Memorandum by Mr David Thrower - continued
354. The Parliamentary Ombudsman can in
principle come to the assistance of parents trying to investigate
an adverse outcome to medical treatment, including degeneration
into autism, but it is likely that few parents get this far, and
only a minority of complaints received are actually able to be
355. The Ombudsman cannot question the technical,
medical and scientific judgement of the Department of Health.
However, the administrative actions of the Department are in principle
investigable by him. An MP is not obliged to forward a complaint
to the Ombudsman.
356. The value of the Parliamentary Ombudsman
is therefore limited from the point of view of parents investigating
vaccine safety and similar related issues, because only some of
the complaints are suitable for investigation, and the Ombudsman
is constrained in what he may investigate by the provisions of
the Parliamentary Commissioner Act 1967. He cannot investigate
complaints which are about the merits of discretionary decisions
that are taken without maladministration.
357. Following investigation, departments
may agree to change guidance or working practices. The Ombudsman
may also raise wider issues, for example systemic defects in the
way departments work. If the department concerned does not accept
the Ombudsman's findings, he has the power to make a special report
358. The Ombudsman's investigations of complaints
about the refusal of access to official information during 1997-98
established important points of principle in relation to information
(in this instance from MAFF) that had been previously refused
on the grounds of commercial confidentiality. This could potentially
have implications in relation to the Department of Health.
359. The Ombudsman anticipates that considerable
changes to his jurisdiction will result when the Freedom of Information
Act is passed.
360. It is assumed that very few parents
investigating adverse medical outcomes in relation to their children
will pursue their inquiries by the Parliamentary Ombudsman route.
361. It could be expected that the creation
of a fully independent health regulatory function would reduce
pressure upon the Parliamentary Ombudsman, and if a regulator
was established, the two functions should be readily capable of
complementing each other effectively.
362. Independent regulation for gas, telephones
and rail travel is now well-established, and has been generally
"toughened" with experience. But health is a critical
factorperhaps the most critical of allin determining
quality of life.
363. Where the Department itself is a working
partner in a programme, as it is in the case of immunisation,
it is clearly unacceptable for it to be its own regulator. This
situation has been described by one parent as "having the
fox in charge of the henhouse".
364. The group of other bodiesthe
Joint Committee on Vaccination and Immunisation, the Committee
on Safety of Medicines, and the Medicines Control Agencyare
not sufficiently independent of the Department of Health, or of
each other, to be able to fully and adequately perform a regulatory
365. Because of the importance of their
decisions, and the risk that an error of judgement or of methodology
by one body will not be sufficiently strongly challenged by the
others, it is considered vital than an independent "Office
of the Health Regulator", or "OFHEALTH", should
366. This could also take over the existing
functions of the Health Ombudsman, and would of course complement
the work of the Parliamentary Ombudsman. Any regulator would need
the benefits of the Freedom of Information Act to be fully effective.
367. Suggested recommendations for action
in relation to this issue have been covered in previous sections.
368. The Citizens' Charter covers responses
from the Department of Health. It is suggested here that most
straightforward letters are answered very promptly, leaving the
proportion of more complex letters to accumulate severe delays.
369. This could enable overall departmental
targets for responses to be addressed, but would not record the
severity of the delays for the remainder. This may be a serious
failing of the way the Charter target system monitors the Department.
370. There are now several leading-edge
parents' groups that provide information and support. The groups
emphasise that they are not campaigning against vaccination, but
are endeavouring to support parents investigating suspected damage.
The most useful in my personal experience have been:
Justice Awareness and Basic Support
(JABS), 1 Gawsworth Road, Golborne, Warrington, Cheshire WA3 3RF;
AIA, 11 Larkfields, Logthorpe, Peterborough
The Informed Parent, PO Box 870,
Harrow, Middlesex HA3 7UW;
National Vaccine Information Centre,
512 West Maple Avenue, 206, Vienna, VA 22180, United States.
371. The parents' groups are assuming an
increasingly-pivotal role. They are funded entirely by the parents
themselves and by other donations, and are single-minded in their
search for answers. They are an essential part of the network
of advice for parents. The quality of the information they disseminate,
and the precise nature of the information itself, is frequently
at complete variance with that provided by the Department of Health.
