News

Media And Political Bulletin – 28 February 2019

Media and Political Bulletin

28 February 2019

Media Summary

Wholesaler body proposes shortages information scheme to rebuild trust

C+D, Thomas Cox, 27 February 2019

C+D reports that Martin Sawer said last week at the Sigma conference that collating information on medicine shortages from manufacturers, wholesalers and pharmacies would rebuild trust across the supply chain.

“An information service [for] the supply chain – up to manufacturers and back down, particularly to community pharmacies – would be quite an achievement,” Mr Sawer said.

He admitted that sharing some data “is a challenge” because of commercial sensitivities, and any information shared “has to be handled properly”. However, exchanging information would help those in the supply chain understand each other better, and would improve trust between pharmacies, wholesalers and manufacturers, Mr Sawer said.

Medical Devices – Post-Brexit Supplies

Politico, Helen Collis, 28 February 2019

Politico reports that the U.K. will continue to accept medical devices safety-marked by EU notified bodies even if there’s a no-deal Brexit, the government confirmed in a new set of guidance. But that doesn’t mean manufacturers have nothing to prepare:

  • Device makers need to register their products with the MHRA by March 29 to place them on the U.K. market. However, depending on the type of device, the government is offering a grace period of four, six or 12 months after that deadline.
  • The U.K. is creating a new position, known as a “responsible person,” who will be physically on the ground in the U.K. to interact with the MHRA on behalf of manufacturers of products made outside the country.

But the European Commission said Wednesday there’s “no need for contingency measures” to keep the supply of devices flowing from the U.K. notified bodies after a no-deal Brexit.

Hydrocortisone shortages due to alleged supplier cartel, CMA concludes

Dispensing Doctors’ Association, Ailsa Colquhoun, 28 February 2019

Dispensing Doctors’ Association reports that the Competition and Markets Authority (CMA) has provisionally identified anti-competitive behaviour that could have led to hydrocortisone shortages between July 2011 and April 2015.

An investigation into suppliers Auden Mckenzie and Waymade has prompted the CMA to assert that Auden Mckenzie abused its dominant position by making monthly payments to Waymade not to enter the market.

As a result of this alleged anti-competitive behaviour, the CMA believes the NHS was denied a choice of suppliers and the potential savings resulting from increased competition.

NHS England updates no-deal Brexit advice

Dispensing Doctors’ Association, Ailsa Colquhoun, 27 February 2019

Dispensing Doctors’ Association reports that NHS England has published updated information on planning for continuity of supply of medicines in the case of a ‘no deal’ EU Exit. This information also includes supporting Q&As which may be helpful in any discussion with patients about their medicines and medical products.

The nhs.uk website has also been updated with some patient facing information on medicines supply.

In addition, Stephen Hammond MP, Minister of State for Health, has also written to, the NHS, Adult Social Care, Royal Colleges and Charities to provide an update on work to ensure the continuity of supply of medicines and medical products in the event the UK leaves the EU with no deal.

Drug shortages blamed on Brexit are ‘harming thousands of patients’ because GPs are being forced to dole out second-choice medicines

MailOnline, Sam Blanchard, 27 February 2019

MailOnline reports that patients are being harmed because drug shortages are forcing doctors to change their prescriptions, a survey has revealed. One in seven GPs say their patients have experienced negative side effects after they had to switch to second-choice drugs.

Shortages of medicines have this year been described as ‘worse than ever’ and there are concerns Brexit is contributing by causing patients and companies to stockpile.

More than a third of doctors say they ‘fairly often’ have to switch to less desirable drugs because of availability, while 16 per cent say they have to do it ‘very often’. In a survey of 586 GPs by the news website GP Online, nine out of 10 of them said they noticed their go-to medicines were becoming unavailable more often.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Wholesaler body proposes shortages information scheme to rebuild trust

C+D, Thomas Cox, 27 February 2019

Collating information on medicine shortages from manufacturers, wholesalers and pharmacies would rebuild trust across the supply chain, the wholesaler body has said.

Community pharmacies in particular would benefit from a tailored service that shows which medicines are experiencing supply disruptions, why, and when they are going to be available, Martin Sawer, head of the Healthcare Distribution Association (HDA) said last week (February 18).

The service would probably need a “third party of mutual engagement” such as the Department of Health and Social Care (DH), to oversee the sharing of supply data between pharmacies, wholesalers and manufacturers, Mr Sawer told C+D after his presentation at the Sigma conference in Muscat, Oman.

“An information service [for] the supply chain – up to manufacturers and back down, particularly to community pharmacies – would be quite an achievement,” Mr Sawer said.

Rebuilding trust

He admitted that sharing some data “is a challenge” because of commercial sensitivities, and any information shared “has to be handled properly”.

However, exchanging information would help those in the supply chain understand each other better, and would improve trust between pharmacies, wholesalers and manufacturers, Mr Sawer said.

“In some specific incidences, an accusation that’s been levelled [is that] wholesalers don’t always communicate why a product isn’t there and when it’s going to be there next. Sometimes we don’t actually know, that’s the trouble,” he told C+D.

