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HDA Media And Political Bulletin – 4 November 2016

Wholesalers: Brexit ‘highly likely’ to cause stock shortages

Chemist & Druggist, Beth Kennedy, 3 November 2016

C&D reports on HDA UK warning that the UK leaving the single market could lead to drug shortages. Parallel imports would no longer be “easily and swiftly” imported in the UK and drugs could be more expensive as a result. Finally, the ease of employing EU nationals could also be affected and the healthcare sector “benefits from skilled workers from the EU”.

The full letter is available on the HDA’s website here.

 

Can EU laws tackle smuggling and forging?

EU Observer, Craig Storbie, 3 November 2016

The EU Observer discusses the effectiveness of EU regulation in tackling the issue of illicit trade in contraband and counterfeit goods. The Falsified Medicines Directive is the first regulation of this type which aims to tackle illicit trade of counterfeit medicines, through harmonised, pan-European measures that control and monitor the trade pathway and authentication of medicines. However, the path to implementing FMD is hurdled with financial and logistical challenges, especially for small to medium sized enterprises.

 

Labour calls for end to pharmacy cuts in the commons

Pharmacy Biz, Neil Trainis, 3 November 2016

Pharmacy Biz reports on a House of Commons debate during which Labour MP’s called for community pharmacy funding cuts to be scrapped. Shadow health secretary Jonathan Ashworth was particularly vocal in his criticism of the cuts and of the Community Health and Social care Minister David Mowat, who had promised that he would take the time to ensure the government’s efficiency measures were “the correct decision.”

Pharmacy Biz further reports that Ian Strachan, Chairman of the NPA, welcomed this support.

 

Parliamentary Coverage

Scottish Parliament, Priority Health & Pharma: “To ask the Scottish Government what information it has regarding the number of counterfeit medical products …” , 1 November 2016

 

Neil Findlay (Lothian, Scottish Labour): To ask the Scottish Government what information it has regarding the number of counterfeit medical products and medicines that have been seized in the last 10 years.

 

Shona Robison: The Medicines and Healthcare products Regulatory Agency is responsible for regulating medicines, medical devices and blood components in the UK, and the Scottish Government does not therefore hold the information sought.

 

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House of Commons, Drugs: UK Trade with EU, 3 November 2016  

 

Daniel Zeichner: What assessment he has made of the potential merits of different possible trading arrangements with the EU for pharmaceuticals exports after the UK leaves the EU.

 

Department for International Trade

Greg Hands: The pharmaceutical sector is strategically important for the United Kingdom and we are having an active and ongoing dialogue with industry. We want the best possible arrangements for trade in all goods and services with the EU, including the pharmaceutical sector.

 

Full Coverage

Wholesalers: Brexit ‘highly likely’ to cause stock shortages

Chemist & Druggist, Beth Kennedy, 3 November 2016

There is a “high probability” that Britain’s exit from the European Union (EU) will lead to medicines shortages, wholesalers have warned.

Parallel imports would no longer be “easily and swiftly” imported into the UK if it leaves the single market, the Healthcare Distribution Association (HDA) said on Monday (October 31).

Leaving the European Economic Area could also lead to more expensive drugs due to losing the trading benefits of being part of the single market, the HDA warned in an open letter to the government.

Wider consequences

The HDA said it is concerned Brexit could affect the ease of employing EU nationals. The healthcare sector – including community and hospital pharmacy – “benefit from skilled workers from the EU”, it stressed.

British patients could also experience delays in receiving the latest treatments when the European Medicines Agency moves its headquarters from London to an EU country, the HDA added.

Last month, Sigma director Rajiv Shah warned that the falling value of the pound and potential rise in importing fees could cost pharmacies around £2,400 a year.

Over-the-counter medicines manufacturers have already become more expensive in the wake of the Brexit vote, he told delegates at Avicenna’s annual UK conference.

 

Can EU laws tackle smuggling and forging?

