HDA Media And Political Bulletin – 16 December 2015

FMD Delegated Act – the letter of the law or the spirit?

Securing Industry, Graham Smith, 15 December 2015

Securing Industry discusses the interpretation of the Falsified Medicines Directive’s current draft, in particular regarding the implementation process. It is argued that the prohibition clause in the text aims to encourage all parts of the supply chain to comply before the deadline of 2019, rather than hinder progress.  National Medicines Verification Organisations (NMVO’s) are also mentioned as a critical tool for success.

 

George Osborne announces start of London NHS devolution

BBC News, 15 December 2015

Chancellor George Osborne signed a devolution deal for London launching five pilot schemes to transfer NHS power to local groups. The plan for a local-led health system was outlined in the Autumn Spending review. Boris Johnson stated that it would contribute to a better management of resources and ensure more responsive services.

The deal was also reported by Health News Business.

 

‘Disappointing’ watchdog will not investigate shortages

C&D, Beth Kennedy, 15 December 2015

Pharmacy Voice has criticised the Competition and Market Authority’s announcement not to investigate further the issue of stock shortages. The association highlighted that pharmacists dealt with stock shortages most weeks. This position was corroborated by Stephen Fishwick, head of communication at the NPA who deplored it caused stress for pharmacists and inconvenience for patients.

 

Parliamentary Coverage

 

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FMD Delegated Act – the letter of the law or the spirit?

Securing Industry, Graham Smith, 15 December 2015

A recent article in this publication highlighted a potential log jam in the implication of the Falsified Medicines Directive. The article, authored by Tim Marsh, is a classic case of interpretation and how intent can mean different things to different people.

For those that did not see the piece the crux was this:

‘The tamper evident packaging technology can be applied before the deadline of the FMD Delegated Act. However, the Unique Identifier should only be placed once there is an operational repository (EMVS) where the relevant identification data can be uploaded. Retroactive implementation of the Unique Identifier and uploading is not permitted.’

There is no doubting the accuracy of the article, it could not be clearer could it? There is a problem on the horizon. Except that this is not the Commission’s intent. This provision has been made to encourage the setting up of an operational repository so as not to impede the work of pharmaceutical manufacturers and the wider supply chain as they progress towards meeting the requirements of the new legislation.

This makes sense as a repository clearly has to be in place and the EU Commission has recognised that this is an area where indirect pressure, or motivation, may need to be applied to speed up decision making.

In addition, the period required for integrating and testing the new authentication system will be extensive and the work intense. With all member states required to comply, the potential for a last minute rush to meet the deadline is real. The Commission understands this and has set this prohibition in to help and not hinder.

Perhaps they have been too subtle and more direct language would have helped understanding. It does not change the fact though that this is a joined up process. For the FMD to work manufacturers must work with others in the process to ensure the deployment of an effective authentication service. They need to use their influence positively to speed up the creation of operational repositories.

So what of the interpretation? The article referenced above rightly states that “manufacturers need a significant amount of time and planning to ensure compliance by the 2019 deadline” but it seems clear to us that the prohibition Issue is intended to motivate action to assist industry rather than hinder their progress. The EU Commission is undoubtedly committed to patient safety and we feel that the Commission has not been given enough credit in the framing of the law and the intended motivations and actions required from those involved in the process of implementing the Falsified Medicines Directive.

This leads us to our point of concern, which is ensuring that National Medicines Verification Organisations (NMVO’s) are set up in each country promptly to facilitate the creation of national databases. This would seem to us to be a better use of resources than being worried about a situation which should not arise.

We are all in this together and we stand shoulder to shoulder with Tim Marsh in his advocacy of dialogue between all stakeholders in the process. We are equally delighted that he is using this platform to discuss possible issues with the roll out of the FMD and so perhaps we should summarise our differing interpretation as an instance where we see that as a glass half full and not a glass half empty.

 

George Osborne announces start of London NHS devolution

BBC News, 15 December 2015

Chancellor George Osborne has signed a health devolution deal for London.

The agreement will see the launch of five pilot schemes designed to transfer power over NHS services from Whitehall to local groups.

It has the backing of Health Secretary Jeremy Hunt, London Clinical Commissioning Groups, NHS England and councils, the Treasury said.

Labour mayoral candidate Sadiq Khan said London could not wait as long as Manchester had for devolved powers.

The five pilot areas include Haringey, Barking and Dagenham with Havering and Redbridge, North Central London – which includes Barnet, Camden, Enfield, Haringey and Islington – as well as Lewisham and Hackney.

Hackney will run a health and social care integration pilot, aiming for full integration of health and social care budgets and joint provision of services. This will also have a particular focus on prevention.

Boris Johnson said it paved the way for a “revolution” in healthcare

The plan for a local-led, integrated health and social care system by 2020 backed by local authorities was outlined in the spending review.

