Letter from the Lord Warner, Parliamentary
Under Secretary of State, Department of Health to the Chairman
of the Committee (PI 1C)
You will recall that when I gave evidence to
the above inquiry on 3 February I agreed to provide you with extra
information on a number of areas, and I am now writing with this
additional material.
MHRA FUNDING
During the session, Dr Richard Taylor asked
about comparisons of funding of regulation of medicines prior
to the establishment of the Medicines Control Agency (MCA) in
1989-90, and the current arrangements. I should first like to
clarify one point that may not have been clear during the evidence
session. In the UK industry has always paid some level of fees
towards the regulation of medicines, but before the MCA received
Trading Fund status in 1993 this was supplemented by Government
funding.
Prior to 1989-90 medicines were regulated by
the Medicines Division of the Department of Health and Social
Security. In 1987, the then ministers commissioned a review of
licensing in the UK. The report from that review showed that the
Medicines Division received its funding from two sources:
— 62% from receipts from pharmaceutical
companies, of which 89% came from charges on company turnover
and 11% from licence application fees; and
— 38% from the Department of Health.
The report noted the growing increase in numbers
of applications for licences and the complexity of such applications.
It also noted the increasing delays which were denying patients
access to medicines and also damaging companies commercial interests.
For example, in 1987, the median time taken to grant a licence
for an established drug substance which was reviewed by the Committee
on Safety of Medicines was 25 months. To resolve issues such as
those highlighted in the report the authors made a number of recommendations,
not least the move to a funding regime based entirely on fees
related to the services provided. This was put into effect when
the MCA was given Trading Fund status in 1993.
The Medicines Division budget in 1986-87 was
some £9 million (with receipts from the pharmaceutical industry
amounting to some £5.7 million). In 2003-04 the Agency's
medicines operation had a budget of some £46 million, which
was fully funded by user fees.
SIMVASTAIN
I promised to let you have information on the
decision making around simvastatin, and this is in the attachment
to this letter.
MERSEYSIDE STUDY
ON ADRS
Dr Taylor also asked some specific questions
about the Merseyside study which looked at adverse drug reactions
(ADRs). This study was funded by the MHRA, and looked at admissions
to two general hospitals in Merseyside. It excluded patients under
16 years of age and women presenting with obstetric or gynaecological
complaints.
There were 1,225 admissions related to an ADR
out of 18,820 patients, accounting for approximately 4% of hospital
bed capacity. ADRs were responsible for the death of 0.15% of
all the patients admitted. This study estimated that that the
annual cost to the NHS in 2002 of hospital admissions for adverse
drug reactions was £466 million. This is based on the average
cost of £228 per medical bed day (data from Institute of
Public Finance). The estimate of costs to the NHS does not take
into account the bed days saved through the beneficial effects
of the medicines.
The study concluded that most ADRs were predictable
from the known pharmacology of the drugs and many represented
known interactions which were therefore likely to be preventable.
The study did not evaluate the burden caused
by ADRs occurring whilst patients are in hospital or ADRs occurring
in primary care that do not result in hospital admission, and
therefore costs to Primary Care Trusts (PCTs) and costs related
to time off work are not known.
SEROXAT/SSRIS
Dr June Raine agreed to let John Austin have
a concise note on the report into the safety of selective serotonin
reuptake inhibitors (SSRIs). Seroxat was the first SSRI to be
considered in detail by the Committee on Safety of Medicines'
Expert Working Group on the safety of SSRIs in the context of
a Europe-wide review. The Working Group used three separate approaches
to analyse the data. The marketing authorisation (MA) holder provided
analyses in response to specific questions. Each original clinical
trial study report was then evaluated to confirm the consistency
and completeness of the MA holder analysis. Finally the Agency
conducted a systematic review of the adult clinical trial data
on seroxat, going to the level of individual patient data. All
three approaches produced the same results ie there was no strong
evidence of an increased risk of suicidal events for adults patients
exposed to seroxat compared with placebo, although it was not
possible to rule out an increased risk. There was no evidence
to suggest an increased risk compared with comparator products.
