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HDA UK Media And Political Bulletin – 12 October 2017

Media and Political Bulletin

12 October 2017

Media Summary

Potential supply issues

MHRA Inspectorate Blog, Ian Jackson, 11 October 2017

 

The MHRA blog reports on the effect of the catastrophic weather conditions across the globe that have had a significant impact on the pharmaceutical supply chain in the last couple of months.

 

The blog highlights that the Inspectorate has already received reports of some manufacturing sites being affected and possible shortages occurring as a result.  Therefore, they are requesting that those companies that have sites within their supply chain that could be at risk due to recent weather events (such as those in Puerto Rico, Southern USA, India and Bangladesh) take steps to identify any potential supply issues.

 

The blog states that there is an obligation for licence holders to notify the MHRA of any interruption in supply, for GMP matters this can be done via the Interim Compliance report which should be submitted to gmpinspectorate@mhra.gov.uk

 

Assurances that there are no issues would also be welcomed via the same email address.

 

NHS unprepared for no Brexit deal, says NHS England boss

Politico, Helen Collis, 11 October 2017

 

Politico reports on comments by the head of NHS England in a parliamentary health committee hearing on 11 October.  Simon Stevens highlighted that the U.K. government has not instructed the National Health Service to prepare for a Brexit “no deal” scenario, under which the citizenship rights of a significant proportion of the workforce would be in jeopardy.

 

Mr Stevens said that the system has a “superb contribution from staff who’ve trained and come from the rest of the European Union.” They account for over 9 percent of NHS doctors and about 5 percent of the 1.3 million NHS workforce.

 

Generic shortages: what can be done?

The Pharmaceutical Journal, Mark Burdon, 11 October 2017

 

The Pharmaceutical Journal publishes an opinion piece by Mark Burdon on potential solutions to generic shortages. Mr Burdon is an independent community pharmacy contractor and PSNC regional representative. The article highlights that the supply of generic medicines is vulnerable to the vicissitudes of market forces, with exchange rates fluctuating and manufacturers restricting distribution. Mr Burdon writes that the Department of Health needs to intervene to shield pharmacies from the impact of price spikes and ensure the resilience of the supply chain.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

Potential supply issues

MHRA Inspectorate Blog, Ian Jackson, 11 October 2017

 

The last couple of months have seen some catastrophic weather conditions across the globe.  These can have a significant impact upon the pharmaceutical supply chain.

 

We have already received reports of some manufacturing sites being affected and possible shortages occurring as a result.  Therefore, we request those companies that have sites within their supply chain that could be at risk due to recent weather events (such as those in Puerto Rico, Southern USA, India and Bangladesh) take steps to identify any potential supply issues.

 

We are also liaising with our international regulatory partners in order to gain additional information on potential supply issues and support plans to ensure continued supply of products to patients.

 

You can play a big part by providing relevant information to help with this process.

 

Notifying MHRA

 

There is an obligation for licence holders to notify the MHRA of any interruption in supply, for GMP matters this can be done via the Interim Compliance report which should be submitted to gmpinspectorate@mhra.gov.uk

 

Assurances that there are no issues would also be welcomed via the same email address.

 

NHS unprepared for no Brexit deal, says NHS England boss

Politico, Helen Collis, 11 October 2017

 

The U.K. government has not instructed the National Health Service to prepare for a Brexit “no deal” scenario, under which the citizenship rights of a significant proportion of the workforce would be in jeopardy.

 

Speaking to the parliamentary health committee today, Simon Stevens, head of NHS England, said the system has a “superb contribution from staff who’ve trained and come from the rest of the European Union.” They account for over 9 percent of NHS doctors and about 5 percent of the 1.3 million NHS workforce.

 

Pressed by Labour committee member Ben Bradshaw if he’d been asked to prepare for a no-deal scenario “which is what the Prime Minister [Theresa May] was talking about yesterday,” Stevens responded: “We have not.”

 

Stevens said he remained confident the U.K. government would ensure the health service can continue to employ EU workers after Brexit. “I don’t detect any disagreement with the proposition that … we will continue to rely on our international staff,” he said.

 

Interviewed today on LBC radio station, May said the message to EU citizens was “we want you to be able to stay” but that there were no guarantees if negotiations collapsed without agreement.

 

After the meeting, Bradshaw told anti-hard Brexit movement Open Britain it was “shockingly irresponsible” for May to “repeatedly threaten a no-deal Brexit” without asking the head of the NHS to prepare for the consequences.

 

“Theresa May and the hard Brexiters in Cabinet are putting our NHS at risk,” he said.

