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UK Weathers Challenges Of COVID-19 And Brexit

UK Weathers Challenges Of COVID-19 And Brexit

Source : 'Generics Bulletin'

Over the past year, Brexit and the COVID-19 pandemic have represented two major threats to the smooth functioning of the UK generics and biosimilars market. And after discussing how far the country’s off-patent industry has come over the past 25 years (), departing British Generic Manufacturers Association leader Warwick Smith turned his attention to these two more recent challenges in the second part of our exclusive interview.

Casting his mind back a year to the early days of the pandemic, Smith described how the UK generics industry had been part of the country’s wider efforts to address COVID-19.

“If we are just looking at sterile injectables for intensive care and intubation, which is where the pressure clearly was, I think it was a tremendous collective effort, and it was a tremendous collective success,” he described.

Warwick Smith

While “industry played its part,” he said, “the National Health Service was brilliant. The degree of co-operation between industry and NHS – and you can always find places or times when it didn’t work on one side or the other – but it was brilliant.”

Recalling that industry chiefs had worked around the clock – including the BGMA assisting in “tracking down individual medicines supplies to get moved” – Smith also credited “the [medical] Royal Colleges in giving the advice they did about use of alternatives, spreading the load; wholesalers making sure they got to the right place; clinicians changing practice; a whole bunch of stuff came together and it was absolutely brilliant.”

However, he emphasized, “it was a close run thing. The medicines we’re talking about are old, tricky – not difficult to make, but tricky in terms of environmental impact – and low-volume. You’ve normally only got 8,000 ICU beds in the UK, and not many on intubation.”

“So old products, difficult environmental handling, not many suppliers: exactly the sort of medicine that you would think the supply would buckle if it was put under pressure.”

Smith described how “we had one company who basically produced one batch of one product a year, and it lasted the year. They sold it in a fortnight.” So the industry saw “a huge spike in demand, and we got through it,” he stated. “No patient that should have been on intubation failed to be intubated because of a lack of medicines. And that’s a tremendous amount of credit to everybody, not just us. Everybody working together.”

“So I think that’s a huge success, yes for the generics industry but also for everybody else.”

One significant outcome from the pandemic was the change that it made in terms of people’s perception of the generics industry, Smith suggested. “I think there are some people out there who still think generics are the simple things,” he said. “It actually showed that we are the life-saving things.”

Asked whether the positive trial results for dexamethasone in treating COVID-19 patients that came midway through 2020 had been part of this (), Smith agreed that “we’re huge advocates for medicines repurposing.”

“A health minister said to me when I was discussing it with him ‘I wasn’t surprised: I was always advised that the first treatment would be an old generic’,” he said. “So there is, I think, an understanding of that.”

“If we have the expertise in some of those older medicines, we’re going to be the people that can help with the repurposing.”

On repurposing medicines in general, he predicted that “there’s a tremendous boost coming for medicines repurposing,” noting that “NHS England has set up a separate unit now to drive repurposing.” ()

Asked whether this was an important frontier for value added medicines, he said “I think repurposed medicines is a huge example.”

Setting out how this fit with the generics industry’s mission, he explained that “our job is to treat patients where there are known medications and we can produce them very cost-effectively. The originator’s job is to produce medications to deal with conditions where there aren’t currently treatments.”

And “if we have the expertise in some of those older medicines, we’re going to be the people that can help with the repurposing.”

“I think that has been understood by the NHS,” Smith said, “and I am expecting to see them come forward with ways of making that commercially viable. Because at the moment, if a company does the work, they bear the cost and all the other companies get the license.”

“And I think you’ll see that happening over the next couple of months. There is a lot of work going on with it. And we’ve been working on it for two or three years. But I think we are getting to the stage where people are beginning to understand what needs to be done and ways in which it can be done.”

Moving on to the upheaval that has been seen – and is continuing to play out – as a result of the UK’s departure from the EU, Smith admitted that “as I depart, I am probably being less diplomatic about Brexit.”