“We need to tell a pharmacy that we don’t know – it’s just exchanging basic information. If that happened, there would be better trust established.”

“Getting hold of medicines is a huge challenge”

Mr Sawer would like to start developing the service later this year, he said. “I’ve mentioned it to a few pharmacy leaders and they’ve been supportive.

“The information supply is one thing – once that’s sorted, we need to move to how we sort out [shortages of] individual medicines,” he continued.

“Getting hold of medicines is a huge challenge, but if the information exchange allows an understanding of the level of demand and concern, then maybe medicines can be moved around if they’re in the wrong place, and supply can be added to more quickly.

“It will be on a case-by-case basis, medicine-by-medicine, because there’s different reasons for shortages,” Mr Sawer explained.

Watch Mr Sawer explain the proposals in more detail.

Medical Devices – Post-Brexit Supplies

Politico, Helen Collis, 28 February 2019

The U.K. will continue to accept medical devices safety-marked by EU notified bodies even if there’s a no-deal Brexit, the government confirmed in a new set of guidance. But that doesn’t mean manufacturers have nothing to prepare.

— Device makers need to register their products with the Medicines and the Healthcare products Regulatory Agency (MHRA) by March 29 to place them on the U.K. market. However, depending on the type of device, the government is offering a grace period of four, six or 12 months after that deadline.

— The U.K. is creating a new position, known as a “responsible person,” who will be physically on the ground in the U.K. to interact with the MHRA on behalf of manufacturers of products made outside the country. (It’s essentially the same role as an “authorized representative,” an official position within the EU’s device rules, who’s supposed to be on the ground in EU countries on behalf of manufacturers from the U.S., China, etc.)

EU declines to reciprocate: The European Commission said Wednesday there’s “no need for contingency measures” to keep the supply of devices flowing from the U.K. notified bodies after a no-deal Brexit.

Transparency wars: The appearance of DG GROW officials at a hearing in the European Parliament’s Environment, Public Health and Food Safety Committee turned into a heated debate about how much information on problems should be shared with the public in the EU’s new medtech database. Scroll down for the full article.

Lords talk: James O’Shaughnessy’s debate on the safety of medical devices was up in the House of Lords this morning.

Hydrocortisone shortages due to alleged supplier cartel, CMA concludes

Dispensing Doctors’ Association, Ailsa Colquhoun, 28 February 2019

The Competition and Markets Authority (CMA) has provisionally identified anti-competitive behaviour that could have led to hydrocortisone shortages between July 2011 and April 2015.

An investigation into suppliers Auden Mckenzie and Waymade has prompted the CMA to assert that Auden Mckenzie abused its dominant position by making monthly payments to Waymade not to enter the market.

As a result of this alleged anti-competitive behaviour, the CMA believes the NHS was denied a choice of suppliers and the potential savings resulting from increased competition.

From 2011 to 2015, while Auden Mckenzie remained the sole supplier of 20 mg hydrocortisone tablets, charges to the NHS rose from around £46 to £90 for a pack of 30 tablets, increasing the annual costs incurred by the NHS for the medicine from £1.7 million to £3.7m.

The CMA provisionally finds that in May 2011, Waymade was ready to enter the market for 20 mg hydrocortisone tablets, but then failed to do so until July 2015. Instead, it froze its own stock and agreed a deal with Auden Mckenzie under which it received monthly payments aimed at delaying its entry as a competitor in the market.

Waymade also obtained a licence to sell 10 mg hydrocortisone tablets in September 2012. In exchange for Waymade not entering the market and competing with its own tablets, the CMA alleges that Auden Mckenzie significantly lowered the price it charged Waymade from the market rate of around £32 per pack to £1.

This is a provisional finding. The companies now have the chance to make representations to the CMA before a final decision is reached. This will be made by a case decision group, which is separate from the case investigation team and was not involved in the decision to issue the statement of objections.

A final decision against the companies could result in a financial penalty of up to 10 per cent of annual worldwide group turnover.

For more information see the hydrocortisone tablets: alleged anti-competitive agreements and conduct case page.

NHS England updates no-deal Brexit advice

Dispensing Doctors’ Association, Ailsa Colquhoun, 27 February 2019

NHS England has published updated information on planning for continuity of supply of medicines in the case of a ‘no deal’ EU Exit. This information also includes supporting Q&As which may be helpful in any discussion with patients about their medicines and medical products.

The nhs.uk website has also been updated with some patient facing information on medicines supply.

In addition, Stephen Hammond MP, Minister of State for Health, has also written to, the NHS, Adult Social Care, Royal Colleges and Charities to provide an update on work to ensure the continuity of supply of medicines and medical products in the event the UK leaves the EU with no deal.

Drug shortages blamed on Brexit are ‘harming thousands of patients’ because GPs are being forced to dole out second-choice medicines

MailOnline, Sam Blanchard, 27 February 2019

Patients are being harmed because drug shortages are forcing doctors to change their prescriptions, a survey has revealed.

