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Media And Political Bulletin – 16 October 2018

Media and Political Bulletin

16 October 2018

Media Summary

AstraZeneca will keep UK investment freeze if no Brexit clarity

EuroNews, 15 October 2018

Euronews reports that AstraZeneca will keep its freeze on manufacturing investments in Britain if the country’s exit from the European Union fails to give enough clarity on future trading relations, the drugmaker’s chairman was quoted as saying on Monday.

The comments add to pressure on British Prime Minister Theresa May to rethink her plan for leaving the EU after Brexit talks reached a stand-off at the weekend over arrangements for the UK border with Ireland.

“If a transition deal does not make clear what will happen in the future, we will maintain our decision not to invest,” Leif Johansson told France’s Le Monde newspaper.

“A Brexit agreement will need to ensure that Britain does not become an isolated island in the middle of the Atlantic Ocean,” he added.

Response to the Public Accounts Committee (PAC) report into price increases in generic medicines

BGMA, 15 October 2018

The British Generic Manufacturers Association has published a response to the Public Account Committee’s report into price increases in generic medicines.

Warwick Smith, Director General of the British Generic Manufacturers Association, who gave evidence at the hearing, said: “We have welcomed the Public Accounts Committee’s interest in this area following on from the National Audit Office (NAO) report. Importantly, the PAC report states that patients did not suffer as a result of the shortages and all in the supply chain should be recognised for their efforts in ensuring medicines were delivered.”

He added that “in the wider context, it is important to note the price paid by the NHS for generic medicines is not that charged by manufacturers, but includes distribution costs from wholesalers and the retained margin for community pharmacy which is targeted to be £800m per annum. This means that typically, the reimbursement price of a generic medicine listed in Category M of the Drug Tariff may amount to approximately twice the manufacturer’s actual selling price.”

 

Parliamentary Coverage

House of Lords, Tabled and Written Questions, 15 October 2018

Lord Hunt of Kings Heath: To ask Her Majesty’s Government how the proposed statutory scheme for branded drugs will improve access to cost-effective medicines for patients in the UK.

Answered by Lord O’Shaughnessy: The proposals outlined in the recent consultation, Proposed changes to the statutory scheme to control the costs of branded health service medicines, ensure that the scheme can continue to fulfil its purpose of safeguarding the financial position of the National Health Service, alongside the voluntary Pharmaceutical Price Regulation Scheme.

A copy of the consultation document is attached. The proposals set out in the recent consultation are aimed at constraining the cost of branded health service medicines to a level that balances the interests of patients, the NHS, industry and the taxpayer. The consultation’s impact assessment demonstrates significant overall benefits to patient health, driven by the reinvestment of any savings generated from the statutory scheme in NHS budgets. A copy of the impact assessment, 2018 Statutory Scheme for Branded Medicines Pricing, is attached.

There is a wider framework in place to ensure the cost-effectiveness of medicines used in the NHS, most importantly, through National Institute for Health and Care Excellence (NICE) appraisals. This existing framework remains unchanged by the proposals set out in the consultation, with the NHS still required to fund all medicines approved through a NICE technology appraisal. The Department is committed to ensuring access to clinically and cost-effective medicines, and is working with NHS England and the pharmaceutical industry to support improvements in the speed and rate of access to new medicines for NHS patients.

Full Coverage

AstraZeneca will keep UK investment freeze if no Brexit clarity

EuroNews, 15 October 2018

AstraZeneca <AZN.L> will keep its freeze on manufacturing investments in Britain if the country’s exit from the European Union fails to give enough clarity on future trading relations, the drugmaker’s chairman was quoted as saying on Monday.

The comments add to pressure on British Prime Minister Theresa May to rethink her plan for leaving the EU after Brexit talks reached a stand-off at the weekend over arrangements for the UK border with Ireland.

“If a transition deal does not make clear what will happen in the future, we will maintain our decision not to invest,” Leif Johansson told France’s Le Monde newspaper.

“A Brexit agreement will need to ensure that Britain does not become an isolated island in the middle of the Atlantic Ocean,” he added.

A spokesman for AstraZeneca said Johansson was referring to a freeze on investments in manufacturing announced in 2017.

