News

Media And Political Bulletin – 03 December 2018

Media and Political Bulletin

03 December 2018

Media Summary

Buyers’ clubs re-emerge to tackle issues in access to HIV drugs

Pharmacy Business, Kiran Paul, 1 December 2018

Pharmacy Business reports that a new generation of drug buyers’ clubs like those set up at the height of the AIDS epidemic is seeking to combat a ‘crisis’ in preventing new HIV infections by providing access to cheap generics of a breakthrough prophylactic.

The original buyers’ groups, made famous in the film “Dallas Buyers Club”, were set up in the 1980s to import experimental drugs not approved by U.S. authorities when AIDS treatments were in their infancy and the disease was a death sentence for many.

Treatment rates have risen dramatically since then, but 1.8 million people became infected with HIV in 2017 and the United Nations has warned high infection rates threaten to derail efforts to defeat the disease.

Pre-exposure prophylaxis (PrEP) is a groundbreaking daily pill that can prevent infection, but for many at risk, the cost puts it out of reach – leading to a re-emergence of the buyers’ clubs.

PSNC says pharmacists should be able to substitute drugs to ease Brexit supply pressures

The Pharmaceutical Journal, Debbie Andalo, 30 November 2018

The Pharmaceutical Journal reports that pharmacy negotiators have suggested that community pharmacists should be able to automatically substitute an alternative medicine If they cannot dispense the prescribed item, as a way to help deal with any possible drugs shortages post-Brexit.

The article reports that the PSNC has suggested a number of ‘secondary measures’ following ongoing discussions with the Department of Health and Social Care over managing the risk to the medicines supply chain after Brexit. These include introducing routine therapeutic substitution, which means a community pharmacist would no longer have to go back to the GP or other prescriber for approval to switch to an alternative product; and more responsive drug tariff pricing, to ensure that pharmacy contractors are properly reimbursed for any additional incurred costs.

Survey shows pharma industry pessimism about post-Brexit UK

Politico, Sarah Wheaton, 30 November 2018  

Politico reports that the pharmaceutical industry’s perception of the business climate in the U.K. after Brexit is tanking, according to a new survey from data analytics firm GlobalData.

About 23 percent of industry professionals from the U.K., EU and United States said the U.K. would be an ‘attractive destination for health care companies to conduct research and manufacturing after Brexit,’ according to the Q3 edition of GlobalData’s quarterly poll.

That reflects an increasingly pessimistic outlook since Q1 in each region, but the change is most pronounced within the U.K. In Q1, 48 percent of U.K. respondents thought their country would remain a good place to do business after March 2019, but now it’s down to 17 percent.

Refrigeration for ‘no-deal’ Brexit medicine stockpiles to cost tens of millions of pounds, says Hancock

The Pharmaceutical Journal, Carolyn Wickware, 28 November 2018

The Pharmaceutical Journal reports that Health Secretary, Matt Hancock, has said that building refrigeration capacity to store stockpiles of medicines in the event of a ‘no-deal’ Brexit is expected to cost in the ‘low tens of millions’ of pounds.

Speaking to MPs at a House of Commons health and social care select committee meeting on 26 November 2018, Hancock stated that the exact amount would become clear ‘shortly’ after contract bids were finalised.

He clarified that the money would not come from the extra £20.5bn promised to the NHS in June 2018, but from the £1.5bn fund ‘that the Treasury has set aside for Brexit contingency planning.’

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 30 November 2018

Edward Vaizey, MP: To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the availability of essential epilepsy medicines from the EU during the transition period for the UK leaving the EU; and if he will make a statement.

Steve Brine: The Government has now agreed the Withdrawal Agreement with the European Commission. As a consequence, the Department does not expect market access to medicines for the United Kingdom to change under the terms of that agreement during the implementation period, which will run from March 2019 until December 2020.

The Department does not expect to see significant changes to the continuity of medicine supply in the intervening period, although we will be monitoring this closely.

Full Coverage

Buyers’ clubs re-emerge to tackle issues in access to HIV drugs

Pharmacy Business, Kiran Paul, 1 December 2018

A new generation of drug buyers’ clubs like those set up at the height of the AIDS epidemic is seeking to combat a “crisis” in preventing new HIV infections by providing access to cheap generics of a breakthrough prophylactic.

The original buyers’ groups, made famous in the film “Dallas Buyers Club”, were set up in the 1980s to import experimental drugs not approved by U.S. authorities when AIDS treatments were in their infancy and the disease was a death sentence for many.

Treatment rates have risen dramatically since then, but 1.8 million people became infected with HIV in 2017 and the United Nations has warned high infection rates threaten to derail efforts to defeat the disease.