The Internet is revolutionising communication between parents.
372. The Department of Health seems hostile
to parents' groups that do not share its viewpoint that there
is no link between vaccination and autism. For example, it dismisses
the JABS parents' group, which has compiled data on cases of children
believed to have been damaged and gives support and advice to
parents investigating their child's damage, as:
". . . an immunisation pressure group"
(source: letter of Department of Health of 14 November 1997).
OBLIGATIONS RELATING TO DISCLOSURE OF INFORMATION
373. Personal and anecdotal evidence points
to a high rate of lack of completeness of child health records.
In the example of my son:
the clinic responsible failed to
record the batch number of his monovalent measles vaccine (thereby
making it impossible to trace the manufacturer);
the supply records for the above,
supposedly microfilmed by a contractor on behalf of the Health
Authority, could not be traced.
374. The starting point is the NHS (General
Medical Services) Regulations. Paragraph 36 to schedule 2 of the
"A doctor shall (a) keep adequate records
of the illnesses and treatments of his patients". There is
no definition of what constitutes an adequate record for these
purposes, and the content is down to the clinical judgement of
the GP" (source: letter of 27 July 1998 from Tessa Jowell,
Minister of State, to Helen Southworth MP).
375. Clearly, this failure to be more specific
leaves the opportunity for a GP to fail to record a vaccine batch
number. If and when this is needed for investigative purposes,
a GP can still claim that it was not specifically required for
them to note it. This makes investigation by parents extremely
difficult from the outset.
376. The fact that the requirement to keep
records under paragraph 36 is a legal requirement appears to be
therefore of litle practical value in this instance. A patient
can complain via the NHS Complaints Procedure, or can complain
to the General Medical Council, but it is the information that
the parent of a child is seeking, not the opportunity to lodge
complaints that in themselves will not produce the missing data.
"All NHS records are public records under
ther temrs of the Public Records Act and all NHS bodies are accountable
for records management within their organisation. They have a
duty to make arrangements for the safe keeping of those records
. . . for medical purposes, including possible use in litigation".
(source as above).
378. Again, these provisions are useful
back-up, though one suspects they are seldom tested to the limit,
but do not in themselves ensure that for example vaccine supply
contract records are kept. If advances in scientific research
throw new light upon a child's condition, but the records have
meanwhile been destroyed, or simply lost, then a patient cannot
begin possible legal proceedings, nor have their case properly
Mismatch in Preservation of Records
379. If child patient records must be kept
until the patient's 25th birthday (as is the case), then it is
not clear why batch numbers are sometimes not recorded (at the
discretion of a GP, apparently) and why a Health Authority/Trust
does not have to maintain records of supplies of vaccines (or
other commodities) for a parallel period.
Failure of the Department to Monitor Compliance
380. The Department does not monitor local
levels of compliance, and this is clearly unsatisfactory. In fact,
the stance of the Department is one of aloofness:
"The Department does not monitor local records;
does not define what constitutes an adequate record, and cannot
comment on individual cases of lost records" (source: letter
of 1 February 1999 from Minister of State to Helen Southworth
381. Issues for Discussion:
do the legal requirements to maintain
child health records have sufficient practical clarity to have
any tangible benefit?
how could their usefulness be improved?
should it be a specific legal requirement
to record vaccine batch numbers on each child's card?
should the department of Health maintain
supply records for the same length of time as is required for
child health records, 25 years?
how should local compliance in record
keeping be properly monitored?
should central Departmental compliance
also be independently monitored?
