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Mr. Oliver Heald (North-East Hertfordshire): I thank the Minister for an early sight of her statement; it was a most useful quarter of an hour.

The statement is important. We all remember the fears expressed when the polio vaccine was recalled that new variant CJD might have been spread and that something like 100,000 doses of the vaccine had been used in the preceding year. So today's reassurance about the safety of the vaccines is welcome. However, it seems that the advice of the Medicines Control Agency to Ministers was comprehensively inaccurate and led to many UK vaccines breaching European guidance and—perhaps the Minister can confirm this—European law. How did that happen? What steps will she take to ensure that it does not happen again?

We have four concerns: first, that advice to Ministers is accurate; secondly, that the mechanisms by which the authorities are alerted to non-compliance of vaccines with national and international standards is robust; thirdly, that the tendering process is effective and transparent; and fourthly, that the Government's response is speedy and swift when they are alerted to such problems.

Will the Minister publish the guidance that Ministers were given, including the new guidance? Can she confirm whether the Medicines Control Agency licensed products that were not compliant with European guidance, as apparently it was allowed to do, and will she identify which products? Which licence holders were unable to show compliance with the guidance issued in Europe, as set out in her statement? What were the inaccuracies with regard to the switch from UK-derived materials and what expiry dates were wrong? Will she also outline the

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involvement of the company that gave rise to the original concerns—PowderJect—given its dominant position in the UK market and the fact that the company's chief executive is a major donor to the Labour party?

On the particular case of the oral polio vaccine, how did the authorities discover that it was not compliant or that there were concerns about it, and on what date? Did PowderJect inform the authorities, or was it the other way around? When was Medeva made aware of the concerns of the authorities? PowderJect purchased Medeva in September 2000 and the recall occurred just a few weeks later on 20 October 2000. In its press statement, PowderJect said that it

the Medeva oral polio vaccine. Did the authorities alert PowderJect to the concerns about the oral polio vaccine prior to the purchase of the company? What was the lapse of time between the authorities becoming aware of non-compliance and acting to recall the vaccine? What reassurances can the Minister give that the tendering process for vaccines will be transparent and effective in ensuring compliance and safety?

Finally, the speed of the Government's response is crucial. We know that there were concerns that they did not act quickly enough over foot and mouth. What can she say to reassure us that swift and prompt action was taken in this particular case given that it involved human health rather than that of animals, important though that is?

Ms Blears: The guidance available to Ministers from the European guidelines is published and available. A full description is in the report by the Committee on Safety of Medicines, which has been placed in the Library.

On whether the MCA licensed products that did not comply with guidelines, the example of lactose has been brought to my attention. As the necessary risk assessment had been carried out, it was proper for the MCA to do that. Statements were made that it was not possible to license a product that did not comply with the guidelines, but those statements were wrong, hence my correction. In fact, it was possible providing the necessary risk assessment had been carried out. It is important to be aware that in the UK a risk assessment of every vaccine has been carried out and that no risks have been found. That applies equally to lactose products.

The hon. Gentleman asked about licence holders who are unable to comply. At the moment, 26 vaccines are going through the European process. Some of them do not comply because the working seeds and working cells contain UK-derived bovine material. When the guidelines are revised later on in the summer, working seeds and working cells will comply because the guidelines are evolving. Already master seeds and master cells are outwith the guidelines. We anticipate that in the latest revision of the guidelines working seeds and working cells will be compliant. A number of vaccines are simply waiting for that revision to the guideline. Other vaccines require further documentary evidence of the audit trail of their materials before they can be fully compliant. I do not have a list of the individual licence holders who are unable to comply at the moment, but a range of manufacturers and vaccines are in that position because of the vaccines' components.

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PowderJect was in the same position as many other manufacturers because the oral polio vaccine did not comply with guidelines. The legal advice received by the MCA was that while companies were trying to comply and going through the lengthy European process of providing documentary evidence, prosecution for non-compliance would have been a disproportionate step to take. PowderJect was treated no differently from other manufacturers that were in the same position.

On the mechanisms for alerting PowderJect, I am not aware of advice given to it in the way that the hon. Gentleman describes. On 17 August 2000, the company itself, having received an inquiry about the status of the vaccine, notified the MCA that the product had been made using material that had been exposed to UK-derived calf serum. On 18 August, the MCA began to investigate, and in the week commencing 16 October, after two months of investigations, it informed the Department of Health of the matter. Ministers decided, on the precautionary principle, to withdraw the vaccine, and it was recalled from 20 October, so it is clear that swift action was taken on the oral polio vaccine.

As I said, that was a precaution because at the time that the vaccine was withdrawn the European guideline did not have legal effect; that did not begin until March 2001. In October 2000, it had the status only of guidance, so technically there was not an offence or a breach of a legally binding guideline. It is therefore fair to say that Ministers acted very swiftly. The chronology of events is set out in the chief medical officer's report, which is in the Library. That goes into great detail about the various stages at which information was known and about what action was taken. The chief medical officer has confirmed that the correct decision was made on the oral polio vaccine.