EU Observer, Craig Storbie, 3 November 2016

The European Union has a fight on its hands, and this time we aren’t talking about Brexit. The battle is against the illicit trade in contraband and counterfeit goods and the culprits are organised crime and even terrorists, its prime beneficiaries.

According to a report published by the OECD and the EU’s Intellectual Property Office in April 2016, imports of counterfeited and pirated goods have doubled in less than a decade and are worth nearly $500 billion a year, or around 2.5% of global imports.

Perhaps surprisingly for most people, the two most frequently smuggled product sectors in Europe are pharmaceuticals and tobacco. Research from KPMG showed that one in every 10 cigarettes smoked is from illicit sources, while the European Commission estimates that globally 10,000 deaths each year can be attributed to falsified medicines.

Not only does the illicit trade sell dangerous products, which puts consumers at risk, and fund serious crime, but it also costs governments billions of euros in lost tax revenue.

The EU is determined to tackle this problem by introducing legislation that seeks to improve track and trace and authentication of the most commonly smuggled products. Businesses from different sectors have also voluntarily tested and introduced measures against this criminal practice that erodes their revenue and reputation.

But the question remains, can EU legislation really be effective in tackling the problem? Especially one that often originates beyond Europe’s borders?

The Falsified Medicines Directive (FMD) was the first piece of European legislation designed to specifically tackle illicit trade through harmonised, pan-European measures that control and monitor the trade pathway and authentication of medicines.

Coming into force in 2019, its key requirements are that all medical products for sale in the EU carry a unique identifier (a 2D data matrix code and human readable information) that can be scanned at fixed points along the supply chain and have visible tamper evident features on the pack.

Manufacturers will be responsible for uploading the unique and serialised product identifier via a European hub to country-based national data repositories. The FMD requires verification of the safety features, including the serialised product identifier, at least once before the product leaves the supply chain, normally by pharmacies at point of dispensation.

But will it work? From the outset those involved in the pharmaceutical supply chain – brand manufacturers, wholesalers, traders and pharmacies – have argued that they should take the initiative on creating and developing existing serialisation technology and databases for them to then input unique serial numbers into an EU Hub database.

This will then supply the numbers to a stakeholder-led database in the local market. Sounds complicated, but this ensures ownership of commercial data – like pharmacy dispensing data – is retained by those who put it there in the first place.

The challenge is that manufacturers need to design their serialisation and compliance infrastructure both for the extreme scalability challenges presented by the FMD and the flexibility required to serve the member states.

For many larger pharmaceutical manufacturers serialisation was already implemented but for small to mid-size entities who do not have the infrastructure or resources readily available to create a bespoke solution or to integrate with an Enterprise Resource Planning system, this will be a significant cost and logistical challenge. There are also concerns that member states will not have their own systems ready for 2019.

A small price to pay

The main burden however will fall on pharmacies, including hospital pharmacies, which will be required to scan barcodes, check tamper-proof devices and decommission medicines at the point of dispensation.

The European Commission estimated average costs at €530 a year for each pharmacy, with a particular burden on smaller family run businesses lacking the economies of scale.

This may seem a small price to pay for patient safety but the difficulties surrounding implementation could be argued to be the result of the European Commission not taking sufficient time to consult with industry, especially smaller players, and not sufficiently understanding the logistical and cost implications of reporting and storing data across multiple systems, which requires open standards and interoperable solutions in order to be effective.

The European Commission is currently working on a second piece of legislation designed to tackle the trade in counterfeit and contraband goods, the Tobacco Products Directive Articles 15 (Track & Trace) and 16 (Security Feature) and is consulting with stakeholders, including the industry and supply chain, on the implementing Acts covering these articles, with submissions due by 4 November.

As with the FMD, the challenge is to ensure that a system dealing with product in the billions is sufficiently flexible and interoperable to allow international tracking and tracing distributors, beyond EU borders, to integrate with other product sectors, and manufacturers to continue to be involved in the authentication process.

