HDA Media And Political Bulletin – 12 February 2016


Pharmacy Biz, Neil Trainis, 11 February 2016

There is an increasing concern amongst community pharmacy that budget reductions will go beyond the 6% funding cut the government has announced for 2016-17. Kirit Patel, from Day Lewis and a member of the PSNC negotiating team, stated that he was hopeful that the funding cut proposal would be revisited.


PSNC responds to funding cuts with ‘clinical’ vision

Chemist and Druggist, Annabelle Collins, 11 February 2016

In response to the announced 6% funding cut, PSNC has released a plan for community pharmacy which proposes to expand the clinical role of the sector. The proposal, rolled out in three phases, aims to paint a picture of the pharmacy service with 6% less funding.

You can review the full proposal here.


Bar codes to be added to medicines packaging

P3 Pharmacy, 11 February 2016

P3 Pharmacy reports on the introduction of safety features to be added on packaging following the publication of the Falsified Medicines Directive delegated regulation on Tuesday. These measures aim to tackle the threat of falsified medicines entering the supply chain.


Ministers scramble to introduce new NHS cancer drugs scheme

FT, Andrew Ward, 11 February 2016

The Financial Times discusses the future of the Cancer Drugs Fund as it is set to expire on March 31. The scheme, which aims to ensure access to the latest treatments, has come under scrutiny as the industry warns that the United Kingdom is a hostile environment for medical innovation and the country is lagging behind European counterparts in cancer treatment.

The ABPI has issued a statement calling on the government to seize the opportunity to transform patient access to cancer treatments in the UK.


Parliamentary Coverage

Medicines and Healthcare products Regulatory Agency: New rules to help fight falsified medicines

HM Government – Press Releases, 11 February 2016


New rules approved by the European Parliament will require safety features on the packaging of medicines at risk of falsification.

The European Parliament and Council has approved and published a Delegated Regulation (EU2016/161)  in the Official Journal of the European Union. This supplements the Falsified Medicines Directive (FMD) and introduces two mandatory safety features that will allow medicines to be verified and authenticated.

These safety features are:

• a unique identifier (a 2D data matrix code and human readable information) to be placed on medical products that can be scanned at fixed points along the supply chain

• tamper evident features on the pack

The delegated regulation comes into force in the UK in 2019. Marketing authorisation holders will be required to place the safety features on the packaging of medicines which fall within the remit of the delegated regulation no later than 9 February 2019.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health will continue to work with the European Commission and other Member States on implementation plans for the new regulation. We will also be working with stakeholders throughout the supply chain to secure implementation within the three years.

Further guidance will be published as it becomes available.


Full Coverage


Pharmacy Biz, Neil Trainis, 11 February 2016


Kirit Patel, the chief executive of Day Lewis and a member of the PSNC negotiating team, has warned that community pharmacy is likely to suffer further cuts to its revenue on top of the £170 million the government has pledged to take out for 2016-17.

Fears that the government intends to take an even larger slice of money beyond the 6% reduction that has already been earmarked arose after Sue Sharpe, the chief executive of the PSNC, accused NHS England and the Department of Health last month of failing to meet her request for future funding figures for community pharmacy.

That vagueness generated apprehension within the ranks of the PSNC and concern that ministers will take a bigger slice of pharmacy revenue for 2017-18.

Patel reinforced those concerns by suggesting community pharmacists should expect further reductions. The figure he came up with was at least another £80 million taken out of community pharmacy over the next five years.

“The DH announced a 6% reduction in pharmacy remuneration in the year April 2016 to March 2017, the intention being that the whole 6% totalling £170 million would be taken out over six months from the beginning of October 2016,” he told Pharmacy Business.

“The letter (sent by NHS England to the PSNC in December explaining the funding cut) went on to say this was the maximum they would take out in the year, implying there would be more to follow. So let’s examine how much more is likely to be taken out.

“The NHS target of £22 billion in savings announced by Simon Stevens in the NHS forward plan was in a five-year plan and hence it’s safe to say that all the funds they intend to take out from pharmacy would be within five years.

“The clue lies in the rest of the three-page letter. The letter goes on to say that all establishment payments totalling £25,000 per pharmacy is to be phased out. With over 11,500 pharmacies this totals £270 million.

“So there is every likelihood of at least another £80 million being withdrawn from pharmacies over the next five years, bearing in mind £20 million is being put back for integration funds.

“On average that will work out at approximately £15,000 per pharmacy, going up to £25,000. This reduction in establishment payments will affect every single pharmacy in England.”

Patel added: “All the pharmacy bodies and the whole profession have united to fight back and many are confident that some of these proposals may be watered down and some revisited.

“I am hopeful that once the DH realises that pharmacy does far more for patient care than is obvious to the DH, they may not be so keen to throw out the baby with the bath water.”

He refused to say whether the community pharmacy profession should strike in protest at the cut or whether he would encourage Day Lewis pharmacies to strike.

Patel did, however, express his hope that the Pharmacy Integration Fund, set at £20 million for 2016-17 and described by chief pharmaceutical officer Keith Ridge as designed “to help transform how pharmacists, their teams and community pharmacy will operate in the NHS,” will specifically benefit community pharmacy. Sharpe has said the fund will be geared more towards pharmacists working in general practice.

“We should ensure that all this money does not go to GP surgery pharmacists alone and that hopefully a fair amount of it will end up back in community pharmacy,” Patel said.

“At Day Lewis we own 275 pharmacies and our reduction of revenue in the first year alone is £3.4 million, possibly rising to £5 million in the fifth year. I cannot see how we can recover from this loss of income and at the same time be expected to invest for the future.”


