HDA UK Media and Political Bulletin – 1 June 2021
Indian crisis risks severing supply of vital drugs to the UK
The Telegraph, Julia Bradshaw, 29 May 2021
The Telegraph reports that Britain is facing disruptions and shortages of everyday medications including painkillers, steroids and anaesthetics. This is due to the Covid crisis in India, which is causing problematic disruptions to factory output.
While a third of generic medicines used by the NHS are manufactured in Britain, approximately a third of generic medication is produced in India.
Representatives from the generic drug industry in the UK have raised concerns that stocks could reach dangerously low levels as the volume of medicine being shipped to the UK is slowing down.
The British Generic Manufacturers Association (BGMA) says around two thirds of its members have suffered disruption to supplies.
These drug makers are already facing challenges as a result of the pandemic, so the disruptions to the supply chain from India poses a real threat.
Mark Samuels, the BGMA’s Chief Executive, said: “[Manufacturers] are now on amber alert because of India’s terrible crisis. This situation is a risk to the NHS. Our manufacturers and others in Europe will try to mitigate any disruption, but we are worried.”
Janssen single-dose Covid vaccine approved by UK
BBC News, Philippa Roxby, 29 May 2021
BBC News reports that the UK medicines regulator has approved the single-dose Janssen vaccine. This will be the fourth vaccine approved to use as protection against Covid in the UK. The vaccine was 85% effective in preventing severe illness from Covid in trials and has passed expected safety standards.
This vaccine has already been authorised by the European Medicines Agency (EMA) and the World Health Organisation (WHO). Twenty million doses have been ordered for the UK and will arrive later this year.
The vaccine can be given to people aged 18 and over. The UK’s Joint Committee on Vaccination and Immunisation (JCVI) will produce advice on exactly who should receive the Belgian-made jab.
Claire Hanna (Social Democratic & Labour Party, Belfast South): To ask the Secretary of State for Health and Social Care, what discussions he has had with his EU counterparts on access to medicines and equipment to Northern Ireland after the end of the grace period in December 2021.
Edward Argar (Conservative, Charnwood): The Department is working closely with the European Union, to resolve any outstanding issues relating to implementation of the Northern Ireland Protocol, including supply of medicines.
We are taking this forward at the Specialised Committee for the Protocol on Ireland/Northern Ireland and through official-level talks.
Indian crisis risks severing supply of vital drugs to the UK
The Telegraph, Julia Bradshaw, 29 May 2021
Britain is on amber alert. The country faces the prospect of a shortage of everyday medications, from painkillers and steroids to anaesthetics. While one third of generic medicines used by the NHS are manufactured in Britain, the same proportion comes from India. The Covid crisis unfolding on the subcontinent has drastically reduced factory output.
The volume of medication being shipped to the UK is dropping and stocks could reach dangerously low levels in the coming months, the trade body representing generic drug makers in the UK has warned.
The British Generic Manufacturers Association (BGMA) says around two thirds of its members have suffered disruption to supplies. Of those, nearly three quarters say the impact could be felt in the next three months.
These drug makers are already stretched thanks to the pandemic so the supply chain squeeze from India poses a real threat, Mark Samuels, the BGMA’s chief executive, says.
“They are now on amber alert because of India’s terrible crisis. This situation is a risk to the NHS. Our manufacturers and others in Europe will try to mitigate any disruption, but we are worried.”
Battling pandemic shortages
It’s not the first time during this pandemic that the generic drugs industry has been under pressure, although so far shortages have been avoided.
“It was a close run, a very close run, but during the pandemic no patient has missed out a generic medicine,” says Samuels. “There were shortages of personal protective equipment and ventilators, but not the drugs needed to keep patients ventilated and alive.”
Generic medicines have been crucial in the pandemic. The sector supplies four out of five NHS prescription medicines in the UK and has supplied all of the drugs needed to ventilate patients with Covid and keep them in intensive care. It makes everyday over-the-counter medicines such as paracetamol and ibuprofen.
Fears over shortages led the NHS to put an increasing number of medicines on their “concession list”, which is a list of important medications the NHS is willing to pay an increased cost for to ensure a stable supply.
The sector has faced enormous logistical and manufacturing challenges over the course of the last 14 months, but because these companies operate low-margin, high-volume businesses, they are in fact very nimble and quick to adapt and scale up. Staff worked around the clock, seven days a week to fulfil orders.
Take Accord, the largest generic manufacturer in Britain by volume. It picked, packed and distributed 18m units of medicines in March last year for dispatch to the NHS Nightingale hospitals, including 80,000 packets of medicine in one weekend. Between May and December 2020 the volume of Covid-related medication it distributed to the NHS increased from 63m packs to 94m packs.
“It’s just staggering,” Samuels says. “Outside a pandemic some of these meds would only have been required in small amounts, but Covid increased their usage by 4,000-fold and that is an incredible feat for any manufacturing sector to turn around in a heartbeat.”
Wockhardt, a generics company with a big site in Wrexham that specialises in injectable drugs, is another good example. The Government called its UK managing director, Ravi Limaye, in March, asking how quickly it could begin doing “fill and finish” – putting a potential Covid vaccine into vials for distribution – a process that sounds simple but it is actually quite complex.
“I happened to be in the office and there was this person on the other line from the Government asking about the country’s injectable capacity to fill and finish vaccines,” says Limaye.
That conversation quickly led to a contract. Wockhardt makes 34m vials of AstraZeneca’s vaccine a year, equal to 270m doses. This accounts for half of the facility’s manufacturing capability and output across the site has doubled.
“We hadn’t done vaccines, but vaccines are biologics, and we are experts in that, so this was just an extension,” Limaye says. Timing was right too, as Wockhardt was in the process of expanding its facility anyway, to make the UK a global hub for its injectable supplies across the world. “That line was just getting ready and it was fate, as if it was made to manufacture vaccines,” Limaye adds.