 

Generic shortages: what can be done?

The Pharmaceutical Journal, Mark Burdon, 11 October 2017

The supply of generic medicines is vulnerable to the vicissitudes of market forces, with exchange rates fluctuating and manufacturers restricting distribution. The Department of Health needs to intervene to shield pharmacies from the impact of price spikes and ensure the resilience of the supply chain.

Way back in 2012, before funding cuts and Brexit and countless other of today’s challenges were on the horizon, one problem was already coming to light. In fact, the voices of community pharmacy had grown so loud warning about the problem that the All-Party Pharmacy Group (APPG) — a group of MPs across all parties, with an interest in pharmacy — decided to hold an inquiry into it. Their verdict? Medicines stock shortages are a problem; sort them out.

But fast-forward half a decade and if you’re working in a community pharmacy it won’t feel like much has changed. We are still spending hours every week trying to get hold of the medicines our patients need; and things seem to be getting worse, rather than better.

Medicines sources limited

There are many factors currently affecting the supply of medicines to pharmacies and causing these problems. The restricted distribution models implemented by many manufacturers — whereby they only allow a few selected pharmacy wholesalers to stock their medicines — certainly had an impact. They have limited the places from which we can source medicines and diluted competition in the market. This makes the market less resilient, so when things go wrong — a power outage at a major wholesaler, for instance — it can be chaos for pharmacies who have to borrow medicines from one another to meet patient needs.

For many years the UK could import drugs cheaply, but exchange rates mean importing is often no longer a good way to source reasonably priced medicines

A second factor is the global nature of the market for medicines. For many years this benefited the UK as we could import drugs cheaply, but exchange rates mean importing is often no longer a good way to source reasonably priced medicines. In fact, generics prices in the UK are now so low that it is not difficult to imagine why the UK market might not appeal to generics manufacturers at all — why would any business want to sell at lower prices when they could fetch higher ones elsewhere?

Manufacturing plant closures

Another recent and unprecedented problem has been the inspections by regulatory authorities which led to the closures of manufacturing plants owned by two major generics companies. Inevitably, a plant closure means fewer medicines can be produced, prompting potential worldwide shortages of some medicines.

But alongside issues like these which can create real physical shortages of some medicines, a whole host of other market factors come into play and can affect our ability to source medicines. Pricing is a major worry; when medicines are in short supply they tend to become more expensive, and sometimes we simply cannot obtain medicines for anywhere near the Drug Tariff (which sets out how much we will be reimbursed for medicines) prices.

Manipulation of the market can make it very difficult for pharmacy contractors to purchase medicines and can lead to price distortions

Generics pricing is complicated at the best of times, because prices are adjusted regularly to try to set the amount of margin that pharmacy contractors can make on the medicines (this margin forms part of our core funding). But when shortages come into play the market can be even more volatile. There can also be manipulation of the market, which can make it very difficult for pharmacy contractors to purchase medicines as they usually would.

Branded generics distort prices

One example of this is when local NHS commissioners ask GPs to prescribe medicines called ‘branded generics’. Branded generics are produced by manufacturers and priced at levels below the Drug Tariff levels, making them attractive locally because they bring down local drugs bills. But nationally, because generic medicines are priced at a level designed to assure delivery of our core funding, this does not lead to savings. And in fact the local distortions of pricing can mean that pharmacies are not able to earn core parts of their funding, which is a problem.

So what can we do about all of this? Well some things we are already doing. Every month a huge amount of work goes into assessing market prices for any medicines known to be in short supply, to ensure that ‘concessions’ are granted. These mean pharmacies can purchase and be reimbursed for the medicines at the higher market prices. But this system takes a lot of work, and pharmacies often have to go for long periods without knowing whether they will be granted a concession price.

The PSNC is seeking urgent intervention from the Department of Health to ensure the resilience of the medicines supply chain

The Pharmaceutical Services Negotiating Committee (PSNC) would like to see a simpler process, with the Department of Health making speedy adjustments to address the impact of high price rises like the ones we are now seeing. With so many medicines lines currently affected we are also seeking urgent intervention from the Department of Health to ensure the resilience of the medicines supply chain. Unfortunately, there is no simple answer in such a complex market — if there were, they would have done it.

So in the meantime, for community pharmacies the job remains pretty much the same as back when the MPs investigated in 2012. Keep pushing your wholesalers for the best possible deal; keep telling us about the problems; and keep explaining to patients that you are doing all you can, but that sometimes the supply problems are national, and simply out of your control.

HDA UK Media And Political Bulletin – 12 October 2017

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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