Medeva: Polio Vaccine (Hansard, 26 October 2000)

§ The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)
My Lords, Ministers are establishing what can be learnt from the events leading to the decision to withdraw the oral polio vaccine and the adequacy of the MCA's procedures to gather and validate information from vaccine manufacturers and its advice to Ministers on this issue.

§ Lord Clement-Jones
My Lords, I thank the Minister for that reply. I hope he will accept that it was regrettable that no ministerial Statement was made last week, particularly as it took two months after discovery for the department to announce the problems with the polio vaccine. Is the Minister satisfied that the MCA will not be misled about the contents of vaccines and that their manufacture in the factories is of a sufficiently high standard, particularly at the Medeva factory in Speke?

§ Lord Hunt of Kings Heath
My Lords, the review which we undertake must examine the procedures 485 which the MCA uses to ensure that manufacturers are conducting their affairs in accordance with the standards and guidelines laid down. We shall want to examine that carefully.
I can assure the noble Lord that the MCA has inspected the Speke site vigorously and frequently. Indeed, I understand that it inspected the site four times this year in order to ensure that problems are not giving rise to public health hazards, that they are being resolved satisfactorily and that appropriate standards are being met.

§ Baroness Gardner of Parkes
My Lords, is the flu vaccine, which is in such short supply, manufactured by the same company? Why is it that so many people over 65 who responded to the superb advertisements for flu inject ions cannot get them?

§ Lord Hunt of Kings Heath
My Lords, Medeva is one of the companies which produces the flu vaccine. Of the five manufacturers supplying the UK market, all except one are on target to produce the supplies when required. That one company is called Solva and it supplies about 15 per cent of the total market. It has estimated that it will be able to resolve the problems and deliver the additional doses required during the week 20th to 24th November.

§ Lord Williamson of Horton
My Lords, as one of those who has received a polio vaccine manufactured by Medeva within the past month, I want to ask whether the company breached the European guidelines. If it did, will there be a penalty? I want to be a Member of this House for some years yet.

§ Lord Hunt of Kings Heath
My Lords, I understand that it is considered that it did breach the 1999 guidelines and consideration will be given to action being taken against the company in relation to that. However, the guidelines will have the full force of law for existing products from spring next year. As regards their legal status, the guidelines at present relate to new products. However, in order to ensure public confidence in the vaccine programme, the Government took the decision that, because this product breached 1999 guidelines, it was right to withdraw that vaccine.
Perhaps I may reassure the noble Lord that the Committee on the Safety of Medicines established a working party yesterday and, on the basis of additional information available to it, it confirmed its conclusions that no TSE safety issues arose from the use of UK source bovine materials in the manufacture of vaccines currently marketed in the UK.

§ Baroness Northover
My Lords, can the Minister confirm that oral vaccines will now be treated in the same way as injectable vaccines?

§ Lord Hunt of Kings Heath
My Lords, yes, I can confirm that. Undoubtedly, they are covered by the 1999 guidelines.

§ Earl Howe
My Lords, does the Minister agree that public confidence in the NHS vaccination programme 486 is a paramount consideration? Does he also agree that, if that is to be achieved and if false fears are to be banished, there must be absolute openness both by government and the pharmaceutical industry? Will he confirm that government and industry have firmly adhered to that principle?

§ Lord Hunt of Kings Heath
My Lords, I agree that enhancing and ensuring public confidence in the vaccine programme in this country is essential. It is worth reminding the House that the success of our immunisation programme has resulted in the incidence of childhood diseases falling to their lowest ever levels. It is very important to ensure that the public are aware of the importance of immunisation.
It is important that there is openness in the performance of the regulatory agencies. I believe that this Government have proved themselves to be as open as possible as regards these issues. When the matter was reported to Ministers last week, we took action effectively and speedily.

§ Earl Russell
My Lords, is the Minister aware that the views of the noble Earl, Lord Howe, on the need to maintain public confidence are widely shared? Would he further agree that, as secrecy reaches epidemic proportions within both Whitehall and business, that objective might be more easily achieved in the light of a more tightly drafted Freedom of Information Bill?

§ Lord Hunt of Kings Heath
My Lords, I would say only that the Department of Health wants to ensure public confidence in the vaccine programme. We accept that openness and vigour in the process of licensing and regulation is an important component of that. We are as committed as anyone can be to ensuring that that is done satisfactorily.