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HDA Media And Political Bulletin – 28 June 2016

FMD to carry on despite Brexit

28 June 2016, DDA, Ailsa Colquhoun

 

The DDA reports on a letter from the MHRA addressed to businesses who hold a Wholesale Dealer Licence (WDL) or Wholesale Distribution Authorisation (WDA) to present the requirements as set up by the Falsified Medicines Directive, Delegated Regulation. It explains that plans to implement FMD are expected to continue despite the UK’s decision to leave the EU.

 

Brexit: could European Medicines Agency stay in London?

27 June 2016, pharmaphorum, Richard Staines

 

pharmaphorum reports on the future of the European Medicines Agency (EMA) which has been based in London since it first began its operations in 1985. The agency is responsible for approving the vast majority of new medicines in the European Union member states, as well as those part of the EEA. While Germany has called for the EMA to be relocated to another large European city, industry leaders have called for the regulatory system to be preserved if possible. Sarah Rickwood, from IMS Health, stated that there were several potential Brexit scenarios, one of which being keeping the status quo.

 

Hunt tells EU staff ‘you are a crucial part of our NHS’

27 June 2016, Health Service Journal, Shaun Lintern

Health Secretary Jeremy Hunt has spoken for the first time since the EU Referendum result, calling on the country to value the contribution of EU workers in the health service. He highlighted the value these workers provide to the NHS, stating: “Ten per cent of our doctors, and more than 20,000 NHS nurses, are from another EU country, and we simply could not do without their contribution.”

 

SmartViews: Uber healthcare

June 2016, Pharma Times, Eliot Foster

 

Dr. Eliot Forster discusses how a disruptive model like Uber could impact healthcare and respond to a growing demand for innovative health services. Advances in global electronic connectivity have resulted in patients expecting businesses to deliver faster, better services as well as providing instant feedback. While these advances offer innovative patient solutions, their scope remains limited as they face institutional resistance to change. Consequently, major innovation is likely to come from new suppliers rather than established healthcare providers.

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FMD to carry on despite Brexit

28 June 2016, DDA, Ailsa Colquhoun

 

Plans to implement the European falsified medicines directive (FMD) are expected to continue, despite the UK’s recent decision to leave the European Union.

 

Dispensers, and practices with a wholesaler’s licence have been told to put anti-counterfeit technology in place by early 2019. And, from a letter to stakeholders, it is now clear that manufacturers and licence holders are not expected to pick up the bill for the new FMD dispensary and wholesaler equipment.

 

The Medicines and Healthcare products Regulatory Agency and the Department of Health have confirmed that they “are working to consider how best to transpose the delegated regulation and its flexibilities into UK law.”

 

The DDA, which has also been involved in the development of delegated FMD regulation,  added: “It will largely be a condition of the UK trading with the EU in the future.”

 

Under the expected terms of the FMD, wholesalers and practices will each verify most prescription medicines: wholesalers at the point of receipt (and when returned) and dispensaries at the point of dispensing.

 

The delegated regulation, and the new medicine verification system it lays down, will come into force on 9 February 2019.

 

Further details on the published delegated regulation are available on the MHRA website and from the DDA.  Safety features introduced by the FMD will consist of an anti-tampering device on the outer packaging and a unique identifier within a 2D barcode.

 

Manufacturers have warned that leaving the EU could result in slower access to new medicines. Mike Thompson, chief executive officer of the Association of the British Pharmaceutical Industry, said: “Applications for UK licence would come after the European licence due to the smaller patient population in the UK. EU exit risks the breakdown of international collaboration between scientists, doctors and industry which could slow down access to new drugs for patients in the UK… and a funding gap.”

 

Warwick Smith, director general of the British Generic Manufacturers Association and the British Biosimilars Association, said: “The single European marketing authorisation reduces cost and complexity for manufacturers, facilitating the production and regulation of high quality medicines and their availability to patients.”

 

Brexit: could European Medicines Agency stay in London?

27 June 2016, pharmaphorum, Richard Staines

 

As the UK, Europe and the rest of the world digest the implications of Britain’s decision to leave the European Union, the pharma industry is considering the potential impact on drug regulation in Europe.

 

The European Medicines Agency is based in London, and with more than 600 staff, the EMA is the largest EU organisation based in Britain. It has been based in the UK capital since it first began operations in 1995.