I entirely agree with the hon. Gentleman that we must ensure that advice to Ministers is accurate. That is essential, particularly when we are dealing with issues of safety and public confidence. I agree too that mechanisms for alerting Ministers should be robust and rigorous. On the MCA, various steps have been taken. It was announced on 13 June that it is to merge with the Medical Devices Agency to create a new agency.

We are also introducing non-executive directors, which the MCA did not previously have, and appointing a chairman to the authority to make sure that its governance is more robust. On its reporting mechanisms, particularly concerning TSE issues, it has been directed to set up a database to ensure that everything is properly calculated and monitored.

We have also asked for more steps to be taken to try to check the validity of what manufacturers tell the MCA. It is an established principle that regulators would find it impossible to follow up or question the validity of every statement made to them by companies. The role of a regulator is to set a regulatory framework and to leave accountability with the producers. However, there is a case for the MCA to carry out more sampling to establish the validity of some of the information supplied by companies.

It was the information supplied by companies about the expiry dates of vaccines, which the MCA gave to Ministers, which proved to be incorrect, so it is important to follow up such information, but we must recognise that

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it would not be appropriate or possible to check everything. Certainly we must try to make the process more robust.

The hon. Gentleman referred to the need for the tendering process to be transparent. That is important, and people ought to have access to the decision-making process.

Dr. Evan Harris (Oxford, West and Abingdon): I too thank the Minister for the day's notice that she gave me of this statement and for giving me three reports to read in 20 minutes, plus a statement saying that there is another important document in another building. This experience, which started just over half an hour ago, has been interesting.

Will the Minister pay tribute to my hon. Friend the Member for Lewes (Norman Baker), who has been assiduous in pursuing his concerns about the presence of bovine material in the vaccine manufacturing process? He began with a parliamentary question on 25 March 1999 to the Minister's predecessor but two, the right hon. Member for Dulwich and West Norwood (Tessa Jowell), which is when the inadvertent misinformation started. My hon. Friend also secured an Adjournment debate in March 2000 in which further inaccurate information was passed on.

I understand that my hon. Friend wrote a letter to the hon. Member for Pontefract and Castleford (Yvette Cooper), who is in her place, in May 2000. Two years later, he says that he has still not had a reply, so in addition to the supply of inaccurate information, there is a question about Ministers giving no information at all in response to questions.

I want to place on record my belief that the current vaccine programme has integrity, that it is important that people should continue to have vaccinations and that their enormous benefits outweigh any risk from TSEs, however small that may be or have been. Does the Minister accept, however, that faith in that important and effective vaccine programme is based on full openness and clarity on the issues from Ministers and their advisers to the public at large?

In her statement, the Minister said "Nothing in any of the reports alters the assessment of experts: there are no transmissible spongiform encephalopathy-related safety issues arising from the use of relevant animal-derived materials in the production of vaccines authorised for use in the United Kingdom." However, the report talks about "no demonstrable" TSE-related safety issues. It is not clear whether the Minister was talking about the vaccine programme now—I am sure that if there was a risk, the programme is much safer than it was—or whether it was always the case that there were no safety issues. It is important that that is clarified. The Minister also talked, in her statement, about the manufacture of vaccines that are currently available on the UK market, and it is not clear whether her remarks relate to vaccines that were previously available. People will have concerns about that.

The Minister did not answer the question asked by the hon. Member for North-East Hertfordshire (Mr. Heald) about whether she had published the guidance given to her. She said that Ministers were misled by advice and information from the MCA in five areas, and some of those, such as the presence or not of excipients in the finished vaccine product, are so obvious that it would be

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useful for the House, in judging whether her actions on the MCA are sufficient, to see that guidance in its original form. We could then judge just how deficient it was, not only in what the MCA had been told by the manufacturers but in its conclusions about the basic make-up of the finished vaccine.

Will the Minister clarify certain issues relating to PowderJect? As was set out in her statement, in the chief medical officer's report and in her response just now, the MCA was informed in August 2000 that the oral polio vaccine was not compliant. Indeed, the agency established that for itself on a visit to the Speke factory in September 2000. Why did it take until 16 October for Ministers to be informed, during which period another company paid to take over Medeva and Evans vaccines? Clearly the company, and possibly the purchasers, had market- sensitive information that Ministers and other market players did not.

What action does the Minister propose to take against manufacturers such as Evans who failed to respond quickly to the request for information made in spring 2000 and who may have given misleading information? I am sure that although there was no breach of the law the Government must have some sanction, such as the withdrawal of preferred supplier status, that they could use against those companies.

Clearly we need a debate on this subject. Will the Minister ask her business managers whether we can have a proper exchange, in Government time, so that we can have a full and frank discussion of the extent to which Members of the House have been inadvertently misled by Ministers? We could use the opportunity further to reinforce the confidence that the public should have in the current vaccine programme.

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