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HDA UK Media And Political Bulletin – 1 December 2016

Pharma companies argue against new UK regulator

Financial Times, David Crow and Gonzalo Viña, 1 December 2016

 

The Financial Times reports that British pharmaceutical companies have been lobbying against the creation of a new regulator in the UK, to replace the European Medicines Agency (EMA). According to a briefing on the negotiations, ministers in favour of a “hard” Brexit are pushing for a British regulator which would decide whether medicines were safe, effective and affordable in a single, streamlined process. The ABPI explained on Wednesday to MPs that the EMA was not a single entity, but a network of co-operation between countries, including countries outside the European Union.

 

The news was also reported by Reuters UK.

 

DH reveals payment scheme for pharmacy urgent supply service

Chemist and Druggist, Grace Lewis, 30 November 2016

 

The Department of Health has announced how much community pharmacies will get paid for providing emergency medication, and in which areas its pilot service will be rolled out first. Those community pharmacies taking part in the programme will be paid a total of £12.50 for any request for urgent medicine received from NHS 111, regardless of whether or not a supply is made, the PSNC confirmed on Tuesday.

 

Review of the year 2016: Brexit

Pharma Times, George Underwood, December 2016

 

Pharma Times discusses the implication of the Brexit vote for the pharma industry in the UK. The negotiations and outcomes are yet to be clarified, creating uncertainty for a number of things including the fate of the European Medicines Agency based in London, the availability of doctors, nurses and health workers and more generally regulation of medicines in the UK.   Mike Thompson, ABPI Chief Executive stated it “creates immediate challenges for future investment, research and jobs in our industry in the UK”.

 

EU drug spending fell after 2008 recession

The Pharmaceutical Journal, Santiago Saez, 30 November 2016

 

Pharmaceutical spending reportedly fell since the financial crisis, combined with an increased disparity in public medicines coverage across the EU. The report by the OECD and the European Commission found that the EU spent more than €200bn on pharmaceuticals, around 17% of its total health spending, making the EU’s third largest expense, after inpatient and outpatient care costs. The report also acknowledges the cost benefits derived from using generic medicines and encourages EU countries to take steps towards using them.

 

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Pharma companies argue against new UK regulator

Financial Times, David Crow and Gonzalo Viña, 1 December 2016

 

The UK pharmaceuticals industry is lobbying against the creation of a British drugs regulator following Brexit, arguing that severing ties with Europe would turn the country into a third-class market.

 

Some ministers — mainly those in favour of a “hard Brexit” — want a brand new UK body, according to two people briefed on the negotiations.

 

This would assess whether medicines are safe and effective to be sold in the UK, and would be combined with Nice, the gatekeeper for drug companies selling to the NHS, these people said.

 

Supporters argue it would offer global pharmaceuticals companies a simpler way of winning approval for their drugs in Britain, because the agency would decide whether medicines were safe, effective and affordable in a single, streamlined process.

 

Currently, drugmakers must get regulatory approval from the European Medicines Agency before negotiating separately over price with Nice.

 

However, the pharma industry, including the largest UK companies GlaxoSmithKline and AstraZeneca, is opposed to the plan. It would prefer the government to come to an arrangement with the EMA, which currently decides whether drugs are safe and effective enough to go on sale in Britain.

 

Virginia Acha, of the Association of the British Pharmaceutical Industry, the lobby group, told MPs on Wednesday that the existing European regulator was not a “monolith” but a “network of co-operation” among countries, including some outside the EU.

 

“There is a precedent there for co-operation,” she told the commons committee on exiting the EU.

 

An industry document provided to ministers ahead of talks in September said a standalone UK regulator would have “significant disadvantages” including “additional regulatory burden” that would “add cost for industry and the UK government”.

 

One person briefed on the talks warned that Britain would fall behind countries such as China and Japan when drugmakers sought approval for their medicines, because it is a relatively small market that tends to drive a hard bargain when setting prices.

 

The UK industry believes it benefits from the European framework because global drugmakers prioritise approval by the EMA, which gives them clearance in all 28 EU countries.

 

Many companies seek a green light from the EMA in tandem with approval by the US Food and Drug Administration, and in some cases go through the European process first.

 

“Increasingly, China and Japan are massive markets, so it would make sense to concentrate on those big clusters before going to the UK,” said one person briefed on the talks. “The risk is the UK falls further down the list and that is not a good development for British patients. It would be a shame and a risk.”

 

David Mowat, a health minister who was against Brexit, told parliament in October that whatever approach the UK takes “it would be disappointing if that happened, and many of us will be working hard to ensure that it does not”.

 

Industry has also said Britain would in effect have to “recognise EU authorisation for the majority of products, aiming to use the same file, same timeline and ensure a quick, pain-free process for industry.” It has also noted “there is no appetite” to find extra money to fund a standalone regulatory framework.

 

GlaxoSmithKline and AstraZeneca are privately opposed to the plans but have avoided putting their concerns on the record for fear of alienating ministers during the negotiations, the people said.

 

DH reveals payment scheme for pharmacy urgent supply service

Chemist and Druggist, Grace Lewis, 30 November 2016

 

The Department of Health (DH) has confirmed how much community pharmacies will get paid for providing emergency medication, and in which areas its pilot service will be rolled out first.

Under the ‘Pharmacy Urgent Care’ pilot programme announced by the DH last month, patients who call NHS 111 for urgent repeat medication will be directed straight to a community pharmacy, instead of an out-of-hours GP surgery.

 

Those community pharmacies taking part in the programme will be paid a total of £12.50 for any request for urgent medicine received from NHS 111, regardless of whether or not a supply is made, the Pharmaceutical Services Negotiating Committee (PSNC) confirmed yesterday (November 29).

