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HDA UK Media And Political Bulletin – 12 December 2017

Media and Political Bulletin

12 December 2017

The Health Select Committee has published a transcript of the oral evidence given to its inquiry on Brexit on 5 December. The witnesses who appeared at this session include Martin Sawer, Executive Director of the HDA. The full transcript is available to view on the website here.

Media Summary

Brexit could hinder medicines supply to UK, MPs told

The Pharmaceutical Journal, Debbie Andalo, 8 December 2017

 

The Pharmaceutical Journal reports on the comments by UK drug distributors and those involved in the parallel importing of drugs, in which they highlighted to the parliamentary Health Select Committee that they want to see the UK remain in the customs union and the single market.

Martin Sawer, executive director of the Healthcare Distribution Association told MPs at an evidence session for the Health Select Committee’s inquiry on Brexit on 5 December that “we take the drugs supply chain for granted. I think we are invisible. It’s important to recognise that this supply chain is there. This [Brexit] jolt to it like this could throw a lot of cogs out of a very complicated machine.”

Chemical and pharma groups urge Gove to stick to EU regime

Financial Times, George Parker, Sarah Neville and Robert Wright, 11 December 2017

The Financial Times highlights that Britain’s chemicals and pharmaceuticals industries have called on the government to let them remain within EU rules at the time when some ministers have stepped up a campaign to break away from the bloc’s regulations.

In a letter to Michael Gove, the Chemical Industries Association urged the government “to do all it can to remain within or as close as possible” to the EU’s rule book for the sector, which exports about £50bn a year.

Steve Elliott, the chemicals association’s chief executive, said leaving the EU framework “would seriously bring into question 10 years of investment, as registrations and authorisations that permit access to the EU single market would suddenly become non-existent on exit day”.

The Association of the British Pharmaceutical Industry also said securing co-operation between the UK and EU on chemicals legislation and medicines regulation would be vital to ensuring there was no disruption for patients “and that 82m packs of medicines can move between the UK and EU every single month without delay”.

PSNC responds to Department of Health on list of concessionary drug prices for November

Pharmacy Business. Neil Trainis, 11 December 2017  

Pharmacy Business highlights the PSNC response to the Department of Health on its list of concessionary drug prices for November. The PSNC said on Friday that it had received a list of proposed concession prices for 52 of 67 outstanding requests for November amid growing concerns that pharmacists were being made to wait for prices for numerous medicines.

“DH’s action in delaying many November concessions has caused massive concerns for contractors as they will need to pay for November supplies at the end of December and this will include many lines purchased at very high prices,” the PSNC said.

PSNC receiving ‘unprecedented’ number of calls from pharmacies struggling with drugs shortages

Pharmacy Business, Neil Trainis, 7 December 2017

Pharmacy Business reports on a statement from Mike Dent, the director of pharmacy funding at the PSNC, in which he has said that the negotiating body is receiving an “unprecedented” number of calls from community pharmacies who are struggling to get hold of medicines.

The issue of drugs shortages was shunted back into the spotlight, after a story appeared in The Times on 7 December, claiming medicines have cost the NHS £180 million in six months. Drugs currently in short supply include those used to treat breast and prostate cancer, epilepsy, schizophrenia and bipolar disorder.

Martin Sawer, the executive director of the HDA, told the Times that his members “do not sit on stock, they make generics available to customers as soon as they get them.”

Yet wherever the source of the problem, shortages are getting worse as Mike Dent revealed.

“We are receiving unprecedented numbers of calls from community pharmacy teams who cannot get hold of certain medicines that patients need despite their best efforts; or who are having to pay prices many times more than the NHS reimbursement price. This has been going on for many months,” he said.

Drug shortages featured in national press

PSNC, 7 December 2017

The PSNC responded to The Times article on 7 December underlining that community pharmacy contractors and their teams will be all too aware of the current generic supply situation.

The Committee also noted that PSNC Committee Member and independent contractor Mark Burdon was quoted in The Times article referencing the difficult situation that pharmacy teams were being put in trying to explain the situation to patients whilst they were “scratching around” for crucial supplies.

