HDA UK Media And Political Bulletin – 15 February 2017

Media Summary

Exports and customs procedures

MHRA Blog, Cheryl Blake, 14 February 2017

MHRA events in December 2016 discussed the Unified Customs Codes (UCC) and their latest article elaborates on this by explaining the central export procedures and requirements. The need to provide accurate and correct information on customs declarations is underscored. To facilitate this, export documentation must be carefully managed to prevent problems with poor control or lack of visibility within the supply chain. Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) will be routinely requesting full export documentation at inspection to support these measures.

Hub on EU falsified medicines directive developed for UK pharmacists

The Pharmaceutical Journal, 13 February 2017

A website has been launched to inform community pharmacists about the introduction of the EU Falsified Medicines Directive (FMD). It outlines new authentication systems and dates of implementation, as well as offering information on how to implement changes. The UK database will be developed by SecurMed UK. Chair of the UK FMD working group for community pharmacy and dispensing entities director of SecurMed UK, said: “FMD aims to reduce [falsification] by allowing pharmacists to verify the authenticity of prescription medicines during the dispensing process”.

Revealed: 23 trusts chosen for new Carter review

HSJ, Joe Gammie, 14 February 2017

Twenty-three trusts have been selected for the first phase of Lord Carter’s new review on productivity at mental health and community service organisations. The review will follow a similar format to Lord Carter’s previous investigation into hospital productivity. The engagement phase will include a focus on what ‘good’ looks like, how to drive existing efficiency measures, and what metrics and indicators are required to support the development of the model for these sectors. Benchmarking criteria for an ‘optimal model’ NHS community or mental health care trust will also be created.

Parliamentary Coverage

There is no Parliamentary Coverage.

Full Coverage

Exports and customs procedures

MHRA Blog, Cheryl Blake, 14 February 2017

Those of you who attended our symposiums in either Glasgow or London during December 2016 will have heard Jane Sewell – International Trade Development Liaison Officer from HMRC speak about the Unified Customs Code.

This is a major change in customs legislation affecting the international freight industry and businesses making customs declarations. The Union Customs Code (UCC) was introduced across the European Union on 1st May 2016 and consequently it introduced a number of changes to how goods cross EU borders.  Jane spoke of the importance of providing accurate and correct information on customs declarations and also touched upon the Incoterm Ex Works and the difficulties of proving export has taken place when entering into trade agreements in this manner.

Those of you who are regular attendees at these events will have heard me speak on similar themes over the years.  The changes brought about by the introduction of the UCC are important and far reaching and may have been new to many delegates and to many of you that may be reading this post.

Also at the symposium delegates heard a shocking, but interesting, presentation by my colleague Naseem Hudroge, Senior Intelligence Analyst, which gave further insight into the importance of getting customs declarations correct and also highlighted the need for you to be able to present such export documentation when it is asked for during an inspection. Both the MHRA and HMRC will expect these declarations to be correct, accurate and available.

In this, my first blog post, I shall attempt to put this information into context and to suggest ways in which you can actively prevent your company receiving deficiencies in the area of lack of documentation and poor control, or lack of visibility within the supply chain, simply by making small changes to and increasing your understanding of export procedures and requirements.

When exporting a medicinal product, a declaration must be made to HMRC to indicate exactly what is being shipped, who is making the shipment and where the product is ultimately going.

The product should be accompanied by a commercial invoice – proforma invoices are to be avoided as this can, and has led to misleading customs declarations being completed. A false declaration may result in seizure of the product and may also lead to a fine.

It is the responsibility of the exporter to enquire into the import and export regulations (any prohibitions, restrictions, trade embargoes, etc.) that may be in force in relation to the destination country. The exporter must ensure that certificates of origin, export licenses and the like which may be required in relation to the trade in the particular commodity within the destination country are applied for and that the correct documentation accompanies the shipment. Copies of this documentation should routinely be retained.

HMRC paperwork

The exporter (consignor) is also responsible for ensuring that:

  • medicinal products remain in the legal supply chain,
  • export paperwork is correctly completed,
  • proof of export is obtained and retained,
  • the consignee is entitled to receive the product, and
  • the product has been stored, handled and shipped in accordance with GDP.