Asked whether he was reassured by moves such as the UK’s recent decision to introduce a two-year notice period on any potential changes to its recognition of EU/EEA batch testing (), he was clear that “all of these things that the government does to help, is trying to make what it has changed slightly less bad.”

“I’m not going to be hugely applauding of a decision by the government that actually takes us back to where we were a year ago, when we were looking at a no-deal Brexit, and only has to be put in place because of Brexit and the deal [that] didn’t work,” he maintained.

“So yes, OK, you’ve acknowledged the real world, and maybe you’ve acknowledged that ‘project fear’ has become ‘project real’, but actually, no great round of applause.”

“I’m not going to be hugely applauding of a decision by the government that actually takes us back to where we were a year ago, when we were looking at a no-deal Brexit.”

“As we were saying earlier, for the generic market to work, you need volumes, you need lack of complexity, and you need certainty. Brexit destroys a lot of that.”

“I can see the government is trying to make up for that – joining the Access Consortium, for example, of like-minded regulators which has a generics regulation program going.” () “But as I say, it is a way of filling the gap rather than adding to what we have.”

Overall, Smith summarized, “we need to find ways to get back to the advantages that being in a 28-member club gave us. And they particularly apply to generics.”

“The EU has naturally negotiated in a way that maintains the biggest share of economic activity in this space for it. Why would you be surprised? Why would you not do that?” But ultimately, Smith noted, from the UK perspective “we were the asker.” And “we’re going to have to find a way forward.”

“I do think Brexit takes us backwards,” Smith reiterated. “I think a lot of those things that the generic market needs to be successful, it has taken away.”

“Will we survive and recover and prosper? Yes of course we will. That’s what we do as an industry. Once we know what the market looks like, once we know what the rules are, we will adapt very quickly to meeting them.”

Asked how long the uncertainty around the fallout from Brexit could be expected to continue, Smith acknowledged that “it’s crystal ball gazing. Does there come a stage where a full mutual recognition agreement between the UK and EU happens? It’s clearly sensible. It would actually benefit each side.”

“I think the European Commission hasn’t offered it because it does see a bit of advantage,” he suggested. “But I think that actually, that advantage would not be lost if there was to be an MRA in six months’ time, because everybody will already have changed where they do things. Knowing other things change at the end of this year, you can’t wait until November before you act.”

“So I think that the commercial advantage for the Commission in not doing an MRA disappears later this year. So let’s hope that that happens.”

“As I say, co-operation with other like-minded regulators is really good. The UK Medicines and Healthcare Regulatory Agency is clearly going out of its way to not place any burdens on industry that it doesn’t need to. Picking up new product registrations from the EU and bringing in new faster better quicker national procedures, all of which helps. But we’ll have to see.”

Meanwhile, he added, “I’m bound to say that Northern Ireland was always going to be the big issue, and is going to continue to be the big issue.”

Responding to the suggestion that progress could be made as the political heat around the formal separation of the UK and EU dies down, Smith said “I think we will get to the stage where the current [UK] government and the current Commission feels that it is less important to prove that it was right on each side, and can just get back to business as usual.”

“And I think that pragmatically, and in the interests of patients, we should all hope that that day comes on both sides of the channel sooner rather than later. But there is clearly a bit of angst to get over on both sides.”

One potentially positive development that has come for the UK off-patent industry in the wake of Brexit is a new MHRA licensing pathway for biosimilars, which offers the opportunity to register a biosimilar without the need for comparative efficacy data. The British Biosimilars Association labelled it “a breakthrough opportunity for the UK to become the first country where new biosimilar medicines are made available to patients.” ()

Asked whether this shift could represent a chance for the UK to lead on the world stage, in terms of showing a path forward for biosimilars licensing procedures that could be replicated across the globe, Smith said there had been a particular effort on the part of industry to work with international counterparts to ensure a globally acceptable approach.