Parliamentary Coverage

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Full Coverage

Brexit could hinder medicines supply to UK, MPs told

The Pharmaceutical Journal, Debbie Andalo, 8 December 2017

Medicines could become more difficult to import into the UK post-Brexit, MP members of the House of Commons Health Select Committee were told on 5 December 2017.

UK drug distributors and those involved in the parallel importing of drugs told the committee that they wanted to see the UK remain in the customs union and the single market in any negotiated Brexit deal.

And they believed a transition period of between two to five years was needed to work out with the Medicines and Healthcare products Regulatory Agency (MHRA) how to protect the medicines supply chain after March 2019, the date the UK is scheduled to leave the European Union (EU).

Martin Sawer, executive director of the Healthcare Distribution Association, which represents businesses that supply medicines to the UK chain, told MPs: “We take the drugs supply chain for granted. I think we are invisible. It’s important to recognise that this supply chain is there. This [Brexit] jolt to it like this could throw a lot of cogs out of a very complicated machine.”

Inquiry into impact of Brexit

Sawyer was speaking at the committee’s ongoing inquiry into the impact of Brexit on the UK’s medicines supply chain (Brexit — medicines, medical devices and substances of human origin inquiry), which was announced in September.

MPs are looking at the logistics of the supply chains for medicines and medical devices, the current issues and the risks and opportunities that Brexit poses for the sector and patients.

Sawyer revealed that 90% of UK medicines are imported, and of that number 45% come from the EU. Businesses were unable to plan for uncertainty and needed at least two years after the UK leaves the EU in March 2019 to work out a new supply system with the MHRA and others.

Consequences for imports/exports

Richard Freudenberg, secretary-general of the British Association of European Pharmaceutical Distributors, which represents companies involved in the parallel importing of medicines, said the sector would be hard hit if the UK became part of World Trade Organization rules.

He told MPs: “My understanding in these circumstances would be that exports from the UK would cease… in licensing terms I think imports could continue with agreement.”

He said: “My understanding is that we would be able to trade with the rest of the world, but the medicines regulations would not be in place to bring those in line with trade laws.”

Sawyer pointed out that if the UK had a post-Brexit trade agreement with the US for example it would mean drugs would start to leave the UK because they were 50% cheaper than the cost of the same medicines in the US: “We have got to be really careful about doing trade deals with well-off countries because they could start sucking medicines out of the UK.”

First report

This is the second part of the inquiry the committee has held into the impact of Brexit on the health service. In April 2017, it published its findings on the effect leaving the EU would have on the UK’s health and social care sectors.

The government published its response to this report on 1 December 2017, saying that “all policy teams with the DH [Department of Health] have assessed the implications of the UK’s withdrawal from the EU on their area”, but that there were no plans to publish these assessments.

The DH also said it would submit evidence to the government-commissioned Migration Advisory Committee “to ensure that the staffing needs of health and social care are fully considered”.

Chemical and pharma groups urge Gove to stick to EU regime

Financial Times, George Parker, Sarah Neville and Robert Wright, 11 December 2017

Britain’s chemicals and pharmaceuticals industries have called on the government to let them remain within EU rules as Eurosceptic ministers step up a campaign to break away from the bloc’s regulations.

In a letter to Michael Gove, the cabinet’s champion of regulatory divergence, the Chemical Industries Association urged the government “to do all it can to remain within or as close as possible” to the EU’s rule book for the sector, which exports about £50bn a year.

The issue of regulatory divergence has moved centre stage in the Brexit debate since Friday’s divorce deal with Brussels, in which Theresa May, prime minister, agreed that Northern Ireland would not stray far from EU rules to ensure there would be no hard border with the Republic of Ireland.

That promise has cheered pro-business cabinet members but raised alarm in Eurosceptic circles, where the prospect of sweeping deregulation has been one of the main policy goals Brexiters have promoted in leaving the EU.

A split in the cabinet looms as it prepares to discuss Britain’s future relations with the EU this week. Mr Gove has the backing of defence secretary Gavin Williamson, along with foreign secretary Boris Johnson, trade secretary Liam Fox and Brexit secretary David Davis to push for a clean break.

