HDA UK Media And Political Bulletin – 9 March 2017

Media Summary

Spring Budget: What it means for STPs, social care, A&E and devolution

HSJ, Rebecca Thomas, 8 March 2017

Philip Hammond announced in the Spring Budget that funding would be injected into the “most advanced” STPs, upgrading A&E departments and social care. The chancellor announced £325m of new capital funding to support the “strongest” Sustainability and Transformation Plans (STPs). However, some have described this increase as modest, considering the significant capital requirements set out in STP plans. Agreements will soon be laid out for the new London devolution deal, and it is thought that NHS organisations will have no formal influence over how the new social care funding is spent, but that a “tight accountability framework” will be introduced in 2018-19.

BIA CEO Steve Bates responds to the Budget

UK BioIndustry Association, 8 March 2017

Responding to the Spring Budget, BIA CEO Steve Bates praised the focus on investment in biotechnology and skills. He also referenced the BIA’s policy proposals such as Citizens’ Innovation Funds – said to create opportunities for middle-earners to invest in new areas of technology.

New Green guide, MHRA

Dispensing Doctors, Ailsa Colquhoun, 9 March 2017

MHRA ‘orange’ and ‘green’ guides have been revised and updated. The Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors) contains information and legislation on the manufacture and distribution of human medicines. The tenth edition of the Green Guide includes new sections, such as the guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use, matters relating to unlicensed medicines, EU regulation on safety features for medicines, and data integrity.

Parliamentary Coverage

House of Commons, Written Answers, Wednesday 8 March 2017

Mr Jim Cunningham:

What recent assessment he has made of the adequacy of regulation for online doctor services.

Department of Health

Nicola Blackwood, MP:

Online medical services in England are required to register with the Care Quality Commission (CQC) and to meet a set of registration requirements around safety and quality and are further regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) for prescribing purposes.

The MHRA is responsible for the regulation of all medicines available in the United Kingdom. There are legal controls on the retail sale, supply and advertising of medicines which are set out in the Human Medicines Regulations 2012.

The Department monitors the CQC’s financial and operational performance and risks at a general and strategic level through regular formal accountability meetings.

Full Coverage

Spring Budget: What it means for STPs, social care, A&E and devolution

HSJ, Rebecca Thomas, 8 March 2017

In his first budget as chancellor, Philip Hammond announced funding for the “most advanced” STPs, upgrading A&E departments and social care.

£2bn for social care

Mr Hammond’s budget included a commitment to inject £2bn into adult social care spending over the next three years, with £1bn available in 2017-18.

The chancellor pledged £2bn for social care

HSJ understands NHS organisations will have no formal influence over how the new social care funding is spent in the next financial year, but that a “tight accountability framework” will be introduced in 2018-19.

A very senior NHS source said hospitals needed to be “quite lippy” about what was required to deliver reduced delayed transfers of care, adding that the funds were enough to “free up 2,000 to 3,000 beds”.

Capital for sustainability and transformation plans

The chancellor announced £325m of new capital funding to support the “strongest” STPs.

Mr Hammond said the investment will be spread over three years, with further funding expected to be announced in the autumn budget for more STPs.

However, the increase has been described as “very modest” by experts, considering the significant capital requirements set out in STP documents.

£100m to reform A&E

Capital investment of £100m specifically for accident and emergency departments was also announced.

Luton and Dunstable Hospital NHS Foundation Trust

Trusts will copy Luton and Dunstable’s A&E model

The money is expected to put an urgent treatment centre based on the model of Luton and Dunstable University Hospital Foundation Trust in every A&E in England. HSJ understands equivalents, accounting for local differences, will be permitted.

Mr Hammond said the money “will enable trusts to invest in measures to help manage demand on A&E services”, and he gave the example of “onsite GP facilities”.

New London devolution deal

Details of a second government deal to devolve further health powers in London are to be agreed imminently.

It was announced that a new memorandum of understanding on health in the capital will be agreed next week.

It will “cement progress made to date and support London’s future plans for preventing ill-health”, according to a London devolution agreement published today.

The mayor’s office said the MoU will outline how devolution will “lead to better services that meet the needs of local communities”.

BIA CEO Steve Bates responds to the Budget

UK BioIndustry Association, 8 March 2017

Responding to the Budget announcement by Chancellor Philip Hammond, BIA CEO Steve Bates said:

“The Chancellor is right to focus on keeping the UK at the cutting edge of the global economy by investing in biotechnology and skills. The £270 million to keep the UK at the forefront of disruptive technologies like biotech, gives us a real opportunity to lead the world in new industries such as advanced therapy manufacturing – highly specialised production techniques that allow us to use cells and genes to treat a wide range of diseases from cancer to dementia.

“The Chancellor also announced £90 million for 1,000 PhD places in Science, Engineering, Technology and Maths (STEM) subjects and £200 million to support new fellowships for early and mid-career researchers, in areas identified as important to the industrial strategy (including biotechnology and medicines manufacturing); £50 million of this will be for programmes to attract “top global talent”. Industry must be involved in the design and delivery of training to ensure these investments properly allow the UK to stay at the cutting edge of the global economy.

“The review of R&D tax credits provided an opportunity to enhance the system to put it head and shoulders above other highly-competitive regimes, such as Belgium and France. It’s a shame the government hasn’t taken that opportunity but we are pleased that it listened to the BIA’s call to reduce the admin burden for businesses claiming R&D tax reliefs.”

What else would we liked to have seen

“The BIA has put forward a range of policy proposals that would increase private investment in biotechnology at minimal cost to the public purse, such as Citizens’ Innovation Funds that will open up opportunities for middle-earners to invest in exciting areas of technology.

“The BIA had called for the government to enhance the R&D tax credit scheme to allow companies to claim relief on investments in experimental and manufacturing equipment and the purchase of data for use in R&D. Medical data is as essential to modern drugs research as chemicals and clinical trials so it is a real missed opportunity not to address this discrepancy in the current system.”

New Green guide, MHRA

Dispensing Doctors, Ailsa Colquhoun, 9 March 2017

MHRA ‘orange’ and ‘green’ guides have been revised and updated.

The Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors), now in its tenth edition, contains information and legislation relating to the manufacture and distribution of human medicines.

The Green Guide (Rules and Guidance for Pharmaceutical Distributors) reproduces all the elements of the new orange’guide that are relevant to distributors, such as pharmacy owner GPs.

This tenth edition of the green guide includes new sections on:

• the guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)

• matters relating to unlicensed medicines

• sourcing and exporting medicinal products – non-EEA countries

• data integrity

• the EU regulation on safety features for medicines

It includes revised sections on:

• qualification of suppliers and customers

• controls on certain medicinal products

• parallel importation and parallel distribution

• the application and inspection process for new licences: “what to expect”

• updated UK legislation

• temperature control and monitoring.

New orange guide content includes:

• qualification of suppliers and customers

• parallel importation and parallel distribution

• temperature control and monitoring

• UK legislation

• unlicensed medicines

New MHRA sections on:

• GMP for excipients

• guidance on revised Annex 16 of GMP

• data Integrity definitions and guidance for industry

New commission guidance on:

• principles and guidelines of GMP for active substances

• principles of GDP of active substances

• setting health based exposure limits

• formalised risk assessment for ascertaining the appropriate GMP for excipients.

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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