“There has been no change to our investment plans in the UK,” the spokesman said.

AstraZenca has already spent 40 million pounds ($53 million) stockpiling medicines in Britain and continental Europe to prevent supply disruptions if the two sides fail to reach a withdrawal agreement.

Some pharmaceutical companies including AstraZeneca have warned of medicine shortages in the event of a ‘no deal’ Brexit.

More than 2,600 drugs have some part of their manufacturing carried out in Britain. Britain exports some 45 million medical packs to EU countries each month, industry figures show, while 37 million flow to Britain from the EU.

France’s largest drugmaker Sanofi said in August it would increase medicine stockpiles in Britain, echoing moves made by GlaxoSmithKline <GSK.L>, Roche <ROG.S> and Novartis <NOVN.S>.

“In business, uncertainty often forces you to make decisions. But what is frustrating is to have to do so when the existing system works very well,” Johansson said. “This is costing us money and brings us no benefit.”

Response to the Public Accounts Committee (PAC) report into price increases in generic medicines

BGMA, 15 October 2018

In response to the Public Accounts Committee (PAC) report into price increases in generic medicines, Warwick Smith, Director General of the British Generic Manufacturers Association (BGMA), who gave evidence at the hearing, said: “We have welcomed the Public Accounts Committee’s interest in this area following on from the National Audit Office (NAO) report. Importantly, the PAC report states that patients did not suffer as a result of the shortages and all in the supply chain should be recognised for their efforts in ensuring medicines were delivered.

“In the wider context, it is important to note the price paid by the NHS for generic medicines is not that charged by manufacturers, but includes distribution costs from wholesalers and the retained margin for community pharmacy which is targeted to be £800m per annum. This means that typically, the reimbursement price of a generic medicine listed in Category M of the Drug Tariff may amount to approximately twice the manufacturer’s actual selling price (ASP).

Indeed, for many of the medicines highlighted in the NAO report and subsequently looked at by the PAC, the manufacturer actual selling price made up a far smaller proportion of the overall reimbursement price charged to the NHS.  In cases where supplies of generic medicines are inadequate, the reimbursement price may well be based on the list price of the branded originator product.

“Indeed, our own data shows that whilst there was a higher value of concessions in 2017 (£341m in 2017 v £75m in 2016) the actual average reimbursement price (including the effect of concessions) of a pack of generic medicines fell from £2.80 in 2016 to £2.46 overall in 2017. So, even during the period where high levels of concessionary prices were being set by the Department of Health and Social Care, the average cost to the NHS of generic medicines as a whole continued to fall. More widely, generic competition provides clear value for money for the NHS. Looking at all branded products to come off patent since the start of 2014, the introduction of generics saw prices reduce by an average of 89% in this time.

“Like the PAC, we welcome clarification of the Government’s price-setting powers for where competition isn’t working to protect the interests of the NHS. Importantly, the Government will now have full visibility across the full medicines supply chain, including manufacturers, distributors and pharmacies, allowing it better to understand and scrutinise what is happening in the supply chain.

“We echo the PAC’s call for clarity on the Government’s plans to ensure supply of medicines following the UK’s exit from the European Union next year. We have been discussing with the Government for some time how to ensure that the medicines supply chain continues to operate effectively particularly in the event of a no-deal Brexit. Clearly, the complex nature of the manufacture and supply of medicines in Europe means that they and their constituent parts may cross many borders before reaching patients. A deal between the UK and the EU27 to maintain these free flows is obviously the only way to ensure that the supply of medicines is not disrupted.

“A survey of our own members shows that the vast majority have been actively planning and implementing measures to ensure that the impact of a disorderly Brexit is minimised wherever possible. No-one wants to see delays at the UK’s borders risking the supply of medicines to patients and we still need further clarity from Government on its intentions. As we have consistently said, what is needed to ensure the supply of medicines to British patients is an agreement between the UK and the EU27 to allow the free flow of medicines and their components. Ideally, we want the UK to remain part of the European medicines regulatory environment, or more pragmatically a mutual recognition agreement to be agreed quickly.”

Media And Political Bulletin – 16 October 2018

From Factory to Pharmacy

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