 

Responsible for approving the vast majority of new medicines across Europe, the EMA gives approval for drugs to be marketed across the European Union’s 28 member states, but its approvals are also recognised by European Economic Area (EEA) members Iceland, Liechtenstein and Norway.

 

The EMA relies heavily on the expertise of national regulators to review new drug filings on its behalf – as ‘rapporteur’ or co-rapporteur’ and the UK’s MHRA is one of the leaders in Europe in this role.

 

Although Germany’s pharma trade body has already called for the EMA to be relocated to a large European city, industry leaders have called for the regulatory system to preserved if possible.

 

The EMA will continue with its business as usual in the short term, and has said it is waiting for instructions from the European Commission.

 

Richard Bergstrom, director general at the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing European pharma, has said that the UK could remain within the EU system, via means such as EEA membership.

 

It may take as long as two years before any changes to the EU regulatory system are agreed, a period of uncertainty which will be damaging for the UK and Europe as a whole.

 

“The EMA situation is disruptive but is doable,” said Bergstrom in an interview with pharmaphorum.

 

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI), agreed: “In Europe they have huge respect for the talented group of people working at the MHRA. It is clearly not in anybody’s interests to have two regulatory processes.

 

“We have to be creative and do what is right for British patients and not follow some logic of separation that makes no sense.”

 

Sarah Rickwood, vice president of thought leadership for Europe at IMS Health says there are a number of potential post-Brexit scenarios for European drug regulation.

 

She says the question about the EMA and its location immediately comes into play.

 

One of these is a “no change” where the UK adheres to all EMA regulation, although this could require the UK to sign up to the terms of the European Economic Area in a Norway-style arrangement.

 

One stumbling block to this could be the issue of migration, which was a leading reason for many voters to back the ‘Leave’ campaign.

 

Becoming an EEA member would mean the UK would also have to maintain a commitment to a free movement of labour agreement with Europe – but this would pose problems given that many people voted to leave because of concerns about border control.

 

Other options include a new relationship negotiated between the UK and Europe more akin to that between the EU and Switzerland, which has bilateral trade agreements with Europe, but also has caps on migration.

 

The latter option would be possible if the UK ends up with looser ties to Europe through the European Free Trade Association, World Trade Organisation rules, or an entirely independent relationship.

 

Hunt tells EU staff ‘you are a crucial part of our NHS’

27 June 2016, Health Service Journal, Shaun Lintern

 

EXCLUSIVE: Health secretary Jeremy Hunt has spoken for the first time since the EU referendum result, calling on the country to value the contribution of EU workers in the health service.

 

Mr Hunt told HSJ he wanted to speak directly to the 110,000 EU staff in the health and care sector, telling them: “You do a brilliant job for your patients, you are a crucial part of our NHS, and as a country we value you.

 

Jeremy Hunt told EU staff ‘you do a brilliant job for your patients’

“We all must now do everything we can to ensure our whole workforce feels secure – because that is the only way we’ll ensure we can deliver high quality care for all.”

 

Mr Hunt also said the country must accept the outcome of the referendum and the challenges it had created “whilst a new relationship with Europe is determined”. However, he added that the British people expect “continuity and stability” particularly in relation to their public services and the NHS.

 

Mr Hunt’s comments follow reports that EU workers in the NHS have expressed concerns about the vote last week and there have been isolated reports of staff facing racist abuse.

The health secretary was named as a potential candidate for the leadership of the Conservative Party by The Sunday Times at the weekend, although his odds, according to bookmaker William Hill, were running at 66/1 on Monday.

 

Mr Hunt told HSJ: “On Friday morning, the country woke to the news of a majority vote to leave the European Union.

 

“We must accept that decision and the challenges it brings, not least in the short term whilst a new relationship with Europe is determined. But however they voted, the British people expect continuity and stability in public life – nowhere more so than in terms of our NHS, something we all depend on and the most highly valued and loved public service of all.

 

“That’s why I want to say directly to the 110,000 EU workers in our health and care system – you do a brilliant job for your patients, you are a crucial part of our NHS, and as a country we value you.

 

“Ten per cent of our doctors, and more than 20,000 NHS nurses, are from another EU country, and we simply could not do without their contribution.

 

“As Professor Sir Bruce Keogh rightly said last week, we all must now do everything we can to ensure our whole workforce feels secure – because that is the only way we’ll ensure we can deliver high quality care for all.”