Pre-exposure prophylaxis (PrEP) is a groundbreaking daily pill that can prevent infection, but for many at risk, the cost puts it out of reach – leading to a re-emergence of the buyers’ clubs.

“History may not repeat itself, but it sure rhymes a lot,” said Mitchell Warren of the US-based AIDS Vaccine Advocacy Coalition (AVAC).

“This is a really remarkable example of the rhyming … There is a prevention crisis, we need oral PrEP as part of our prevention programmes.”

The commercially available Truvada brand produced by Gilead Sciences can cost more than $1,000 for a three-month supply and access remains patchy.

Last year fewer than 400,000 people obtained PrEP through mainstream health programmes, pilots, and trials, according to data collected by AVAC.

The unmet demand has led some campaigners to set up clubs to help those at risk to import generic drugs produced in developing countries for a fraction of the branded price.

The new buyers’ clubs do not sell drugs. Instead they provide details of trusted online pharmacies and manufacturers based in countries such as India, which sell generic drugs for as little as £19 per month.

The clubs exploit a loophole in World Trade Organization patent rules that allows small-scale imports of medicines for personal use.

For users in many countries, the process can be completed legally, and several small-scale trials have found no evidence of fake drugs among the generics.

Game-changer

Experts say the buyers’ clubs appear to be most used in Europe, but can also be found from North America to Australia.

Joshua Edward, 44, who got his PrEP through a Canadian buyers’ club for several years until his province introduced coverage last year, called it a game-changer.

“For a lot of us it felt like a ticking bomb,” he said.

“One of the things that stands out most is how long I can go without even thinking about HIV, which previously, especially when I was single, was something I would think about constantly.”

PrEP buyers’ clubs remain niche in the United States, but their use is growing, said Leslie Hall, a spokesman for the LGBT+ rights group Human Rights Commission (HRC).

“I’m enthusiastic about any programme that allows folks to who live on the margins of society to have access to life-saving drugs,” he said.

“If you don’t have the top-of-the line healthcare plan it can really get expensive for you … For some people a buyers’ club is the only way they will have access to this drug.”

Historian Lucas Richert said PrEP clubs had prompted discussions on drug prices and access to healthcare, especially since many of those who struggled to get the medication were fromvulnerable groups.

“The buyers’ clubs in the 1980s challenged policy-makers and academics to think about patient autonomy and access to health care, but also the barriers in the medical marketplace across different countries,” said Richert, of the University of Strathclyde in Scotland.

But there was one key difference, he said – many of the experimental drugs the 1980s clubs imported proved to be ineffective, whereas PrEP has been shown to work.

Experts and campaigners said there was no sign that PrEP clubs were dwindling, with many countries still lacking comprehensive access.

“Our community has always good at taking responsibility for themselves, so yes, I think until it’s available people will continue to self-source,” said Marc Thompson, a spokesman for the British HIV/AIDS charity Terrence Higgins Trust.

PSNC says pharmacists should be able to substitute drugs to ease Brexit supply pressures

The Pharmaceutical Journal, Debbie Andalo, 30 November 2018

The Pharmaceutical Services Negotiating Committee proposes several solutions to “reduce the negative impact of a chaotic exit from the EU”

Pharmacy negotiators have suggested that community pharmacists should be able to automatically substitute an alternative medicine if they cannot dispense the prescribed item, as a way to help deal with any possible drugs shortages post-Brexit.

The move to introduce routine therapeutic substitution has already been proposed by Sibby Buckle, vice chair of the Royal Pharmaceutical Society (RPS) English pharmacy board and chair of the RPS pharmacy digital forum.

And now the Pharmaceutical Services Negotiating Committee (PSNC) and local pharmaceutical committees (LPCs) are supporting the proposed change.

The PSNC has suggested a number of ‘secondary measures’ following ongoing discussions with the Department of Health and Social Care over managing the risk to the medicines supply chain after Brexit. These include introducing routine therapeutic substitution, which means a community pharmacist would no longer have to go back to the GP or other prescriber for approval to switch to an alternative product; and more responsive drug tariff pricing, to ensure that pharmacy contractors are properly reimbursed for any additional incurred costs.

The PSNC is concerned that current government plans for wholesalers and drug manufacturers to stockpile supplies for six weeks prior to Brexit are not enough to guarantee that patients will be able to get essential drugs after 29 March 2019 — especially in the event of a ‘no deal’.

Simon Dukes, chief executive of the PSNC, said: “Quite rightly a lot of community pharmacists and LPCs are concerned about Brexit and the impact it will have on patients, communities and of course businesses. I share your concerns. From a medicine supply perspective, an agreed deal is essential if we are to reduce the negative impact of a chaotic exit from the EU.”