Mr Williamson has told friends he is “definitely for divergence”, pitting him against a “hugger” cabinet faction led by chancellor Philip Hammond and home secretary Amber Rudd, who want to align Britain more closely to the EU.

While Mr Gove and his colleagues argue that Britain could achieve high standards of regulatory protection through a lighter-touch regime, business fears it could create new barriers to trade with the EU.

In the letter to Mr Gove, Steve Elliott, the chemicals association’s chief executive, said leaving the EU framework “would seriously bring into question 10 years of investment, as registrations and authorisations that permit access to the EU single market would suddenly become non-existent on exit day”.

Meanwhile, the Association of the British Pharmaceutical Industry said securing co-operation between the UK and EU on chemicals legislation and medicines regulation would be vital to ensuring there was no disruption for patients “and that 82m packs of medicines can move between the UK and EU every single month without delay”.

Referring to the EU regulation for the sector Mr Elliott said that although it was “far from perfect”, the bloc’s legislation was the best way of ensuring that “cars continue to run, planes continue to fly and medicines continue to work”.

But the European Chemicals Agency, which determines standard-setting for chemicals and single market access, comes under the framework of the European Court of Justice — a red line for Brexiters.

The EU has always resisted accepting the chemicals regulations of other countries as automatically equivalent to Reach, emphasising that it considers its own rules as the gold standard. In practice, without any formal agreements in trade deals, companies around the world often adopt the Reach standards as their default regulation in order to be able to sell into the EU.

Several countries, including China, Malaysia and South Korea, have amended their own chemicals regulation along similar principles to Reach, though without being formally recognised as equivalent.

Mr Gove’s department is consulting on a new independent body to uphold environmental standards in England after Brexit, but the chemicals sector could be forced to engage in costly duplication of registration of products in the UK and EU.

“We are working to ensure a smooth transition for the chemical industry as we leave the EU,” said a spokesman for the Department for Environment, Food and Rural Affairs.

“Our priority is to maintain an effective regulatory system for the management and control of chemicals to safeguard human health and the environment, respond to emerging risks and allow trade with the EU that is as frictionless as possible.”

The government has already been willing to fudge its Brexit “red lines” in other areas: it will ask for its aviation industry to be regulated by the EU after Brexit, in a move that will place it under the indirect jurisdiction of the European Court of Justice.

PSNC responds to Department of Health on list of concessionary drug prices for November

Pharmacy Business. Neil Trainis, 11 December 2017  

The PSNC has said it has responded to the Department of Health on its list of concessionary drug prices for November although pharmacy’s negotiator has yet to provide details around its response.

The PSNC said on Friday that it had received a list of proposed concession prices for 52 of 67 outstanding requests for November amid growing concerns that pharmacists were being made to wait for prices for numerous medicines.

“DH’s action in delaying many November concessions has caused massive concerns for contractors as they will need to pay for November supplies at the end of December and this will include many lines purchased at very high prices,” the PSNC said.

“In light of these extreme pressures and the high level of press interest in this area we are advising contractors of this latest news now. We will provide further details as soon as we can via our website and email news alerts.”

The DoH’s list of concessionary prices was released last week following pressure from the PSNC who said it was “pressing for confirmation of December concessions as soon as possible.”

The PSNC added: “We are also working to ensure that the DoH understands the problems and risks if pharmacies are not able to obtain medicines for patients in a timely manner, and pressing for better systems to address the impact of high price rises.”

PSNC receiving ‘unprecedented’ number of calls from pharmacies struggling with drugs shortages

Pharmacy Business, Neil Trainis, 7 December 2017

Mike Dent, the director of pharmacy funding at the PSNC, has said the negotiating body is receiving an “unprecedented” number of calls from community pharmacies who are struggling to get hold of medicines.

The issue of drugs shortages was shunted back into the spotlight, a story appearing in today’s Times claiming they have cost the NHS £180 million in six months. Drugs in short supply include those used to treat breast and prostate cancer, epilepsy, schizophrenia and bipolar disorder.

