Chamber and committees

The Medicines and Healthcare products Regulatory Agency (MHRA) has reported that it has received a total of 58 adverse drug reaction (ADR) reports associated with Factor VIII and 15 ADR reports associated with Factor IX in the last 10 years. The numbers of ADR reports per year are detailed in Table 1. Table 1. Number of UK Adverse Drug Reaction (ADR) Reports¹ Associated with Factor VIII and Factor IX products in the Last 10 years (1993-2002)

Year	Factor VIII	Factor IX
1993	5	0
1994	8	3
1995	5	1
1996	10	2
1997	6	2
1998	4	1
1999	1	1
2000	6	3
2001	1	2
2002	12	0
Total:	58	15

Note:1. The number of ADR reports relates to the total number of reports associated with the active products Factor VIII and Factor IX. No distinction has been made as to whether the product originated from human blood or from recombinant DNA technology.MHRA point out that it is important to note that a report of a suspected ADR does not necessarily mean that it was caused by the medicine.

This information is currently not held centrally. The Advocacy Safeguards Agency is conducting a mapping exercise which aims to produce a comprehensive picture of the provision and resourcing of advocacy services across Scotland. This process is expected to be concluded before the Act comes into effect.NHS boards will be submitting their advocacy plans for the following three years at the end of February 2004, and local authorities will be expected to contribute to the preparation and submission of these plans. A clear commitment from the boards and their planning partners to identify the appropriate resourcing will also be required.

Recruitment to positions within the Scottish Criminal Record Office (SCRO) is the responsibility of the SCRO Executive Committee. The normal procedures are for the post to be advertised widely within the police service if the vacancy is for a serving officer or in the press if a civilian is to be appointed.Earlier this year, following his retiral from the police service, the director of SCRO was offered and accepted a temporary, short-term appointment as civilian Director. The offer was made by the SCRO Executive Committee to ensure management continuity at the time when SCRO and the other Scottish common police services were being reviewed.

The efficacy of all Factor VIII and Factor IX products are assessed by clinical trials carried out in Haemophilia centres on behalf of the product manufacturers as a prerequisite to the manufacturer being granted a license to market the product by the Medicines and Healthcare Products Regulatory Agency. Efficacy is defined for this purpose as stopping or preventing bleeding.The efficacy of Factor VIII and IX has been established for over 30 years. Treatments with these products are very effective, without them patients would suffer spontaneous bleeding which caused severe disability and in severe cases ultimately death.

I am not aware of any such investigations.

The announcement of 1 January 2005 as the date on which the Freedom of Information (Scotland) Act 2002 will be fully implemented has assisted Scottish public authorities in their preparations for the act by removing any uncertainties about when the new rights will come into force. The timetable is challenging yet deliverable. We do not intend to reconsider the date.

The Scottish Criminal Record Office (SCRO) was the subject of a primary inspection by Her Majesty's Inspector of Constabulary in 2000. There were two follow-up review inspections carried out in 2001 and 2002. The cost of these inspections cannot, however, be separately identified. The review inspection reports were both positive and noted that considerable progress that had been made since the primary inspection. While the primary inspection was brought forward in terms of scheduling, these inspections are essentially part of normal Her Majesty's Inspectorate of the Constabulary activity. The cost of the involvement of the Procurator Fiscal at Paisley in the investigation and consideration of criminal proceedings against SCRO officers, which resulted in no proceedings being taken, also cannot be separately identified.An independent investigator, external to the police service, carried out an assessment of the process and procedures in place at SCRO Fingerprint Bureau in 1997. He concluded that there were no matters of misconduct or lack of capability surrounding the fingerprint comparisons carried out at the time. An Independent Scrutiny Committee later endorsed that conclusion. The cost of these assessments was £19,725.

The details requested on the usage and type of products in each of the years from 1989-90 to 2002-03 are shown in the following tables.Details of the how many patients were treated using each product are not held centrally.Yearly Usage of Factor VIII in Scotland (IU x 10⁶)

Year	89-90	90-91	91-92	92-93	93-94	94-95	95-96	96-97	97-98	98-99	99-00	00-01	01-02	02-03
PFC FVIII	6.99	7.68	8.24	10.85	11.63	11.54	13.41	10.94	8.62	6.72	4.94	3.35	5.17	1.48
Com FVIII	1.18	0.95	2.08	1.24	0.98	0.82	1.07	1.04	0.57	0.34	0.79	0.79	0.62	0.67
r FVIII	0	0	0	0	0	0.33	0.38	3.18	6.94	8.38	13.85	16.62	15.96	23.97
Tot FVIII	8.16	8.63	10.32	12.09	12.62	12.69	14.85	15.17	16.13	15.45	19.58	20.76	21.76	26.13

Notes:PFC FVIII Factor VIII manufactured by the Scottish National Blood Transfusion Service at the Protein Fractionation Centre.Com FVIII Factor VIII purchased from a commercial manufacturer. These figures do not include recombinant factor VIII.r FVIII Recombinant factor VIII.Tot FVIII Total factor VIII usage.Yearly Usage of Factor IX in Scotland (IU x 10⁶)

Year	89-90	90-91	91-92	92-93	93-94	94-95	95-96	96-97	97-98	98-99	99-00	00-01	01-02	02-03
DEFIX	2.33	2.08	2.21	2.48	2.80	2.02	0.66	0.77	0.76	0.85	1.01	0.85	0.75	0.84
HIPFIX	0	0	0.11	0.14	0.23	0.77	2.41	1.22	0.09	0.09	0.01	0.00	0.00	0.00
Com HP9	0	0	0	0	0	0.10	0.14	2.09	3.98	3.13	1.14	0.69	0.59	0.52
r FIX	0	0	0	0	0	0	0	0.01	0.02	0.60	2.84	4.83	4.27	6.11
Tot HP9	0	0	0.11	0.14	0.23	0.87	2.55	3.32	4.09	3.82	3.99	5.52	4.86	6.63
Tot FIX	2.33	2.08	2.32	2.63	3.03	2.89	3.22	4.09	4.85	4.67	5.00	6.37	5.60	7.47

Notes:DEFIX Prothrombin complex concentrate containing factors II, IX and X manufactured by the Scottish National Blood Transfusion Service at the Protein Fractionation Centre.HIPFIX High purity factor IX manufactured by the Scottish National Blood Transfusion Service at the Protein Fractionation Centre.Com HP9 High purity factor IX purchased from a commercial manufacturer. These figures do not include recombinant factor IX.r FIX Recombinant factor IX.Tot HP9 Total high purity factor IX. These figures do not include DEFIX usage.Tot FIX Total factor IX usage including DEFIX.

I refer the member to the answer given to question S2W-01547 today, which can be found on the Parliament's website, the search facility for which can be found at http://www.scottish.parliament.uk/webapp/search_wa.

The trials have been completed by GW Pharmaceuticals and the results are currently being considered by The Medicines and Health Care Products Regulatory Agency. The Home Secretary has said that the UK Government will do whatever is needed to amend the law quickly to permit the prescribing of a cannabis-based medicine, in the event that the agency approves the product.