Your freight forwarder or shipping agent is a key partner. It is best practice to routinely provide the freight forwarder, shipping department or freight agent with the following:

  • your Economic Operator Registration and Identification (EORI) number
  • details of whom the goods are to be consigned to (name and address in full)
  • commercial reference to be incorporated into the Declaration Unique Consignment Reference (DUCR) to assist with export audit trails
  • details of the country of final destination
  • shipping or flight details
  • correct value of goods in the correct currency code
  • the Commodity Code and a clear and unambiguous description of the goods, their quantity, marks and numbers.
  • any reference numbers already issued by HMRC – such as any previous declarations made in respect of the product. For example, the declaration made when the product was ‘introduced’.

Whilst on inspection, upon asking for documentation relating to an export to a third country we are frequently presented with invoices which show the Incoterm ‘Ex Works’. This generally causes issues at inspection as the consignor may have handed the product over for export to a representative of a company appointed by the consignee. Where this is the case, the consignor generally will be unable to demonstrate GDP compliance or indeed produce any paperwork showing the product has been exported as claimed. Companies should request copies of the documentation (which is interchangeably referred to as the SAD, C88 or export declaration) from their shipping agent and check this for accuracy.

The Incoterm EXW (Ex Works) puts the onus on the consignee to arrange the pre-carriage from the seller’s premises to the point of export, and to complete and pay for the export formalities.  In most export scenarios this presents practical difficulties. Realistically for all export transactions the exporter needs to be involved in export reporting formalities and cannot realistically leave this to the consignee.

A lesser used but more practical Incoterm when an exporter does not wish to pay for the carriage of the product, is FCA – Free Carrier (named place of delivery). Generally the named place of delivery will be the port through which the product is leaving. With this Incoterm, the seller has control regarding the transport and customs formalities prior to the goods leaving the territory, and the buyer pays for the main transport.

Since it is the legal responsibility of the declarant to ensure that the goods are accurately declared when presented to HMRC, using this Incoterm gives the seller the control required. Crucially the seller also takes responsibility for arranging the transport to the point of shipment (or consolidation) and can therefore control where the goods are held and by whom prior to shipment, hence ensuring that the product remains within the legal supply chain and under GDP

control up to the point of main transport, which will have risk assessed according to Chapter 9 of 2013/C 343/01.

Both the GDP and GMP inspectorate will be routinely requesting full export documentation at inspection – and this extends to the CHIEF (Customs Handling of Import and Export Freight) entry – bills of lading or airway bills, export licences where applicable, and any certificates of origin that may be required for that particular commodity to be sent to the destination country. For exports we still expect that you can show the same due diligence.

Finally, I would like to leave you with the thought that, as the exporter, the responsibility in ensuring the information you provide to HMRC rests with you.

I intend to produce a second post during 2017 on the subject of introduction.

Hub on EU falsified medicines directive developed for UK pharmacists

The Pharmaceutical Journal, 13 February 2017

A website containing information to help community pharmacists prepare for the introduction of the EU Falsified Medicines Directive (FMD) has been launched by the UK FMD working group for community pharmacy, which includes representatives of all the main bodies in community pharmacy.

The website’s aim is to help UK pharmacies prepare for whatever new authentication systems are developed and introduced, and has been tailored to reflect the way UK pharmacies operate, rather than a theoretical ‘European’ model.

Under the FMD, all new packets of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a unique barcode and an anti-tamper device.

The website says that it is likely that FMD scanning will come into effect before the UK leaves the EU. Any changes made to the 2012 UK Human Medicines Regulations to implement FMD would remain in place until the UK government decides to change them.

At present, the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA), have stated that they are continuing with work to implement FMD in the UK and this is “business as usual” for them.

The UK database will be developed by SecurMed UK, a new organisation representing all the main supply-chain bodies for manufacturers, wholesalers and pharmacies. SecurMed UK represents pharmacy jointly with the National Pharmacy Association and the Company Chemists’ Association.

Raj Patel, a member of the National Pharmacy Association board, who is also chair of the UK FMD working group for community pharmacy as well as the dispensing entities director of SecurMed UK, comments: “Falsification of medicines is a major threat to patient safety and cases of falsification continue to be discovered by authorities. FMD aims to reduce this by allowing pharmacists to verify the authenticity of prescription medicines during the dispensing process.