Samuels says: “Our industry’s expertise is in agile manufacturing so they could only turn to us, which they probably only discovered during the throes of the pandemic.”
Calls grow for more domestic production
Despite this, successive governments, Samuels says, have failed to support the generics industry or put together a policy framework for the sector. It’s a large industry too. Accord and Teva, the UK’s two biggest generics players, contribute £6bn in GDP to the UK every year and support 30,500 jobs.
“We are one of the UK’s most critical sectors and pre-pandemic we were completely ignored. It’s like an invisible world. I have spent my career in life sciences and came into generics and thought, how did this happen?”
Now, that’s all starting to change – thanks to Covid.
Samuels has suddenly found himself invited to top-level meetings with ministers. He regularly attends the life sciences Covid response group meeting. There is real-time monitoring and communication of impending drug shortages between the industry and government.
“When the pandemic struck, it dawned on everybody that we supply all the meds for intensive units and most of the country’s other medicines,” he says.
Generic drug makers are now trying to capitalise on their closer relationship with the Government. They want an industrial strategy for the sector to ensure more of them are manufactured in the UK and that the country retains and develops the expertise needed to make them in the first place.
“There has been a policy vacuum here as generics have not been a priority,” Samuels says. The focus, understandably, has been on innovation and new, cutting-edge treatments, rather than “old” generics.
“The industry has stepped forward to maintain the supply of drugs in the most demanding circumstances, but we cannot continue to operate in a constant crisis mode and need support and investment to ensure supply chains remain resilient in the face of global challenges,” Samuels argues.
The country needs graduates with the correct skills to work in generics manufacturing, Samuels says. “One of our companies struggles to get any graduates from the UK who have enough knowledge in how to apply what they learned at university, so funding specific training for that line of work would be helpful.”
Other proposals the industry is setting forward include a framework around pricing stability and government funding for research looking into repurposing generic medicines that could be used to treat other diseases.
The National Institute for Health Research, for instance, did work early on in the pandemic into dexamethasone, a cheap, off-patent steroid that helped patients admitted to hospital with Covid.
There are almost certainly scores of generic medicines that could be repurposed like that, according to Samuels.
“Because we have not had a medicine shortage, the risk is the Government doesn’t learn, and that they miss that trick,” Samuels warns. “There is no guarantee in the next pandemic it will be the same.”
Janssen single-dose Covid vaccine approved by UK
BBC News, Philippa Roxby, May 2021
A single-dose Covid vaccine made by Janssen has been approved for use in the UK by the medicines regulator.
The vaccine was 85% effective in stopping severe illness from Covid-19 in trials and has met expected safety standards.
Twenty million doses have been ordered for the UK and will arrive later this year.
It will be the fourth vaccine to be used in the UK to protect against Covid-19.
More than 38 million people have now received a first dose of a vaccine in the UK – nearly three-quarters of the adult population.
The vaccine can be given to people aged 18 and over and is likely to be used as a booster jab for care home residents ahead of winter because it can be easily stored and transported at fridge temperatures.
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) will produce advice on exactly who should receive the Belgian-made jab in due course.
The single-dose option has already been authorised by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) in the US and the World Health Organization (WHO).
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Nadhim Zahawi, vaccine deployment minister, said the Janssen jab would be “another weapon in our arsenal to beat this pandemic”.
“We are doing everything we can to vaccinate all adults as quickly as possible and I encourage everybody to come forward for a jab as soon as they are eligible.”
First Minister Nicola Sturgeon said the approval was “really good news” but “we’re focused right now on the supplies we actually have and getting them into people’s arms as quickly as possible”, she said.
Originally, the UK ordered 30 million doses but reduced its order after the vaccination programme in the UK picked up pace.
The vaccine, developed by Johnson & Johnson’s pharmaceutical arm, Janssen, uses the same technology as the Oxford-AstraZeneca one and is likely to be more suitable for older adults than younger people. Under-40s are being offered an alternative to AstraZeneca in the UK because of a potential link to a type of rare blood clot in the brain.
Both vaccines use a modified version of a different virus to deliver instructions to the body’s cells to fire up the immune system and produce antibodies.
Since the Janssen jab is given as one single dose, it could speed up rollout to vulnerable people in care homes and those living in remote locations.
It has not yet been tested against the variant first detected in India which is spreading fast in the UK, although at low levels.
The US, South Africa and the European Union briefly paused the rollout of the Janssen vaccine in April after reports of rare blood clots in very small numbers of people after their jab.
The US is now offering the vaccine to people over 18, after concluding that the benefits of using it outweighed any risks of side-effects. The European Medicines Agency (EMA) came to the same conclusion after looking at a potential link between the vaccine and clots.
The Janssen jab is currently being tested as part of a UK study to find out whether a third dose could protect against new variants.
Dr June Raine, head of the body which approves vaccines in the UK – the Medicines and Healthcare products Regulatory Agency (MHRA) – said information on quality, safety and effectiveness of the Janssen jab had been thoroughly reviewed.
“We now have four safe and effective vaccines approved to help protect us from Covid-19,” she said, adding that their work did not end there.
“We are continually monitoring all Covid-19 vaccines in use once they have been approved to ensure that the benefits in protecting people against the disease continue to outweigh any risks.
“The safety of the public will always come first – you can be absolutely sure of our commitment to this.”
The MHRA said pregnant or breast-feeding women should decide whether to have the Janssen option in consultation with a healthcare professional after considering the benefits and risks.
There have been a further 10 deaths within 28 days of a positive test for coronavirus and another 4,182 confirmed cases on Friday.
From Factory to Pharmacy
As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.See the Infographic
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