Mr Osborne, who made the earlier announcement at Great Ormond Street Hospital, said it was “another crucial step in our devolution revolution and is the start of us handing over valuable healthcare power to local leaders in London”.

He said it would lead to “better, more joined up healthcare in the capital”.

What devolution could mean for London boroughs in five pilot areas

Haringey said it would try to tackle its “obesity crisis”, above average numbers of people with mental health problems and health inequalities within the borough. It is looking at options such as setting a minimum unit price for alcohol or restrictions on gambling shops

Hospitals and GP surgeries could be sold off in Hackney and north central London boroughs including Barnet, Camden, Enfield, Haringey and Islington. The land would be used for housing and the money raised used locally or to create modern “fit-for-purpose” facilities

Barking and Dagenham hopes to plug a £400m funding gap and tackle preventable hospital admissions for people with chronic diseases, as well as address issues caused by a significant growth in its population of children and over 75-year-olds

Hackney also said funding pressures were putting its health and social care under “immense strain”. It hopes combining its health and social care budgets can “transform its services”. It says its pilot will create incentives for prevention and early intervention, better access to community services and the creation of safe and high quality alternatives to higher cost hospital-based or residential care

Lewisham hopes to get better value for the money spent within health and social care locally by integrating physical and mental health services alongside social care

The Treasury said that as part of the agreement the partners involved had agreed to look at the “vast NHS estate in London and increase incentives for trusts to make better use of property”.

Mr Johnson said: “As we’ve shown through transport, policing and planning, devolution is already working in London and this agreement paves the way for a revolution in how health and social care are delivered across the capital.

“With our city’s population continuing to grow, it is essential that we have a health service better equipped to manage its own resources so that it can become even more responsive to the needs of Londoners.”

It was announced in February that Greater Manchester would obtain full control of its health spending from April 2016.

Mayoral candidate Mr Khan said while he supported giving London more power over health services, the city could not afford to wait as long as Manchester, which was promised control “years ago”.

He said: “We must ensure that the fine print of any devolution proposal works for London, and that the proper management and financial structures are in place.”

 

London devolution deal paves the way for radical NHS transformation

Health Business News, 15 December 2015

The government, NHS and local authorities have signed an agreement to devolve health and care services in London to local commissioners and councils.

Chancellor George Osborne and Health Secretary Jeremy Hunt signed the agreement with ‘London partners’ including all of London’s CCGs, local authorities, the Greater London Authority and national bodies including NHS England, Health Education England, NHS Improvement and Public Health England.

A similar deal was signed in February for Greater Manchester, resulting in a single £6 billion budget for health and social care across the region.

The London agreement was signed on 15 December at the Great Ormond Street Hospital and will begin with five new integration pilots which will be rolled out across the capital. The areas trailing the scheme include: Barking & Dagenham, Havering and Redbridge in north east London, where a new accountable care organisation (ACO) will integrate primary and secondary care and redesign patient pathways with a focus on early intervention and managing chronically ill patients; Lewisham will run a pilot seeking to integrate physical and mental health services alongside social care; Haringey will trial a prevention pilot which will use planning and licensing power to develop new approaches to public health; Hackney will run a health and social care integration pilot, aiming for full integration of health and social care budgets and joint provision of services; Barnet, Camden, Enfield, Haringey and Islington will run an estates pilot testing new approaches to collaboration.

The five pilots will be used to develop new care models that can be used long term, to further devolution of control to local health and civic leaders.

The new plans will look to explore local flexibilities on payment and tariff mechanisms, by testing and developing mechanisms which could see integration of primary care budgets with those of other services.

Osborne said: “Today’s agreement is another crucial step in our devolution revolution and is the start of us handing over valuable healthcare power to local leaders in London.

“This deal means that not only will the people of London have more control over decisions that affect their lives, it will also lead to better, more joined up healthcare in the capital for Londoners.”

Hunt commented: “This exciting new deal will help improve services even further for Londoners. The pilot areas we have announced today will be trailblazers as we move towards a fully integrated health and care service by 2020.

“By empowering more places in the capital to make the best decisions for themselves we will improve patient experience, and help keep people well for longer.”

Mayor of London Boris Johnson said: “This agreement paves the way for a revolution in how health and social care are delivered across the capital. With our city’s population continuing to grow, it is essential that we have a health service better equipped to manage its own resources so that it can become even more responsive to the needs of Londoners.”

NHS England chief executive Simon Stevens said: ‘“Today the NHS and London local government commit to testing better prevention for our children’s health, to new ways of joining up care for older people, and to shared action to free up unused buildings and land to reinvest in the modern primary care that our fast growing city clearly needs.”

From Factory to Pharmacy

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