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Bovine Material in Vaccine Manufacture

Lord Woolmer of Leeds asked Her Majesty's Government:

The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath): European guidelines issued in 1999 made clear that the manufacturing process for medicinal products should not use bovine materials from countries in which there are known cases of Bovine Spongiform Encephalopathy. The first guidance on this subject was issued by the Committee on Safety of Medicines in 1989. From 1989 onwards, the Medicines Control Agency sought and received assurances from drug companies that they were implementing this guidance and subsequent guidance produced at a European level on a phased basis.

On the advice of the MCA, I informed the House on 4 May 2000 that the 1989 guidelines obliged all pharmaceutical companies to source bovine material from outside the United Kingdom. I am now advised by the MCA that these 1989 guidelines did not have the full force of law and that they applied to injectable

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medicines and medicines applied to the eyes or open wounds. However, the 1999 guidelines do apply to bovine materials and pharmaceuticals generally. From March 2001, these guidelines, which at present are not legally binding, will have the full force of the law.

I also informed the House on 4 May 2000 that vaccines that use bovine material in the manufacturing process manufactured since March 1989 had used bovine material from non-UK sources and that the MCA had established that the latest date that vaccines manufactured before the guidelines came into force could have been used was November 1993. On 28 March 2000, my honourable friend the Parliamentary Under-Secretary for Public Health informed Parliament on the advice of the MCA that from April 1989 no bovine materials sourced in the United Kingdom were introduced as an element of the manufacturing process for vaccines produced at that time. In particular, she told the other place on the advice of the MCA that all vaccines manufactured by Wellcome after 1989 used bovine material from New Zealand. She also informed the other place on 19 October 1999 on the advice of the MCA that since 1993 all vaccines in use were manufactured without UK-sourced bovine material. I have now been advised that the advice from the MCA that formed the basis of these statements was incorrect. The MCA was provided with information by manufacturers.

The MCA advised Ministers last week that in the case of the Wellcome oral polio vaccine, the assurances given by the company have proved inaccurate. This oral polio vaccine was originally produced by Wellcome. Part of Wellcome's vaccine business was transferred over to Medeva in 1991. Part of the oral polio vaccine was manufactured in 1985 using growth medium containing foetal calf serum of UK bovine origin, and this element continued to be used in the production process after 1989.

This oral polio vaccine continued to be used up until 2000, in specific breach of the 1999 guidance. The Department of Health has therefore recalled this oral polio vaccine manufactured by Medeva (supplied by Medeva under the brand name Evans).

The MCA has carried out a risk assessment and people who have received this oral polio vaccine in the past can be advised that the breach is of guidance which has been formulated on a precautionary basis; under the European guidelines. Foetal calf serum is in category IV (no detectable infectivity); the processes used in manufacturing are designed to remove all but a remote trace of unwanted proteins such as foetal calf serum. The MCA, taking all these points together, have advised that any risk associated with this Medeva oral polio vaccine is incalculably small.

My honourable friend the Parliamentary Under-Secretary for Public Health asked the CSM in March to produce a comprehensive assessment of BSE-related issues in vaccines. The Government are committed to publishing the assesssment. In the light of the new information, we are also reviewing the advice given to Ministers on this issue to ensure that all the information given to Parliament is correct.

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Chief Dental Officers: Support Staff

Lord Colwyn asked Her Majesty's Government:

    How many full time senior dental officers, dental officers and regional dental officers assisted the previous three Chief Dental Officers (Dr Robin Wild, Mr Brian Mouatt and Professor Martin Downer); and how many full-time dental officers will be available to assist the new Chief Dental Officer, Dame Margaret Seward. [HL4203]

The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath): Mr Robin Wild is currently supported by two full-time senior dental officers, as well as a part-time dental adviser in each regional office of the National Health Service Executive and a number of administrative staff. Dame Margaret Seward will succeed Mr Wild on 1 November and will inherit the current staff complement. I regret that information is no longer available about the staffing arrangements under previous Chief Dental Officers.

