News

HDA UK Media And Political Bulletin – 17 February 2017

Media Summary

Brexit won’t stop UK implementation of Falsified Medicines Directive

The Pharmaceutical Journal, 15 February 2017

HDA UK Chief Executive Martin Sawer told delegates at the Sigma conference that Brexit will not disrupt plans to implement the EU’s Falsified Medicines Directive. The Directive — a legal framework that seeks to strengthen the medicines supply chain — will come into effect on 9 February 2019. “FMD and medications verification scanning will happen whether the sector is ready or not”, Sawer said. SecurMed UK will appoint an IT provider to deliver the UK’s Medicines Verification System over the coming weeks. With this, systems will need to be tested and pharmacies will need to consider altering the flow of the dispensing process to ensure that efficiency and data protection are safeguarded.

Next four months “very difficult” warns Sharpe

Pharmacy Magazine, 16 February 2017

PSNC chief executive Sue Sharpe has criticised the Government for its ‘complete ignorance about the tremendous value’ community pharmacy delivers. Condemning the funding cuts, Sharpe said that they will particularly hit low volume, urban pharmacies.  “You really need to be prepared for what’s coming down the line.”, she said, focusing on the need to develop relationships with commissioners and establish local links.

Drug companies propped up NHS with £250m after cabinet’s threat

The Times, Chris Smyth and Oliver Wright, 17 February 2017

The big pharmaceutical companies were driven into a £250 million bailout to help fill a £500 million gap in the NHS budget; now, with fear over NHS finances Sir Jeremy Heywood has threatened to impose statutory price caps on drugs in an “aggressive” attempt to raise more money. Opposition MPs say that ministers must come clean on the gap in the NHS budget. Shadow health secretary Jonathan Ashworth said: “Yet again it exposes the reality that the NHS simply hasn’t been given the investment it needs. With Brexit and the consequent upcoming negotiations over the future of medicine regulation it’s crucial that all transactions between government and the pharmaceutical industry are totally transparent”.

Countries line up to host European Medicines Agency after it leaves UK

The Guardian, Patrick Wintour, 15 February 2017

As many as 20 EU countries are hoping to benefit from the relocation of the European Medicines Agency (EMA). This week, Portugal joined the competition, with the Portuguese minister of health, Adalberto Campos Fernandes, saying: “We have been actively engaged in the European medicine system from its inception and the Portuguese medicine agency, Infarmed, is highly regarded in the assessment procedures of medicines”. In the UK, Hunt has promised that the UK will keep the closest possible regulatory equivalence with the EU. The array of countries courting the EMA voice their commitment to the EU, strong cities, and vibrant medical research industries as points of merit.

Parliamentary Coverage

House of Lords, Written Answers, Department of Health

16 February 2017

Lord Bradshaw: further to the Written Answer by Lord O’Shaughnessy on 19 January (HL4501), whether the Answer also applies to the Automated Repeat Prescription Service offered by some high street pharmacies; and what checks there are to ensure that this does not lead to over-ordering.

Lord O’shaughnessy:

My Written Answer of 19 January applies also to repeatable prescriptions provided through the Electronic Prescription Service.

Any service provided by a pharmacist including ordering prescriptions on behalf of patients, should be carried out in accordance with their professional code of conduct, ethics and performance and the standards for registered pharmacies – both regulated by the General Pharmaceutical Council. This would include obtaining all the information they require to assess a person’s needs in order to give safe and effective treatment and to obtain consent for professional services they provide.

Full Coverage

Murray review of community pharmacy services will ‘direct’ government policy, says health minister

The Pharmaceutical Journal, 15 February 2017

UK health minister David Mowat says that the Murray review into the provision of community pharmacy services will “direct” government policy.

The independent review, published on 14 December 2016 and led by Richard Murray, director of policy at the King’s Fund, looked at clinical services provided by community pharmacy and recommended greater use of repeat dispensing and independent prescribing. It also called for pharmacists to have full read and write access to the patient medical record.

Speaking to delegates at the Sigma conference in Rio de Janeiro on 13 February 2017 via a video recording, Mowat said that the report’s findings are now with England’s chief pharmaceutical officer Keith Ridge, who commissioned the review.

David Mowat told delegates at the Sigma conference in Rio de Janeiro that a “great deal” of the recommendations within the Murray review are worthwhile and will direct government policy.