“We recognise that this will be a big change for everyone in the medicines supply chain, especially community pharmacists. That’s why we’ve been working closely with the Department of Health

and the MHRA to ensure that this is implemented in a proportionate way that fully reflects the UK’s unique dispensing models.”

Revealed: 23 trusts chosen for new Carter review

HSJ, Joe Gammie, 14 February 2017

More than 20 trusts have been chosen to be part of a new NHS efficiency review led by Lord Carter.

The Labour peer and a team from NHS Improvement will look into organisational productivity and performance at mental health and community service organisations.

In a letter seen by HSJ, NHSI said the review will follow a similar structure and methodology to Lord Carter’s previous investigation into acute hospital productivity, published last year.

The letter was written by NHSI director of sector development Luke Edwards, and was sent to all mental health and community trust chief executives and chairs last week.

It reveals the 23 mental health and community service providers that will begin six months of detailed engagement in the first phase of the review with Lord Carter and a team from NHSI’s operational productivity directorate.

HDA WELCOMES RISK-BASED VERIFICATION IN FALSIFIED MEDICINES DIRECTIVE

Pharmacy Biz, 10 February 2016

 

Pharmacy Biz reports on the Association welcoming the Falsified Medicines Directive delegated regulation. Executive Director Martin Sawer emphasised the importance of taking a “risk-based approach” to avoid unnecessary administrative burdens for the supply chain.

 

Carter review calls for more clinical pharmacists to be deployed by NHS trusts

The Pharmaceutical Journal, George Winter and Harriet Adcock, 10 February 2016

 

The Pharmaceutical Journal evaluates the Lord Carter independent review of English NHS acute hospitals. The review, which proposes a ‘Hospital Pharmacy Transformation Programme (HPTP)’, was welcomed by the healthcare community, including the Royal Pharmaceutical Society and HDA UK.

 

No controlled drugs on EPS until 2018

C&D, Samuel Horti, 10 February 2016

 

Chemist and Druggist has learned that schedule 2 and 3 of controlled drugs will not be available for pharmacists to dispense through the electronic prescription service (EPS) until 2018. Pharmacists have taken their discontent to social media and highlighted the contrast with the Government’s emphasis on online dispensing.

 

Tory MPs ‘burying heads in the sand’ over funding cuts

C&D, Annabelle Collins, 10 February 2016

 

Labour MP Paula Sherriff, treasurer of the All Party Pharmacy Group, blamed the Conservative party for not acknowledging the impact of the 6% funding cut on community pharmacy. She announced that she would be using Parliamentary Questions as a way to fight this proposal.

 

Parliamentary Coverage

Royal Pharmaceutical Society: RPS response to Lord Carter Review, 10 February 2016

 

Royal Pharmaceutical Society response to Operational productivity and performance in English NHS acute hospitals: Unwarranted variations. An independent report for the Department of Health by Lord Carter of Coles.

 

Commenting on the report Sandra Gidley, RPS English Pharmacy Board Chair said:

“There is much for hospital pharmacists to consider in this report. At its heart is an assertion that makes clear that the role of hospital pharmacists is intrinsic to the delivery of value from the £6.7bn the NHS spends on medicines in hospitals. A statement of fact as well as a testament to the expertise and skills of hospital pharmacists.

“There is also clear recognition of the vital governance and clinical leadership that hospital chief pharmacists provide now, and that this will be even more important in future. Enabling chief pharmacists to make recommendations within their NHS Trust to improve care will need access to high quality comparative data to allow the spread of best practice.

“We agree completely that increased input from hospital pharmacists, working in teams with doctors, nurses and all other health care professionals, will improve patient outcomes, reduce waste, improve prescribing decisions and reduce avoidable harm. We support the increased role of hospital pharmacists within clinical teams, and see much merit in learning from the best and applying this across all NHS Trusts.