Moreover, fair market competition among services providers based on best in class and latest technologies should be encouraged rather than undermined.

The European Union is at its most effective when it pools resources across member states to address a multinational problem like the trade in illicit goods. However, it must always remember that (unlike some of its parts) it is not an island, and that for its legislation to be effective it must also be flexible and adaptable, encouraging effective implementation rather than formal box ticking within and beyond its member states.

Craig Stobie is director – global sector management and development at Domino Printing Sciences

 

Labour calls for end to pharmacy cuts in the commons

Pharmacy Biz, Neil Trainis, 3 November 2016

Labour attempted to raise the pressure on the government to reverse its decision to slash community pharmacy funding and called for pharmacies to be protected from closure yesterday during a heated House of Commons debate.

The shadow health secretary Jonathan Ashworth led Labour’s assault on the measures which will see funding for community pharmacy reduced by £113 million in 2016/17 and a further £95 million in 2017/18. The funding changes will start from December 1.

Ashworth first attacked the cuts themselves which he said threatened to cause a reduction in pharmacy services and bring about the closure of pharmacies before criticising the way the government went about introducing the cuts.

In particular he was critical of the community health and social care minister David Mowat for breaking a promise made during this year’s Royal Pharmaceutical Society conference to take time to ensure the government’s efficiency measures were “the correct decision.”

Ashworth said: “That this House notes that community pharmacies are valued assets that offer face-to-face healthcare advice which relieves pressure on other NHS services; calls on the government to rethink its changes to community pharmacy funding; and further calls on the government to ensure that community pharmacies are protected from service reduction and closure and that local provision of community pharmacy services is protected.”

He added: “Now we have a new Minister, and we are delighted to ​welcome the hon. Member for Warrington South (David Mowat) to his place – not least because in one of his first interventions when he was allowed out, he visited the Royal Pharmaceutical Society’s annual conference in September and said he was delaying the cuts.

“He said: ‘I think it is right that we spend the time, particularly me as an incoming minister, to make sure that we are making the correct decision.’ He continued by saying that ‘what we do is going to be right for you, is going to be right for the NHS and right for the public more generally.’

“When the Minister came before the House last month we found out that, far from having listened, taken account of various consultations and decided to do what was best for the NHS, he intended to impose a 12% cut on current levels to pharmacy budgets for the remainder of this financial year – giving pharmacists just six weeks’ notice – and a 7% cut the year after that.”

The Labour MP Michael Dugher used the Commons to criticise Mowat and his predecessor Alistair Burt for what he perceived as unclear thinking over the impact of the cuts on community pharmacy.

“It is a pleasure to follow the right hon. Member for North East Bedfordshire (Alistair Burt), who tried to be extremely helpful to the current minister – most ex-ministers have ex-ministeritis and tend to be extremely unhelpful to current ministers, but not so the right hon. Gentleman,” Dugher said.

“However, he did use that figure of 3,000 pharmacies – one in four – facing closure. He has attempted to qualify it now, and his defence seems to be that he made the estimate without properly thinking it through. To that extent, there is remarkable continuity with his successor, who makes a number of assertions without remotely thinking them through.”

Following the Commons debate Dugher, the MP for Barnsley East, warned the cuts will force the closure of hundreds of pharmacies in Yorkshire.

“Ministers are pursuing a scorched earth policy that is bad for Barnsley and will force the closure of hundreds of pharmacies in Yorkshire and thousands across the country,” he said.

“The expertise and dedication front-line healthcare staff out in our communities supporting the NHS will be replaced by empty shopfronts, with patients forced to travel further for the medicine and advice they need.

“MPs must send a message to the government to think again and drop these flawed plans for the sake of the health of more than two million people who have already signed the biggest ever healthcare petition opposing to their plans.”

HDA Media And Political Bulletin – 4 November 2016

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.

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