HDA UK MEDIA AND POLITICAL BULLETIN – 20 July 2017

MEDIA SUMMARY 

C+D’s open letter to new pharmacy minister Steve Brine
Chemist and Druggist, James Waldron, 19 July 2017

In an open letter, Chemist and Druggist congratulated the newly appointed minister while also making clear that pharmacies felt “undermined by their own government”. C+D criticized the recent cuts as being overly harsh, and laid out three changes that could be made to better support the pharmacy industry:
1. Pursue a funding model that is “fair, realistic and sustainable”.
2. Embrace legal changes that reform the legal framework around dispensing errors.
3. Work with pharmacists and the National Pharmacy Association to fulfill the 2017 manifesto commitment to better integrate pharmacies into the wide healthcare system.

MHRA continues to regulate in run-up to Brexit
The Pharmaceutical Journal, Debbie Andalo, 19 July 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed its continuing role in regulating medicines in the run-up to Brexit. The MHRA also continues to respond to regulatory inquiries and notices from the European Medicines Agency. As the MHRA has recently noted, “until the exit negotiations are concluded, the UK remains a full member of the EU and all the rights and obligations of of EU membership remain in force.” The MHRA is currently working closely with the government to analyse the impact of Brexit and develop a regulatory framework post-leaving.

Arvato Systems signs deal with SecurMed UK to deliver medicines verification
The European Pharmaceutical Journal, Steve Bremer, 19 July 2017

The EPJ reported on the recent press release announcing the Arvato and SecurMed collaboration. First reported in this update yesterday, Arvato and SecurMed are collaborating to implement the UK’s Medicines Verification System. SecurMed is the not-for-profit organization responsible for implementation, while Avarto is an IT company that is helping companies transform their digital offerings and regulatory systems.

China slashes prices of patented western drugs by up to 70%
The Financial Times, Tom Hancock and Wang Xueqiao, 19 July 2017

China has slashed the prices for a number of top brand-name drugs by as much as 70%. Thirty-six brand-name drugs, mainly developed by overseas companies, will see average price cuts of 44%. The regulatory changes make medicines eligible for co-payment, bringing them into the reach of more consumers. China is the world’s second largest pharmaceutical market. Cancer is becoming a major concern in China, and drugs designed to tackle it have seen the steepest reductions. Roche’s anti-breast cancer drug saw price reductions of 67%. Almost all drugs that saw their prices drops are still patent protected, sending a signal that China will be more open to seeing Western companies in the pharmaceutical market.

July 2017 Retail Report – GIRP
GIRP, 18 July 2017

The European Healthcare Distribution Association (GIRP) has released it’s July retail report, covering both international and domestic news. On the international front, it notes the growing use of big data, and asks whether it is the future of the industry. In the United Kingdom, it notes that the Care Quality Commission (CQC) has raised concerns about the quality of care delivered by online pharmacies, saying they do not do enough to ensure that what patients order “is appropriate”. This follows developments in Germany, which has not seen an increase in mail-order pharmaceuticals – with in-person pharmacies driving sales.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

 

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

Arvato Systems signs deal with SecurMed UK to deliver medicines verification
The European Pharmaceutical Journal, Steve Bremer, 19 July 2017

SecurMed UK, the UK Medicines Verification Organisation, is entering into a Letter of Intent with Arvato Systems as its IT blueprint service provider.

In a joint statement, SecurMed UK and Arvato Systems said they were looking forward to “working together to enable the UK medicines supply and healthcare sectors to successfully implement the UK Medicines Verification System by 9 February 2019”.

​​​The UK is one of the largest and most complex markets for medicines supply within Europe and the appointment of Arvato Systems represents a significant milestone in the UK’s journey to meet its obligations under the Falsified Medicines Directive and associated Delegated Regulation, according to the statement.

