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Ms Blears: I am happy to acknowledge the contribution of the hon. Member for Lewes (Norman Baker) in pursuing these matters in parliamentary questions and in an Adjournment debate in March 2000. Following that debate, Ministers asked the Committee on Safety of Medicines to start the first of its three reviews on the matter, so the hon. Gentleman certainly played an important role.
I am grateful also to the hon. Member for Oxford, West and Abingdon (Dr. Harris) for confirming his support for the current vaccine programme and the important role that vaccinations play in public health. He is right that openness and clarity on the issue is crucial to public confidence, and that is why I am here today: to set the record straight and to reassure the public about the safety of the manufacturing of vaccines.
The hon. Gentleman asked about the conclusions of the Committee on Safety of Medicines reviews. I can confirm that there were three reviews, one of which was looking at the current vaccines that are available. There was a risk assessment of the components, and the reports looked at the matrix of where materials came from and what kind of materials were used at what stage of the production process. There was a good examination of all the current products that are used.
At the request of Ministers, the committee went on to look at the possibility raised in the Phillips report on BSE as to whether BSE might have emerged earlier than is the accepted case, in the 1970s. The committee was looking at the worst possible scenario. It said that there was no
Clearly, the further we go back, the less documentary evidence is available. In looking at the master seeds that were manufactured in the 1960s, it is difficult to find a paper audit trail to take source material and traceability back to that level. However, the committee asked what the situation would be had BSE been around in the 1970s and what the effect would have been on TSEs in vaccines. That matter is in the full CSM report, which is in the Library.
In terms of the advice given by the MCA to Ministers, I can do no better than say that the advice given by the MCA was contained in the incorrect answers to the parliamentary questions. That was the advice given to Ministers and clearly the parliamentary answers were prepared on the basis of that advice. That is in the public domain.
In terms of the oral polio vaccine withdrawn in October 2000, the two month gap between the MCA being notified and Department of Health of Ministers being informed was criticised in the chief medical officer's report, which, again, is in the Library. This was too long a period for action to be taken and I have set out, in my reply to the hon. Member for North-East Hertfordshire (Mr. Heald), the steps taken with regard to strengthening the advice and the systems at the MCA and the merger with the MDA.
In terms of action against individual manufacturers, I have explained that, where they are going through the process of seeking compliance with European guidelines, the advice is that prosecution would be disproportionate. Clearly, if there is a deliberate and wilful failure to present information, the MCA has a mechanism open to it through the suspension of licences.
The European committee is considering 400 different substances. It is half way through the process, and it will be some months yet before full documentary evidence is available to qualify for what is called the EQDM process. That process is ongoing and we are keen to make sure that we get as many products to comply with the guideline as quickly as we can. I am pleased that the guideline is to be varied to allow the working seeds and working cells to comply. That is a recognition that the science has developed a little faster than the legislation in this area. It is a constantly evolving process.
I am more than happy to discuss with Members the question of a debate. There is a need to make a request to the business managers in the usual way. I am keen that we are open and that we have the fullest disclosure to the public and Members of Parliament about the safety of UK-marketed vaccines. That must be in the public domain and discussed.
Ross Cranston (Dudley, North): I thank my hon. Friend for the frankness of her statement. I remind her that the vaccines victims support group, with which I have had a close relationship since coming to the House, supports the vaccination programme and has nothing but praise for the Government in terms of the way in which they have made up to £100,000 available for parents of children damaged by vaccine. In this area, confidence is crucial. Can she say more about the changes in procedure
Ms Blears: I am grateful to my hon. and learned Friend for his support for the Government's action in relation to vaccine damage payments. We are all too well aware of the tragic nature of the cases involving those families. As he says, confidence in the vaccination programme is crucial. Vaccinations have saved millions of lives throughout the world and continue to do so.
I have outlined some changes in the procedure, organisation and governance of the MCA and the way in which it will perform in future. A decision has been taken to merge the MCA with the MDA. There will be a stronger unit and organisation and that will take account of the increasingly blurred lines between medicines and devices. As technology develops, products are becoming increasingly difficult to distinguish. In addition, we will have the non-executive directors and there will be a rigorous external perspective on the work of the MCA. There will be also be a chairman who will be able to represent the MCA, so that we have a more public presentation of the agency. It is important that there should be transparency so that the public can be confident in the procedures.
I have explained that we want to strengthen the database and the information management of the MCA; again, that issue was raised by the chief medical officer in his report. I can reassure my hon. and learned Friend that that will be done.
Mr. David Tredinnick (Bosworth): The hon. Lady deserves congratulations on doing something very rare for this Governmentcoming to the House to apologise for a mistake. What will she do to reassure the public that these products are safe? One of the greatest health failures of the Government has been their inability to persuade the public that the MMR vaccine is safe. What is she going to do to improve that desperate situation? Can she confirm that despite the Oxford survey showing that anti-oxidants are not necessarily effective in treating heart disease, generally speaking vitamin supplements can be very helpful to the health of the nation?
Ms Blears: The hon. Gentleman is absolutely right that the key issue is to reassure hon. Members and the public about safety and about the rigorous way in which the issues are examined. That is why the three reports in the Libraryfrom the chief medical officer, the Committee on Safety of Medicines and the MCAare important. These reports must be fully available.
I say to my hon. and learned Friend the Member for Dudley, North (Ross Cranston) that the summaries at the beginning of the reports set out the main recommendations, and making those accessible is very important. At all stages of the vaccination programme, Ministers have tried to be as open and honest as possible and have tried to share the advice of the medical experts. The amount of consideration that a range of scientific experts have applied to the vaccination programme has been immense. I am sure that the hon. Member for Bosworth (Mr. Tredinnick) will be aware of the wide range of authorities involved. As I have said, the CSM,
The hon. Gentleman referred to vitamin supplements. I have not had an opportunity to look at the issue, which is clearly of concern to him. I can assure him that all the matters that arise are considered by the Government and by experts in the field.
Mr. Keith Simpson (Mid-Norfolk): I am sure that the Minister and hon. Members will be grateful that the ministerial reaction to this matter came about largely as a consequence of hon. Members raising it in the form of questions and in the course of a debate. That should prove to people outside the House that Parliament often has an effective role.
I want to put two questions to the Minister. First, as a member of the Select Committee on the Environment, Food and Rural Affairs, it is clear to me that there is a read-across between health and agriculture in terms of science, disease and farming. Is the Minister satisfied that there are no other areas where the Department of Health is having to reassess statements or answers to the House concerning major health questions?