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18 Dec 2007 : Column 1369W—continued
Ambulance Services: Cumbria
Tim Farron: To ask the Secretary of State for Health when he expects every ambulance serving South Lakeland to be equipped with a 12 lead electrocardiogram machine. [175388]
Ann Keen: The information is not held centrally.
Tim Farron: To ask the Secretary of State for Health when the North West Ambulance Service expects to be able to provide at least one fully trained paramedic in addition to a driver on each ambulance serving the South Lakeland area. [175393]
Ann Keen: This information is not held centrally. However, the North West Ambulance Service Trust may be able to provide this information direct.
Ankylosing Spondylitis: Medical Treatments
Mr. Amess: To ask the Secretary of State for Health what processes the National Institute for Health and Clinical Excellence has in place to ensure that the issuing of final guidance on the two anti-TNF treatments for ankylosing spondylitis it has recommended is not affected by appeals relating to the one anti-TNF treatment in that class that was rejected; and if he will make a statement. [174062]
Dawn Primarolo: The National Institute for Health and Clinical Excellence (NICE) will not publish final guidance on adalimumab, etanercept and infliximab for the treatment of ankylosing spondylitis until any appeals it has received have been heard. The closing date for appeals was 23 November and no appeals have yet been announced.
Funding for licensed treatments should not be withheld because guidance from NICE is unavailable. In December 2006, we issued refreshed good practice guidance which asks national health service bodies to continue with local arrangements for the managed introduction of new technologies where guidance from NICE is not available at the time the treatment or technology first becomes available.
Arthritis
Mr. Stephen O'Brien: To ask the Secretary of State for Health how many finished episodes of care there were for patients with a (a) primary diagnosis and (b) secondary diagnosis of rheumatoid arthritis in each year since 1997-98. [172909]
Ann Keen: The total finished consultant episodes for patient with a primary and secondary diagnosis of rheumatoid arthritis are given in the following table.
| Total finished consultant episodes for primary diagnosis of Rheumatoid Arthritis( 1) | Total finished consultant episodes for primary and secondary diagnosis of Rheumatoid Arthritis( 1) | |
| Source: Hospital Episode Statistics, The Information Centre for health and social care | ||
Biotechnology
Dr. Desmond Turner: To ask the Secretary of State for Health (1) what discussions he has had with the Joint Formulary Committee on biotechnology medicines with respect to biosimilars; [173113]
(2) what assessment he has made of the potential risk to human health from adverse drug reactions arising from the interchange of innovator biological medicines with biosimilar medicines; [173114]
(3) if he will recommend that the British National Formulary designate biotechnology medicines as caution advised until research data demonstrate that they pose no risk to human health; [173115]
(4) if he will direct the Medicines and Healthcare Products Regulatory Agency to require biosimilar medicines to carry a warning symbol until research demonstrate that they pose no risk to human health; [173116]
(5) what guidance is issued to (a) clinicians and (b) pharmacists on (i) the potential substitution risks associated with switching from innovator biological medicines to biosimilar medicines and (ii) the role of clinician choice in the prescription and dispensing of innovator biological medicines and biosimilar medicines; [173117]
(6) if he will take steps to ensure that biopharmaceutical products are prescribed uniquely by brand name rather than by international nonproprietary name; [173118]
(7) what measures are in place to ensure it is clear which adverse drug reaction arises as a result of the administration of which biopharmaceutical product. [173119]
Dawn Primarolo:
An article will be published in a forthcoming issue of the Medicines and Healthcare products Regulatory Agency (MHRA) bulletin Drug Safety Update in early January, which will remind
prescribers that it is important to assign adverse drug reactions to a specific named product when reporting adverse reactions associated with biosimilar medicines. The European guidelines for marketing authorisation holders—Volume 9A of “The Rules Governing Medicinal Products in the European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use” is currently being updated to include the following text in relation to reporting of adverse reactions to biosimilar products:
“For adverse reaction reports relating to biological products, the definite identification of the product with regard to its manufacturing is of particular importance. Therefore, Marketing Authorisation Holders should give advice to reporters to provide the (invented) name of the medicinal product and the batch number and should follow up the reports where this information is missing for completion.”
A similar biological medicinal product (biosimilar) is one that is claimed to be similar to a reference biological medicinal product authorised in the European Union (EU). Because biosimilar medicines are not identical copies of reference products, subtle differences may exist which may make a difference to their effect or side effects when taken by patients. It is preferable, therefore, that when such products are prescribed they should be clearly identified and prescribed by brand name to ensure that patients receive the exact product prescribed and that their safety in use can be properly monitored.
The MHRA encourages companies who manufacture generic copies of biopharmaceutical products (known as “biosimilar products”) to give them a brand name so that there is no possibility that the pharmacist can substitute another biosimilar product when dispensing the doctor's prescription.
MHRA has not issued a specific guideline to clinicians on substitution. All medicines, including biological medicines, should be prescribed by clinicians in accordance with the approved advice provided in the Summary of Product Characteristics which provides full information about the product, including its side effects and its use.
The Royal Pharmaceutical Society of Great Britain's Professional standards and guidance for the sale and supply of medicines provides advice to pharmacists on switching from innovator biological medicines to biosimilar medicines and states that, except in an emergency, a specifically named product should not be substituted by any other product without the approval of the patient or carer and the prescriber, and in the case of hospital drugs, the approval of the therapeutics committee, or in line with other similar locally agreed protocols.
All new medicines carry a black triangle symbol when they are first marketed in the United Kingdom. This denotes that the product is under intensive surveillance and this period usually lasts for two years in the first instance. All biosimilar products should also have in place at the time of licensing a full Risk Management Plan which describes what is known about the safety of a product and describes the activities required on behalf of the company to ensure that relevant safety information is collected in the post marketing period.
The British National Formulary (BNF) includes biotechnology medicines that are licensed in the UK. The BNF usually reflects the safety information contained
within the Summary of Product Characteristics (SPC) that relates to the product. Biosimilar products will be designated “Black Triangle” medicines and will carry the black triangle symbol in the BNF.
The information contained in the BNF about a product can be different from information in the SPC when it is supported by reliable clinical evidence. The BNF takes advice on the information to include from expert clinical advisers and the BNF Joint Formulary Committee.
All biosimilar products are assessed for safety, and the safety data are compared with that of the innovator biological medicinal product to which similarity is claimed, prior to its authorisation. It is also mandatory for the applicant to submit an appropriate risk management plan at the time of initial marketing authorisation application, which is assessed to ensure that it demonstrates that adequate arrangements are made for continued safety evaluation.
Breast Cancer: Humberside
David Davis: To ask the Secretary of State for Health for what reasons breast screening waiting times in the Humberside breast screening area are beyond the three year target; and what plans there are to bring such waiting times within the target. [173439]
Ann Keen: The Yorkshire and the Humber Strategic Health Authority (SHA) reports that in Humberside the age extension for breast screening, from 65 to 70 years, increased activity by over 30 per cent. As a result there has been an increase in the length of wait for breast screening locally.
The Hull and East Yorkshire Hospitals Trust in partnership with the East Riding of Yorkshire Primary Care Trust is putting in place a number of actions to help improve the current situation. Details of these can be found in the trust's press release which has been issued. A copy of this document has been placed in the Library.
We take the issue of the 36-month standard between screens very seriously. That is why Professor Mike Richards, the National Cancer Director, wrote to the chief executives of all ten SHAs in England on 9 February 2007 highlighting the importance of maintaining the 36-month interval.
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