Under current legislation, pharmacists can substitute a medicine without going back to the prescriber only in cases where a prescribed generic drug is unavailable and an equivalent branded medicine can be dispensed instead. But they are unable to substitute the other way around — substituting a generic medicine for a branded product — without prescriber approval.

Buckle told The Pharmaceutical Journal: “The present system is time-consuming, inconvenient and unnecessary.

“The status quo only prevails because there is no imperative to change it. Generally things get changed because of patient demand but I suspect not many patients hare written to their MP [about medicine supply issues] because my pharmacist colleagues try and find a solution and protect patients from supply problems.”

She said if there was political will, then the necessary changes to the law could be made “very quickly”.

The proposal for routine therapeutic substitution without the need to return to the prescriber was welcomed by Nick Hunter, chief officer for Nottinghamshire LPC and secretary of Doncaster and Rotherham LPCs.

“The drug supply situation is dire at the moment — without even getting to Brexit,” he said.

The Company Chemists’ Association (CCA), which represents high street pharmacy chains, also accepted that Brexit may trigger the need to review the law around the substitution of medicines.

Malcolm Harrison, chief executive of the CCA, said in a statement: “We recognise that in the light of potential shortages of medicines, provision is needed in the planning to allow pharmacists to take all reasonable steps to supply patients with medicines they need. This may include a review of current legislation to ensure any proposed actions — which could include the substitution of medicines — are made on a solid legal basis.”

Survey shows pharma industry pessimism about post-Brexit UK

Politico, Sarah Wheaton, 30 November 2018  

The pharmaceutical industry’s perception of the business climate in the U.K. after Brexit is tanking, according to a new survey from data analytics firm GlobalData.

About 23 percent of industry professionals from the U.K., EU and United States said the U.K. would be an “attractive destination for health care companies to conduct research and manufacturing after Brexit,” according to the Q3 edition of GlobalData’s quarterly poll.

That reflects an increasingly pessimistic outlook since Q1 in each region, but the change is most pronounced within the U.K. In Q1, 48 percent of U.K. respondents thought their country would remain a good place to do business after March 2019, but now it’s down to 17 percent.

U.S. pharma remains most optimistic, but that’s on the decline too, from 53 percent saying the U.K. is attractive in Q1 to 38 percent in Q3. EU respondents went from 28 percent positive in Q1 to 19 percent in the latest survey.

Alexandra Annis, a health care analyst with GlobalData, noted the spate of negative press about no-deal Brexit preparations, including the the call for companies to stockpile drugs and plans by AstraZeneca to stop investments in the U.K., saying they “likely played a part in negatively affecting industry professionals’ confidence in the U.K.”

Refrigeration for ‘no-deal’ Brexit medicine stockpiles to cost tens of millions of pounds, says Hancock

The Pharmaceutical Journal, Carolyn Wickware, 28 November 2018

The health and social care secretary told MPs that the cost of securing cold-chain storage for stockpiling medicines in the event of a ‘no-deal’ Brexit would amount to tens of millions of pounds.

Building refrigeration capacity to store stockpiles of medicines in the event of a ‘no-deal’ Brexit is expected to cost in the “low tens of millions” of pounds, the health and social care secretary Matt Hancock has said.

Speaking to MPs at a House of Commons health and social care select committee meeting on 26 November 2018, Hancock stated that the exact amount would become clear “shortly” after contract bids were finalised.

He clarified that the money would not come from the extra £20.5bn promised to the NHS in June 2018, but from the £1.5bn fund “that the Treasury has set aside for Brexit contingency planning”.

Hancock first told the committee in October 2018 that the government had put contracts out to tender for suppliers of cold-chain storage, with the possibility that space may be converted to medical storage “which currently isn’t” up to the required standards.

In the latest session in front of the committee, he said the response to the contract tender “has been good”.

He told the committee: “We’ll shortly be concluding that, and that will involve spending the first money in preparation for no-deal, in the low tens of millions [of pounds].

“The exact figure will depend on the response to the invitation to tender and which of the bids we choose.”

In August 2018, the government told community pharmacists not to stockpile drugs because it was working with manufacturers to secure six weeks’ worth of medicines in the event of a no-deal scenario.

Hancock clarified that six-week’s worth of contingency planning “is a cross-government planning assumption”, which is being reviewed “all the time”.

He added: “We have further contingency work on a range of contingencies, should the disruptions go on for longer than that.

“But our planning assumption is that then we’ll need a range of other options, such as prioritisation rather than stockpiling — there’s only so much stockpiling that you can do.”

Hancock told the committee that responding to its recent request for a list of medicines at risk under a no-deal Brexit would be “a challenge” as “the nature of their supply chains and the nature of their contracts is commercially confidential” but committed to providing “as much information on the planning as we think is feasible”.

Media And Political Bulletin – 03 December 2018

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