SecurMed UK is the not-for profit organisation that will manage the UK Medicines Verification System under the supervision of the UK national competent authorities – MHRA and Department of Health. SecurMed UK has been incorporated by the principal supply chain stakeholder associations (Association of British Pharmaceutical Industry (ABPI), British Generic Manufacturers Association (BGMA), British Association of European Pharmaceutical Distributors (BAEPD), Healthcare Distribution Association (HDA), National Pharmacy Association (NPA) and Company Chemists’ Association (CCA)) as required by the Falsified Medicines Directive.

Global IT specialist Arvato Systems supports major companies through digital transformation. It develops innovative IT solutions, transitions its clients into the Cloud, integrates digital processes and take on IT systems operation and support.​ In Healthcare, Arvato Systems provides its own serialisation solutions covering the entire end-to-end process chain that support both individual producers and national verification systems. It was chosen as an official service provider by the European Medicines Verification Organization (EMVO).

MHRA continues to regulate in run-up to Brexit
The Pharmaceutical Journal, Debbie Andalo, 19 July 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed its continuing role in regulating medicines safety while the Brexit negotiations continue.

The UK drugs regulator took the step in response to the public statement made earlier this month (4 July) by health secretary Jeremy Hunt and business secretary Greg Clark, confirming the UK government’s desire “to retain a close working partnership in aspects of medicines regulation after the UK leaves the EU in the interest of public health and safety”.

The two secretaries of state wrote to the Financial Timesoutlining three principles that would underpin the challenge of developing a new regulatory system post-Brexit. The MHRA was also responding to notices issued by the European drugs safety regulator — the European Medicines Agency (EMA) — and the Human Coordination Group for Mutual Recognition and Decentralised Procedures, the body which helps to resolve any differences in marketing authorisation data involving two or more European Union (EU) member states.

The notices highlight issues that marketing authorisation holders should be considering as the UK begins talks to leave the EU, and they include an EMA question and answer document for pharmaceutical companies published by the EMA in May.

In its statement published on 17 July, the MHRA said: “Until the exit negotiations are concluded, the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force.

Judicial review unhelpful, suggests biotech association
Pharmaphorum, Andrew McConaghie, 11 July 2017

The UK pharmaceutical industry launched a judicial review this week on the NHS’ new drug pricing system, but the biotech industry has been quick to express reservations. Speaking to reporters, the CEO of the Biotech Industry Association (BIA), Steve Bates was quick to point that the BIA was not a party to the dispute nor had it been consulted beforehand. Bates insisted that this move ‘must not impact or delay broader industry engagement with the UK government at a time of significant external change.’ Conversely, the Breast Cancer Now charity supported the ABPI’s application, saying that the NHS proposal could result in ‘delays in accessing vital and cost-effective drugs’. While the application is likely to be successful, it is far from clear whether they will be successful in having the NHS post-NICE pricing regulations overturned.

Pharma turns to big data to gauge care and pricing
Financial Times, Sarah Neville, 11 July 2017

Increasingly, pharmaceutical and manufacturing firms are turning to big data to confront price pressures, empowered consumers and the sheer quantity of patient data. Novartis, Pfizer, Merck and other large companies have created the position of Chief Digital Officer for the first time, with Merck appointing their first 6 months ago. Novartis now employs over 1200 people to sift and analyze big data. However, while many stepts are being taken, a recent study by McKinsey notes that pharma remains ahead of only the public sector when it comes to ‘digital maturity’, and the integration of big data and digital mechanisms into research and pricing.

PARLIAMENTARY COVERAGE

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FULL COVERAGE 

 

Judicial review unhelpful, suggests biotech association
Pharmaphorum, Andrew McConaghie, 11 July 2017

The UK pharma industry association yesterday declared war on the latest NHS price control system – but the UK biotech industry counterpart seems far from convinced the move is helpful.

The ABPI confirmed that it has applied for a judicial review of the decision to introduce the ‘budget impact test’ – a new post-NICE approval price control mechanism. This will target any new medicines which could cost the health service £20 million or more in its first three years on the market.