 

This consists of a £10 consultation fee and a £2.50 administration fee “to reflect the additional work and documentation required”, PSNC said.

 

A supply fee of £1.50 will be paid for the first item provided, and an additional 50p for each additional item.

 

PSNC said “a phased introduction” of the scheme will take place from December 2016 to March 2017, with the pilot ending in March 2018.

 

The four phases of the roll-out are:

 

Phase 1 – December 2016 – Brighton and Hove clincial commissioning group (CCG); Guildford and Waverley CCG; Blackpool CCG; Fylde and Wyre CCG; Nottingham City CCG; Cambridgeshire and Peterborough CCG

 

Phase 2 – January 2017 – East of England; North East; North West

 

Phase 3 – February 2017 – South East Coast; West Midlands; East Midlands; South West

 

Phase 4 – March 2017 – London; Yorkshire and Humber; South Central; Isle of Wight

 

All contractors in England will be able to sign up to provide the service from tomorrow (December 1) via the NHS Business Services Authority website.

 

However, this sign-up process is only to “register contractors’ intention”, PSNC said. “Most” contractors will not be able to start providing the service immediately, it added.

 

Details not agreed with PSNC

 

When the pilot scheme was first announced, the National Pharmacy Association branded it a “smoke screen… clearly timed to draw attention away” from the cuts to pharmacy funding.

 

PSNC said yesterday that while it supports the commissioning of an emergency supply service “in principle”, the final details of the programme “have not been agreed by PSNC”.

 

“PSNC is pleased to see recognition of how community pharmacies can help patients and the NHS, but we are disappointed that the scheme has only been commissioned as a pilot,” it said.

 

“We are also disappointed that the service will not cover patients who have been referred by other health professionals or come to pharmacies in the first instance themselves.”

 

More expensive than planned?

 

In its initial assessment of the programme’s funding, PSNC said it would be more expensive to run the service than NHS England has suggested.

 

The volume of referrals from NHS 111 to contractors “is likely to be relatively low…based on information provided by NHS England”, it added.

 

“The maximum number of potential referrals is in the region of 200,000 per annum. Based on the experience of similar locally commissioned services, it is unlikely that it will be possible to transfer all of these patient requests to community pharmacy, at least to begin with,” the negotiator said.

 

The lack of funding to provide IT support for the service is “regrettable”, PSNC said, and will incur additional “bureaucracy” and costs for contractors in the long-run.

 

The negotiator suggested the Pharmacy Integration Fund – a £300 million fund designed to assimilate pharmacy into the NHS and other care settings, which is being used to fund this pilot service – should also be used to provide the IT infrastructure needed for the scheme.

 

EU drug spending fell after 2008 recession

The Pharmaceutical Journal, Santiago Saez, 30 November 2016

 

Spending on medicines fell by an average of 1.1% across the EU in the six years following the 2008 financial crisis, finds a report by the OECD and the European Commission.

 

The reductions were “triggered” mainly by cuts in public spending over the 2009–2014 period, the ‘Health at a Glance: Europe 2016’ report says. Some countries saw greater falls than others, such as Greece and Portugal, where drug expenditure fell by more than 7%.

 

In 2014, the EU spent more than €200bn on pharmaceuticals — around 17% of its total health spending. Medicines were the EU’s third largest expense, after inpatient and outpatient care costs.

 

“Pharmaceuticals play a vital role in the health system and policy makers must balance the access of patients to new effective medicines, while providing the right incentives to manufacturers to go on developing new generations of drugs. At the same time, healthcare budgets are limited,” says the report.

 

Thomas Allvin, director for healthcare systems at the European Federation of Pharmaceutical Industries and Associations, the body representing the drug industry in Europe, says that the reduction in medicine sales could be attributed to budget changes of crisis-stricken states.

 

“[R]esource allocation of healthcare budgets must be based on a thorough assessment of the value of different health interventions for patients and societies as a whole”, says Allvin. An investment in medicines can help reduce expensive hospital costs in the same way that prevention measures can help cut treatment costs, he says.

 

The EU spent €402 per capita on medicines, on average, in 2014. However, there were wide differences when individual country spend was analysed. For instance, Germany (€551 per capita) and Ireland (€523) spent more than double that of Denmark (€201) and Estonia (€230). Expenditure per UK citizen was €361. All figures were adjusted for purchasing power in each country and included prescription and over-the-counter drugs but omitted medicines used in hospitals and other healthcare centres.

 

Public cost protection schemes covered about 64% of EU pharmaceutical expenses, but there was disparity in coverage between EU countries. Public coverage of medicines was greater than 80% in some northern and western European states, such as Germany, but lower in countries such as Bulgaria and Cyprus, which paid less than 25% of their citizens’ medicine expenses.

 

The report acknowledges the cost benefits derived from using generic medicines and encourages EU countries to take steps towards using them. The market for these products has grown rapidly since the 2000s. In countries, such as Portugal and Spain, where generic drugs had little or no presence in 2000, generic spending rose to cover more than 40% of the market in 2014.

 

More than 70% of medicines used (in volume terms) in the UK, Germany, the Netherlands and Slovakia were generic in 2014, but these products represented only around 20% of the market in other countries such as Italy and Greece, the report notes.

 

“All EU countries see the development of generic markets as a good opportunity to increase efficiency in pharmaceutical spending, but many do not fully exploit the potential of generics”, says the report.

 

The report presents a wide range of indicators of health and health systems in the EU, including increased life expectancy. Specifically, the report states that life expectancy across the EU has risen by 6 years from an average of 74.2 years in 1990, to around 80.9 years in 2014. However, it notes that there is inequality between western countries with the highest life expectancy, compared with countries in central and eastern Europe, where people die at a younger age.

HDA UK Media And Political Bulletin – 1 December 2016

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