Bar codes to be added to medicines packaging

P3 Pharmacy, 11 February 2016


An implementation plan for the Europe-wide introduction of measures to protect patients from fake or “falsified” medicines has been released by The European Medicines Agency. Safety features to be added to medicines packaging include a 2-D barcode and an anti-tampering device.

Falsified medicines could contain ingredients, including active ingredients, which are of low quality or in the wrong dosage, and could potentially put patients’ health at risk, says the EMA. The measures are being taken to help prevent falsified medicines from entering the legal supply chain and posing a risk to patients and to ensure that any medicines bought online are supplied through verified sources.

The new measures must be introduced for all medicines for human use across Europe by February 2019 – three years time.

It has previously been suggested the pharmacies may be required to scan the 2-D barcode.

Martin Sawer, executive director of the UK’s Healthcare Distribution Association, representing organisations in the medicines supply chain, commented: “It is good news to finally see the publication of the Delegated Regulation that sets the clock ticking in the UK and other EU member states.”

He welcomed the model chosen for the initiative, after long debate in Europe. “Alternatives would have placed unnecessary burdens on the supply chain, including delays in being able to supply life-saving medicines speedily to patients,” he said.


Ministers scramble to introduce new NHS cancer drugs scheme

FT, Andrew Ward, 11 February 2016


Ministers have less than two months to thrash out a new system for financing cancer drugs in the NHS as the clock ticks towards expiry of a £340m-a-year fund set up by David Cameron to plug gaps in treatment.

A consultation on the future of the Cancer Drugs Fund, launched by the prime minister in 2010, closes at midnight on Thursday, seven weeks before the scheme is due to run out of money.

The government now faces a scramble to introduce a replacement scheme in the face of fierce lobbying from the pharmaceuticals industry, charities and patient groups over how it should work.

Erik Nordkamp, UK managing director for Pfizer, the US drugmaker, told the BBC on Thursday that the system for funding drugs in England was “really broken” and the country was a “hostile environment” for medical innovation.

The Cancer Drugs Fund was intended to ensure access to the latest treatments by paying for cancer medicines deemed too expensive under the usual criteria for assessing cost-effectiveness in the NHS.

However, the fund’s annual budget has soared from £200m to £340m and dozens of drugs have had funding removed in an attempt to control costs.

NHS England announced proposals in November for a system that would provide temporary funding for some new drugs while evidence was collected to decide whether they offered value for money in the long term.

Final details are due before the existing scheme expires on March 31 — although there will be a transition period before full implementation.

Sir Harpal Kumar, chief executive of Cancer Research UK, the charity, said he was hopeful of swifter access to breakthrough treatments. “The Cancer Drugs Fund hasn’t been fit for purpose for some time, so the proposed reforms are a promising step.”

However, the plans would involve tougher scrutiny of new drugs — with funding removed from those that fail to prove their cost-effectiveness during an initial trial period.

Mark Hicken, managing director of Johnson & Johnson’s UK pharma business, said the proposals would raise, rather than lower, barriers to market access. “This will have a significant impact on the availability of many new cancer medicines and we are very worried for patients in England.”

Drugmakers have become increasingly vociferous in their warnings that the NHS is falling behind the rest of Europe in cancer treatment.

Critics blame the industry for excessive pricing with some new cancer drugs costing thousands of pounds a month. The Association of the British Pharmaceuticals Industry said UK prices were among the lowest in Europe.

Under the NHS England proposals, new cancer medicines would be evaluated by the National Institute for Health and Care Excellence, the drug cost watchdog, within 90 days of regulatory approval. Those showing clear cost-effectiveness would be immediately recommended for use, while others would be granted temporary funding while further evidence was collected.

NHS England said: “For those drug companies willing to price their products affordably while sharing transparent information about ‘real world’ patient benefit, the new [fund] will offer a new fast-track route to NHS funding.”

Cancer drugs pose especially difficult economic and ethical dilemmas for the NHS because the most expensive ones are those usually used in the last few months of life — requiring pharma companies to recoup high development costs in relatively short periods of treatment. Some critics have questioned why cancer drugs — and patients — are given special funding unavailable for other conditions.


Cancer Drugs Fund consultation – an opportunity to introduce a sustainable, affordable solution that benefits patients and the economy

ABPI, 12 February 2016


As the consultation on the way forward for the Cancer Drugs Fund (CDF) closes, the Association of the British Pharmaceutical Industry (ABPI) urges the government to seize the opportunity and transform the way cancer medicines are assessed by the National Institute for Health and Care Excellence (NICE) and commissioned and funded by NHS England. If we do this, we can achieve a sustainable, affordable solution that will provide rapid access to new medicines for NHS patients.

​​​The role of the CDF has been to fund medicines while they are undergoing assessment, that have been rejected, or are not going to be assessed by NICE, in order to ensure that NHS patients have access to them as they do in other EU countries.

Everybody agrees that the current approach to the Cancer Drugs Fund is no longer workable. We need wholesale evolution of the medicines assessment process used by NICE to address this.


Dr Paul Catchpole, Director – Value and Access, said,

“We remain committed to working with the Department of Health, NHS England, NICE, charities and patient groups to evolve the way that NICE assesses innovative medicines so that they can be made more rapidly available to NHS patients. Compared to other EU countries, the UK has some of the lowest prices for medicines, and a unique national pricing scheme in place which, since 2014, has seen the pharmaceutical industry pay over £1billion to the NHS to support investment in the latest medicines.

“We want the best for all cancer patients so they can get sustainable and rapid access to new medicines. The aim needs to be to get the right medicines to the right patients at the right time, but significant revisions are needed to the current proposals to permit new medicines to fully deliver their potential in improving NHS cancer outcomes.”

HDA Media And Political Bulletin – 12 February 2016

From Factory to Pharmacy

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