The Scottish Government

1. The combined measles, mumps and rubella (MMR) vaccines was introduced into the UK childhood immunisation programme in 1988. However, speculation has surrounded MMR because of hypothesised connections to inflammatory bowel disease and autism, with a minority of parents in Scotland (now 12%) declining to have their children immunised by the age of two years. There have been calls for a change in policy to allow parents to choose between MMR and single vaccines.

2. In 2001 the Scottish Parliament's Health and Community Care Committee (HCCC) published a report on MMR which stated that "on the basis of currently available evidence, there is no proven scientific link between the MMR vaccine and autism or Crohn's disease and therefore the Committee has no reason to doubt the safety of MMR. The Committee does not recommend any change in the current immunisation programme at this time." The Committee also suggested establishing an Expert Group to consider questions underpinning parents' concerns.

3. In June 2001, the Scottish Executive agreed to establish an Expert Group "to consider the matters raised by HCCC relating to immunisation against measles, mumps and rubella, with particular reference to:
a) describing the consequences of pursuing an alternative vaccination policy to MMR;
b) reviewing evidence on the apparent rise in the incidence of autism, taking account of the (then) current work of Medical Research Council;
c) describing the process of vaccine testing and the monitoring of adverse effects; and
d) in all its work, having regard to the role and remit of the Joint Committee on Vaccination and Immunisation, the Committee on Safety of Medicines and the Medicines Control Agency".

4. The report of MMR Expert Group was published on 30 ^th April 2002 ( http://www.show.scot.nhs.uk/mmrexpertgroup/). It:

5. The Scottish Executive immediately accepted, in principle, the recommendations relevant to its statutory functions, pending discussion with UK Government Departments and other bodies, and publication of this more detailed response. The Executive also stated that there are no plans to change current immunisation policy, given that the MMR Expert Group, the HCCC and expert opinion across the world confirm that MMR remains the safest and most effective way to protect children against measles mumps and rubella. That remains the case.

6. This document sets out the formal response of the Scottish Executive Health Department, the Joint Committee on Vaccination and Immunisation (JCVI), the Committee on Safety of Medicines (CSM), and the Medicines Control Agency (MCA) to the recommendations set out in the report of the MMR Expert Group. It also takes account of comments from Health Departments across the UK. The following chapter lists each recommendation, and describes what action has been (or is being) taken as a consequence.

7. The Scottish Executive is grateful to the Chairman and members of the MMR Expert Group for producing a comprehensive and very valuable report, and the contribution of JCVI, CSM, MCA and the Health Departments in England, Wales, and Northern Ireland, to this response.

8. This chapter addresses the detailed recommendations made by the MMR Expert Group, and what action has been (or is being) taken as a consequence.

9. The Scottish Executive and the Medical Research Council welcome the Expert Group's endorsement of the conclusions and recommendations of the MRC Review of Autism Research: Epidemiology and Causes.

10. The Scottish Executive and the Medical Research Council are developing a joint-funded research programme based on the agenda outlined in the final chapter of the MRC Review of Autism Research. It is worth pointing out that, whilst the remit of that Review was focussed on epidemiology and causes, the proposed research strategy, included the consideration of the design and evaluation of interventions, key areas that currently lack a strong evidence base.

11. The Medical Research Council will continue to maintain its portfolio of high quality research on autistic spectrum disorders, through its normal funding schemes, with established autism researchers being able to compete successfully for support alongside all other calls on MRC's resources. An additional 2.75 million will be used primarily to support proposals that are targeted to areas highlighted in the recent MRC Review where research evidence is lacking. That total combines the 2.5 million that was given to the Medical Research Council by the Department of Health in England in February 2002 and 0.25 million from the Chief Scientist Office of the Scottish Executive Health Department.

12. A Steering Group has been established by the Medical Research Council, to guide the implementation of a strategy to develop this research programme on ASDs. The members are:

• Professor Carol Dezateux (Institute of Child Health) - Chair

• Professor Diana Elbourne (Institute of Education)

• Professor Stephen Evans (London School of Hygiene and Tropical Medicine)

• Professor Derek Jewell (University of Oxford)

• Mrs Elaine Kay (Disability Law Service - lay member)

• Mrs Helen Millar (MRC Consumer Liaison Group - lay member)

• Professor Trevor Robbins (University of Cambridge)

13. The Scottish Executive and the Medical Research Council acknowledge the importance of international collaboration in ASD research, and have asked the Steering Group to take appropriate account of this in their work.

