What's new to MAP in July

EU Regulation of Medical Device Apps

A mobile app will only need to be CE marked, if it meets the criteria that classes it as a medical device under either the Medical Device Directive (MDD) or the In Vitro Diagnostic Devices Directive (IVDD). This page, which is new to the MAP Europe site, is designed to help subscribers decide whether their app is classed as a medical device and if so, under which directive it will be regulated.

Public Affairs in France and Germany

These sections new to the MAP France and MAP Germany sites outline the executive and legislative powers in each country. There is also a page on each site about the country's attitude towards lobbying and the rules that govern it.

Clinical Studies in France

For investigational devices and for CE marked devices, applications for clinical trial approval in France are made though the centralised, electronic system DEDIM. This page on the MAP France site explains the processes behind gaining ethics and R&D approval in France and explains some of the laws that govern clinical trials.

The National Tariff

This section, new to the MAP UK site explains the payment by results system and its key components; classification, currency and costing. This section also explores the history of the tariff as well as its limitations.

The Five Main Routes to the NHS

This page on the MAP UK site takes a look at the five main routes through which companies can sell their products to the NHS. This section explores the possible advantages and disadvantages of each route in order to provide subcribers with an idea as to which route will best suit their product.

Decision Makers in Germany

There are a number of decision makers in Germany that medical device manufacturers may need to engage with along the road to market access. This section on the Germany site provides information about a number of stakeholders that companies are likely to encounter, as well as detailed pages on the key bodies such as IQWiG, BfArM and the G-BA and their role in the different stages of a product's lifecycle.

July Market Access News

MHRA Guidance on the Re-Manufacture of Single Use Devices

A number of manufacturers who have a CE mark for a re-manufactured single-use device (SUD) want to put them on the market in the UK.

A single-use device is used on an individual patient during a single procedure and then discarded. Single-use devices have to be marked by a symbol on the device or packaging.

Re-manufacturing (of single-use devices) is different to reprocessing and is where a company obtains a CE mark for the re-manufacturing of single-use devices. Prior to placing on the market or putting into service, the device will be cleaned, disinfected and sterilised and be tested against the re-manufacturer’s specifications to ensure the single-use continues to operate safely and as intended. Over the last 3 years, MHRA has conducted a detailed review of re-manufacturers, assessing their technical, regulatory and clinical processes.

Following this review, MHRA has developed a guidance document on the re-manufacture of single use devices and expectations around their use.

Data Security Review Results Published

The CQC review into existing levels of data security across the NHS, as well as Dame Fiona Caldicott’s recommendations in new data security standards for health and social care, have been published today.

Both reports recommend:

leaders of every organisation should demonstrate clear accountability and responsibility for data security, just as they do for clinical and financial matters
internal and external scrutiny of whether the new data standards are being implemented

More specifically, Dame Fiona’s review proposes a new model of how patients are able to opt out of their data being shared for purposes beyond direct care.

The Life Sciences Minister George Freeman has published a written ministerial statement on these reviews:

The Care Quality Commission and National Data Guardian for Health and Care’s Independent Reviews into Data Security, Consent and Opt-Outs.

NHS Technology and Information Modernisation

NHS England and NHS Improvement have announced three key appointments which will help transform how the NHS uses technology and information.

The NHS Chief Clinical Information Officer will be Professor Keith McNeil, the new NHS Chief Information Officer will be Will Smart and Juliet Bauer has been appointed as Director of Digital Experience at NHS England.

EMA Statement on the Outcome of the UK Referendum

The EMA has released a statement on the outcome of the UK Referendum and the relocation of the EMA offices from London. The statement said that:

“the decision on the seat of the Agency will however not be taken by EMA, but will be decided by common agreement among the representatives of the Member States.”

King’s Fund Report on Relationship Between Patients and NHS Professionals

The King’s Fund has published a report on the relationship between patients and NHS professionals.