“On the proposals we made to the MHRA – that they have effectively taken up – we deliberately worked with colleagues elsewhere across the world, to make sure that they would not be anathema in their country,” Smith described. “So we worked closely with the International Generic and Biosimilar medicines Association and Medicines for Europe to put forward something which could be picked up globally.”

“That’s not being altruistic, that’s how most generic manufacturers want development,” Smith said. “So it was pragmatic as well as helpful to others.”

“I do think that the UK outside of the EU is in a position to drive some of these things more than it was inside,” Smith observed. “I say this as pro-European, but I think there are things that a single country can do, to show the way, that it is really difficult for an institution of 27 countries to do. And I think it is important to the UK that it can lead in that way, and helpful for others if they are able to take that lead and follow it.”

And when queried over whether this could make the UK a particularly attractive market despite now being a smaller individual market outside the EU and despite the global nature of biosimilar development programs, Smith responded in the affirmative. “Absolutely. There’s a very simple cost-benefit analysis actually, which is: does a slimmed-down regulatory pathway save enough in time and money to make it worthwhile doing something for one market? And we think it probably does.”

He added that the effect of this was expected to be seen “fairly quickly, by which I mean this year, because these things don’t happen overnight.”

“Part of what we’ve been doing with the MHRA over the past year – and they are up for this, this is not us hammering at the door and saying ‘can we work together?’ – is to find ways of making the UK attractive still,” Smith elaborated. “We are quite a big market, with fairly low barriers to entry. If we can do things which make it even easier then we can still be an attractive market.”

“And the trick – given what I said about lack of complexity, size and certainty – the trick we are facing is to make Northern Ireland part of that. And that is really politically difficult.” ()

Moving on to trade deals – as the UK continues to negotiate its trading relationship with other countries now that it has left the EU – Smith was asked whether the US-Mexico-Canada trade agreement that received a warm welcome from the off-patent industry over a year ago was still seen as a model to follow. ()

“I would give a two-part answer,” Smith replied. “One is that some of the more anti-generic intellectual property provisions that were originally in there were of course taken out in the US Congress. And my feeling is that – given that the current US trade representative [Katherine Tai] was actually legal counsel to the Ways And Means committee that looked at that – there is a chance of that becoming mainstream USTR thinking. And I think that is probably helpful. So I think that is the floor.”

“But I would go further,” he added. “And all credit to UK ministers, health and trade, that have held the line on this. I have this very simple description, which is that IP is a balance between giving enough incentive for innovation and opening up the market at the right time, to reduce costs to the NHS but also incentivize innovation. Because if you’ve got a patent forever, why are you ever going to develop another product?”

“So generic competition helps in both ways. Getting that balance right is critical. In the UK, we have the highest level of innovation other than in the US – and by the way, they are a bit bigger! We have one of the highest generic usage rates in the western world. And we have the lowest prices in Europe. That sort of suggests we got the balance right. Why would you want to mess about with that?”

And while the UK government might have “put it less colloquially,” Smith acknowledged, “ministers have been very clear on that. If you look at the Conservative party manifesto at the [last general] election, if you look at the negotiating mandates that have been published for the various trade deals, it always says – in slightly hyperbolic language – the NHS is off the table, and we will do nothing that increases the cost of medicines.”

“And therefore, the UK has in these trade deals stuck to our current regime. And we will be encouraging them to continue to do so. They’ve come under a lot of pressure, as you would imagine. And they have held the line. So my feeling is that we do better than the floor that was established in the USCMA.”

“We’ve always had challenges. As an industry we have always met those challenges.”

“One of the things I’ve learned over my 30 years being associated with the BGMA is that we’ve always had challenges.” Smith concluded. “The challenges have changed. The actors have changed. As an industry we have always met those challenges.”

“And we’ve met them because we’re actually quite good at it, and we’ve made them because we have become essential to the NHS and to the availability of medicines to patients.”

“So if nothing is certain in life other than death and taxes, I would put generics in third place.”

By David Wallace