14. The Executive welcomes the Expert Group's recommendation, which builds on the foundation laid by the Public Health Institute of Scotland's (PHIS) Autistic Spectrum Disorders Needs Assessment Report published earlier this year. That Report has a key role to play in shaping the strategic direction of services for people with autistic spectrum disorders.

15. The MMR Expert Group report rightly focuses on the need for improvements in the range and quality of services for those affected by autistic spectrum disorders. The Executive recognises the importance of appropriate services to support individuals affected by autistic spectrum disorders, and their families and carers.

16. The Group recommends that the Executive should consult widely, in order to publish a firm timetable for addressing all the detailed recommendations set out in the PHIS Report. The Executive proposes to deliver this through the Working Group established by PHIS for the development of its Autistic Spectrum Disorders Needs Assessment Report. The Group is continuing to meet, and its members cover a strong range of autism interests. The Executive believes that to proceed by working with the Group will allow early progress, with an emphasis on action.

17. The first such meeting took place on 24 June 2002, and provided an opportunity to begin discussion on the PHIS report, particularly on priorities and timeframes. A further meeting of the Group is planned in early November. In the meantime the Executive will be taking forward action on recommendations in the PHIS Report.

18. One question that has arisen in relation to the recommendations in The same as you? review of services for people with learning disabilities is whether or not its recommendations include people with autistic spectrum disorders but without a learning disability. The Executive has confirmed that people with autistic spectrum disorders are included in The same as you? recommendations , even if they do not have a learning disability.

19. Turning to the different aspects of recommendation c, the Executive's response is as follows:

20. Experts on autism agree that treatment for autistic children should preferably be begun early. They advise that children with autism do not respond best to conventional medical treatment but rather to a long-term combination of psychological and educational inputs.

21. The National Initiative on Autism: Screening and Assessment (NIASA) is looking at issues around screening, diagnosis and early interventions in autism. It is chaired by Professor Ann Le Couteur, a respected psychiatrist from Newcastle, and funded by the National Autistic Society. It includes representatives of the Royal Colleges of Psychiatrists and Paediatrics and Child Health. Its report is expected later this year.

22. The Scottish Executive is committed to reforming and to improving services across a range of services, and notably in health. Much work is already underway. The Executive wants to see sustainable and long-term improvements in the range and quality of services for those affected by autistic spectrum disorders across Scotland as a whole, working in partnership with local service providers and users. The Scottish Executive will continue to build on that foundation and work towards the ideal described by PHIS.

23. Autistic spectrum disorders are already included in the work being done to implement The same as you?. Its aim is the same as the PHIS Report - to ensure that services are co-ordinated and seamless. Change Funds have been provided to local authorities - 36 million over the three years to 2003-04, and 16 million each year thereafter. While this is for learning disability, individuals with autistic spectrum disorders will benefit too. Local agencies have put in place Partnership in Practice (PiP) agreements. These are plans that show how agencies will work together to implement the recommendations of The same as you?. Every area in Scotland therefore has a clear strategy for implementing The same as you?.

24. The Executive's view, consistent with the PHIS Report, is that early priorities for services must include:

• early assessment

• integrated joint planning

• involving individuals with ASD and their families or representatives, and

• a coherent approach to training and workforce development

25. Professional awareness of autism is improving. There is, of course, more to be done to raise awareness and improve expertise. The National Society for Autism and the Scottish Society for Autism are already involved in general awareness training for education and health authorities, and that is something the Executive wishes to encourage.

26. Local statutory authorities are responsible for ensuring that they have sufficient knowledge of local needs and priorities to inform the pattern of services in their area. The MRC review of autism research provides an authoritative overview of the current state of knowledge on the prevalence and incidence of autism. We are looking carefully at how we can improve data collection on autism.

27. Work is in the early stages to develop a database that includes people with autism, to support better care delivery. This stems from a recommendation of The same as you? review of services for people with learning disabilities, that local authorities, health boards and primary care trusts should set up and maintain local databases. The database will cover autism.

28. The aim is that these agencies have planning and monitoring information, so that they can provide services to those who need them and are aware of future needs in, say, 5 years time. It will also enable agencies to deal with transitions (e.g. from school to adult services) more readily. Monitoring of service delivery and outcomes will be enhanced.

