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 Executive Summary

Professor Sir Michael Rawlins, chair of the MHRA, has told a UK committee of his concerns over Brexit, including possible delays in access to new drugs, a decline in revenues for regulatory work on behalf of the EU, and the possibility that some firms’ HQs might follow the European Medicines Agency if it relocates to another European country.

 

Brexit_Pink_sheet

 

As UK prime minister Theresa May prepares to trigger Article 50 sometime within the next three months, the chair of one of the UK bodies that will be most affected by Brexit – the Medicines and Healthcare products Regulatory Agency – has expressed concern that the country could be relegated to the “back of the queue” in terms of access to new drugs.


MHRA chair Professor Sir Michael Rawlins also raised concerns over the loss of revenue from the work that the MHRA currently does on behalf of the European Medicines Agency, and the possibility that international companies might be tempted to move their headquarters and follow the EMA if it relocates to another country in Europe.


Giving evidence before the House of Lords science and technology select committee on Jan. 10, Rawlins said that whatever the future arrangements between the UK and the EU, his agency would continue to ensure all medicines marketed in the UK were of high quality, effective and safe.


But as a non-member of the EU, and with the MHRA no longer an integral part of the EU regulatory network, he feared that the UK could become a much less attractive proposition for companies seeking early launches in key markets.


“One of the biggest worries I have about Brexit and standing alone as a regulator is that we are only 3% of the world market for new drugs, and if we’re not careful we’re going to be at the back of the queue.” Japan, the US and the EU would be at the front, he said.


This is not the first time the specter of delays in new drug approvals and launches following Brexit has been raised, but it is significant that the chair of the MHRA, a highly regarded medicines agency and a key contributor to the work of the EMA and the EU regulatory network, sees it as a real possibility.


Rawlins told the committee it was important to “put ourselves in the position where we can be in the front of the queue, not in the back.” One way of doing this, he said, would be to speed up access to new drugs by ensuring that the MHRA’s regulatory evaluations and the health technology assessments conducted by the National Institute for Health and Care Excellence (NICE) were carried out in parallel, not sequentially.


Noting that the UK Early Access to Medicines Scheme already allows drugs to be made available on the National Health Service before marketing authorization where there is a clear unmet need, Rawlins also raised the possibility of the UK issuing conditional drug approvals – something that the EU already does for certain centrally authorized products.


He suggested that the MHRA could in fact become “swifter than the EU” in terms of the overall approval process. “In the end it is not the EMA that gives the marketing authorization, it’s the [European] Commission… and they take on average 67 days. As someone I know very well in the pharmaceutical industry said, each day of delay for a pharmaceutical marketing authorization costs a company about a million dollars, so that’s 67 million dollars gone just waiting for the commission to decide to meet en collège. That’s just one bit of it and there are many other aspects. Without impeding the quality or the standards or anything like that, we would want to speed up the process.”

 

The EMA And The Future Relationship

 

A key question is whether, and if so how, the UK might continue to play some sort of part in the EMA and medicines agency regulatory network post-Brexit, especially if the EMA moves elsewhere – the MHRA does “about a third of the scientific reviews” for EU new drug applications, Rawlins said.


Asked whether the EMA would relocate, he said that “allegedly it is not legally obliged to move but it seems politically difficult for the European Commission to have one of its significant agencies outside the EU, so I presume it will go.”


This, he said, would be “a great loss for a number of reasons: it is 20 minutes on the tube to our offices in Victoria, and one of the reasons why international companies have their base in the UK is to be close to the regulator. Japanese companies for example are based in London or the southeast of England, and that is a great worry – will they move to wherever their regulator goes?”


If the EMA does relocate, and the MHRA becomes a more “standalone” agency, its workload could increase and it would also lose a sizeable chunk of its income. One member of the committee asked whether the agency had discussed how to resource any extra work it had to take on, and suggested it might have to “staff up colossally”.


Rawlins said the extent to which the UK remained part of the EU regulatory framework would determine whether it needed to take on more staff and resources. “If we are part of the system, no we wouldn’t, but as a sovereign regulator, yes we would have to. We have been discussing it for some months now with ministers and officials in the Department of Health, pointing out some of the intricacies of it all.”


One issue, he said, was the fee waiver offered to companies seeking approval of an orphan drug, which is currently covered by the commission. “Now, what are we going to do with that? There will have to be a cost somewhere along the line, otherwise we might lose orphan drugs, which would be a tragedy.”


Moreover, he pointed out, unless the MHRA could “come to some arrangement” with the EU, the MHRA would no longer do the detailed assessment work that it currently does, “which we get paid for. We get money when we do the detailed scientific assessments, and that would go.”


He said there were “two broad options” for the UK post-Brexit. One was to “remain within the system” and contribute to scientific discussions in the regulatory network. “We might even be able to remain within the system not just operationally but also have influence over new regulations and directives.”


If, on the other hand, the MHRA became a “sovereign regulator” it would need some kind of mutual recognition arrangements with the EU, for example in inspection activity. “We contribute to the EU inspectorate, going round India, China, looking at manufacturing sites, but we can’t do that on our own. We need to share the burden.”

 

Rubber-stamping other agency approvals would “emasculate the MHRA” - Professor Sir Michael Rawlins

 

As for new drug approvals, he dismissed a suggestion by the committee that the UK could simply accept decisions taken by another regulator – the US Food and Drug Administration, for example. “It has been suggested that we just rubber-stamp decisions made elsewhere,” he noted. “I would regret that for all sorts of reasons.” Such a move, he said would “emasculate the MHRA and the UK would not have a strong regulator.”

 

Potential Benefits

 

Also facing the committee’s scrutiny was Dr Beth Thompson, senior policy adviser at the Wellcome Trust, who focused on issues such as the regulations governing clinical trials, data privacy and the use of animals in research, and the fact that the UK and EU rules are closely entwined with a “variety of different models of regulation and enforcement.”


She said that continued equivalence or harmonization would be “a benefit and there are some elements of that you would want to keep,” citing the EU clinical trial portal provided for in the new Clinical Trial Regulation that will allow data to be shared among regulators.


“If you are in the UK setting up a clinical trial and you need a bigger population, for example you want to cover the EU countries too, this will make it easier to do so – there will be real benefits for countries setting up multi-country trials, also for rare diseases, to be part of a harmonized approach.”


But Thompson also pointed out some potential upsides to Brexit, noting there were areas where the UK could be more flexible and introduce more “risk-proportionate” regulation, for example in gene editing and data privacy.


“There is real potential that we could use the UK almost as a test bed to try out new regulatory approaches and within a robust framework be more experimental. We have seen with mitochondria donation that the UK regulators are in a really good place to try some very innovative things, and that will bring new treatments to patients faster and make the UK a great location to do research,” she said.

 

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