Chamber and committees

Issues of competition policyare for the Office of Fair Trading, who I understand are currently considering complaintsin relation to one such case.

For our part, we are committedto working in co-operation with all manufacturers and suppliers of pharmaceuticalsto ensure that patients get the medicines they need. We expect patients to continueto receive the current high level of service and prompt delivery of medicines, atno extra cost to the NHS, wherever they live in Scotland.

The Executive has been consideringfor some time the results of a strategic review of the future of Protein FractionationCentre (PFC) and Alba Bioscience, and our future strategy for the supply of plasmaproducts. The review has looked at whether plasma products should be made in Scotland or shouldbe purchased from elsewhere. The key aim has been to secure a safe and sustainablesource of high quality products that provides value for money for the taxpayer.

The Scottish National Blood TransfusionService (SNBTS) currently operates the PFC in Edinburgh to supply plasma productsfor the NHS in Scotland, together with Alba Bioscience which makes blood groupingreagents. Plasma products are important for many NHS patients in Scotland. Forexample, some people who lack normal immunity to infection are dependent on plasmaproducts long-term. As these products are derived from human plasma safety is of the utmost importance, and manufacturing is tightly controlled and regulated.

The role of the PFC has beensignificantly affected by a number of changes in recent years which mean that itis no longer viable in economic terms. Since 1998, as a precautionary measure becauseof vCJD risks, the PFC has purchased plasma from Germany and the US for manufactureof plasma products. Previously plasma was available free from blood donation inScotland, and this has added significant new costs to the operation. There is noprospect of a return to the use of UK plasma in the foreseeable future.

Since January this year, manufacturingat the PFC has been suspended following an inspection by the Medicines and Healthcareproducts Regulatory Agency (MHRA) which identified weaknesses in quality assuranceprocesses. As a result plasma products are currently being bought in from outsideScotland, either from the NHS Bio Products Laboratory (BPL) in England or fromcommercial sources. A number of these products are more advanced and of higher qualitythan PFC products, and offer benefits for health professionals and patients. ThePFC is at present unable to produce equivalent products. It would be unacceptableto return to using products that are of lower quality, and it would take a numberof years to develop new products to the point of licensing. Indeed, there are strongclinical reasons which support the use of quality products from commercial sources,in particular in relation to patients with primary immuno-deficiency who are treatedwith immunoglobulin on a lifelong basis. These include patient safety, convenienceand choice, treatment flexibility, service efficiency and sustainability of approachin immunoglobulin usage.

In addition, the need for someproducts - such as blood clotting factors - is now met by recombinant products,rather then products based on human plasma, and this has reduced the value and outputof products from the plant. The PFC’s production costs are now higher than the marketvalue of its products and the facility also requires significant upgrading and investment(estimated at approximately £20 million) to bring the plant up to modern manufacturingstandards, and to ensure continued compliance with regulatory requirements.

Even with this substantial investmentit is questionable whether the PFC, one of the smallest facilities of its kind inthe world, would be an economic and viable operation with estimated long-term marginalcosts of 20 to 25% above those of commercial competitors. Given secure and sustainablesources of commercial products which are of greater quality and safety, we haveconcluded that it would be both injudicious and inadvisable to invest further NHSresources in the PFC.

As a result of the plant no longerbeing viable, we have decided not to authorise the full-scale resumption in productionof the PFC product range. We have asked SNBTS to explore whether the plant can besold, or whether some of its activities can be developed in the private sector inScotland. The PFC has significant skills and knowledge, and some innovative productswhich could earn commercial returns. For example, PFC has been involved in a long-termcollaboration with the Ministry of Defence (MoD) Defence Science and TechnologyLaboratory to produce and licence a heptavalent botulinum anti-toxin. The productis currently produced under the terms of a Manufacturer’s (Specials) Licence whichenables it to be administered to individual patients under the supervision of adoctor, in the event of an emergency. It is the MoD’s intent to continue studiesto support an application for a Marketing Authorisation (Product Licence) for thebotulinum anti-toxin in due course. SNBTS believe there are potential commercialopportunities in the development of anti-toxin products which could be attractiveto the private sector.

This means that the future procurementroute for plasma products for the NHS in Scotland will be from external sources in the same way as mostmodern pharmaceutical products are bought by the NHS. This will ensure a sustainablesupply of high quality product for patients in Scotland.

Alba Bioscience already has significantcommercial business as well as supplying products to the NHS. We believe this isa potentially successful business with the opportunity for growth. We have askedSNBTS to develop and prepare Alba Bioscience for sale at an appropriate time.

PFC is a manufacturing unit whichproduces a range of blood products from plasma. This decision about the future ofPFC has nothing to do with the mainstream blood donor and collection activitiesof SNBTS. It is essential that people continue to support these by giving bloodto save lives and enabling important operations to go ahead for people who needthem

There are at present 145 jobsin the PFC. We hope to find a buyer who would preserve as many of these jobs aspossible. In the event that there is not a suitable buyer and plasma processingdoes not resume, we will aim to ensure as far as we can that staff are redeployedin the NHS in Scotland in terms of the national Organisational Change Policy.The NHS aims to offer its staff secure employment and, where possible, we will offeravailable and appropriate posts elsewhere in SNBTS or in the NHS. We cannot guaranteethat these changes will involve no compulsory redundancies but we would aim to avoidthem.

