Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Baroness Bennett of Manor Castle Excerpts

Wednesday 2nd December 2020 Lords Chamber

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, it is a pleasure to follow the noble Lords, Lord Blunkett and Lord Goddard, with another northern perspective. The noble Lord, Lord Blunkett, made a good choice of location today, being in your Lordships’ House rather than in Sheffield, because here the emergency services are dealing with an unexploded World War II bomb just up the road from me. I thank those emergency services workers. This is a reminder that all our essential services and workers have so many things to deal with at the moment, including all the medical professionals dealing with the complexities that we are discussing today.

I agree with the noble Lord, Lord Blunkett, about the importance of acknowledging international collaboration. Whether we are talking about vaccines or medical research, the nature of science today is innately collaborative, and we need to keep that in focus.

I also agree with the noble Lord that the Minister has been highly informative and helpful to your Lordships’ House right through the pandemic. That has built trust, which is so crucial. I hope that the Government will ensure that the information they provide is always accurate and trustworthy—as other representatives, I am afraid, have not been today, in their claims that exiting the EU made it possible to approve the vaccine so quickly.

Turning to the detail of these complex and detailed instruments, I decided to engage in the debate because I have also been heavily involved with the Medicines and Medical Devices Bill. As the Minister said in his introduction, it is clear that these instruments and the Bill are closely interrelated. It is also clear from our debates on the Bill, and from the report by the noble Baroness, Lady Cumberlege, that we need a great deal of improvement in our regulation and oversight of medicines and medical devices.

These statutory instruments also address the issue of falsified medicines. With fake medicines estimated to cost the pharmaceutical sector about €10 billion, and considerable evidence that the Covid-19 pandemic has accelerated that problem, this is truly a key issue.

I shall address four key points. The first is the Northern Ireland complexities, with which the SIs are heavily involved. The second is the extra costs for the NHS, and potentially for private patients, for medicines and medical devices. The third is falsified medicines, which I have already mentioned, and the fourth is the risk of shortages in the immediate post-transition period and the later post-transition period.

In relation to the first point, about Northern Ireland, the Explanatory Memorandum says, at paragraph 7.10:

“To ensure unfettered access only benefits NI businesses, these regulations require that:


a) only an NI business should be able to apply for a licence from MHRA … and


b) the market authorisation holder … will need to be located in NI.”


It will have to provide information and data, and take

“legal responsibility for the medicine once on the GB market, including access to a suitably qualified person for UK regulators to interact with on ongoing safety monitoring … related to those medicines”

and medical devices. My first question for the Minister is: are there enough qualified, appropriately registered, people in Northern Ireland for those roles? Secondly, are small independent businesses, such as small pharmacies in rural areas, ready for this situation?

As of early November, a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021 has been agreed, which means that the current batch testing, importation, and falsified medicines directive requirements will remain in place for another 12 months. December 2021 is not very far away. Are these regulations future-proofed? Will they still cover the situation in 12 months’ time?

The Explanatory Memorandum also notes all the extra costs—for example, £18,000 for a new active substance, £10,000 for a complex abridged application, and so on. Can the Minister provide any information on what extra costs the end of the Brexit transition period will bring, for drugs both for the NHS and for people with private prescriptions?

On the third point, about falsified medicines, in October the Royal Pharmaceutical Society wrote to the Health Secretary, Matt Hancock, asking for “robust plans” to be put in place

“to help authenticate the legitimacy of medicines”.

The RPS also said:

“We are concerned that removal of these safeguards could leave the UK vulnerable to an influx of counterfeit medicines, impacting on patient care in the UK and across the EU”.


Can the Minister provide assurances on that point?

Finally, I want to ask about shortages. In August the Government recommended that pharmacies and hospitals build up a six-week stockpile before 31 December. Is the Minister confident that that is in place, given all the many other pressures from Covid-19, normal winter illnesses and the general pressure on our medical systems? In the shorter long term, at the end of those six weeks, will the supply be secured? Can we be confident that we will have the medicines we need?