The legal challenge is a rare step for the ABPI, and reflects anger in the pharmaceutical industry that another means of controlling cost has been introduced, adding to the existing PPRS pricing system and NICE’s own cost-conscious approach.

NHS England is the chief driver behind the budget impact test, as it is charged with controlling NHS finances but is struggling to do so.  Growing patient demand is not being matched by government funding, and a wave of high cost new drugs is among the most significant factors behind the problems.

The ABPI looks likely to have its judicial review granted by the UK courts, but there is no guarantee that its legal challenge will ultimately succeed.

Responding today to the news, Steve Bates, the chief executive of the UK’s biotech association the BIA stated plainly that it was neither party to the process nor had it been consulted.

BIA chief executive Steve Bates

Bates declined to comment on the details of the challenge, which will hinge on whether NHS England and NICE have followed proper procedures and observed existing laws and regulations.

Nevertheless, it was clear from his statement that the BIA thinks the move is an unhelpful distraction.

He said: “…there are several other complex issues the full life sciences sector is currently engaging with the government on. Namely, how we can make Brexit a success for the life sciences sector and how we can develop the most impactful industrial strategy to support the BIA’s ambition that the UK sustains itself a leading global cluster for life sciences.”

Bates concluded: “This legal move must not impact or delay broader industry engagement with the UK government at a time of significant external change.”

This difference of opinion is in contrast to recent collaborations between the ABPI and BIA, especially in regard to the Brexit question.

The BIA is clearly concerned that a legal battle might sour relations between the life sciences sector and the UK government.  The government had promised to produce a full Life Sciences Industrial Strategy, however the tumult around Brexit and the general election has meant only an outline document has so far emerged from Whitehall.

However breast cancer charity Breast Cancer Now put out a statement which was more supportive of the ABPI’s stance.

Baroness Delyth Morgan, chief executive at Breast Cancer Now, said: “We remain extremely concerned that the budget impact test could see NHS patients experience delays in accessing vital and cost-effective drugs.”

Baroness Morgan said it was “incredibly disappointing” that NICE and NHS England went ahead with the budget impact test despite widespread opposition from those representing patients, as well as a willingness to discuss alternative solutions.

“Getting modern breast cancer drugs through to the NHS patients that desperately need them is already very difficult, and this test could represent a major additional hurdle. Thousands of women living with incurable breast cancer are relying on effective drugs to give them significant and precious extra time with their loved ones, and any further delays could sadly see patients lose their lives as they wait.”

She concluded: “We will now be monitoring the progress of this possible legal action closely, and hope that it will provide clarity on the issue of timely access to drugs in England. We, alongside many other charities, remain ready and willing to work with all involved to look at how this critical issue can be resolved.”

The judicial review process has two steps and was begun last month. The first step of the process is to apply to the court for permission and this usually takes around two months from the date that the permission application is submitted.

The decision to mount the legal challenge was made by the ABPI Board, which includes senior executives from across the pharma industry, and it collectively decided to apply for a judicial review.

NICE responded to pharmaphorum’s enquiries to say that it will not be commenting on the case.

MEDIA SUMMARY 

UK drugs groups seek court block on NHS price limits
Financial Times, Sarah Neville, 11 July 2017

The UK drug industry has entered legal proceedings in an attempt to stop the NHS from imposing new price limits. This was prompted by a recent crackdown in April that means medicines will no longer automatically be funded if they are set to cost more than £20 million a year. This means that manufacturers will have to cut separate deals for each approval of a drug over the £20 million limit. Manufacturers claim that this will deprive patients of cutting edge pharmaceuticals, and that they have thus ‘reluctantly’ applied for a judicial review. However, legal action has divided the industry, with GSK stating that it was “not supportive of this action”. AstraZeneca also made it clear it head reservations, although it did not publically oppose the application. The NHS only devotes 10 percent of its funding to medicines, but many observers claim the NHS is in the middle of a funding crisis.