“For pharmacists working in procurement, manufacturing, dispensing and other roles labelled as “infrastructure” in this report, there will naturally be concern that this report describes the potential for outsourcing as well as local national and regional collaborative models to reduce costs and drive efficiency.  Balanced against this the report recognises the importance of the so-called “infrastructure” functions and there is a clear message of investment in clinical, patient facing hospital pharmacists, significantly this is recommended in all NHS Trusts.

 

Hospital Pharmacy Transformation Programme

 

“We are pleased that Lord Carter has recognised the need for a programme to support NHS Trusts in developing their hospital pharmacy service. This programme needs to be properly resourced and take into account the significant work required. The Royal Pharmaceutical Society will play its part through supporting and developing pharmacists to deliver enhanced patient care.”

 

Full Coverage

HDA WELCOMES RISK-BASED VERIFICATION IN FALSIFIED MEDICINES DIRECTIVE

Pharmacy Biz, 10 February 2016

 

The Healthcare Distribution Association has welcomed the inclusion of risk-based wholesaler verification into the delegated regulation of the Falsified Medicines Directive, insisting it will help to avoid “unnecessary burdens on the supply chain.”

 

Martin Sawer, the executive director of the HDA (pictured), said risk-based wholesaler verification was “crucial” to establishing a secure European medicines supply chain. Progress had been made on the issue following the efforts of the European Healthcare Distribution Association and HDA.

 

Manufacturers of prescription medicines will now have to place safety features on all their medicines sold in the EU, which will be verified by dispensers.

 

“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,” Sawer said.

 

“Risk-based wholesaler verification was crucial in securing a credible and sustainable solution to secure the European medicines supply chain.

 

“We look forward to working with our supply chain partners to ensure the delegated regulation is implemented to the highest standards so that patients can continue to benefit from a safe medicines distribution sector.”

 

The delegated regulation and the new medicines verification system is expected to come into force in early 2019.

 

Carter review calls for more clinical pharmacists to be deployed by NHS trusts

The Pharmaceutical Journal, George Winter and Harriet Adcock, 10 February 2016

 

Recommendations highlight why NHS trusts need to focus pharmacists on optimising medicines use.

 

NHS trusts should deploy more clinical pharmacists, including pharmacist prescribers, Lord Patrick Carter, pictured, has advised in his review of English NHS acute hospitals

 

Lord Carter found significant variation in the rates of prescribing pharmacists employed by hospital trusts in England

 

NHS trusts should deploy more clinical pharmacists, including pharmacist prescribers, and use them to drive value from the £6.7bn that NHS hospitals spends on medicines every year, Lord Carter has advised in his final review[1] of English NHS acute hospitals.

 

Lord Carter recommends that NHS trusts use at least 80% of their pharmacist resource for direct medicines optimisation activities, medicines governance and safety remits. However, his review, published on 5 February 2016, found significant variation in the number of prescribing pharmacists in hospitals and in the total pharmacy and medicines costs across acute trusts.

 

Lord Carter estimated in his interim report published in June 2015 that £5.0bn of the £55.6bn spent annually by NHS acute hospitals could be saved by reducing unwarranted variation across the workforce, hospital pharmacy services and medicines optimisation, estates management and procurement.

 

“If all trusts looked at how they might achieve the average [total pharmacy and medicines] cost, then the NHS could save at least £800m,” the final report says.

 

Lord Carter judges the delivery of hospital pharmacy services, which cost the NHS £600m, to be inseparable from the optimisation of medicines. “In hospital pharmacy we know that the more time pharmacists spend on clinical services rather than infrastructure or back-office services, the more likely medicines use is optimised,” the report says.

 

“Simply put, the NHS needs to focus the pharmacy workforce to drive optimal value and outcomes from the £6.7bn it spends on medicines,” says the report. “Trusts should ensure clinical pharmacists are in place, with sufficient capacity, to meet this challenge.”

 

Lord Carter proposes a ‘Hospital Pharmacy Transformation Programme (HPTP)’ to ensure trusts implement his recommendations, which also include the accurate cost coding of medicines and the consolidation of medicines stocks to reduce stock holding from 20 days to 15. He also wants NHS Improvement to publish a monthly list of the top 10 medicines that provide trusts with savings opportunities. Trusts will need to have plans in place by April 2017 to achieve the recommendations by April 2020, says the report.