382. Suggested Recommendations for Action:
clarify the practical implications
of the requirement to keep child records for 25 years, and make
it clear who takes legal action against whom in the event of non-compliance;
make the recording of batch numbers
a legal requirement;
computerisation of health records
should make it possible for a patient to have a duplicated copy
of their health record, and this should be implemented and regularly
updated (at least annually) so that errors and omissions can be
the Department of Health, which now
keeps vaccine supply records, should be made to maintain these
for 25 years, and deposit a duplicate set of records with the
Public Records Office;
local compliance in keeping accurate
health records should be monitored for compliance by the Department
monitoring should be subject to independent
random audit by a newly-created Health Regulator.
383. Responses from the pharmaceuticals
industry are generally very slow (sometimes no response being
received at all), and are circumspect in the extreme in the release
384. An example of recent reply is that
from Medeva Pharma, formerly Evans Medical, dated 22 April 1999,
in response to a letter seeking information of how many shots
there are in a batch:
"We have been looking into your request
for information regarding the number of doses in batches of monovalent
measles vaccine and in batches of MMR. You will appreciate that
such information is confidential and I have been asked to clarify
why the information is being requested . . . You will be aware
that we are prevented from entering into direct discussion with
individuals regarding treatment . . .".
385. This question had previously been raised
with the Health Minister, who had responded by stating that the
information was held by the vaccine manufacturers.
386. It is also not clear why vaccine manufacturers
only have to keep records of supplies of vaccine for only five
to six years. At present it is a requirement of European medicines
legislation that manufacturers maintain information on batch and
quantity details of their products for five years from the date
when the manufacturer or assembly of the relevant batch occurred,
or until a year after the expiry date whichever is the longer.
At present, parents approaching a manufacturer more than five
or six years from the date of immunisation are simply told that
the records have been destroyed.
387. Clearly it is in the narrow legal/financial
interests of manufacturers to destroy records at the earliest
legal opportunity. This is profoundly unsatisfactory from the
point of view of a damaged child.
388. The Department of Health took on the
central supply of vaccines for the childhood immunisation programme,
and has systems in place to record the details of vaccine supply.
However, it is not clear how long records will be kept (the Department
has been directly questioned on this, without result), nor whether
such information will be accessible to parents.
389. It would also be desirable for greater
transparency in these arrangements, in terms of which manufacturers
offered to supply specific vaccines, which one(s) was/were chosen,
and the reasons why, together with the previous safety record
of each selected vaccine make. Such information should be available
to any patient that requests it.
390. Greater transparency would presumably
also be beneficial in terms of the Department's own tendering
391. Issues for Discussion:
should manufacturers be obliged to
respond promptly to patient enquiries, and to provide all reasonable
information. Could this be a condition of tendering for contracts
to supply vaccines?
how should compliance with the above,
if adopted, be monitored?
should the period of manufacturers
maintaining records be lengthened?
392. Suggested Recommendations For Action:
manufacturers should be obliged as
a condition of tendering to sign up to a Code of Practice for
responding to enquiries from patients/families;
compliance with the above should
be monitored by a regulator;
retention of supply records by manufacturers
should also be extended, from the present six, to25 years;
again, compliance should be independently
393. It is hoped that the Committee will
be able to make recommendations in relation to access to information.
At present, parents' investigation of the adverse consequences
of vaccination is seriously hampered by the secrecy surounding
the subject. For example;
"Information regarding the cancellation
of product licences is commercially confidential. The recommendations
of the Committee on Safety of Medicines are confidential"
(Parliamentary Written Answer 2313 of 1997).
394. The outcome of the Freedom of Information
Bill may or may not alter this situation. Parents are not optimistic.
At present, the balance of advantage in terms of secrecy lies
very much in the favour of the manufacturers of vaccines, and
the Department of Health, Committee on Safety of Medicines, and
Joint Committee on Vaccination and Immunisation, and against the
interests of children believed to have been damaged by vaccines.