News

Media And Political Bulletin 31 July 2018

Media and Political Bulletin

31 July 2018

Media Summary

No Deal Brexit: ‘Could UK’s medicine supply be disrupted?’

Channel 4 News, 30 July 2018

HDA was referenced in last night’s Channel 4 news bulletin. The news report considered what would happen to the country’s insulin supplies in the event of a no-deal Brexit. It references the head of the medicines regulator, Sir Michael Rawlins, who recently raised a red flag about the drug, stating that we ‘make no insulin… we import every drop of it.’

Referencing a HDA spokesperson, the program states that ‘the Healthcare Distribution Association told Channel 4 News today that it was aware of government plans for “stockpiling medicines of all types” which the association described as “sensible planning”.

The HDA was also referenced in a Channel 4 write up, read it here.

‘Perfect storm’ behind generics price hikes, PAC hears

Pharmacy Magazine, 30 July 2018

Pharmacy Magazine reports on the recent Public Accounts Committee (PAC) hearing into price increases on generic medicines in 2017. The article reports that the Committee were told that a ‘perfect storm’ of events was behind the price increases on generic medicines in 2017.

An investigation from the National Audit Office said that medicines shortages were a contributing factor to the “unprecedented rise” in spending on generic medicines in 2017-18, with an unexpected rise in wholesaler margins cited as another potential factor.

The article states that speaking before the PAC on July 4, Warwick Smith, director of the British Generic Manufacturers Association, said the shortages were partly due to regulatory action taken against four companies, including “two of our members who were scale manufacturers”.

This was a “perfect storm” of events such as rarely happens, Mr Smith said, adding that he “would be surprised to see this recurring quickly”.

Commenting on how shortages can sometimes come about and how different stakeholders are affected, Mr Smith said: “I think it is important we distinguish between different circumstances that lead to these occurrences… Most shortages… occur because of third party events… without any warning for manufacturers, for anyone, as much as pharmacy or patients”.

Compliance with EU scanning law could be part of pharmacy inspections

Chemist and Druggist, Lilian Anekwe, 30 July 2018

Chemist and Druggist reports that an impact assessment, published alongside the government’s consultation document on FMD legislation, set out the potential risks from its implementation. The impact assessment said that ‘the implementation of safety features will not fully prevent the entry into the legal supply chain of falsified medicinal products.’

The article also reports that in its consultation documents, the government proposed ‘legislative changes to provide sanctions to enforce compliance’ of the FMD. One approach that it suggested was ‘the sole use of criminal sanctions for failure to comply,’ in the form og an ‘unlimited fine…or imprisonment for a term not exceeding two years, or both.’

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

No Deal Brexit: ‘Could UK’s medicine supply be disrupted?’

Channel 4 News, 30 July 2018

Transcript: ‘One very specific but potentially vital issue is what will happen to the country’s supplies of insulin in the event of no deal. There are just over 1 million people in the UK with diabetes who rely on insulin to treat themselves. The head of the medicines regulator, Sir Michael Rawlins, raised a red flag about the drug last week, saying, “we make no insulin in the UK. We import every drop of it.”

Some critics have picked Sir Michael up on the words, “we import every drop of it”. This isn’t quite true. We found one UK company making insulin derived from animals, but only for around 2,000 patients. Insulin from human cells is supplied by three companies, but none of them manufacture the drug in the UK. So more than 99% of insulin used in this country is being imported. However, the Healthcare Distribution Association told Channel 4 News today that it was aware of government plans for “stockpiling medicines of all types” which it described as “sensible planning”.

‘Perfect storm’ behind generics price hikes, PAC hears

Pharmacy Magazine, 30 July 2018

A recent Public Accounts Committee hearing was told that a “perfect storm” of events was behind the dramatic price increases on generic medicines in 2017 that were the basis of a National Audit Office investigation.

The NAO report said that medicines shortages were a contributing factor to the “unprecedented rise” in spending on generic medicines in 2017-18, with an unexpected rise in wholesaler margins cited as another potential factor.

Speaking before the PAC on July 4, Warwick Smith, director of the British Generic Manufacturers Association, said the shortages were partly due to regulatory action taken against four companies, including “two of our members who were scale manufacturers”.

This was a “perfect storm” of events such as rarely happens, Mr Smith said, adding that he “would be surprised to see this recurring quickly”.

Commenting on how shortages can sometimes come about and how different stakeholders are affected, Mr Smith said: “I think it is important we distinguish between different circumstances that lead to these occurrences… Most shortages… occur because of third party events… without any warning for manufacturers, for anyone, as much as pharmacy or patients”.