“I do know that [Keith Ridge] welcomed the review, there was a great deal in there which is very worthwhile and will direct policy,” Mowat said, adding that community pharmacists should become a more “clinically focused” and “services-orientated” profession.

Mowat also pointed out that 50% of pharmacies in England were delivering a minor ailment service and he, along with NHS England, wanted the rest of the country to have the service in place by April 2018.

He told delegates that pharmacists wanted greater integration with the NHS and to contribute more: “I agree with both of those objectives, as we build a seven-day NHS. We frankly don’t have enough GPs, health professionals and it really is a massive opportunity for the pharmacy sector to step up and work with us as we try to get things integrated right across the primary care sector.”

Earlier at the conference, a message was read out to delegates from prime minister Theresa May, who said that government reforms would “ensure we have a modern and efficient community pharmacy sector, properly integrated in primary care and public health, offering better patient choice and easier access”.

Brexit won’t stop UK implementation of Falsified Medicines Directive

The Pharmaceutical Journal, 15 February 2017

The UK government has confirmed that Brexit will not put a stop to its plans to implement the EU’s Falsified Medicines Directive, Martin Sawer, executive director of the Healthcare Distribution Association, told delegates at the Sigma conference in Rio de Janeiro on 14 February 2017 via a live video link.

Martin Sawer told delegates at this year’s Sigma conference in Rio de Janeiro that the Falsified Medicines Directive “will happen whether the sector is ready or not”

The directive — a legal framework that seeks to strengthen the medicines supply chain — will come into effect on 9 February 2019.

As part of the directive, measures to verify the authenticity of medicines at certain points in the supply chain will be introduced — for example, 2D barcodes on individual medicines packs to be scanned and checked before dispensing.

“FMD and medications verification scanning will happen whether the sector is ready or not,” Sawer said, adding that implementation will probably have “significant costs and training requirements”.

Also, speaking via live video link, Gareth Jones, head of corporate affairs at the National Pharmacy Association, which represents independent pharmacies, said the pharmacy sector was unlikely to see a “big bang” on launch day but that it should expect to see an increase in the number of packs with barcodes from that date. Pharmacies will likely need to fund software and hardware updates to link with a new medicines database, he added.

SecurMed UK, a not-for-profit organisation set up to deliver the UK’s Medicines Verification System, will appoint an IT provider for the project in the next few weeks, said Sawer. After this, a verification system will be developed and will then need to be tested with UK system suppliers.

Jones said that decisions still have to be made on when pharmacies will need to scan each medicine pack, adding that the fact that medicines cannot be returned into a pharmacy’s stock after ten days “could create a lot of waste”.

“Pharmacies need to consider changing the flow of the dispensing process for efficiency, and data protection needs to be considered,” he concluded.

Next four months “very difficult” warns Sharpe

Pharmacy Magazine, 16 February 2017

PSNC chief executive Sue Sharpe has slammed the Government for making “stupid decisions” about community pharmacy borne of “complete ignorance about the tremendous value it delivers to the NHS and general public”.

The funding cuts were targeting urban pharmacies, she said. “If you’re a low volume pharmacy in an urban area, you need to think really carefully about what the future looks like for you.” Now is the time to focus on developing local services to meet local needs, develop good relationships with commissioners and maybe even merge or join forces with other pharmacies in the locality.

“You need to make sure that local commissioners, GPs and social care think you’re the people they want to deal with.”

Address delegates in a pre-recorded video, she warned that the funding situation for contractors over the next four months would be “very, very difficult” before becoming a little easier. “You really need to be prepared for what’s coming down the line.”

Contractors should aim to get 100 per cent of the new quality payments. “This is going to be a great differentiator between pharmacies in the future. Commissioners may well look at that”.

Drug companies propped up NHS with £250m after cabinet’s threat

The Times, Chris Smyth and Oliver Wright, 17 February 2017

Britain’s top civil servant forced the big pharmaceutical companies into a £250 million bailout to help to plug a £500 million hole in the NHS budget.

In the latest sign of panic over NHS finances, Sir Jeremy Heywood, the cabinet secretary, threatened to impose statutory price caps on drugs in an “aggressive” attempt to raise more money.

The pharmaceutical industry then agreed to cover part of a shortfall in an attempt to win government goodwill in talks over medicines regulation and avoid an “acrimonious” row.