One in seven GPs say their patients have experienced negative side effects after they had to switch to second-choice drugs.

Shortages of medicines have this year been described as ‘worse than ever’ and there are concerns Brexit is contributing by causing patients and companies to stockpile.

More than a third of doctors say they ‘fairly often’ have to switch to less desirable drugs because of availability, while 16 per cent say they have to do it ‘very often’.

In a survey of 586 GPs by the news website GP Online, nine out of 10 of them said they noticed their go-to medicines were becoming unavailable more often.

Figures last month revealed the Government was in December paying over the odds for 80 drugs because they were hard to get hold of – this has dropped to 61 so far for February.

‘Shortages do affect patient management tremendously as second line medications are not always ideal and in rare cases not as effective,’ said one anonymous GP in the survey.

Another said anti-inflammatory painkillers, such as ibuprofen, high-strength aspirin and naproxen, pose a particular problem.

They wrote: ‘It is a particular nuisance for the anti-inflammatories. Patients are having to take stronger or unequal doses which is causing harm.’

And one said it was ‘terrifying’ to think about what might happen ‘if Brexit goes ahead’.

There have been concerns patients will try to stash medicines out of fear they won’t be able to get prescriptions filled if Britain leaves the EU next month.

International supply lines may also be disrupted if there are no agreements put in place before Brexit – even the Dutch government has admitted it is trying to secure access to ‘vital’ medicines out of fear European supplies will dry up.

And the country’s health minister, Bruno Bruins, said he wouldn’t reveal which medicines they were concerned about in case other countries tried to take them.

There has been disagreement over whether Brexit is the real cause, and the Government denies the link.

In January, chair of the English Pharmacy Board at the Royal Pharmaceutical Society, Sandra Gidley, said: ‘This has been a problem for some time.

‘There was a group set up by the Department of Health in 2010 to look at these shortages. But it is fair to say that recently the shortages have been worse than ever.’

Gareth Jones, from the National Pharmacy Association, told the BBC at the time: ‘Uncertainty over Brexit appears to be a significant factor.’

And Martin Sawer, executive director of the Healthcare Distribution Association, said people might be stockpiling medicines.

‘Some businesses could be speculating on Brexit,’ he added. ‘That’s the nature of the market.’

The Government has this month passed rules on ‘serious shortage protocols’, which will allow pharmacists to give a patient drugs different to what is on their prescription if supplies run out.

A Department of Health and Social Care spokesperson told GP Online: ‘There is no hard evidence to date to suggest current medicine supply issues are increasing as a result of EU exit.

‘Our number one priority is to ensure the continued supply of medicines and we are working closely with industry and partners in the health system to help prevent disruption, including increasing UK buffer stocks.

‘We are confident that, if everyone does what they need to do, the supply of medicines should be uninterrupted in the event of a no deal.

‘We have well-established processes to manage and mitigate the small number of supply problems that may arise at any one time due to manufacturing or distribution issues and this has always been the case – every day over 2m prescription items are successfully dispensed in England.’

How the NHS is planning for a no-deal Brexit

The Week, 27 February 2019

All forms of Brexit will negatively impact the NHS but a no-deal scenario could prove disastrous, according to a new health policy review.

The study, by leading experts in public health and law, found that leaving the EU without a deal would have negative repercussions on the NHS workforce and financing, and would also adversely affect the availability of medicines and vaccines, and the sharing of information and medical research.

“Our analysis shows that a no-deal Brexit is substantially worse for the NHS than a future involving the Withdrawal Agreement, which provides certainty and continuity in legal relations while the Political Declaration on the Future Relationship is negotiated and put into legal form,” says the paper, published in The Lancet.

Freedom of Information disclosures and board papers uncovered by Sky News reveal that hospitals around the UK are preparing for “shortages of medicines and staff” in the event of a no-deal Brexit. The London North West University Healthcare Trust is reportedly considering increasing security at its pharmacy “because of fears of break-ins” by people attempting to steal supplies.

The pharmaceutical industry has reportedly told the Government that it should “act to prevent medicine stockpiles being depleted by middle-men cashing in on a fall in the pound by selling no-deal supplies to European distributors”.

The Guardian reports that the government has already created a “logistics hub in Belgium” where “vital medical supplies will be stockpiled to stop the NHS running short of equipment if there is a no-deal Brexit”.

The paper adds that the Department of Health and Social Care has “arranged to get NHS supplies – including drugs – into Britain using seven new ferry routes” in order to “bypass the chaos that is widely expected in and around Dover in the event of no deal”.

A number of hospitals and trusts have also stated that they may be forced to cancel or postpone operations and other medical procedures in the event of no deal.

The Dudley Group NHS Foundation Trust said a no-deal Brexit would “adversely affect” supply chains, making it necessary for the trust to consider “prioritisation of key services and cancellation of non-critical services”.

Prime Minister Theresa May said yesterday that the UK would only leave the EU without a deal with the explicit consent of parliament, but insisted that the option had not been taken off the table.

Media And Political Bulletin – 28 February 2019

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

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?