1. I am responding to the consultation on behalf of the British Association of
Dermatologists (BAD), via its Access to Medicines Working Group and Clinical
Services Unit.

2-3. The white paper has key proposals about how the integration and innovation of
services will improve health outcomes. However, the need for timely access to
medicines and medical devices is paramount to achieving this aim. It is envisioned that
improvements in outcomes will be reliant on ease of accessing appropriate medicines
and medical devices to help achieve the triple aim of better health and well-being for
everyone, better quality of health for all individuals and sustainable use of NHS
resources. Indeed, access to medicines and medical devices should be embedded in
the White Paper to address how these will be commissioned and also to make sure
there will be access throughout the UK to abolish postcode lotteries.

4-13. The proposals set out the formation of the new Integrated Care Systems (ICS).
These will hopefully help to reduce bureaucracy and improve access locally, helping to
tackle local needs by encouraging integration of the different layers of health and
social care such as primary, intermediate, secondary, and tertiary.
There should be completely separate, clear, and concise protocols for commissioning
of devices; the standards for this should be as rigorous and robust as they are for
commissioning of medicines. At present, there is a significant lack of knowledge about
procurement of devices, especially on artificial intelligence (AI), amongst clinicians and
managers – and a tendency to accept a much lower standard of evidence base before
commissioning which could risk patient safety.

The new ICS will also help to make sure commissioning decisions are made by taking
into account the views of a wide variety of stakeholders. However, at a national level,
this may still lead to difficulties accessing medicines and medical devices in certain
areas due to differing commissioning decisions at local levels. Therefore, an
overarching system to ensure there is flexibility to allow local needs to be taken into
consideration in commissioning by ICS, but also to maintain national standards of
access to medicines and medical devices needed by specific groups of patients.
National formularies could be helpful in this regard, but all too often local formularies
may result in obstructions that prevent patients getting access to the care they need,
leading to increasing bureaucracy for patients and healthcare professionals trying to
access specific medicines and medical devices for their patients with specific
conditions. Integrated primary and secondary care formularies, including a traffic light
system to identify those drugs that 1) are designated for initiated in secondary care
only, 2) can be started in primary care and 3) needing initiation in secondary care but
can be continued in primary care, will help patients access their medication and also
help to get more care delivered in the community preventing unneeded hospital
appointments. However, these should be comparable across the UK and hence there
should not be a large variation in these between areas to prevent problems if a patient
relocated. Indeed, this continued access when relocating should be included as a
statutory duty for the new ICS and should not be disincentivised, e.g. by
altered/removal of tariffs or the need for financial balance.

For licensed and unlicensed medicines and medical devices, access should be at the
point of need, so should be based on a needs’ analysis of local the population and
regularly reassessed to pick up changes in the requirements of medicines and medical
devices locally. However, the routes to get access to specific medicines and medical
devices for those with rare conditions should not be onerous so as to act as a barrier to
prevent patients getting the care they need. Therefore, local commissioning pathways
should be streamlined to help get access in a timely manner. Indeed this was seen
recently with COVID-19 and the need to get specific medications to help manage
patients with severe COVID-19 requiring ITU. There were shortages of medications
and the White Paper should aim to help prevent problems like this from occurring again
in the future.

14-18. To maximise innovation, it is important to involve all stakeholders in the future of
how care is delivered, including research bodies and the life science industries. Whilst
some barriers may constrain innovation, it is important to make sure that there i s
adequate safety assessment for new medications and medical devices such as well
performed clinical trial and post-marketing surveillance, to keep the public safe and
help to pick up new dangers as soon as possible to prevent further harm. However,
there should be mechanisms to quickly assess these to also provide reassurance if the
worries are unfounded.

Current barriers include a lack of recognition of this work when done by NHS clinicians
– difficulties accessing national funding to support this, diff iculties accessing the right
advice from R&D (even in well-established Trusts with a track record for research),
duplication of effort to undertake very similar studies across different disciplines (lack
of cross-talk), unrealistic expectations from Trusts/government about the time taken,
and resources needed to support this to ensure robust research takes place.
Post-market surveillance for devices, and for AI in particular, needs to be considered
separately; with the continual update and improvements of algorithms, the current
strategies used for drugs will not be fit-for-purpose for AI to ensure that safety and
efficacy is maintained over time.

Setting up registries with mandated imputing of information, to make sure important
information is not missed, would be helpful in allowing informed decisions about the
use of medicines or medical devices which are new or where there were concerns.
However, the collaboration should be as wide as possible, including other international
bodies as well as private providers, and a sharing of data would allow for even quicker
safety signals to be picked up as part of post-marketing surveillance.

19-21. The formation of new bodies in the White Paper may lead to more red tape and
rationalising them or having a clear delineation of their individual roles/remits would be
helpful in allowing patients and their healthcare professionals access to medicines and
medical devices when needed. Without this clarity they may prevent rather than help
patients and healthcare professionals get access to what is needed.

22-26. Overall, the White Paper focuses us on the recent threats to our national health
but as well as looking at this, the paper should also be trying to prepare us, as a nation,
for the next (public) health threat. To some extent it does this by the reorganisation of
powers, formation of new bodies, and the ability by the MHRA to set up registries.
However, one of the learning points of COVID-19 is the need to move rapidly to deal
with a threat, mobilising resources for frontline staff, and make sure that new and novel
treatments can be assessed in a timely manner to help protect public health. All of this
was demonstrated by the response to COVID-19 but needs to be built on further.
There also should be wider powers for the MHRA to look at those products that focus
on well-being and also to act on and assess products that are being brought into the
UK without a licence and sold as natural remedies. From examples in the past, some
of these products have had medical ingredients added to them which have not been
declared and should have been licensed, e.g. topical corticosteroids in Wau Wa cream
and Etin Skin Solution. The MHRA should have greater powers to tackle this to protect
patients who would be unaware of the risks from these products.

In addition, MHRA should extend regulation of dermal filler devices, which are often
traded as cosmetic devices. However, these injectable products can have life-ruining
and long-term side effects. The CE mark requires minimal safety or efficacy data, and
the status of these injectable devices should be upgraded to prescription-only. The
same goes for digital apps; many apps claim to be regulated by the MHRA with a CE
class 1 marking and there is no oversight of this category. Furthermore, it is easy to not
even have that if an app classifies themself as for well-being. However, many of these
apps will collect patient data and will provide healthcare advice, and more clarity is
needed.

The paper also needs to do more to safeguard the ability to manufacture medicines or
medical devices in the UK where there is a shortage or difficulty importing in sufficient
quantities. This is important for most medicines that can have occasional difficulties in
supply chains but is especially important if facing another pandemic-level threat.
Ingredients are becoming scarce or more expensive internationally and this means
some medicines are being discontinued. Medicines also may become financially
not-profitable to manufacture due to other factors resulting in high costs but are niche
products for certain patients, e.g. Calmurid for ichthyosis. There should be
mechanisms in place to tackle shortages when they occur or have the ability to
manufacture alternatives to these medications in a timely manner. At present ,
licensing may adversely affect this, and reformulation of a new product will take time,
impacting on patient care. Removing barriers from this process would help to maintain
stocks of important medication and improve access resulting in benefits for patient
health.

Dr Bryan McDonald
Consultant Dermatologist
BAD Assistant Honorary Secretary
Chair, BAD Access To Medicines Working Group
Member, BAD Therapy & Guidelines sub-committee