House of Commons Hansard Written Ministerial Statements for 1 Mar 2006 (pt 3)

HEALTH

Herceptin

The Secretary of State for Health (Ms Patricia Hewitt): Following the recent ruling by the High Court on a decision by Swindon Primary Care Trust concerning the drug Herceptin, I can confirm to the House that the policy on the prescription and provision of Herceptin for HER2 positive early stage breast cancer, ahead of a decision on licensing or National Institute for Health and Clinical Excellence (NICE) appraisal, remains as set out in the NHS Chief Executive's Bulletin: Issue 294, 4–10 November 2005. This is that:

It is down to individual clinicians to decide whether to prescribe Herceptin for a woman who has tested HER2 positive after discussions with the woman about potential risks and taking into account her medical history.

Primary care trusts (PCTs) should not refuse to fund Herceptin solely on the grounds of its cost.

PCTs should not rule out treatments on principle but consider individual circumstances.

This policy does not, in any way, replace either the licensing process or the NICE appraisal process. It is possible for a clinician to prescribe a drug outside its licensed indications ("off-licence" or "off-label" use).

The manufacturers of Herceptin have now applied to the European Medicines Agency for a licence for the use of Herceptin in the treatment of early stage breast cancer and a decision is expected in summer 2006. I referred Herceptin for early stage breast cancer to NICE in July 2005, and in November 2005 I announced that we had agreed with NICE that their evaluation of Herceptin would begin immediately after a licence had been applied for. I can confirm that NICE has now started work on its appraisal. We expect the NICE evaluation to be completed shortly after any licence is granted. NICE technology appraisals are covered by a three-month funding direction. This means that PCTs

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must provide funding for the uses recommended by NICE within three months of publication to allow clinicians to follow the guidance.

In addition, Professor Mike Richards, the National Cancer Director, is working with cancer networks to ensure that testing arrangements are put in place to enable women who require it to be tested for HER2 status. This work is ongoing.

HOME DEPARTMENT

Immigration

The Minister for Immigration, Citizenship and Nationality (Mr. Tony McNulty): The Government are firmly committed to maintaining effective immigration controls while at the same time ensuring that genuine passengers are able to pass through our ports with the least possible inconvenience.

Nationals of Malawi have generated an increasing number of asylum applications; 45 in 2001, 95 in 2002, 150 in 2003, 170 in 2004 and 110 in the first three quarters of 2005. But asylum is only part of the problem and the level of other immigration abuse by Malawi nationals is also significant, with large numbers being refused entry or presenting forged documents on arrival, overstaying or working in breach. Furthermore, there is a risk that the visa free access to the UK being enjoyed by Malawi nationals may be exploited by other nationals fraudulently obtaining Malawi passports and travelling to the UK. It is of course difficult to quantify this problem as many asylum seekers are without documents when they make their application and it is difficult to identify how they reached the UK. But in view of the serious problem posed by nationals of neighbouring countries, and the immigration threat posed by Malawi nationals themselves, I have decided to impose a visa regime on all Malawi nationals wishing to visit the UK. I have also decided to introduce a transit visa requirement for nationals of Malawi to deal with the increased number of passengers that are arriving in the UK without documents and submitting an asylum application.

The new arrangements will take effect on 2 March. To avoid undue hardship for those who had already made their travel plans, we have agreed to operate a grace period. This means that those who purchased tickets before 23:59 hours on 1 March and arrive in the UK on a direct journey from Malawi by 23:59 on 8 March, will not be refused entry or permission to transit the UK solely on the basis of not holding a valid visa or transit visa. Furthermore, a transit passenger who is a national or citizen of Malawi and who is transiting the United Kingdom as part of his journey back to his point of origin, will be allowed to do so without a visa until 23:59 hours on 29 March 2006, providing he can demonstrate that he bought his ticket on or before 1 March and transited the United Kingdom on the outward leg of his journey on or before 8 March 2006.

I would want to provide reassurance that the presence of a visa regime should not be a bar to those Malawi nationals who genuinely wish to visit the UK. The rules under which decisions are made are the same whether that decision is made on arrival or before. This visa regime simply allows officials to consider the application

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before the passenger embarks for the UK. Providing greater certainty that a person has satisfied the Immigration Rules will also smooth the passage of genuine visitors through the immigration controls, giving advantage to all concerned.

I recognise that visa regimes do represent an inconvenience for some passengers and we will therefore only maintain them where the immigration threat is such as to justify doing so. At present Croatia nationals require a visa in order to visit the UK. However, I judge that there is no longer any significant threat to our immigration controls from Croatia nationals. I have therefore decided that the visa regime should be lifted and standard on-entry immigration controls will apply. Changes to the Immigration Rules will have been made today and the visa regime will be lifted from on 22 March.

TRANSPORT

London and Continental Railways

The Secretary of State for Transport (Mr. Alistair Darling): I announced on 14 February 2006 that my Department had been independently approached by a third party, with an interest in the potential acquisition of the shareholders' interests in London and Continental Railways (LCR). LCR is the company responsible for the development of the Channel Tunnel

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Rail Link, including the railway itself, the associated development sites and the operation of the UK interest in the Eurostar train company.

LCR is a heavily indebted company, owned by private sector shareholders, but funded by approximately £6 billion of Government-backed debt. In recognition of this Government support, the contracts governing the development of the Channel Tunnel Rail Link give the Government certain rights, including the right to consent, refuse or force a sale.

The Government believe that, in the current circumstances, the best way of delivering continuing value for money for the taxpayer is for there to be an open, transparent, competitive process. Accordingly, as a first step, potentially interested parties should put their propositions to my Department as well as to the LCR shareholders, so that we can establish how overall best value for the taxpayer can be achieved.

My Department is continuing to discuss this approach with LCR's shareholders so as to ensure value and transparency, with a level playing field for all participants, including the incumbents.

The Government's objective will be to ensure continuing value for taxpayers' money, including the successful delivery of the Channel Tunnel Rail Link and the continuing safe and efficient operation of Eurostar, as, for instance, under the existing arrangements whereby the Government is entitled to 50 per cent. share of any future profits on the development of the sites around the CTRL.