My Lords, I will address Amendment 11, to which I have added my name. There are a large number of partnership agreements concerning medicines and clinical devices between the UK and Europe, and they are both formal and informal. They are important to our economy, as well as to the health and well-being of our citizens. Amendment 11 seeks to avoid these being ruptured. One of the most important of these international collaborations is of course the European Medicines Agency—the EMA—which provides and co-ordinates licensing, expertise and support for medicines and medical devices throughout the EU. For any pharmaceutical company seeking to license its product across Europe, the EMA is the body through which this is achieved. Our own domestic regulator, the Medicines and Healthcare products Regulatory Agency, operates as a crucial part of the EMA’s regulatory network to ensure frictionless access to medicines for the NHS without delay.
As the Secretary of State for Health and Social Care told the House of Commons Select Committee
on Health on 24 January last year, we are one of the EMA’s most important members, overseeing up to 40% of its testing and taking on,
“often the most difficult and challenging cases”,
presented to it for testing and licensing. We have already lost the EMA’s headquarters, and the 900 or so jobs it provided and the economic benefits that came with these, from London to Amsterdam. A greater concern is the potential loss of quality assurance that our membership presently guarantees. For example, the common trademark system allows parallel imports across Europe.
The Healthcare Distribution Association, which represents medicines and medical device suppliers in the UK, has warned that our departure from this framework risks medical shortages and potential increases in the cost of medicines. The Healthcare Distribution Association estimates that the current system saves the NHS more than £100 million a year. Its executive director, Martin Sawyer, has already warned MPs that, when it comes to drugs,
“we take the supply chain for granted”,
and that Brexit could,
“throw a lot of cogs out of a very complicated machine”.
It is a warning worth echoing in this Chamber.
Our current perilous predicament seems to originate from the Government’s refusal to accept that appeals over licensing ultimately go to the European Court of Justice. But the EMA is not officially part of the EU, so there seems to be no constitutional justification for UK leaving it as part of Brexit. Indeed, this position has been put forward by the current chairman of the MHRA, Professor Sir Michael Rawlins, who in evidence to the Lords Science and Technology Select Committee last year stated that not only could the UK technically remain within the current system but that it may even be able to continue to influence new regulations and directives by doing so.
The sole reason that the Government have outlined for voiding their membership of the EMA is that it means accepting the jurisdiction of the European Court of Justice, which deals with legal processes such as licensing appeals. Having identified the jurisdiction of the European Court as one of their negotiating red lines, the Government therefore seem to believe that this renders the continuation of our membership untenable. In short, as is increasingly the case in a number of areas pertaining to Brexit, the Government would appear to be willing to jeopardise the security of our own medicines, drugs and medical devices for our citizens, and the prosperity of industry, for the sake of an ideological inclination.
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While both the Health and Social Care and Business Secretaries of State maintain that they would like to find a way to continue to collaborate with the EU in the interests of public health and safety, the Government have made it clear that they intend to leave the EMA post Brexit in the hope of securing a new regulatory alignment. One of the Government’s outlines for this is in a policy paper on collaboration in science and innovation, published in September 2017, which stated that the UK would draw upon existing agreements
between the EMA and third countries such as Switzerland or the USA to provide a precedent.
However, this is not the simple solution the Government make it out to be. In Switzerland, for example, regulatory processes mean that marketing approvals are agreed on average 157 days after EMA approval—in other words, almost six months after they otherwise would be under EMA authority. Both current and former heads of the MHRA have expressed concern that, given that the UK market is relatively small compared to that of Europe, America or Japan, drug manufacturers may not view obtaining a licence to sell in the UK as a priority. This apprehension has been restated in a report by the Government’s own UK-EU Life Sciences Steering Committee, which admitted that, by leaving the EMA, the UK would, among other concerns, effectively become a “second priority” launch market.
The MHRA has stated that, rather than the sovereign authority the Government are so keen to impose on it, it wants a system of mutual recognition whereby the UK and the EMA abide by the recommendations of one another’s regulatory systems. The Nuffield Trust has called for a single regulatory process across the two jurisdictions to enable pharmaceutical companies to approach either the MHRA or the EMA, with the resulting recommendation adopted potentially across both organisations. Such a situation would leave the UK outside the supervision of the European Court, even though the Commission and its decisions would remain within its domain.
That scenario may provide a best-case solution to the current predicament, but the Government must clearly commit to ensuring the mutual recognition of medicines and medical devices across the two areas to assuage present uncertainties. In realising their dream of escaping the oversight of the European Court of Justice, the Government, I fear, risk driving us towards a future which damages our life sciences sector and the global standing of the UK as a leader in this field, potentially jeopardising parts of our highly skilled workforce and risking delays in access to new treatments for patients.
Patients often ask about advances. They want to know about new-horizon drugs and trials. They willingly enter trials across many nations because they realise that that is the way to advance care, not only for themselves but for others. This applies particularly to people with rare conditions, where we will never have enough patients for a critical mass in this country to conduct the appropriate trials. So the mutual recognition of medicines and clinical devices across both the UK and the EU, as set out in Amendment 11, is essential for our scientific advancement and for our patients.
I will make one comment on Amendment 9. I fear that we may have a bureaucratic nightmare in trying to define who is or is not eligible, and the criteria for such eligibility, among people in our country—not only when we go abroad, as has been clearly outlined.
In answering, it would be helpful if the Minister could tell us exactly how much money is involved in cross-border billing at the moment and what the estimate is of the costs of the bureaucracy behind the processes that will have to be put in place in order that we can recoup funding for those people from Europe who happen to have an accident or fall ill while they are here.