Westminster Health Forum Keynote Seminar; Next steps for delivering the new models of care and vanguard sites
Westminster Forums, 11 July, 2017

The Westminster Forum Project is excited to invite guests to its conference on delivering new models of care, October 25, 2017. Following on from a very successful conference in 2016, delegates will be able to further assess the NHS New Model of Care targets for 2020. Chaired by the Lord Warner, former Minister of State for Health, issues relating to service delivery, integration and redesign will be at the heart of this forum, and will involve stakeholders from across the health sector. The agenda can be found here.

2017 International Pharmaceutical Distribution Conference
HDA, 11 July 2017

For the fourth year in a row, healthcare distribution associations from around the world will gather in Geneva, Switzerland for the annual Pharmaceutical Distribution Conference. The conference will feature expert-led sessions on the political and policy landscape, product traceability, value-based outcomes and the global financial outlook. To register, go to the HDA website. For inquiries, call the HDA Conference Department at (703) 885-0278 or for information regarding the conference programming, contact Anne Nevel, Senior Director, Industry Education, at (703) 885-0283.

Pharmacies have been marginalised by Sustainability and Transformation Plans claim pharmacy bodies
Pharmacy Business, Neil Trainis, 11 July 2017

Despite the fact that Sustainability and Transformation Plans (STPs) were designed to “fuse health and social care in local areas by getting healthcare providers including pharmacists working together effectively”, a survey has shown that community pharmacies feel marginalized and have struggled to engage with those leading STPs. 50% of local pharmacies said they had no input into their local STPs. The NHS Confederation Chief has also called the STPs “extremely challenging”. They have been accused of focusing too much on organizational changes, and not enough on improving system performance.

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FULL COVERAGE

Pharmacies have been marginalised by Sustainability and Transformation Plans claim pharmacy bodies
Pharmacy Business, Neil Trainis, 11 July 2017

A survey carried out by leading pharmacy organisations has found that community pharmacies across England have been marginalised as they try to involve themselves in Sustainability and Transformation Plans (STPs).

The government’s attempt to alleviate pressure on hospitals and A&E by moving care into the community, thus closing the £22 billion NHS funding gap, culminated in STPs which were supposed to fuse health and social care in local areas by getting healthcare providers including pharmacists working together effectively.

Investigations launched last December however into the extent to which community pharmacies are part of STPs by the PSNC, Royal Pharmaceutical Society and Pharmacy Voice, which has since folded, revealed pharmacists and their teams have struggled to engage with those leading STPs and new care models.

Just 10% of Local Pharmaceutical Committees (LPCs) rated community pharmacy involvement in STPs as four or five out of five and 50% of LPCs claimed community pharmacy has no involvement in plans for health and social care devolution.

“Looking across the 44 evolving Sustainability and Transformation Partnerships (STPs) it is clear that in many areas the potential contribution of the community pharmacy sector has not been considered or explored in detail, or fully understood,” a report based on the survey said.

“This reflects anecdotal feedback received by the pharmacy organisations during 2016 which suggested that fruitful relationships between community pharmacy representatives and those leading STPs and New Care Models were far from widespread, with significant differences in levels of engagement by region.”

Only 6% of LPCs rated involvement in vanguards, 50 of which were selected to lead on the development of new care models between January and September 2015, as a four or five out of five and 55% said they had no involvement in the £50 million GP Access Fund.

Concerns raised by the survey coincided with an assertion by NHS Confederation chief executive Niall Dickson that STPs “have proved extremely challenging.”

“In part, this is because they require leaders to set aside organisational interests in favour of the system as a whole,” he told Confed17.

“That is much easier to promise than to deliver. And it is made more difficult because the regulatory and accountability mechanisms that govern providers and commissioners are not always aligned. They continue in law, and too often in practice, to be focused on organisational rather than system performance.”

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