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Media And Political Bulletin – 14 March 2019

Media and Political Bulletin

14 March 2019

Media Summary

21 ways you could be affected by a no deal Brexit

BristolLive, Dan Bloom and Alexander Brock, 13 March 2019

BristolLive reports that since the summer of last year, the UK government has been ramping up preparations for a no deal Brexit. The article outlines 21 ways in which a no deal could affect the public, including the potential for pharmacies and hospitals to start rationing medicine.

The authors recall that pharmacists have requested special powers to ration medicines if there is no Brexit deal, and add that under plans by the Healthcare Distribution Association, they would have special powers to vary doctors’ prescriptions and offer something else if a drug is unavailable.

Pharma urges politicians to stop no-deal Brexit in today’s vote

Pharmaphorum, Richard Staines, 13 March 2019

Pharmaphorum reports that ahead of yesterday’s crunch vote, pharma urged politicians to reject a no-deal Brexit, reiterating warnings that this would disrupt supplies of critical medicines.

Mike Thompson, Chief Executive of the ABPI, said: “Pharmaceutical companies have done everything in their power to prepare for a no-deal Brexit. This includes increasing stocks of medicines, changing and adding new supply routes and duplicating manufacturing processes here and in Europe.

“Despite these efforts, we have always said that in a no-deal scenario we could face the very real possibility of disruption to the supply of some medicines. With just days remaining we need a solution which avoids a no-deal Brexit and the potential harm it could cause.”

‘This challenge against pharmacists’ shortages powers was unexpected’

C+D, David Reissner, 13 March 2019

C+D reports that it’s only a being a few weeks since the Human Medicines (Amendment) Regulations 2019 order came into force, allowing pharmacists to supply an alternative if there is a serious shortage of the medicine prescribed, in accordance with a ‘serious shortage protocol’.

But following the news that the Good Law Project (a non-profit organisation that says it fights cases to defend or change the law in the areas of Brexit, tax and workers’ rights) has applied to the High Court for permission to challenge the regulations came as a surprise to David Reissner, a consultant with law firm Charles Russell Speechlys LLP. He explains.

‘Obviously pressing’ need for pharmacist drug-switching powers behind short consultation, says DHSC

The Pharmaceutical Journal, Julia Robinson, 13 March 2019

The Pharmaceutical Journal reports that the government has argued that “there was no statutory obligation” to formally consult on changes to the law allowing pharmacists to switch patients’ drugs during a medicines shortage under a government-issued protocol.

The Department of Health and Social Care (DHSC) made the argument in response to legal campaigners at the not-for-profit group The Good Law Project, which is seeking a judicial review over the legislation that came into effect on 9 February 2019.

The High Court will now decide whether the judicial review will go ahead.

 

 

Parliamentary Coverage

Guidance – Importing medicines from an EEA State which is on an approved country for import list

Guidance has been published on the arrangements for importing medicines into the UK from countries specified on an approved country for import list, in a no deal scenario. This can be accessed here and here.

As Government Brexit plan is rejected again, Cambridge MP calls for Article 50 revocation “in the national interest”

Daniel Zeichner, 12 March 2019

Daniel Zeichner, MP for Cambridge, has condemned the Government for “recklessly wasting yet more time in order to force a false binary choice“ over Brexit, and called on them to revoke Article 50 to prevent a dangerous cliff edge No Deal Brexit as their plans for exiting the EU were rejected by Parliament again this evening.

The Government lost “Meaningful Vote 2”, by 242 votes to 391, a gap of 149 – despite Theresa May’s latest attempts to negotiate further in Brussels.

Mr Zeichner comments “We are now only two and a half weeks away from crashing out of the EU without a deal, which would have extremely serious economic, social and political ramifications – hitting the most vulnerable hardest with possible food price rises and medicine shortages. The government’s no deal impact assessment published just two weeks ago told us that “food prices are likely to increase”, and that custom checks could cost business £13 billion a year. It is completely irresponsible for the Conservatives to continue to put their party ahead of the national interest. They must now move to revoke Article 50 as a matter of urgency, or give the country the final say in a referendum on the Prime Minister’s plan.”

 

Full Coverage

21 ways you could be affected by a no deal Brexit

BristolLive, Dan Bloom and Alexander Brock, 13 March 2019

The UK is scheduled to leave the European Union later this month, which means a No Deal Brexit could soon be on the horizon.

MPs are voting tonight (March 13) on whether to avoid a no deal Brexit, which remains the default option if MPs, the EU and the UK government can’t agree a ‘Withdrawal Agreement’ by March 29.

