the need for these powers during public health emergencies. He specifically cited the use of protocols as currently allowed under the Human Medicines Regulations 2012 to disapply provisions in anticipation of pandemic which were used in 2009 in response to swine flu. He defended the need to use protocols by looking at the example of a covid-19 vaccine, arguing that certain details, such as the number of injections required and the numbers and type of people who can administer the vaccine, would be unknowable when regulations disapplying certain provisions are made.
This line of reasoning seemed to backfire when Lord Patel accused the Minister of creating ‘smokescreens’. He argued that by his own reasoning the Minister already had the powers for emergency disapplication that he is seeking in this Bill as demonstrated by the later vote on covid-19 restrictions and the example from the Human Medicines Regulations 2012. He also attacked the example of a covid-19 vaccination and the unknown number of doses as requiring a protocol, arguing that this would be a clinical decision and not something that should be or is subject to legislation.
Whilst Lord Bethell responded that pandemic emergencies were likely to be a feature of our future and that these powers were, therefore, still necessary, it seems unlikely that this particular argument will persuade critics in the House.
The next session is due to sit on 11th November 2020, it will be interesting to see how these debates develop.
Written by: Laura Downey and Rachael Dickson
Funding: Work on this was generously supported by a Wellcome Trust Investigator Award in Humanities and Social Sciences 2019-2024 (Grant No: 212507/Z/18/Z) and an ESRC Impact Acceleration Award.