29. The Scottish Executive and the Medical Research Council welcome the MMR Expert Group's recognition of the incidence and prevalence of inflammatory bowel disease (IBD), and the related importance of further research.

30. The Medical Research Council will continue to maintain its portfolio of high quality research into inflammatory bowel disorders, through its normal funding schemes, with established researchers being able to compete successfully for support alongside all other calls on MRC's resources.

31. The Chief Scientist Office (CSO), the part of the Scottish Executive Health Department responsible for encouraging and supporting research to improve both the health of the people in Scotland and the services provided by the NHS, will continue to fund well-designed research on inflammatory bowel disease through its response-mode grant funding scheme. This is widely publicised and well known to the research community in Scotland.

32. The Medicines Control Agency will continue to work closely with other Member States in the European Union in monitoring vaccine safety issues. Through active involvement with the European Committee for Proprietary Medicinal Products' Pharmacovigilance Working Party, the Medicines Control Agency does, and will continue to, work very closely with other European regulatory bodies in monitoring and assessing the safety of vaccines. There is also now a multidisciplinary Vaccines Expert Group set up by the European Agency for the Evaluation of Medicinal Products (EMEA) to consider vaccine issues and the Medicines Control Agency will fully support the remit of this Group.

33. The Yellow Card Scheme is recognised to be one of the best spontaneous reporting schemes in the world in terms of the level of reporting, and has a proven track record in the early detection of new drug safety hazards. The Medicines Control Agency and the Committee on Safety of Medicines continually work to increase the quality and quantity of reports received via the Scheme in order to enhance its effectiveness. The Scheme was recently extended to allow community pharmacists to report Yellow Cards and the MCA is currently evaluating the role that nurses can play in the Scheme. The monitoring of drug safety, including vaccines, does not rely solely on the Yellow Card Scheme and the Medicines Control Agency and the Committee on Safety of Medicines regularly use many other data sources such as formal safety studies, the published medical literature and data from other Regulatory Authorities throughout the world in monitoring the safety of medicines, including vaccines.

34. The launch of a Scottish Regional Monitoring Centre is planned for Autumn 2002 and work is also underway to introduce reporting for health professionals via the Internet.

35.The Executive welcomes the MMR Expert Group's recognition of the importance of accurate and comprehensive recording of immunisation data, and will implement this recommendation primarily by building on an established programme of work to establish a national Scottish Immunisation Recall System. The merger of two existing systems is expected to be completed by the end of November 2002.

36. The Chief Medical Officer for Scotland wrote to NHS Boards in October 2002 highlighting the associated requirement to put in place adequate quality assurance mechanisms to ensure accuracy and completeness of recording of vaccination data. In that letter the Chief Medical Officer also indicated that in November 2003 he would initiate an audit of Boards' response to this recommendation.

37. Both the Committee on Safety of Medicines and the Joint Committee on Vaccination and Immunisation have carefully considered all relevant studies as they have appeared, and have, during the last five years, given specific consideration to problems which might arise in those with inflammatory bowel disease and in those with, for example, family histories of autism. All new information or research specifically relevant to the postulated link between MMR vaccine and autism and inflammatory bowel disease, or relevant to the general safety of the vaccine, is considered in detail. Advice on appropriate action, that may include amendments to the contraindications of MMR vaccine, would be given if considered necessary.

38. The Joint Committee on Vaccination and Immunisation has concluded that neither the occurrence of IBD nor liability to autism pose risks, which should alter childhood immunisation policies.

39. The Committees take the safety of vaccines very seriously, and are committed to ensuring that all new evidence of potential safety issues is quickly reviewed. The Committees keep evidence of vaccine contraindications under review, and will continue to do so.

40. At its meeting on 5 ^th May 2002, the Joint Committee on Vaccination and Immunisation agreed to consider whether, following this recommendation, there was a need to produce core values for the Committee.

41. This matter will be considered at the next meeting of the Committee in November 2002. The intention is that any such principles agreed will be placed on the Committee's website.

42. The Joint Committee on Vaccination and Immunisation has already affirmed and implemented a policy of presenting open minutes (subject to standard concerns over confidentiality in relation to particular matters of commercial or scientific sensitivity, etc.). It is the intention to use these minutes as a means of presenting, inter alia, the views of the Committee on the safety of vaccines in public use.