Leaving with no deal means falling back on World Trade Organisation trade tariffs, increasing the price of imports and exports.

Since summer last year, the UK government has been ramping up preparations for a no deal Brexit, the effects of which would include disruption on motorways, plane tickets being cancelled and job losses.

The article outlines 21 ways in which a no deal Brexit could affect the public, according to Mirror Online. Of particular relevance is point 11:

Pharmacies and hospitals could start rationing medicine

Pharmacists have requested special powers to ration medicines if there is no Brexit deal.

Under plans by the Healthcare Distribution Association, they would have special powers to vary doctors’ prescriptions and offer something else if a drug is unavailable.

37 million packs of medicines are imported to the UK from the EU every month, and the NHS is preparing for a doomsday scenario to prevent supplies running dry.

Government and NHS chiefs have set up a “war room” called the ‘Operational Response Centre’ and industry firms are creating six-week stockpiles of medicine.

Health Secretary Matt Hancock has chartered a plane to fly in short-shelf-life products, like isotopes for cancer treatment, from Maastricht. Insulin could also be stockpiled.

Mr Hancock claimed he’s become the biggest buyer of fridges in the world, after fitting out facilities for storage of the crucial drugs.

NHS staff are being “directed” to urge patients not to stockpile medicines personally to avoid shortages throughout the system.

Pharma urges politicians to stop no-deal Brexit in today’s vote

Pharmaphorum, Richard Staines, 13 March 2019

Pharma has urged politicians to reject a no-deal Brexit in today’s crunch vote, reiterating warnings that this would disrupt supplies of critical medicines.

A motion on a no-deal Brexit is scheduled to be put before MPs at 2.30pm today, and a vote could take place any time after this.

However it’s expected that the vote is most likely to occur in the early evening as the debate over the motion is likely to be long and fierce.

After MPs rejected Theresa May’s final attempt to get her deal through Parliament, the Association of the British Pharmaceutical Industry (ABPI) warned that politicians must find a solution that avoids a no-deal scenario to maintain steady supplies.

Around 45 million packs of medicines leave the UK destined for patients in Europe every month and 37 million packs head the other way, according to ABPI estimates.

That is more than a billion packs of medicine crossing the border between the UK and EU each year.

Pharma companies have been stockpiling medicines in preparation for any disruption at borders caused by a no-deal scenario.

But Health minister Stephen Hammond last month said that no-deal could disrupt medicines supplies to the UK for at least six months, because of delays as they are shipped across the channel.

Previous estimates had suggested delays would last only six weeks after Brexit, which is due to take place on 29th March.

Mike Thompson, Chief Executive of the ABPI, said: “Pharmaceutical companies have done everything in their power to prepare for a no-deal Brexit. This includes increasing stocks of medicines, changing and adding new supply routes and duplicating manufacturing processes here and in Europe.

“Despite these efforts, we have always said that in a no-deal scenario we could face the very real possibility of disruption to the supply of some medicines.

“With just days remaining we need a solution which avoids a no-deal Brexit and the potential harm it could cause.”

‘This challenge against pharmacists’ shortages powers was unexpected’

C+D, David Reissner, 13 March 2019

For David Reissner, one organisation’s legal challenge to allowing pharmacists to dispense an alternative in the case of a major medicine shortage was a surprise.

It’s only a been a few weeks since the Human Medicines (Amendment) Regulations 2019 order came into force, which allows pharmacists to supply an alternative if there is a serious shortage of the medicine prescribed, in accordance with a ‘serious shortage protocol’.

News that the Good Law Project – a non-profit organisation that says it fights cases to defend or change the law in the areas of Brexit, tax and workers’ rights – has applied to the High Court for permission to challenge the regulations comes as a surprise.

I wouldn’t have expected the shortage protocol to be on the Good Law Project’s hit list. This is partly because ministers’ new powers can be used in the case of any serious shortage – not just in the event of a Brexit-related shortage – and partly because, when patients need medicines, everyone wants them to be available without delay.

The Good Law Project says – among other things – the shortage protocol regulations are unlawful because:

  • they contradict section 64 of the Medicines Act, which prohibits a supply of a medicine which is not of the nature or quality demanded
  • they are inconsistent with the prohibition on supplying a prescription-only medicine (POM), except in accordance with a prescription
  • there should have been a proper consultation before implementing a “complex, sensitive and life-endangering proposal”.

As far as section 64 of the Medicines Act is concerned, it only takes effect if what is supplied harms a patient. As for the prohibition on supplying a POM without a prescription, there are already a number of exceptions to this requirement, including emergency supplies and patient group directions.