Our first responsibility is toprotect the interests of patients. We believe this approach is the best way to achievethis, recognising that it would not be a justifiable use of NHS resources to committo significant additional investment in the PFC. It is through the continued sourcingof plasma products commercially that we can ensure a safe and sustainable supplyof high quality products for the people of Scotland.

The new Charities Accounts(Scotland) Regulations 2006 (S.S.I No. 218) have been published and are available on the Office of PublicSector Information website: http://www.opsi.gov.uk/legislation/index.htm.

They were laid before the Scottish Parliament on 25 April 2006, coming into force on 17 May 2006 subject to parliamentary approval.

At present the key treatmentis photo-dynamic therapy, which has been approved by NICE and subsequently endorsedby NHS Quality Improvement Scotland. Health boards are committed to providing thistherapy, where clinical need can be demonstrated.

The relevant provisions of theLicensing (Scotland) Act 2005 are to be commenced with effect from 1 June 2006 to maketransitional provision for an alcohol test purchasing pilot scheme to take placein the Fife Constabulary area. The pilot is expected to begin this summer and willrun for a 12 month period. The main aim is to trial alcohol test purchasing arrangementsto ensure it is carried out safely, fairly and effectively in a Scottish contextby the time the provisions of the Licensing (Scotland) Act 2005 are generally commencedin 2009. The establishment of measures to ensure the welfare of the young peopletaking part in test purchasing exercises is of particular concern.

The pilot will be overseen byan Advisory Group which in addition to Scottish Executive and Crown Office officialsincludes representatives from ACPOS, COSLA and licensed trade and retail interests.It will be subject to an independent evaluation the results of which will be usedto inform the development of common operating protocols and procedures to be adoptedby forces across Scotland when the test purchasing arrangements are rolled outmore generally.

We remain committed to the fundamental principles of the full-cost recovery policy for the Care Commission. These are that the cost of regulating each care service should be identified and that the costs should either be met by the services concerned or explicitly be subsidised by the Executive where there are policy reasons to do so, as we do in the case of childminders and children’s day care services.

We are, however, aware of the impact of that policy on care service providers. That is why we have been working closely with the Care Commission on identifying the inputs and costs associated with the regulation of the individual care service sectors they regulate.

We are also mindful of the Health Committee’s review of the Regulation of Care (Scotland) Act 2001. That review will look at the Care Commission and the wider inspection regime, including funding issues.

After carefully considering the implications of the commission’s work on fee levels, and in recognition of the Health Committee’s review, we have decided to freeze maximum registration and annual continuation fees at their current level in 2006-07. This means that fees for services currently regulated by the commission will remain below full cost recovery levels.

The exception to the freezing of fee levels will be care homes. The fees charged by the Care Commission will be reduced by around 10% on current levels to around £148 per place. This change reflects the input now required by the commission to regulate these services in light of its experience since 2002.

In order further to reduce the administrative and financial burden on care service providers I have asked the Care Commission to set the fee levels for variation, cancellation and a new certificate at nil for all services.

The Care Commission will continue to strengthen its evidence base on the activity needed to regulate care services. This will help inform our thinking on future fee levels.

In 2001 the Scottish Executive consulted key stakeholders in public agencies, representative bodies, and tattooing and skin piercing businesses, about the possible tighter regulation of these businesses.

An independent analysis of the responses was prepared and was placed in the Scottish Parliament Information Centre on 9 October 2001 (Bib. number 16633). In the light of the consultation, the Executive concluded that further controls of tattooing and skin piercing activities are advisable in order to reduce the risk of transmission of blood-borne infection.

An order, which is subject to the affirmative resolution procedure, has today been laid before the Parliament. This will provide for, a mandatory licensing regime, supported by monitoring and non-compliance penalties. The order will also introduce the requirement for written parental consent for skin and body piercing of children aged under 16 years.

The Executive does not issue clinical guidelines. The Scottish Intercollegiate Guidelines Network (SIGN), which is a part of NHS Quality Improvement Scotland, is funded to develop clinical guidelines but has not issued any on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis. The English National Institute for Clinical Excellence is currently developing a Chronic Fatigue Syndrome/Myalgic Encephalomyelitis guideline which will be available to clinicians in Scotland.

NHS boards are given unified budgets, increased by an average of 7.6% in the current financial year, from which they are expected to meet the costs of services for people with CFS/ME and all other chronic conditions. It is for NHS boards to decide how their unified budgets should be distributed, based on their assessments of local needs.

The Chief Scientist Office (CSO), within the Scottish Executive Health Department, has responsibility for encouraging and supporting research into health and health care needs in Scotland. CSO is currently contributing £250,000 to the Medical Research Council project Pacing, Activity and Cognitive behaviour therapy: a randomised Evaluation (PACE) which compares different approaches to the clinical management of patients with CFS/ME.

Policy responsibility for all occupational pensions issues is reserved.

The UK Government’s proposals to reform the Local Government Pension Scheme (LGPS) in England and Wales are being taken forward through a tripartite working group chaired by the Deputy Prime Minister and involving government, employers and trade unions.

A similar tripartite group chaired by the Scottish Public Pension Agency, and involving COSLA and trade unions, is to discuss how the UK Government’s reforms are to be applied to the LGPS in Scotland.