Full details of the analyses of clinical trial
data undertaken and the results are available on pages 75 to 83
of the report of the Expert Working Group which is available on
the MHRA website.
"ME TOOS"
AND REGULATION
I agreed to let Dr Taylor have some evidence
where the first in a class has not always proved the most effective
for patients. The issue of "me toos" involves balancing
the conflicting priorities of the innovative pharmaceutical industry,
desirable clinical outcomes and individual patients' needs. It
would be wrong to start from the point of view that "me toos"
do not represent any form of clinical advance. There are differences
between products that might be "me toos" in terms of
safety and possibly in efficacy. Additionally, interactions between
the drug and other medicines might be different. A good example
is the class of beta-blockers where the first in class was indicated
for hypertension and angina. The second and subsequent members
in the class allow once daily dosing and more selectivity in action.
In particular, later beta-blockers have been shown in large trials
to reduce mortality after heart attack (secondary prevention)
for which they are now routinely given.
Furthermore, seeking to address issues such
as clinical or cost effectiveness of "me toos" through
the legislation which underpins the regulatory system is likely
to be challenged in the courts as the current system is based
on the evaluation of the safety, quality and efficacy of medicinal
products. The legislation cannot be used to restrict the commercial
freedom of the innovative industry (or any other sector of the
pharmaceutical industry).
However, there are other regulatory tools at
our disposal which we can use to encourage the development of
drugs where there is a clearly defined clinical need. For example,
the EC Orphan Drugs Regulation (Reg (EC) No 141/2000) has clearly
defined criteria for designation with Orphan Drugs status (the
prevalence of the (medical) condition must be less than five per
10,000 of the EU population) and incentives for innovators (additional
marketing exclusivity, free access to scientific advice). Similar
provisions will apply in the forthcoming EU legislation on paediatric
medicines and the UK is also currently implementing its own strategy
(consisting of regulatory incentives, information to prescribers
and coordination of research to encourage industry to develop
paediatric indications for its products.
Such regulatory action as we can take to encourage
innovation must be balanced with information to prescribers from
the local and national bodies I described in my evidence. Initiatives
such as the UK Clinical Trials Collaboration which I have asked
to organise a "Futures Forum" to advise Ministers on
priority areas for innovation in healthcare intervention.
CHARITIES COMMISSION
I agreed to look into whether the issue of pharmaceutical
companies funding patient organisations has been raised with the
Charity Commission. I have done this and the Commission advises
that it does not believe this issue has been raised with them
as a policy matter before.
However, the Commission provides advice and
guidance for many thousands of cases each year across a wide range
of issues. It is possible that this issue may have been raised
on an individual case level. Advice would have been given in the
context of the specifics and merits of the individual cases.
Whilst the Charity Commission has not produced
guidance that specifically addresses the issue of voluntary organisations
accepting funding from industry, other Charity Commission guidance
dealing with Trustee responsibility and duty of care to their
charity; the independence of charities; and guidance relating
to ethical investment sets out general principles which are applicable.
In summary, this guidance covers principles such as the need to
have a clear policy, and the need to act in the best interests
of the charity and its beneficiaries—weighing up both financial
and reputational considerations.
The Charity Commission works closely with the
Institute of Fund Raising's Standards Committee on fund raising
issues. The Institute has published two codes of practice that
are relevant in this context:
— The Acceptance and Refusal of
Donations; and
— Charities Working with Business.
Crucially, it is the duty of Trustees of the
charity to determine whether it is in the charity's best interest
to accept a donation from a source that could, or could be perceived
to, compromise the charity's independence.
The Charity Commission is currently considering
whether there is a need to draw together the range of inferred
guidance in this area into a more accessible format. This could
result in a published set of principles by Spring 2005.
I hope that this addresses the specific points
raised by the Committee.
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