The government normally consults for at least 12 weeks before implementing changes in the law. The Good Law Project complains that the Department of Health and Social Care (DH) only conducted an informal consultation with selected pharmacy stakeholders over a few days.

The DH said the shortage protocol will not extend to epilepsy medicines. However, the Good Law Project complains that other groups, such as those concerned with Parkinson’s or multiple sclerosis, were also not consulted.

I am not convinced about the legal argument. The impending Brexit may cause or exacerbate shortages, and there wasn’t time for the proper consultation good government usually requires. The DH has made it clear a shortage protocol for any medicine will involve clinical input; it is hardly likely that the clinicians who advise the DH will suggest alternative medicines if it would destabilise a patient’s regime.

Judicial review is a two-stage process. A judge will now consider the Good Law Project’s documents and the DH’s written response, possibly without a hearing. If the judge considers the organisation has an arguable case, a full hearing will be ordered. If the Good Law Project is successful at the full hearing, amendments to the regulations will have to be withdrawn, and a full consultation may have to be carried out.

If a serious shortage occurs in the meanwhile, I expect the DH will have to use its powers if the alternative would be damaging to the health of patients. I’d like to know what the Good Law Project would expect the DH to do.

[David Reissner is a consultant with law firm Charles Russell Speechlys LLP]

‘Obviously pressing’ need for pharmacist drug-switching powers behind short consultation, says DHSC

The Pharmaceutical Journal, Julia Robinson, 13 March 2019

The UK government has claimed that it had no obligation to consult on the recent change to pharmacist drug-switching powers, as the High Court decides whether or not there will be a judicial review, requested by The Good Law Project.

The government has argued that “there was no statutory obligation” to formally consult on changes to the law allowing pharmacists to switch patients’ drugs during a medicines shortage under a government-issued protocol.

The Department of Health and Social Care (DHSC) made the argument in response to legal campaigners at the not-for-profit group The Good Law Project, which is seeking a judicial review over the legislation that came into effect on 9 February 2019.

In a legal document sent to the DHSC on 19 February 2019, the group said that the “serious shortage protocols” consultation, which was open for one week in December 2018, was “insufficient and unlawful”.

But the government has now said that none of the challenges made by The Good Law Project were arguable owing to the “clear and pressing need” for the change to the Human Medicines Regulation 2012.

It said that while the secretary of state would normally consult publicly for 12 weeks before making changes to the Regulation 2012, it was not an “immutable” position, and this was “plainly not a normal situation”.

“The need for the power created by Regulation 9 was obviously important and obviously pressing — both generally … and in the context of Brexit (and the particular risks of shortages to which that might give rise),” the papers said.

Therefore, it argued that “there was no statutory obligation to hold a formal consultation in relation to Regulation 9” — the regulation enabling the government to issue protocols that would allow drug-switching.

The government noted that its invitations for responses to the consultation “stressed the need to move quickly, not least because of the potential need to have legislation in place before 29 March 2019”.

It also said that without the protocols, the consequences would be “highly unfortunate”, as the UK would be “left without an important tool by which the secretary of state can address any serious drug shortages arising, including post-Brexit”.

However, The Good Law Project responded to the government’s claims saying that there was not “any” need, especially not a “pressing” need, for the change in regulation.

“It was expressly not linked to Brexit and, in any event, Brexit day has been known for the last two years,” the response said.

The government has previously said on 14 January 2019 that the use of serious shortage protocols “was prompted” by Brexit, but was not linked to leaving the EU without a deal.

Jolyon Maugham, barrister and director of The Good Law Project, said he had not read anything in the government’s response that caused him to think it was a bad idea to continue to pursue a judicial review.

“There was a breach in the way that the government conducted the consultation — a lot of organisations did not know that there was a consultation — we think that that evidence is there that the consultation was not conducted properly.”

He also said that it was “a remarkable state of affairs” that the government had admitted that there was a risk of serious shortages in the event of a no-deal Brexit.

“That’s something that ought to trouble any MP — there’s no suggestion that the government plans to delay to avoid the risk to patient health of a no-deal [Brexit], but it admits the risk exists.”

He added: “The principle of the serious shortage protocol is not that it means that more medicines are magicked out of thin air, it’s just that patients don’t need to go back to clinicians to have those drugs prescribed.

“If the protocols are struck down — it remains open to patients to go back to GPs, who understand their medical history best of all, to prescribe their medicine. I don’t accept that striking down the measure will affect patients.”

The High Court will now decide whether the judicial review will go ahead.

Media And Political Bulletin – 14 March 2019

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