 

The recommendations also say that infrastructure services should be delivered through collaborative or shared service type-models, suggesting that such services do not always need to be delivered by NHS employed staff. The report also highlights the potential of centralised dispensing for increasing efficiencies in the supply of medicines to outpatients and to patients when they are discharged from hospital. Lord Carter also recommends that every trust should adopt electronic prescribing and medicines administration systems.

 

The Royal Pharmaceutical Society (RPS) supports the report’s recommendation for an increased role for hospital pharmacists within clinical teams. “We agree completely that increased input from hospital pharmacists, working in teams with doctors, nurses and all other healthcare professionals, will improve patient outcomes, reduce waste, improve prescribing decisions and reduce avoidable harm,” says Sandra Gidley, chair of the RPS English Pharmacy Board, adding that the report provides “clear recognition of the vital governance and clinical leadership that hospital chief pharmacists provide”, a role that will be even more important in future.

 

The RPS also supports the sharing of best practice but warns that chief pharmacists will need access to high quality comparative data to allow its spread.

 

Vilma Gilis, president of the Guild of Healthcare Pharmacists, says the guild is pleased that Lord Carter has placed such “high importance” on clinical pharmacists but is concerned that employers may interpret the report to mean that infrastructure roles can be outsourced, saving money on staff costs and threatening jobs.

 

“Whilst we understand that many support functions in the pharmacy service may be suitable for outsourcing, hospital pharmacy has had to compete with other organisations which have the advantage of not having to pay VAT on medicines, which has given them an unfair advantage in the tendering process (and possible false impression of efficiency),” says Gilis.

 

The Healthcare Distribution Association (HDA UK) welcomed Lord Carter’s report. “Healthcare distributors can act as the stockroom for secondary care, storing supplies and delivering them to the right place at the right time, often with only 30 minutes notice,” says Martin Sawer, executive director of the HDA UK.

Review shows how NHS hospitals can save money and improve care

5 February 2016, Gov.co.uk, Department of Health

 

Having identified a large range of variations across the NHS, the Lord Carter review published on Friday developed a “model hospital” which will advise NHS trusts on the most efficient allocation of resources to save hospitals £5 billion a year by 2020.

 

The full report is available here.

 

The importance of the supply chain is particularly emphasised in the sections below (p. 30-35):

 

  • Hospital pharmacy infrastructure services

 

On average, 55% of pharmacy staff time (43% of costs) is spent on infrastructure services, with the largest element being supply chain activities (at 45% of staff time) encompassing the buying, making and supplying of medicines. Contracting for medicines takes place at national and regional levels only; however, we found that not all trusts make best use of these arrangements. We believe the nationally coordinated approach is well organised and is most likely achieving good prices, although this needs to be checked. In contrast, many trusts still have local pharmacy buying of ces, stores and distribution services and we found significant variation in their efficiency, for example, with the adoption of e-ordering some trusts are still placing orders via telephone or fax. More efficient trusts, such as Plymouth make good use of e-ordering and invoicing facilities to reduce staff time in both pharmacy and finance departments.

 

We also found significant variation in medicines stockholding. Data for 120 acute trusts showed stockholding variance of between 11 and 36 days, with the average being 20 days. We estimate at 20 days, NHS trusts are holding £200m of stock at any one time. In addition, around 50% of medicines deliveries come from a small number of wholesalers, but the other 50% come direct from manufacturers. This can mean that an acute trust will receive up to 30 medicines deliveries every day which is time consuming for staff. We also learnt that some trusts have outsourced out-patient dispensing to community pharmacy providers. This is cost effective and frees up clinical pharmacy staff to focus on clinical services.

 

  • We believe there is scope for improving supply chain management, though more effective collaboration at local, regional and national levels. Some trusts have developed more efficient centralised arrangements and some are working with pharmacy wholesalers to consolidate buying and reduce the number of daily medicines deliveries to hospitals. Closer working with manufacturers and pharmacy wholesalers, should lead to consolidation of the medicines supply chain, making full use of e-ordering and invoicing and aggregating and rationalising deliveries – preferably ready for use and to the ward. This would significantly reduce the numbers of daily deliveries to hospitals to less than five, thereby reducing stock holding (a reduction to 15 days would generate a £50 million one-off saving to the NHS in-year), as well as reducing pharmacy staff supply chain costs. We also believe that buying and supply services do not need to be delivered by NHS employed staff.

