Select Committee on Health Minutes of Evidence

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 fully investigated.

  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 to Parliament.

  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 factor—perhaps the most critical of all—in 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 bodies—the Joint Committee on Vaccination and Immunisation, the Committee on Safety of Medicines, and the Medicines Control Agency—are not sufficiently independent of the Department of Health, or of each other, to be able to fully and adequately perform a regulatory function.

  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 be established.

  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 PE3 6LL;

    —  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).




  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 regulations states:

    "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.

  377.  Similarly:

    "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 investigated.

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 MP).

  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 promptly resolved;

    —  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 of Health;

    —  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 of information.

  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 arrangements.

  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 verified.


  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.

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Prepared 27 July 1999