Housing Benefit: Backdating

Lord Blackwell asked Her Majesty's Government:

    Whether the recent announcement of regulations to restrict the backdating of housing benefit to three months is consistent with the assurances given by the Baroness Hollis of Heigham on 6 April 1998 (H.L. Deb., cols. 546-547) in withdrawing the proposed clause 72 of the Social Security Bill. [HL4109]

The Parliamentary Under-Secretary of State, Department of Social Security (Baroness Hollis of Heighham): The intended changes to the backdating rules are consistent with our aims to improve the structure and administration of housing benefit. These proposals have been now considered by the Social Security Advisory Committee (SSAC), and we expect to receive their report to the Secretary of State shortly. We have also consulted the local authority associations (LAAs) on these proposals.

We will consider the responses from the LAA consultation and points raised in SSAC's report very carefully and will take these into account along with other representations made.

Working Time Directive: Extension to Excluded Sectors

Lord Berkeley asked Her Majesty's Government:

    What are the regulations, and the dates on which they come into effect, in the European Union's Working Time Directive in respect of: (a) railway workers; (b) self-employed road freight transport drivers; (c) other road freight transport drivers; (d) public service vehicle drivers; (e) marine operatives; and (f) port operatives. [HL4086]

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The Minister for Science, Department of Trade and Industry (Lord Sainsbury of Turville): Directive 2000/34/EC was published in the Official Journal of the European Union on 1 August 2000. It extends the provisions of the existing Working Time Directive in full to non-mobile workers in the previously excluded sectors (air, rail, road, sea, inland waterway and lake transport, sea fishing, other work at sea--mainly the offshore oil and gas industry--and doctors in training).

For mobile workers, the amending directive provides an entitlement to paid annual leave, a 48-hour working week and health checks for night workers. Member states have until 1 August 2003 (1 August 2004 for junior doctors) to implement the directive. Industry representatives within these sectors will be consulted on proposals to implement the directive in due course.

Negotiations for a separate road transport directive, covering breaks and rest periods for mobile workers, are continuing within the transport working group. At this stage we are unable to say when this proposal is likely to be agreed, or when it is likely to be implemented into UK legislation.

House of Lords Office Accommodation

Lord Dubs asked the Chairman of Committees:

    What discussions have taken place with the House of Commons authorities regarding the return to the House of Lords of certain Commons office accommodation in the light of the extra space that will be available at Portcullis House. [HL4187]

The Chairman of Committees (Lord Boston of Faversham): There have been no such discussions. I wrote to the Speaker of the House of Commons on 28 July to draw to her attention the views of Members of this House, and to inform her that Black Rod had been instructed to obtain comparative information on the accommodation available to the two Houses. This information is now to hand, and the Administration and Works Sub-Committee and the Offices Committee will use it to help them reach a decision on how to proceed.

Refreshment Department: EPOS System

Lord Dubs asked the Chairman of Committees:

    What was the cost of installing the Refreshment Department's new computerised billing system; what benefits were supposed to be achieved; and what assessment he has made of the delays that have resulted. [HL4188]

The Chairman of Committees: The cost to date of installing the new EPOS (electronic point of sale) system in the Refreshment Department is £60,846. A further £20,000 will be spent on an associated stock control system. The introduction of the system in the Refreshment Department follows a recommendation

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by the National Audit Office. EPOS systems are, and have been for some time, standard in the retail and catering industries and enable accounting procedures to be improved while delivering more accurate information to management on sales and stock control. The staff of the Refreshment Department have put a great deal of effort into ensuring the smooth roll-out of the system in the department's eight outlets. The roll-out is now complete and, while the introduction of a major new system of this kind is bound to lead to teething problems, I understand that, with the temporary exception of the Home Room, no significant delays to customers have been identified. The problems in the Home Room have now been resolved.

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