43. In this context it should be noted that the formal assessment of vaccine safety, both at vaccine introduction into use, and during use, is a matter for the Medicines Control Agency who receive advice from the Committee on Safety of Medicines. The advice of the Committee on Safety of Medicines is made available to the Joint Committee on Vaccination and Immunisation. The minutes of the Committee on Safety of Medicines are also made publicly available (subject to concerns over confidentiality in relation to matters of commercial or scientific sensitivity).

44. Health Departments (in the UK Government and devolved administrations) have confirmed the appointment of a lay member, Mrs Vivienne Parry, to the Joint Committee on Vaccination and Immunisation. Mrs Parry is a freelance writer and broadcaster. She has been a presenter of "Tomorrow's World" and "Panorama". In 1998 she was a Trustee and spokesperson for the Diana Memorial Fund and from 1979-1994 she was National Organiser for Birthright (a women's health charity).

45. The Scottish Executive has long recognised the importance of providing parents with access to the factual information that they require in order to reach an informed and considered view on childhood immunisation generally, and MMR in particular.

46. The Health Education Board for Scotland has produced and disseminated leaflets and posters on:

47. It is recognised good practice to ensure informed consent prior to starting any treatment. This not only involves the provision of factual information but the establishment of a trusting relationship between health professional and patient or parent. This allows questions and concerns to be raised and addressed. The final section of the leaflet for parents MMR - your questions answered advises parents to "ask their GP, health visitor or practice nurse for more information or visit www.hebs.com/mmr or call the NHS Helpline".

48. In addition, in September 2001 the Executive, the Scottish Centre for Infection and Environmental Health and the Health Education Board for Scotland published and disseminated the "MMR Discussion Pack" to health professionals across Scotland.

49. The rationale and purpose of the "MMR Discussion Pack" is best described by the introduction:

50. As such, the Executive welcomes and accepts the Expert Group's recommendation. It is wholly consistent with established policy and practice. The following steps have therefore been taken to continue to improve the level and quality of information available to parents whose children are due to be immunised against measles, mumps and rubella:

• The Chief Medical Officer for Scotland wrote to NHS Boards on 27 ^th April 2002 to confirm that the Executive accepts all the Expert Group's recommendations, and highlight in particular the need to put in place systematic arrangements for providing further advice to parents who, despite discussions with their GP or other health professional, have concerns and questions about MMR or the particular circumstances of their child.

• the Chief Medical Officer for Scotland wrote to NHS Boards in October 2002 to confirm that that all parents should receive a copy of the HEBS leaflet MMR - your questions answered with the invitation to the immunisation clinic and seeking information on current arrangements for providing further advice. The latter will inform further consideration of how best to frame a requirement for systematic arrangements for providing further advice to parents who, despite discussions with their GP or other health professional, have concerns and questions about MMR or the particular circumstances of their child.

• HEBS has commissioned Scottish Health Feedback to undertake an extensive evaluation of both the parents' leaflet MMR - your questions answered and The MMR Discussion Pack. The evaluation has received ethical approval and 5,000 parents and 2,000 health professionals will be surveyed for their opinions on the MMR materials. The results of the evaluation are expected towards the end of 2002 and will be used to develop and enhance the material and support available to both parents and professionals.

51. The Scottish Centre for Infection and Environmental Health (SCIEH), in collaboration with the Department of Statistics and Modelling Science (STAMS), University of Strathclyde, has been undertaking some preliminary research with the aim of developing mathematical models. These might help demonstrate the range of possible outcomes, for the population as a whole, arising out of decisions made by individual parents about vaccination against measles, mumps, and rubella. Initial investigations were presented to a meeting of the MMR Expert Group in October 2001 and, although the work was at an early stage, the Group recognised that, in time, it may help to achieve a better understanding of these public health policy options and their effect on the level of immunity in the population.

52. The Scottish Executive has allocated an additional 100,000 to SCIEH for the development of detailed stochastic models for measles, mumps and rubella. These are based upon existing models from research into measles by Babad et al (1995). This work is expected to yield estimates of the probability of an epidemic occurring at some time over the next 5 to 10 years as a consequence of various vaccination strategies. A limited exercise has already been performed for existing levels of measles population immunity. The new model should extend this work to future possible levels of population immunity, under different assumptions about possible alternative vaccination strategies. It will also be able to provide more information on the probable size and burden to the health service and extend the work to include analysis of mumps and rubella. The model will therefore permit the potential risks associated with any changes in vaccination uptake to be investigated more fully. The time scale for this work is 18 months.