 

SmartViews: Uber healthcare

June 2016, Pharma Times, Eliot Foster

 

With consumers taking ever more interest in their own health, the demand for innovative health services is building. Collating the views of industry experts,Dr Eliot Forsterconsiders how disruptive ‘Uber-thinking’ could impact healthcare

 

Advances in global electronic connectivity – especially the rise of smart devices and the

Internet of Things giving access to information and online services virtually anywhere – have increased pressure on businesses to deliver faster, better services.

 

One clear example of this new thinking is the Uber transportation model, which has revolutionised the taxi market in major cities around the globe by allowing the location of available drivers to be viewed in real time.

 

The advantages of Uber-style services are clear – they are intelligent, standardised and instant. In taxi terms, only vehicles available for hire are shown, a minimum level of service is guaranteed and the network is almost entirely automated. By ensuring a more streamlined operation while reducing overheads, companies are able to provide an extremely rapid and cost-effective service with minimal user input. The resulting popularity can be extremely disruptive to established markets as consumer demand effectively overrides resistance from existing suppliers.

 

Instant feedback

 

The rise of social media means that consumers are accustomed to providing instant feedback – positive or negative – on everything from fast food to public transport to ambulance waiting times. Combined with an increased awareness of the performance of individual hospitals and Trusts through the publication of KPI data, there is continuous community pressure to improve healthcare services. As a result, the clinical sector is far from immune to ‘Uber thinking’ and we are beginning to see novel uses of technology to overcome traditional limitations.

 

One of the earliest and probably best-known examples of technology-driven change in healthcare is the development of home blood-glucose meters for people with diabetes. By allowing patients to monitor their glucose levels – through delivery of real-time, precise and personalised information – the technology has dramatically improved the management of Type 1 diabetes and significantly reduced the burden on hospital and community care providers. Although highly portable glucose monitors have existed for many years, the latest generation of devices take full advantage of technological developments, offering connectivity to wearable devices and smartphones, as well as online databases and communities.

 

Another development gaining traction is the use of remote monitoring technologies, such as wearable heart monitors for post-MI patients, particularly in remote areas without local diagnostic services. Unlike the user-operated glucose monitors, these fully automated devices continuously monitor key health parameters and transmit the data for interpretation and analysis via wireless or mobile networks. Alerts and advice can then be sent back to the patient, enabling potentially life-saving short-term interventions and long-term improvements in both management and survival rates. Key benefits are that medical staff can review data from numerous patients from a central location, reducing resource requirements, and improvements in patient engagement and education, helping to put the patients in control of their own care.

 

What’s next?

 

So far, the scope of these solutions has been limited, mostly streamlining existing pathways and services, and there are several reasons for this, from a lack of education to poor funding for new technologies. However, a major factor is institutional resistance to change; people will not support any new initiative that could lead to their own role becoming redundant.

 

Consequently, as with Uber, major innovation is likely to come from new suppliers rather than established healthcare providers. Working in collaboration with these new players – taking advantage of the services they offer to transform working practices – will provide a unique opportunity to establish new cultures and approaches, as well as gaining valuable experience and insight into the possibilities of digital healthcare without having to develop their own resources using already limited budgets.

 

Outside of patient care, there are a number of opportunities for technology to help match supply and demand, including the use of interim personnel to cover both planned and unplanned staff absences. For example, an Uber-style solution that, for a pre-determined fee, could show the availability of clinical staff directly employed within the same Trust could be more efficient and cost-effective than using external agencies to fill temporary vacancies. The relatively low overheads required for such a system could provide significant savings for the NHS, with the added benefit that these ‘additional’ staff would already be familiar with both the Trust and its practices.

 

The same approach could be applied to recruitment for clinical trials; a central database of local volunteers, with details of their clinical and family histories, could allow research organisations to rapidly recruit cohorts without the need for protracted pre-qualification. Organisations such as MedCity – a collaboration between local government and leading academic centres in London – are already moving in this direction through a ‘low tech’ solution to connect research organisations, biotechs and volunteers, and the rise of digital services will make this process far more streamlined in the future.

 

Whatever form such services take, it is crucial for organisations to make the most of the digital revolution to avoid being left behind.

HDA Media And Political Bulletin – 28 June 2016

From Factory to Pharmacy

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