NICE Guideline on Diagnostic Services

The final scope and equality impact assessment for this NICE guideline have now been published, along with all the stakeholder comments that were received during consultation and NICE's responses to these comments.

National Cancer Patient Experience Survey Results

The National Cancer Patient Experience Survey results have now been published for CCGs and Trusts.

NHS England has published a summary of the national and local results.

Making Health Data Work Better

Professor John Newton who is the National Information Board (NIB) Interim Chair, talks about making health data work better.

In his first annual exchange of letters with the Secretary of State for Health, Professor Newton discussed the robustness of data and how it could be improved.

A Public Affairs Update from MAP MedTech

Ministerial Changes

A number of key issues have arisen in recent days following the ministerial changes made by the new Prime Minister:

George Freeman MP, the Minister for Life Sciences, has been removed from office and is no longer part of the Government. This is a real surprise, given his enthusiastic and knowledgeable support for life sciences, and there seems no justification for it. As a consolation prize, he has been made chair of the Prime Minister’s Policy Board.
At the time of writing, it appears that the position of Minister for Life Sciences no longer exists. If this is correct, his work will be split among other departments.
In the Department of Health, there are three new ministers: Philip Dunne MP is the new Minister of State responsible for Community and Social Care. Nicola Blackwood MP and David Mowat MP are more junior Parliamentary Under Secretaries of State. Their responsibilities, including those for NICE and the pharmaceutical industry, have yet to be announced and this may take a while. It is worth noting that the last two have had a genuine interest in science.
The Office for Life Sciences (OLS) has confirmed that it will be part of the new Department for Business, Energy and Industrial Strategy (the Department for Business, Innovation and Skills having been abolished). Jo Johnson MP is continuing as Minister of State for Universities and Science in the new department, but will have to split his workload with the Department for Education, where he is now also Minister of State for Universities and Science. Whether he or another minister will be responsible for the OLS is not yet known.
The publication of the Accelerated Access Review, already delayed until September due to the referendum result, may be further delayed as the new ministers will want to read the draft and amend it if necessary before signing it off.
One of the last acts by George Freeman was to announce the creation of a Steering Group, to be chaired by GSK and AZ, to address regulatory and other problems facing the pharmaceutical industry following the decision to leave the EU. This decision and the group’s membership and terms of reference, will need to be confirmed by the new ministers.

A number of companies may want to consider the above points and how they might affect their Public Affairs strategy.

Life Sciences - Changing Departmental Responsibilities

The life sciences sector in the new Government is in a difficult state after the loss of George Freeman, the Minister for Life Sciences. He has not been replaced so his duties have been split up.

In the Department of Health, responsibility for technology and life sciences innovation has been given to Nicola Blackwood MP, whilst the life sciences industry comes under Lord Prior. It is unclear what exactly this distinction means, but as, in practice, Nicola Blackwood is also responsible for public health, a very important area in its own right, it seems likely that Lord Prior will have the more senior role. Furthermore, he has responsibility for drug spending, which is a crucial element for the life sciences industry. Both are Under-Secretaries of State.

In the new Department for Business, Energy and Industrial Strategy, the Minister responsible for the Office for Life Sciences has yet to be announced.

The future spending on medicines in the NHS is part of a much wider issue. The Chancellor’s Autumn Statement (usually delivered in November or early December) will set out the Government’s position on growth, employment, inflation and the budget deficit in the current and future years. The Prime Minister and the Chancellor are still committed to reducing the budget deficit, even though the targets are expected to be pushed back into the 2020s. Although the Chancellor understands the NHS, having been a Shadow Health Minister in Opposition, there will be limits to what he can do. Even if some new relief is provided, the pressures on the NHS finances will not go away.

Ministers are also aware of the concern expressed by the life sciences industry about the future of science in the UK. Assuming that the industry continues to press its case, this will be among the issues being considered by the Chancellor before he makes his Statement.