Opposition MPs say that ministers must come clean on the gap in the NHS budget and explain why they were spending money that they had yet to receive. The bailout stems from an

agreement in 2014 which capped NHS spending on branded medicines at about £8 billion, with any costs above that level refunded by drugs companies.

The pharmaceutical industry had hoped that this would free doctors and hospitals from worrying about the cost of medicines and encourage them to change Britain’s traditional reluctance to use new drugs.

However, instead of funnelling rebates back to areas that spent the most, ministers opted to use the money to prop up the central NHS budget. As a result the Department of Health was caught short when rebates were less than predicted, having already allocated the expected refunds to NHS budgets for 2017-18.

At a meeting in November, Sir Jeremy told the industry that the scheme was failing and threatened statutory price cuts to medicines unless they stumped up more money.

The Association of the British Pharmaceutical Industry said that while it “fundamentally disagree[d]” with the government’s approach, it felt that it was best to agree some sort of deal.

“At best even if the government does not end the scheme early, there would be a significantly more acrimonious relationship going into the next negotiations. There would be significant immediate impact on industry ability to influence and shape the UK commercial environment now and in the future,” industry minutes say.

David Watson of the association told The Times that goodwill with ministers was crucial as the industry approached talks on the shape of the economy and how drugs would be approved once Britain left the EU.

“We are aware that we’ve got a new industrial strategy coming along and there is a lot up for grabs about regulation after Brexit that we want to be working on as partners with the government,” he said.

“Having allocated that money in advance, they found there was a gap in their budget for 2017-18 of £400-£500 million. We agreed to meet them halfway.”

Jonathan Ashworth, the shadow health secretary, said: “It’s embarrassing that ministers have had to go cap in hand to big pharmaceutical industry to plug gaps in the NHS finances. Yet again it exposes the reality that the NHS simply hasn’t been given the investment it needs. With Brexit and the consequent upcoming negotiations over the future of medicine regulation it’s crucial that all transactions between government and the pharmaceutical industry are totally transparent.”

Norman Lamb, the Liberal Democrat health spokesman, said: “What these arrangements expose is the government’s appalling financial planning for the NHS. They have scraped around to find ways of claiming that funding for the NHS has been increased, and now resort to these emergency deals which will inevitably raise eyebrows.”

Countries line up to host European Medicines Agency after it leaves UK

The Guardian, Patrick Wintour, 15 February 2017

As many as 20 EU countries are seeking to take the headquarters of the European Medicines Agency from the UK once Brexit is complete – and with it 900 highly skilled staff.

Portugal has joined the competition for the EMA this week, which is fiercely sought after because acting as host is likely to have a huge knock-on effect for any country’s medical and pharmaceutical industry. As well as the loss of 900 staff, there is already deep concern in the UK about the ripple effect of the move on the industry.

The EMA’s chief role is to act as the regulatory agency deciding if products are safe for the European single market. Two Portuguese ministers visited its HQ in Canary Wharf on Monday and acknowledged that competition to house the agency is going to be stiff across Europe.

Nationals from every EU industry save Malta and Luxembourg work at the agency. France has 112 employees in the headquarters, and there are 50 British staff. No precise timetable for the transfer has been set, and the EMA itself will have no direct say in the decision.

Germany is the single largest manufacturer of medical products followed by Italy, and Rome has been arguing that apart from the European Food Safety Authority, it has been given no major EU agency so far. Other countries making bids are the Netherlands, Ireland, Sweden, Austria, Denmark and Spain.

The health secretary, Jeremy Hunt, has acknowledged this month that the EMA would quit Britain as part of Brexit, largely because Theresa May has asserted that the UK would no longer be subject to the decisions of the European court of justice.

The ECJ at present adjudicates appeals against EMA decisions or rulings that require interpretation of pharmaceutical legislation, such as the recent clash between Novartis and Apozyt over the use of the label Avastin.

Hunt has promised the UK would keep the closest possible regulatory equivalence with the EU. Critics claim that this means UK firms would largely have to accept the rules devised in the EU if they are to trade in the single market.

The Portuguese minister of health, Adalberto Campos Fernandes, said before the visit: “We have been actively engaged in the European medicine system from its inception and the Portuguese medicine agency, Infarmed, is highly regarded in the assessment procedures of medicines, being one of its major contributors in several roles.”

Lisbon, like almost every candidate city, is touting itself as being committed to the EU, with a cosmopolitan culture and a vibrant medical research industry.

HDA UK Media And Political Bulletin – 17 February 2017

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