 

  • Recommendation 3

g)  consolidating medicines stock-holding and modernising the supply chain to aggregate and rationalise deliveries to reduce stock-holding days from 20 to 15, deliveries to less than 5 per day and ensuring 90% of orders and invoices are sent and processed electronically.

 

Pharmacy Voice and ABPI both welcomed the publication of the report.

 

APPG: Funding cuts show ‘worrying’ lack of planning

5 February 2016, C&D, Beth Kennedy

 

Speaking at the launch of the Healthcare Distribution Association in the House of Parliament, Kevin Barron stated that the rationale behind the announced 6% cut to pharmacy funding must be “seriously questioned”.

 

Kevin Barron’s statement was also reported by The Pharmaceutical Journal.

 

British wholesalers association relaunches as Healthcare Distribution Association UK

5 February 2016, The Pharmaceutical Journal

 

The Pharmaceutical Journal reported on the launch of the Healthcare Distribution Association in the House of Parliament, highlighting the changing nature of the industry.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

Treasury driving 6% pharmacy cuts, warns All Party Pharmacy Group

5 February 2016, The Pharmaceutical Journal

 

The ‘worrying’ 6% cut to community pharmacy is being motivated by the Treasury rather than being about better planning for the sector, Sir Kevin Barron, the chair of the All Party Pharmacy Group, has warned

 

Sir Kevin Barron, chair of the All Party Pharmacy Group, told the HDA UK parliamentary reception the planning around the community pharmacy cuts must be “seriously questioned”

 

The ‘worrying’ 6% cut to community pharmacy funding is being motivated by the Treasury rather than being about better planning for the sector, Sir Kevin Barron, the chair of the All Party Pharmacy Group, has warned.

 

Speaking at a parliamentary reception on 3 February 2016 to mark the evolution of the British Association of Pharmaceutical Wholesalers (BAPW) to the Healthcare Distribution Association UK, Barron said that the entire cross party group had been “shocked” by the letter in December 2015 announcing the cut.

 

“We met the minister about the proposals and we will be taking further evidence on the implications to all of the pharmacy sector in terms of this change in the funding of pharmacy that is going to take place later this year. It is potentially very worrying,” he said.

 

What was particularly concerning was that it was being done at the “motivation of the Treasury” rather than through better planning of the pharmacy sector. “When you have something like the Treasury driving this, the issue of planning must be seriously questioned,” he said.

 

“If we are going to plan services for the 21st century fit for the needs of patients now and taking into account how old this generation is going to be and everything else, we need it to be more than taking a 6% cut out mid-year.”

 

British wholesalers association relaunches as Healthcare Distribution Association UK

5 February 2016, The Pharmaceutical Journal

 

The British Association of Pharmaceutical Wholesalers (BAPW) has rebranded itself the Healthcare Distribution Association UK to reflect the evolving nature of the healthcare supply chain and the services provided by its members.

 

The organisation decided that change was needed because its members, which distribute over 92% of NHS medicines, no longer provide only medicines wholesaling services to community pharmacies, hospitals and dispensing doctors – they now provide more comprehensive healthcare services including medicines supply direct to patients’ homes.

 

The relaunch took place at a parliamentary reception, hosted by MP Sir Kevin Barron, chair of the All Party Pharmacy Group, and was attended by pharmaceutical industry representatives, and regulator and government officials.

 

The organisation, which can trace its history back to the 19th century, has gone through several iterations, becoming the BAPW in 1991. Steve Anderson, BAPW chair and operations director at Celesio Group (UK), told guests at the reception that the pressure to provide ever higher quality at lower costs plus patient expectations for healthcare to be delivered at a time and place that is convenient to them was driving innovation and change, a shift away from the traditional wholesale model and a consolidation of our industry.

 

“As this change continues, the BAPW must of course change,” he explained. “Our new association the HDA wants to reflect these changes as wholesalers and distributors are becoming much more integrated healthcare service providers, and the strong growth in homecare also needs to be recognised by the association.”

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

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