The current system whereby market competition determines generic medicine prices works well and makes drugs affordable, some witnesses claimed. Sir Chris Wormald, permanent secretary at the Department of Health and Social Care, said: “Our spend on generics in the year of fluctuations went down, not up.”

Pharmacy helped prevent patient harm

Pharmaceutical Services Negotiating Committee regional member for the North East and Cumbria, Mark Burdon, said: “I have not observed and am not hearing reports of patients going without medicines for any length of time, or indeed of patient harm. Much of that is down to the efforts of community pharmacists.”

Mr Burdon agreed with the written evidence provided by Dorset contractor Mike Hewitson, which stated that stock shortages “were sometimes caused by rumours by wholesalers that resulted in a self-fulfilling prophecy, as pharmacists ordered several months’ stock at a time.”

“Not a new problem”

Professor Karim Meeran of Imperial College’s medical education department said shortages and resulting price hikes have been “going on since about 2010 with different drugs” and are “not a new problem.”

Professor Meeran suggested that health bodies should consider whether it is viable to manufacture drugs on the World Health Organization list of essential medicines in the UK, in order to ensure a steady supply of these medicines.

“All of the drugs on that list should be very cheap to make,” Professor Meeran said. “Why don’t we make it in the UK and sell it and use the NHS as a bulk buyer rather than go through wholesalers, because the wholesalers are splitting the NHS?”

However, the BGMA’s Warwick Smith argued that this could come up against ‘commercial realities’: “Overall, the UK is a net exporter of medicines but a net importer of generic medicines, and that is simply because we cannot make them cheaply enough here to compete with prices that come out of the other markets, be they central Europe, India or China. I’m afraid that that is just the commercial reality, unless there is some public policy decision to change that.”

New powers welcomed

Anne Marie Morris MP questioned whether new measures that came into force in July that give the DHSC more power to obtain information about generics prices would be sufficient.

“Even if these new regulations make [information relating to generic medicines] available, it is limited, because it comes in blocks,” Ms Morris said, addressing the BGMA’s Warwick Smith. “Secondly, as far as I can see, to make your members divulge it, there really isn’t much of a penalty.”

Mr Smith countered: “My members, with one or two exceptions, have already been providing the data voluntarily to the Department of Health, which is how they calculate the category M tariff reimbursement price.”

Mr Smith said that while that information currently “flows four times a year,” there are provisions to make this monthly or weekly “if things are happening in the market that make that a more sensible way of behaving”.

He added: “We welcome the new powers, because they will bring into that mix companies that have not been providing the data voluntarily… I think the Department will now be able to track, almost, individual products throughout the supply chain, so they can see what is happening at the different stages. They will be able to see if product is going “missing” within the supply chain, which is important.”

Compliance with EU scanning law could be part of pharmacy inspections

Chemist and Druggist, Lilian Anekwe, 30 July 2018

Ensuring pharmacies have installed a medicines scanner and are checking anti-tampering devices could form part of pharmacy inspections next year, the government has revealed.

Under EU anti-counterfeiting legislation the Falsified Medicines Directive (FMD), every pharmacy in the UK will be required to scan barcodes on medicines and check their anti-tampering device at the point of dispensing from February 9, 2019.

Earlier this month, the government published a consultation document on the legislation, “to identify a solution which results in the lowest burden to UK stakeholders as a whole”.

Ongoing risks

An impact assessment published alongside the document set out the potential risks from implementation, including “that the implementation of safety features will not fully prevent the entry into the legal supply chain of falsified medicinal products”.

One reason for this could be the “failure to decommission products”, which could allow the “unique identifiers” on medicines packaging to be “reused on falsified products”, the government said. It suggested mitigating this risk by using “regulatory inspections” to ensure compliance, as well as introducing “sanctions to enforce” it.

However, when asked by C+D to confirm that monitoring FMD compliance would become part of its pharmacy inspections, the General Pharmaceutical Council (GPhC) said it is “too early to say” what its “respective role” would be.

“We are considering the detail of the consultation document and will respond to any proposals relevant to us as the regulator of registered pharmacy premises,” it said.

Threat of sanctions

In its consultation documents, the government also proposed “legislative changes to provide sanctions to enforce compliance” of the FMD. One approach it suggested was “the sole use of criminal sanctions for failure to comply”, in the form of “an unlimited fine…or imprisonment for a term not exceeding two years, or both”.

However, it also stated it “is minded” to “use a mixture of both criminal and civil sanctions”, which might include “written warnings, stop notices and civil fines”. Under this system, criminal sanctions would only be used for the most serious, “intentionally fraudulent breaches”.

Media And Political Bulletin 31 July 2018

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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