The paper revealed pharmacists struggled to obtain 97 drugs last month alone compared with 27 in April, with health officials forced to approve temporary price increases of up to 4,000% to ensure stocks of medicines are replenished.

The key players in the supply chain also appear to be engaging in finger-pointing and blame-shifting. Warwick Smith, the director-general of the British Generic Manufacturers Association, told the Times that wholesalers were artificially inflating prices, a claim rejected by the Healthcare Distribution Association (HDA) who in turn called for greater focus to be placed on smaller wholesalers.

Rajiv Shah, a director at Sigma, said during the Avicenna conference in Vietnam in October that his customers had informed him that wholesalers were deliberately stockpiling and hoarding medicines.

Those medicines, he alleged, would remain unavailable until concessionary prices were announced prompting wholesalers to start calling pharmacies telling them stocks were available. Shah did not reveal the identity of those wholesalers when contacted by Pharmacy Business.

Martin Sawer, the executive director of the HDA, told the Times that his members “do not sit on stock, they make generics available to customers as soon as they get them.”

Yet wherever the source of the problem, shortages are getting worse as Dent (pictured) revealed.

“We are receiving unprecedented numbers of calls from community pharmacy teams who cannot get hold of certain medicines that patients need despite their best efforts; or who are having to pay prices many times more than the NHS reimbursement price. This has been going on for many months,” he said.

“When we request price concessions, the Department of Health always makes its own inquiries following reports from us to validate the availability and prices around the country.”

The PSNC said it “continues to press urgently for a decision on the outstanding November price concession applications” and has “been assured by the Department of Health that this is a priority.”

Smith told Pharmacy Business: “There have been disruptions to the supply of a number of generic medicines due to production issues that have impacted a small number of manufacturers.

“Other generic medicines manufacturers have increased their production of the affected products or have entered or re-entered the market in them. The industry’s focus has rightly been on ensuring continuity of supply to the greatest extent possible in the interest of patients.

“Production changes such as this, however, inevitably incur additional costs and the prices of these products have increased. To reflect higher costs incurred by community pharmacists, the Department of Health sets so-called concessionary prices for these products based on surveys of actual selling prices in the market.

“A survey of our members shows that the concessionary price set of these products in October were on average 2½ times actual prices charged by manufacturers.”

Drug shortages featured in national press

PSNC, 7 December 2017

The front cover of this morning’s (Thursday 7th December) The Times featured an article raising concerns about patients not being able to get hold of vital medicines due to drug shortages.

The Times reports that cancer patients and people with severe mental illness are being particularly affected by the shortages, which have cost the NHS £180 million in the last six months due to substantial price increases. The article goes on to state that at least 100 drugs have been affected by supply problems, forcing health officials to approve temporary price rises of up to 4,000% to boost stocks.

Community pharmacy contractors and their teams will be all too aware of the current generic supply situation. PSNC Committee Member and independent contractor Mark Burdon is quoted in the article referencing the difficult situation that pharmacy teams were being put in trying to explain the situation to patients whilst they were “scratching around” for crucial supplies.

PSNC continues to press urgently for a decision on the outstanding November price concession applications and we have been assured by the Department of Health that this is a priority. We hope to receive a reply soon and well before November prescription pricing is finalised. As soon as any announcement is made we will inform pharmacies via our website and email news alerts.

The PSNC Dispensing and Supply Team has set up a specific email address for community pharmacy teams to contact us regarding the outstanding November price concessions: novemberconcessions@psnc.org.uk. Please use this address to submit any further relevant information about the impact the delay in granting the concessions is having on patients and pharmacies.

Mike Dent, Director of Pharmacy Funding at PSNC, said:

“We are receiving unprecedented numbers of calls from community pharmacy teams who cannot get hold of certain medicines that patients need despite their best efforts; or who are having to pay prices many times more than the NHS reimbursement price. This has been going on for many months. When we request price concessions, the Department of Health always makes its own inquiries following reports from us to validate the availability and prices around the country.”

HDA UK Media And Political Bulletin – 12 December 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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